Trial Outcomes & Findings for A Phase III Study of Abatacept (BMS-188667) in Patients With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate (NCT NCT00048568)
NCT ID: NCT00048568
Last Updated: 2011-12-05
Results Overview
ACR 20 response requires a patient to have a 20% reduction in the number of swollen and tender joints, and a reduction of 20% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in Health Assessment Questionnaire (HAQ) score. A participant achieved a sustained ACR 20 response if the participant had ACR 20 observed for at least 2 consecutive study visits.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1250 participants
Primary outcome timeframe
Day 169
Results posted on
2011-12-05
Participant Flow
Participants in this evaluation were enrolled 116 sites worldwide: 31 sites in the United States; 32 sites in Europe, 13 sites in Canada; 4 sites in Australia; 7 sites in Argentina; 7 sites in Brazil; 7 sites in Mexico; 3 sites in Peru; 5 sites in South Africa; 3 sites in Taiwan; and 4 sites in Turkey.
Of 1250 participants enrolled, 594 participants were not randomized (519 no longer met study criteria, 37 for unknown reasons, 33 withdrew consent, 3 lost to follow-up, 1 administrative reason by sponsor, and 1 adverse event). Four participants (2 per group) were randomized but never treated; 2 no longer met study criteria and 2 withdrew consent.
Participant milestones
| Measure |
Abatacept (ABA) + Methotrexate (MTX) DB
Abatacept was dosed intravenously by weight with participants weighing \< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of (10-30 mg/wk), although doses of \< 10 mg/wk were acceptable if due to toxicity.
|
MTX + Placebo DB
Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of (10-30 mg/wk), although doses of \< 10 mg/wk were acceptable if due to toxicity. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
|
ABA + MTX [Open-label (OL)]
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|---|
|
Double-Blind Period Days 1 to 169
STARTED
|
433
|
219
|
0
|
|
Double-Blind Period Days 1 to 169
COMPLETED
|
401
|
174
|
0
|
|
Double-Blind Period Days 1 to 169
NOT COMPLETED
|
32
|
45
|
0
|
|
Double-Blind Period Days 170 to 365
STARTED
|
401
|
174
|
0
|
|
Double-Blind Period Days 170 to 365
COMPLETED
|
385
|
162
|
0
|
|
Double-Blind Period Days 170 to 365
NOT COMPLETED
|
16
|
12
|
0
|
|
Open-Label Period
STARTED
|
0
|
0
|
539
|
|
Open-Label Period
COMPLETED
|
0
|
0
|
379
|
|
Open-Label Period
NOT COMPLETED
|
0
|
0
|
160
|
Reasons for withdrawal
| Measure |
Abatacept (ABA) + Methotrexate (MTX) DB
Abatacept was dosed intravenously by weight with participants weighing \< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of (10-30 mg/wk), although doses of \< 10 mg/wk were acceptable if due to toxicity.
|
MTX + Placebo DB
Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of (10-30 mg/wk), although doses of \< 10 mg/wk were acceptable if due to toxicity. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
|
ABA + MTX [Open-label (OL)]
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|---|
|
Double-Blind Period Days 1 to 169
Adverse Event
|
11
|
3
|
0
|
|
Double-Blind Period Days 1 to 169
Lack of Efficacy
|
11
|
33
|
0
|
|
Double-Blind Period Days 1 to 169
Lost to Follow-up
|
1
|
1
|
0
|
|
Double-Blind Period Days 1 to 169
Withdrawal by Subject
|
7
|
4
|
0
|
|
Double-Blind Period Days 1 to 169
Unknown Reasons
|
2
|
4
|
0
|
|
Double-Blind Period Days 170 to 365
Death
|
1
|
1
|
0
|
|
Double-Blind Period Days 170 to 365
Adverse Event
|
7
|
1
|
0
|
|
Double-Blind Period Days 170 to 365
Lack of Efficacy
|
2
|
7
|
0
|
|
Double-Blind Period Days 170 to 365
Withdrawal by Subject
|
3
|
1
|
0
|
|
Double-Blind Period Days 170 to 365
Poor/Non-Compliance
|
0
|
1
|
0
|
|
Double-Blind Period Days 170 to 365
Pregnancy
|
2
|
0
|
0
|
|
Double-Blind Period Days 170 to 365
No Longer Met Study Criteria
|
1
|
1
|
0
|
|
Open-Label Period
Death
|
0
|
0
|
13
|
|
Open-Label Period
Adverse Event
|
0
|
0
|
49
|
|
Open-Label Period
Lack of Efficacy
|
0
|
0
|
32
|
|
Open-Label Period
Withdrawal by Subject
|
0
|
0
|
26
|
|
Open-Label Period
Pregnancy
|
0
|
0
|
5
|
|
Open-Label Period
No Longer Met Study Criteria
|
0
|
0
|
2
|
|
Open-Label Period
Administrative Decision By Sponsor
|
0
|
0
|
1
|
|
Open-Label Period
Unknown Reasons
|
0
|
0
|
25
|
|
Open-Label Period
Lost to Follow-up
|
0
|
0
|
7
|
Baseline Characteristics
A Phase III Study of Abatacept (BMS-188667) in Patients With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate
Baseline characteristics by cohort
| Measure |
ABA + MTX DB
n=433 Participants
Abatacept was dosed by weight with participants weighing \< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of (10-30 mg/wk), although doses of \< 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
|
MTX + Placebo DB
n=219 Participants
Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of (10-30 mg/wk), although doses of \< 10 mg/wk were acceptable if due to toxicity. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
|
Total
n=652 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
51.5 years
STANDARD_DEVIATION 12.9 • n=5 Participants
|
50.4 years
STANDARD_DEVIATION 12.4 • n=7 Participants
|
51.1 years
STANDARD_DEVIATION 12.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
96 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
136 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
337 Participants
n=5 Participants
|
179 Participants
n=7 Participants
|
516 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
18 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
379 Participants
n=5 Participants
|
193 Participants
n=7 Participants
|
572 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
23 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Duration of Rheumatoid Arthritis (RA) Disease
<= 2 years
|
99 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
144 Participants
n=5 Participants
|
|
Duration of Rheumatoid Arthritis (RA) Disease
> 2 years to <= 5 years
|
93 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
139 Participants
n=5 Participants
|
|
Duration of Rheumatoid Arthritis (RA) Disease
> 5 years to <=10 years
|
106 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
160 Participants
n=5 Participants
|
|
Duration of Rheumatoid Arthritis (RA) Disease
> 10 years
|
135 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
209 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 169Population: Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis.
ACR 20 response requires a patient to have a 20% reduction in the number of swollen and tender joints, and a reduction of 20% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in Health Assessment Questionnaire (HAQ) score. A participant achieved a sustained ACR 20 response if the participant had ACR 20 observed for at least 2 consecutive study visits.
Outcome measures
| Measure |
ABA + MTX DB
n=424 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=214 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Number of American College of Rheumatology 20 (ACR 20) Responders at Day 169
|
288 Participants
|
85 Participants
|
PRIMARY outcome
Timeframe: Day 365Population: Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis.
The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.
Outcome measures
| Measure |
ABA + MTX DB
n=424 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=214 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Number of Participants Achieving Clinically Meaningful Improvement in Health Assessment Questionnaire (HAQ) at Day 365
|
270 Participants
|
84 Participants
|
PRIMARY outcome
Timeframe: BL (Day 0), Day 365Population: All randomized and treated participants in the DB period with radiographic data available at baseline and Day 365. Due to the compliance issues of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis.
To assess joint damage progression, the Genant-modified Sharp scoring method was used to evaluate radiographs of hands/wrists and feet for erosions. The erosion score range is 0 (no radiographic damage) to 145 (worst possible radiographic damage). Change from baseline = Post-baseline - Baseline value
Outcome measures
| Measure |
ABA + MTX DB
n=391 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=195 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Baseline and Mean Change From Baseline (BL) in Radiographic Erosion Score Results at Day 365
BL
|
21.68 Units on a Scale
Standard Deviation 18.07
|
21.83 Units on a Scale
Standard Deviation 18.63
|
|
Baseline and Mean Change From Baseline (BL) in Radiographic Erosion Score Results at Day 365
Mean Change From BL
|
0.63 Units on a Scale
Standard Deviation 1.77 • Interval 0.0 to 1.02
|
1.14 Units on a Scale
Standard Deviation 2.81 • Interval 0.0 to 1.27
|
PRIMARY outcome
Timeframe: Day 365 to Day 2,185Population: All treated participants in the OL period.
AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE was defined as any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.
Outcome measures
| Measure |
ABA + MTX DB
n=539 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Participants With Deaths, Adverse Events (AEs) and SAEs in the Open-Label (OL) Period
Deaths
|
17 Participants
|
—
|
|
Participants With Deaths, Adverse Events (AEs) and SAEs in the Open-Label (OL) Period
SAEs
|
215 Participants
|
—
|
|
Participants With Deaths, Adverse Events (AEs) and SAEs in the Open-Label (OL) Period
Related SAEs
|
60 Participants
|
—
|
|
Participants With Deaths, Adverse Events (AEs) and SAEs in the Open-Label (OL) Period
Discontinuations Due to SAEs
|
36 Participants
|
—
|
|
Participants With Deaths, Adverse Events (AEs) and SAEs in the Open-Label (OL) Period
AEs
|
518 Participants
|
—
|
|
Participants With Deaths, Adverse Events (AEs) and SAEs in the Open-Label (OL) Period
Related AEs
|
323 Participants
|
—
|
|
Participants With Deaths, Adverse Events (AEs) and SAEs in the Open-Label (OL) Period
Discontinued Due to AEs
|
49 Participants
|
—
|
PRIMARY outcome
Timeframe: Day 365 to Day 2,185Population: All treated participants in the OL period.
Marked abnormality criteria are: Hemoglobin (HGB): \>3 g/dL decrease from BL; Hematocrit: \<0.75 \* BL; Erythrocytes: \<0.75 \* BL; Platelets (PLT): \<0.67 \* LLN/\>1.5 \* ULN, or if BL \< LLN then use \<0.5 \* BL and \<100,000 mm\^3; Leukocytes: \<0.75 \* LLN/ \>1.25 \* ULN, or if BL\<LLN then use \<0.8 \* BL or \>ULN, or if BL\>ULN then use \>1.2 \* BL or \<LLN; neutrophils+bands: \<1.0 \* 10\^3 c/uL; eosinophils: \>0.750 \* 10\^3 c/uL; basophils: \> 400 mm\^3; monocytes: \>2000 mm\^3; lymphocytes: \<0.750 \* 10\^3 c/uL/ \>7.50 \* 10\^3 c/uL.
Outcome measures
| Measure |
ABA + MTX DB
n=536 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Participants With Hematology Values Meeting the Marked Abnormality Criteria in the OL Period
Low Hemoglobin (LLN 11.5 g/dL)
|
21 Participants
|
—
|
|
Participants With Hematology Values Meeting the Marked Abnormality Criteria in the OL Period
Low Hematocrit (LLN 34%)
|
20 Participants
|
—
|
|
Participants With Hematology Values Meeting the Marked Abnormality Criteria in the OL Period
Low Erythrocytes (LLN 38 x 10^6 c/µL)
|
15 Participants
|
—
|
|
Participants With Hematology Values Meeting the Marked Abnormality Criteria in the OL Period
Low Platelet Count (LLN 140 x 10^3 c/µL)
|
9 Participants
|
—
|
|
Participants With Hematology Values Meeting the Marked Abnormality Criteria in the OL Period
High Platelet Count (ULN 415 x 10^3 c/µL)
|
4 Participants
|
—
|
|
Participants With Hematology Values Meeting the Marked Abnormality Criteria in the OL Period
Low Leukocytes (LLN 4 x 10^3 c/µL)
|
53 Participants
|
—
|
|
Participants With Hematology Values Meeting the Marked Abnormality Criteria in the OL Period
High Leukocytes (ULN 10.5 x 10^3 c/µL)
|
68 Participants
|
—
|
|
Participants With Hematology Values Meeting the Marked Abnormality Criteria in the OL Period
Low Absolute Neutrophils (LLN 1.8 x 10^3 c/µL)
|
14 Participants
|
—
|
|
Participants With Hematology Values Meeting the Marked Abnormality Criteria in the OL Period
Low Absolute Lymphocytes (LLN 0.7 x 10^3 c/µL)
|
109 Participants
|
—
|
|
Participants With Hematology Values Meeting the Marked Abnormality Criteria in the OL Period
High Absolute Lymphocytes (ULN 4.5 x 10^3 c/µL)
|
4 Participants
|
—
|
|
Participants With Hematology Values Meeting the Marked Abnormality Criteria in the OL Period
High Absolute Monocytes (ULN 1.0 x 10^3 c/µL)
|
9 Participants
|
—
|
|
Participants With Hematology Values Meeting the Marked Abnormality Criteria in the OL Period
High Absolute Basophils (ULN 0.2 x 10^3 c/µL)
|
3 Participants
|
—
|
|
Participants With Hematology Values Meeting the Marked Abnormality Criteria in the OL Period
High Absolute Eosinophils (ULN 0.4 x 10^3 c/µL)
|
49 Participants
|
—
|
PRIMARY outcome
Timeframe: Day 365 to Day 2,185Population: All treated participants in the OL period.
Marked abnormality criteria are: Hemoglobin (HGB): \>3 g/dL decrease from BL; Hematocrit: \<0.75 \* BL; Erythrocytes: \<0.75 \* BL; Platelets (PLT): \<0.67 \* LLN/\>1.5 \* ULN, or if BL \< LLN then use \<0.5 \* BL and \<100,000 mm\^3; Leukocytes: \<0.75 \* LLN/ \>1.25 \* ULN, or if BL\<LLN then use \<0.8 \* BL or \>ULN, or if BL\>ULN then use \>1.2 \* BL or \<LLN; neutrophils+bands: \<1.0 \* 10\^3 c/uL; eosinophils: \>0.750 \* 10\^3 c/uL; basophils: \> 400 mm\^3; monocytes: \>2000 mm\^3; lymphocytes: \<0.750 \* 10\^3 c/uL/ \>7.50 \* 10\^3 c/uL.
Outcome measures
| Measure |
ABA + MTX DB
n=536 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Participants With Liver and Kidney Function Values Meeting the Marked Abnormality Criteria in the OL Period
High ALP (ULN 150 U/L)
|
3 Participants
|
—
|
|
Participants With Liver and Kidney Function Values Meeting the Marked Abnormality Criteria in the OL Period
High AST (ULN 40 U/L)
|
14 Participants
|
—
|
|
Participants With Liver and Kidney Function Values Meeting the Marked Abnormality Criteria in the OL Period
High ALT (ULN 55 U/L)
|
20 Participants
|
—
|
|
Participants With Liver and Kidney Function Values Meeting the Marked Abnormality Criteria in the OL Period
High GGT (ULN 65 U/L)
|
36 Participants
|
—
|
|
Participants With Liver and Kidney Function Values Meeting the Marked Abnormality Criteria in the OL Period
High Bilirubin (ULN 1.2 mg/dL)
|
6 Participants
|
—
|
|
Participants With Liver and Kidney Function Values Meeting the Marked Abnormality Criteria in the OL Period
High BUN (ULN 26 mg/dL)
|
40 Participants
|
—
|
|
Participants With Liver and Kidney Function Values Meeting the Marked Abnormality Criteria in the OL Period
High Creatinine (ULN 1.5 mg/dL)
|
92 Participants
|
—
|
PRIMARY outcome
Timeframe: Day 365 to Day 2,185Population: All treated participants in the OL period.
Sodium \< 0.9 \* LLN or \> 1.05 \* ULN or if BL \< LLN then use \< 0.95 \* BL or \> ULN or if BL \> ULN then use \>1.05 \*BL or \< LLN; Potassium: \< 0.9 \* LLN or \> 1.1 \* ULN or if BL \< LLN then use \< 0.9 \* BL or \> ULN or if BL \> ULN then use 1.1 \* BL or \< LLN; Chloride: \< 0.9 \* LLN or \> 1.1 \* ULN or if BL \< LLN then use \<0.9 \* BL or \>ULN or if BL \> ULN then use \> 1.1 \* BL or \< LLN; Calcium \<0.8 \* LLN or \> 1.2 \* ULN or if BL \< LLN then use \<0.67 \* BL or \> ULN or if BL \> ULN then use \> 1.3 \* BL or \< LLN.
Outcome measures
| Measure |
ABA + MTX DB
n=536 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Participants With Electrolyte Values Meeting the Marked Abnormality Criteria in the OL Period
Low Sodium (LLN 135 mmol/L)
|
11 Participants
|
—
|
|
Participants With Electrolyte Values Meeting the Marked Abnormality Criteria in the OL Period
High Sodium (ULN 148 mmol/L)
|
2 Participants
|
—
|
|
Participants With Electrolyte Values Meeting the Marked Abnormality Criteria in the OL Period
Low Potassium (LLN 3.5 mmol/L)
|
11 Participants
|
—
|
|
Participants With Electrolyte Values Meeting the Marked Abnormality Criteria in the OL Period
High Potassium (ULN 5.5 mmol/L)
|
32 Participants
|
—
|
|
Participants With Electrolyte Values Meeting the Marked Abnormality Criteria in the OL Period
Low Chloride (LLN 96 mmol/L)
|
1 Participants
|
—
|
|
Participants With Electrolyte Values Meeting the Marked Abnormality Criteria in the OL Period
High Chloride (ULN 109 mmol/L)
|
0 Participants
|
—
|
|
Participants With Electrolyte Values Meeting the Marked Abnormality Criteria in the OL Period
Low Calcium (LLN 8.5 mg/dL)
|
0 Participants
|
—
|
|
Participants With Electrolyte Values Meeting the Marked Abnormality Criteria in the OL Period
High Calcium (ULN 10.6 mg/dL)
|
1 Participants
|
—
|
|
Participants With Electrolyte Values Meeting the Marked Abnormality Criteria in the OL Period
Low Phosphorous (LLN 2.5 mg/dL)
|
16 Participants
|
—
|
|
Participants With Electrolyte Values Meeting the Marked Abnormality Criteria in the OL Period
High Phosphorous (ULN 5.6 mg/dL)
|
8 Participants
|
—
|
PRIMARY outcome
Timeframe: Day 365 to Day 2,185Population: All treated participants in the OL period.
Glucose: \< 65 mg/dL or \> 220 mg/dL; Fasting Glucose: \<0.8 \* LLN or \> 1.5 \* ULN or if BL \< LLN then use \< 0.8 \* BL or \> ULN or if BL \> ULN then use 1.1 \* BL or \< LLN; Total protein: \< 0.9 \* LLN or 1.1 \* ULN or if BL \< LLN then use 0.9 \* BL or \> ULN or if BL \> ULN then use 1.1 \* BL or \< LLN; Albumin: \< 0.9 \* LLN or if BL \< LLN then use 0.75 \* BL; Uric acid: \> 1.5 \* ULN or if BL \> ULN then use \> 2.0 \* BL. All urinalysis abnormalities were defined as: if missing BL then use \>= 2 or if value \>=4, or if BL = 0 or 0.5 then use \>= 2, or if BL = 1.0 then use \>= 3, or if BL = 2.0 then use \>=4.
Outcome measures
| Measure |
ABA + MTX DB
n=536 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Participants With Glucose, Protein, Metabolites, and Urinalysis Values Meeting the Marked Abnormality Criteria in the OL Period
High Urine Blood (ULN >=0)
|
141 Participants
|
—
|
|
Participants With Glucose, Protein, Metabolites, and Urinalysis Values Meeting the Marked Abnormality Criteria in the OL Period
Low Serum Glucose (LLN 64 mg/dL)
|
120 Participants
|
—
|
|
Participants With Glucose, Protein, Metabolites, and Urinalysis Values Meeting the Marked Abnormality Criteria in the OL Period
High Serum Glucose (ULN 140 mg/dL)
|
36 Participants
|
—
|
|
Participants With Glucose, Protein, Metabolites, and Urinalysis Values Meeting the Marked Abnormality Criteria in the OL Period
Low Serum Fasting Glucose (LLN 65 mg/dL)
|
25 Participants
|
—
|
|
Participants With Glucose, Protein, Metabolites, and Urinalysis Values Meeting the Marked Abnormality Criteria in the OL Period
High Serum Fasting Glucose (ULN 109 mg/dL)
|
22 Participants
|
—
|
|
Participants With Glucose, Protein, Metabolites, and Urinalysis Values Meeting the Marked Abnormality Criteria in the OL Period
Low Total Protein (LLN 6 g/dL)
|
11 Participants
|
—
|
|
Participants With Glucose, Protein, Metabolites, and Urinalysis Values Meeting the Marked Abnormality Criteria in the OL Period
High Total Protein (ULN 8.5 g/dL)
|
6 Participants
|
—
|
|
Participants With Glucose, Protein, Metabolites, and Urinalysis Values Meeting the Marked Abnormality Criteria in the OL Period
Low Albumin (LLN 3.5 g/dL)
|
15 Participants
|
—
|
|
Participants With Glucose, Protein, Metabolites, and Urinalysis Values Meeting the Marked Abnormality Criteria in the OL Period
High Uric Acid (ULN 8.7 mg/dL)
|
4 Participants
|
—
|
|
Participants With Glucose, Protein, Metabolites, and Urinalysis Values Meeting the Marked Abnormality Criteria in the OL Period
High Urine Protein (ULN Trace)
|
39 Participants
|
—
|
|
Participants With Glucose, Protein, Metabolites, and Urinalysis Values Meeting the Marked Abnormality Criteria in the OL Period
High Urine Glucose (ULN Trace)
|
39 Participants
|
—
|
|
Participants With Glucose, Protein, Metabolites, and Urinalysis Values Meeting the Marked Abnormality Criteria in the OL Period
High Urine Ketones (ULN Positive)
|
1 Participants
|
—
|
|
Participants With Glucose, Protein, Metabolites, and Urinalysis Values Meeting the Marked Abnormality Criteria in the OL Period
High Urine Leukocyte Esterase (ULN >=0)
|
35 Participants
|
—
|
|
Participants With Glucose, Protein, Metabolites, and Urinalysis Values Meeting the Marked Abnormality Criteria in the OL Period
High Urine White Blood Count (ULN 12 hpf)
|
232 Participants
|
—
|
|
Participants With Glucose, Protein, Metabolites, and Urinalysis Values Meeting the Marked Abnormality Criteria in the OL Period
High Urine Red Blood Count (ULN 8 hpf)
|
181 Participants
|
—
|
PRIMARY outcome
Timeframe: BL (Day 0), Day 365, Day 729, Day 1,093Population: All treated participants in the OL period (treatment groups represent treatment received in the double-blind period).
Mean baseline values are those that are reported for each cohort at each time point on Day 365, Day 729, and Day 1,093.
Outcome measures
| Measure |
ABA + MTX DB
n=378 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=161 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Mean BL Immunoglobulins Over Time in the OL Period
Immunoglobulin A (IgA) Day 365
|
327.0 mg / mL
Standard Deviation 135.2
|
319.2 mg / mL
Standard Deviation 145.1
|
|
Mean BL Immunoglobulins Over Time in the OL Period
Immunoglobulin G (IgG) Day 365
|
1278 mg / mL
Standard Deviation 412.4
|
1317 mg / mL
Standard Deviation 425.4
|
|
Mean BL Immunoglobulins Over Time in the OL Period
Immunoglobulin M (IgM) Day 365
|
145.1 mg / mL
Standard Deviation 86.72
|
154.3 mg / mL
Standard Deviation 85.53
|
|
Mean BL Immunoglobulins Over Time in the OL Period
IgA Day 729
|
328.0 mg / mL
Standard Deviation 133.8
|
317.0 mg / mL
Standard Deviation 145.0
|
|
Mean BL Immunoglobulins Over Time in the OL Period
IgG Day 729
|
1280 mg / mL
Standard Deviation 410.4
|
1315 mg / mL
Standard Deviation 425.3
|
|
Mean BL Immunoglobulins Over Time in the OL Period
IgM Day 729
|
146.2 mg / mL
Standard Deviation 87.34
|
153.1 mg / mL
Standard Deviation 85.80
|
|
Mean BL Immunoglobulins Over Time in the OL Period
IgA Day 1,093
|
321.8 mg / mL
Standard Deviation 133.4
|
318.5 mg / mL
Standard Deviation 145.7
|
|
Mean BL Immunoglobulins Over Time in the OL Period
IgG Day 1,093
|
1273 mg / mL
Standard Deviation 392.3
|
1319 mg / mL
Standard Deviation 436.8
|
|
Mean BL Immunoglobulins Over Time in the OL Period
IgM Day 1,093
|
148.6 mg / mL
Standard Deviation 91.01
|
153.5 mg / mL
Standard Deviation 88.82
|
PRIMARY outcome
Timeframe: BL (Day 0), Day 365, Day 729, Day 1,093Population: All treated participants in the OL period (treatment groups represent treatment received in the double-blind period).
Outcome measures
| Measure |
ABA + MTX DB
n=378 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=161 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Mean Change From BL in Immunoglobulins in the OL Period
IgA Day 365
|
-47.8 mg / mL
Standard Error 3.16
|
-8.30 mg / mL
Standard Error 6.41
|
|
Mean Change From BL in Immunoglobulins in the OL Period
IgG Day 365
|
-212 mg / mL
Standard Error 12.77
|
-52.7 mg / mL
Standard Error 18.96
|
|
Mean Change From BL in Immunoglobulins in the OL Period
IgM Day 365
|
-5.05 mg / mL
Standard Error 1.98
|
6.95 mg / mL
Standard Error 9.73
|
|
Mean Change From BL in Immunoglobulins in the OL Period
IgA Day 729
|
-38.6 mg / mL
Standard Error 4.24
|
-26.6 mg / mL
Standard Error 9.95
|
|
Mean Change From BL in Immunoglobulins in the OL Period
IgG Day 729
|
-215 mg / mL
Standard Error 14.10
|
-206 mg / mL
Standard Error 21.86
|
|
Mean Change From BL in Immunoglobulins in the OL Period
IgM Day 729
|
8.04 mg / mL
Standard Error 3.96
|
6.49 mg / mL
Standard Error 5.76
|
|
Mean Change From BL in Immunoglobulins in the OL Period
IgA Day 1,093
|
-46.8 mg / mL
Standard Error 4.76
|
-37.9 mg / mL
Standard Error 9.66
|
|
Mean Change From BL in Immunoglobulins in the OL Period
IgG Day 1,093
|
-236 mg / mL
Standard Error 15.94
|
-245 mg / mL
Standard Error 25.44
|
|
Mean Change From BL in Immunoglobulins in the OL Period
IgM Day 1,093
|
4.38 mg / mL
Standard Error 3.19
|
6.01 mg / mL
Standard Error 5.01
|
PRIMARY outcome
Timeframe: Day 1 to Day 1,821Population: Participants with serum samples available for evaluation of titers to abatacept.
Participants with titers to abatacept in the DB and OL periods. Serum samples from abatacept-treated adult participants with active Rheumatoid Arthritis (RA) were screened for the presence of drug-specific antibodies using two validated direct-format enzyme-linked immunosorbent assays (ELISAs) to determine the presence of antibodies to abatacept and or CTLA4-T.
Outcome measures
| Measure |
ABA + MTX DB
n=586 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Participants With Immunogenicity to Abatacept in the Cumulative DB + OL Period
|
56 Participants
|
—
|
PRIMARY outcome
Timeframe: Day 365 to Day 1,821. All changes in participant vital signs were monitored on each day of study drug administration prior to dosing and 60 minutes after dosing.Population: All treated participants entering the OL period.
Vital signs included body temperature, heart rate, and seated blood pressure. Clinically significant changes were defined as those that were not within the normal range for the participant.
Outcome measures
| Measure |
ABA + MTX DB
n=529 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Number of Participants Experiencing Clinically Significant Changes in Vital Signs in the OL Period
Body Temperature
|
0 Participants
|
—
|
|
Number of Participants Experiencing Clinically Significant Changes in Vital Signs in the OL Period
Heart Rate
|
0 Participants
|
—
|
|
Number of Participants Experiencing Clinically Significant Changes in Vital Signs in the OL Period
Blood Pressure
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: Day 365 to Day 2,185Population: All treated participants in the OL period.
AEs were defined as any new untoward medical occurrence or worsening of a pre- existing medical condition which does not necessarily have a causal relationship with this treatment. AEs of special interest have been identified to be those which may be associated with the use of immunomodulatory agents or infusion of therapeutic proteins. Acute infusional AEs were defined as those that occurred within 1 hour after the start of the infusion.
Outcome measures
| Measure |
ABA + MTX DB
n=529 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Number of Participants Experiencing AEs of Special Interest in the OL Period
Infections/Infestations
|
452 Participants
|
—
|
|
Number of Participants Experiencing AEs of Special Interest in the OL Period
Neoplasms
|
71 Participants
|
—
|
|
Number of Participants Experiencing AEs of Special Interest in the OL Period
Autoimmune Disorders
|
52 Participants
|
—
|
|
Number of Participants Experiencing AEs of Special Interest in the OL Period
Acute Infusional AEs
|
30 Participants
|
—
|
|
Number of Participants Experiencing AEs of Special Interest in the OL Period
Peri-Infusional AEs
|
86 Participants
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185Population: All treated participants in the OL period (treatment groups represent treatment received in the double-blind period). N = number of participants analyzed and n = the number of participants with measurements for that time point.
Mean baseline values are those that are reported for each cohort at each time point on Day 365 to Day 2,185.
Outcome measures
| Measure |
ABA + MTX DB
n=378 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=161 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Mean BL Hematocrit in the OL Period
Day 365 (n=365, 157)
|
38.79 Percentage of Red Blood Cells
Standard Deviation 4.60
|
39.38 Percentage of Red Blood Cells
Standard Deviation 4.32
|
|
Mean BL Hematocrit in the OL Period
Day 729 (n=328, 143)
|
38.72 Percentage of Red Blood Cells
Standard Deviation 4.52
|
39.39 Percentage of Red Blood Cells
Standard Deviation 4.19
|
|
Mean BL Hematocrit in the OL Period
Day 1,093 (n=312, 138)
|
38.69 Percentage of Red Blood Cells
Standard Deviation 4.57
|
39.46 Percentage of Red Blood Cells
Standard Deviation 4.33
|
|
Mean BL Hematocrit in the OL Period
Day 1,457 (n=292, 130)
|
38.59 Percentage of Red Blood Cells
Standard Deviation 4.48
|
39.40 Percentage of Red Blood Cells
Standard Deviation 4.27
|
|
Mean BL Hematocrit in the OL Period
Day 1,821 (n=262,124)
|
38.70 Percentage of Red Blood Cells
Standard Deviation 4.44
|
39.48 Percentage of Red Blood Cells
Standard Deviation 4.43
|
|
Mean BL Hematocrit in the OL Period
Day 1,905 (n=134, 68)
|
38.11 Percentage of Red Blood Cells
Standard Deviation 4.56
|
39.83 Percentage of Red Blood Cells
Standard Deviation 3.90
|
|
Mean BL Hematocrit in the OL Period
Day 1,989 (n=121,56)
|
38.07 Percentage of Red Blood Cells
Standard Deviation 4.78
|
39.99 Percentage of Red Blood Cells
Standard Deviation 4.12
|
|
Mean BL Hematocrit in the OL Period
Day 2,073 (n=81,38)
|
37.11 Percentage of Red Blood Cells
Standard Deviation 3.92
|
39.12 Percentage of Red Blood Cells
Standard Deviation 3.45
|
|
Mean BL Hematocrit in the OL Period
Day 2,185 (n=82,37)
|
37.25 Percentage of Red Blood Cells
Standard Deviation 3.83
|
39.02 Percentage of Red Blood Cells
Standard Deviation 3.45
|
PRIMARY outcome
Timeframe: BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185Population: All treated participants in the OL period (treatment groups represent treatment received in the double-blind period).N = number of participants analyzed and n = the number of participants with measurements for that time point.
All changes in participant laboratory parameters were monitored on each day of study drug administration.
Outcome measures
| Measure |
ABA + MTX DB
n=378 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=161 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Mean Change From BL in Participant Hematocrit in the OL Period
Day 365 (n=365, 157)
|
1.87 Percentage Blood Volume Occupied by RBCs
Standard Error 0.21
|
-0.04 Percentage Blood Volume Occupied by RBCs
Standard Error 0.24
|
|
Mean Change From BL in Participant Hematocrit in the OL Period
Day 729 (n=328, 143)
|
2.16 Percentage Blood Volume Occupied by RBCs
Standard Error 0.20
|
1.36 Percentage Blood Volume Occupied by RBCs
Standard Error 0.31
|
|
Mean Change From BL in Participant Hematocrit in the OL Period
Day 1,093 (n=312, 138)
|
1.41 Percentage Blood Volume Occupied by RBCs
Standard Error 0.20
|
0.56 Percentage Blood Volume Occupied by RBCs
Standard Error 0.35
|
|
Mean Change From BL in Participant Hematocrit in the OL Period
Day 1,457 (n=292, 130)
|
1.60 Percentage Blood Volume Occupied by RBCs
Standard Error 0.23
|
1.01 Percentage Blood Volume Occupied by RBCs
Standard Error 0.38
|
|
Mean Change From BL in Participant Hematocrit in the OL Period
Day 1,821 (n=262,124)
|
0.85 Percentage Blood Volume Occupied by RBCs
Standard Error 0.25
|
0.78 Percentage Blood Volume Occupied by RBCs
Standard Error 0.34
|
|
Mean Change From BL in Participant Hematocrit in the OL Period
Day 1,905 (n=134, 68)
|
1.63 Percentage Blood Volume Occupied by RBCs
Standard Error 0.34
|
0.59 Percentage Blood Volume Occupied by RBCs
Standard Error 0.48
|
|
Mean Change From BL in Participant Hematocrit in the OL Period
Day 1,989 (n=121,56)
|
1.42 Percentage Blood Volume Occupied by RBCs
Standard Error 0.38
|
0.94 Percentage Blood Volume Occupied by RBCs
Standard Error 0.49
|
|
Mean Change From BL in Participant Hematocrit in the OL Period
Day 2,073 (n=81,38)
|
1.79 Percentage Blood Volume Occupied by RBCs
Standard Error 0.42
|
0.20 Percentage Blood Volume Occupied by RBCs
Standard Error 0.62
|
|
Mean Change From BL in Participant Hematocrit in the OL Period
Day 2,185 (n=82,37)
|
1.42 Percentage Blood Volume Occupied by RBCs
Standard Error 0.37
|
0.65 Percentage Blood Volume Occupied by RBCs
Standard Error 0.61
|
PRIMARY outcome
Timeframe: BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185Population: All treated participants in the OL period (treatment groups represent treatment received in the double-blind period).N = number of participants analyzed and n = the number of participants with measurements for that time point.
Mean baseline values are those that are reported for each cohort at each time point on Day 365 to Day 2,185.
Outcome measures
| Measure |
ABA + MTX DB
n=378 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=161 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Mean BL Platelet Count in the OL Period
Day 365 (n=365, 157)
|
352.7 10^9 c/L
Standard Deviation 108.5
|
339.2 10^9 c/L
Standard Deviation 97.92
|
|
Mean BL Platelet Count in the OL Period
Day 729 (n=328, 143)
|
351.8 10^9 c/L
Standard Deviation 110.4
|
334.2 10^9 c/L
Standard Deviation 91.41
|
|
Mean BL Platelet Count in the OL Period
Day 1,093 (n=312, 138)
|
351.7 10^9 c/L
Standard Deviation 107.9
|
334.8 10^9 c/L
Standard Deviation 96.35
|
|
Mean BL Platelet Count in the OL Period
Day 1,457 (n=292, 130)
|
352.7 10^9 c/L
Standard Deviation 106.4
|
335.0 10^9 c/L
Standard Deviation 98.59
|
|
Mean BL Platelet Count in the OL Period
Day 1,821 (n=262,124)
|
351.1 10^9 c/L
Standard Deviation 98.28
|
334.2 10^9 c/L
Standard Deviation 97.52
|
|
Mean BL Platelet Count in the OL Period
Day 1,905 (n=134, 68)
|
365.7 10^9 c/L
Standard Deviation 113.9
|
333.7 10^9 c/L
Standard Deviation 89.66
|
|
Mean BL Platelet Count in the OL Period
Day 1,989 (n=121,56)
|
366.1 10^9 c/L
Standard Deviation 115.3
|
326.6 10^9 c/L
Standard Deviation 86.82
|
|
Mean BL Platelet Count in the OL Period
Day 2,073 (n=81,38)
|
375.2 10^9 c/L
Standard Deviation 118.6
|
321.2 10^9 c/L
Standard Deviation 90.51
|
|
Mean BL Platelet Count in the OL Period
Day 2,185 (n=82,37)
|
380.4 10^9 c/L
Standard Deviation 119.7
|
320.3 10^9 c/L
Standard Deviation 91.59
|
PRIMARY outcome
Timeframe: BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185Population: All treated participants in the OL period (treatment groups represent treatment received in the double-blind period). N = number of participants analyzed and n = the number of participants with measurements for that time point.
All changes in participant laboratory parameters were monitored on each day of study drug administration.
Outcome measures
| Measure |
ABA + MTX DB
n=378 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=161 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Mean Change From BL in Participant Platelet Count in the OL Period
Day 365 (n=365, 157)
|
-66.9 10^9 c/L
Standard Error 4.29
|
-29.9 10^9 c/L
Standard Error 5.58
|
|
Mean Change From BL in Participant Platelet Count in the OL Period
Day 729 (n=328, 143)
|
-59.5 10^9 c/L
Standard Error 4.64
|
-45.4 10^9 c/L
Standard Error 6.64
|
|
Mean Change From BL in Participant Platelet Count in the OL Period
Day 1,093 (n=312, 138)
|
-53.5 10^9 c/L
Standard Error 5.10
|
-36.8 10^9 c/L
Standard Error 7.21
|
|
Mean Change From BL in Participant Platelet Count in the OL Period
Day 1,457 (n=292, 130)
|
-59.0 10^9 c/L
Standard Error 5.64
|
-48.7 10^9 c/L
Standard Error 7.40
|
|
Mean Change From BL in Participant Platelet Count in the OL Period
Day 1,821 (n=262,124)
|
-68.9 10^9 c/L
Standard Error 4.92
|
-59.2 10^9 c/L
Standard Error 7.38
|
|
Mean Change From BL in Participant Platelet Count in the OL Period
Day 1,905 (n=134, 68)
|
-55.1 10^9 c/L
Standard Error 14.57
|
-47.5 10^9 c/L
Standard Error 10.71
|
|
Mean Change From BL in Participant Platelet Count in the OL Period
Day 1,989 (n=121,56)
|
-63.7 10^9 c/L
Standard Error 8.33
|
-50.3 10^9 c/L
Standard Error 9.83
|
|
Mean Change From BL in Participant Platelet Count in the OL Period
Day 2,073 (n=81,38)
|
-69.6 10^9 c/L
Standard Error 10.64
|
-55.3 10^9 c/L
Standard Error 11.68
|
|
Mean Change From BL in Participant Platelet Count in the OL Period
Day 2,185 (n=82,37)
|
-80.5 10^9 c/L
Standard Error 10.68
|
-53.9 10^9 c/L
Standard Error 10.34
|
PRIMARY outcome
Timeframe: BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185Population: All treated participants in the OL period (treatment groups represent treatment received in the double-blind period). N = number of participants analyzed and n = the number of participants with measurements for that time point.
Mean baseline values are those that are reported for each cohort at each time point on Day 365 to Day 2,185.
Outcome measures
| Measure |
ABA + MTX DB
n=378 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=161 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Mean BL Hemoglobin, Total Protein, and Albumin in the OL Period
Hemoglobin Day 365 (n=365, 157)
|
12.49 g/dL
Standard Deviation 1.57
|
12.70 g/dL
Standard Deviation 1.56
|
|
Mean BL Hemoglobin, Total Protein, and Albumin in the OL Period
Total Protein Day 365 (n=365, 157)
|
7.23 g/dL
Standard Deviation 0.52
|
7.35 g/dL
Standard Deviation 0.56
|
|
Mean BL Hemoglobin, Total Protein, and Albumin in the OL Period
Albumin Day 365 (n=365, 157)
|
4.03 g/dL
Standard Deviation 0.33
|
4.13 g/dL
Standard Deviation 0.30
|
|
Mean BL Hemoglobin, Total Protein, and Albumin in the OL Period
Hemoglobin Day 729 (n=328, 143)
|
12.50 g/dL
Standard Deviation 1.54
|
12.72 g/dL
Standard Deviation 1.49
|
|
Mean BL Hemoglobin, Total Protein, and Albumin in the OL Period
Total Protein Day 729 (n=328, 143)
|
7.22 g/dL
Standard Deviation 0.52
|
7.34 g/dL
Standard Deviation 0.55
|
|
Mean BL Hemoglobin, Total Protein, and Albumin in the OL Period
Albumin Day 729 (n=328, 143)
|
4.01 g/dL
Standard Deviation 0.33
|
4.12 g/dL
Standard Deviation 0.29
|
|
Mean BL Hemoglobin, Total Protein, and Albumin in the OL Period
Hemoglobin Day 1,093 (n=312, 138)
|
12.48 g/dL
Standard Deviation 1.55
|
12.75 g/dL
Standard Deviation 1.55
|
|
Mean BL Hemoglobin, Total Protein, and Albumin in the OL Period
Total Protein Day 1,093 (n=312, 138)
|
7.23 g/dL
Standard Deviation 0.51
|
7.34 g/dL
Standard Deviation 0.55
|
|
Mean BL Hemoglobin, Total Protein, and Albumin in the OL Period
Albumin Day 1,093 (n=312, 138)
|
4.02 g/dL
Standard Deviation 0.33
|
4.11 g/dL
Standard Deviation 0.30
|
|
Mean BL Hemoglobin, Total Protein, and Albumin in the OL Period
Hemoglobin Day 1,457 (n=292, 130)
|
12.46 g/dL
Standard Deviation 1.54
|
12.74 g/dL
Standard Deviation 1.50
|
|
Mean BL Hemoglobin, Total Protein, and Albumin in the OL Period
Total Protein Day 1,457 (n=292, 130)
|
7.23 g/dL
Standard Deviation 0.51
|
7.35 g/dL
Standard Deviation 0.57
|
|
Mean BL Hemoglobin, Total Protein, and Albumin in the OL Period
Albumin Day 1,457 (n=292, 130)
|
4.02 g/dL
Standard Deviation 0.33
|
4.12 g/dL
Standard Deviation 0.30
|
|
Mean BL Hemoglobin, Total Protein, and Albumin in the OL Period
Hemoglobin Day 1,821 (n=262,124)
|
12.49 g/dL
Standard Deviation 1.51
|
12.79 g/dL
Standard Deviation 1.57
|
|
Mean BL Hemoglobin, Total Protein, and Albumin in the OL Period
Total Protein Day 1,821 (n=262,124)
|
7.23 g/dL
Standard Deviation 0.49
|
7.37 g/dL
Standard Deviation 0.56
|
|
Mean BL Hemoglobin, Total Protein, and Albumin in the OL Period
Albumin Day 1,821 (n=262,124)
|
4.02 g/dL
Standard Deviation 0.33
|
4.13 g/dL
Standard Deviation 0.30
|
|
Mean BL Hemoglobin, Total Protein, and Albumin in the OL Period
Hemoglobin Day 1,905 (n=134, 68)
|
12.35 g/dL
Standard Deviation 1.55
|
12.88 g/dL
Standard Deviation 1.33
|
|
Mean BL Hemoglobin, Total Protein, and Albumin in the OL Period
Total Protein Day 1,905 (n=134, 68)
|
7.27 g/dL
Standard Deviation 0.52
|
7.35 g/dL
Standard Deviation 0.53
|
|
Mean BL Hemoglobin, Total Protein, and Albumin in the OL Period
Albumin Day 1,905 (n=134, 68)
|
4.03 g/dL
Standard Deviation 0.32
|
4.13 g/dL
Standard Deviation 0.30
|
|
Mean BL Hemoglobin, Total Protein, and Albumin in the OL Period
Hemoglobin Day 1,989 (n=121,56)
|
12.35 g/dL
Standard Deviation 1.60
|
12.98 g/dL
Standard Deviation 1.46
|
|
Mean BL Hemoglobin, Total Protein, and Albumin in the OL Period
Total Protein Day 1,989 (n=121,56)
|
7.25 g/dL
Standard Deviation 0.51
|
7.38 g/dL
Standard Deviation 0.55
|
|
Mean BL Hemoglobin, Total Protein, and Albumin in the OL Period
Albumin Day 1,989 (n=121,56)
|
4.03 g/dL
Standard Deviation 0.33
|
4.12 g/dL
Standard Deviation 0.30
|
|
Mean BL Hemoglobin, Total Protein, and Albumin in the OL Period
Hemoglobin Day 2,073 (n=81,38)
|
12.21 g/dL
Standard Deviation 1.46
|
12.84 g/dL
Standard Deviation 1.18
|
|
Mean BL Hemoglobin, Total Protein, and Albumin in the OL Period
Total Protein Day 2,073 (n=81,38)
|
7.18 g/dL
Standard Deviation 0.47
|
7.27 g/dL
Standard Deviation 0.44
|
|
Mean BL Hemoglobin, Total Protein, and Albumin in the OL Period
Albumin Day 2,073 (n=81,38)
|
3.98 g/dL
Standard Deviation 0.33
|
4.08 g/dL
Standard Deviation 0.33
|
|
Mean BL Hemoglobin, Total Protein, and Albumin in the OL Period
Hemoglobin Day 2,185 (n=82,37)
|
12.25 g/dL
Standard Deviation 1.44
|
12.82 g/dL
Standard Deviation 1.19
|
|
Mean BL Hemoglobin, Total Protein, and Albumin in the OL Period
Total Protein Day 2,185 (n=82,37)
|
7.18 g/dL
Standard Deviation 0.47
|
7.28 g/dL
Standard Deviation 0.45
|
|
Mean BL Hemoglobin, Total Protein, and Albumin in the OL Period
Albumin Day 2,185 (n=82,37)
|
3.97 g/dL
Standard Deviation 0.32
|
4.08 g/dL
Standard Deviation 0.33
|
PRIMARY outcome
Timeframe: BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185Population: All treated participants in the OL period (treatment groups represent treatment received in the double-blind period). N = number of participants analyzed and n = the number of participants with measurements for that time point.
All changes in participant laboratory parameters were monitored on each day of study drug administration.
Outcome measures
| Measure |
ABA + MTX DB
n=378 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=161 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Mean Change From BL in Hemoglobin, Total Protein, and Albumin in the OL Period
Hemoglobin Day 2,185 (n=82,37)
|
0.69 g/dL
Standard Error 0.14
|
0.40 g/dL
Standard Error 0.21
|
|
Mean Change From BL in Hemoglobin, Total Protein, and Albumin in the OL Period
Albumin Day 1,457 (n=292, 130)
|
0.07 g/dL
Standard Error 0.02
|
-0.02 g/dL
Standard Error 0.03
|
|
Mean Change From BL in Hemoglobin, Total Protein, and Albumin in the OL Period
Hemoglobin Day 365 (n=365, 157)
|
0.62 g/dL
Standard Error 0.07
|
-0.09 g/dL
Standard Error 0.08
|
|
Mean Change From BL in Hemoglobin, Total Protein, and Albumin in the OL Period
Total Protein Day 365 (n=365, 157)
|
-0.26 g/dL
Standard Error 0.02
|
-0.25 g/dL
Standard Error 0.04
|
|
Mean Change From BL in Hemoglobin, Total Protein, and Albumin in the OL Period
Albumin Day 365 (n=365, 157)
|
0.22 g/dL
Standard Error 0.02
|
0.02 g/dL
Standard Error 0.02
|
|
Mean Change From BL in Hemoglobin, Total Protein, and Albumin in the OL Period
Hemoglobin Day 729 (n=328, 143)
|
0.95 g/dL
Standard Error 0.07
|
0.61 g/dL
Standard Error 0.10
|
|
Mean Change From BL in Hemoglobin, Total Protein, and Albumin in the OL Period
Total Protein Day 729 (n=328, 143)
|
-0.01 g/dL
Standard Error 0.03
|
-0.05 g/dL
Standard Error 0.05
|
|
Mean Change From BL in Hemoglobin, Total Protein, and Albumin in the OL Period
Albumin Day 729 (n=328, 143)
|
0.31 g/dL
Standard Error 0.02
|
0.23 g/dL
Standard Error 0.03
|
|
Mean Change From BL in Hemoglobin, Total Protein, and Albumin in the OL Period
Hemoglobin Day 1,093 (n=312, 138)
|
0.75 g/dL
Standard Error 0.07
|
0.40 g/dL
Standard Error 0.11
|
|
Mean Change From BL in Hemoglobin, Total Protein, and Albumin in the OL Period
Total Protein Day 1,093 (n=312, 138)
|
-0.16 g/dL
Standard Error 0.03
|
-0.26 g/dL
Standard Error 0.04
|
|
Mean Change From BL in Hemoglobin, Total Protein, and Albumin in the OL Period
Albumin Day 1,093 (n=312, 138)
|
0.13 g/dL
Standard Error 0.02
|
0.02 g/dL
Standard Error 0.03
|
|
Mean Change From BL in Hemoglobin, Total Protein, and Albumin in the OL Period
Hemoglobin Day 1,457 (n=292, 130)
|
0.80 g/dL
Standard Error 0.07
|
0.52 g/dL
Standard Error 0.12
|
|
Mean Change From BL in Hemoglobin, Total Protein, and Albumin in the OL Period
Total Protein Day 1,457 (n=292, 130)
|
-0.28 g/dL
Standard Error 0.03
|
-0.35 g/dL
Standard Error 0.05
|
|
Mean Change From BL in Hemoglobin, Total Protein, and Albumin in the OL Period
Hemoglobin Day 1,821 (n=262,124)
|
0.79 g/dL
Standard Error 0.08
|
0.70 g/dL
Standard Error 0.11
|
|
Mean Change From BL in Hemoglobin, Total Protein, and Albumin in the OL Period
Total Protein Day 1,821 (n=262,124)
|
-0.27 g/dL
Standard Error 0.03
|
-0.35 g/dL
Standard Error 0.05
|
|
Mean Change From BL in Hemoglobin, Total Protein, and Albumin in the OL Period
Albumin Day 1,821 (n=262,124)
|
0.06 g/dL
Standard Error 0.02
|
-0.05 g/dL
Standard Error 0.03
|
|
Mean Change From BL in Hemoglobin, Total Protein, and Albumin in the OL Period
Hemoglobin Day 1,905 (n=134, 68)
|
0.74 g/dL
Standard Error 0.12
|
0.39 g/dL
Standard Error 0.16
|
|
Mean Change From BL in Hemoglobin, Total Protein, and Albumin in the OL Period
Total Protein Day 1,905 (n=134, 68)
|
-0.32 g/dL
Standard Error 0.05
|
-0.31 g/dL
Standard Error 0.07
|
|
Mean Change From BL in Hemoglobin, Total Protein, and Albumin in the OL Period
Albumin Day 1,905 (n=134, 68)
|
0.05 g/dL
Standard Error 0.03
|
-0.06 g/dL
Standard Error 0.04
|
|
Mean Change From BL in Hemoglobin, Total Protein, and Albumin in the OL Period
Hemoglobin Day 1,989 (n=121,56)
|
0.59 g/dL
Standard Error 0.13
|
0.41 g/dL
Standard Error 0.17
|
|
Mean Change From BL in Hemoglobin, Total Protein, and Albumin in the OL Period
Total Protein Day 1,989 (n=121,56)
|
-0.29 g/dL
Standard Error 0.05
|
-0.33 g/dL
Standard Error 0.07
|
|
Mean Change From BL in Hemoglobin, Total Protein, and Albumin in the OL Period
Albumin Day 1,989 (n=121,56)
|
0.08 g/dL
Standard Error 0.03
|
0.01 g/dL
Standard Error 0.05
|
|
Mean Change From BL in Hemoglobin, Total Protein, and Albumin in the OL Period
Hemoglobin Day 2,073 (n=81,38)
|
0.78 g/dL
Standard Error 0.15
|
0.23 g/dL
Standard Error 0.22
|
|
Mean Change From BL in Hemoglobin, Total Protein, and Albumin in the OL Period
Total Protein Day 2,073 (n=81,38)
|
-0.21 g/dL
Standard Error 0.04
|
-0.24 g/dL
Standard Error 0.09
|
|
Mean Change From BL in Hemoglobin, Total Protein, and Albumin in the OL Period
Albumin Day 2,073 (n=81,38)
|
0.22 g/dL
Standard Error 0.03
|
0.09 g/dL
Standard Error 0.06
|
|
Mean Change From BL in Hemoglobin, Total Protein, and Albumin in the OL Period
Total Protein Day 2,185 (n=82,37)
|
-0.20 g/dL
Standard Error 0.04
|
-0.12 g/dL
Standard Error 0.09
|
|
Mean Change From BL in Hemoglobin, Total Protein, and Albumin in the OL Period
Albumin Day 2,185 (n=82,37)
|
0.30 g/dL
Standard Error 0.03
|
0.25 g/dL
Standard Error 0.06
|
PRIMARY outcome
Timeframe: BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185Population: All treated participants in the OL period (treatment groups represent treatment received in the double-blind period). N = number of participants analyzed and n = the number of participants with measurements for that time point.
Mean baseline values are those that are reported for each cohort at each time point on Day 365 to Day 2,185.
Outcome measures
| Measure |
ABA + MTX DB
n=378 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=161 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Mean BL White Blood Cells in the OL Period
White Blood Cells Day 365 (n=365, 157)
|
8.78 10^3 c/uL
Standard Deviation 2.83
|
8.81 10^3 c/uL
Standard Deviation 3.01
|
|
Mean BL White Blood Cells in the OL Period
Absolute Neutrophils Day 365 (n=365, 157)
|
6.45 10^3 c/uL
Standard Deviation 2.63
|
6.39 10^3 c/uL
Standard Deviation 2.67
|
|
Mean BL White Blood Cells in the OL Period
Absolute Eosinophils Day 365 (n=365, 157)
|
0.18 10^3 c/uL
Standard Deviation 0.16
|
0.18 10^3 c/uL
Standard Deviation 0.12
|
|
Mean BL White Blood Cells in the OL Period
Absolute Monocytes Day 365 (n=365, 157)
|
0.42 10^3 c/uL
Standard Deviation 0.25
|
0.41 10^3 c/uL
Standard Deviation 0.26
|
|
Mean BL White Blood Cells in the OL Period
White Blood Cells Day 729 (n=328, 143)
|
8.89 10^3 c/uL
Standard Deviation 2.87
|
8.73 10^3 c/uL
Standard Deviation 2.96
|
|
Mean BL White Blood Cells in the OL Period
Absolute Neutrophils Day 729 (n=328, 143)
|
6.50 10^3 c/uL
Standard Deviation 2.63
|
6.35 10^3 c/uL
Standard Deviation 2.66
|
|
Mean BL White Blood Cells in the OL Period
Absolute Eosinophils Day 729 (n=328, 143)
|
0.18 10^3 c/uL
Standard Deviation 0.16
|
0.18 10^3 c/uL
Standard Deviation 0.12
|
|
Mean BL White Blood Cells in the OL Period
Absolute Monocytes Day 729 (n=328, 143)
|
0.43 10^3 c/uL
Standard Deviation 0.25
|
0.40 10^3 c/uL
Standard Deviation 0.25
|
|
Mean BL White Blood Cells in the OL Period
White Blood Cells Day 1,093 (n=312, 138)
|
8.81 10^3 c/uL
Standard Deviation 2.83
|
8.80 10^3 c/uL
Standard Deviation 3.08
|
|
Mean BL White Blood Cells in the OL Period
Absolute Neutrophils Day 1,093 (n=312, 138)
|
6.46 10^3 c/uL
Standard Deviation 2.63
|
6.37 10^3 c/uL
Standard Deviation 2.71
|
|
Mean BL White Blood Cells in the OL Period
Absolute Eosinophils Day 1,093 (n=312, 138)
|
0.18 10^3 c/uL
Standard Deviation 0.16
|
0.18 10^3 c/uL
Standard Deviation 0.12
|
|
Mean BL White Blood Cells in the OL Period
Absolute Monocytes Day 1,093 (n=312, 138)
|
0.43 10^3 c/uL
Standard Deviation 0.25
|
0.41 10^3 c/uL
Standard Deviation 0.27
|
|
Mean BL White Blood Cells in the OL Period
White Blood Cells Day 1,457 (n=292, 130)
|
8.80 10^3 c/uL
Standard Deviation 2.81
|
8.74 10^3 c/uL
Standard Deviation 3.10
|
|
Mean BL White Blood Cells in the OL Period
Absolute Neutrophils Day 1,457 (n=292, 130)
|
6.43 10^3 c/uL
Standard Deviation 2.59
|
6.32 10^3 c/uL
Standard Deviation 2.73
|
|
Mean BL White Blood Cells in the OL Period
Absolute Eosinophils Day 1,457 (n=292, 130)
|
0.18 10^3 c/uL
Standard Deviation 0.17
|
0.18 10^3 c/uL
Standard Deviation 0.12
|
|
Mean BL White Blood Cells in the OL Period
Absolute Monocytes Day 1,457 (n=292, 130)
|
0.43 10^3 c/uL
Standard Deviation 0.25
|
0.40 10^3 c/uL
Standard Deviation 0.25
|
|
Mean BL White Blood Cells in the OL Period
White Blood Cells Day 1,821 (n=262,124)
|
8.82 10^3 c/uL
Standard Deviation 2.76
|
8.70 10^3 c/uL
Standard Deviation 3.06
|
|
Mean BL White Blood Cells in the OL Period
Absolute Neutrophils Day 1,821 (n=262,124)
|
6.45 10^3 c/uL
Standard Deviation 2.56
|
6.35 10^3 c/uL
Standard Deviation 2.72
|
|
Mean BL White Blood Cells in the OL Period
Absolute Eosinophils Day 1,821 (n=262,124)
|
0.18 10^3 c/uL
Standard Deviation 0.16
|
0.18 10^3 c/uL
Standard Deviation 0.12
|
|
Mean BL White Blood Cells in the OL Period
Absolute Monocytes Day 1,821 (n=262,124)
|
0.42 10^3 c/uL
Standard Deviation 0.24
|
0.39 10^3 c/uL
Standard Deviation 0.22
|
|
Mean BL White Blood Cells in the OL Period
White Blood Cells Day 1,905 (n=134, 68)
|
9.14 10^3 c/uL
Standard Deviation 2.83
|
8.80 10^3 c/uL
Standard Deviation 2.91
|
|
Mean BL White Blood Cells in the OL Period
Absolute Neutrophils Day 1,905 (n=134, 68)
|
6.78 10^3 c/uL
Standard Deviation 2.67
|
6.56 10^3 c/uL
Standard Deviation 2.68
|
|
Mean BL White Blood Cells in the OL Period
Absolute Eosinophils Day 1,905 (n=134, 68)
|
0.17 10^3 c/uL
Standard Deviation 0.16
|
0.16 10^3 c/uL
Standard Deviation 0.11
|
|
Mean BL White Blood Cells in the OL Period
Absolute Monocytes Day 1,905 (n=134, 68)
|
0.37 10^3 c/uL
Standard Deviation 0.21
|
0.34 10^3 c/uL
Standard Deviation 0.19
|
|
Mean BL White Blood Cells in the OL Period
White Blood Cells Day 1,989 (n=121,56)
|
9.16 10^3 c/uL
Standard Deviation 2.87
|
8.81 10^3 c/uL
Standard Deviation 2.93
|
|
Mean BL White Blood Cells in the OL Period
Absolute Neutrophils Day 1,989 (n=121,56)
|
6.86 10^3 c/uL
Standard Deviation 2.77
|
6.69 10^3 c/uL
Standard Deviation 2.74
|
|
Mean BL White Blood Cells in the OL Period
Absolute Eosinophils Day 1,989 (n=121,56)
|
0.15 10^3 c/uL
Standard Deviation 0.14
|
0.15 10^3 c/uL
Standard Deviation 0.10
|
|
Mean BL White Blood Cells in the OL Period
Absolute Monocytes Day 1,989 (n=121,56)
|
0.35 10^3 c/uL
Standard Deviation 0.21
|
0.35 10^3 c/uL
Standard Deviation 0.18
|
|
Mean BL White Blood Cells in the OL Period
White Blood Cells Day 2,073 (n=81,38)
|
9.64 10^3 c/uL
Standard Deviation 3.05
|
9.22 10^3 c/uL
Standard Deviation 3.12
|
|
Mean BL White Blood Cells in the OL Period
Absolute Neutrophils Day 2,073 (n=81,38)
|
7.25 10^3 c/uL
Standard Deviation 2.90
|
6.97 10^3 c/uL
Standard Deviation 2.99
|
|
Mean BL White Blood Cells in the OL Period
Absolute Eosinophils Day 2,073 (n=81,38)
|
0.12 10^3 c/uL
Standard Deviation 0.10
|
0.13 10^3 c/uL
Standard Deviation 0.09
|
|
Mean BL White Blood Cells in the OL Period
Absolute Monocytes Day 2,073 (n=81,38)
|
0.41 10^3 c/uL
Standard Deviation 0.22
|
0.38 10^3 c/uL
Standard Deviation 0.19
|
|
Mean BL White Blood Cells in the OL Period
White Blood Cells Day 2,185 (n=82,37)
|
9.73 10^3 c/uL
Standard Deviation 2.98
|
9.22 10^3 c/uL
Standard Deviation 3.16
|
|
Mean BL White Blood Cells in the OL Period
Absolute Neutrophils Day 2,185 (n=82,37)
|
7.35 10^3 c/uL
Standard Deviation 2.84
|
6.93 10^3 c/uL
Standard Deviation 3.03
|
|
Mean BL White Blood Cells in the OL Period
Absolute Eosinophils Day 2,185 (n=82,37)
|
0.12 10^3 c/uL
Standard Deviation 0.11
|
0.13 10^3 c/uL
Standard Deviation 0.09
|
|
Mean BL White Blood Cells in the OL Period
Absolute Monocytes Day 2,185 (n=82,37)
|
0.40 10^3 c/uL
Standard Deviation 0.22
|
0.38 10^3 c/uL
Standard Deviation 0.20
|
PRIMARY outcome
Timeframe: BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185Population: All treated participants in the OL period (treatment groups represent treatment received in the double-blind period). N = number of participants analyzed and n = the number of participants with measurements for that time point.
All changes in participant laboratory parameters were monitored on each day of study drug administration.
Outcome measures
| Measure |
ABA + MTX DB
n=378 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=161 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Mean Change From BL in White Blood Cells in the OL Period
Absolute Neutrophils Day 2,185 (n=82,37)
|
-1.78 10^3 c/uL
Standard Error 0.33
|
-2.39 10^3 c/uL
Standard Error 0.43
|
|
Mean Change From BL in White Blood Cells in the OL Period
Absolute Eosinophils Day 2,185 (n=82,37)
|
0.03 10^3 c/uL
Standard Error 0.02
|
-0.01 10^3 c/uL
Standard Error 0.02
|
|
Mean Change From BL in White Blood Cells in the OL Period
Absolute Monocytes Day 2,185 (n=82,37)
|
0.08 10^3 c/uL
Standard Error 0.04
|
0.08 10^3 c/uL
Standard Error 0.04
|
|
Mean Change From BL in White Blood Cells in the OL Period
Absolute Monocytes Day 1,989 (n=121,56)
|
0.03 10^3 c/uL
Standard Error 0.02
|
0.03 10^3 c/uL
Standard Error 0.03
|
|
Mean Change From BL in White Blood Cells in the OL Period
White Blood Cells Day 2,073 (n=81,38)
|
-1.00 10^3 c/uL
Standard Error 0.33
|
-1.54 10^3 c/uL
Standard Error 0.44
|
|
Mean Change From BL in White Blood Cells in the OL Period
Absolute Neutrophils Day 2,073 (n=81,38)
|
-1.57 10^3 c/uL
Standard Error 0.35
|
-2.17 10^3 c/uL
Standard Error 0.47
|
|
Mean Change From BL in White Blood Cells in the OL Period
Absolute Eosinophils Day 2,073 (n=81,38)
|
0.02 10^3 c/uL
Standard Error 0.01
|
0.04 10^3 c/uL
Standard Error 0.02
|
|
Mean Change From BL in White Blood Cells in the OL Period
White Blood Cells Day 365 (n=365, 157)
|
-.10 10^3 c/uL
Standard Error 0.13
|
-0.44 10^3 c/uL
Standard Error 0.17
|
|
Mean Change From BL in White Blood Cells in the OL Period
Absolute Neutrophils Day 365 (n=365, 157)
|
-1.20 10^3 c/uL
Standard Error 0.12
|
-0.43 10^3 c/uL
Standard Error 0.18
|
|
Mean Change From BL in White Blood Cells in the OL Period
Absolute Eosinophils Day 365 (n=365, 157)
|
-0.02 10^3 c/uL
Standard Error 0.01
|
-0.01 10^3 c/uL
Standard Error 0.01
|
|
Mean Change From BL in White Blood Cells in the OL Period
Absolute Monocytes Day 365 (n=365, 157)
|
-0.03 10^3 c/uL
Standard Error 0.01
|
-0.03 10^3 c/uL
Standard Error 0.02
|
|
Mean Change From BL in White Blood Cells in the OL Period
White Blood Cells Day 729 (n=328, 143)
|
-1.35 10^3 c/uL
Standard Error 0.15
|
-1.19 10^3 c/uL
Standard Error 0.20
|
|
Mean Change From BL in White Blood Cells in the OL Period
Absolute Neutrophils Day 729 (n=328, 143)
|
-1.50 10^3 c/uL
Standard Error 0.14
|
-1.49 10^3 c/uL
Standard Error 0.19
|
|
Mean Change From BL in White Blood Cells in the OL Period
Absolute Eosinophils Day 729 (n=328, 143)
|
-0.02 10^3 c/uL
Standard Error 0.01
|
-0.04 10^3 c/uL
Standard Error 0.01
|
|
Mean Change From BL in White Blood Cells in the OL Period
Absolute Monocytes Day 729 (n=328, 143)
|
-0.06 10^3 c/uL
Standard Error 0.02
|
-0.03 10^3 c/uL
Standard Error 0.02
|
|
Mean Change From BL in White Blood Cells in the OL Period
White Blood Cells Day 1,093 (n=312, 138)
|
-1.50 10^3 c/uL
Standard Error 0.16
|
-1.55 10^3 c/uL
Standard Error 0.22
|
|
Mean Change From BL in White Blood Cells in the OL Period
Absolute Neutrophils Day 1,093 (n=312, 138)
|
-1.57 10^3 c/uL
Standard Error 0.15
|
-1.66 10^3 c/uL
Standard Error 0.22
|
|
Mean Change From BL in White Blood Cells in the OL Period
Absolute Eosinophils Day 1,093 (n=312, 138)
|
-0.01 10^3 c/uL
Standard Error 0.01
|
-0.01 10^3 c/uL
Standard Error 0.01
|
|
Mean Change From BL in White Blood Cells in the OL Period
Absolute Monocytes Day 1,093 (n=312, 138)
|
-0.07 10^3 c/uL
Standard Error 0.02
|
-0.08 10^3 c/uL
Standard Error 0.02
|
|
Mean Change From BL in White Blood Cells in the OL Period
White Blood Cells Day 1,457 (n=292, 130)
|
-1.36 10^3 c/uL
Standard Error 0.16
|
-1.62 10^3 c/uL
Standard Error 0.25
|
|
Mean Change From BL in White Blood Cells in the OL Period
Absolute Neutrophils Day 1,457 (n=292, 130)
|
-1.44 10^3 c/uL
Standard Error 0.15
|
-1.68 10^3 c/uL
Standard Error 0.24
|
|
Mean Change From BL in White Blood Cells in the OL Period
Absolute Eosinophils Day 1,457 (n=292, 130)
|
-0.00 10^3 c/uL
Standard Error 0.01
|
0.01 10^3 c/uL
Standard Error 0.02
|
|
Mean Change From BL in White Blood Cells in the OL Period
Absolute Monocytes Day 1,457 (n=292, 130)
|
-0.06 10^3 c/uL
Standard Error 0.02
|
-0.07 10^3 c/uL
Standard Error 0.02
|
|
Mean Change From BL in White Blood Cells in the OL Period
White Blood Cells Day 1,821 (n=262,124)
|
-1.56 10^3 c/uL
Standard Error 0.18
|
-1.71 10^3 c/uL
Standard Error 0.24
|
|
Mean Change From BL in White Blood Cells in the OL Period
Absolute Neutrophils Day 1,821 (n=262,124)
|
-1.72 10^3 c/uL
Standard Error 0.17
|
-1.92 10^3 c/uL
Standard Error 0.23
|
|
Mean Change From BL in White Blood Cells in the OL Period
Absolute Eosinophils Day 1,821 (n=262,124)
|
-0.00 10^3 c/uL
Standard Error 0.01
|
0.01 10^3 c/uL
Standard Error 0.02
|
|
Mean Change From BL in White Blood Cells in the OL Period
Absolute Monocytes Day 1,821 (n=262,124)
|
-0.03 10^3 c/uL
Standard Error 0.02
|
-0.04 10^3 c/uL
Standard Error 0.02
|
|
Mean Change From BL in White Blood Cells in the OL Period
White Blood Cells Day 1,905 (n=134, 68)
|
-0.82 10^3 c/uL
Standard Error 0.38
|
-1.11 10^3 c/uL
Standard Error 0.32
|
|
Mean Change From BL in White Blood Cells in the OL Period
Absolute Neutrophils Day 1,905 (n=134, 68)
|
-1.30 10^3 c/uL
Standard Error 0.31
|
-1.53 10^3 c/uL
Standard Error 0.33
|
|
Mean Change From BL in White Blood Cells in the OL Period
Absolute Eosinophils Day 1,905 (n=134, 68)
|
-0.00 10^3 c/uL
Standard Error 0.02
|
-0.02 10^3 c/uL
Standard Error 0.02
|
|
Mean Change From BL in White Blood Cells in the OL Period
Absolute Monocytes Day 1,905 (n=134, 68)
|
0.03 10^3 c/uL
Standard Error 0.02
|
0.05 10^3 c/uL
Standard Error 0.03
|
|
Mean Change From BL in White Blood Cells in the OL Period
White Blood Cells Day 1,989 (n=121,56)
|
-1.07 10^3 c/uL
Standard Error 0.26
|
-0.97 10^3 c/uL
Standard Error 0.30
|
|
Mean Change From BL in White Blood Cells in the OL Period
Absolute Neutrophils Day 1,989 (n=121,56)
|
-.152 10^3 c/uL
Standard Error 0.26
|
-1.47 10^3 c/uL
Standard Error 0.33
|
|
Mean Change From BL in White Blood Cells in the OL Period
Absolute Eosinophils Day 1,989 (n=121,56)
|
0.01 10^3 c/uL
Standard Error 0.02
|
-0.00 10^3 c/uL
Standard Error 0.02
|
|
Mean Change From BL in White Blood Cells in the OL Period
Absolute Monocytes Day 2,073 (n=81,38)
|
0.13 10^3 c/uL
Standard Error 0.03
|
0.11 10^3 c/uL
Standard Error 0.04
|
|
Mean Change From BL in White Blood Cells in the OL Period
White Blood Cells Day 2,185 (n=82,37)
|
-1.41 10^3 c/uL
Standard Error 0.33
|
-1.96 10^3 c/uL
Standard Error 0.39
|
PRIMARY outcome
Timeframe: BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185Population: All treated participants in the OL period (treatment groups represent treatment received in the double-blind period). N = number of participants analyzed and n = the number of participants with measurements for that time point.
Mean baseline values are those that are reported for each cohort at each time point on Day 365 to Day 2,185.
Outcome measures
| Measure |
ABA + MTX DB
n=378 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=161 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Mean BL Liver Function Parameters in the OL Period
Alkaline Phosphatase Day 365 (n=365, 157)
|
99.56 U/L
Standard Deviation 37.11
|
98.73 U/L
Standard Deviation 41.23
|
|
Mean BL Liver Function Parameters in the OL Period
Alanine Aminotransferase Day 365 (n=365, 157)
|
22.35 U/L
Standard Deviation 22.07
|
23.40 U/L
Standard Deviation 27.35
|
|
Mean BL Liver Function Parameters in the OL Period
Aspartate Aminotransferase Day 365 (n=365, 157)
|
21.53 U/L
Standard Deviation 12.00
|
22.87 U/L
Standard Deviation 15.14
|
|
Mean BL Liver Function Parameters in the OL Period
G-Glutamyl Transferase Day 365 (n=365, 157)
|
34.89 U/L
Standard Deviation 32.59
|
30.73 U/L
Standard Deviation 26.54
|
|
Mean BL Liver Function Parameters in the OL Period
Alkaline Phosphatase Day 729 (n=328, 143)
|
98.30 U/L
Standard Deviation 35.22
|
99.49 U/L
Standard Deviation 41.24
|
|
Mean BL Liver Function Parameters in the OL Period
Alanine Aminotransferase Day 729 (n=328, 143)
|
22.74 U/L
Standard Deviation 22.91
|
23.21 U/L
Standard Deviation 28.38
|
|
Mean BL Liver Function Parameters in the OL Period
Aspartate Aminotransferase Day 729 (n=328, 143)
|
21.62 U/L
Standard Deviation 12.35
|
22.87 U/L
Standard Deviation 15.50
|
|
Mean BL Liver Function Parameters in the OL Period
G-Glutamyl Transferase Day 729 (n=328, 143)
|
35.37 U/L
Standard Deviation 33.62
|
28.73 U/L
Standard Deviation 19.92
|
|
Mean BL Liver Function Parameters in the OL Period
Alkaline Phosphatase Day 1,093 (n=312, 138)
|
99.18 U/L
Standard Deviation 34.95
|
99.43 U/L
Standard Deviation 40.80
|
|
Mean BL Liver Function Parameters in the OL Period
Alanine Aminotransferase Day 1,093 (n=312, 138)
|
22.75 U/L
Standard Deviation 23.38
|
23.01 U/L
Standard Deviation 28.87
|
|
Mean BL Liver Function Parameters in the OL Period
Aspartate Aminotransferase Day 1,093 (n=312, 138)
|
21.60 U/L
Standard Deviation 12.55
|
22.91 U/L
Standard Deviation 15.69
|
|
Mean BL Liver Function Parameters in the OL Period
G-Glutamyl Transferase Day 1,093 (n=312, 138)
|
34.34 U/L
Standard Deviation 29.93
|
28.43 U/L
Standard Deviation 20.15
|
|
Mean BL Liver Function Parameters in the OL Period
Alkaline Phosphatase Day 1,457 (n=292, 130)
|
100.8 U/L
Standard Deviation 36.04
|
99.75 U/L
Standard Deviation 41.90
|
|
Mean BL Liver Function Parameters in the OL Period
Alanine Aminotransferase Day 1,457 (n=292, 130)
|
23.05 U/L
Standard Deviation 23.95
|
23.43 U/L
Standard Deviation 29.67
|
|
Mean BL Liver Function Parameters in the OL Period
Aspartate Aminotransferase Day 1,457 (n=292, 130)
|
21.88 U/L
Standard Deviation 12.84
|
23.29 U/L
Standard Deviation 16.08
|
|
Mean BL Liver Function Parameters in the OL Period
G-Glutamyl Transferase Day 1,457 (n=292, 130)
|
35.80 U/L
Standard Deviation 34.83
|
28.34 U/L
Standard Deviation 20.35
|
|
Mean BL Liver Function Parameters in the OL Period
Alkaline Phosphatase Day 1,821 (n=262,124)
|
99.80 U/L
Standard Deviation 34.22
|
97.68 U/L
Standard Deviation 33.66
|
|
Mean BL Liver Function Parameters in the OL Period
Alanine Aminotransferase Day 1,821 (n=262,124)
|
23.22 U/L
Standard Deviation 24.74
|
23.55 U/L
Standard Deviation 30.34
|
|
Mean BL Liver Function Parameters in the OL Period
Aspartate Aminotransferase Day 1,821 (n=262,124)
|
21.63 U/L
Standard Deviation 12.98
|
23.50 U/L
Standard Deviation 16.37
|
|
Mean BL Liver Function Parameters in the OL Period
G-Glutamyl Transferase Day 1,821 (n=262,124)
|
35.50 U/L
Standard Deviation 34.74
|
27.76 U/L
Standard Deviation 19.77
|
|
Mean BL Liver Function Parameters in the OL Period
Alkaline Phosphatase Day 1,905 (n=134, 68)
|
97.33 U/L
Standard Deviation 35.95
|
92.19 U/L
Standard Deviation 35.33
|
|
Mean BL Liver Function Parameters in the OL Period
Alanine Aminotransferase Day 1,905 (n=134, 68)
|
22.57 U/L
Standard Deviation 22.33
|
25.65 U/L
Standard Deviation 39.19
|
|
Mean BL Liver Function Parameters in the OL Period
Aspartate Aminotransferase Day 1,905 (n=134, 68)
|
21.43 U/L
Standard Deviation 12.21
|
24.60 U/L
Standard Deviation 20.64
|
|
Mean BL Liver Function Parameters in the OL Period
G-Glutamyl Transferase Day 1,905 (n=134, 68)
|
35.08 U/L
Standard Deviation 31.28
|
30.01 U/L
Standard Deviation 22.38
|
|
Mean BL Liver Function Parameters in the OL Period
Alkaline Phosphatase Day 1,989 (n=121,56)
|
97.46 U/L
Standard Deviation 35.63
|
95.18 U/L
Standard Deviation 36.81
|
|
Mean BL Liver Function Parameters in the OL Period
Alanine Aminotransferase Day 1,989 (n=121,56)
|
23.15 U/L
Standard Deviation 23.24
|
27.80 U/L
Standard Deviation 42.76
|
|
Mean BL Liver Function Parameters in the OL Period
Aspartate Aminotransferase Day 1,989 (n=121,56)
|
21.55 U/L
Standard Deviation 12.72
|
25.82 U/L
Standard Deviation 22.44
|
|
Mean BL Liver Function Parameters in the OL Period
G-Glutamyl Transferase Day 1,989 (n=121,56)
|
35.27 U/L
Standard Deviation 32.43
|
31.39 U/L
Standard Deviation 23.44
|
|
Mean BL Liver Function Parameters in the OL Period
Alkaline Phosphatase Day 2,073 (n=81,38)
|
86.87 U/L
Standard Deviation 30.05
|
78.53 U/L
Standard Deviation 22.77
|
|
Mean BL Liver Function Parameters in the OL Period
Alanine Aminotransferase Day 2,073 (n=81,38)
|
22.34 U/L
Standard Deviation 24.62
|
27.50 U/L
Standard Deviation 50.75
|
|
Mean BL Liver Function Parameters in the OL Period
Aspartate Aminotransferase Day 2,073 (n=81,38)
|
20.93 U/L
Standard Deviation 12.70
|
25.37 U/L
Standard Deviation 26.59
|
|
Mean BL Liver Function Parameters in the OL Period
G-Glutamyl Transferase Day 2,073 (n=81,38)
|
35.62 U/L
Standard Deviation 37.07
|
30.47 U/L
Standard Deviation 21.40
|
|
Mean BL Liver Function Parameters in the OL Period
Alkaline Phosphatase Day 2,185 (n=82,37)
|
87.33 U/L
Standard Deviation 30.52
|
78.97 U/L
Standard Deviation 22.92
|
|
Mean BL Liver Function Parameters in the OL Period
Alanine Aminotransferase Day 2,185 (n=82,37)
|
20.80 U/L
Standard Deviation 12.29
|
25.81 U/L
Standard Deviation 26.81
|
|
Mean BL Liver Function Parameters in the OL Period
G-Glutamyl Transferase Day 2,185 (n=82,37)
|
36.23 U/L
Standard Deviation 37.42
|
30.46 U/L
Standard Deviation 21.69
|
PRIMARY outcome
Timeframe: BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185Population: All treated participants in the OL period (treatment groups represent treatment received in the double-blind period). N = number of participants analyzed and n = the number of participants with measurements for that time point.
All changes in participant laboratory parameters were monitored on each day of study drug administration.
Outcome measures
| Measure |
ABA + MTX DB
n=378 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=161 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Mean Change From BL in Liver Function Parameters in the OL Period
Alkaline Phosphatase Day 365 (n=365, 157)
|
-7.27 U/L
Standard Error 1.60
|
-10.8 U/L
Standard Error 2.30
|
|
Mean Change From BL in Liver Function Parameters in the OL Period
Alanine Aminotransferase Day 365 (n=365, 157)
|
1.10 U/L
Standard Error 1.25
|
-2.64 U/L
Standard Error 2.18
|
|
Mean Change From BL in Liver Function Parameters in the OL Period
Aspartate Aminotransferase Day 365 (n=365, 157)
|
1.50 U/L
Standard Error 0.76
|
-1.42 U/L
Standard Error 1.20
|
|
Mean Change From BL in Liver Function Parameters in the OL Period
G-Glutamyl Transferase Day 365 (n=365, 157)
|
-4.42 U/L
Standard Error 1.48
|
-2.83 U/L
Standard Error 1.79
|
|
Mean Change From BL in Liver Function Parameters in the OL Period
Alkaline Phosphatase Day 729 (n=328, 143)
|
-13.3 U/L
Standard Error 1.70
|
-18.8 U/L
Standard Error 2.85
|
|
Mean Change From BL in Liver Function Parameters in the OL Period
Alanine Aminotransferase Day 729 (n=328, 143)
|
0.39 U/L
Standard Error 1.39
|
-1.69 U/L
Standard Error 2.38
|
|
Mean Change From BL in Liver Function Parameters in the OL Period
Aspartate Aminotransferase Day 729 (n=328, 143)
|
1.30 U/L
Standard Error 0.83
|
0.47 U/L
Standard Error 1.43
|
|
Mean Change From BL in Liver Function Parameters in the OL Period
G-Glutamyl Transferase Day 729 (n=328, 143)
|
-4.96 U/L
Standard Error 1.62
|
-3.98 U/L
Standard Error 1.68
|
|
Mean Change From BL in Liver Function Parameters in the OL Period
Alkaline Phosphatase Day 1,093 (n=312, 138)
|
-10.0 U/L
Standard Error 1.69
|
-13.0 U/L
Standard Error 2.74
|
|
Mean Change From BL in Liver Function Parameters in the OL Period
Alanine Aminotransferase Day 1,093 (n=312, 138)
|
0.81 U/L
Standard Error 1.40
|
-0.17 U/L
Standard Error 2.52
|
|
Mean Change From BL in Liver Function Parameters in the OL Period
Aspartate Aminotransferase Day 1,093 (n=312, 138)
|
1.11 U/L
Standard Error 0.85
|
0.07 U/L
Standard Error 1.39
|
|
Mean Change From BL in Liver Function Parameters in the OL Period
G-Glutamyl Transferase Day 1,093 (n=312, 138)
|
-6.81 U/L
Standard Error 1.55
|
-4.51 U/L
Standard Error 1.54
|
|
Mean Change From BL in Liver Function Parameters in the OL Period
Alkaline Phosphatase Day 1,457 (n=292, 130)
|
-12.4 U/L
Standard Error 1.73
|
-12.0 U/L
Standard Error 3.02
|
|
Mean Change From BL in Liver Function Parameters in the OL Period
Alanine Aminotransferase Day 1,457 (n=292, 130)
|
1.43 U/L
Standard Error 2.66
|
-3.11 U/L
Standard Error 2.57
|
|
Mean Change From BL in Liver Function Parameters in the OL Period
Aspartate Aminotransferase Day 1,457 (n=292, 130)
|
1.40 U/L
Standard Error 1.73
|
-1.82 U/L
Standard Error 1.40
|
|
Mean Change From BL in Liver Function Parameters in the OL Period
G-Glutamyl Transferase Day 1,457 (n=292, 130)
|
-5.15 U/L
Standard Error 2.35
|
-3.66 U/L
Standard Error 1.54
|
|
Mean Change From BL in Liver Function Parameters in the OL Period
Alkaline Phosphatase Day 1,821 (n=262,124)
|
-14.6 U/L
Standard Error 1.70
|
-14.7 U/L
Standard Error 1.99
|
|
Mean Change From BL in Liver Function Parameters in the OL Period
Alanine Aminotransferase Day 1,821 (n=262,124)
|
-0.95 U/L
Standard Error 1.49
|
-0.75 U/L
Standard Error 2.65
|
|
Mean Change From BL in Liver Function Parameters in the OL Period
Aspartate Aminotransferase Day 1,821 (n=262,124)
|
0.14 U/L
Standard Error 0.85
|
-0.52 U/L
Standard Error 1.52
|
|
Mean Change From BL in Liver Function Parameters in the OL Period
G-Glutamyl Transferase Day 1,821 (n=262,124)
|
-5.63 U/L
Standard Error 2.04
|
-4.65 U/L
Standard Error 1.55
|
|
Mean Change From BL in Liver Function Parameters in the OL Period
Alkaline Phosphatase Day 1,905 (n=134, 68)
|
-14.9 U/L
Standard Error 2.82
|
-10.6 U/L
Standard Error 3.19
|
|
Mean Change From BL in Liver Function Parameters in the OL Period
Alanine Aminotransferase Day 1,905 (n=134, 68)
|
-2.35 U/L
Standard Error 2.03
|
-5.74 U/L
Standard Error 4.66
|
|
Mean Change From BL in Liver Function Parameters in the OL Period
Aspartate Aminotransferase Day 1,905 (n=134, 68)
|
-0.49 U/L
Standard Error 1.18
|
-3.00 U/L
Standard Error 2.46
|
|
Mean Change From BL in Liver Function Parameters in the OL Period
G-Glutamyl Transferase Day 1,905 (n=134, 68)
|
-6.76 U/L
Standard Error 3.16
|
-3.09 U/L
Standard Error 2.91
|
|
Mean Change From BL in Liver Function Parameters in the OL Period
Alkaline Phosphatase Day 1,989 (n=121,56)
|
-12.4 U/L
Standard Error 2.80
|
-13.0 U/L
Standard Error 3.80
|
|
Mean Change From BL in Liver Function Parameters in the OL Period
Alanine Aminotransferase Day 1,989 (n=121,56)
|
-1.41 U/L
Standard Error 2.04
|
-4.98 U/L
Standard Error 5.60
|
|
Mean Change From BL in Liver Function Parameters in the OL Period
Aspartate Aminotransferase Day 1,989 (n=121,56)
|
0.20 U/L
Standard Error 1.24
|
-1.71 U/L
Standard Error 2.98
|
|
Mean Change From BL in Liver Function Parameters in the OL Period
G-Glutamyl Transferase Day 1,989 (n=121,56)
|
-3.66 U/L
Standard Error 3.58
|
-4.00 U/L
Standard Error 2.95
|
|
Mean Change From BL in Liver Function Parameters in the OL Period
Alkaline Phosphatase Day 2,073 (n=81,38)
|
-10.6 U/L
Standard Error 3.40
|
-4.24 U/L
Standard Error 3.57
|
|
Mean Change From BL in Liver Function Parameters in the OL Period
Alanine Aminotransferase Day 2,073 (n=81,38)
|
-0.56 U/L
Standard Error 2.82
|
-8.08 U/L
Standard Error 7.91
|
|
Mean Change From BL in Liver Function Parameters in the OL Period
Aspartate Aminotransferase Day 2,073 (n=81,38)
|
0.95 U/L
Standard Error 1.68
|
-2.37 U/L
Standard Error 4.26
|
|
Mean Change From BL in Liver Function Parameters in the OL Period
G-Glutamyl Transferase Day 2,073 (n=81,38)
|
-10.2 U/L
Standard Error 4.23
|
-4.92 U/L
Standard Error 3.49
|
|
Mean Change From BL in Liver Function Parameters in the OL Period
Alkaline Phosphatase Day 2,185 (n=82,37)
|
-14.2 U/L
Standard Error 2.79
|
-7.76 U/L
Standard Error 3.40
|
|
Mean Change From BL in Liver Function Parameters in the OL Period
Alanine Aminotransferase Day 2,185 (n=82,37)
|
0.60 U/L
Standard Error 1.60
|
-1.43 U/L
Standard Error 4.64
|
|
Mean Change From BL in Liver Function Parameters in the OL Period
G-Glutamyl Transferase Day 2,185 (n=82,37)
|
-13.9 U/L
Standard Error 3.81
|
-4.51 U/L
Standard Error 2.95
|
PRIMARY outcome
Timeframe: BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185Population: All treated participants in the OL period (treatment groups represent treatment received in the double-blind period). N = number of participants analyzed and n = the number of participants with measurements for that time point.
Mean baseline values are those that are reported for each cohort at each time point on Day 365 to Day 2,185.
Outcome measures
| Measure |
ABA + MTX DB
n=378 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=161 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Mean BL Select Laboratory Parameters in the OL Period
Uric Acid Day 2,185 (n=82,37)
|
4.61 mg/dL
Standard Deviation 1.22
|
4.60 mg/dL
Standard Deviation 1.39
|
|
Mean BL Select Laboratory Parameters in the OL Period
Total Bilirubin Day 365 (n=365, 157)
|
0.42 mg/dL
Standard Deviation 0.18
|
0.48 mg/dL
Standard Deviation 0.23
|
|
Mean BL Select Laboratory Parameters in the OL Period
Blood Urea Nitrogen (BUN) Day 365 (n=365, 157)
|
16.05 mg/dL
Standard Deviation 5.19
|
15.09 mg/dL
Standard Deviation 4.41
|
|
Mean BL Select Laboratory Parameters in the OL Period
Creatinine Day 365 (n=365, 157)
|
0.74 mg/dL
Standard Deviation 0.17
|
0.74 mg/dL
Standard Deviation 0.17
|
|
Mean BL Select Laboratory Parameters in the OL Period
Serum Calcium Day 365 (n=365, 157)
|
9.26 mg/dL
Standard Deviation 0.44
|
9.26 mg/dL
Standard Deviation 0.50
|
|
Mean BL Select Laboratory Parameters in the OL Period
Inorganic Phosphorous Day 365 (n=365, 157)
|
3.48 mg/dL
Standard Deviation 0.57
|
3.56 mg/dL
Standard Deviation 0.54
|
|
Mean BL Select Laboratory Parameters in the OL Period
Serum Glucose Day 365 (n=365, 157)
|
96.63 mg/dL
Standard Deviation 29.30
|
98.78 mg/dL
Standard Deviation 58.76
|
|
Mean BL Select Laboratory Parameters in the OL Period
Uric Acid Day 365 (n=365, 157)
|
4.80 mg/dL
Standard Deviation 1.45
|
4.83 mg/dL
Standard Deviation 1.50
|
|
Mean BL Select Laboratory Parameters in the OL Period
Total Bilirubin Day 729 (n=328, 143)
|
0.42 mg/dL
Standard Deviation 0.18
|
0.48 mg/dL
Standard Deviation 0.23
|
|
Mean BL Select Laboratory Parameters in the OL Period
BUN Day 729 (n=328, 143)
|
16.02 mg/dL
Standard Deviation 5.23
|
15.03 mg/dL
Standard Deviation 4.40
|
|
Mean BL Select Laboratory Parameters in the OL Period
Creatinine Day 729 (n=328, 143)
|
0.74 mg/dL
Standard Deviation 0.18
|
0.73 mg/dL
Standard Deviation 0.17
|
|
Mean BL Select Laboratory Parameters in the OL Period
Serum Calcium Day 729 (n=328, 143)
|
9.26 mg/dL
Standard Deviation 0.44
|
9.24 mg/dL
Standard Deviation 0.50
|
|
Mean BL Select Laboratory Parameters in the OL Period
Inorganic Phosphorous Day 729 (n=328, 143)
|
3.50 mg/dL
Standard Deviation 0.57
|
3.55 mg/dL
Standard Deviation 0.50
|
|
Mean BL Select Laboratory Parameters in the OL Period
Serum Glucose Day 729 (n=328, 143)
|
97.36 mg/dL
Standard Deviation 30.59
|
98.56 mg/dL
Standard Deviation 60.79
|
|
Mean BL Select Laboratory Parameters in the OL Period
Uric Acid Day 729 (n=328, 143)
|
4.79 mg/dL
Standard Deviation 1.41
|
4.75 mg/dL
Standard Deviation 1.34
|
|
Mean BL Select Laboratory Parameters in the OL Period
Total Bilirubin Day 1,093 (n=312, 138)
|
0.42 mg/dL
Standard Deviation 0.18
|
0.48 mg/dL
Standard Deviation 0.22
|
|
Mean BL Select Laboratory Parameters in the OL Period
BUN Day 1,093 (n=312, 138)
|
-0.36 mg/dL
Standard Deviation 0.26
|
0.00 mg/dL
Standard Deviation 0.40
|
|
Mean BL Select Laboratory Parameters in the OL Period
Creatinine Day 1,093 (n=312, 138)
|
0.73 mg/dL
Standard Deviation 0.17
|
0.74 mg/dL
Standard Deviation 0.17
|
|
Mean BL Select Laboratory Parameters in the OL Period
Serum Calcium Day 1,093 (n=312, 138)
|
0.04 mg/dL
Standard Deviation 0.03
|
0.02 mg/dL
Standard Deviation 0.04
|
|
Mean BL Select Laboratory Parameters in the OL Period
Inorganic Phosphorous Day 1,093 (n=312, 138)
|
0.02 mg/dL
Standard Deviation 0.04
|
0.10 mg/dL
Standard Deviation 0.05
|
|
Mean BL Select Laboratory Parameters in the OL Period
Serum Glucose Day 1,093 (n=312, 138)
|
96.49 mg/dL
Standard Deviation 29.70
|
97.65 mg/dL
Standard Deviation 61.54
|
|
Mean BL Select Laboratory Parameters in the OL Period
Uric Acid Day 1,093 (n=312, 138)
|
-0.15 mg/dL
Standard Deviation 0.06
|
-0.32 mg/dL
Standard Deviation 0.09
|
|
Mean BL Select Laboratory Parameters in the OL Period
Total Bilirubin Day 1,457 (n=292, 130)
|
0.42 mg/dL
Standard Deviation 0.18
|
0.49 mg/dL
Standard Deviation 0.23
|
|
Mean BL Select Laboratory Parameters in the OL Period
BUN Day 1,457 (n=292, 130)
|
15.86 mg/dL
Standard Deviation 5.28
|
15.02 mg/dL
Standard Deviation 4.36
|
|
Mean BL Select Laboratory Parameters in the OL Period
Creatinine Day 1,457 (n=292, 130)
|
0.73 mg/dL
Standard Deviation 0.17
|
0.74 mg/dL
Standard Deviation 0.18
|
|
Mean BL Select Laboratory Parameters in the OL Period
Serum Calcium Day 1,457 (n=292, 130)
|
9.26 mg/dL
Standard Deviation 0.45
|
9.25 mg/dL
Standard Deviation 0.46
|
|
Mean BL Select Laboratory Parameters in the OL Period
Inorganic Phosphorous Day 1,457 (n=292, 130)
|
3.49 mg/dL
Standard Deviation 0.54
|
3.54 mg/dL
Standard Deviation 0.50
|
|
Mean BL Select Laboratory Parameters in the OL Period
Serum Glucose Day 1,457 (n=292, 130)
|
95.81 mg/dL
Standard Deviation 28.90
|
95.35 mg/dL
Standard Deviation 55.47
|
|
Mean BL Select Laboratory Parameters in the OL Period
Uric Acid Day 1,457 (n=292, 130)
|
4.73 mg/dL
Standard Deviation 1.40
|
4.75 mg/dL
Standard Deviation 1.32
|
|
Mean BL Select Laboratory Parameters in the OL Period
Total Bilirubin Day Day 1,821 (n=262,124)
|
0.42 mg/dL
Standard Deviation 0.18
|
0.50 mg/dL
Standard Deviation 0.23
|
|
Mean BL Select Laboratory Parameters in the OL Period
BUN Day 1,821 (n=262,124)
|
15.93 mg/dL
Standard Deviation 5.29
|
14.88 mg/dL
Standard Deviation 3.96
|
|
Mean BL Select Laboratory Parameters in the OL Period
Creatinine Day 1,821 (n=262,124)
|
0.73 mg/dL
Standard Deviation 0.16
|
0.74 mg/dL
Standard Deviation 0.18
|
|
Mean BL Select Laboratory Parameters in the OL Period
Serum Calcium Day 1,821 (n=262,124)
|
9.25 mg/dL
Standard Deviation 0.45
|
9.25 mg/dL
Standard Deviation 0.46
|
|
Mean BL Select Laboratory Parameters in the OL Period
Inorganic Phosphorous Day 1,821 (n=262,124)
|
3.49 mg/dL
Standard Deviation 0.53
|
3.54 mg/dL
Standard Deviation 0.51
|
|
Mean BL Select Laboratory Parameters in the OL Period
Serum Glucose Day 1,821 (n=262,124)
|
96.81 mg/dL
Standard Deviation 30.21
|
98.59 mg/dL
Standard Deviation 64.79
|
|
Mean BL Select Laboratory Parameters in the OL Period
Uric Acid Day 1,821 (n=262,124)
|
4.66 mg/dL
Standard Deviation 1.29
|
4.68 mg/dL
Standard Deviation 1.31
|
|
Mean BL Select Laboratory Parameters in the OL Period
Total Bilirubin Day 1,905 (n=134, 68)
|
0.43 mg/dL
Standard Deviation 0.18
|
0.50 mg/dL
Standard Deviation 0.25
|
|
Mean BL Select Laboratory Parameters in the OL Period
BUN Day 1,905 (n=134, 68)
|
16.15 mg/dL
Standard Deviation 5.74
|
14.77 mg/dL
Standard Deviation 3.78
|
|
Mean BL Select Laboratory Parameters in the OL Period
Creatinine Day 1,905 (n=134, 68)
|
0.72 mg/dL
Standard Deviation 0.16
|
0.75 mg/dL
Standard Deviation 0.16
|
|
Mean BL Select Laboratory Parameters in the OL Period
Serum Calcium Day 1,905 (n=134, 68)
|
9.30 mg/dL
Standard Deviation 0.45
|
9.30 mg/dL
Standard Deviation 0.40
|
|
Mean BL Select Laboratory Parameters in the OL Period
Inorganic Phosphorous Day 1,905 (n=134, 68)
|
3.50 mg/dL
Standard Deviation 0.56
|
3.44 mg/dL
Standard Deviation 0.52
|
|
Mean BL Select Laboratory Parameters in the OL Period
Serum Glucose Day 1,905 (n=134, 68)
|
96.82 mg/dL
Standard Deviation 31.18
|
101.1 mg/dL
Standard Deviation 74.67
|
|
Mean BL Select Laboratory Parameters in the OL Period
Uric Acid Day 1,905 (n=134, 68)
|
4.70 mg/dL
Standard Deviation 1.25
|
4.93 mg/dL
Standard Deviation 1.30
|
|
Mean BL Select Laboratory Parameters in the OL Period
Total Bilirubin Day 1,989 (n=121,56)
|
0.43 mg/dL
Standard Deviation 0.18
|
0.52 mg/dL
Standard Deviation 0.27
|
|
Mean BL Select Laboratory Parameters in the OL Period
BUN Day 1,989 (n=121,56)
|
16.26 mg/dL
Standard Deviation 5.68
|
15.18 mg/dL
Standard Deviation 3.88
|
|
Mean BL Select Laboratory Parameters in the OL Period
Creatinine Day 1,989 (n=121,56)
|
0.71 mg/dL
Standard Deviation 0.14
|
0.72 mg/dL
Standard Deviation 0.15
|
|
Mean BL Select Laboratory Parameters in the OL Period
Serum Calcium Day 1,989 (n=121,56)
|
9.31 mg/dL
Standard Deviation 0.44
|
9.33 mg/dL
Standard Deviation 0.42
|
|
Mean BL Select Laboratory Parameters in the OL Period
Inorganic Phosphorous Day 1,989 (n=121,56)
|
3.51 mg/dL
Standard Deviation 0.57
|
3.45 mg/dL
Standard Deviation 0.53
|
|
Mean BL Select Laboratory Parameters in the OL Period
Serum Glucose Day 1,989 (n=121,56)
|
98.59 mg/dL
Standard Deviation 33.41
|
104.80 mg/dL
Standard Deviation 81.64
|
|
Mean BL Select Laboratory Parameters in the OL Period
Uric Acid Day 1,989 (n=121,56)
|
4.72 mg/dL
Standard Deviation 1.25
|
4.99 mg/dL
Standard Deviation 1.36
|
|
Mean BL Select Laboratory Parameters in the OL Period
Total Bilirubin Day 2,073 (n=81,38)
|
0.42 mg/dL
Standard Deviation 0.19
|
0.52 mg/dL
Standard Deviation 0.30
|
|
Mean BL Select Laboratory Parameters in the OL Period
BUN Day 2,073 (n=81,38)
|
16.36 mg/dL
Standard Deviation 5.83
|
15.27 mg/dL
Standard Deviation 3.91
|
|
Mean BL Select Laboratory Parameters in the OL Period
Creatinine Day 2,073 (n=81,38)
|
0.68 mg/dL
Standard Deviation 0.13
|
0.69 mg/dL
Standard Deviation 0.13
|
|
Mean BL Select Laboratory Parameters in the OL Period
Serum Calcium Day 2,073 (n=81,38)
|
9.41 mg/dL
Standard Deviation 0.36
|
9.48 mg/dL
Standard Deviation 0.38
|
|
Mean BL Select Laboratory Parameters in the OL Period
Inorganic Phosphorous Day 2,073 (n=81,38)
|
3.61 mg/dL
Standard Deviation 0.58
|
3.52 mg/dL
Standard Deviation 0.60
|
|
Mean BL Select Laboratory Parameters in the OL Period
Serum Glucose Day 2,073 (n=81,38)
|
100.4 mg/dL
Standard Deviation 31.96
|
111.1 mg/dL
Standard Deviation 97.97
|
|
Mean BL Select Laboratory Parameters in the OL Period
Uric Acid Day 2,073 (n=81,38)
|
4.58 mg/dL
Standard Deviation 1.19
|
4.60 mg/dL
Standard Deviation 1.37
|
|
Mean BL Select Laboratory Parameters in the OL Period
Total Bilirubin Day 2,185 (n=82,37)
|
0.42 mg/dL
Standard Deviation 0.18
|
0.52 mg/dL
Standard Deviation 0.30
|
|
Mean BL Select Laboratory Parameters in the OL Period
BUN Day 2,185 (n=82,37)
|
16.40 mg/dL
Standard Deviation 5.86
|
15.22 mg/dL
Standard Deviation 3.95
|
|
Mean BL Select Laboratory Parameters in the OL Period
Creatinine Day 2,185 (n=82,37)
|
0.68 mg/dL
Standard Deviation 0.13
|
0.69 mg/dL
Standard Deviation 0.13
|
|
Mean BL Select Laboratory Parameters in the OL Period
Serum Calcium Day 2,185 (n=82,37)
|
9.43 mg/dL
Standard Deviation 0.41
|
9.48 mg/dL
Standard Deviation 0.38
|
|
Mean BL Select Laboratory Parameters in the OL Period
Inorganic Phosphorous Day 2,185 (n=82,37)
|
3.58 mg/dL
Standard Deviation 0.58
|
3.54 mg/dL
Standard Deviation 0.61
|
|
Mean BL Select Laboratory Parameters in the OL Period
Serum Glucose Day 2,185 (n=82,37)
|
99.29 mg/dL
Standard Deviation 30.71
|
111.4 mg/dL
Standard Deviation 99.31
|
PRIMARY outcome
Timeframe: BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185Population: All treated participants in the OL period (treatment groups represent treatment received in the double-blind period). N = number of participants analyzed and n = the number of participants with measurements for that time point.
All changes in participant laboratory parameters were monitored on each day of study drug administration.
Outcome measures
| Measure |
ABA + MTX DB
n=378 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=161 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Mean Change From BL in Select Laboratory Parameters in the OL Period
Total Bilirubin Day 365 (n=365, 157)
|
0.06 mg/dL
Standard Error 0.01
|
0.00 mg/dL
Standard Error 0.01
|
|
Mean Change From BL in Select Laboratory Parameters in the OL Period
Blood Urea Nitrogen (BUN) Day 365 (n=365, 157)
|
16.05 mg/dL
Standard Error 5.19
|
15.09 mg/dL
Standard Error 4.41
|
|
Mean Change From BL in Select Laboratory Parameters in the OL Period
Creatinine Day 365 (n=365, 157)
|
0.74 mg/dL
Standard Error 0.17
|
0.74 mg/dL
Standard Error 0.17
|
|
Mean Change From BL in Select Laboratory Parameters in the OL Period
Serum Calcium Day 365 (n=365, 157)
|
0.25 mg/dL
Standard Error 0.02
|
0.22 mg/dL
Standard Error 0.04
|
|
Mean Change From BL in Select Laboratory Parameters in the OL Period
Inorganic Phosphorous Day 365 (n=365, 157)
|
-0.02 mg/dL
Standard Error 0.03
|
-0.12 mg/dL
Standard Error 0.04
|
|
Mean Change From BL in Select Laboratory Parameters in the OL Period
Serum Glucose Day 365 (n=365, 157)
|
-1.65 mg/dL
Standard Error 1.26
|
-4.06 mg/dL
Standard Error 4.29
|
|
Mean Change From BL in Select Laboratory Parameters in the OL Period
Uric Acid Day 365 (n=365, 157)
|
0.04 mg/dL
Standard Error 0.05
|
-0.06 mg/dL
Standard Error 0.07
|
|
Mean Change From BL in Select Laboratory Parameters in the OL Period
Total Bilirubin Day 729 (n=328, 143)
|
0.09 mg/dL
Standard Error 0.01
|
0.05 mg/dL
Standard Error 0.02
|
|
Mean Change From BL in Select Laboratory Parameters in the OL Period
BUN Day 729 (n=328, 143)
|
-0.38 mg/dL
Standard Error 0.31
|
-0.06 mg/dL
Standard Error 0.35
|
|
Mean Change From BL in Select Laboratory Parameters in the OL Period
Creatinine Day 729 (n=328, 143)
|
0.08 mg/dL
Standard Error 0.01
|
0.08 mg/dL
Standard Error 0.01
|
|
Mean Change From BL in Select Laboratory Parameters in the OL Period
Serum Calcium Day 729 (n=328, 143)
|
0.14 mg/dL
Standard Error 0.03
|
0.18 mg/dL
Standard Error 0.05
|
|
Mean Change From BL in Select Laboratory Parameters in the OL Period
Inorganic Phosphorous Day 729 (n=328, 143)
|
-0.06 mg/dL
Standard Error 0.03
|
-0.10 mg/dL
Standard Error 0.05
|
|
Mean Change From BL in Select Laboratory Parameters in the OL Period
Serum Glucose Day 729 (n=328, 143)
|
-1.77 mg/dL
Standard Error 1.67
|
-4.74 mg/dL
Standard Error 5.18
|
|
Mean Change From BL in Select Laboratory Parameters in the OL Period
Uric Acid Day 729 (n=328, 143)
|
0.11 mg/dL
Standard Error 0.06
|
0.00 mg/dL
Standard Error 0.09
|
|
Mean Change From BL in Select Laboratory Parameters in the OL Period
Total Bilirubin Day 1,093 (n=312, 138)
|
0.05 mg/dL
Standard Error 0.01
|
0.01 mg/dL
Standard Error 0.02
|
|
Mean Change From BL in Select Laboratory Parameters in the OL Period
BUN Day 1,093 (n=312, 138)
|
-0.36 mg/dL
Standard Error 0.26
|
0.00 mg/dL
Standard Error 0.40
|
|
Mean Change From BL in Select Laboratory Parameters in the OL Period
Creatinine Day 1,093 (n=312, 138)
|
-0.00 mg/dL
Standard Error 0.01
|
-0.03 mg/dL
Standard Error 0.01
|
|
Mean Change From BL in Select Laboratory Parameters in the OL Period
Serum Calcium Day 1,093 (n=312, 138)
|
0.04 mg/dL
Standard Error 0.03
|
0.02 mg/dL
Standard Error 0.04
|
|
Mean Change From BL in Select Laboratory Parameters in the OL Period
Inorganic Phosphorous Day 1,093 (n=312, 138)
|
0.02 mg/dL
Standard Error 0.04
|
0.10 mg/dL
Standard Error 0.05
|
|
Mean Change From BL in Select Laboratory Parameters in the OL Period
Serum Glucose Day 1,093 (n=312, 138)
|
0.36 mg/dL
Standard Error 1.63
|
-4.95 mg/dL
Standard Error 4.84
|
|
Mean Change From BL in Select Laboratory Parameters in the OL Period
Uric Acid Day 1,093 (n=312, 138)
|
-0.15 mg/dL
Standard Error 0.06
|
-0.32 mg/dL
Standard Error 0.09
|
|
Mean Change From BL in Select Laboratory Parameters in the OL Period
Total Bilirubin Day 1,457 (n=292, 130)
|
0.01 mg/dL
Standard Error 0.01
|
-0.04 mg/dL
Standard Error 0.02
|
|
Mean Change From BL in Select Laboratory Parameters in the OL Period
BUN Day 1,457 (n=292, 130)
|
-0.48 mg/dL
Standard Error 0.27
|
-0.47 mg/dL
Standard Error 0.42
|
|
Mean Change From BL in Select Laboratory Parameters in the OL Period
Creatinine Day 1,457 (n=292, 130)
|
0.02 mg/dL
Standard Error 0.01
|
-0.03 mg/dL
Standard Error 0.01
|
|
Mean Change From BL in Select Laboratory Parameters in the OL Period
Serum Calcium Day 1,457 (n=292, 130)
|
-0.08 mg/dL
Standard Error 0.03
|
-0.08 mg/dL
Standard Error 0.04
|
|
Mean Change From BL in Select Laboratory Parameters in the OL Period
Inorganic Phosphorous Day 1,457 (n=292, 130)
|
-0.00 mg/dL
Standard Error 0.04
|
0.02 mg/dL
Standard Error 0.05
|
|
Mean Change From BL in Select Laboratory Parameters in the OL Period
Serum Glucose Day 1,457 (n=292, 130)
|
0.43 mg/dL
Standard Error 1.53
|
-0.12 mg/dL
Standard Error 5.09
|
|
Mean Change From BL in Select Laboratory Parameters in the OL Period
Uric Acid Day 1,457 (n=292, 130)
|
-0.19 mg/dL
Standard Error 0.06
|
-0.43 mg/dL
Standard Error 0.09
|
|
Mean Change From BL in Select Laboratory Parameters in the OL Period
Total Bilirubin Day Day 1,821 (n=262,124)
|
0.01 mg/dL
Standard Error 0.01
|
-0.01 mg/dL
Standard Error 0.04
|
|
Mean Change From BL in Select Laboratory Parameters in the OL Period
BUN Day 1,821 (n=262,124)
|
-0.54 mg/dL
Standard Error 0.28
|
0.30 mg/dL
Standard Error 0.44
|
|
Mean Change From BL in Select Laboratory Parameters in the OL Period
Creatinine Day 1,821 (n=262,124)
|
-0.01 mg/dL
Standard Error 0.01
|
-0.04 mg/dL
Standard Error 0.02
|
|
Mean Change From BL in Select Laboratory Parameters in the OL Period
Serum Calcium Day 1,821 (n=262,124)
|
-0.07 mg/dL
Standard Error 0.03
|
-0.04 mg/dL
Standard Error 0.04
|
|
Mean Change From BL in Select Laboratory Parameters in the OL Period
Inorganic Phosphorous Day 1,821 (n=262,124)
|
0.02 mg/dL
Standard Error 0.04
|
0.01 mg/dL
Standard Error 0.05
|
|
Mean Change From BL in Select Laboratory Parameters in the OL Period
Serum Glucose Day 1,821 (n=262,124)
|
3.27 mg/dL
Standard Error 1.86
|
-0.02 mg/dL
Standard Error 5.51
|
|
Mean Change From BL in Select Laboratory Parameters in the OL Period
Uric Acid Day 1,821 (n=262,124)
|
-0.13 mg/dL
Standard Error 0.06
|
-0.30 mg/dL
Standard Error 0.09
|
|
Mean Change From BL in Select Laboratory Parameters in the OL Period
Total Bilirubin Day 1,905 (n=134, 68)
|
0.01 mg/dL
Standard Error 0.02
|
-0.05 mg/dL
Standard Error 0.04
|
|
Mean Change From BL in Select Laboratory Parameters in the OL Period
BUN Day 1,905 (n=134, 68)
|
-0.36 mg/dL
Standard Error 0.39
|
0.56 mg/dL
Standard Error 0.57
|
|
Mean Change From BL in Select Laboratory Parameters in the OL Period
Creatinine Day 1,905 (n=134, 68)
|
-0.04 mg/dL
Standard Error 0.01
|
-0.03 mg/dL
Standard Error 0.02
|
|
Mean Change From BL in Select Laboratory Parameters in the OL Period
Serum Calcium Day 1,905 (n=134, 68)
|
-0.12 mg/dL
Standard Error 0.04
|
-0.11 mg/dL
Standard Error 0.05
|
|
Mean Change From BL in Select Laboratory Parameters in the OL Period
Inorganic Phosphorous Day 1,905 (n=134, 68)
|
-0.03 mg/dL
Standard Error 0.06
|
0.11 mg/dL
Standard Error 0.08
|
|
Mean Change From BL in Select Laboratory Parameters in the OL Period
Serum Glucose Day 1,905 (n=134, 68)
|
3.00 mg/dL
Standard Error 2.96
|
-0.50 mg/dL
Standard Error 9.71
|
|
Mean Change From BL in Select Laboratory Parameters in the OL Period
Uric Acid Day 1,905 (n=134, 68)
|
-0.29 mg/dL
Standard Error 0.09
|
-0.29 mg/dL
Standard Error 0.12
|
|
Mean Change From BL in Select Laboratory Parameters in the OL Period
Total Bilirubin Day 1,989 (n=121,56)
|
0.01 mg/dL
Standard Error 0.02
|
-0.03 mg/dL
Standard Error 0.03
|
|
Mean Change From BL in Select Laboratory Parameters in the OL Period
BUN Day 1,989 (n=121,56)
|
-0.31 mg/dL
Standard Error 0.45
|
0.09 mg/dL
Standard Error 0.64
|
|
Mean Change From BL in Select Laboratory Parameters in the OL Period
Creatinine Day 1,989 (n=121,56)
|
-0.01 mg/dL
Standard Error 0.01
|
-0.02 mg/dL
Standard Error 0.02
|
|
Mean Change From BL in Select Laboratory Parameters in the OL Period
Serum Calcium Day 1,989 (n=121,56)
|
-0.10 mg/dL
Standard Error 0.04
|
-0.08 mg/dL
Standard Error 0.05
|
|
Mean Change From BL in Select Laboratory Parameters in the OL Period
Inorganic Phosphorous Day 1,989 (n=121,56)
|
-0.07 mg/dL
Standard Error 0.06
|
0.08 mg/dL
Standard Error 0.08
|
|
Mean Change From BL in Select Laboratory Parameters in the OL Period
Serum Glucose Day 1,989 (n=121,56)
|
-1.58 mg/dL
Standard Error 2.85
|
-2.70 mg/dL
Standard Error 11.88
|
|
Mean Change From BL in Select Laboratory Parameters in the OL Period
Uric Acid Day 1,989 (n=121,56)
|
-0.29 mg/dL
Standard Error 0.09
|
-0.38 mg/dL
Standard Error 0.14
|
|
Mean Change From BL in Select Laboratory Parameters in the OL Period
Total Bilirubin Day 2,073 (n=81,38)
|
0.04 mg/dL
Standard Error 0.02
|
-0.100 mg/dL
Standard Error 0.04
|
|
Mean Change From BL in Select Laboratory Parameters in the OL Period
BUN Day 2,073 (n=81,38)
|
0.33 mg/dL
Standard Error 0.47
|
0.84 mg/dL
Standard Error 0.72
|
|
Mean Change From BL in Select Laboratory Parameters in the OL Period
Creatinine Day 2,073 (n=81,38)
|
0.05 mg/dL
Standard Error 0.01
|
0.04 mg/dL
Standard Error 0.03
|
|
Mean Change From BL in Select Laboratory Parameters in the OL Period
Serum Calcium Day 2,073 (n=81,38)
|
-0.10 mg/dL
Standard Error 0.04
|
-0.20 mg/dL
Standard Error 0.08
|
|
Mean Change From BL in Select Laboratory Parameters in the OL Period
Inorganic Phosphorous Day 2,073 (n=81,38)
|
-0.11 mg/dL
Standard Error 0.07
|
-0.11 mg/dL
Standard Error 0.12
|
|
Mean Change From BL in Select Laboratory Parameters in the OL Period
Serum Glucose Day 2,073 (n=81,38)
|
-0.74 mg/dL
Standard Error 3.13
|
-18.2 mg/dL
Standard Error 16.92
|
|
Mean Change From BL in Select Laboratory Parameters in the OL Period
Uric Acid Day 2,073 (n=81,38)
|
-0.08 mg/dL
Standard Error 0.11
|
-0.15 mg/dL
Standard Error 0.16
|
|
Mean Change From BL in Select Laboratory Parameters in the OL Period
Total Bilirubin Day 2,185 (n=82,37)
|
0.05 mg/dL
Standard Error 0.02
|
0.00 mg/dL
Standard Error 0.04
|
|
Mean Change From BL in Select Laboratory Parameters in the OL Period
BUN Day 2,185 (n=82,37)
|
0.51 mg/dL
Standard Error 0.53
|
0.18 mg/dL
Standard Error 0.56
|
|
Mean Change From BL in Select Laboratory Parameters in the OL Period
Creatinine Day 2,185 (n=82,37)
|
0.03 mg/dL
Standard Error 0.01
|
0.04 mg/dL
Standard Error 0.02
|
|
Mean Change From BL in Select Laboratory Parameters in the OL Period
Serum Calcium Day 2,185 (n=82,37)
|
-0.27 mg/dL
Standard Error 0.04
|
-0.19 mg/dL
Standard Error 0.07
|
|
Mean Change From BL in Select Laboratory Parameters in the OL Period
Inorganic Phosphorous Day 2,185 (n=82,37)
|
-0.14 mg/dL
Standard Error 0.07
|
-0.13 mg/dL
Standard Error 0.13
|
|
Mean Change From BL in Select Laboratory Parameters in the OL Period
Serum Glucose Day 2,185 (n=82,37)
|
6.85 mg/dL
Standard Error 3.81
|
-8.86 mg/dL
Standard Error 17.98
|
|
Mean Change From BL in Select Laboratory Parameters in the OL Period
Uric Acid Day 2,185 (n=82,37)
|
-0.12 mg/dL
Standard Error 0.10
|
-0.17 mg/dL
Standard Error 0.14
|
PRIMARY outcome
Timeframe: BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185Population: All treated participants in the OL period (treatment groups represent treatment received in the double-blind period). N = number of participants analyzed and n = the number of participants with measurements for that time point.
Mean baseline values are those that are reported for each cohort at each time point on Day 365 to Day 2,185.
Outcome measures
| Measure |
ABA + MTX DB
n=378 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=161 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Mean BL Serum Electrolytes in the OL Period
Serum Sodium Day 365 (n=365, 157)
|
139.9 mEq/L
Standard Deviation 2.89
|
140.7 mEq/L
Standard Deviation 3.03
|
|
Mean BL Serum Electrolytes in the OL Period
Serum Potassium Day 365 (n=365, 157)
|
4.27 mEq/L
Standard Deviation 0.37
|
4.29 mEq/L
Standard Deviation 0.43
|
|
Mean BL Serum Electrolytes in the OL Period
Serum Chloride Day 365 (n=365, 157)
|
104.1 mEq/L
Standard Deviation 3.17
|
105.0 mEq/L
Standard Deviation 3.63
|
|
Mean BL Serum Electrolytes in the OL Period
Serum Sodium Day 729 (n=328, 143)
|
139.8 mEq/L
Standard Deviation 2.97
|
140.7 mEq/L
Standard Deviation 3.06
|
|
Mean BL Serum Electrolytes in the OL Period
Serum Potassium Day 729 (n=328, 143)
|
4.27 mEq/L
Standard Deviation 0.36
|
4.30 mEq/L
Standard Deviation 0.42
|
|
Mean BL Serum Electrolytes in the OL Period
Serum Chloride Day 729 (n=328, 143)
|
103.9 mEq/L
Standard Deviation 3.13
|
104.9 mEq/L
Standard Deviation 3.65
|
|
Mean BL Serum Electrolytes in the OL Period
Serum Sodium Day 1,093 (n=312, 138)
|
139.9 mEq/L
Standard Deviation 2.88
|
140.7 mEq/L
Standard Deviation 3.11
|
|
Mean BL Serum Electrolytes in the OL Period
Serum Potassium Day 1,093 (n=312, 138)
|
4.27 mEq/L
Standard Deviation 0.36
|
4.27 mEq/L
Standard Deviation 0.39
|
|
Mean BL Serum Electrolytes in the OL Period
Serum Chloride Day 1,093 (n=312, 138)
|
104.0 mEq/L
Standard Deviation 3.08
|
104.9 mEq/L
Standard Deviation 3.64
|
|
Mean BL Serum Electrolytes in the OL Period
Serum Sodium Day 1,457 (n=292, 130)
|
139.9 mEq/L
Standard Deviation 2.83
|
140.7 mEq/L
Standard Deviation 3.16
|
|
Mean BL Serum Electrolytes in the OL Period
Serum Potassium Day 1,457 (n=292, 130)
|
4.27 mEq/L
Standard Deviation 0.35
|
4.27 mEq/L
Standard Deviation 0.38
|
|
Mean BL Serum Electrolytes in the OL Period
Serum Chloride Day 1,457 (n=292, 130)
|
104.0 mEq/L
Standard Deviation 3.06
|
105.0 mEq/L
Standard Deviation 3.64
|
|
Mean BL Serum Electrolytes in the OL Period
Serum Sodium Day 1,821 (n=262,124)
|
140.0 mEq/L
Standard Deviation 2.84
|
140.7 mEq/L
Standard Deviation 3.11
|
|
Mean BL Serum Electrolytes in the OL Period
Serum Potassium Day 1,821 (n=262,124)
|
4.26 mEq/L
Standard Deviation 0.36
|
4.28 mEq/L
Standard Deviation 0.40
|
|
Mean BL Serum Electrolytes in the OL Period
Serum Chloride Day 1,821 (n=262,124)
|
104.1 mEq/L
Standard Deviation 3.08
|
104.8 mEq/L
Standard Deviation 3.60
|
|
Mean BL Serum Electrolytes in the OL Period
Serum Sodium Day 1,905 (n=134, 68)
|
139.6 mEq/L
Standard Deviation 3.13
|
140.5 mEq/L
Standard Deviation 3.56
|
|
Mean BL Serum Electrolytes in the OL Period
Serum Potassium Day 1,905 (n=134, 68)
|
4.25 mEq/L
Standard Deviation 0.37
|
4.25 mEq/L
Standard Deviation 0.42
|
|
Mean BL Serum Electrolytes in the OL Period
Serum Chloride Day 1,905 (n=134, 68)
|
103.9 mEq/L
Standard Deviation 3.44
|
104.9 mEq/L
Standard Deviation 4.03
|
|
Mean BL Serum Electrolytes in the OL Period
Serum Sodium Day 1,989 (n=121,56)
|
139.5 mEq/L
Standard Deviation 3.14
|
140.1 mEq/L
Standard Deviation 3.72
|
|
Mean BL Serum Electrolytes in the OL Period
Serum Potassium Day 1,989 (n=121,56)
|
4.27 mEq/L
Standard Deviation 0.41
|
4.24 mEq/L
Standard Deviation 0.43
|
|
Mean BL Serum Electrolytes in the OL Period
Serum Chloride Day 1,989 (n=121,56)
|
103.8 mEq/L
Standard Deviation 3.61
|
104.8 mEq/L
Standard Deviation 4.33
|
|
Mean BL Serum Electrolytes in the OL Period
Serum Sodium Day 2,073 (n=81,38)
|
138.2 mEq/L
Standard Deviation 2.33
|
139.0 mEq/L
Standard Deviation 3.91
|
|
Mean BL Serum Electrolytes in the OL Period
Serum Potassium Day 2,073 (n=81,38)
|
4.31 mEq/L
Standard Deviation 0.44
|
4.27 mEq/L
Standard Deviation 0.48
|
|
Mean BL Serum Electrolytes in the OL Period
Serum Chloride Day 2,073 (n=81,38)
|
102.3 mEq/L
Standard Deviation 2.57
|
103.0 mEq/L
Standard Deviation 4.23
|
|
Mean BL Serum Electrolytes in the OL Period
Serum Sodium Day 2,185 (n=82,37)
|
138.2 mEq/L
Standard Deviation 2.31
|
138.9 mEq/L
Standard Deviation 3.93
|
|
Mean BL Serum Electrolytes in the OL Period
Serum Potassium Day 2,185 (n=82,37)
|
4.30 mEq/L
Standard Deviation 0.43
|
4.28 mEq/L
Standard Deviation 0.49
|
|
Mean BL Serum Electrolytes in the OL Period
Serum Chloride Day 2,185 (n=82,37)
|
102.3 mEq/L
Standard Deviation 2.51
|
102.9 mEq/L
Standard Deviation 4.24
|
PRIMARY outcome
Timeframe: BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185Population: All treated participants in the OL period (treatment groups represent treatment received in the double-blind period). N = number of participants analyzed and n = the number of participants with measurements for that time point.
All changes in participant laboratory parameters were monitored on each day of study drug administration.
Outcome measures
| Measure |
ABA + MTX DB
n=378 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=161 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Mean Change From BL in Serum Electrolytes in the OL Period
Serum Sodium Day 365 (n=365, 157)
|
-0.42 mEq/L
Standard Error 0.17
|
-1.37 mEq/L
Standard Error 0.27
|
|
Mean Change From BL in Serum Electrolytes in the OL Period
Serum Potassium Day 365 (n=365, 157)
|
-0.01 mEq/L
Standard Error 0.02
|
-0.06 mEq/L
Standard Error 0.03
|
|
Mean Change From BL in Serum Electrolytes in the OL Period
Serum Chloride Day 365 (n=365, 157)
|
0.43 mEq/L
Standard Error 0.14
|
-0.21 mEq/L
Standard Error 0.25
|
|
Mean Change From BL in Serum Electrolytes in the OL Period
Serum Sodium Day 729 (n=328, 143)
|
0.71 mEq/L
Standard Error 0.19
|
-0.29 mEq/L
Standard Error 0.29
|
|
Mean Change From BL in Serum Electrolytes in the OL Period
Serum Potassium Day 729 (n=328, 143)
|
-0.03 mEq/L
Standard Error 0.02
|
-0.12 mEq/L
Standard Error 0.04
|
|
Mean Change From BL in Serum Electrolytes in the OL Period
Serum Chloride Day 729 (n=328, 143)
|
0.63 mEq/L
Standard Error 0.17
|
0.15 mEq/L
Standard Error 0.27
|
|
Mean Change From BL in Serum Electrolytes in the OL Period
Serum Sodium Day 1,093 (n=312, 138)
|
-0.29 mEq/L
Standard Error 0.21
|
-1.34 mEq/L
Standard Error 0.34
|
|
Mean Change From BL in Serum Electrolytes in the OL Period
Serum Potassium Day 1,093 (n=312, 138)
|
-0.05 mEq/L
Standard Error 0.02
|
-0.08 mEq/L
Standard Error 0.04
|
|
Mean Change From BL in Serum Electrolytes in the OL Period
Serum Chloride Day 1,093 (n=312, 138)
|
-0.35 mEq/L
Standard Error 0.18
|
-1.17 mEq/L
Standard Error 0.31
|
|
Mean Change From BL in Serum Electrolytes in the OL Period
Serum Sodium Day 1,457 (n=292, 130)
|
-0.18 mEq/L
Standard Error 0.25
|
-0.88 mEq/L
Standard Error 0.40
|
|
Mean Change From BL in Serum Electrolytes in the OL Period
Serum Potassium Day 1,457 (n=292, 130)
|
-0.03 mEq/L
Standard Error 0.03
|
-0.08 mEq/L
Standard Error 0.04
|
|
Mean Change From BL in Serum Electrolytes in the OL Period
Serum Chloride Day 1,457 (n=292, 130)
|
104.0 mEq/L
Standard Error 3.06
|
105.0 mEq/L
Standard Error 3.64
|
|
Mean Change From BL in Serum Electrolytes in the OL Period
Serum Sodium Day 1,821 (n=262,124)
|
-0.68 mEq/L
Standard Error 0.24
|
-1.29 mEq/L
Standard Error 0.38
|
|
Mean Change From BL in Serum Electrolytes in the OL Period
Serum Potassium Day 1,821 (n=262,124)
|
-0.08 mEq/L
Standard Error 0.02
|
-0.15 mEq/L
Standard Error 0.04
|
|
Mean Change From BL in Serum Electrolytes in the OL Period
Serum Chloride Day 1,821 (n=262,124)
|
-0.19 mEq/L
Standard Error 0.22
|
-0.69 mEq/L
Standard Error 0.34
|
|
Mean Change From BL in Serum Electrolytes in the OL Period
Serum Sodium Day 1,905 (n=134, 68)
|
-0.27 mEq/L
Standard Error 0.36
|
-0.75 mEq/L
Standard Error 0.54
|
|
Mean Change From BL in Serum Electrolytes in the OL Period
Serum Potassium Day 1,905 (n=134, 68)
|
-0.06 mEq/L
Standard Error 0.04
|
-0.06 mEq/L
Standard Error 0.05
|
|
Mean Change From BL in Serum Electrolytes in the OL Period
Serum Chloride Day 1,905 (n=134, 68)
|
0.31 mEq/L
Standard Error 0.33
|
-0.15 mEq/L
Standard Error 0.53
|
|
Mean Change From BL in Serum Electrolytes in the OL Period
Serum Sodium Day 1,989 (n=121,56)
|
-0.02 mEq/L
Standard Error 0.40
|
-0.25 mEq/L
Standard Error 0.66
|
|
Mean Change From BL in Serum Electrolytes in the OL Period
Serum Potassium Day 1,989 (n=121,56)
|
-0.05 mEq/L
Standard Error 0.04
|
-0.12 mEq/L
Standard Error 0.06
|
|
Mean Change From BL in Serum Electrolytes in the OL Period
Serum Chloride Day 1,989 (n=121,56)
|
0.40 mEq/L
Standard Error 0.38
|
-0.52 mEq/L
Standard Error 0.60
|
|
Mean Change From BL in Serum Electrolytes in the OL Period
Serum Sodium Day 2,073 (n=81,38)
|
2.56 mEq/L
Standard Error 0.32
|
2.05 mEq/L
Standard Error 0.71
|
|
Mean Change From BL in Serum Electrolytes in the OL Period
Serum Potassium Day 2,073 (n=81,38)
|
-0.10 mEq/L
Standard Error 0.05
|
-0.14 mEq/L
Standard Error 0.08
|
|
Mean Change From BL in Serum Electrolytes in the OL Period
Serum Chloride Day 2,073 (n=81,38)
|
2.27 mEq/L
Standard Error 0.40
|
1.89 mEq/L
Standard Error 0.72
|
|
Mean Change From BL in Serum Electrolytes in the OL Period
Serum Sodium Day 2,185 (n=82,37)
|
2.76 mEq/L
Standard Error 0.34
|
2.24 mEq/L
Standard Error 0.68
|
|
Mean Change From BL in Serum Electrolytes in the OL Period
Serum Potassium Day 2,185 (n=82,37)
|
-0.11 mEq/L
Standard Error 0.05
|
-0.20 mEq/L
Standard Error 0.08
|
|
Mean Change From BL in Serum Electrolytes in the OL Period
Serum Chloride Day 2,185 (n=82,37)
|
2.95 mEq/L
Standard Error 0.40
|
1.81 mEq/L
Standard Error 0.72
|
SECONDARY outcome
Timeframe: BL (Day 0)Population: All randomized and treated participants in the DB period.
Outcome measures
| Measure |
ABA + MTX DB
n=433 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=219 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Mean Number of Tender Joints and Swollen Joints at DB BL
Tender Joints
|
31.0 Joints
Standard Deviation 13.2
|
32.3 Joints
Standard Deviation 13.6
|
|
Mean Number of Tender Joints and Swollen Joints at DB BL
Swollen Joints
|
21.4 Joints
Standard Deviation 8.8
|
22.1 Joints
Standard Deviation 8.8
|
SECONDARY outcome
Timeframe: BL (Day 0)Population: All randomized and treated participants in the DB period.
Participant physical pain assessment was determined at baseline on the Visual Analog Scale (VAS) of 0 mm to 100 mm where 0mm is no pain and 100mm is worst pain possible. The mean participant global assessment is a measure of overall disease burden and is a component of the ACR and evaluated using the VAS 100 mm. The physician global assessment is a measure of overall disease burden and is a component of the ACR and evaluated using the VAS 0mm to 100 mm with 0mm indicating no disease burden and 100mm indicating worse disease burden possible.
Outcome measures
| Measure |
ABA + MTX DB
n=433 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=219 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Mean DB BL Participant Physical Pain Assessment, Participant Global Assessment, and Physician Global Assessment
Participant Physical Pain Assessment
|
63.3 Units on a Scale
Standard Deviation 21.1
|
65.9 Units on a Scale
Standard Deviation 20.6
|
|
Mean DB BL Participant Physical Pain Assessment, Participant Global Assessment, and Physician Global Assessment
Participant Global Assessment
|
62.7 Units on a Scale
Standard Deviation 21.2
|
62.8 Units on a Scale
Standard Deviation 21.6
|
|
Mean DB BL Participant Physical Pain Assessment, Participant Global Assessment, and Physician Global Assessment
Physician Global Assessment
|
68.0 Units on a Scale
Standard Deviation 16.0
|
67.4 Units on a Scale
Standard Deviation 17.0
|
SECONDARY outcome
Timeframe: BL (Day 365)Population: All treated participants in the OL period (treatment groups represent treatment received in the DB period).
This analysis determined whether participants in the OL period were RF positive or RF negative based on serum samples. A positive value for RF was \> 20 IU/ml; a negative value for RF was ≤ 20 IU/mL.
Outcome measures
| Measure |
ABA + MTX DB
n=378 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=161 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
BL Rheumatoid Factor (RF) Status for Participants Continuing in the OL Period
RF Negative
|
42 Participants
|
18 Participants
|
|
BL Rheumatoid Factor (RF) Status for Participants Continuing in the OL Period
RF Positive
|
312 Participants
|
130 Participants
|
SECONDARY outcome
Timeframe: Day 365Population: Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis.
ACR 20 response requires a patient to have a 20% reduction in the number of swollen and tender joints, and a reduction of 20% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score. A participant achieved a sustained ACR 20 response if the participant had ACR 20 observed for at least 2 consecutive study visits.
Outcome measures
| Measure |
ABA + MTX DB
n=424 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=214 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
ACR 20 Responders at Day 365
|
310 Participants
|
85 Participants
|
SECONDARY outcome
Timeframe: Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365Population: Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis.
ACR 20 response requires a patient to have a 20% reduction in the number of swollen and tender joints, and a reduction of 20% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score.
Outcome measures
| Measure |
ABA + MTX DB
n=424 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=214 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
ACR 20 Responders in the Double-Blind (DB) Period
Day 15
|
97 Participants
|
30 Participants
|
|
ACR 20 Responders in the Double-Blind (DB) Period
Day 29
|
155 Participants
|
51 Participants
|
|
ACR 20 Responders in the Double-Blind (DB) Period
Day 57
|
237 Participants
|
75 Participants
|
|
ACR 20 Responders in the Double-Blind (DB) Period
Day 85
|
262 Participants
|
80 Participants
|
|
ACR 20 Responders in the Double-Blind (DB) Period
Day 113
|
283 Participants
|
86 Participants
|
|
ACR 20 Responders in the Double-Blind (DB) Period
Day 141
|
291 Participants
|
93 Participants
|
|
ACR 20 Responders in the Double-Blind (DB) Period
Day 169
|
288 Participants
|
85 Participants
|
|
ACR 20 Responders in the Double-Blind (DB) Period
Day 225
|
318 Participants
|
91 Participants
|
|
ACR 20 Responders in the Double-Blind (DB) Period
Day 281
|
312 Participants
|
94 Participants
|
|
ACR 20 Responders in the Double-Blind (DB) Period
Day 365
|
310 Participants
|
85 Participants
|
SECONDARY outcome
Timeframe: Day 169Population: Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis.
ACR 50 response requires a patient to have a 50% reduction in the number of swollen and tender joints, and a reduction of 50% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score. A participant achieved a sustained ACR 50 response if the participant had ACR 50 observed for at least 2 consecutive study visits.
Outcome measures
| Measure |
ABA + MTX DB
n=424 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=214 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
ACR 50 Responders at Day 169
|
169 Participants
|
36 Participants
|
SECONDARY outcome
Timeframe: Day 365Population: Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis.
ACR 50 response requires a patient to have a 50% reduction in the number of swollen and tender joints, and a reduction of 50% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score.
Outcome measures
| Measure |
ABA + MTX DB
n=424 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=214 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
ACR 50 Responders at Day 365
|
205 Participants
|
39 Participants
|
SECONDARY outcome
Timeframe: Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365Population: Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis.
ACR 50 response requires a patient to have a 50% reduction in the number of swollen and tender joints, and a reduction of 50% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score. A participant achieved a sustained ACR 50 response if the participant had ACR 50 observed for at least 2 consecutive study visits.
Outcome measures
| Measure |
ABA + MTX DB
n=424 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=214 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
ACR 50 Responders in the DB Period
Day 15
|
12 Participants
|
2 Participants
|
|
ACR 50 Responders in the DB Period
Day 29
|
36 Participants
|
9 Participants
|
|
ACR 50 Responders in the DB Period
Day 57
|
87 Participants
|
16 Participants
|
|
ACR 50 Responders in the DB Period
Day 85
|
135 Participants
|
17 Participants
|
|
ACR 50 Responders in the DB Period
Day 113
|
148 Participants
|
27 Participants
|
|
ACR 50 Responders in the DB Period
Day 141
|
162 Participants
|
39 Participants
|
|
ACR 50 Responders in the DB Period
Day 169
|
169 Participants
|
36 Participants
|
|
ACR 50 Responders in the DB Period
Day 225
|
197 Participants
|
42 Participants
|
|
ACR 50 Responders in the DB Period
Day 281
|
200 Participants
|
38 Participants
|
|
ACR 50 Responders in the DB Period
Day 365
|
205 Participants
|
39 Participants
|
SECONDARY outcome
Timeframe: Day 169Population: Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis.
ACR 70 response requires a patient to have a 70% reduction in the number of swollen and tender joints, and a reduction of 70% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score.
Outcome measures
| Measure |
ABA + MTX DB
n=424 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=214 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
ACR 70 Responders at Day 169
|
84 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: Day 365Population: Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis.
ACR 70 response requires a patient to have a 70% reduction in the number of swollen and tender joints, and a reduction of 70% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score.
Outcome measures
| Measure |
ABA + MTX DB
n=424 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=214 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
ACR 70 Responders at Day 365
|
122 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365Population: Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis.
ACR 70 response requires a patient to have a 70% reduction in the number of swollen and tender joints, and a reduction of 70% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score.
Outcome measures
| Measure |
ABA + MTX DB
n=424 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=214 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
ACR 70 Responders in the DB Period
Day 365
|
122 Participants
|
13 Participants
|
|
ACR 70 Responders in the DB Period
Day 15
|
4 Participants
|
1 Participants
|
|
ACR 70 Responders in the DB Period
Day 29
|
8 Participants
|
2 Participants
|
|
ACR 70 Responders in the DB Period
Day 57
|
27 Participants
|
6 Participants
|
|
ACR 70 Responders in the DB Period
Day 85
|
54 Participants
|
7 Participants
|
|
ACR 70 Responders in the DB Period
Day 113
|
57 Participants
|
12 Participants
|
|
ACR 70 Responders in the DB Period
Day 141
|
75 Participants
|
12 Participants
|
|
ACR 70 Responders in the DB Period
Day 169
|
84 Participants
|
14 Participants
|
|
ACR 70 Responders in the DB Period
Day 225
|
103 Participants
|
16 Participants
|
|
ACR 70 Responders in the DB Period
Day 281
|
106 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 365. Data were collected monthly during the first 6 months and then every other month (with the exception of Day 337) during the second 6 months of the DB period.Population: Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis.
A Major Clinical Response (MCR) is defined as maintenance of an ACR 70 response over a continuous 6-month period.
Outcome measures
| Measure |
ABA + MTX DB
n=424 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=214 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Number of Participants Achieving Major Clinical Response By Day 365
|
60 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: BL (Day 0), Day 169, Day 365, Day 169, Day 365Population: Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. Last Observation Carried Forward (LOCF) analysis. N = participants analyzed and n = participants with measurements for that time point.
The DAS 28 is an assessment of disease activity measured on a visual analog scale (VAS)of 100 mm. The scale reports from 1 to 10, with increasing number indicating increasing extent of disease progression. Scores for disease activity are defined as high (\>5.1); low (≤3.2); remission (\<2.6). Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.
Outcome measures
| Measure |
ABA + MTX DB
n=424 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=214 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Mean BL and Disease Activity Score 28 (DAS-28; Erythrocyte Sedimentation Rate [ESR]) at Day 169 and Day 365
BL (Day 0) for Day 169 Cohort (n=366, 179)
|
4.34 Units on a Scale
Standard Deviation 1.38
|
5.50 Units on a Scale
Standard Deviation 1.35
|
|
Mean BL and Disease Activity Score 28 (DAS-28; Erythrocyte Sedimentation Rate [ESR]) at Day 169 and Day 365
BL (Day 0) for Day 365 Cohort (n=375, 183)
|
3.97 Units on a Scale
Standard Deviation 1.40
|
5.36 Units on a Scale
Standard Deviation 1.32
|
SECONDARY outcome
Timeframe: Day 1 to Day 365Population: All treated subjects in the DB period.
AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE was defined as any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.
Outcome measures
| Measure |
ABA + MTX DB
n=433 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=219 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, Discontinuation Due to SAEs, AEs, Related AEs, or Discontinued Due to AEs in the DB Period
Deaths
|
1 Participants
|
1 Participants
|
|
Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, Discontinuation Due to SAEs, AEs, Related AEs, or Discontinued Due to AEs in the DB Period
SAEs
|
65 Participants
|
26 Participants
|
|
Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, Discontinuation Due to SAEs, AEs, Related AEs, or Discontinued Due to AEs in the DB Period
Related SAEs
|
15 Participants
|
1 Participants
|
|
Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, Discontinuation Due to SAEs, AEs, Related AEs, or Discontinued Due to AEs in the DB Period
Discontinuations Due to SAEs
|
10 Participants
|
3 Participants
|
|
Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, Discontinuation Due to SAEs, AEs, Related AEs, or Discontinued Due to AEs in the DB Period
AEs
|
378 Participants
|
184 Participants
|
|
Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, Discontinuation Due to SAEs, AEs, Related AEs, or Discontinued Due to AEs in the DB Period
Related AEs
|
214 Participants
|
104 Participants
|
|
Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, Discontinuation Due to SAEs, AEs, Related AEs, or Discontinued Due to AEs in the DB Period
Discontinued Due to AEs
|
18 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: BL (Day 0), Day 365Population: All randomized and treated participants in the DB period with radiographic data available at baseline and Day 365. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis.
To assess joint damage progression, the Genant-modified Sharp scoring method was used to evaluate radiographs of hands/wrists and feet for erosions and joint space narrowing (JSN). The total Genant-modified Sharp score ranges from 0 (no radiographic damage) to 290 (worst possible radiographic damage) and is the sum of the erosion score (range 0-145) and the joint space narrowing score (range 0-145). Higher scores indicated more damage. Change from baseline = Post-baseline - Baseline value.
Outcome measures
| Measure |
ABA + MTX DB
n=391 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=195 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Mean DB BL and Mean Change From BL in Joint Space Narrowing (JSN) and Total Score (TS)
Baseline Mean JSN
|
22.79 Units on a Scale
Standard Deviation 20.16
|
23.02 Units on a Scale
Standard Deviation 20.36
|
|
Mean DB BL and Mean Change From BL in Joint Space Narrowing (JSN) and Total Score (TS)
Mean Change From Baseline JSN Day 365
|
0.58 Units on a Scale
Standard Deviation 1.54
|
1.18 Units on a Scale
Standard Deviation 2.58
|
|
Mean DB BL and Mean Change From BL in Joint Space Narrowing (JSN) and Total Score (TS)
Baseline Mean TS
|
44.47 Units on a Scale
Standard Deviation 37.33
|
44.85 Units on a Scale
Standard Deviation 37.72
|
|
Mean DB BL and Mean Change From BL in Joint Space Narrowing (JSN) and Total Score (TS)
Mean Change From Baseline TS Day 365
|
1.21 Units on a Scale
Standard Deviation 2.94
|
2.32 Units on a Scale
Standard Deviation 5.04
|
SECONDARY outcome
Timeframe: BL (Day 0), Day 169, Day 365Population: Analyses of efficacy were based on the intent-to-treat population.Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. Last Observation Carried Forward (LOCF) analysis. N = participants analyzed and n = participants with measurements for that time point.
The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of \> 3 points were considered clinically meaningful. Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.
Outcome measures
| Measure |
ABA + MTX DB
n=424 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=214 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Mean DB BL Physical Component Summary of Health-Related Quality of Life (SF-36)
BL (Day 0) for Day 169 Cohort (n= 416, 207)
|
30.49 Units on a Scale
Standard Deviation 7.18
|
30.61 Units on a Scale
Standard Deviation 7.42
|
|
Mean DB BL Physical Component Summary of Health-Related Quality of Life (SF-36)
BL (Day 0) for Day 365 Cohort (n=417, 207)
|
30.51 Units on a Scale
Standard Deviation 7.17
|
30.62 Units on a Scale
Standard Deviation 7.42
|
SECONDARY outcome
Timeframe: BL (Day 0), Day 169, Day 365Population: Analyses of efficacy were based on the intent-to-treat population.Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. Last Observation Carried Forward (LOCF) analysis. N = participants analyzed and n = participants with measurements for that time point.
The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of \> 3 points were considered clinically meaningful.
Outcome measures
| Measure |
ABA + MTX DB
n=424 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=214 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Adjusted Mean Change From BL in the Physical Component Summary of Health-Related Quality of Life (SF-36) in the DB Period
Day 169 (n=416, 207)
|
8.82 Units on a Scale
Standard Error 0.42
|
4.77 Units on a Scale
Standard Error 0.59
|
|
Adjusted Mean Change From BL in the Physical Component Summary of Health-Related Quality of Life (SF-36) in the DB Period
Day 365 (n=417, 207)
|
9.12 Units on a Scale
Standard Error 0.43
|
4.97 Units on a Scale
Standard Error 0.61
|
SECONDARY outcome
Timeframe: Day 1 to Day 365Population: Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis.
An extended major clinical response (MCR) was defined as a continuous ACR 70 response over any nine month treatment period with study medications. ACR 70 response criteria requires a patient to have a 70% reduction in the number of swollen and tender joints, and a reduction of 70% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score.
Outcome measures
| Measure |
ABA + MTX DB
n=424 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=214 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Participants in the DB Period Achieving an Extended Major Clinical Response
|
26 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: BL (Day 0), Day 169, Day 365Population: Analyses of efficacy were based on the intent-to-treat population.Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. Last Observation Carried Forward (LOCF) analysis. N = participants analyzed and n = participants with measurements for that time point.
The mean baseline CRP and ESR in the DB period on Day 169 and Day 365 was evaluated for all treated participants. Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.
Outcome measures
| Measure |
ABA + MTX DB
n=424 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=214 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Mean BL DAS-28 C-Reactive Protein (CRP) and ESR in the DB Period
BL (Day 0) CRP for Day 169 Cohort (n=418, 211)
|
6.37 mg / mL
Standard Deviation 0.83
|
6.36 mg / mL
Standard Deviation 0.82
|
|
Mean BL DAS-28 C-Reactive Protein (CRP) and ESR in the DB Period
BL (Day 0) ESR for Day 169 Cohort (n=418, 211)
|
6.82 mg / mL
Standard Deviation 0.87
|
6.84 mg / mL
Standard Deviation 0.82
|
|
Mean BL DAS-28 C-Reactive Protein (CRP) and ESR in the DB Period
BL (Day 0) CRP for Day 365 Cohort (n=424, 212)
|
6.38 mg / mL
Standard Deviation 0.83
|
6.35 mg / mL
Standard Deviation 0.82
|
|
Mean BL DAS-28 C-Reactive Protein (CRP) and ESR in the DB Period
BL (Day 0) ESR for Day 365 Cohort (n=424, 212)
|
6.82 mg / mL
Standard Deviation 0.87
|
6.83 mg / mL
Standard Deviation 0.82
|
SECONDARY outcome
Timeframe: BL (Day 0), Day 169, Day 365Population: Due to the closure of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
The mean change from baseline in CRP and ESR in the DB period was evaluated for all treated participants. Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.
Outcome measures
| Measure |
ABA + MTX DB
n=424 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=214 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Adjusted Mean Change From BL in DAS-28 CRP and ESR in the DB Period
DAS-28 CRP Day 169 (n=418, 211)
|
-2.38 mg / mL
Standard Error 0.06
|
-1.29 mg / mL
Standard Error 0.09
|
|
Adjusted Mean Change From BL in DAS-28 CRP and ESR in the DB Period
DAS-28 ESR Day 169 (n=418, 211)
|
-2.48 mg / mL
Standard Error 0.07
|
-1.33 mg / mL
Standard Error 0.10
|
|
Adjusted Mean Change From BL in DAS-28 CRP and ESR in the DB Period
DAS-28 CRP Day 365 (n=424, 212)
|
-2.71 mg / mL
Standard Error 0.06
|
-1.41 mg / mL
Standard Error 0.09
|
|
Adjusted Mean Change From BL in DAS-28 CRP and ESR in the DB Period
DAS-28 ESR Day 365 (n=424, 212)
|
-2.85 mg / mL
Standard Error 0.07
|
-1.46 mg / mL
Standard Error 0.10
|
SECONDARY outcome
Timeframe: BL (Day 0), Day 169, Day 365Population: All treated subjects in the DB period. N = number of participants analyzed and n = the number of participants with measurements for that time point.
The mean baseline sIL2-r in the DB period was evaluated from serum samples for all treated participants.
Outcome measures
| Measure |
ABA + MTX DB
n=424 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=214 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Mean BL Soluble Interleukin-2 Receptors (sIL2-r) in the DB Period
Day 169 (n=370, 171)
|
1776.0 mg / mL
Standard Deviation 946.5
|
1603.0 mg / mL
Standard Deviation 933.1
|
|
Mean BL Soluble Interleukin-2 Receptors (sIL2-r) in the DB Period
Day 365 (n=235, 106)
|
1674.0 mg / mL
Standard Deviation 835.1
|
1601.0 mg / mL
Standard Deviation 1076.0
|
SECONDARY outcome
Timeframe: BL (Day 0), Day 169, Day 365Population: All treated subjects in the DB period.
The mean change from baseline in sIL2-r in the DB period was evaluated for all treated participants.
Outcome measures
| Measure |
ABA + MTX DB
n=424 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=214 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Mean Change From BL in Soluble Interleukin-2 Receptors (sIL2-r) in the DB Period
Day 169 (n=370, 171)
|
-519.00 mg / mL
Standard Error 23.72
|
-85.50 mg / mL
Standard Error 32.78
|
|
Mean Change From BL in Soluble Interleukin-2 Receptors (sIL2-r) in the DB Period
Day 365 (n=235, 106)
|
-562.00 mg / mL
Standard Error 40.82
|
-290.00 mg / mL
Standard Error 87.97
|
SECONDARY outcome
Timeframe: Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365Population: Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. Last observation carried forward (LOCF) analysis. N = participants analyzed and n = participants with measurements for that time point.
Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.
Outcome measures
| Measure |
ABA + MTX DB
n=424 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=214 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
ACR Core Component: Mean Number of Tender Joints at All Post-BL Visits in the DB Period
BL (Day 0) for Day 15 Cohort (n=416, 210)
|
25.19 Joints
Standard Deviation 14.62
|
27.93 Joints
Standard Deviation 14.27
|
|
ACR Core Component: Mean Number of Tender Joints at All Post-BL Visits in the DB Period
BL (Day 0) for Day 29 Cohort (n=419, 211)
|
21.14 Joints
Standard Deviation 14.69
|
24.11 Joints
Standard Deviation 14.97
|
|
ACR Core Component: Mean Number of Tender Joints at All Post-BL Visits in the DB Period
BL (Day 0) for Day 57 Cohort (n=421, 210)
|
16.70 Joints
Standard Deviation 14.06
|
21.41 Joints
Standard Deviation 14.15
|
|
ACR Core Component: Mean Number of Tender Joints at All Post-BL Visits in the DB Period
BL (Day 0) for Day 85 Cohort (n=417, 208)
|
14.84 Joints
Standard Deviation 13.98
|
20.58 Joints
Standard Deviation 15.61
|
|
ACR Core Component: Mean Number of Tender Joints at All Post-BL Visits in the DB Period
BL (Day 0) for Day 113 Cohort (n=415, 210)
|
13.55 Joints
Standard Deviation 13.35
|
19.83 Joints
Standard Deviation 15.29
|
|
ACR Core Component: Mean Number of Tender Joints at All Post-BL Visits in the DB Period
BL (Day 0) for Day 141 Cohort (n=420, 211)
|
12.59 Joints
Standard Deviation 13.39
|
19.78 Joints
Standard Deviation 15.74
|
|
ACR Core Component: Mean Number of Tender Joints at All Post-BL Visits in the DB Period
BL (Day 0) for Day 169 Cohort (n=420, 211)
|
11.69 Joints
Standard Deviation 12.37
|
18.70 Joints
Standard Deviation 15.42
|
|
ACR Core Component: Mean Number of Tender Joints at All Post-BL Visits in the DB Period
BL (Day 0) for Day 225 Cohort (n=419, 212)
|
10.42 Joints
Standard Deviation 12.04
|
18.22 Joints
Standard Deviation 15.46
|
|
ACR Core Component: Mean Number of Tender Joints at All Post-BL Visits in the DB Period
BL (Day 0) for Day 281Cohort (n=419, 211)
|
9.92 Joints
Standard Deviation 11.37
|
17.10 Joints
Standard Deviation 16.04
|
|
ACR Core Component: Mean Number of Tender Joints at All Post-BL Visits in the DB Period
BL (Day 0) for Day 365 Cohort (n=424, 212)
|
9.96 Joints
Standard Deviation 11.87
|
18.31 Joints
Standard Deviation 15.72
|
SECONDARY outcome
Timeframe: Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365Population: Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. Last observation carried forward (LOCF) analysis. N = participants analyzed and n = participants with measurements for that time point.
The mean number of swollen joints in the DB period was evaluated based on the swollen joint core component of the ACR scoring system where increasing score indicates increasing level of severity. Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.
Outcome measures
| Measure |
ABA + MTX DB
n=424 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=214 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
ACR Core Component: Mean Number of Swollen Joints at All Post-BL Visits in the DB Period
BL (Day 0) for Day 85 Cohort (n=417, 208)
|
9.76 joints
Standard Deviation 8.99
|
14.56 joints
Standard Deviation 10.83
|
|
ACR Core Component: Mean Number of Swollen Joints at All Post-BL Visits in the DB Period
BL (Day 0) for Day 113 Cohort (n=415, 210)
|
8.73 joints
Standard Deviation 8.64
|
13.93 joints
Standard Deviation 10.69
|
|
ACR Core Component: Mean Number of Swollen Joints at All Post-BL Visits in the DB Period
BL (Day 0) for Day 141 Cohort (n=420, 211)
|
7.84 joints
Standard Deviation 8.10
|
13.28 joints
Standard Deviation 10.70
|
|
ACR Core Component: Mean Number of Swollen Joints at All Post-BL Visits in the DB Period
BL (Day 0) for Day 169 Cohort (n=420, 211)
|
7.54 joints
Standard Deviation 7.77
|
13.14 joints
Standard Deviation 11.05
|
|
ACR Core Component: Mean Number of Swollen Joints at All Post-BL Visits in the DB Period
BL (Day 0) for Day 225 Cohort (n=419, 212)
|
6.80 joints
Standard Deviation 7.57
|
12.78 joints
Standard Deviation 11.06
|
|
ACR Core Component: Mean Number of Swollen Joints at All Post-BL Visits in the DB Period
BL (Day 0) for Day 281 Cohort (n=419, 211)
|
6.50 joints
Standard Deviation 7.52
|
12.46 joints
Standard Deviation 10.98
|
|
ACR Core Component: Mean Number of Swollen Joints at All Post-BL Visits in the DB Period
BL (Day 0) for Day 365 Cohort (n=424, 212)
|
6.31 joints
Standard Deviation 7.16
|
12.69 joints
Standard Deviation 10.84
|
|
ACR Core Component: Mean Number of Swollen Joints at All Post-BL Visits in the DB Period
BL (Day 0) for Day 15 Cohort (n=416, 210)
|
16.40 joints
Standard Deviation 8.63
|
18.49 joints
Standard Deviation 9.92
|
|
ACR Core Component: Mean Number of Swollen Joints at All Post-BL Visits in the DB Period
BL (Day 0) for Day 29 Cohort (n=419, 211)
|
14.04 joints
Standard Deviation 9.26
|
16.03 joints
Standard Deviation 9.23
|
|
ACR Core Component: Mean Number of Swollen Joints at All Post-BL Visits in the DB Period
BL (Day 0) for Day 57 Cohort (n=421, 210)
|
11.02 joints
Standard Deviation 8.64
|
14.77 joints
Standard Deviation 9.85
|
SECONDARY outcome
Timeframe: Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365Population: Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. Last observation carried forward (LOCF) analysis. N = participants analyzed and n = participants with measurements for that time point.
Participant self-reported pain assessment core component of the ACR scoring system where increasing score indicates increasing level of severity as indicated on a 100mm Visual Analog Scale (VAS) with 0mm representing no pain and 100mm representing the most pain possible.
Outcome measures
| Measure |
ABA + MTX DB
n=424 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=214 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
ACR Core Component: Mean Participant Pain Assessment at All Post-BL Visits in the DB Period
Day 15 (n=413, 210)
|
52.39 Units on a Scale
Standard Deviation 22.85
|
60.08 Units on a Scale
Standard Deviation 21.90
|
|
ACR Core Component: Mean Participant Pain Assessment at All Post-BL Visits in the DB Period
Day 29 (n=418, 211)
|
47.03 Units on a Scale
Standard Deviation 23.84
|
54.69 Units on a Scale
Standard Deviation 23.86
|
|
ACR Core Component: Mean Participant Pain Assessment at All Post-BL Visits in the DB Period
Day 57 (n=419, 209)
|
40.34 Units on a Scale
Standard Deviation 24.29
|
50.11 Units on a Scale
Standard Deviation 25.16
|
|
ACR Core Component: Mean Participant Pain Assessment at All Post-BL Visits in the DB Period
Day 85 (n=417, 207)
|
35.97 Units on a Scale
Standard Deviation 24.01
|
48.36 Units on a Scale
Standard Deviation 25.53
|
|
ACR Core Component: Mean Participant Pain Assessment at All Post-BL Visits in the DB Period
Day 113 (n=418, 210)
|
34.31 Units on a Scale
Standard Deviation 23.61
|
48.60 Units on a Scale
Standard Deviation 26.99
|
|
ACR Core Component: Mean Participant Pain Assessment at All Post-BL Visits in the DB Period
Day 141 (n=420, 211)
|
33.93 Units on a Scale
Standard Deviation 25.47
|
48.26 Units on a Scale
Standard Deviation 27.19
|
|
ACR Core Component: Mean Participant Pain Assessment at All Post-BL Visits in the DB Period
Day 169 (n=421, 211)
|
32.69 Units on a Scale
Standard Deviation 24.32
|
49.21 Units on a Scale
Standard Deviation 27.13
|
|
ACR Core Component: Mean Participant Pain Assessment at All Post-BL Visits in the DB Period
Day 225 (n=418, 211)
|
31.39 Units on a Scale
Standard Deviation 24.01
|
47.20 Units on a Scale
Standard Deviation 26.77
|
|
ACR Core Component: Mean Participant Pain Assessment at All Post-BL Visits in the DB Period
Day 281 (n=419, 210)
|
31.06 Units on a Scale
Standard Deviation 24.58
|
46.18 Units on a Scale
Standard Deviation 27.23
|
|
ACR Core Component: Mean Participant Pain Assessment at All Post-BL Visits in the DB Period
Day 365 (n=424, 212)
|
29.78 Units on a Scale
Standard Deviation 24.20
|
48.17 Units on a Scale
Standard Deviation 27.82
|
SECONDARY outcome
Timeframe: Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365Population: Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. Last observation carried forward (LOCF) analysis. N = participants analyzed and n = participants with measurements for that time point.
The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.
Outcome measures
| Measure |
ABA + MTX DB
n=424 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=214 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
ACR Core Component: Mean Participant Physical Function Assessment at All Post-BL Visits in the DB Period
Day 15 (n=405, 206)
|
1.51 Units on a Scale
Standard Deviation 0.64
|
1.58 Units on a Scale
Standard Deviation 0.56
|
|
ACR Core Component: Mean Participant Physical Function Assessment at All Post-BL Visits in the DB Period
Day 29 (n=406, 207)
|
1.41 Units on a Scale
Standard Deviation 0.64
|
1.47 Units on a Scale
Standard Deviation 0.60
|
|
ACR Core Component: Mean Participant Physical Function Assessment at All Post-BL Visits in the DB Period
Day 57 (n=412, 205)
|
1.29 Units on a Scale
Standard Deviation 0.65
|
1.42 Units on a Scale
Standard Deviation 0.63
|
|
ACR Core Component: Mean Participant Physical Function Assessment at All Post-BL Visits in the DB Period
Day 85 (n=407, 203)
|
1.18 Units on a Scale
Standard Deviation 0.68
|
1.32 Units on a Scale
Standard Deviation 0.65
|
|
ACR Core Component: Mean Participant Physical Function Assessment at All Post-BL Visits in the DB Period
Day 113 (n=409, 206)
|
1.16 Units on a Scale
Standard Deviation 0.67
|
1.35 Units on a Scale
Standard Deviation 0.68
|
|
ACR Core Component: Mean Participant Physical Function Assessment at All Post-BL Visits in the DB Period
Day 141 (n=411, 207)
|
1.13 Units on a Scale
Standard Deviation 0.71
|
1.35 Units on a Scale
Standard Deviation 0.70
|
|
ACR Core Component: Mean Participant Physical Function Assessment at All Post-BL Visits in the DB Period
Day 169 (n=413, 207)
|
1.11 Units on a Scale
Standard Deviation 0.70
|
1.31 Units on a Scale
Standard Deviation 0.69
|
|
ACR Core Component: Mean Participant Physical Function Assessment at All Post-BL Visits in the DB Period
Day 225 (n=409, 207)
|
1.06 Units on a Scale
Standard Deviation 0.70
|
1.35 Units on a Scale
Standard Deviation 0.70
|
|
ACR Core Component: Mean Participant Physical Function Assessment at All Post-BL Visits in the DB Period
Day 281 (n=408, 207)
|
1.05 Units on a Scale
Standard Deviation 0.70
|
1.31 Units on a Scale
Standard Deviation 0.68
|
|
ACR Core Component: Mean Participant Physical Function Assessment at All Post-BL Visits in the DB Period
Day 365 (n=415, 208)
|
1.04 Units on a Scale
Standard Deviation 0.70
|
1.34 Units on a Scale
Standard Deviation 0.70
|
SECONDARY outcome
Timeframe: Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365Population: Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. Last observation carried forward (LOCF) analysis. N = participants analyzed and n = participants with measurements for that time point.
Participant self-reported global RA assessment core component of the ACR scoring system where increasing score indicates increasing level of severity as indicated on a 100mm Visual Analog Scale (VAS) with 0mm representing no pain and 100mm representing the most pain possible.
Outcome measures
| Measure |
ABA + MTX DB
n=424 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=214 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
ACR Core Component: Mean Participant Global Assessment at All Post-BL Visits in the DB Period
Day 15 (n=413, 210)
|
50.90 Units on a Scale
Standard Deviation 22.42
|
56.66 Units on a Scale
Standard Deviation 22.33
|
|
ACR Core Component: Mean Participant Global Assessment at All Post-BL Visits in the DB Period
Day 29 (n=418, 211)
|
45.26 Units on a Scale
Standard Deviation 22.72
|
53.11 Units on a Scale
Standard Deviation 22.81
|
|
ACR Core Component: Mean Participant Global Assessment at All Post-BL Visits in the DB Period
Day 57 (n=419, 209)
|
39.78 Units on a Scale
Standard Deviation 23.02
|
49.34 Units on a Scale
Standard Deviation 23.98
|
|
ACR Core Component: Mean Participant Global Assessment at All Post-BL Visits in the DB Period
Day 85 (n=417, 207)
|
35.07 Units on a Scale
Standard Deviation 23.37
|
46.82 Units on a Scale
Standard Deviation 24.71
|
|
ACR Core Component: Mean Participant Global Assessment at All Post-BL Visits in the DB Period
Day 113 (n=418, 210)
|
33.98 Units on a Scale
Standard Deviation 22.59
|
47.26 Units on a Scale
Standard Deviation 25.69
|
|
ACR Core Component: Mean Participant Global Assessment at All Post-BL Visits in the DB Period
Day 141 (n=420, 211)
|
33.52 Units on a Scale
Standard Deviation 24.06
|
47.52 Units on a Scale
Standard Deviation 26.57
|
|
ACR Core Component: Mean Participant Global Assessment at All Post-BL Visits in the DB Period
Day 169 (n=421, 211)
|
32.37 Units on a Scale
Standard Deviation 23.26
|
47.93 Units on a Scale
Standard Deviation 26.24
|
|
ACR Core Component: Mean Participant Global Assessment at All Post-BL Visits in the DB Period
Day 225 (n=418, 210)
|
30.63 Units on a Scale
Standard Deviation 22.48
|
46.06 Units on a Scale
Standard Deviation 26.21
|
|
ACR Core Component: Mean Participant Global Assessment at All Post-BL Visits in the DB Period
Day 281 (n=419, 211)
|
29.98 Units on a Scale
Standard Deviation 23.25
|
44.45 Units on a Scale
Standard Deviation 26.13
|
|
ACR Core Component: Mean Participant Global Assessment at All Post-BL Visits in the DB Period
Day 365 (n=424, 212)
|
28.95 Units on a Scale
Standard Deviation 23.60
|
45.62 Units on a Scale
Standard Deviation 26.92
|
SECONDARY outcome
Timeframe: Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365Population: Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. Last observation carried forward (LOCF) analysis. N = participants analyzed and n = participants with measurements for that time point.
Physician global RA assessment core component of the ACR scoring system where increasing score indicates increasing level of severity as indicated on a 100mm Visual Analog Scale (VAS) with 0mm representing very good global RA assessment and 100mm representing very poor global RA assessment.
Outcome measures
| Measure |
ABA + MTX DB
n=424 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=214 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
ACR Core Component: Mean Physician Global Assessment at All Post-BL Visits in the DB Period
Day 15 (n=415, 209)
|
52.79 Units on a Scale
Standard Deviation 19.24
|
56.68 Units on a Scale
Standard Deviation 18.93
|
|
ACR Core Component: Mean Physician Global Assessment at All Post-BL Visits in the DB Period
Day 29 (n=418, 211)
|
45.24 Units on a Scale
Standard Deviation 20.58
|
51.83 Units on a Scale
Standard Deviation 20.14
|
|
ACR Core Component: Mean Physician Global Assessment at All Post-BL Visits in the DB Period
Day 57 (n=421, 210)
|
35.89 Units on a Scale
Standard Deviation 19.84
|
45.21 Units on a Scale
Standard Deviation 22.61
|
|
ACR Core Component: Mean Physician Global Assessment at All Post-BL Visits in the DB Period
Day 85 (n=416, 208)
|
31.07 Units on a Scale
Standard Deviation 20.12
|
42.59 Units on a Scale
Standard Deviation 23.87
|
|
ACR Core Component: Mean Physician Global Assessment at All Post-BL Visits in the DB Period
Day 113 (n=412, 209)
|
29.01 Units on a Scale
Standard Deviation 20.40
|
42.20 Units on a Scale
Standard Deviation 24.72
|
|
ACR Core Component: Mean Physician Global Assessment at All Post-BL Visits in the DB Period
Day 141 (n=420, 211)
|
26.71 Units on a Scale
Standard Deviation 20.38
|
41.22 Units on a Scale
Standard Deviation 25.33
|
|
ACR Core Component: Mean Physician Global Assessment at All Post-BL Visits in the DB Period
Day 169 (n=421, 211)
|
25.44 Units on a Scale
Standard Deviation 19.65
|
41.75 Units on a Scale
Standard Deviation 25.79
|
|
ACR Core Component: Mean Physician Global Assessment at All Post-BL Visits in the DB Period
Day 225 (n=418, 212)
|
24.34 Units on a Scale
Standard Deviation 19.27
|
40.68 Units on a Scale
Standard Deviation 26.15
|
|
ACR Core Component: Mean Physician Global Assessment at All Post-BL Visits in the DB Period
Day 281 (n=419, 210)
|
23.33 Units on a Scale
Standard Deviation 19.09
|
38.76 Units on a Scale
Standard Deviation 26.70
|
|
ACR Core Component: Mean Physician Global Assessment at All Post-BL Visits in the DB Period
Day 365 (n=424, 212)
|
21.58 Units on a Scale
Standard Deviation 19.53
|
41.04 Units on a Scale
Standard Deviation 25.91
|
SECONDARY outcome
Timeframe: Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365Population: Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. Last observation carried forward (LOCF) analysis. N = participants analyzed and n = participants with measurements for that time point.
CRP core component of the ACR scoring system was evaluated from serum samples in which increasing levels indicate increasing level of disease.
Outcome measures
| Measure |
ABA + MTX DB
n=424 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=214 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
ACR Core Component: Mean CRP at All Post-BL Visits in the DB Period
Day 15 (n=401, 199)
|
3.27 IU / mL
Standard Deviation 3.13
|
2.65 IU / mL
Standard Deviation 2.34
|
|
ACR Core Component: Mean CRP at All Post-BL Visits in the DB Period
Day 29 (n=410, 208)
|
1.94 IU / mL
Standard Deviation 1.99
|
2.65 IU / mL
Standard Deviation 2.48
|
|
ACR Core Component: Mean CRP at All Post-BL Visits in the DB Period
Day 57 (n=416, 209)
|
1.70 IU / mL
Standard Deviation 2.02
|
2.36 IU / mL
Standard Deviation 2.34
|
|
ACR Core Component: Mean CRP at All Post-BL Visits in the DB Period
Day 85 (n=412, 203)
|
1.53 IU / mL
Standard Deviation 1.97
|
2.53 IU / mL
Standard Deviation 2.39
|
|
ACR Core Component: Mean CRP at All Post-BL Visits in the DB Period
Day 113 (n=417, 209)
|
1.49 IU / mL
Standard Deviation 1.69
|
2.55 IU / mL
Standard Deviation 2.59
|
|
ACR Core Component: Mean CRP at All Post-BL Visits in the DB Period
Day 141 (n=414, 209)
|
1.27 IU / mL
Standard Deviation 1.52
|
2.48 IU / mL
Standard Deviation 2.61
|
|
ACR Core Component: Mean CRP at All Post-BL Visits in the DB Period
Day 169 (n=420, 211)
|
1.42 IU / mL
Standard Deviation 1.67
|
2.56 IU / mL
Standard Deviation 2.43
|
|
ACR Core Component: Mean CRP at All Post-BL Visits in the DB Period
Day 225 (n=414, 212)
|
1.30 IU / mL
Standard Deviation 1.55
|
2.46 IU / mL
Standard Deviation 2.70
|
|
ACR Core Component: Mean CRP at All Post-BL Visits in the DB Period
Day 281 (n=412, 210)
|
1.36 IU / mL
Standard Deviation 1.80
|
2.60 IU / mL
Standard Deviation 3.09
|
|
ACR Core Component: Mean CRP at All Post-BL Visits in the DB Period
Day 365 (n=424, 212)
|
1.27 IU / mL
Standard Deviation 1.63
|
2.41 IU / mL
Standard Deviation 2.58
|
SECONDARY outcome
Timeframe: Day 1 to Day 169, Day 170 to Day 365Population: All randomized and treated participants in the DB period.
Participants that discontinued treatment during the DB period for any reason were evaluated after 6 months and 1 year of treatment.
Outcome measures
| Measure |
ABA + MTX DB
n=433 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=219 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Number of Participants Discontinuing in the DB Period
Day 1 to 169 Discontinuations (DC) - All Causes
|
32 Participants
|
45 Participants
|
|
Number of Participants Discontinuing in the DB Period
Day 1 to 169 DC Due to Lack of Efficacy
|
11 Participants
|
33 Participants
|
|
Number of Participants Discontinuing in the DB Period
Day 170 to Day 365 DC - All Causes
|
16 Participants
|
12 Participants
|
|
Number of Participants Discontinuing in the DB Period
Day 170 to Day 365 DC Due to Lack of Efficacy
|
2 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: BL (Day 0), Day 365Population: This analysis was not completed.
To assess joint damage progression, the Genant-modified Sharp scoring method was used to evaluate radiographs of hands/wrists and feet for erosions and joint space narrowing (JSN). The total Genant-modified Sharp score ranges from 0 (no radiographic damage) to 290 (worst possible radiographic damage) and is the sum of the erosion score (range 0-145) and the joint space narrowing score (range 0-145). Higher scores indicated more damage. Improvement=decreases from BL, stable=same as BL, worsening=increases from BL.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1 to Day 365Population: All randomized and treated participants.
All changes in participant vital signs were monitored on each day of study drug administration prior to dosing and 60 minutes after dosing. Vital signs included body temperature, heart rate, and seated blood pressure. Clinical significance was defined as any change from baseline that resulted in a value outside the normal limits for the participant.
Outcome measures
| Measure |
ABA + MTX DB
n=433 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=219 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Participants Experiencing Clinically Significant Changes in Vital Signs in the DB Period
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 365Population: All treated participants in the DB period.
AEs were defined as any new untoward medical occurrence or worsening of a pre- existing medical condition which does not necessarily have a causal relationship with this treatment. AEs were identified as those which may be associated with the use of immunomodulatory agents or infusion of therapeutic proteins. Acute infusional AEs were defined as those that occurred within 1 hour after the start of the infusion.
Outcome measures
| Measure |
ABA + MTX DB
n=433 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=219 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Participants Experiencing AEs of Special Interest in the DB Period
Infections/Infestations
|
50 Participants
|
12 Participants
|
|
Participants Experiencing AEs of Special Interest in the DB Period
Neoplasms
|
14 Participants
|
9 Participants
|
|
Participants Experiencing AEs of Special Interest in the DB Period
Autoimmune Disorders
|
13 Participants
|
2 Participants
|
|
Participants Experiencing AEs of Special Interest in the DB Period
Acute Infusional AEs
|
38 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: BL (Day 0), Day 169, Day 365Population: Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. Last observation carried forward (LOCF) analysis. N = participants analyzed and n = participants with measurements for that time point.
The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.
Outcome measures
| Measure |
ABA + MTX DB
n=424 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=214 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Mean BL Individual Components of the HAQ DI at Day 169 and Day 365
HAQ DI Day 169 (n=373, 159)
|
1.68 Units on a Scale
Standard Deviation 0.63
|
1.70 Units on a Scale
Standard Deviation 0.59
|
|
Mean BL Individual Components of the HAQ DI at Day 169 and Day 365
HAQ DI Day 365 (n=369, 160)
|
1.68 Units on a Scale
Standard Deviation 0.63
|
1.70 Units on a Scale
Standard Deviation 0.58
|
|
Mean BL Individual Components of the HAQ DI at Day 169 and Day 365
Dressing and Grooming Day 169 (n=374, 159)
|
1.48 Units on a Scale
Standard Deviation 0.75
|
1.48 Units on a Scale
Standard Deviation 0.73
|
|
Mean BL Individual Components of the HAQ DI at Day 169 and Day 365
Dressing and Grooming Day 365 (n=372, 160)
|
1.47 Units on a Scale
Standard Deviation 0.75
|
1.49 Units on a Scale
Standard Deviation 0.73
|
|
Mean BL Individual Components of the HAQ DI at Day 169 and Day 365
Arising Day 169 (n=373, 159)
|
1.42 Units on a Scale
Standard Deviation 0.83
|
1.45 Units on a Scale
Standard Deviation 0.79
|
|
Mean BL Individual Components of the HAQ DI at Day 169 and Day 365
Arising Day 365 (n=372, 160)
|
1.42 Units on a Scale
Standard Deviation 0.82
|
1.46 Units on a Scale
Standard Deviation 0.78
|
|
Mean BL Individual Components of the HAQ DI at Day 169 and Day 365
Eating Day 169 (n=374, 159)
|
1.63 Units on a Scale
Standard Deviation 0.97
|
1.67 Units on a Scale
Standard Deviation 0.84
|
|
Mean BL Individual Components of the HAQ DI at Day 169 and Day 365
Eating Day 365 (n=372, 160)
|
1.63 Units on a Scale
Standard Deviation 0.97
|
1.68 Units on a Scale
Standard Deviation 0.84
|
|
Mean BL Individual Components of the HAQ DI at Day 169 and Day 365
Walking Day 169 (n=373, 158)
|
1.40 Units on a Scale
Standard Deviation 0.83
|
1.36 Units on a Scale
Standard Deviation 0.78
|
|
Mean BL Individual Components of the HAQ DI at Day 169 and Day 365
Walking Day 365 (n=372, 158)
|
1.40 Units on a Scale
Standard Deviation 0.83
|
1.37 Units on a Scale
Standard Deviation 0.78
|
|
Mean BL Individual Components of the HAQ DI at Day 169 and Day 365
Hygiene Day 169 (n=373, 159)
|
1.93 Units on a Scale
Standard Deviation 0.90
|
1.91 Units on a Scale
Standard Deviation 0.89
|
|
Mean BL Individual Components of the HAQ DI at Day 169 and Day 365
Hygiene Day 365 (n=370, 160)
|
1.93 Units on a Scale
Standard Deviation 0.90
|
1.91 Units on a Scale
Standard Deviation 0.89
|
|
Mean BL Individual Components of the HAQ DI at Day 169 and Day 365
Reaching Day 169 (n=373, 159)
|
1.94 Units on a Scale
Standard Deviation 0.86
|
1.97 Units on a Scale
Standard Deviation 0.80
|
|
Mean BL Individual Components of the HAQ DI at Day 169 and Day 365
Reaching Day 365 (n=370, 160)
|
1.94 Units on a Scale
Standard Deviation 0.86
|
1.97 Units on a Scale
Standard Deviation 0.80
|
|
Mean BL Individual Components of the HAQ DI at Day 169 and Day 365
Gripping Day 169 (n=374, 159)
|
1.80 Units on a Scale
Standard Deviation 0.76
|
1.90 Units on a Scale
Standard Deviation 0.67
|
|
Mean BL Individual Components of the HAQ DI at Day 169 and Day 365
Gripping Day 365 (n=371, 160)
|
1.80 Units on a Scale
Standard Deviation 0.76
|
1.90 Units on a Scale
Standard Deviation 0.67
|
|
Mean BL Individual Components of the HAQ DI at Day 169 and Day 365
Activities Day 169 (n=373, 159)
|
1.87 Units on a Scale
Standard Deviation 0.79
|
1.86 Units on a Scale
Standard Deviation 0.82
|
|
Mean BL Individual Components of the HAQ DI at Day 169 and Day 365
Activities Day 365 (n=369, 160)
|
1.87 Units on a Scale
Standard Deviation 0.79
|
1.86 Units on a Scale
Standard Deviation 0.82
|
SECONDARY outcome
Timeframe: Day 169Population: Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. Last observation carried forward (LOCF) analysis.
The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.
Outcome measures
| Measure |
ABA + MTX DB
n=424 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=214 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Adjusted Mean Change From BL in Individual Components of the HAQ DI at Day 169
HAQ DI
|
-0.62 Units on a Scale
Standard Error 0.03
|
-0.52 Units on a Scale
Standard Error 0.05
|
|
Adjusted Mean Change From BL in Individual Components of the HAQ DI at Day 169
Dressing and Grooming
|
-0.73 Units on a Scale
Standard Error 0.04
|
-0.55 Units on a Scale
Standard Error 0.05
|
|
Adjusted Mean Change From BL in Individual Components of the HAQ DI at Day 169
Arising
|
-0.69 Units on a Scale
Standard Error 0.03
|
-0.65 Units on a Scale
Standard Error 0.05
|
|
Adjusted Mean Change From BL in Individual Components of the HAQ DI at Day 169
Eating
|
-0.68 Units on a Scale
Standard Error 0.04
|
-0.48 Units on a Scale
Standard Error 0.06
|
|
Adjusted Mean Change From BL in Individual Components of the HAQ DI at Day 169
Walking
|
-0.58 Units on a Scale
Standard Error 0.04
|
-0.45 Units on a Scale
Standard Error 0.05
|
|
Adjusted Mean Change From BL in Individual Components of the HAQ DI at Day 169
Hygiene
|
-0.48 Units on a Scale
Standard Error 0.05
|
-0.40 Units on a Scale
Standard Error 0.07
|
|
Adjusted Mean Change From BL in Individual Components of the HAQ DI at Day 169
Reaching
|
-0.64 Units on a Scale
Standard Error 0.04
|
-0.52 Units on a Scale
Standard Error 0.06
|
|
Adjusted Mean Change From BL in Individual Components of the HAQ DI at Day 169
Gripping
|
-0.53 Units on a Scale
Standard Error 0.04
|
-0.43 Units on a Scale
Standard Error 0.06
|
|
Adjusted Mean Change From BL in Individual Components of the HAQ DI at Day 169
Activities
|
-0.57 Units on a Scale
Standard Error 0.04
|
-0.43 Units on a Scale
Standard Error 0.06
|
SECONDARY outcome
Timeframe: Day 365Population: Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. Last observation carried forward (LOCF) analysis.
The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.
Outcome measures
| Measure |
ABA + MTX DB
n=424 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=214 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Adjusted Mean Change From BL in Individual Components of the HAQ DI at Day 365
HAQ DI
|
-0.68 Units on a Scale
Standard Error 0.03
|
-0.51 Units on a Scale
Standard Error 0.06
|
|
Adjusted Mean Change From BL in Individual Components of the HAQ DI at Day 365
Dressing and Grooming
|
-0.78 Units on a Scale
Standard Error 0.04
|
-0.61 Units on a Scale
Standard Error 0.06
|
|
Adjusted Mean Change From BL in Individual Components of the HAQ DI at Day 365
Arising
|
-0.75 Units on a Scale
Standard Error 0.04
|
-0.58 Units on a Scale
Standard Error 0.05
|
|
Adjusted Mean Change From BL in Individual Components of the HAQ DI at Day 365
Eating
|
-0.81 Units on a Scale
Standard Error 0.04
|
-0.44 Units on a Scale
Standard Error 0.06
|
|
Adjusted Mean Change From BL in Individual Components of the HAQ DI at Day 365
Walking
|
-0.61 Units on a Scale
Standard Error 0.04
|
-0.50 Units on a Scale
Standard Error 0.06
|
|
Adjusted Mean Change From BL in Individual Components of the HAQ DI at Day 365
Hygiene
|
-0.53 Units on a Scale
Standard Error 0.05
|
-0.37 Units on a Scale
Standard Error 0.07
|
|
Adjusted Mean Change From BL in Individual Components of the HAQ DI at Day 365
Reaching
|
-0.70 Units on a Scale
Standard Error 0.04
|
-0.59 Units on a Scale
Standard Error 0.07
|
|
Adjusted Mean Change From BL in Individual Components of the HAQ DI at Day 365
Gripping
|
-0.65 Units on a Scale
Standard Error 0.04
|
-0.44 Units on a Scale
Standard Error 0.07
|
|
Adjusted Mean Change From BL in Individual Components of the HAQ DI at Day 365
Activities
|
-0.66 Units on a Scale
Standard Error 0.44
|
-0.47 Units on a Scale
Standard Error 0.07
|
SECONDARY outcome
Timeframe: Day 1 to Day 365Population: Participants treated with abatacept in the DB period with at least one immunogenicity sample collected in the DB period.
Participants with titers to abatacept in the DB period. Serum samples from abatacept-treated adult participants with active RA were screened for the presence of drug-specific antibodies using two validated direct-format enzyme-linked immunosorbent assays (ELISAs) to determine the presence of antibodies to abatacept and/or CTLA4-T.
Outcome measures
| Measure |
ABA + MTX DB
n=406 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Number of Participants With Immunogenicity to Abatacept in the DB Period
|
6 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 169, Day 365Population: These data were not summarized as it was determined that no meaningful information would be obtained.
Tender joints and swollen joints are core components of the ACR 20, 50, and 70. The incidences of new tender joints and new swollen joints were evaluated in the DB period after 6 months and 1 year of treatment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 169, Day 365Population: Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. Last observation carried forward (LOCF) analysis.
Outcome measures
| Measure |
ABA + MTX DB
n=424 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=214 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Number of Participants Experiencing a 100% Reduction in Tender Joints or 100% Reduction in Swollen Joints in the DB Period
100% Reduction in New Tender Joints Day 169
|
43 Participants
|
9 Participants
|
|
Number of Participants Experiencing a 100% Reduction in Tender Joints or 100% Reduction in Swollen Joints in the DB Period
100% Reduction in New Swollen Joints Day 169
|
59 Participants
|
14 Participants
|
|
Number of Participants Experiencing a 100% Reduction in Tender Joints or 100% Reduction in Swollen Joints in the DB Period
100% Reduction in New Tender Joints Day 365
|
67 Participants
|
8 Participants
|
|
Number of Participants Experiencing a 100% Reduction in Tender Joints or 100% Reduction in Swollen Joints in the DB Period
100% Reduction in New Swollen Joints Day 365
|
78 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 365Population: All treated participants in the DB period.
Marked abnormality criteria were: Hemoglobin (HGB): \>3 g/dL decrease from BL; Hematocrit: \<0.75 \* BL; Erythrocytes: \<0.75 \* BL; Platelets (PLT): \<0.67 \* LLN/\>1.5 \* ULN, or if BL \< LLN then use \<0.5 \* BL and \<100,000 mm\^3; Leukocytes: \<0.75 \* LLN/ \>1.25 \* ULN, or if BL\<LLN then use \<0.8 \* BL or \>ULN, or if BL\>ULN then use \>1.2 \* BL or \<LLN; neutrophils+bands: \<1.0 \* 10\^3 c/uL; eosinophils: \>0.750 \* 10\^3 c/uL; basophils: \> 400 mm\^3; monocytes: \>2000 mm\^3; lymphocytes: \<0.750 \* 10\^3 c/uL/ \>7.50 \* 10\^3 c/uL.
Outcome measures
| Measure |
ABA + MTX DB
n=433 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=219 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Number of Participants With Hematology Laboratories Meeting Marked Abnormality Criteria in the DB Period
Low Hemoglobin (LLN 11.5 g/dL)
|
7 Participants
|
4 Participants
|
|
Number of Participants With Hematology Laboratories Meeting Marked Abnormality Criteria in the DB Period
Low Hematocrit (LLN 34%)
|
4 Participants
|
3 Participants
|
|
Number of Participants With Hematology Laboratories Meeting Marked Abnormality Criteria in the DB Period
Low Platelet Count (LLN 140 x 10^3 c/uL)
|
4 Participants
|
1 Participants
|
|
Number of Participants With Hematology Laboratories Meeting Marked Abnormality Criteria in the DB Period
High Platelet Count (ULN 415 x 10^3 c/uL)
|
1 Participants
|
0 Participants
|
|
Number of Participants With Hematology Laboratories Meeting Marked Abnormality Criteria in the DB Period
Low Leukocytes (LLN 4.0 x 10^3 c/uL)
|
15 Participants
|
4 Participants
|
|
Number of Participants With Hematology Laboratories Meeting Marked Abnormality Criteria in the DB Period
High Leukocytes (ULN 10.5 x 10^3 c/uL)
|
45 Participants
|
33 Participants
|
|
Number of Participants With Hematology Laboratories Meeting Marked Abnormality Criteria in the DB Period
Low Absolute Neutrophils (LLN 1.8 x 10^3 c/uL)
|
10 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 365Population: All treated participants in the DB period.
Marked abnormality criteria were: Aspartate Aminotransferase (AST) \>3 \* ULN or if BL \> ULN then use \>4 \*BL; Alanine Aminotransferase (ALT) \>3 \* ULN or if BL \> ULN then use \> 4 \* BL; Creatinine \> 1.5 \* BL.
Outcome measures
| Measure |
ABA + MTX DB
n=433 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=219 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Number of Participants With Liver and Kidney Function Tests Meeting Marked Abnormality Criteria in the DB Period
High AST (ULN 40 U/L)
|
4 Participants
|
2 Participants
|
|
Number of Participants With Liver and Kidney Function Tests Meeting Marked Abnormality Criteria in the DB Period
High ALT (ULN 55 U/L)
|
7 Participants
|
5 Participants
|
|
Number of Participants With Liver and Kidney Function Tests Meeting Marked Abnormality Criteria in the DB Period
High Creatinine (ULN 1.5 mg/ dL)
|
23 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,989, Day 2,185Population: All treated participants in the OL period. Treatment groups represent treatment received in the DB period. N = number of participants analyzed and n = the number of participants with measurements for that time point.
Mean baseline values are reported for each cohort at each time point.
Outcome measures
| Measure |
ABA + MTX DB
n=378 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=161 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Mean BL ESR and CRP Levels in the OL Period
ESR Day 365 (n=343, 141)
|
43.56 IU / mL
Standard Deviation 22.98
|
43.61 IU / mL
Standard Deviation 25.25
|
|
Mean BL ESR and CRP Levels in the OL Period
CRP Day 365 (n=373, 160)
|
32.48 IU / mL
Standard Deviation 31.41
|
24.72 IU / mL
Standard Deviation 20.74
|
|
Mean BL ESR and CRP Levels in the OL Period
ESR Day 729 (n=307, 132)
|
43.74 IU / mL
Standard Deviation 23.44
|
41.37 IU / mL
Standard Deviation 24.15
|
|
Mean BL ESR and CRP Levels in the OL Period
CRP Day 729 (n=348, 153)
|
32.12 IU / mL
Standard Deviation 30.99
|
23.46 IU / mL
Standard Deviation 19.65
|
|
Mean BL ESR and CRP Levels in the OL Period
ESR Day 1,093 (n=283, 123)
|
43.57 IU / mL
Standard Deviation 23.34
|
42.41 IU / mL
Standard Deviation 25.25
|
|
Mean BL ESR and CRP Levels in the OL Period
CRP Day 1,093 (n=306, 131)
|
31.96 IU / mL
Standard Deviation 30.35
|
24.09 IU / mL
Standard Deviation 19.85
|
|
Mean BL ESR and CRP Levels in the OL Period
ESR Day 1,457 (n=270, 111)
|
43.49 IU / mL
Standard Deviation 23.71
|
42.87 IU / mL
Standard Deviation 24.27
|
|
Mean BL ESR and CRP Levels in the OL Period
CRP Day 1,457 (n=295, 132)
|
32.13 IU / mL
Standard Deviation 30.14
|
23.20 IU / mL
Standard Deviation 19.22
|
|
Mean BL ESR and CRP Levels in the OL Period
ESR Day 1,821 (n=257, 109)
|
43.03 IU / mL
Standard Deviation 22.86
|
41.83 IU / mL
Standard Deviation 24.01
|
|
Mean BL ESR and CRP Levels in the OL Period
CRP Day 1,821 (n=275, 124)
|
31.41 IU / mL
Standard Deviation 29.30
|
22.14 IU / mL
Standard Deviation 18.34
|
|
Mean BL ESR and CRP Levels in the OL Period
ESR Day 1,989 (n=114, 49)
|
42.61 IU / mL
Standard Deviation 24.00
|
38.78 IU / mL
Standard Deviation 19.64
|
|
Mean BL ESR and CRP Levels in the OL Period
CRP Day 1,989 (n=128, 61)
|
33.22 IU / mL
Standard Deviation 34.65
|
20.39 IU / mL
Standard Deviation 14.43
|
|
Mean BL ESR and CRP Levels in the OL Period
ESR Day 2,185 (n=76, 29)
|
45.04 IU / mL
Standard Deviation 23.46
|
39.17 IU / mL
Standard Deviation 21.30
|
|
Mean BL ESR and CRP Levels in the OL Period
CRP Day 2,185 (n=83, 38)
|
34.73 IU / mL
Standard Deviation 36.05
|
22.08 IU / mL
Standard Deviation 15.69
|
SECONDARY outcome
Timeframe: BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,989, Day 2,185Population: All treated participants in the OL period. Treatment groups represent treatment received in the DB period. N = number of participants analyzed and n = the number of participants with measurements for that time point.
Serum samples were evaluated from study participants to determine the mean change from baseline in ESR values.
Outcome measures
| Measure |
ABA + MTX DB
n=378 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=161 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Mean Change From BL in ESR in the OL Period
Day 365 (n=343, 141)
|
-17.9 IU / mL
Standard Error 1.21
|
-6.85 IU / mL
Standard Error 1.74
|
|
Mean Change From BL in ESR in the OL Period
Day 729 (n=307, 132)
|
-19.3 IU / mL
Standard Error 1.29
|
-16.3 IU / mL
Standard Error 1.91
|
|
Mean Change From BL in ESR in the OL Period
Day 1,093 (n=283, 123)
|
-17.2 IU / mL
Standard Error 1.55
|
-16.6 IU / mL
Standard Error 2.15
|
|
Mean Change From BL in ESR in the OL Period
Day 1,457 (n=270, 111)
|
-17.7 IU / mL
Standard Error 1.41
|
-16.3 IU / mL
Standard Error 2.33
|
|
Mean Change From BL in ESR in the OL Period
Day 1,821 (n=257, 109)
|
-17.7 IU / mL
Standard Error 1.46
|
-16.6 IU / mL
Standard Error 2.26
|
|
Mean Change From BL in ESR in the OL Period
Day 1,989 (n=114, 49)
|
-17.3 IU / mL
Standard Error 2.33
|
-13.3 IU / mL
Standard Error 3.12
|
|
Mean Change From BL in ESR in the OL Period
Day 2,185 (n=76, 29)
|
-22.1 IU / mL
Standard Error 2.92
|
-21.0 IU / mL
Standard Error 4.45
|
SECONDARY outcome
Timeframe: Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 2,185Population: All treated participants in the OL period. Treatment groups represent treatment received in the DB period. N = number of participants analyzed and n = the number of participants with measurements for that time point.
This analysis determined participant RF status (positive or RF negative) based on serum samples at each specified timepoint. A positive value for RF was \> 20 IU/ml; a negative value for RF was ≤ 20 IU/mL.
Outcome measures
| Measure |
ABA + MTX DB
n=378 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=161 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Participant RF Seroconversion in the OL Period
Positive Seroconversion Day 365 (n=347, 146)
|
2 Participants
|
3 Participants
|
|
Participant RF Seroconversion in the OL Period
Negative Seroconversion Day 365 (n=347, 146)
|
31 Participants
|
2 Participants
|
|
Participant RF Seroconversion in the OL Period
Positive Seroconversion Day 729 (n=330, 143)
|
8 Participants
|
1 Participants
|
|
Participant RF Seroconversion in the OL Period
Negative Seroconversion Day 729 (n=330, 143)
|
31 Participants
|
10 Participants
|
|
Participant RF Seroconversion in the OL Period
Positive Seroconversion Day 1,093 (n=280, 119)
|
6 Participants
|
3 Participants
|
|
Participant RF Seroconversion in the OL Period
Negative Seroconversion Day 1,093 (n=280, 119)
|
27 Participants
|
7 Participants
|
|
Participant RF Seroconversion in the OL Period
Positive Seroconversion Day 1,457 (n=275, 118)
|
5 Participants
|
4 Participants
|
|
Participant RF Seroconversion in the OL Period
Negative Seroconversion Day 1,457 (n=275, 118)
|
27 Participants
|
8 Participants
|
|
Participant RF Seroconversion in the OL Period
Positive Seroconversion Day 1,821 (n=255, 115)
|
4 Participants
|
5 Participants
|
|
Participant RF Seroconversion in the OL Period
Negative Seroconversion Day 1,821 (n=255, 115)
|
25 Participants
|
9 Participants
|
|
Participant RF Seroconversion in the OL Period
Positive Seroconversion Day 2,185 (n=75, 31)
|
3 Participants
|
3 Participants
|
|
Participant RF Seroconversion in the OL Period
Negative Seroconversion Day 2,185 (n=75, 31)
|
7 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,083, Day 1,177, Day 1,261, Day 1,345, Day 1,497, Day 1,625, Day 1,821Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
ACR 20 response requires a patient to have a 20% reduction in the number of swollen and tender joints, and a reduction of 20% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, CRP or ESR, and degree of disability in HAQ score. A participant achieved a sustained ACR 20 response if the participant had ACR 20 observed for at least 2 consecutive study visits.
Outcome measures
| Measure |
ABA + MTX DB
n=376 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=160 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Number of ACR 20 Responders in the DB and OL Periods
Day 365 (n = 373, n = 159)
|
307 Participants
|
86 Participants
|
|
Number of ACR 20 Responders in the DB and OL Periods
Day 449 (n = 363, n = 155)
|
299 Participants
|
122 Participants
|
|
Number of ACR 20 Responders in the DB and OL Periods
Day 533 (n = 353, n = 155)
|
300 Participants
|
127 Participants
|
|
Number of ACR 20 Responders in the DB and OL Periods
Day 617 (n = 347, n = 155)
|
299 Participants
|
127 Participants
|
|
Number of ACR 20 Responders in the DB and OL Periods
Day 729 (n = 337, n = 147)
|
296 Participants
|
122 Participants
|
|
Number of ACR 20 Responders in the DB and OL Periods
Day 813 (n = 322, n = 143)
|
273 Participants
|
124 Participants
|
|
Number of ACR 20 Responders in the DB and OL Periods
Day 15 (n = 370, n = 158)
|
95 Participants
|
26 Participants
|
|
Number of ACR 20 Responders in the DB and OL Periods
Day 29 (n = 368, n=158)
|
145 Participants
|
44 Participants
|
|
Number of ACR 20 Responders in the DB and OL Periods
Day 57 (n = 371, n = 159)
|
218 Participants
|
66 Participants
|
|
Number of ACR 20 Responders in the DB and OL Periods
Day 85 (n = 367, n = 158)
|
246 Participants
|
70 Participants
|
|
Number of ACR 20 Responders in the DB and OL Periods
Day 113 (n = 367, n = 159)
|
266 Participants
|
79 Participants
|
|
Number of ACR 20 Responders in the DB and OL Periods
Day 141 (n = 368, n = 159)
|
275 Participants
|
85 Participants
|
|
Number of ACR 20 Responders in the DB and OL Periods
Day 169 (n = 371, n = 159)
|
272 Participants
|
79 Participants
|
|
Number of ACR 20 Responders in the DB and OL Periods
Day 225 (n = 369, n = 158)
|
302 Participants
|
86 Participants
|
|
Number of ACR 20 Responders in the DB and OL Periods
Day 281 (n = 367, n = 159)
|
299 Participants
|
92 Participants
|
|
Number of ACR 20 Responders in the DB and OL Periods
Day 897 (n = 311, n = 136)
|
260 Participants
|
117 Participants
|
|
Number of ACR 20 Responders in the DB and OL Periods
Day 981 (n = 298, n = 133)
|
243 Participants
|
110 Participants
|
|
Number of ACR 20 Responders in the DB and OL Periods
Day 1,093 (n = 303, n = 134)
|
257 Participants
|
111 Participants
|
|
Number of ACR 20 Responders in the DB and OL Periods
Day 1,177 (n = 265, n = 117)
|
228 Participants
|
101 Participants
|
|
Number of ACR 20 Responders in the DB and OL Periods
Day 1,261 (n = 289, n = 131)
|
251 Participants
|
107 Participants
|
|
Number of ACR 20 Responders in the DB and OL Periods
Day 1,345 (n = 133, n = 53)
|
108 Participants
|
43 Participants
|
|
Number of ACR 20 Responders in the DB and OL Periods
Day 1,457 (n = 288, n = 128)
|
253 Participants
|
110 Participants
|
|
Number of ACR 20 Responders in the DB and OL Periods
Day 1,625 (n = 273, n= 126)
|
236 Participants
|
112 Participants
|
|
Number of ACR 20 Responders in the DB and OL Periods
Day 1,821 (n = 268, n = 123)
|
224 Participants
|
106 Participants
|
|
Number of ACR 20 Responders in the DB and OL Periods
Day 1,989 (n = 119, n = 54)
|
103 Participants
|
45 Participants
|
|
Number of ACR 20 Responders in the DB and OL Periods
Day 2,185 (n = 85, n = 37)
|
72 Participants
|
34 Participants
|
SECONDARY outcome
Timeframe: Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,083, Day 1,177, Day 1,261, Day 1,345, Day 1,497, Day 1,625, Day 1,821Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
ACR 50 response requires a patient to have a 50% reduction in the number of swollen and tender joints, and a reduction of 50% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, CRP or ESR, and degree of disability in HAQ score.
Outcome measures
| Measure |
ABA + MTX DB
n=376 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=160 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Number of ACR 50 Responders in the DB and OL Periods
Day 15 (n = 371, n = 160)
|
12 Participants
|
2 Participants
|
|
Number of ACR 50 Responders in the DB and OL Periods
Day 29 (n = 368, n=158)
|
35 Participants
|
8 Participants
|
|
Number of ACR 50 Responders in the DB and OL Periods
Day 57 (n = 373, n = 159)
|
82 Participants
|
15 Participants
|
|
Number of ACR 50 Responders in the DB and OL Periods
Day 85 (n = 367, n = 158)
|
128 Participants
|
16 Participants
|
|
Number of ACR 50 Responders in the DB and OL Periods
Day 113 (n = 368, n = 159)
|
142 Participants
|
25 Participants
|
|
Number of ACR 50 Responders in the DB and OL Periods
Day 141 (n = 371, n = 159)
|
157 Participants
|
38 Participants
|
|
Number of ACR 50 Responders in the DB and OL Periods
Day 169 (n = 373, n = 159)
|
163 Participants
|
35 Participants
|
|
Number of ACR 50 Responders in the DB and OL Periods
Day 225 (n = 370, n = 159)
|
188 Participants
|
42 Participants
|
|
Number of ACR 50 Responders in the DB and OL Periods
Day 281 (n = 369, n = 159)
|
193 Participants
|
38 Participants
|
|
Number of ACR 50 Responders in the DB and OL Periods
Day 365 (n = 372, n = 160)
|
202 Participants
|
40 Participants
|
|
Number of ACR 50 Responders in the DB and OL Periods
Day 449 (n = 366, n = 155)
|
214 Participants
|
70 Participants
|
|
Number of ACR 50 Responders in the DB and OL Periods
Day 533 (n = 348, n = 156)
|
213 Participants
|
82 Participants
|
|
Number of ACR 50 Responders in the DB and OL Periods
Day 617 (n = 346, n = 155)
|
213 Participants
|
87 Participants
|
|
Number of ACR 50 Responders in the DB and OL Periods
Day 729 (n = 338, n = 147)
|
207 Participants
|
93 Participants
|
|
Number of ACR 50 Responders in the DB and OL Periods
Day 813 (n = 321, n = 145)
|
196 Participants
|
85 Participants
|
|
Number of ACR 50 Responders in the DB and OL Periods
Day 897 (n = 314, n = 136)
|
184 Participants
|
78 Participants
|
|
Number of ACR 50 Responders in the DB and OL Periods
Day 981 (n = 302, n = 133)
|
182 Participants
|
79 Participants
|
|
Number of ACR 50 Responders in the DB and OL Periods
Day 1,093 (n = 306, n = 135)
|
194 Participants
|
77 Participants
|
|
Number of ACR 50 Responders in the DB and OL Periods
Day 1,177 (n = 266, n = 118)
|
158 Participants
|
64 Participants
|
|
Number of ACR 50 Responders in the DB and OL Periods
Day 1,261 (n = 289, n = 130)
|
176 Participants
|
76 Participants
|
|
Number of ACR 50 Responders in the DB and OL Periods
Day 1,345 (n = 141, n = 56)
|
83 Participants
|
31 Participants
|
|
Number of ACR 50 Responders in the DB and OL Periods
Day 1,457 (n = 288, n = 127)
|
193 Participants
|
75 Participants
|
|
Number of ACR 50 Responders in the DB and OL Periods
Day 1,625 (n = 274, n= 126)
|
181 Participants
|
84 Participants
|
|
Number of ACR 50 Responders in the DB and OL Periods
Day 1,821 (n = 270, n = 123)
|
165 Participants
|
75 Participants
|
|
Number of ACR 50 Responders in the DB and OL Periods
Day 1,989 (n = 121, n = 55)
|
78 Participants
|
33 Participants
|
|
Number of ACR 50 Responders in the DB and OL Periods
Day 2,185 (n = 83, n = 37)
|
46 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,083, Day 1,177, Day 1,261, Day 1,345, Day 1,497, Day 1,625, Day 1,821Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
ACR 70 response requires a patient to have a 70% reduction in the number of swollen and tender joints, and a reduction of 70% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, CRP or ESR, and degree of disability in HAQ score. A participant achieved a sustained ACR 70 response if the participant had ACR 70 observed for at least 2 consecutive study visits.
Outcome measures
| Measure |
ABA + MTX DB
n=376 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=160 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Number of ACR 70 Responders in the DB and OL Periods
Day 15 (n = 371, n = 160)
|
4 Participants
|
1 Participants
|
|
Number of ACR 70 Responders in the DB and OL Periods
Day 29 (n = 369, n=159)
|
8 Participants
|
2 Participants
|
|
Number of ACR 70 Responders in the DB and OL Periods
Day 57 (n = 374, n = 159)
|
27 Participants
|
6 Participants
|
|
Number of ACR 70 Responders in the DB and OL Periods
Day 85 (n = 370, n = 158)
|
51 Participants
|
7 Participants
|
|
Number of ACR 70 Responders in the DB and OL Periods
Day 113 (n = 371, n = 159)
|
56 Participants
|
10 Participants
|
|
Number of ACR 70 Responders in the DB and OL Periods
Day 141 (n = 371, n = 159)
|
73 Participants
|
12 Participants
|
|
Number of ACR 70 Responders in the DB and OL Periods
Day 169 (n = 374, n = 159)
|
83 Participants
|
14 Participants
|
|
Number of ACR 70 Responders in the DB and OL Periods
Day 225 (n = 369, n = 160)
|
100 Participants
|
16 Participants
|
|
Number of ACR 70 Responders in the DB and OL Periods
Day 281 (n = 372, n = 160)
|
104 Participants
|
20 Participants
|
|
Number of ACR 70 Responders in the DB and OL Periods
Day 365 (n = 374, n = 160)
|
121 Participants
|
14 Participants
|
|
Number of ACR 70 Responders in the DB and OL Periods
Day 449 (n = 367, n = 157)
|
122 Participants
|
33 Participants
|
|
Number of ACR 70 Responders in the DB and OL Periods
Day 533 (n = 350, n = 156)
|
126 Participants
|
47 Participants
|
|
Number of ACR 70 Responders in the DB and OL Periods
Day 617 (n = 347, n = 154)
|
116 Participants
|
51 Participants
|
|
Number of ACR 70 Responders in the DB and OL Periods
Day 729 (n = 340, n = 147)
|
130 Participants
|
49 Participants
|
|
Number of ACR 70 Responders in the DB and OL Periods
Day 813 (n = 325, n = 146)
|
117 Participants
|
42 Participants
|
|
Number of ACR 70 Responders in the DB and OL Periods
Day 897 (n = 314, n = 138)
|
109 Participants
|
40 Participants
|
|
Number of ACR 70 Responders in the DB and OL Periods
Day 981 (n = 306, n = 134)
|
116 Participants
|
39 Participants
|
|
Number of ACR 70 Responders in the DB and OL Periods
Day 1,093 (n = 309, n = 137)
|
116 Participants
|
44 Participants
|
|
Number of ACR 70 Responders in the DB and OL Periods
Day 1,177 (n = 265, n = 122)
|
94 Participants
|
40 Participants
|
|
Number of ACR 70 Responders in the DB and OL Periods
Day 1,261 (n = 289, n = 132)
|
105 Participants
|
45 Participants
|
|
Number of ACR 70 Responders in the DB and OL Periods
Day 1,345 (n = 139, n = 57)
|
52 Participants
|
18 Participants
|
|
Number of ACR 70 Responders in the DB and OL Periods
Day 1,457 (n = 288, n = 128)
|
121 Participants
|
47 Participants
|
|
Number of ACR 70 Responders in the DB and OL Periods
Day 1,625 (n = 278, n= 125)
|
115 Participants
|
50 Participants
|
|
Number of ACR 70 Responders in the DB and OL Periods
Day 1,821 (n = 270, n = 125)
|
107 Participants
|
46 Participants
|
|
Number of ACR 70 Responders in the DB and OL Periods
Day 1,989 (n = 119, n = 54)
|
50 Participants
|
22 Participants
|
|
Number of ACR 70 Responders in the DB and OL Periods
Day 2,185 (n = 83, n = 37)
|
32 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,083, Day 1,177, Day 1,261, Day 1,345, Day 1,497, Day 1,625, Day 1,821, Day 1,989, Day 2,185Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
The DAS 28 is a continuous measure evaluating extent of disease activity in RA, and is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, erythrocyte sedimentation rate (ESR) and participant assessment of disease activity measure on a visual analog scale (VAS) of 100 mm. The scale reports from 1 to 10, with increasing number indicating increasing extent of disease progression. Scores for disease activity are defined as high (\> 5.1); low (≤ 3.2); remission (\< 2.6).
Outcome measures
| Measure |
ABA + MTX DB
n=376 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=160 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time
Remission Day 15 (n = 355, n = 152)
|
1 Participants
|
0 Participants
|
|
Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time
Low Disease Activity Day 15 (n=355, 152)
|
5 Participants
|
1 Participants
|
|
Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time
Remission Day 29 (n = 362, n =157)
|
8 Participants
|
0 Participants
|
|
Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time
Low Disease Activity Day 29 (n=362, 157)
|
24 Participants
|
2 Participants
|
|
Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time
Remission Day 57 (n = 367, n = 156)
|
19 Participants
|
1 Participants
|
|
Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time
Low Disease Activity Day 57 (n=367, 156)
|
44 Participants
|
7 Participants
|
|
Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time
Remission Day 85 (n = 366, n = 152)
|
39 Participants
|
3 Participants
|
|
Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time
Low Disease Activity Day 85 (n=366, 152)
|
76 Participants
|
16 Participants
|
|
Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time
Remission Day 113 (n = 367, n = 159)
|
39 Participants
|
9 Participants
|
|
Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time
Low Disease Activity Day 113 (n=367, 159)
|
89 Participants
|
20 Participants
|
|
Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time
Remission Day 141 (n = 366, n = 158)
|
57 Participants
|
7 Participants
|
|
Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time
Low Disease Activity Day 141 (n=366, 158)
|
104 Participants
|
20 Participants
|
|
Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time
Remission Day 169 (n = 371, n = 159)
|
63 Participants
|
6 Participants
|
|
Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time
Low Disease Activity Day 169 (n=371, 159)
|
117 Participants
|
19 Participants
|
|
Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time
Remission Day 225 (n = 366, n = 158)
|
75 Participants
|
9 Participants
|
|
Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time
Low Disease Activity Day 225 (n=366, 158)
|
147 Participants
|
21 Participants
|
|
Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time
Remission Day 281 (n = 364, n = 159)
|
89 Participants
|
14 Participants
|
|
Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time
Low Disease Activity Day 281 (n=364, 159)
|
150 Participants
|
33 Participants
|
|
Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time
Remission Day 365 (n = 370, n = 159)
|
94 Participants
|
4 Participants
|
|
Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time
Low Disease Activity Day 365 (n=370, 159)
|
163 Participants
|
19 Participants
|
|
Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time
Remission Day 449 (n = 357, n = 150)
|
100 Participants
|
32 Participants
|
|
Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time
Low Disease Activity Day 449 (n=357, 150)
|
162 Participants
|
55 Participants
|
|
Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time
Remission Day 533 (n = 343, n = 150)
|
101 Participants
|
42 Participants
|
|
Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time
Low Disease Activity Day 553 (n=343, 150)
|
158 Participants
|
61 Participants
|
|
Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time
Remission Day 617 (n = 334, n = 153)
|
100 Participants
|
46 Participants
|
|
Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time
Low Disease Activity Day 617 (n=334, 153)
|
159 Participants
|
74 Participants
|
|
Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time
Remission Day 729 (n = 337, n = 148)
|
97 Participants
|
45 Participants
|
|
Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time
Low Disease Activity Day 729 (n=337, 148)
|
175 Participants
|
77 Participants
|
|
Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time
Remission Day 813 (n = 317, n = 143)
|
97 Participants
|
46 Participants
|
|
Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time
Low Disease Activity Day 813 (n=317, 143)
|
160 Participants
|
72 Participants
|
|
Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time
Remission Day 897 (n = 303, n = 135)
|
91 Participants
|
48 Participants
|
|
Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time
Low Disease Activity Day 897 (n=303, 135)
|
152 Participants
|
70 Participants
|
|
Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time
Remission Day 981 (n = 297, n = 133)
|
102 Participants
|
46 Participants
|
|
Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time
Low Disease Activity Day 981 (n=297, 133)
|
168 Participants
|
72 Participants
|
|
Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time
Remission Day 1,093 (n = 300, n = 129)
|
112 Participants
|
42 Participants
|
|
Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time
Low Disease Activity Day 1,093 (n=300, 129)
|
160 Participants
|
77 Participants
|
|
Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time
Remission Day 1,177 (n = 158, n = 71)
|
55 Participants
|
27 Participants
|
|
Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time
Low Disease Activity Day 1,177 (n=158, 71)
|
84 Participants
|
42 Participants
|
|
Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time
Remission Day 1,261 (n = 267, n = 119)
|
91 Participants
|
50 Participants
|
|
Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time
Low Disease Activity Day 1,261 (n=267, 119)
|
146 Participants
|
70 Participants
|
|
Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time
Remission Day 1,457 (n = 284, n = 129)
|
111 Participants
|
51 Participants
|
|
Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time
Low Disease Activity Day 1,457 (n=284, 129)
|
161 Participants
|
79 Participants
|
|
Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time
Remission Day 1,625 (n = 272, n= 124)
|
96 Participants
|
47 Participants
|
|
Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time
Low Disease Activity Day 1,625 (n=272, 124)
|
145 Participants
|
71 Participants
|
|
Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time
Remission Day 1,821 (n = 270, n = 124)
|
89 Participants
|
47 Participants
|
|
Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time
Low Disease Activity Day 1,821 (n=270, 124)
|
147 Participants
|
73 Participants
|
|
Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time
Remission Day 1,989 (n=118, 54)
|
43 Participants
|
21 Participants
|
|
Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time
Low Disease Activity Day 1,989 (n=118, 54)
|
65 Participants
|
31 Participants
|
|
Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time
Remission Day 2,185 (n=82, 37)
|
25 Participants
|
18 Participants
|
|
Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time
Low Disease Activity Day 2,185 (n=82, 37)
|
41 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: BL(Day 0), Day 15, Day 29,Day 57,Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,083, Day 1,177, Day 1,261, Day 1,345, Day 1,497, Day 1,625, Day 1,821, Day 1,989, Day 2,185Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
Time-matched BL (Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.
Outcome measures
| Measure |
ABA + MTX DB
n=376 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=160 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Mean BL DAS-28 CRP Over Time for Participants Continuing in the OL Period
BL (Day 0) for Day 15 Cohort (n=352, 150)
|
6.36 mg / mL
Standard Deviation 0.81
|
6.32 mg / mL
Standard Deviation 0.81
|
|
Mean BL DAS-28 CRP Over Time for Participants Continuing in the OL Period
BL (Day 0) for Day 29 Cohort (n=357, 154)
|
6.36 mg / mL
Standard Deviation 0.81
|
6.35 mg / mL
Standard Deviation 0.81
|
|
Mean BL DAS-28 CRP Over Time for Participants Continuing in the OL Period
BL (Day 0) for Day 57 Cohort (n=362, 153)
|
6.36 mg / mL
Standard Deviation 0.81
|
6.35 mg / mL
Standard Deviation 0.79
|
|
Mean BL DAS-28 CRP Over Time for Participants Continuing in the OL Period
BL (Day 0) for Day 85 Cohort (n=362, 149)
|
6.35 mg / mL
Standard Deviation 0.81
|
6.33 mg / mL
Standard Deviation 0.81
|
|
Mean BL DAS-28 CRP Over Time for Participants Continuing in the OL Period
BL (Day 0) for Day 113 Cohort (n=362, 149)
|
6.35 mg / mL
Standard Deviation 0.81
|
6.34 mg / mL
Standard Deviation 0.81
|
|
Mean BL DAS-28 CRP Over Time for Participants Continuing in the OL Period
BL (Day 0) for Day 141 Cohort (n=361, 155)
|
6.34 mg / mL
Standard Deviation 0.80
|
6.33 mg / mL
Standard Deviation 0.82
|
|
Mean BL DAS-28 CRP Over Time for Participants Continuing in the OL Period
BL (Day 0) for Day 169 Cohort (n=366, 156)
|
6.35 mg / mL
Standard Deviation 0.80
|
6.34 mg / mL
Standard Deviation 0.80
|
|
Mean BL DAS-28 CRP Over Time for Participants Continuing in the OL Period
BL (Day 0) for Day 225 Cohort (n=361, 155)
|
6.35 mg / mL
Standard Deviation 0.81
|
6.33 mg / mL
Standard Deviation 0.81
|
|
Mean BL DAS-28 CRP Over Time for Participants Continuing in the OL Period
BL (Day 0) for Day 281 Cohort (n=359, 156)
|
6.35 mg / mL
Standard Deviation 0.81
|
6.33 mg / mL
Standard Deviation 0.81
|
|
Mean BL DAS-28 CRP Over Time for Participants Continuing in the OL Period
BL (Day 0) for Day 365 Cohort (n=365, 156)
|
6.36 mg / mL
Standard Deviation 0.81
|
6.33 mg / mL
Standard Deviation 0.81
|
|
Mean BL DAS-28 CRP Over Time for Participants Continuing in the OL Period
BL (Day 0) for Day 449 Cohort (n=352, 147)
|
6.37 mg / mL
Standard Deviation 0.81
|
6.34 mg / mL
Standard Deviation 0.81
|
|
Mean BL DAS-28 CRP Over Time for Participants Continuing in the OL Period
BL (Day 0) for Day 533 Cohort (n=338, 147)
|
6.38 mg / mL
Standard Deviation 0.81
|
6.35 mg / mL
Standard Deviation 0.80
|
|
Mean BL DAS-28 CRP Over Time for Participants Continuing in the OL Period
BL (Day 0) for Day 617 Cohort (n=329, 150)
|
6.37 mg / mL
Standard Deviation 0.80
|
6.35 mg / mL
Standard Deviation 0.81
|
|
Mean BL DAS-28 CRP Over Time for Participants Continuing in the OL Period
BL (Day 0) for Day 729 Cohort (n=333, 145)
|
6.37 mg / mL
Standard Deviation 0.81
|
6.36 mg / mL
Standard Deviation 0.83
|
|
Mean BL DAS-28 CRP Over Time for Participants Continuing in the OL Period
BL (Day 0) for Day 813 Cohort (n=313, 140)
|
6.39 mg / mL
Standard Deviation 0.82
|
6.37 mg / mL
Standard Deviation 0.82
|
|
Mean BL DAS-28 CRP Over Time for Participants Continuing in the OL Period
BL (Day 0) for Day 897 Cohort (n=301, 133)
|
6.38 mg / mL
Standard Deviation 0.83
|
6.37 mg / mL
Standard Deviation 0.83
|
|
Mean BL DAS-28 CRP Over Time for Participants Continuing in the OL Period
BL (Day 0) for Day 981 Cohort (n=294, 131)
|
6.39 mg / mL
Standard Deviation 0.82
|
6.37 mg / mL
Standard Deviation 0.83
|
|
Mean BL DAS-28 CRP Over Time for Participants Continuing in the OL Period
BL (Day 0) for Day 1,093 Cohort (n=296, 127)
|
6.37 mg / mL
Standard Deviation 0.83
|
6.37 mg / mL
Standard Deviation 0.84
|
|
Mean BL DAS-28 CRP Over Time for Participants Continuing in the OL Period
BL (Day 0) for Day 1,177 Cohort (n=156, 70)
|
6.43 mg / mL
Standard Deviation 0.85
|
6.38 mg / mL
Standard Deviation 0.86
|
|
Mean BL DAS-28 CRP Over Time for Participants Continuing in the OL Period
BL (Day 0) for Day 1,261 Cohort (n=267, 117)
|
6.39 mg / mL
Standard Deviation 0.80
|
6.34 mg / mL
Standard Deviation 0.85
|
|
Mean BL DAS-28 CRP Over Time for Participants Continuing in the OL Period
BL (Day 0) for Day 1,457 Cohort (n=281, 126)
|
6.40 mg / mL
Standard Deviation 0.82
|
6.35 mg / mL
Standard Deviation 0.81
|
|
Mean BL DAS-28 CRP Over Time for Participants Continuing in the OL Period
BL (Day 0) for Day 1,625 Cohort (n=269, 121)
|
6.39 mg / mL
Standard Deviation 0.81
|
6.40 mg / mL
Standard Deviation 0.77
|
|
Mean BL DAS-28 CRP Over Time for Participants Continuing in the OL Period
BL (Day 0) for Day 1,821 Cohort (n=267, 122)
|
6.39 mg / mL
Standard Deviation 0.81
|
6.33 mg / mL
Standard Deviation 0.76
|
|
Mean BL DAS-28 CRP Over Time for Participants Continuing in the OL Period
BL (Day 0) for Day 1,989 Cohort (n=118, 53)
|
6.53 mg / mL
Standard Deviation 0.77
|
6.49 mg / mL
Standard Deviation 0.75
|
|
Mean BL DAS-28 CRP Over Time for Participants Continuing in the OL Period
BL (Day 0) for Day 2,185 Cohort (n=82, 36)
|
6.41 mg / mL
Standard Deviation 0.77
|
6.38 mg / mL
Standard Deviation 0.82
|
SECONDARY outcome
Timeframe: BL(Day 0),Day 15,Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,083, Day 1,177, Day 1,261, Day 1,345, Day 1,497, Day 1,625, Day 1,821, Day 1,989, Day 2,185Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
Change from baseline in participant were calculated at all study visits in the DB and OL periods.
Outcome measures
| Measure |
ABA + MTX DB
n=376 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=160 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Mean Change From BL in DAS-28 CRP Over Time for Participants Continuing in the OL Period
Day 15 (n=352, 150)
|
-0.83 mg / mL
Standard Error 0.04
|
-0.47 mg / mL
Standard Error 0.06
|
|
Mean Change From BL in DAS-28 CRP Over Time for Participants Continuing in the OL Period
Day 29 (n=357, 154)
|
-1.27 mg / mL
Standard Error 0.05
|
-0.87 mg / mL
Standard Error 0.08
|
|
Mean Change From BL in DAS-28 CRP Over Time for Participants Continuing in the OL Period
Day 57 (n=362, 153)
|
-1.80 mg / mL
Standard Error 0.06
|
-1.17 mg / mL
Standard Error 0.09
|
|
Mean Change From BL in DAS-28 CRP Over Time for Participants Continuing in the OL Period
Day 85 (n=362, 149)
|
-2.12 mg / mL
Standard Error 0.06
|
-1.37 mg / mL
Standard Error 0.10
|
|
Mean Change From BL in DAS-28 CRP Over Time for Participants Continuing in the OL Period
Day 113 (n=362, 149)
|
-2.30 mg / mL
Standard Error 0.06
|
-1.47 mg / mL
Standard Error 0.11
|
|
Mean Change From BL in DAS-28 CRP Over Time for Participants Continuing in the OL Period
Day 141 (n=361, 155)
|
-2.46 mg / mL
Standard Error 0.07
|
-1.52 mg / mL
Standard Error 0.11
|
|
Mean Change From BL in DAS-28 CRP Over Time for Participants Continuing in the OL Period
Day 169 (n=366, 156)
|
-2.48 mg / mL
Standard Error 0.07
|
-1.57 mg / mL
Standard Error 0.11
|
|
Mean Change From BL in DAS-28 CRP Over Time for Participants Continuing in the OL Period
Day 225 (n=361, 155)
|
-2.72 mg / mL
Standard Error 0.07
|
-1.70 mg / mL
Standard Error 0.11
|
|
Mean Change From BL in DAS-28 CRP Over Time for Participants Continuing in the OL Period
Day 281 (n=359, 156)
|
-2.81 mg / mL
Standard Error 0.07
|
-1.87 mg / mL
Standard Error 0.10
|
|
Mean Change From BL in DAS-28 CRP Over Time for Participants Continuing in the OL Period
Day 365 (n=365, 156)
|
-2.83 mg / mL
Standard Error 0.07
|
-1.68 mg / mL
Standard Error 0.10
|
|
Mean Change From BL in DAS-28 CRP Over Time for Participants Continuing in the OL Period
Day 449 (n=352, 147)
|
-2.91 mg / mL
Standard Error 0.07
|
-2.68 mg / mL
Standard Error 0.10
|
|
Mean Change From BL in DAS-28 CRP Over Time for Participants Continuing in the OL Period
Day 533 (n=338, 147)
|
-3.01 mg / mL
Standard Error 0.07
|
-2.79 mg / mL
Standard Error 0.11
|
|
Mean Change From BL in DAS-28 CRP Over Time for Participants Continuing in the OL Period
Day 617 (n=329, 150)
|
-3.00 mg / mL
Standard Error 0.07
|
-2.92 mg / mL
Standard Error 0.11
|
|
Mean Change From BL in DAS-28 CRP Over Time for Participants Continuing in the OL Period
Day 729 (n=333, 145)
|
-3.10 mg / mL
Standard Error 0.07
|
-3.02 mg / mL
Standard Error 0.11
|
|
Mean Change From BL in DAS-28 CRP Over Time for Participants Continuing in the OL Period
Day 813 (n=313, 140)
|
-3.09 mg / mL
Standard Error 0.07
|
-3.05 mg / mL
Standard Error 0.12
|
|
Mean Change From BL in DAS-28 CRP Over Time for Participants Continuing in the OL Period
Day 897 (n=301, 133)
|
-3.06 mg / mL
Standard Error 0.07
|
-3.11 mg / mL
Standard Error 0.11
|
|
Mean Change From BL in DAS-28 CRP Over Time for Participants Continuing in the OL Period
Day 981 (n=294, 131)
|
-3.21 mg / mL
Standard Error 0.08
|
-3.14 mg / mL
Standard Error 0.12
|
|
Mean Change From BL in DAS-28 CRP Over Time for Participants Continuing in the OL Period
Day 1,093 (n=296, 127)
|
-3.21 mg / mL
Standard Error 0.08
|
-3.15 mg / mL
Standard Error 0.12
|
|
Mean Change From BL in DAS-28 CRP Over Time for Participants Continuing in the OL Period
Day 1,177 (n=156, 70)
|
-3.27 mg / mL
Standard Error 0.11
|
-3.21 mg / mL
Standard Error 0.16
|
|
Mean Change From BL in DAS-28 CRP Over Time for Participants Continuing in the OL Period
Day 1,261 (n=267, 117)
|
-3.22 mg / mL
Standard Error 0.08
|
-3.15 mg / mL
Standard Error 0.13
|
|
Mean Change From BL in DAS-28 CRP Over Time for Participants Continuing in the OL Period
Day 1,457 (n=281, 126)
|
-3.29 mg / mL
Standard Error 0.08
|
-3.23 mg / mL
Standard Error 0.11
|
|
Mean Change From BL in DAS-28 CRP Over Time for Participants Continuing in the OL Period
Day 1,625 (n=269, 121)
|
-3.23 mg / mL
Standard Error 0.08
|
-3.34 mg / mL
Standard Error 0.11
|
|
Mean Change From BL in DAS-28 CRP Over Time for Participants Continuing in the OL Period
Day 1,821 (n=267, 122)
|
-3.14 mg / mL
Standard Error 0.08
|
-3.26 mg / mL
Standard Error 0.12
|
|
Mean Change From BL in DAS-28 CRP Over Time for Participants Continuing in the OL Period
Day 1,989 (n=118, 53)
|
-3.39 mg / mL
Standard Error 0.12
|
-3.31 mg / mL
Standard Error 0.19
|
|
Mean Change From BL in DAS-28 CRP Over Time for Participants Continuing in the OL Period
Day 2,185 (n=82, 36)
|
-3.04 mg / mL
Standard Error 0.16
|
-3.30 mg / mL
Standard Error 0.23
|
SECONDARY outcome
Timeframe: BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,083, Day 1,177, Day 1,261, Day 1,345, Day 1,497, Day 1,625, Day 1,821, Day 1,989, Day 2,185Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
Mean baseline values are reported for each cohort at each time point. Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.
Outcome measures
| Measure |
ABA + MTX DB
n=376 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=160 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Mean BL DAS-28 ESR Over Time in the OL Period
BL (Day 0) for Day 365 Cohort (n=352, 148)
|
6.82 IU / mL
Standard Deviation 0.85
|
6.88 IU / mL
Standard Deviation 0.85
|
|
Mean BL DAS-28 ESR Over Time in the OL Period
BL (Day 0) for Day 449 Cohort (n=345, 145)
|
6.82 IU / mL
Standard Deviation 0.86
|
6.89 IU / mL
Standard Deviation 0.85
|
|
Mean BL DAS-28 ESR Over Time in the OL Period
BL (Day 0) for Day 533 Cohort (n=332, 146)
|
6.83 IU / mL
Standard Deviation 0.86
|
6.88 IU / mL
Standard Deviation 0.86
|
|
Mean BL DAS-28 ESR Over Time in the OL Period
BL (Day 0) for Day 617 Cohort (n=325, 148)
|
6.85 IU / mL
Standard Deviation 0.86
|
6.86 IU / mL
Standard Deviation 0.86
|
|
Mean BL DAS-28 ESR Over Time in the OL Period
BL (Day 0) for Day 729 Cohort (n=315, 139)
|
6.82 IU / mL
Standard Deviation 0.88
|
6.87 IU / mL
Standard Deviation 0.88
|
|
Mean BL DAS-28 ESR Over Time in the OL Period
BL (Day 0) for Day 813 Cohort (n=303, 134)
|
6.82 IU / mL
Standard Deviation 0.87
|
6.90 IU / mL
Standard Deviation 0.88
|
|
Mean BL DAS-28 ESR Over Time in the OL Period
BL (Day 0) for Day 897 Cohort (n=296, 128)
|
6.83 IU / mL
Standard Deviation 0.88
|
6.85 IU / mL
Standard Deviation 0.90
|
|
Mean BL DAS-28 ESR Over Time in the OL Period
BL (Day 0) for Day 981 Cohort (n=282, 119)
|
6.82 IU / mL
Standard Deviation 0.87
|
6.88 IU / mL
Standard Deviation 0.88
|
|
Mean BL DAS-28 ESR Over Time in the OL Period
BL (Day 0) for Day 1,093 Cohort (n=287, 130)
|
6.83 IU / mL
Standard Deviation 0.88
|
6.87 IU / mL
Standard Deviation 0.89
|
|
Mean BL DAS-28 ESR Over Time in the OL Period
BL (Day 0) for Day 1,177 Cohort (n=241, 110)
|
6.86 IU / mL
Standard Deviation 0.87
|
6.89 IU / mL
Standard Deviation 0.92
|
|
Mean BL DAS-28 ESR Over Time in the OL Period
BL (Day 0) for Day 1,261 Cohort (n=271, 121)
|
6.82 IU / mL
Standard Deviation 0.87
|
6.86 IU / mL
Standard Deviation 0.89
|
|
Mean BL DAS-28 ESR Over Time in the OL Period
BL (Day 0) for Day 1,457 Cohort (n=269, 117)
|
6.87 IU / mL
Standard Deviation 0.85
|
6.88 IU / mL
Standard Deviation 0.87
|
|
Mean BL DAS-28 ESR Over Time in the OL Period
BL (Day 0) for Day 1,625 Cohort (n=260, 118)
|
6.86 IU / mL
Standard Deviation 0.85
|
6.86 IU / mL
Standard Deviation 0.86
|
|
Mean BL DAS-28 ESR Over Time in the OL Period
BL (Day 0) for Day 1,821 Cohort (n=259, 114)
|
6.85 IU / mL
Standard Deviation 0.86
|
6.87 IU / mL
Standard Deviation 0.84
|
|
Mean BL DAS-28 ESR Over Time in the OL Period
BL (Day 0) for Day 1,989 Cohort (n=108, 47)
|
6.95 IU / mL
Standard Deviation 0.83
|
7.04 IU / mL
Standard Deviation 0.85
|
|
Mean BL DAS-28 ESR Over Time in the OL Period
BL (Day 0) for Day 2,185 Cohort (n=76, 31)
|
6.90 IU / mL
Standard Deviation 0.82
|
6.97 IU / mL
Standard Deviation 0.92
|
SECONDARY outcome
Timeframe: BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,083, Day 1,177, Day 1,261, Day 1,345, Day 1,497, Day 1,625, Day 1,821, Day 1,989, Day 2,185Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
Change from baseline in participant serum values of ESR were calculated at all study visits in the OL period.
Outcome measures
| Measure |
ABA + MTX DB
n=376 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=160 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Mean Change From BL in DAS-28 ESR Over Time in the OL Period
Day 365 (n=352, 148)
|
-2.96 IU / mL
Standard Error 0.07
|
-1.76 IU / mL
Standard Error 0.11
|
|
Mean Change From BL in DAS-28 ESR Over Time in the OL Period
Day 449 (n=345, 145)
|
-3.04 IU / mL
Standard Error 0.08
|
-2.87 IU / mL
Standard Error 0.11
|
|
Mean Change From BL in DAS-28 ESR Over Time in the OL Period
Day 533 (n=332, 146)
|
-3.14 IU / mL
Standard Error 0.08
|
-2.95 IU / mL
Standard Error 0.12
|
|
Mean Change From BL in DAS-28 ESR Over Time in the OL Period
Day 617 (n=325, 148)
|
-3.17 IU / mL
Standard Error 0.08
|
-3.02 IU / mL
Standard Error 0.11
|
|
Mean Change From BL in DAS-28 ESR Over Time in the OL Period
Day 729 (n=315, 139)
|
-3.27 IU / mL
Standard Error 0.07
|
-3.20 IU / mL
Standard Error 0.12
|
|
Mean Change From BL in DAS-28 ESR Over Time in the OL Period
Day 813 (n=303, 134)
|
-3.13 IU / mL
Standard Error 0.08
|
-3.18 IU / mL
Standard Error 0.12
|
|
Mean Change From BL in DAS-28 ESR Over Time in the OL Period
Day 897 (n=296, 128)
|
-3.11 IU / mL
Standard Error 0.08
|
-3.10 IU / mL
Standard Error 0.12
|
|
Mean Change From BL in DAS-28 ESR Over Time in the OL Period
Day 981 (n=282, 119)
|
-3.26 IU / mL
Standard Error 0.09
|
-3.19 IU / mL
Standard Error 0.14
|
|
Mean Change From BL in DAS-28 ESR Over Time in the OL Period
Day 1,093 (n=287, 130)
|
-3.23 IU / mL
Standard Error 0.08
|
-3.22 IU / mL
Standard Error 0.13
|
|
Mean Change From BL in DAS-28 ESR Over Time in the OL Period
Day 1,177 (n=241, 110)
|
-3.33 IU / mL
Standard Error 0.09
|
-3.29 IU / mL
Standard Error 0.15
|
|
Mean Change From BL in DAS-28 ESR Over Time in the OL Period
Day 1,261 (n=271, 121)
|
-3.25 IU / mL
Standard Error 0.08
|
-3.18 IU / mL
Standard Error 0.14
|
|
Mean Change From BL in DAS-28 ESR Over Time in the OL Period
Day 1,457 (n=269, 117)
|
-3.32 IU / mL
Standard Error 0.08
|
-3.23 IU / mL
Standard Error 0.12
|
|
Mean Change From BL in DAS-28 ESR Over Time in the OL Period
Day 1,625 (n=260, 118)
|
-3.30 IU / mL
Standard Error 0.09
|
-3.27 IU / mL
Standard Error 0.12
|
|
Mean Change From BL in DAS-28 ESR Over Time in the OL Period
Day 1,821 (n=259, 114)
|
-3.22 IU / mL
Standard Error 0.09
|
-3.34 IU / mL
Standard Error 0.12
|
|
Mean Change From BL in DAS-28 ESR Over Time in the OL Period
Day 1,989 (n=108, 47)
|
-3.41 IU / mL
Standard Error 0.13
|
-3.42 IU / mL
Standard Error 0.23
|
|
Mean Change From BL in DAS-28 ESR Over Time in the OL Period
Day 2,185 (n=76, 31)
|
-3.25 IU / mL
Standard Error 0.17
|
-3.66 IU / mL
Standard Error 0.33
|
SECONDARY outcome
Timeframe: Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,083, Day 1,177, Day 1,261, Day 1,345, Day 1,497, Day 1,625, Day 1,821Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.
Outcome measures
| Measure |
ABA + MTX DB
n=376 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=160 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Number of Participants Achieving HAQ Response Over Time for Participants Continuing in the OL Period
Day 15 (n = 367, n = 160)
|
115 Participants
|
46 Participants
|
|
Number of Participants Achieving HAQ Response Over Time for Participants Continuing in the OL Period
Day 29 (n = 365, n = 159)
|
148 Participants
|
57 Participants
|
|
Number of Participants Achieving HAQ Response Over Time for Participants Continuing in the OL Period
Day 57 (n = 372, n = 157)
|
199 Participants
|
73 Participants
|
|
Number of Participants Achieving HAQ Response Over Time for Participants Continuing in the OL Period
Day 85 (n = 366, n = 156)
|
228 Participants
|
76 Participants
|
|
Number of Participants Achieving HAQ Response Over Time for Participants Continuing in the OL Period
Day 113 (n = 369, n = 159)
|
239 Participants
|
85 Participants
|
|
Number of Participants Achieving HAQ Response Over Time for Participants Continuing in the OL Period
Day 141 (n = 370, n = 159)
|
238 Participants
|
85 Participants
|
|
Number of Participants Achieving HAQ Response Over Time for Participants Continuing in the OL Period
Day 169 (n = 373, n = 159)
|
247 Participants
|
89 Participants
|
|
Number of Participants Achieving HAQ Response Over Time for Participants Continuing in the OL Period
Day 225 (n = 368, n = 159)
|
252 Participants
|
87 Participants
|
|
Number of Participants Achieving HAQ Response Over Time for Participants Continuing in the OL Period
Day 281 (n = 368, n = 160)
|
249 Participants
|
89 Participants
|
|
Number of Participants Achieving HAQ Response Over Time for Participants Continuing in the OL Period
Day 365 (n = 369, n = 160)
|
265 Participants
|
86 Participants
|
|
Number of Participants Achieving HAQ Response Over Time for Participants Continuing in the OL Period
Day 449 (n = 366, n = 157)
|
268 Participants
|
114 Participants
|
|
Number of Participants Achieving HAQ Response Over Time for Participants Continuing in the OL Period
Day 533 (n = 354, n = 157)
|
259 Participants
|
109 Participants
|
|
Number of Participants Achieving HAQ Response Over Time for Participants Continuing in the OL Period
Day 617 (n = 348, n = 154)
|
257 Participants
|
107 Participants
|
|
Number of Participants Achieving HAQ Response Over Time for Participants Continuing in the OL Period
Day 729 (n = 337, n = 148)
|
248 Participants
|
100 Participants
|
|
Number of Participants Achieving HAQ Response Over Time for Participants Continuing in the OL Period
Day 813 (n = 325, n= 146)
|
237 Participants
|
98 Participants
|
|
Number of Participants Achieving HAQ Response Over Time for Participants Continuing in the OL Period
Day 897 (n = 318, n = 140)
|
232 Participants
|
99 Participants
|
|
Number of Participants Achieving HAQ Response Over Time for Participants Continuing in the OL Period
Day 981 (n = 312, n = 137)
|
227 Participants
|
91 Participants
|
|
Number of Participants Achieving HAQ Response Over Time for Participants Continuing in the OL Period
Day 1,093 (n = 308, n = 137)
|
225 Participants
|
94 Participants
|
|
Number of Participants Achieving HAQ Response Over Time for Participants Continuing in the OL Period
Day 1,177 (n = 274, n = 124)
|
205 Participants
|
85 Participants
|
|
Number of Participants Achieving HAQ Response Over Time for Participants Continuing in the OL Period
Day 1,261 (n = 292, n = 134)
|
214 Participants
|
88 Participants
|
|
Number of Participants Achieving HAQ Response Over Time for Participants Continuing in the OL Period
Day 1,345 (n = 152, n = 62)
|
106 Participants
|
40 Participants
|
|
Number of Participants Achieving HAQ Response Over Time for Participants Continuing in the OL Period
Day 1,457 (n = 289, n = 129)
|
218 Participants
|
94 Participants
|
|
Number of Participants Achieving HAQ Response Over Time for Participants Continuing in the OL Period
Day 1,625 (n =280, n = 126)
|
210 Participants
|
92 Participants
|
|
Number of Participants Achieving HAQ Response Over Time for Participants Continuing in the OL Period
Day 1,821 (n = 271, n = 125)
|
201 Participants
|
90 Participants
|
|
Number of Participants Achieving HAQ Response Over Time for Participants Continuing in the OL Period
Day 1,989 (n = 119, n = 55)
|
90 Participants
|
35 Participants
|
|
Number of Participants Achieving HAQ Response Over Time for Participants Continuing in the OL Period
Day 2,185 (n = 85, n = 38)
|
63 Participants
|
26 Participants
|
SECONDARY outcome
Timeframe: BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
Change from baseline in the Genant-modified Sharp erosion score, JSN, TS were evaluated for all participants at the end of the OL period. The total Genant-modified Sharp score (TS) ranges from 0 (no radiographic damage) to 290 (worst possible radiographic damage) and is the sum of the erosion score (range 0-145) and the joint space narrowing score (range 0-145).Higher scores indicated more damage. Time-matched BL (Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.
Outcome measures
| Measure |
ABA + MTX DB
n=376 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=160 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
BL and Mean Change From BL in Radiographic Erosion, Joint Space Narrowing (JSN), and Total Scores (TS) in the OL Period
Day 1457 Erosion Change From BL (n=290, 128)
|
1.16 Units on a Scale
Standard Deviation 3.14
|
1.76 Units on a Scale
Standard Deviation 4.30
|
|
BL and Mean Change From BL in Radiographic Erosion, Joint Space Narrowing (JSN), and Total Scores (TS) in the OL Period
BL (Day 0) for Day 1457 Cohort JSN (n=290, 128)
|
10.66 Units on a Scale
Standard Deviation 13.71
|
12.12 Units on a Scale
Standard Deviation 14.64
|
|
BL and Mean Change From BL in Radiographic Erosion, Joint Space Narrowing (JSN), and Total Scores (TS) in the OL Period
Day 1457 JSN Change From BL (n=290, 128)
|
0.85 Units on a Scale
Standard Deviation 2.30
|
1.51 Units on a Scale
Standard Deviation 3.73
|
|
BL and Mean Change From BL in Radiographic Erosion, Joint Space Narrowing (JSN), and Total Scores (TS) in the OL Period
BL (Day 0) for Day 1457 Cohort TS (n=290, 128)
|
28.12 Units on a Scale
Standard Deviation 28.35
|
31.06 Units on a Scale
Standard Deviation 31.16
|
|
BL and Mean Change From BL in Radiographic Erosion, Joint Space Narrowing (JSN), and Total Scores (TS) in the OL Period
Day 1457 TS Change From BL (n=290, 128)
|
2.01 Units on a Scale
Standard Deviation 5.00
|
3.27 Units on a Scale
Standard Deviation 7.55
|
|
BL and Mean Change From BL in Radiographic Erosion, Joint Space Narrowing (JSN), and Total Scores (TS) in the OL Period
BL (Day 0) for Day 1821 Cohort Erosion (n=233,114)
|
17.62 Units on a Scale
Standard Deviation 15.62
|
18.93 Units on a Scale
Standard Deviation 17.37
|
|
BL and Mean Change From BL in Radiographic Erosion, Joint Space Narrowing (JSN), and Total Scores (TS) in the OL Period
Day 1821 Erosion Change From BL (n=233, 114)
|
1.12 Units on a Scale
Standard Deviation 2.99
|
2.05 Units on a Scale
Standard Deviation 4.88
|
|
BL and Mean Change From BL in Radiographic Erosion, Joint Space Narrowing (JSN), and Total Scores (TS) in the OL Period
BL (Day 0) for Day 1821 Cohort JSN (n=233, 114)
|
10.77 Units on a Scale
Standard Deviation 13.73
|
12.01 Units on a Scale
Standard Deviation 14.47
|
|
BL and Mean Change From BL in Radiographic Erosion, Joint Space Narrowing (JSN), and Total Scores (TS) in the OL Period
Day 1821 JSN Change From BL (n=233, 114)
|
0.90 Units on a Scale
Standard Deviation 2.54
|
1.73 Units on a Scale
Standard Deviation 4.11
|
|
BL and Mean Change From BL in Radiographic Erosion, Joint Space Narrowing (JSN), and Total Scores (TS) in the OL Period
BL (Day 0) for Day 1821 Cohort TS (n=233, 114)
|
28.39 Units on a Scale
Standard Deviation 28.50
|
30.94 Units on a Scale
Standard Deviation 30.99
|
|
BL and Mean Change From BL in Radiographic Erosion, Joint Space Narrowing (JSN), and Total Scores (TS) in the OL Period
Day 1821 TS Change From BL (n=233, 114)
|
2.02 Units on a Scale
Standard Deviation 4.93
|
3.78 Units on a Scale
Standard Deviation 8.46
|
|
BL and Mean Change From BL in Radiographic Erosion, Joint Space Narrowing (JSN), and Total Scores (TS) in the OL Period
BL (Day 0) for Day 365 Cohort Erosion (n=291, 131)
|
17.65 Units on a Scale
Standard Deviation 15.81
|
18.69 Units on a Scale
Standard Deviation 17.12
|
|
BL and Mean Change From BL in Radiographic Erosion, Joint Space Narrowing (JSN), and Total Scores (TS) in the OL Period
Day 365 Erosion Change From BL (n=291, 131)
|
0.42 Units on a Scale
Standard Deviation 1.20
|
0.84 Units on a Scale
Standard Deviation 1.93
|
|
BL and Mean Change From BL in Radiographic Erosion, Joint Space Narrowing (JSN), and Total Scores (TS) in the OL Period
BL (Day 0) for Day 365 Cohort JSN (n=291, 131)
|
10.83 Units on a Scale
Standard Deviation 14.02
|
12.02 Units on a Scale
Standard Deviation 14.53
|
|
BL and Mean Change From BL in Radiographic Erosion, Joint Space Narrowing (JSN), and Total Scores (TS) in the OL Period
Day 365 JSN Change From BL(n=291, 131)
|
0.38 Units on a Scale
Standard Deviation 1.05
|
0.64 Units on a Scale
Standard Deviation 1.67
|
|
BL and Mean Change From BL in Radiographic Erosion, Joint Space Narrowing (JSN), and Total Scores (TS) in the OL Period
BL (Day 0) for Day 365 Cohort TS (n=291, 131)
|
28.48 Units on a Scale
Standard Deviation 29.01
|
30.71 Units on a Scale
Standard Deviation 30.84
|
|
BL and Mean Change From BL in Radiographic Erosion, Joint Space Narrowing (JSN), and Total Scores (TS) in the OL Period
Day 365 TS Change From BL (n=291, 131)
|
0.80 Units on a Scale
Standard Deviation 1.99
|
1.48 Units on a Scale
Standard Deviation 3.35
|
|
BL and Mean Change From BL in Radiographic Erosion, Joint Space Narrowing (JSN), and Total Scores (TS) in the OL Period
BL (Day 0) for Day 729 Cohort Erosion (n=290, 130)
|
17.40 Units on a Scale
Standard Deviation 15.41
|
18.88 Units on a Scale
Standard Deviation 17.18
|
|
BL and Mean Change From BL in Radiographic Erosion, Joint Space Narrowing (JSN), and Total Scores (TS) in the OL Period
Day 729 Erosion Change From BL (n=291, 131)
|
0.59 Units on a Scale
Standard Deviation 1.67
|
1.14 Units on a Scale
Standard Deviation 2.74
|
|
BL and Mean Change From BL in Radiographic Erosion, Joint Space Narrowing (JSN), and Total Scores (TS) in the OL Period
BL (Day 0) for Day 729 Cohort JSN (n=291, 131)
|
10.65 Units on a Scale
Standard Deviation 13.80
|
12.21 Units on a Scale
Standard Deviation 14.56
|
|
BL and Mean Change From BL in Radiographic Erosion, Joint Space Narrowing (JSN), and Total Scores (TS) in the OL Period
Day 729 JSN Change From BL(n=291, 131)
|
0.55 Units on a Scale
Standard Deviation 1.40
|
1.05 Units on a Scale
Standard Deviation 2.79
|
|
BL and Mean Change From BL in Radiographic Erosion, Joint Space Narrowing (JSN), and Total Scores (TS) in the OL Period
BL (Day 0) for Day 729 Cohort TS (n=291, 131)
|
28.05 Units on a Scale
Standard Deviation 28.41
|
31.09 Units on a Scale
Standard Deviation 30.93
|
|
BL and Mean Change From BL in Radiographic Erosion, Joint Space Narrowing (JSN), and Total Scores (TS) in the OL Period
Day 729 TS Change From BL(n=291, 131)
|
1.14 Units on a Scale
Standard Deviation 2.69
|
2.19 Units on a Scale
Standard Deviation 5.22
|
|
BL and Mean Change From BL in Radiographic Erosion, Joint Space Narrowing (JSN), and Total Scores (TS) in the OL Period
BL (Day 0) for Day 1093 Cohort Erosion (n=293,130)
|
17.66 Units on a Scale
Standard Deviation 15.78
|
18.69 Units on a Scale
Standard Deviation 17.12
|
|
BL and Mean Change From BL in Radiographic Erosion, Joint Space Narrowing (JSN), and Total Scores (TS) in the OL Period
Day 1093 Erosion Change From BL (n=293, 130)
|
0.92 Units on a Scale
Standard Deviation 2.60
|
1.48 Units on a Scale
Standard Deviation 3.65
|
|
BL and Mean Change From BL in Radiographic Erosion, Joint Space Narrowing (JSN), and Total Scores (TS) in the OL Period
BL (Day 0) for Day 1093 Cohort JSN (n=293, 130)
|
10.84 Units on a Scale
Standard Deviation 13.97
|
12.02 Units on a Scale
Standard Deviation 14.53
|
|
BL and Mean Change From BL in Radiographic Erosion, Joint Space Narrowing (JSN), and Total Scores (TS) in the OL Period
Day 1093 JSN Change From BL (n=293, 130)
|
0.73 Units on a Scale
Standard Deviation 2.02
|
1.31 Units on a Scale
Standard Deviation 3.40
|
|
BL and Mean Change From BL in Radiographic Erosion, Joint Space Narrowing (JSN), and Total Scores (TS) in the OL Period
BL (Day 0) for Day 1093 Cohort TS (n=293, 130)
|
28.50 Units on a Scale
Standard Deviation 28.94
|
30.71 Units on a Scale
Standard Deviation 30.84
|
|
BL and Mean Change From BL in Radiographic Erosion, Joint Space Narrowing (JSN), and Total Scores (TS) in the OL Period
Day 1093 Total Score Change From BL (n=293, 130)
|
1.65 Units on a Scale
Standard Deviation 4.20
|
2.79 Units on a Scale
Standard Deviation 6.60
|
|
BL and Mean Change From BL in Radiographic Erosion, Joint Space Narrowing (JSN), and Total Scores (TS) in the OL Period
BL (Day 0) for Day 1457 Cohort Erosion (n=290,128)
|
17.46 Units on a Scale
Standard Deviation 15.46
|
18.94 Units on a Scale
Standard Deviation 17.30
|
SECONDARY outcome
Timeframe: BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 14,57, Day 1,625, Day 1,821, Day 1,989, Day 2,185Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of \> 3 points were considered clinically meaningful. Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.
Outcome measures
| Measure |
ABA + MTX DB
n=376 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=160 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Mean BL Physical Component Summary of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 365 Cohort (n=370, 157)
|
30.69 Units on a Scale
Standard Deviation 6.84
|
30.94 Units on a Scale
Standard Deviation 7.32
|
|
Mean BL Physical Component Summary of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 449 Cohort (n=362, 156)
|
30.55 Units on a Scale
Standard Deviation 6.78
|
30.95 Units on a Scale
Standard Deviation 7.34
|
|
Mean BL Physical Component Summary of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 533 Cohort (n=355, 155)
|
30.64 Units on a Scale
Standard Deviation 6.79
|
30.86 Units on a Scale
Standard Deviation 7.34
|
|
Mean BL Physical Component Summary of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 617 Cohort (n=348, 153)
|
30.70 Units on a Scale
Standard Deviation 6.81
|
30.88 Units on a Scale
Standard Deviation 7.37
|
|
Mean BL Physical Component Summary of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 729 Cohort (n=338, 146)
|
30.75 Units on a Scale
Standard Deviation 6.78
|
30.88 Units on a Scale
Standard Deviation 7.25
|
|
Mean BL Physical Component Summary of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 813 Cohort (n=323, 145)
|
30.58 Units on a Scale
Standard Deviation 6.66
|
31.00 Units on a Scale
Standard Deviation 7.29
|
|
Mean BL Physical Component Summary of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 897 Cohort (n=320, 139)
|
30.52 Units on a Scale
Standard Deviation 6.69
|
30.87 Units on a Scale
Standard Deviation 7.41
|
|
Mean BL Physical Component Summary of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 981 Cohort (n=312, 136)
|
30.49 Units on a Scale
Standard Deviation 6.64
|
30.98 Units on a Scale
Standard Deviation 7.46
|
|
Mean BL Physical Component Summary of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 1,093 Cohort (n=308, 137)
|
30.51 Units on a Scale
Standard Deviation 6.67
|
30.93 Units on a Scale
Standard Deviation 7.45
|
|
Mean BL Physical Component Summary of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 1,177 Cohort (n=273, 124)
|
30.58 Units on a Scale
Standard Deviation 6.78
|
30.87 Units on a Scale
Standard Deviation 7.19
|
|
Mean BL Physical Component Summary of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 1,261 Cohort (n=289, 133)
|
30.64 Units on a Scale
Standard Deviation 6.86
|
31.02 Units on a Scale
Standard Deviation 7.47
|
|
Mean BL Physical Component Summary of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 1,345 Cohort (n=146, 60)
|
30.40 Units on a Scale
Standard Deviation 6.32
|
29.37 Units on a Scale
Standard Deviation 7.07
|
|
Mean BL Physical Component Summary of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 1,457 Cohort (n=288, 128)
|
30.51 Units on a Scale
Standard Deviation 6.76
|
31.23 Units on a Scale
Standard Deviation 7.46
|
|
Mean BL Physical Component Summary of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 1,625 Cohort (n=278, 125)
|
30.70 Units on a Scale
Standard Deviation 6.78
|
30.90 Units on a Scale
Standard Deviation 7.30
|
|
Mean BL Physical Component Summary of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 1,821 Cohort (n=273, 124)
|
30.54 Units on a Scale
Standard Deviation 6.81
|
31.27 Units on a Scale
Standard Deviation 7.42
|
|
Mean BL Physical Component Summary of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 1,989 Cohort (n=118, 54)
|
29.80 Units on a Scale
Standard Deviation 6.72
|
30.66 Units on a Scale
Standard Deviation 7.61
|
|
Mean BL Physical Component Summary of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 2,185 Cohort (n=84, 38)
|
28.80 Units on a Scale
Standard Deviation 5.77
|
29.74 Units on a Scale
Standard Deviation 5.72
|
SECONDARY outcome
Timeframe: BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 14,57, Day 1,625, Day 1,821, Day 1,989, Day 2,185Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of \> 3 points were considered clinically meaningful.
Outcome measures
| Measure |
ABA + MTX DB
n=376 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=160 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Mean Change From BL by Visit in the Physical Component Summary of the SF-36 in the OL Period
Day 365 (n=370, 157)
|
9.70 Units on a Scale
Standard Error 0.50
|
6.61 Units on a Scale
Standard Error 0.74
|
|
Mean Change From BL by Visit in the Physical Component Summary of the SF-36 in the OL Period
Day 449 (n=362, 156)
|
10.51 Units on a Scale
Standard Error 0.50
|
9.91 Units on a Scale
Standard Error 0.78
|
|
Mean Change From BL by Visit in the Physical Component Summary of the SF-36 in the OL Period
Day 533 (n=355, 155)
|
10.27 Units on a Scale
Standard Error 0.51
|
10.53 Units on a Scale
Standard Error 0.86
|
|
Mean Change From BL by Visit in the Physical Component Summary of the SF-36 in the OL Period
Day 617 (n=348, 153)
|
10.46 Units on a Scale
Standard Error 0.52
|
10.74 Units on a Scale
Standard Error 0.85
|
|
Mean Change From BL by Visit in the Physical Component Summary of the SF-36 in the OL Period
Day 729 (n=338, 146)
|
10.71 Units on a Scale
Standard Error 0.53
|
10.36 Units on a Scale
Standard Error 0.84
|
|
Mean Change From BL by Visit in the Physical Component Summary of the SF-36 in the OL Period
Day 813 (n=323, 145)
|
10.79 Units on a Scale
Standard Error 0.55
|
10.41 Units on a Scale
Standard Error 0.84
|
|
Mean Change From BL by Visit in the Physical Component Summary of the SF-36 in the OL Period
Day 897 (n=320, 139)
|
10.30 Units on a Scale
Standard Error 0.53
|
9.87 Units on a Scale
Standard Error 0.85
|
|
Mean Change From BL by Visit in the Physical Component Summary of the SF-36 in the OL Period
Day 981 (n=312, 136)
|
11.05 Units on a Scale
Standard Error 0.58
|
10.78 Units on a Scale
Standard Error 0.87
|
|
Mean Change From BL by Visit in the Physical Component Summary of the SF-36 in the OL Period
Day 1,093 (n=308, 137)
|
10.83 Units on a Scale
Standard Error 0.55
|
11.07 Units on a Scale
Standard Error 0.94
|
|
Mean Change From BL by Visit in the Physical Component Summary of the SF-36 in the OL Period
Day 1,177 (n=273, 124)
|
11.02 Units on a Scale
Standard Error 0.61
|
11.20 Units on a Scale
Standard Error 1.01
|
|
Mean Change From BL by Visit in the Physical Component Summary of the SF-36 in the OL Period
Day 1,261 (n=289, 133)
|
10.40 Units on a Scale
Standard Error 0.60
|
11.34 Units on a Scale
Standard Error 0.94
|
|
Mean Change From BL by Visit in the Physical Component Summary of the SF-36 in the OL Period
Day 1,345 (n=146, 60)
|
9.81 Units on a Scale
Standard Error 0.87
|
10.81 Units on a Scale
Standard Error 1.55
|
|
Mean Change From BL by Visit in the Physical Component Summary of the SF-36 in the OL Period
Day 1,457 (n=288, 128)
|
11.12 Units on a Scale
Standard Error 0.58
|
10.68 Units on a Scale
Standard Error 0.97
|
|
Mean Change From BL by Visit in the Physical Component Summary of the SF-36 in the OL Period
Day 1,625 (n=278, 125)
|
10.76 Units on a Scale
Standard Error 0.61
|
11.05 Units on a Scale
Standard Error 0.90
|
|
Mean Change From BL by Visit in the Physical Component Summary of the SF-36 in the OL Period
Day 1,821 (n=273, 124)
|
10.81 Units on a Scale
Standard Error 0.63
|
10.09 Units on a Scale
Standard Error 0.91
|
|
Mean Change From BL by Visit in the Physical Component Summary of the SF-36 in the OL Period
Day 1,989 (n=118, 54)
|
11.69 Units on a Scale
Standard Error 0.93
|
9.65 Units on a Scale
Standard Error 1.47
|
|
Mean Change From BL by Visit in the Physical Component Summary of the SF-36 in the OL Period
Day 2,185 (n=84, 38)
|
9.69 Units on a Scale
Standard Error 0.99
|
11.39 Units on a Scale
Standard Error 1.71
|
SECONDARY outcome
Timeframe: BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of \> 3 points were considered clinically meaningful.Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.
Outcome measures
| Measure |
ABA + MTX DB
n=376 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=160 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Mean BL Mental Component Summary of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 365 Cohort (n=370, 157)
|
41.40 Units on a Scale
Standard Deviation 11.35
|
40.56 Units on a Scale
Standard Deviation 11.18
|
|
Mean BL Mental Component Summary of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 449 Cohort (n=362, 156)
|
41.20 Units on a Scale
Standard Deviation 11.29
|
40.47 Units on a Scale
Standard Deviation 11.11
|
|
Mean BL Mental Component Summary of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 533 Cohort (n=355, 156)
|
41.28 Units on a Scale
Standard Deviation 11.20
|
40.53 Units on a Scale
Standard Deviation 11.25
|
|
Mean BL Mental Component Summary of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 617 Cohort (n=348, 153)
|
41.23 Units on a Scale
Standard Deviation 11.28
|
40.67 Units on a Scale
Standard Deviation 11.26
|
|
Mean BL Mental Component Summary of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 729 Cohort (n=338, 146)
|
41.21 Units on a Scale
Standard Deviation 11.28
|
40.24 Units on a Scale
Standard Deviation 11.11
|
|
Mean BL Mental Component Summary of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 813 Cohort (n=323, 145)
|
41.23 Units on a Scale
Standard Deviation 11.34
|
40.19 Units on a Scale
Standard Deviation 11.20
|
|
Mean BL Mental Component Summary of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 897 Cohort (n=320, 139)
|
41.36 Units on a Scale
Standard Deviation 11.41
|
40.28 Units on a Scale
Standard Deviation 11.33
|
|
Mean BL Mental Component Summary of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 981 Cohort (n=312, 136)
|
41.40 Units on a Scale
Standard Deviation 11.39
|
40.32 Units on a Scale
Standard Deviation 11.45
|
|
Mean BL Mental Component Summary of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 1,093 Cohort (n=308, 137)
|
41.40 Units on a Scale
Standard Deviation 11.25
|
40.33 Units on a Scale
Standard Deviation 11.41
|
|
Mean BL Mental Component Summary of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 1,177 Cohort (n=273, 124)
|
41.28 Units on a Scale
Standard Deviation 11.47
|
40.19 Units on a Scale
Standard Deviation 11.06
|
|
Mean BL Mental Component Summary of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 1,261 Cohort (n=289, 133)
|
41.29 Units on a Scale
Standard Deviation 11.45
|
40.26 Units on a Scale
Standard Deviation 11.50
|
|
Mean BL Mental Component Summary of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 1,345 Cohort (n=146, 60)
|
42.11 Units on a Scale
Standard Deviation 11.81
|
39.99 Units on a Scale
Standard Deviation 10.83
|
|
Mean BL Mental Component Summary of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 1,457 Cohort (n=288, 128)
|
41.35 Units on a Scale
Standard Deviation 11.45
|
40.06 Units on a Scale
Standard Deviation 11.35
|
|
Mean BL Mental Component Summary of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 1,625 Cohort (n=278, 125)
|
41.25 Units on a Scale
Standard Deviation 11.60
|
40.16 Units on a Scale
Standard Deviation 11.44
|
|
Mean BL Mental Component Summary of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 1,821 Cohort (n=273, 124)
|
41.39 Units on a Scale
Standard Deviation 11.60
|
40.03 Units on a Scale
Standard Deviation 11.23
|
|
Mean BL Mental Component Summary of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 1,989 Cohort (n=118, 54)
|
41.73 Units on a Scale
Standard Deviation 11.58
|
39.61 Units on a Scale
Standard Deviation 9.98
|
|
Mean BL Mental Component Summary of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 2,185 Cohort (n=84, 38)
|
42.00 Units on a Scale
Standard Deviation 11.97
|
37.55 Units on a Scale
Standard Deviation 9.95
|
SECONDARY outcome
Timeframe: BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of \> 3 points were considered clinically meaningful.
Outcome measures
| Measure |
ABA + MTX DB
n=376 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=160 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Mean Change From BL by Visit in the Mental Component Summary of the SF-36 in the OL Period
Day 365 (n=370, 157)
|
7.29 Units on a Scale
Standard Error 0.60
|
6.41 Units on a Scale
Standard Error 0.85
|
|
Mean Change From BL by Visit in the Mental Component Summary of the SF-36 in the OL Period
Day 449 (n=362, 156)
|
6.84 Units on a Scale
Standard Error 0.63
|
7.73 Units on a Scale
Standard Error 0.97
|
|
Mean Change From BL by Visit in the Mental Component Summary of the SF-36 in the OL Period
Day 533 (n=355, 156)
|
7.30 Units on a Scale
Standard Error 0.62
|
7.20 Units on a Scale
Standard Error 0.96
|
|
Mean Change From BL by Visit in the Mental Component Summary of the SF-36 in the OL Period
Day 617 (n=348, 153)
|
7.15 Units on a Scale
Standard Error 0.64
|
6.88 Units on a Scale
Standard Error 0.94
|
|
Mean Change From BL by Visit in the Mental Component Summary of the SF-36 in the OL Period
Day 729 (n=338, 146)
|
7.31 Units on a Scale
Standard Error 0.61
|
8.07 Units on a Scale
Standard Error 1.01
|
|
Mean Change From BL by Visit in the Mental Component Summary of the SF-36 in the OL Period
Day 813 (n=323, 145)
|
6.98 Units on a Scale
Standard Error 0.67
|
7.15 Units on a Scale
Standard Error 1.01
|
|
Mean Change From BL by Visit in the Mental Component Summary of the SF-36 in the OL Period
Day 897 (n=320, 139)
|
7.26 Units on a Scale
Standard Error 0.69
|
8.54 Units on a Scale
Standard Error 1.02
|
|
Mean Change From BL by Visit in the Mental Component Summary of the SF-36 in the OL Period
Day 981 (n=312, 136)
|
6.82 Units on a Scale
Standard Error 0.69
|
7.76 Units on a Scale
Standard Error 1.02
|
|
Mean Change From BL by Visit in the Mental Component Summary of the SF-36 in the OL Period
Day 1,093 (n=308, 137)
|
7.79 Units on a Scale
Standard Error 0.69
|
6.09 Units on a Scale
Standard Error 1.04
|
|
Mean Change From BL by Visit in the Mental Component Summary of the SF-36 in the OL Period
Day 1,177 (n=273, 124)
|
6.93 Units on a Scale
Standard Error 0.73
|
7.65 Units on a Scale
Standard Error 1.09
|
|
Mean Change From BL by Visit in the Mental Component Summary of the SF-36 in the OL Period
Day 1,261 (n=289, 133)
|
7.33 Units on a Scale
Standard Error 0.74
|
7.04 Units on a Scale
Standard Error 1.05
|
|
Mean Change From BL by Visit in the Mental Component Summary of the SF-36 in the OL Period
Day 1,345 (n=146, 60)
|
6.37 Units on a Scale
Standard Error 1.00
|
7.42 Units on a Scale
Standard Error 1.43
|
|
Mean Change From BL by Visit in the Mental Component Summary of the SF-36 in the OL Period
Day 1,457 (n=288, 128)
|
6.82 Units on a Scale
Standard Error 0.74
|
7.19 Units on a Scale
Standard Error 1.12
|
|
Mean Change From BL by Visit in the Mental Component Summary of the SF-36 in the OL Period
Day 1,625 (n=278, 125)
|
6.60 Units on a Scale
Standard Error 0.74
|
6.99 Units on a Scale
Standard Error 1.15
|
|
Mean Change From BL by Visit in the Mental Component Summary of the SF-36 in the OL Period
Day 1,821 (n=273, 124)
|
6.75 Units on a Scale
Standard Error 0.75
|
9.08 Units on a Scale
Standard Error 1.10
|
|
Mean Change From BL by Visit in the Mental Component Summary of the SF-36 in the OL Period
Day 1,989 (n=118, 54)
|
5.53 Units on a Scale
Standard Error 1.14
|
8.74 Units on a Scale
Standard Error 1.60
|
|
Mean Change From BL by Visit in the Mental Component Summary of the SF-36 in the OL Period
Day 2,185 (n=84, 38)
|
5.28 Units on a Scale
Standard Error 1.28
|
9.91 Units on a Scale
Standard Error 1.72
|
SECONDARY outcome
Timeframe: BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of \> 3 points were considered clinically meaningful. Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.
Outcome measures
| Measure |
ABA + MTX DB
n=376 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=160 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Mean BL Physical Function Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 365 Cohort (n=373, 160)
|
28.79 Units on a Scale
Standard Error 9.12
|
28.09 Units on a Scale
Standard Error 8.88
|
|
Mean BL Physical Function Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 449 Cohort (n=367, 157)
|
28.62 Units on a Scale
Standard Error 9.06
|
28.07 Units on a Scale
Standard Error 8.95
|
|
Mean BL Physical Function Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 533 Cohort (n=355, 157)
|
28.63 Units on a Scale
Standard Error 9.13
|
28.05 Units on a Scale
Standard Error 8.91
|
|
Mean BL Physical Function Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 617 Cohort (n=348, 155)
|
28.71 Units on a Scale
Standard Error 9.13
|
28.02 Units on a Scale
Standard Error 8.91
|
|
Mean BL Physical Function Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 729 Cohort(n=338, 148)
|
28.68 Units on a Scale
Standard Error 9.20
|
28.01 Units on a Scale
Standard Error 8.93
|
|
Mean BL Physical Function Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 813 Cohort (n=324, 147)
|
28.41 Units on a Scale
Standard Error 8.97
|
28.01 Units on a Scale
Standard Error 9.01
|
|
Mean BL Physical Function Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 897 Cohort (n=320, 140)
|
28.36 Units on a Scale
Standard Error 8.99
|
27.93 Units on a Scale
Standard Error 9.11
|
|
Mean BL Physical Function Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 981 Cohort (n=312, 137)
|
28.43 Units on a Scale
Standard Error 9.01
|
28.10 Units on a Scale
Standard Error 9.15
|
|
Mean BL Physical Function Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 1,093 Cohort (n=310, 138)
|
28.43 Units on a Scale
Standard Error 8.98
|
28.10 Units on a Scale
Standard Error 9.11
|
|
Mean BL Physical Function Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 1,177 Cohort (n=275, 125)
|
28.70 Units on a Scale
Standard Error 8.95
|
27.91 Units on a Scale
Standard Error 8.85
|
|
Mean BL Physical Function Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 1,261 Cohort (n=292, 135)
|
28.62 Units on a Scale
Standard Error 9.12
|
28.17 Units on a Scale
Standard Error 9.13
|
|
Mean BL Physical Function Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 1,345 Cohort (n=147, 61)
|
28.70 Units on a Scale
Standard Error 8.97
|
26.49 Units on a Scale
Standard Error 8.34
|
|
Mean BL Physical Function Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 1,457 Cohort (n=290, 129)
|
28.35 Units on a Scale
Standard Error 9.11
|
28.24 Units on a Scale
Standard Error 9.03
|
|
Mean BL Physical Function Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 1,625 Cohort (n=279, 126)
|
28.68 Units on a Scale
Standard Error 9.10
|
27.98 Units on a Scale
Standard Error 8.87
|
|
Mean BL Physical Function Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 1,821 Cohort (n=273, 125)
|
28.50 Units on a Scale
Standard Error 9.07
|
28.50 Units on a Scale
Standard Error 9.03
|
|
Mean BL Physical Function Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 1,989 Cohort (n=118, 55)
|
27.78 Units on a Scale
Standard Error 8.86
|
27.75 Units on a Scale
Standard Error 9.35
|
|
Mean BL Physical Function Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 2,185 Cohort (n=85, 38)
|
26.94 Units on a Scale
Standard Error 7.79
|
26.25 Units on a Scale
Standard Error 7.45
|
SECONDARY outcome
Timeframe: BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of \> 3 points were considered clinically meaningful.
Outcome measures
| Measure |
ABA + MTX DB
n=376 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=160 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Mean Change From BL by Visit in the Physical Function Component of the SF-36 in the OL Period
Day 365 (n=373, 160)
|
8.61 Units on a Scale
Standard Error 0.58
|
6.44 Units on a Scale
Standard Error 0.84
|
|
Mean Change From BL by Visit in the Physical Function Component of the SF-36 in the OL Period
Day 449 (n=367, 157)
|
9.44 Units on a Scale
Standard Error 0.57
|
9.13 Units on a Scale
Standard Error 0.93
|
|
Mean Change From BL by Visit in the Physical Function Component of the SF-36 in the OL Period
Day 533 (n=355, 157)
|
9.43 Units on a Scale
Standard Error 0.59
|
9.46 Units on a Scale
Standard Error 0.97
|
|
Mean Change From BL by Visit in the Physical Function Component of the SF-36 in the OL Period
Day 617 (n=348, 155)
|
9.43 Units on a Scale
Standard Error 0.57
|
9.80 Units on a Scale
Standard Error 0.98
|
|
Mean Change From BL by Visit in the Physical Function Component of the SF-36 in the OL Period
Day 729 (n=338, 148)
|
9.51 Units on a Scale
Standard Error 0.61
|
9.63 Units on a Scale
Standard Error 1.03
|
|
Mean Change From BL by Visit in the Physical Function Component of the SF-36 in the OL Period
Day 1,093 (n=310, 138)
|
9.40 Units on a Scale
Standard Error 0.63
|
10.35 Units on a Scale
Standard Error 1.15
|
|
Mean Change From BL by Visit in the Physical Function Component of the SF-36 in the OL Period
Day 813 (n=324, 147)
|
10.17 Units on a Scale
Standard Error 0.62
|
9.71 Units on a Scale
Standard Error 1.06
|
|
Mean Change From BL by Visit in the Physical Function Component of the SF-36 in the OL Period
Day 897 (n=320, 140)
|
9.95 Units on a Scale
Standard Error 0.60
|
9.39 Units on a Scale
Standard Error 1.07
|
|
Mean Change From BL by Visit in the Physical Function Component of the SF-36 in the OL Period
Day 981 (n=312, 137)
|
10.23 Units on a Scale
Standard Error 0.63
|
10.45 Units on a Scale
Standard Error 1.10
|
|
Mean Change From BL by Visit in the Physical Function Component of the SF-36 in the OL Period
Day 1,177 (n=275, 125)
|
9.74 Units on a Scale
Standard Error 0.71
|
10.57 Units on a Scale
Standard Error 1.17
|
|
Mean Change From BL by Visit in the Physical Function Component of the SF-36 in the OL Period
Day 1,261 (n=292, 135)
|
9.95 Units on a Scale
Standard Error 0.68
|
9.92 Units on a Scale
Standard Error 1.14
|
|
Mean Change From BL by Visit in the Physical Function Component of the SF-36 in the OL Period
Day 1,345 (n=147, 61)
|
9.18 Units on a Scale
Standard Error 1.00
|
10.75 Units on a Scale
Standard Error 1.84
|
|
Mean Change From BL by Visit in the Physical Function Component of the SF-36 in the OL Period
Day 1,457 (n=290, 129)
|
10.55 Units on a Scale
Standard Error 0.70
|
10.03 Units on a Scale
Standard Error 1.15
|
|
Mean Change From BL by Visit in the Physical Function Component of the SF-36 in the OL Period
Day 1,625 (n=279, 126)
|
9.80 Units on a Scale
Standard Error 0.72
|
9.68 Units on a Scale
Standard Error 1.13
|
|
Mean Change From BL by Visit in the Physical Function Component of the SF-36 in the OL Period
Day 1,821 (n=273, 125)
|
9.48 Units on a Scale
Standard Error 0.75
|
9.08 Units on a Scale
Standard Error 1.10
|
|
Mean Change From BL by Visit in the Physical Function Component of the SF-36 in the OL Period
Day 1,989 (n=118, 55)
|
11.35 Units on a Scale
Standard Error 1.17
|
9.22 Units on a Scale
Standard Error 1.92
|
|
Mean Change From BL by Visit in the Physical Function Component of the SF-36 in the OL Period
Day 2,185 (n=85, 38)
|
10.06 Units on a Scale
Standard Error 1.22
|
10.90 Units on a Scale
Standard Error 2.25
|
SECONDARY outcome
Timeframe: BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of \> 3 points were considered clinically meaningful. Time-matched BL (Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.
Outcome measures
| Measure |
ABA + MTX DB
n=376 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=160 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Mean BL Role-Physical Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 365 Cohort (n=372, 160)
|
32.06 Units on a Scale
Standard Deviation 7.78
|
32.08 Units on a Scale
Standard Deviation 7.34
|
|
Mean BL Role-Physical Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 449 Cohort (n=367, 157)
|
31.88 Units on a Scale
Standard Deviation 7.64
|
32.02 Units on a Scale
Standard Deviation 7.40
|
|
Mean BL Role-Physical Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 533 Cohort (n=355, 157)
|
32.02 Units on a Scale
Standard Deviation 7.78
|
32.11 Units on a Scale
Standard Deviation 7.39
|
|
Mean BL Role-Physical Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 617 Cohort (n=348, 156)
|
32.04 Units on a Scale
Standard Deviation 7.81
|
32.14 Units on a Scale
Standard Deviation 7.41
|
|
Mean BL Role-Physical Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 729 Cohort (n=338, 148)
|
32.12 Units on a Scale
Standard Deviation 7.86
|
31.79 Units on a Scale
Standard Deviation 6.83
|
|
Mean BL Role-Physical Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 813 Cohort (n=324, 147)
|
31.93 Units on a Scale
Standard Deviation 7.65
|
31.91 Units on a Scale
Standard Deviation 7.14
|
|
Mean BL Role-Physical Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 897 Cohort (n=320, 140)
|
31.91 Units on a Scale
Standard Deviation 7.56
|
32.01 Units on a Scale
Standard Deviation 7.27
|
|
Mean BL Role-Physical Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 981 Cohort (n=312, 137)
|
31.83 Units on a Scale
Standard Deviation 7.52
|
32.05 Units on a Scale
Standard Deviation 7.32
|
|
Mean BL Role-Physical Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 1,093 Cohort (n=309, 138)
|
31.82 Units on a Scale
Standard Deviation 7.52
|
32.02 Units on a Scale
Standard Deviation 7.31
|
|
Mean BL Role-Physical Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 1,177 Cohort (n=275, 125)
|
31.84 Units on a Scale
Standard Deviation 7.55
|
31.88 Units on a Scale
Standard Deviation 7.22
|
|
Mean BL Role-Physical Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 1,261 Cohort (n=292, 134)
|
31.83 Units on a Scale
Standard Deviation 7.56
|
32.09 Units on a Scale
Standard Deviation 7.38
|
|
Mean BL Role-Physical Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 1,345 Cohort (n=147, 61)
|
31.90 Units on a Scale
Standard Deviation 7.13
|
31.66 Units on a Scale
Standard Deviation 6.53
|
|
Mean BL Role-Physical Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 1,457 Cohort (n=289, 129)
|
31.82 Units on a Scale
Standard Deviation 7.57
|
32.08 Units on a Scale
Standard Deviation 7.34
|
|
Mean BL Role-Physical Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 1,625 Cohort (n=279, 126)
|
31.88 Units on a Scale
Standard Deviation 7.60
|
31.96 Units on a Scale
Standard Deviation 7.25
|
|
Mean BL Role-Physical Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 1,821 Cohort (n=273, 125)
|
31.87 Units on a Scale
Standard Deviation 7.71
|
31.71 Units on a Scale
Standard Deviation 6.95
|
|
Mean BL Role-Physical Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 1,989 Cohort (n=118, 55)
|
31.79 Units on a Scale
Standard Deviation 7.72
|
31.43 Units on a Scale
Standard Deviation 6.92
|
|
Mean BL Role-Physical Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 2,185 Cohort (n=84, 38)
|
30.98 Units on a Scale
Standard Deviation 6.88
|
30.56 Units on a Scale
Standard Deviation 5.05
|
SECONDARY outcome
Timeframe: BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of \> 3 points were considered clinically meaningful.
Outcome measures
| Measure |
ABA + MTX DB
n=376 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=160 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Mean Change From BL by Visit in the Role-Physical Component of the SF-36 in the OL Period
Day 365 (n=372, 160)
|
10.10 Units on a Scale
Standard Error 0.67
|
7.59 Units on a Scale
Standard Error 0.96
|
|
Mean Change From BL by Visit in the Role-Physical Component of the SF-36 in the OL Period
Day 449 (n=367, 157)
|
10.66 Units on a Scale
Standard Error 0.70
|
10.89 Units on a Scale
Standard Error 1.04
|
|
Mean Change From BL by Visit in the Role-Physical Component of the SF-36 in the OL Period
Day 533 (n=355, 157)
|
11.18 Units on a Scale
Standard Error 0.70
|
10.98 Units on a Scale
Standard Error 1.02
|
|
Mean Change From BL by Visit in the Role-Physical Component of the SF-36 in the OL Period
Day 617 (n=348, 156)
|
10.93 Units on a Scale
Standard Error 0.73
|
11.61 Units on a Scale
Standard Error 1.05
|
|
Mean Change From BL by Visit in the Role-Physical Component of the SF-36 in the OL Period
Day 729 (n=338, 148)
|
11.33 Units on a Scale
Standard Error 0.72
|
11.50 Units on a Scale
Standard Error 1.04
|
|
Mean Change From BL by Visit in the Role-Physical Component of the SF-36 in the OL Period
Day 813 (n=324, 147)
|
10.56 Units on a Scale
Standard Error 0.73
|
10.57 Units on a Scale
Standard Error 1.00
|
|
Mean Change From BL by Visit in the Role-Physical Component of the SF-36 in the OL Period
Day 897 (n=320, 140)
|
10.13 Units on a Scale
Standard Error 0.74
|
10.96 Units on a Scale
Standard Error 1.06
|
|
Mean Change From BL by Visit in the Role-Physical Component of the SF-36 in the OL Period
Day 981 (n=312, 137)
|
10.96 Units on a Scale
Standard Error 0.76
|
10.88 Units on a Scale
Standard Error 1.07
|
|
Mean Change From BL by Visit in the Role-Physical Component of the SF-36 in the OL Period
Day 1,093 (n=309, 138)
|
11.82 Units on a Scale
Standard Error 0.76
|
9.72 Units on a Scale
Standard Error 1.04
|
|
Mean Change From BL by Visit in the Role-Physical Component of the SF-36 in the OL Period
Day 1,177 (n=275, 125)
|
11.32 Units on a Scale
Standard Error 0.82
|
11.09 Units on a Scale
Standard Error 1.18
|
|
Mean Change From BL by Visit in the Role-Physical Component of the SF-36 in the OL Period
Day 1,261 (n=292, 134)
|
10.25 Units on a Scale
Standard Error 0.82
|
11.61 Units on a Scale
Standard Error 1.08
|
|
Mean Change From BL by Visit in the Role-Physical Component of the SF-36 in the OL Period
Day 1,345 (n=147, 61)
|
9.09 Units on a Scale
Standard Error 1.13
|
10.32 Units on a Scale
Standard Error 1.67
|
|
Mean Change From BL by Visit in the Role-Physical Component of the SF-36 in the OL Period
Day 1,457 (n=289, 129)
|
10.57 Units on a Scale
Standard Error 0.79
|
11.39 Units on a Scale
Standard Error 1.13
|
|
Mean Change From BL by Visit in the Role-Physical Component of the SF-36 in the OL Period
Day 1,625 (n=279, 126)
|
10.11 Units on a Scale
Standard Error 0.80
|
11.10 Units on a Scale
Standard Error 1.10
|
|
Mean Change From BL by Visit in the Role-Physical Component of the SF-36 in the OL Period
Day 1,821 (n=273, 125)
|
11.25 Units on a Scale
Standard Error 0.84
|
10.62 Units on a Scale
Standard Error 1.15
|
|
Mean Change From BL by Visit in the Role-Physical Component of the SF-36 in the OL Period
Day 1,989 (n=118, 55)
|
10.79 Units on a Scale
Standard Error 1.31
|
10.42 Units on a Scale
Standard Error 1.71
|
|
Mean Change From BL by Visit in the Role-Physical Component of the SF-36 in the OL Period
Day 2,185 (n=84, 38)
|
9.04 Units on a Scale
Standard Error 1.41
|
12.84 Units on a Scale
Standard Error 1.96
|
SECONDARY outcome
Timeframe: BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185Population: AlAll treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of \> 3 points were considered clinically meaningful. Time-matched BL (Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.
Outcome measures
| Measure |
ABA + MTX DB
n=376 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=160 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Mean BL Bodily Pain Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 365 Cohort (n=373, 160)
|
33.13 Units on a Scale
Standard Deviation 7.37
|
33.43 Units on a Scale
Standard Deviation 7.53
|
|
Mean BL Bodily Pain Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 449 Cohort (n=367, 157)
|
32.95 Units on a Scale
Standard Deviation 7.36
|
33.47 Units on a Scale
Standard Deviation 7.56
|
|
Mean BL Bodily Pain Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 533 Cohort (n=355, 157)
|
33.05 Units on a Scale
Standard Deviation 7.36
|
33.27 Units on a Scale
Standard Deviation 7.49
|
|
Mean BL Bodily Pain Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 617 Cohort (n=348, 156)
|
33.00 Units on a Scale
Standard Deviation 7.30
|
33.49 Units on a Scale
Standard Deviation 7.59
|
|
Mean BL Bodily Pain Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 729 Cohort (n=338, 148)
|
32.94 Units on a Scale
Standard Deviation 7.38
|
33.44 Units on a Scale
Standard Deviation 7.57
|
|
Mean BL Bodily Pain Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 813 Cohort (n=324, 147)
|
32.80 Units on a Scale
Standard Deviation 7.27
|
33.53 Units on a Scale
Standard Deviation 7.65
|
|
Mean BL Bodily Pain Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 897 Cohort (n=320, 140)
|
32.80 Units on a Scale
Standard Deviation 7.33
|
33.29 Units on a Scale
Standard Deviation 7.67
|
|
Mean BL Bodily Pain Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 981 Cohort (n=312, 137)
|
32.79 Units on a Scale
Standard Deviation 7.28
|
33.29 Units on a Scale
Standard Deviation 7.74
|
|
Mean BL Bodily Pain Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 1,093 Cohort (n=309, 138)
|
32.88 Units on a Scale
Standard Deviation 7.30
|
33.29 Units on a Scale
Standard Deviation 7.71
|
|
Mean BL Bodily Pain Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 1,177 Cohort (n=275, 125)
|
32.84 Units on a Scale
Standard Deviation 7.34
|
33.13 Units on a Scale
Standard Deviation 7.71
|
|
Mean BL Bodily Pain Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 1,261 Cohort (n=291, 134)
|
32.81 Units on a Scale
Standard Deviation 7.50
|
33.31 Units on a Scale
Standard Deviation 7.77
|
|
Mean BL Bodily Pain Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 1,345 Cohort (n=147, 61)
|
32.57 Units on a Scale
Standard Deviation 7.37
|
31.83 Units on a Scale
Standard Deviation 6.61
|
|
Mean BL Bodily Pain Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 1,457 Cohort (n=289, 129)
|
32.73 Units on a Scale
Standard Deviation 7.35
|
33.48 Units on a Scale
Standard Deviation 7.74
|
|
Mean BL Bodily Pain Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 1,625 Cohort (n=279, 126)
|
32.78 Units on a Scale
Standard Deviation 7.36
|
33.20 Units on a Scale
Standard Deviation 7.52
|
|
Mean BL Bodily Pain Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 1,821 Cohort (n=273, 125)
|
32.85 Units on a Scale
Standard Deviation 7.44
|
33.56 Units on a Scale
Standard Deviation 7.71
|
|
Mean BL Bodily Pain Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 1,989 Cohort (n=118, 55)
|
31.98 Units on a Scale
Standard Deviation 7.20
|
32.81 Units on a Scale
Standard Deviation 7.66
|
|
Mean BL Bodily Pain Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 2,185 Cohort (n=85, 38)
|
31.49 Units on a Scale
Standard Deviation 6.81
|
31.40 Units on a Scale
Standard Deviation 5.91
|
SECONDARY outcome
Timeframe: BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of \> 3 points were considered clinically meaningful.
Outcome measures
| Measure |
ABA + MTX DB
n=376 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=160 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Mean Change From BL by Visit in the Bodily Pain Component of the SF-36 in the OL Period
Day 365 (n=373, 160)
|
12.08 Units on a Scale
Standard Error 0.51
|
7.98 Units on a Scale
Standard Error 0.76
|
|
Mean Change From BL by Visit in the Bodily Pain Component of the SF-36 in the OL Period
Day 449 (n=367, 157)
|
12.38 Units on a Scale
Standard Error 0.53
|
11.78 Units on a Scale
Standard Error 0.82
|
|
Mean Change From BL by Visit in the Bodily Pain Component of the SF-36 in the OL Period
Day 533 (n=355, 157)
|
11.94 Units on a Scale
Standard Error 0.55
|
12.53 Units on a Scale
Standard Error 0.86
|
|
Mean Change From BL by Visit in the Bodily Pain Component of the SF-36 in the OL Period
Day 617 (n=348, 156)
|
12.52 Units on a Scale
Standard Error 0.56
|
11.97 Units on a Scale
Standard Error 0.90
|
|
Mean Change From BL by Visit in the Bodily Pain Component of the SF-36 in the OL Period
Day 729 (n=338, 148)
|
12.84 Units on a Scale
Standard Error 0.57
|
12.06 Units on a Scale
Standard Error 0.88
|
|
Mean Change From BL by Visit in the Bodily Pain Component of the SF-36 in the OL Period
Day 813 (n=324, 147)
|
13.13 Units on a Scale
Standard Error 0.60
|
12.25 Units on a Scale
Standard Error 0.85
|
|
Mean Change From BL by Visit in the Bodily Pain Component of the SF-36 in the OL Period
Day 897 (n=320, 140)
|
12.44 Units on a Scale
Standard Error 0.59
|
11.84 Units on a Scale
Standard Error 0.85
|
|
Mean Change From BL by Visit in the Bodily Pain Component of the SF-36 in the OL Period
Day 981 (n=312, 137)
|
12.86 Units on a Scale
Standard Error 0.63
|
12.87 Units on a Scale
Standard Error 0.87
|
|
Mean Change From BL by Visit in the Bodily Pain Component of the SF-36 in the OL Period
Day 1,093 (n=309, 138)
|
13.34 Units on a Scale
Standard Error 0.60
|
12.93 Units on a Scale
Standard Error 0.91
|
|
Mean Change From BL by Visit in the Bodily Pain Component of the SF-36 in the OL Period
Day 1,177 (n=275, 125)
|
13.21 Units on a Scale
Standard Error 0.67
|
13.44 Units on a Scale
Standard Error 1.02
|
|
Mean Change From BL by Visit in the Bodily Pain Component of the SF-36 in the OL Period
Day 1,261 (n=291, 134)
|
12.83 Units on a Scale
Standard Error 0.68
|
13.31 Units on a Scale
Standard Error 0.94
|
|
Mean Change From BL by Visit in the Bodily Pain Component of the SF-36 in the OL Period
Day 1,345 (n=147, 61)
|
12.44 Units on a Scale
Standard Error 0.98
|
13.40 Units on a Scale
Standard Error 1.42
|
|
Mean Change From BL by Visit in the Bodily Pain Component of the SF-36 in the OL Period
Day 1,457 (n=289, 129)
|
13.13 Units on a Scale
Standard Error 0.60
|
11.74 Units on a Scale
Standard Error 0.97
|
|
Mean Change From BL by Visit in the Bodily Pain Component of the SF-36 in the OL Period
Day 1,625 (n=279, 126)
|
12.89 Units on a Scale
Standard Error 0.63
|
13.36 Units on a Scale
Standard Error 0.89
|
|
Mean Change From BL by Visit in the Bodily Pain Component of the SF-36 in the OL Period
Day 1,821 (n=273, 125)
|
12.56 Units on a Scale
Standard Error 0.67
|
12.65 Units on a Scale
Standard Error 0.95
|
|
Mean Change From BL by Visit in the Bodily Pain Component of the SF-36 in the OL Period
Day 1,989 (n=118, 55)
|
13.45 Units on a Scale
Standard Error 0.98
|
13.19 Units on a Scale
Standard Error 1.41
|
|
Mean Change From BL by Visit in the Bodily Pain Component of the SF-36 in the OL Period
Day 2,185 (n=85, 38)
|
10.44 Units on a Scale
Standard Error 1.18
|
14.28 Units on a Scale
Standard Error 1.47
|
SECONDARY outcome
Timeframe: BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of \> 3 points were considered clinically meaningful. Time-matched BL (Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.
Outcome measures
| Measure |
ABA + MTX DB
n=376 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=160 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Mean BL General Health Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 365 Cohort (n=373, 160)
|
35.43 Units on a Scale
Standard Error 8.41
|
35.27 Units on a Scale
Standard Error 7.73
|
|
Mean BL General Health Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 449 Cohort (n=367, 157)
|
35.33 Units on a Scale
Standard Error 8.45
|
35.28 Units on a Scale
Standard Error 7.80
|
|
Mean BL General Health Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 533 Cohort (n=355, 157)
|
35.34 Units on a Scale
Standard Error 8.40
|
35.17 Units on a Scale
Standard Error 7.73
|
|
Mean BL General Health Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 617 Cohort (n=348, 156)
|
35.41 Units on a Scale
Standard Error 8.38
|
35.21 Units on a Scale
Standard Error 7.72
|
|
Mean BL General Health Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 729 Cohort (n=338, 148)
|
35.47 Units on a Scale
Standard Error 8.46
|
35.16 Units on a Scale
Standard Error 7.61
|
|
Mean BL General Health Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 813 Cohort (n=324, 147)
|
35.59 Units on a Scale
Standard Error 8.45
|
35.19 Units on a Scale
Standard Error 7.62
|
|
Mean BL General Health Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 897 Cohort (n=320, 140)
|
35.72 Units on a Scale
Standard Error 8.50
|
35.22 Units on a Scale
Standard Error 7.78
|
|
Mean BL General Health Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 981 Cohort (n=312, 137)
|
35.67 Units on a Scale
Standard Error 8.46
|
35.38 Units on a Scale
Standard Error 7.79
|
|
Mean BL General Health Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 1,093 Cohort (n=312, 138)
|
35.69 Units on a Scale
Standard Error 8.52
|
35.32 Units on a Scale
Standard Error 7.80
|
|
Mean BL General Health Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 1,177 Cohort (n=275, 125)
|
35.50 Units on a Scale
Standard Error 8.38
|
35.54 Units on a Scale
Standard Error 7.87
|
|
Mean BL General Health Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 1,261 Cohort (n=291, 135)
|
35.65 Units on a Scale
Standard Error 8.38
|
35.31 Units on a Scale
Standard Error 7.88
|
|
Mean BL General Health Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 1,345 Cohort (n=147, 61)
|
35.88 Units on a Scale
Standard Error 8.68
|
33.78 Units on a Scale
Standard Error 7.96
|
|
Mean BL General Health Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 1,457 Cohort (n=290, 129)
|
35.56 Units on a Scale
Standard Error 8.48
|
35.43 Units on a Scale
Standard Error 7.85
|
|
Mean BL General Health Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 1,625 Cohort (n=280, 126)
|
35.67 Units on a Scale
Standard Error 8.33
|
35.23 Units on a Scale
Standard Error 7.91
|
|
Mean BL General Health Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 1,821 Cohort (n=273, 125)
|
35.61 Units on a Scale
Standard Error 8.46
|
35.56 Units on a Scale
Standard Error 7.83
|
|
Mean BL General Health Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 1,989 Cohort (n=119, 55)
|
34.87 Units on a Scale
Standard Error 8.65
|
34.94 Units on a Scale
Standard Error 8.67
|
|
Mean BL General Health Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 2,185 Cohort (n=85, 38)
|
34.29 Units on a Scale
Standard Error 9.03
|
33.71 Units on a Scale
Standard Error 8.26
|
SECONDARY outcome
Timeframe: BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of \> 3 points were considered clinically meaningful.
Outcome measures
| Measure |
ABA + MTX DB
n=376 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=160 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Mean Change From BL by Visit in the General Health Component of the SF-36 in the OL Period
Day 1,345 (n=147, 61)
|
6.19 Units on a Scale
Standard Error 0.73
|
8.45 Units on a Scale
Standard Error 1.36
|
|
Mean Change From BL by Visit in the General Health Component of the SF-36 in the OL Period
Day 1,457 (n=290, 129)
|
7.07 Units on a Scale
Standard Error 0.57
|
8.32 Units on a Scale
Standard Error 0.86
|
|
Mean Change From BL by Visit in the General Health Component of the SF-36 in the OL Period
Day 1,625 (n=280, 126)
|
7.27 Units on a Scale
Standard Error 0.57
|
8.10 Units on a Scale
Standard Error 0.81
|
|
Mean Change From BL by Visit in the General Health Component of the SF-36 in the OL Period
Day 1,821 (n=273, 125)
|
7.50 Units on a Scale
Standard Error 0.60
|
7.53 Units on a Scale
Standard Error 0.81
|
|
Mean Change From BL by Visit in the General Health Component of the SF-36 in the OL Period
Day 1,989 (n=119, 55)
|
6.55 Units on a Scale
Standard Error 0.81
|
7.05 Units on a Scale
Standard Error 1.14
|
|
Mean Change From BL by Visit in the General Health Component of the SF-36 in the OL Period
Day 2,185 (n=85, 38)
|
5.93 Units on a Scale
Standard Error 1.02
|
8.76 Units on a Scale
Standard Error 1.38
|
|
Mean Change From BL by Visit in the General Health Component of the SF-36 in the OL Period
Day 365 (n=373, 160)
|
6.88 Units on a Scale
Standard Error 0.46
|
5.43 Units on a Scale
Standard Error 0.58
|
|
Mean Change From BL by Visit in the General Health Component of the SF-36 in the OL Period
Day 449 (n=367, 157)
|
6.94 Units on a Scale
Standard Error 0.46
|
7.32 Units on a Scale
Standard Error 0.71
|
|
Mean Change From BL by Visit in the General Health Component of the SF-36 in the OL Period
Day 533 (n=355, 157)
|
6.82 Units on a Scale
Standard Error 0.47
|
7.88 Units on a Scale
Standard Error 0.68
|
|
Mean Change From BL by Visit in the General Health Component of the SF-36 in the OL Period
Day 617 (n=348, 156)
|
7.22 Units on a Scale
Standard Error 0.45
|
7.87 Units on a Scale
Standard Error 0.70
|
|
Mean Change From BL by Visit in the General Health Component of the SF-36 in the OL Period
Day 729 (n=338, 148)
|
7.31 Units on a Scale
Standard Error 0.46
|
7.90 Units on a Scale
Standard Error 0.68
|
|
Mean Change From BL by Visit in the General Health Component of the SF-36 in the OL Period
Day 813 (n=324, 147)
|
6.89 Units on a Scale
Standard Error 0.49
|
7.63 Units on a Scale
Standard Error 0.69
|
|
Mean Change From BL by Visit in the General Health Component of the SF-36 in the OL Period
Day 897 (n=320, 140)
|
6.86 Units on a Scale
Standard Error 0.52
|
8.24 Units on a Scale
Standard Error 0.79
|
|
Mean Change From BL by Visit in the General Health Component of the SF-36 in the OL Period
Day 981 (n=312, 137)
|
7.31 Units on a Scale
Standard Error 0.53
|
8.45 Units on a Scale
Standard Error 0.79
|
|
Mean Change From BL by Visit in the General Health Component of the SF-36 in the OL Period
Day 1,093 (n=312, 138)
|
7.24 Units on a Scale
Standard Error 0.55
|
8.36 Units on a Scale
Standard Error 0.82
|
|
Mean Change From BL by Visit in the General Health Component of the SF-36 in the OL Period
Day 1,177 (n=275, 125)
|
7.48 Units on a Scale
Standard Error 0.57
|
8.55 Units on a Scale
Standard Error 0.94
|
|
Mean Change From BL by Visit in the General Health Component of the SF-36 in the OL Period
Day 1,261 (n=291, 135)
|
7.18 Units on a Scale
Standard Error 0.58
|
8.17 Units on a Scale
Standard Error 0.83
|
SECONDARY outcome
Timeframe: BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of \> 3 points were considered clinically meaningful. Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.
Outcome measures
| Measure |
ABA + MTX DB
n=376 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=160 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Mean BL Social Functioning Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 365 Cohort (n=373, 160)
|
35.58 Units on a Scale
Standard Deviation 10.10
|
34.98 Units on a Scale
Standard Deviation 9.72
|
|
Mean BL Social Functioning Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 449 Cohort (n=368, 157)
|
35.42 Units on a Scale
Standard Deviation 10.13
|
34.91 Units on a Scale
Standard Deviation 9.75
|
|
Mean BL Social Functioning Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 533 Cohort (n=355, 157)
|
35.52 Units on a Scale
Standard Deviation 10.18
|
34.94 Units on a Scale
Standard Deviation 9.80
|
|
Mean BL Social Functioning Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 617 Cohort (n=348, 156)
|
35.46 Units on a Scale
Standard Deviation 10.14
|
35.01 Units on a Scale
Standard Deviation 9.80
|
|
Mean BL Social Functioning Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 729 Cohort (n=338, 148)
|
35.70 Units on a Scale
Standard Deviation 10.24
|
34.51 Units on a Scale
Standard Deviation 9.61
|
|
Mean BL Social Functioning Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 813 Cohort (n=324, 147)
|
35.47 Units on a Scale
Standard Deviation 10.17
|
34.57 Units on a Scale
Standard Deviation 9.73
|
|
Mean BL Social Functioning Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 897 Cohort (n=320, 140)
|
35.47 Units on a Scale
Standard Deviation 10.20
|
34.65 Units on a Scale
Standard Deviation 9.82
|
|
Mean BL Social Functioning Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 981 Cohort (n=312, 137)
|
35.46 Units on a Scale
Standard Deviation 10.17
|
34.67 Units on a Scale
Standard Deviation 9.90
|
|
Mean BL Social Functioning Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 1,093 Cohort (n=312, 138)
|
35.60 Units on a Scale
Standard Deviation 10.07
|
34.68 Units on a Scale
Standard Deviation 9.86
|
|
Mean BL Social Functioning Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 1,177 Cohort (n=275, 125)
|
35.52 Units on a Scale
Standard Deviation 10.10
|
34.51 Units on a Scale
Standard Deviation 9.60
|
|
Mean BL Social Functioning Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 1,261 Cohort (n=292, 134)
|
35.48 Units on a Scale
Standard Deviation 10.24
|
34.82 Units on a Scale
Standard Deviation 9.93
|
|
Mean BL Social Functioning Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 1,345 Cohort (n=147, 62)
|
35.65 Units on a Scale
Standard Deviation 10.53
|
33.24 Units on a Scale
Standard Deviation 9.09
|
|
Mean BL Social Functioning Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 1,457 Cohort (n=289, 129)
|
35.56 Units on a Scale
Standard Deviation 10.28
|
34.83 Units on a Scale
Standard Deviation 9.82
|
|
Mean BL Social Functioning Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 1,625 Cohort (n=280, 126)
|
35.44 Units on a Scale
Standard Deviation 10.45
|
34.73 Units on a Scale
Standard Deviation 9.90
|
|
Mean BL Social Functioning Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 1,821 Cohort (n=273, 125)
|
35.56 Units on a Scale
Standard Deviation 10.42
|
34.86 Units on a Scale
Standard Deviation 9.52
|
|
Mean BL Social Functioning Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 1,989 Cohort (n=118, 55)
|
34.50 Units on a Scale
Standard Deviation 10.41
|
33.75 Units on a Scale
Standard Deviation 8.92
|
|
Mean BL Social Functioning Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 2,185 Cohort (n=85, 38)
|
34.66 Units on a Scale
Standard Deviation 10.43
|
31.85 Units on a Scale
Standard Deviation 8.21
|
SECONDARY outcome
Timeframe: BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of \> 3 points were considered clinically meaningful.
Outcome measures
| Measure |
ABA + MTX DB
n=376 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=160 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Mean Change From BL by Visit in the Social Functioning Component of the SF-36 in the OL Period
Day 365 (n=373, 160)
|
9.01 Units on a Scale
Standard Error 0.61
|
7.12 Units on a Scale
Standard Error 0.77
|
|
Mean Change From BL by Visit in the Social Functioning Component of the SF-36 in the OL Period
Day 449 (n=368, 157)
|
9.74 Units on a Scale
Standard Error 0.61
|
9.47 Units on a Scale
Standard Error 0.91
|
|
Mean Change From BL by Visit in the Social Functioning Component of the SF-36 in the OL Period
Day 533 (n=355, 157)
|
9.88 Units on a Scale
Standard Error 0.62
|
9.44 Units on a Scale
Standard Error 0.92
|
|
Mean Change From BL by Visit in the Social Functioning Component of the SF-36 in the OL Period
Day 617 (n=348, 156)
|
9.48 Units on a Scale
Standard Error 0.62
|
8.66 Units on a Scale
Standard Error 0.92
|
|
Mean Change From BL by Visit in the Social Functioning Component of the SF-36 in the OL Period
Day 729 (n=338, 148)
|
9.99 Units on a Scale
Standard Error 0.63
|
9.90 Units on a Scale
Standard Error 0.94
|
|
Mean Change From BL by Visit in the Social Functioning Component of the SF-36 in the OL Period
Day 813 (n=324, 147)
|
9.80 Units on a Scale
Standard Error 0.67
|
8.97 Units on a Scale
Standard Error 0.92
|
|
Mean Change From BL by Visit in the Social Functioning Component of the SF-36 in the OL Period
Day 897 (n=320, 140)
|
9.96 Units on a Scale
Standard Error 0.67
|
9.81 Units on a Scale
Standard Error 0.99
|
|
Mean Change From BL by Visit in the Social Functioning Component of the SF-36 in the OL Period
Day 981 (n=312, 137)
|
9.71 Units on a Scale
Standard Error 0.66
|
9.51 Units on a Scale
Standard Error 1.00
|
|
Mean Change From BL by Visit in the Social Functioning Component of the SF-36 in the OL Period
Day 1,093 (n=312, 138)
|
10.16 Units on a Scale
Standard Error 0.68
|
8.61 Units on a Scale
Standard Error 0.98
|
|
Mean Change From BL by Visit in the Social Functioning Component of the SF-36 in the OL Period
Day 1,177 (n=275, 125)
|
9.28 Units on a Scale
Standard Error 0.71
|
9.64 Units on a Scale
Standard Error 1.06
|
|
Mean Change From BL by Visit in the Social Functioning Component of the SF-36 in the OL Period
Day 1,261 (n=292, 134)
|
9.54 Units on a Scale
Standard Error 0.73
|
9.92 Units on a Scale
Standard Error 0.99
|
|
Mean Change From BL by Visit in the Social Functioning Component of the SF-36 in the OL Period
Day 1,345 (n=147, 62)
|
9.01 Units on a Scale
Standard Error 1.11
|
8.84 Units on a Scale
Standard Error 1.42
|
|
Mean Change From BL by Visit in the Social Functioning Component of the SF-36 in the OL Period
Day 1,457 (n=289, 129)
|
10.16 Units on a Scale
Standard Error 0.72
|
9.26 Units on a Scale
Standard Error 1.01
|
|
Mean Change From BL by Visit in the Social Functioning Component of the SF-36 in the OL Period
Day 1,625 (n=280, 126)
|
9.67 Units on a Scale
Standard Error 0.73
|
9.05 Units on a Scale
Standard Error 0.99
|
|
Mean Change From BL by Visit in the Social Functioning Component of the SF-36 in the OL Period
Day 1,821 (n=273, 125)
|
8.93 Units on a Scale
Standard Error 0.75
|
8.16 Units on a Scale
Standard Error 0.91
|
|
Mean Change From BL by Visit in the Social Functioning Component of the SF-36 in the OL Period
Day 1,989 (n=118, 55)
|
9.34 Units on a Scale
Standard Error 1.17
|
10.17 Units on a Scale
Standard Error 1.37
|
|
Mean Change From BL by Visit in the Social Functioning Component of the SF-36 in the OL Period
Day 2,185 (n=85, 38)
|
7.98 Units on a Scale
Standard Error 1.31
|
10.57 Units on a Scale
Standard Error 1.40
|
SECONDARY outcome
Timeframe: BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of \> 3 points were considered clinically meaningful. Time-matched BL (Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.
Outcome measures
| Measure |
ABA + MTX DB
n=376 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=160 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Mean BL Role-Emotional Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 365 Cohort (n= 370, 158)
|
35.78 Units on a Scale
Standard Error 13.63
|
33.40 Units on a Scale
Standard Error 12.53
|
|
Mean BL Role-Emotional Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 449 Cohort (n=365, 157)
|
35.71 Units on a Scale
Standard Error 13.61
|
33.26 Units on a Scale
Standard Error 12.44
|
|
Mean BL Role-Emotional Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 533 Cohort (n=355, 156)
|
35.61 Units on a Scale
Standard Error 13.57
|
33.39 Units on a Scale
Standard Error 12.61
|
|
Mean BL Role-Emotional Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 617 Cohort (n=348, 155)
|
35.66 Units on a Scale
Standard Error 13.55
|
33.52 Units on a Scale
Standard Error 12.60
|
|
Mean BL Role-Emotional Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 729 Cohort (n=338, 147)
|
35.49 Units on a Scale
Standard Error 13.49
|
33.34 Units on a Scale
Standard Error 12.45
|
|
Mean BL Role-Emotional Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 813 Cohort (n=324, 146)
|
35.38 Units on a Scale
Standard Error 13.42
|
33.26 Units on a Scale
Standard Error 12.52
|
|
Mean BL Role-Emotional Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 897 Cohort (n=320, 139)
|
35.46 Units on a Scale
Standard Error 13.40
|
33.13 Units on a Scale
Standard Error 12.60
|
|
Mean BL Role-Emotional Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 981 Cohort (n=312, 136)
|
35.42 Units on a Scale
Standard Error 13.36
|
33.19 Units on a Scale
Standard Error 12.65
|
|
Mean BL Role-Emotional Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 1,093 Cohort (n=309, 137)
|
35.40 Units on a Scale
Standard Error 13.36
|
33.27 Units on a Scale
Standard Error 12.64
|
|
Mean BL Role-Emotional Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 1,177 Cohort (n=275, 124)
|
35.46 Units on a Scale
Standard Error 13.34
|
33.42 Units on a Scale
Standard Error 12.57
|
|
Mean BL Role-Emotional Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 1,261 Cohort (n=291, 133)
|
35.61 Units on a Scale
Standard Error 13.44
|
33.00 Units on a Scale
Standard Error 12.51
|
|
Mean BL Role-Emotional Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 1,345 Cohort (n=146, 60)
|
36.00 Units on a Scale
Standard Error 13.78
|
32.69 Units on a Scale
Standard Error 12.39
|
|
Mean BL Role-Emotional Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 1,457 Cohort (n=289, 128)
|
35.36 Units on a Scale
Standard Error 13.44
|
32.79 Units on a Scale
Standard Error 12.31
|
|
Mean BL Role-Emotional Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 1,625 Cohort (n=279, 125)
|
35.33 Units on a Scale
Standard Error 13.39
|
32.92 Units on a Scale
Standard Error 12.48
|
|
Mean BL Role-Emotional Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 1,821 Cohort (n=273, 124)
|
35.43 Units on a Scale
Standard Error 13.50
|
32.74 Units on a Scale
Standard Error 12.14
|
|
Mean BL Role-Emotional Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 1,989 Cohort (n=118, 54)
|
35.61 Units on a Scale
Standard Error 13.67
|
30.76 Units on a Scale
Standard Error 11.58
|
|
Mean BL Role-Emotional Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 2,185 Cohort (n=85, 38)
|
35.26 Units on a Scale
Standard Error 13.76
|
29.28 Units on a Scale
Standard Error 10.32
|
SECONDARY outcome
Timeframe: BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of \> 3 points were considered clinically meaningful.
Outcome measures
| Measure |
ABA + MTX DB
n=376 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=160 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Mean Change From BL by Visit in the Role-Emotional Component of the SF-36 in the OL Period
Day 365 (n= 370, 158)
|
8.97 Units on a Scale
Standard Error 0.81
|
8.60 Units on a Scale
Standard Error 1.25
|
|
Mean Change From BL by Visit in the Role-Emotional Component of the SF-36 in the OL Period
Day 449 (n=365, 157)
|
8.02 Units on a Scale
Standard Error 0.86
|
10.80 Units on a Scale
Standard Error 1.28
|
|
Mean Change From BL by Visit in the Role-Emotional Component of the SF-36 in the OL Period
Day 533 (n=355, 156)
|
8.44 Units on a Scale
Standard Error 0.88
|
10.13 Units on a Scale
Standard Error 1.30
|
|
Mean Change From BL by Visit in the Role-Emotional Component of the SF-36 in the OL Period
Day 617 (n=348, 155)
|
8.60 Units on a Scale
Standard Error 0.88
|
10.47 Units on a Scale
Standard Error 1.34
|
|
Mean Change From BL by Visit in the Role-Emotional Component of the SF-36 in the OL Period
Day 729 (n=338, 147)
|
8.96 Units on a Scale
Standard Error 0.86
|
10.89 Units on a Scale
Standard Error 1.34
|
|
Mean Change From BL by Visit in the Role-Emotional Component of the SF-36 in the OL Period
Day 813 (n=324, 146)
|
8.71 Units on a Scale
Standard Error 0.89
|
11.04 Units on a Scale
Standard Error 1.37
|
|
Mean Change From BL by Visit in the Role-Emotional Component of the SF-36 in the OL Period
Day 897 (n=320, 139)
|
8.48 Units on a Scale
Standard Error 0.90
|
11.67 Units on a Scale
Standard Error 1.41
|
|
Mean Change From BL by Visit in the Role-Emotional Component of the SF-36 in the OL Period
Day 981 (n=312, 136)
|
8.61 Units on a Scale
Standard Error 0.92
|
11.70 Units on a Scale
Standard Error 1.42
|
|
Mean Change From BL by Visit in the Role-Emotional Component of the SF-36 in the OL Period
Day 1,093 (n=309, 137)
|
9.31 Units on a Scale
Standard Error 0.94
|
9.46 Units on a Scale
Standard Error 1.41
|
|
Mean Change From BL by Visit in the Role-Emotional Component of the SF-36 in the OL Period
Day 1,177 (n=275, 124)
|
8.35 Units on a Scale
Standard Error 1.01
|
11.17 Units on a Scale
Standard Error 1.48
|
|
Mean Change From BL by Visit in the Role-Emotional Component of the SF-36 in the OL Period
Day 1,261 (n=291, 133)
|
8.43 Units on a Scale
Standard Error 1.00
|
10.53 Units on a Scale
Standard Error 1.42
|
|
Mean Change From BL by Visit in the Role-Emotional Component of the SF-36 in the OL Period
Day 1,345 (n=146, 60)
|
7.22 Units on a Scale
Standard Error 1.35
|
11.41 Units on a Scale
Standard Error 2.23
|
|
Mean Change From BL by Visit in the Role-Emotional Component of the SF-36 in the OL Period
Day 1,457 (n=289, 128)
|
7.51 Units on a Scale
Standard Error 0.98
|
10.70 Units on a Scale
Standard Error 1.46
|
|
Mean Change From BL by Visit in the Role-Emotional Component of the SF-36 in the OL Period
Day 1,625 (n=279, 125)
|
7.91 Units on a Scale
Standard Error 1.02
|
9.44 Units on a Scale
Standard Error 1.53
|
|
Mean Change From BL by Visit in the Role-Emotional Component of the SF-36 in the OL Period
Day 1,821 (n=273, 124)
|
7.39 Units on a Scale
Standard Error 0.71
|
6.56 Units on a Scale
Standard Error 1.09
|
|
Mean Change From BL by Visit in the Role-Emotional Component of the SF-36 in the OL Period
Day 1,989 (n=118, 54)
|
7.81 Units on a Scale
Standard Error 1.60
|
12.49 Units on a Scale
Standard Error 2.18
|
|
Mean Change From BL by Visit in the Role-Emotional Component of the SF-36 in the OL Period
Day 2,185 (n=85, 38)
|
7.06 Units on a Scale
Standard Error 1.69
|
16.08 Units on a Scale
Standard Error 2.17
|
SECONDARY outcome
Timeframe: BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of \> 3 points were considered clinically meaningful. Time-matched BL (Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.
Outcome measures
| Measure |
ABA + MTX DB
n=376 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=160 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Mean BL Vitality Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 365 Cohort (n=373, 159)
|
40.93 Units on a Scale
Standard Deviation 9.14
|
41.29 Units on a Scale
Standard Deviation 8.35
|
|
Mean BL Vitality Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 449 Cohort (n=368, 156)
|
40.77 Units on a Scale
Standard Deviation 9.11
|
41.21 Units on a Scale
Standard Deviation 8.38
|
|
Mean BL Vitality Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 533 Cohort (n=355, 156)
|
40.68 Units on a Scale
Standard Deviation 8.99
|
41.21 Units on a Scale
Standard Deviation 8.40
|
|
Mean BL Vitality Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 617 Cohort (n=348, 155)
|
40.77 Units on a Scale
Standard Deviation 9.02
|
41.40 Units on a Scale
Standard Deviation 8.37
|
|
Mean BL Vitality Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 729 Cohort (n=338, 147)
|
40.74 Units on a Scale
Standard Deviation 9.11
|
41.19 Units on a Scale
Standard Deviation 8.34
|
|
Mean BL Vitality Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 813 Cohort (n=323, 146)
|
40.60 Units on a Scale
Standard Deviation 9.06
|
41.27 Units on a Scale
Standard Deviation 8.46
|
|
Mean BL Vitality Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 897 Cohort (n=320, 140)
|
40.79 Units on a Scale
Standard Deviation 9.11
|
41.34 Units on a Scale
Standard Deviation 8.45
|
|
Mean BL Vitality Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 981 Cohort (n=312, 137)
|
40.85 Units on a Scale
Standard Deviation 9.00
|
41.43 Units on a Scale
Standard Deviation 8.45
|
|
Mean BL Vitality Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 1,093 Cohort (n=312, 138)
|
40.85 Units on a Scale
Standard Deviation 9.07
|
41.33 Units on a Scale
Standard Deviation 8.50
|
|
Mean BL Vitality Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 1,177 Cohort (n=273, 125)
|
40.69 Units on a Scale
Standard Deviation 9.23
|
41.23 Units on a Scale
Standard Deviation 8.42
|
|
Mean BL Vitality Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 1,261 Cohort (n=292, 134)
|
40.78 Units on a Scale
Standard Deviation 9.15
|
41.31 Units on a Scale
Standard Deviation 8.57
|
|
Mean BL Vitality Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 1,345 Cohort (n=147, 62)
|
41.30 Units on a Scale
Standard Deviation 9.39
|
40.64 Units on a Scale
Standard Deviation 7.84
|
|
Mean BL Vitality Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 1,457 Cohort (n=290, 129)
|
40.79 Units on a Scale
Standard Deviation 9.21
|
41.47 Units on a Scale
Standard Deviation 8.17
|
|
Mean BL Vitality Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 1,625 Cohort (n=280, 126)
|
40.84 Units on a Scale
Standard Deviation 9.18
|
41.23 Units on a Scale
Standard Deviation 8.29
|
|
Mean BL Vitality Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 1,821 Cohort (n=273, 125)
|
40.82 Units on a Scale
Standard Deviation 9.27
|
41.47 Units on a Scale
Standard Deviation 8.36
|
|
Mean BL Vitality Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 1,989 Cohort (n=118, 55)
|
42.19 Units on a Scale
Standard Deviation 8.85
|
41.72 Units on a Scale
Standard Deviation 8.01
|
|
Mean BL Vitality Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 2,185 Cohort (n=85, 38)
|
41.16 Units on a Scale
Standard Deviation 9.08
|
39.88 Units on a Scale
Standard Deviation 8.31
|
SECONDARY outcome
Timeframe: BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of \> 3 points were considered clinically meaningful.
Outcome measures
| Measure |
ABA + MTX DB
n=376 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=160 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Mean Change From BL by Visit in the Vitality Component of the SF-36 in the OL Period
Day 365 (n=373, 159)
|
8.58 Units on a Scale
Standard Error 0.55
|
6.04 Units on a Scale
Standard Error 0.68
|
|
Mean Change From BL by Visit in the Vitality Component of the SF-36 in the OL Period
Day 449 (n=368, 156)
|
8.29 Units on a Scale
Standard Error 0.55
|
8.70 Units on a Scale
Standard Error 0.76
|
|
Mean Change From BL by Visit in the Vitality Component of the SF-36 in the OL Period
Day 533 (n=355, 156)
|
8.68 Units on a Scale
Standard Error 0.52
|
8.09 Units on a Scale
Standard Error 0.81
|
|
Mean Change From BL by Visit in the Vitality Component of the SF-36 in the OL Period
Day 617 (n=348, 155)
|
8.61 Units on a Scale
Standard Error 0.53
|
8.46 Units on a Scale
Standard Error 0.79
|
|
Mean Change From BL by Visit in the Vitality Component of the SF-36 in the OL Period
Day 729 (n=338, 147)
|
8.69 Units on a Scale
Standard Error 0.55
|
8.41 Units on a Scale
Standard Error 0.80
|
|
Mean Change From BL by Visit in the Vitality Component of the SF-36 in the OL Period
Day 813 (n=323, 146)
|
8.99 Units on a Scale
Standard Error 0.58
|
8.22 Units on a Scale
Standard Error 0.83
|
|
Mean Change From BL by Visit in the Vitality Component of the SF-36 in the OL Period
Day 897 (n=320, 140)
|
8.69 Units on a Scale
Standard Error 0.57
|
8.53 Units on a Scale
Standard Error 0.81
|
|
Mean Change From BL by Visit in the Vitality Component of the SF-36 in the OL Period
Day 981 (n=312, 137)
|
8.85 Units on a Scale
Standard Error 0.58
|
7.52 Units on a Scale
Standard Error 0.83
|
|
Mean Change From BL by Visit in the Vitality Component of the SF-36 in the OL Period
Day 1,093 (n=312, 138)
|
8.98 Units on a Scale
Standard Error 0.56
|
7.53 Units on a Scale
Standard Error 0.82
|
|
Mean Change From BL by Visit in the Vitality Component of the SF-36 in the OL Period
Day 1,177 (n=273, 125)
|
9.08 Units on a Scale
Standard Error 0.63
|
8.08 Units on a Scale
Standard Error 0.85
|
|
Mean Change From BL by Visit in the Vitality Component of the SF-36 in the OL Period
Day 1,261 (n=292, 134)
|
8.39 Units on a Scale
Standard Error 0.64
|
8.14 Units on a Scale
Standard Error 0.84
|
|
Mean Change From BL by Visit in the Vitality Component of the SF-36 in the OL Period
Day 1,345 (n=147, 62)
|
8.29 Units on a Scale
Standard Error 0.91
|
6.39 Units on a Scale
Standard Error 1.25
|
|
Mean Change From BL by Visit in the Vitality Component of the SF-36 in the OL Period
Day 1,457 (n=290, 129)
|
9.19 Units on a Scale
Standard Error 0.62
|
7.57 Units on a Scale
Standard Error 0.87
|
|
Mean Change From BL by Visit in the Vitality Component of the SF-36 in the OL Period
Day 1,625 (n=280, 126)
|
8.77 Units on a Scale
Standard Error 0.64
|
8.20 Units on a Scale
Standard Error 0.85
|
|
Mean Change From BL by Visit in the Vitality Component of the SF-36 in the OL Period
Day 1,821 (n=273, 125)
|
8.96 Units on a Scale
Standard Error 0.66
|
7.42 Units on a Scale
Standard Error 0.84
|
|
Mean Change From BL by Visit in the Vitality Component of the SF-36 in the OL Period
Day 1,989 (n=118, 55)
|
7.60 Units on a Scale
Standard Error 0.99
|
7.99 Units on a Scale
Standard Error 1.26
|
|
Mean Change From BL by Visit in the Vitality Component of the SF-36 in the OL Period
Day 2,185 (n=85, 38)
|
7.06 Units on a Scale
Standard Error 1.11
|
9.61 Units on a Scale
Standard Error 1.28
|
SECONDARY outcome
Timeframe: BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of \> 3 points were considered clinically meaningful. Time-matched BL (Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.
Outcome measures
| Measure |
ABA + MTX DB
n=376 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=160 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Mean BL Mental Health Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 365 Cohort (n=373, 159)
|
39.08 Units on a Scale
Standard Error 11.55
|
39.43 Units on a Scale
Standard Error 11.09
|
|
Mean BL Mental Health Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 449 Cohort (n=368, 156)
|
38.87 Units on a Scale
Standard Error 11.46
|
39.33 Units on a Scale
Standard Error 11.14
|
|
Mean BL Mental Health Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 533 Cohort (n=355, 156)
|
38.89 Units on a Scale
Standard Error 11.44
|
39.40 Units on a Scale
Standard Error 11.18
|
|
Mean BL Mental Health Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 617 Cohort (n=348, 155)
|
38.76 Units on a Scale
Standard Error 11.46
|
39.49 Units on a Scale
Standard Error 11.14
|
|
Mean BL Mental Health Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 729 Cohort (n=338, 147)
|
38.75 Units on a Scale
Standard Error 11.56
|
39.05 Units on a Scale
Standard Error 11.18
|
|
Mean BL Mental Health Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 813 Cohort (n=323, 146)
|
38.85 Units on a Scale
Standard Error 11.57
|
39.01 Units on a Scale
Standard Error 11.19
|
|
Mean BL Mental Health Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 897 Cohort (n=320, 140)
|
38.96 Units on a Scale
Standard Error 11.66
|
39.03 Units on a Scale
Standard Error 11.35
|
|
Mean BL Mental Health Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 981 Cohort (n=312, 137)
|
39.06 Units on a Scale
Standard Error 11.58
|
39.09 Units on a Scale
Standard Error 11.46
|
|
Mean BL Mental Health Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 1,093 Cohort (n=312, 138)
|
39.16 Units on a Scale
Standard Error 11.47
|
39.08 Units on a Scale
Standard Error 11.42
|
|
Mean BL Mental Health Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 1,177 Cohort (n=273, 125)
|
38.88 Units on a Scale
Standard Error 11.54
|
38.67 Units on a Scale
Standard Error 11.22
|
|
Mean BL Mental Health Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 1,261 Cohort (n=292, 134)
|
38.81 Units on a Scale
Standard Error 11.56
|
39.15 Units on a Scale
Standard Error 11.49
|
|
Mean BL Mental Health Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 1,345 Cohort (n=147, 62)
|
39.91 Units on a Scale
Standard Error 11.46
|
39.33 Units on a Scale
Standard Error 11.21
|
|
Mean BL Mental Health Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 1,457 Cohort (n=290, 129)
|
38.83 Units on a Scale
Standard Error 11.62
|
38.93 Units on a Scale
Standard Error 11.42
|
|
Mean BL Mental Health Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 1,625 Cohort (n=280, 126)
|
38.88 Units on a Scale
Standard Error 11.66
|
38.97 Units on a Scale
Standard Error 11.46
|
|
Mean BL Mental Health Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 1,821 Cohort (n=273, 125)
|
39.06 Units on a Scale
Standard Error 11.72
|
38.95 Units on a Scale
Standard Error 11.44
|
|
Mean BL Mental Health Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 1,989 Cohort (n=118, 55)
|
38.95 Units on a Scale
Standard Error 10.99
|
39.90 Units on a Scale
Standard Error 10.63
|
|
Mean BL Mental Health Component of the SF-36 by Visit in the OL Period
BL (Day 0) for Day 2,185 Cohort (n=85, 38)
|
39.32 Units on a Scale
Standard Error 12.04
|
37.40 Units on a Scale
Standard Error 10.09
|
SECONDARY outcome
Timeframe: BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of \> 3 points were considered clinically meaningful.
Outcome measures
| Measure |
ABA + MTX DB
n=376 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=160 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Mean Change From BL by Visit in the Mental Health Component of the SF-36 in the OL Period
Day 365 (n=373, 159)
|
7.02 Units on a Scale
Standard Error 0.59
|
5.31 Units on a Scale
Standard Error 0.78
|
|
Mean Change From BL by Visit in the Mental Health Component of the SF-36 in the OL Period
Day 449 (n=368, 156)
|
7.27 Units on a Scale
Standard Error 0.58
|
6.45 Units on a Scale
Standard Error 0.89
|
|
Mean Change From BL by Visit in the Mental Health Component of the SF-36 in the OL Period
Day 533 (n=355, 156)
|
7.72 Units on a Scale
Standard Error 0.61
|
6.49 Units on a Scale
Standard Error 0.88
|
|
Mean Change From BL by Visit in the Mental Health Component of the SF-36 in the OL Period
Day 617 (n=348, 155)
|
7.60 Units on a Scale
Standard Error 0.61
|
6.03 Units on a Scale
Standard Error 0.93
|
|
Mean Change From BL by Visit in the Mental Health Component of the SF-36 in the OL Period
Day 729 (n=338, 147)
|
7.49 Units on a Scale
Standard Error 0.61
|
7.38 Units on a Scale
Standard Error 0.96
|
|
Mean Change From BL by Visit in the Mental Health Component of the SF-36 in the OL Period
Day 813 (n=323, 146)
|
7.26 Units on a Scale
Standard Error 0.66
|
5.72 Units on a Scale
Standard Error 0.93
|
|
Mean Change From BL by Visit in the Mental Health Component of the SF-36 in the OL Period
Day 897 (n=320, 140)
|
7.65 Units on a Scale
Standard Error 0.67
|
7.29 Units on a Scale
Standard Error 0.96
|
|
Mean Change From BL by Visit in the Mental Health Component of the SF-36 in the OL Period
Day 981 (n=312, 137)
|
7.13 Units on a Scale
Standard Error 0.65
|
6.97 Units on a Scale
Standard Error 1.00
|
|
Mean Change From BL by Visit in the Mental Health Component of the SF-36 in the OL Period
Day 1,093 (n=312, 138)
|
7.85 Units on a Scale
Standard Error 0.62
|
5.81 Units on a Scale
Standard Error 0.99
|
|
Mean Change From BL by Visit in the Mental Health Component of the SF-36 in the OL Period
Day 1,177 (n=273, 125)
|
7.67 Units on a Scale
Standard Error 0.68
|
7.02 Units on a Scale
Standard Error 1.07
|
|
Mean Change From BL by Visit in the Mental Health Component of the SF-36 in the OL Period
Day 1,261 (n=292, 134)
|
8.18 Units on a Scale
Standard Error 0.70
|
6.14 Units on a Scale
Standard Error 1.03
|
|
Mean Change From BL by Visit in the Mental Health Component of the SF-36 in the OL Period
Day 1,345 (n=147, 62)
|
6.80 Units on a Scale
Standard Error 0.93
|
7.01 Units on a Scale
Standard Error 1.25
|
|
Mean Change From BL by Visit in the Mental Health Component of the SF-36 in the OL Period
Day 1,457 (n=290, 129)
|
7.75 Units on a Scale
Standard Error 0.70
|
6.51 Units on a Scale
Standard Error 1.01
|
|
Mean Change From BL by Visit in the Mental Health Component of the SF-36 in the OL Period
Day 1,625 (n=280, 126)
|
6.96 Units on a Scale
Standard Error 0.70
|
7.13 Units on a Scale
Standard Error 1.10
|
|
Mean Change From BL by Visit in the Mental Health Component of the SF-36 in the OL Period
Day 1,821 (n=273, 125)
|
7.39 Units on a Scale
Standard Error 0.71
|
6.56 Units on a Scale
Standard Error 1.09
|
|
Mean Change From BL by Visit in the Mental Health Component of the SF-36 in the OL Period
Day 1,989 (n=118, 55)
|
6.58 Units on a Scale
Standard Error 1.08
|
6.65 Units on a Scale
Standard Error 1.57
|
|
Mean Change From BL by Visit in the Mental Health Component of the SF-36 in the OL Period
Day 2,185 (n=85, 38)
|
5.92 Units on a Scale
Standard Error 1.22
|
7.10 Units on a Scale
Standard Error 1.60
|
SECONDARY outcome
Timeframe: BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
Mean baseline values are reported for each cohort at each time point using the VAS 100 mm where 0= no fatigue to 100 = the worst fatigue imaginable. Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.
Outcome measures
| Measure |
ABA + MTX DB
n=376 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=160 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Mean BL Fatigue in the OL Period
BL (Day 0) for Day 365 Cohort (n=373, 160)
|
63.52 Units on a Scale
Standard Deviation 23.23
|
65.37 Units on a Scale
Standard Deviation 22.96
|
|
Mean BL Fatigue in the OL Period
BL (Day 0) for Day 449 Cohort (n=358, 156)
|
63.59 Units on a Scale
Standard Deviation 23.51
|
65.28 Units on a Scale
Standard Deviation 23.24
|
|
Mean BL Fatigue in the OL Period
BL (Day 0) for Day 533 Cohort (n=353, 157)
|
63.25 Units on a Scale
Standard Deviation 23.57
|
65.78 Units on a Scale
Standard Deviation 22.89
|
|
Mean BL Fatigue in the OL Period
BL (Day 0) for Day 617 Cohort (n=339, 150)
|
63.19 Units on a Scale
Standard Deviation 23.48
|
64.73 Units on a Scale
Standard Deviation 23.42
|
|
Mean BL Fatigue in the OL Period
BL (Day 0) for Day 729 Cohort (n=329, 143)
|
63.53 Units on a Scale
Standard Deviation 23.15
|
64.59 Units on a Scale
Standard Deviation 23.73
|
|
Mean BL Fatigue in the OL Period
BL (Day 0) for Day 813 Cohort (n=318, 141)
|
63.77 Units on a Scale
Standard Deviation 22.77
|
64.81 Units on a Scale
Standard Deviation 23.59
|
|
Mean BL Fatigue in the OL Period
BL (Day 0) for Day 897 Cohort (n=316, 139)
|
63.61 Units on a Scale
Standard Deviation 23.11
|
65.36 Units on a Scale
Standard Deviation 23.29
|
|
Mean BL Fatigue in the OL Period
BL (Day 0) for Day 981 Cohort (n=312, 137)
|
63.58 Units on a Scale
Standard Deviation 22.99
|
65.51 Units on a Scale
Standard Deviation 23.43
|
|
Mean BL Fatigue in the OL Period
BL (Day 0) for Day 1,093 Cohort (n=307, 138)
|
63.33 Units on a Scale
Standard Deviation 23.18
|
65.47 Units on a Scale
Standard Deviation 23.34
|
|
Mean BL Fatigue in the OL Period
BL (Day 0) for Day 1,177 Cohort (n=271, 123)
|
64.05 Units on a Scale
Standard Deviation 22.73
|
65.18 Units on a Scale
Standard Deviation 23.11
|
|
Mean BL Fatigue in the OL Period
BL (Day 0) for Day 1,261 Cohort (n=289, 133)
|
63.38 Units on a Scale
Standard Deviation 23.37
|
65.56 Units on a Scale
Standard Deviation 23.19
|
|
Mean BL Fatigue in the OL Period
BL (Day 0) for Day 1,345 Cohort (n=141, 59)
|
65.64 Units on a Scale
Standard Deviation 21.44
|
69.00 Units on a Scale
Standard Deviation 20.57
|
|
Mean BL Fatigue in the OL Period
BL (Day 0) for Day 1,457 Cohort (n=283, 129)
|
63.66 Units on a Scale
Standard Deviation 23.51
|
65.50 Units on a Scale
Standard Deviation 23.00
|
|
Mean BL Fatigue in the OL Period
BL (Day 0) for Day 1,625 Cohort (n=275, 124)
|
63.18 Units on a Scale
Standard Deviation 23.78
|
66.34 Units on a Scale
Standard Deviation 22.48
|
|
Mean BL Fatigue in the OL Period
BL (Day 0) for Day 1,821 Cohort (n=263, 125)
|
62.48 Units on a Scale
Standard Deviation 23.84
|
65.00 Units on a Scale
Standard Deviation 23.15
|
|
Mean BL Fatigue in the OL Period
BL (Day 0) for Day 1,989 Cohort (n=115, 53)
|
64.36 Units on a Scale
Standard Deviation 23.88
|
67.45 Units on a Scale
Standard Deviation 22.16
|
|
Mean BL Fatigue in the OL Period
BL (Day 0) for Day 2,185 Cohort (n=81, 37)
|
64.77 Units on a Scale
Standard Deviation 22.45
|
70.17 Units on a Scale
Standard Deviation 19.01
|
SECONDARY outcome
Timeframe: BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
The mean change from baseline in fatigue was measured on the VAS 100 mm where 0= no fatigue to 100 = the worst fatigue imaginable.
Outcome measures
| Measure |
ABA + MTX DB
n=376 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=160 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Mean Change From BL in Fatigue in the OL Period
Day 365 (n=373, 160)
|
-28.0 Units on a Scale
Standard Error 1.49
|
-22.6 Units on a Scale
Standard Error 2.21
|
|
Mean Change From BL in Fatigue in the OL Period
Day 449 (n=358, 156)
|
-28.5 Units on a Scale
Standard Error 1.55
|
-31.1 Units on a Scale
Standard Error 2.43
|
|
Mean Change From BL in Fatigue in the OL Period
Day 533 (n=353, 157)
|
-29.4 Units on a Scale
Standard Error 1.51
|
-31.1 Units on a Scale
Standard Error 2.46
|
|
Mean Change From BL in Fatigue in the OL Period
Day 617 (n=339, 150)
|
-30.4 Units on a Scale
Standard Error 1.60
|
-30.5 Units on a Scale
Standard Error 2.54
|
|
Mean Change From BL in Fatigue in the OL Period
Day 729 (n=329, 143)
|
-31.2 Units on a Scale
Standard Error 1.60
|
-30.0 Units on a Scale
Standard Error 2.67
|
|
Mean Change From BL in Fatigue in the OL Period
Day 813 (n=318, 141)
|
-29.9 Units on a Scale
Standard Error 1.60
|
-31.0 Units on a Scale
Standard Error 2.42
|
|
Mean Change From BL in Fatigue in the OL Period
Day 897 (n=316, 139)
|
-29.7 Units on a Scale
Standard Error 1.66
|
-30.6 Units on a Scale
Standard Error 2.45
|
|
Mean Change From BL in Fatigue in the OL Period
Day 981 (n=312, 137)
|
-30.5 Units on a Scale
Standard Error 1.69
|
-31.1 Units on a Scale
Standard Error 2.56
|
|
Mean Change From BL in Fatigue in the OL Period
Day 1,093 (n=307, 138)
|
-32.8 Units on a Scale
Standard Error 1.61
|
-31.3 Units on a Scale
Standard Error 2.53
|
|
Mean Change From BL in Fatigue in the OL Period
Day 1,177 (n=271, 123)
|
-32.2 Units on a Scale
Standard Error 1.83
|
-33.3 Units on a Scale
Standard Error 2.69
|
|
Mean Change From BL in Fatigue in the OL Period
Day 1,261 (n=289, 133)
|
-30.3 Units on a Scale
Standard Error 1.70
|
-31.2 Units on a Scale
Standard Error 2.62
|
|
Mean Change From BL in Fatigue in the OL Period
Day 1,345 (n=141, 59)
|
-33.9 Units on a Scale
Standard Error 2.42
|
-28.2 Units on a Scale
Standard Error 3.80
|
|
Mean Change From BL in Fatigue in the OL Period
Day 1,457 (n=283, 129)
|
-32.2 Units on a Scale
Standard Error 1.65
|
-32.6 Units on a Scale
Standard Error 2.62
|
|
Mean Change From BL in Fatigue in the OL Period
Day 1,625 (n=275, 124)
|
-30.9 Units on a Scale
Standard Error 1.69
|
-32.3 Units on a Scale
Standard Error 2.56
|
|
Mean Change From BL in Fatigue in the OL Period
Day 1,821 (n=263, 125)
|
-30.3 Units on a Scale
Standard Error 1.82
|
-32.0 Units on a Scale
Standard Error 2.65
|
|
Mean Change From BL in Fatigue in the OL Period
Day 1,989 (n=115, 53)
|
-33.6 Units on a Scale
Standard Error 2.80
|
-33.7 Units on a Scale
Standard Error 4.18
|
|
Mean Change From BL in Fatigue in the OL Period
Day 2,185 (n=81, 37)
|
-29.4 Units on a Scale
Standard Error 3.22
|
-35.0 Units on a Scale
Standard Error 4.49
|
SECONDARY outcome
Timeframe: BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
Mean baseline values are reported for each cohort at each time point using the Medical Outcomes Study Sleep scale (MOS-sleep \[assesses the extent of sleep problems and measures six dimensions of sleep on a 12-item participant-reported measure\]). An overall Sleep Problems Index (SPI) was generated as a summary measure of different types of sleep problems (sleep disturbance, sleep quantity, sleep adequacy, etc.). The score ranges from 0 to 100, with 0 = no problems with sleep and 100 = the most severe problems with sleep. The mean score of the SPI in a population with chronic conditions is 29.
Outcome measures
| Measure |
ABA + MTX DB
n=376 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=160 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Mean BL Sleep Quality in the OL Period
BL (Day 0) for Day 365 Cohort (n=373, 160)
|
42.42 Units on a Scale
Standard Deviation 19.96
|
43.53 Units on a Scale
Standard Deviation 19.59
|
|
Mean BL Sleep Quality in the OL Period
BL (Day 0) for Day 449 Cohort (n=358, 156)
|
42.77 Units on a Scale
Standard Deviation 20.07
|
43.22 Units on a Scale
Standard Deviation 19.64
|
|
Mean BL Sleep Quality in the OL Period
BL (Day 0) for Day 533 Cohort (n=353, 157)
|
42.62 Units on a Scale
Standard Deviation 20.11
|
43.24 Units on a Scale
Standard Deviation 19.39
|
|
Mean BL Sleep Quality in the OL Period
BL (Day 0) for Day 617 Cohort (n=339, 150)
|
42.51 Units on a Scale
Standard Deviation 20.19
|
43.24 Units on a Scale
Standard Deviation 19.90
|
|
Mean BL Sleep Quality in the OL Period
BL (Day 0) for Day 729 Cohort (n=329, 143)
|
42.28 Units on a Scale
Standard Deviation 20.01
|
43.97 Units on a Scale
Standard Deviation 19.75
|
|
Mean BL Sleep Quality in the OL Period
BL (Day 0) for Day 813 Cohort (n=318, 141)
|
42.63 Units on a Scale
Standard Deviation 20.07
|
43.58 Units on a Scale
Standard Deviation 19.70
|
|
Mean BL Sleep Quality in the OL Period
BL (Day 0) for Day 897 Cohort (n=316, 139)
|
42.60 Units on a Scale
Standard Deviation 20.31
|
43.65 Units on a Scale
Standard Deviation 19.83
|
|
Mean BL Sleep Quality in the OL Period
BL (Day 0) for Day 981 Cohort (n=312, 137)
|
42.51 Units on a Scale
Standard Deviation 20.25
|
43.58 Units on a Scale
Standard Deviation 19.78
|
|
Mean BL Sleep Quality in the OL Period
BL (Day 0) for Day 1,093 Cohort (n=307, 138)
|
42.69 Units on a Scale
Standard Deviation 20.36
|
43.78 Units on a Scale
Standard Deviation 19.84
|
|
Mean BL Sleep Quality in the OL Period
BL (Day 0) for Day 1,177 Cohort (n=270, 124)
|
43.08 Units on a Scale
Standard Deviation 20.28
|
43.51 Units on a Scale
Standard Deviation 19.52
|
|
Mean BL Sleep Quality in the OL Period
BL (Day 0) for Day 1,261 Cohort (n=289, 133)
|
42.87 Units on a Scale
Standard Deviation 20.40
|
43.76 Units on a Scale
Standard Deviation 19.83
|
|
Mean BL Sleep Quality in the OL Period
BL (Day 0) for Day 1,345 Cohort (n=141, 59)
|
41.78 Units on a Scale
Standard Deviation 21.79
|
48.39 Units on a Scale
Standard Deviation 20.23
|
|
Mean BL Sleep Quality in the OL Period
BL (Day 0) for Day 1,457 Cohort (n=275, 124)
|
42.93 Units on a Scale
Standard Deviation 20.82
|
44.14 Units on a Scale
Standard Deviation 19.74
|
|
Mean BL Sleep Quality in the OL Period
BL (Day 0) for Day 1,625 Cohort (n=272, 122)
|
42.70 Units on a Scale
Standard Deviation 20.46
|
44.51 Units on a Scale
Standard Deviation 20.00
|
|
Mean BL Sleep Quality in the OL Period
BL (Day 0) for Day 1,821 Cohort (n=263, 125)
|
42.04 Units on a Scale
Standard Deviation 20.53
|
43.59 Units on a Scale
Standard Deviation 20.00
|
|
Mean BL Sleep Quality in the OL Period
BL (Day 0) for Day 1,989 Cohort (n=115, 53)
|
43.15 Units on a Scale
Standard Deviation 22.33
|
47.62 Units on a Scale
Standard Deviation 20.33
|
|
Mean BL Sleep Quality in the OL Period
BL (Day 0) for Day 2,185 Cohort (n=81, 37)
|
42.70 Units on a Scale
Standard Deviation 22.06
|
51.43 Units on a Scale
Standard Deviation 19.75
|
SECONDARY outcome
Timeframe: BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
The mean change from baseline in sleep quality was assessed on the Medical Outcomes Study Sleep scale (MOS-sleep \[assesses the extent of sleep problems and measures six dimensions of sleep on a 12-item participant-reported measure\]). An overall Sleep Problems Index (SPI) was generated as a summary measure of different types of sleep problems (sleep disturbance, sleep quantity, sleep adequacy, etc.). The score ranges from 0 to 100, with 0 = no problems with sleep and 100 = the most severe problems with sleep. The mean score of the SPI in a population with chronic conditions is 29.
Outcome measures
| Measure |
ABA + MTX DB
n=376 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=160 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Mean Change From BL in Sleep Quality in the OL Period
Day 365 (n=373, 160)
|
-10.8 Units on a Scale
Standard Error 0.91
|
-7.97 Units on a Scale
Standard Error 1.25
|
|
Mean Change From BL in Sleep Quality in the OL Period
Day 449 (n=358, 156)
|
-11.0 Units on a Scale
Standard Error 0.97
|
-11.4 Units on a Scale
Standard Error 1.36
|
|
Mean Change From BL in Sleep Quality in the OL Period
Day 533 (n=353, 157)
|
-11.4 Units on a Scale
Standard Error 0.92
|
-10.9 Units on a Scale
Standard Error 1.42
|
|
Mean Change From BL in Sleep Quality in the OL Period
Day 617 (n=339, 150)
|
-10.6 Units on a Scale
Standard Error 0.92
|
-11.9 Units on a Scale
Standard Error 1.41
|
|
Mean Change From BL in Sleep Quality in the OL Period
Day 729 (n=329, 143)
|
-10.9 Units on a Scale
Standard Error 0.99
|
-11.3 Units on a Scale
Standard Error 1.48
|
|
Mean Change From BL in Sleep Quality in the OL Period
Day 813 (n=318, 141)
|
-10.9 Units on a Scale
Standard Error 1.07
|
-10.8 Units on a Scale
Standard Error 1.57
|
|
Mean Change From BL in Sleep Quality in the OL Period
Day 897 (n=316, 139)
|
-12.2 Units on a Scale
Standard Error 1.04
|
-12.0 Units on a Scale
Standard Error 1.46
|
|
Mean Change From BL in Sleep Quality in the OL Period
Day 981 (n=312, 137)
|
-11.4 Units on a Scale
Standard Error 1.05
|
-10.8 Units on a Scale
Standard Error 1.58
|
|
Mean Change From BL in Sleep Quality in the OL Period
Day 1,093 (n=307, 138)
|
-11.9 Units on a Scale
Standard Error 1.09
|
-11.3 Units on a Scale
Standard Error 1.53
|
|
Mean Change From BL in Sleep Quality in the OL Period
Day 1,177 (n=270, 124)
|
-11.9 Units on a Scale
Standard Error 1.19
|
-10.8 Units on a Scale
Standard Error 1.61
|
|
Mean Change From BL in Sleep Quality in the OL Period
Day 1,261 (n=289, 133)
|
-12.2 Units on a Scale
Standard Error 1.16
|
-10.1 Units on a Scale
Standard Error 1.59
|
|
Mean Change From BL in Sleep Quality in the OL Period
Day 1,345 (n=141, 59)
|
-11.6 Units on a Scale
Standard Error 1.68
|
-12.5 Units on a Scale
Standard Error 2.17
|
|
Mean Change From BL in Sleep Quality in the OL Period
Day 1,457 (n=275, 124)
|
-11.7 Units on a Scale
Standard Error 1.16
|
-10.4 Units on a Scale
Standard Error 1.62
|
|
Mean Change From BL in Sleep Quality in the OL Period
Day 1,625 (n=272, 122)
|
-11.2 Units on a Scale
Standard Error 1.19
|
-11.6 Units on a Scale
Standard Error 1.72
|
|
Mean Change From BL in Sleep Quality in the OL Period
Day 1,821 (n=263, 125)
|
-10.8 Units on a Scale
Standard Error 1.23
|
-9.10 Units on a Scale
Standard Error 1.50
|
|
Mean Change From BL in Sleep Quality in the OL Period
Day 1,989 (n=115, 53)
|
-11.7 Units on a Scale
Standard Error 1.98
|
-11.0 Units on a Scale
Standard Error 2.40
|
|
Mean Change From BL in Sleep Quality in the OL Period
Day 2,185 (n=81, 37)
|
-8.76 Units on a Scale
Standard Error 2.03
|
-14.6 Units on a Scale
Standard Error 2.92
|
SECONDARY outcome
Timeframe: BL (Day 0), Day 365, Day 449, Day 533, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
Mean baseline values are reported for each cohort at each time point. Activity limitation was measured by the number of days in the past 30 days a participant was unable to perform usual activities due to RA. Time-matched BL (Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.
Outcome measures
| Measure |
ABA + MTX DB
n=376 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=160 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Mean BL Limitations on Activities of Daily Living in the OL Period
BL (Day 0) for Day 365 Cohort (n=360, 153)
|
13.80 Days
Standard Deviation 10.98
|
13.21 Days
Standard Deviation 12.64
|
|
Mean BL Limitations on Activities of Daily Living in the OL Period
BL (Day 0) for Day 449 Cohort (n=348, 150)
|
13.82 Days
Standard Deviation 10.92
|
13.19 Days
Standard Deviation 12.65
|
|
Mean BL Limitations on Activities of Daily Living in the OL Period
BL (Day 0) for Day 533 Cohort (n=338, 148)
|
13.91 Days
Standard Deviation 11.06
|
13.55 Days
Standard Deviation 12.70
|
|
Mean BL Limitations on Activities of Daily Living in the OL Period
BL (Day 0) for Day 617 Cohort (n=332, 140)
|
14.01 Days
Standard Deviation 11.10
|
13.23 Days
Standard Deviation 12.72
|
|
Mean BL Limitations on Activities of Daily Living in the OL Period
BL (Day 0) for Day 729 Cohort (n=316, 138)
|
13.96 Days
Standard Deviation 11.11
|
13.52 Days
Standard Deviation 12.78
|
|
Mean BL Limitations on Activities of Daily Living in the OL Period
BL (Day 0) for Day 813 Cohort (n=306, 133)
|
14.31 Days
Standard Deviation 11.14
|
13.38 Days
Standard Deviation 12.88
|
|
Mean BL Limitations on Activities of Daily Living in the OL Period
BL (Day 0) for Day 897 Cohort (n=302, 131)
|
14.08 Days
Standard Deviation 11.14
|
13.81 Days
Standard Deviation 12.91
|
|
Mean BL Limitations on Activities of Daily Living in the OL Period
BL (Day 0) for Day 981 Cohort (n=300, 129)
|
14.13 Days
Standard Deviation 11.19
|
13.70 Days
Standard Deviation 13.03
|
|
Mean BL Limitations on Activities of Daily Living in the OL Period
BL (Day 0) for Day 1,093 Cohort (n=292, 130)
|
14.34 Days
Standard Deviation 11.15
|
13.79 Days
Standard Deviation 12.95
|
|
Mean BL Limitations on Activities of Daily Living in the OL Period
BL (Day 0) for Day 1,177 Cohort (n=259, 118)
|
14.53 Days
Standard Deviation 11.17
|
13.80 Days
Standard Deviation 13.28
|
|
Mean BL Limitations on Activities of Daily Living in the OL Period
BL (Day 0) for Day 1,261 Cohort (n=231, 105)
|
15.00 Days
Standard Deviation 11.01
|
13.81 Days
Standard Deviation 13.16
|
|
Mean BL Limitations on Activities of Daily Living in the OL Period
BL (Day 0) for Day 1,345 Cohort (n=133, 57)
|
15.71 Days
Standard Deviation 11.20
|
15.05 Days
Standard Deviation 11.29
|
|
Mean BL Limitations on Activities of Daily Living in the OL Period
BL (Day 0) for Day 1,457 Cohort (n=196, 84)
|
15.36 Days
Standard Deviation 11.16
|
14.87 Days
Standard Deviation 13.96
|
SECONDARY outcome
Timeframe: BL (Day 0), Day 365, Day 449, Day 533, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
The mean change from baseline in limitations on activities of daily living in the OL period. Activity limitation was measured by the number of days in the past 30 days a participant was unable to perform usual activities due to RA.
Outcome measures
| Measure |
ABA + MTX DB
n=376 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=160 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Mean Change From BL in Limitations on Activities of Daily Living in the OL Period
Day 365 (n=360, 153)
|
-9.04 Days
Standard Error 0.60
|
-6.39 Days
Standard Error 1.04
|
|
Mean Change From BL in Limitations on Activities of Daily Living in the OL Period
Day 449 (n=348, 150)
|
-8.75 Days
Standard Error 0.58
|
-8.60 Days
Standard Error 1.03
|
|
Mean Change From BL in Limitations on Activities of Daily Living in the OL Period
Day 533 (n=338, 148)
|
-9.21 Days
Standard Error 0.61
|
-9.00 Days
Standard Error 1.12
|
|
Mean Change From BL in Limitations on Activities of Daily Living in the OL Period
Day 617 (n=332, 140)
|
-9.49 Days
Standard Error 0.63
|
-8.62 Days
Standard Error 1.18
|
|
Mean Change From BL in Limitations on Activities of Daily Living in the OL Period
Day 729 (n=316, 138)
|
-9.55 Days
Standard Error 0.62
|
-8.18 Days
Standard Error 1.21
|
|
Mean Change From BL in Limitations on Activities of Daily Living in the OL Period
Day 813 (n=306, 133)
|
-9.87 Days
Standard Error 0.64
|
-8.67 Days
Standard Error 1.19
|
|
Mean Change From BL in Limitations on Activities of Daily Living in the OL Period
Day 897 (n=302, 131)
|
-9.35 Days
Standard Error 0.65
|
-9.22 Days
Standard Error 1.28
|
|
Mean Change From BL in Limitations on Activities of Daily Living in the OL Period
Day 981 (n=300, 129)
|
-9.48 Days
Standard Error 0.66
|
-8.68 Days
Standard Error 1.26
|
|
Mean Change From BL in Limitations on Activities of Daily Living in the OL Period
Day 1,093 (n=292, 130)
|
-10.1 Days
Standard Error 0.69
|
-8.71 Days
Standard Error 1.25
|
|
Mean Change From BL in Limitations on Activities of Daily Living in the OL Period
Day 1,177 (n=259, 118)
|
-10.6 Days
Standard Error 0.68
|
-8.39 Days
Standard Error 1.34
|
|
Mean Change From BL in Limitations on Activities of Daily Living in the OL Period
Day 1,261 (n=231, 105)
|
-9.96 Days
Standard Error 0.73
|
-8.30 Days
Standard Error 1.51
|
|
Mean Change From BL in Limitations on Activities of Daily Living in the OL Period
Day 1,345 (n=133, 57)
|
-11.1 Days
Standard Error 1.02
|
-9.18 Days
Standard Error 1.61
|
|
Mean Change From BL in Limitations on Activities of Daily Living in the OL Period
Day 1,457 (n=196, 84)
|
-9.73 Days
Standard Error 0.94
|
-10.3 Days
Standard Error 1.61
|
SECONDARY outcome
Timeframe: BL (Day 0), Day 169, Day 365Population: All treated participants in the DB period. N = number of participants analyzed and n = the number of participants with measurements for that time point.
Mean baseline values are reported for each cohort at each time point. Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.
Outcome measures
| Measure |
ABA + MTX DB
n=424 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=214 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Mean BL Interleukin-6 (IL-6), SIL-2R, and Tumor Necrosis Alpha (TNF-Alpha) in the DB Period
BL (Day 0) IL-6 for Day 169 Cohort (n=357, 175)
|
36.35 pg / mL
Standard Deviation 43.53
|
39.90 pg / mL
Standard Deviation 54.43
|
|
Mean BL Interleukin-6 (IL-6), SIL-2R, and Tumor Necrosis Alpha (TNF-Alpha) in the DB Period
BL (Day 0) SIL-2R for Day 169 Cohort (n=370, 171)
|
1776 pg / mL
Standard Deviation 946.5
|
1603 pg / mL
Standard Deviation 933.1
|
|
Mean BL Interleukin-6 (IL-6), SIL-2R, and Tumor Necrosis Alpha (TNF-Alpha) in the DB Period
BL (Day 0) TNF-Alpha for D169 Cohort (n=354,172)
|
5.94 pg / mL
Standard Deviation 7.90
|
7.86 pg / mL
Standard Deviation 29.41
|
|
Mean BL Interleukin-6 (IL-6), SIL-2R, and Tumor Necrosis Alpha (TNF-Alpha) in the DB Period
BL (Day 0) IL-6 for Day 365 Cohort (n=247, 121)
|
35.27 pg / mL
Standard Deviation 49.06
|
37.89 pg / mL
Standard Deviation 49.61
|
|
Mean BL Interleukin-6 (IL-6), SIL-2R, and Tumor Necrosis Alpha (TNF-Alpha) in the DB Period
BL (Day 0) SIL-2R for Day 365 Cohort (n=235, 106)
|
1674 pg / mL
Standard Deviation 835.1
|
1601 pg / mL
Standard Deviation 1076
|
|
Mean BL Interleukin-6 (IL-6), SIL-2R, and Tumor Necrosis Alpha (TNF-Alpha) in the DB Period
BL (Day 0) TNF-Alpha for D365 Cohort (n=246, 119)
|
5.55 pg / mL
Standard Deviation 7.84
|
5.46 pg / mL
Standard Deviation 8.63
|
SECONDARY outcome
Timeframe: BL (Day 0), Day 169, Day 365Population: All treated participants in the DB period. N = number of participants analyzed and n = the number of participants with measurements for that time point.
The mean change from baseline in potential biomarkers of disease (IL-6, SIL-3R, and TNF-Alpha were determined for all participants.
Outcome measures
| Measure |
ABA + MTX DB
n=424 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=214 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Mean Change From BL in Interleukin-6 (IL-6), SIL-2R, and Tumor Necrosis Alpha (TNF-Alpha) in the DB Period
IL-6 Day 169 (n=357, 175)
|
-21.0 pg / mL
Standard Error 2.24
|
-5.81 pg / mL
Standard Error 3.00
|
|
Mean Change From BL in Interleukin-6 (IL-6), SIL-2R, and Tumor Necrosis Alpha (TNF-Alpha) in the DB Period
SIL-2R Day 169 (n=370, 171)
|
-519.0 pg / mL
Standard Error 32.72
|
-85.5 pg / mL
Standard Error 32.78
|
|
Mean Change From BL in Interleukin-6 (IL-6), SIL-2R, and Tumor Necrosis Alpha (TNF-Alpha) in the DB Period
TNF-Alpha Day 169 (n=354, 172)
|
-0.82 pg / mL
Standard Error 0.72
|
2.27 pg / mL
Standard Error 2.49
|
|
Mean Change From BL in Interleukin-6 (IL-6), SIL-2R, and Tumor Necrosis Alpha (TNF-Alpha) in the DB Period
IL-6 Day 365 (n=247, 121)
|
-23.4 pg / mL
Standard Error 3.08
|
-1.82 pg / mL
Standard Error 5.23
|
|
Mean Change From BL in Interleukin-6 (IL-6), SIL-2R, and Tumor Necrosis Alpha (TNF-Alpha) in the DB Period
SIL-2R Day 365(n=235, 106)
|
-562 pg / mL
Standard Error 40.82
|
-290 pg / mL
Standard Error 87.97
|
|
Mean Change From BL in Interleukin-6 (IL-6), SIL-2R, and Tumor Necrosis Alpha (TNF-Alpha) in the DB Period
TNF-Alpha Day 365 (n=246, 119)
|
-0.22 pg / mL
Standard Error 1.04
|
1.22 pg / mL
Standard Error 2.42
|
SECONDARY outcome
Timeframe: BL (Day 0), Day 169, Day 365Population: All treated participants in the DB period. N = number of participants analyzed and n = the number of participants with measurements for that time point.
The mean change from baseline in participant rheumatoid factor was determined after 6 months and 1 year of treatment relative to baseline. Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.
Outcome measures
| Measure |
ABA + MTX DB
n=424 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=214 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Mean Change From BL in RF in the DB Period
BL (Day 0) for Day 169 Cohort (n=308, 126)
|
-49.8 IU / mL
Standard Error 10.90
|
-18.6 IU / mL
Standard Error 10.28
|
|
Mean Change From BL in RF in the DB Period
BL (Day 0) for Day 365 Cohort (n=281, 104)
|
-46.5 IU / mL
Standard Error 11.44
|
-5.83 IU / mL
Standard Error 22.38
|
SECONDARY outcome
Timeframe: BL (Day 0), Day 169, Day 365Population: All treated participants in the DB period. N = number of participants analyzed and n = the number of participants with measurements for that time point.
Mean baseline values are reported for each cohort at each time point. Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.
Outcome measures
| Measure |
ABA + MTX DB
n=424 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=214 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Mean BL E-Selectin, SICAM-1, and MMP3 in the DB Period
BL (Day 0) SICAM-1 for D365 Cohort (n=235, 114)
|
467.2 ng / mL
Standard Error 578.5
|
449.5 ng / mL
Standard Error 356.0
|
|
Mean BL E-Selectin, SICAM-1, and MMP3 in the DB Period
BL (Day 0) E-Selectin for D169 Cohort (n= 256,126)
|
85.89 ng / mL
Standard Error 72.62
|
85.53 ng / mL
Standard Error 68.42
|
|
Mean BL E-Selectin, SICAM-1, and MMP3 in the DB Period
BL (Day 0) SICAM-1 for D169 Cohort (n=264, 130)
|
444.0 ng / mL
Standard Error 398.1
|
426.8 ng / mL
Standard Error 323.5
|
|
Mean BL E-Selectin, SICAM-1, and MMP3 in the DB Period
BL (Day 0) MMP3 for D169 Cohort (n=362, 183)
|
83.37 ng / mL
Standard Error 81.53
|
77.22 ng / mL
Standard Error 73.72
|
|
Mean BL E-Selectin, SICAM-1, and MMP3 in the DB Period
BL (Day 0) E-Selectin fpr D365 Cohort (n=162, 74)
|
85.91 ng / mL
Standard Error 71.66
|
88.39 ng / mL
Standard Error 75.09
|
|
Mean BL E-Selectin, SICAM-1, and MMP3 in the DB Period
BL (Day 0) MMP3 for D365 Cohort (n=232, 112)
|
79.56 ng / mL
Standard Error 78.35
|
64.02 ng / mL
Standard Error 59.05
|
SECONDARY outcome
Timeframe: BL (Day 0), Day 169, Day 365Population: All treated participants in the DB period. N = number of participants analyzed and n = the number of participants with measurements for that time point.
The mean change from basline in particpant biomarkers of RA disease (E-Selectin, SICAM-1, and MMP3) after 6 months and 1 year of treatment, relative to baseline, were evaluated.
Outcome measures
| Measure |
ABA + MTX DB
n=424 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=214 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Mean Change From BL in E-Selectin, SICAM-1, and MMP3 in the DB Period
E-Selectin Day 169 (n= 256, 126)
|
-13.8 ng / mL
Standard Error 3.28
|
-6.52 ng / mL
Standard Error 4.44
|
|
Mean Change From BL in E-Selectin, SICAM-1, and MMP3 in the DB Period
SICAM-1 Day 169 (n=264, 130)
|
-65.0 ng / mL
Standard Error 9.87
|
-42.0 ng / mL
Standard Error 17.02
|
|
Mean Change From BL in E-Selectin, SICAM-1, and MMP3 in the DB Period
MMP3 Day 169 (n=362, 183)
|
-37.2 ng / mL
Standard Error 2.85
|
-8.03 ng / mL
Standard Error 3.88
|
|
Mean Change From BL in E-Selectin, SICAM-1, and MMP3 in the DB Period
E-Selectin Day 365 (n=162, 74)
|
-15.4 ng / mL
Standard Error 4.37
|
-9.94 ng / mL
Standard Error 5.73
|
|
Mean Change From BL in E-Selectin, SICAM-1, and MMP3 in the DB Period
SICAM-1 Day 365 (n=235, 114)
|
-80.0 ng / mL
Standard Error 27.20
|
-43.7 ng / mL
Standard Error 16.25
|
|
Mean Change From BL in E-Selectin, SICAM-1, and MMP3 in the DB Period
MMP3 Day 365 (n=232, 112)
|
-41.0 ng / mL
Standard Error 4.09
|
-12.1 ng / mL
Standard Error 5.01
|
SECONDARY outcome
Timeframe: BL (Day 0), Day 365Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.
Outcome measures
| Measure |
ABA + MTX DB
n=376 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=160 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) for the Day 365 Cohort of Participants Continuing in the OL Period
HAQ DI (n=369, 160)
|
1.68 Units on a Scale
Standard Deviation 0.63
|
1.70 Units on a Scale
Standard Deviation 0.58
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) for the Day 365 Cohort of Participants Continuing in the OL Period
Dressing and Grooming (n=372, 160)
|
1.47 Units on a Scale
Standard Deviation 0.75
|
1.49 Units on a Scale
Standard Deviation 0.73
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) for the Day 365 Cohort of Participants Continuing in the OL Period
Arising (n=372, 160)
|
1.42 Units on a Scale
Standard Deviation 0.82
|
1.46 Units on a Scale
Standard Deviation 0.78
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) for the Day 365 Cohort of Participants Continuing in the OL Period
Eating (n=372, 160)
|
1.63 Units on a Scale
Standard Deviation 0.97
|
1.68 Units on a Scale
Standard Deviation 0.84
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) for the Day 365 Cohort of Participants Continuing in the OL Period
Walking (n=372, 158)
|
1.40 Units on a Scale
Standard Deviation 0.83
|
1.37 Units on a Scale
Standard Deviation 0.78
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) for the Day 365 Cohort of Participants Continuing in the OL Period
Hygiene (n=370, 160)
|
1.93 Units on a Scale
Standard Deviation 0.90
|
1.91 Units on a Scale
Standard Deviation 0.89
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) for the Day 365 Cohort of Participants Continuing in the OL Period
Reaching (n=370, 160)
|
1.94 Units on a Scale
Standard Deviation 0.86
|
1.97 Units on a Scale
Standard Deviation 0.80
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) for the Day 365 Cohort of Participants Continuing in the OL Period
Gripping (n=371, 160)
|
1.80 Units on a Scale
Standard Deviation 0.76
|
1.90 Units on a Scale
Standard Deviation 0.67
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) for the Day 365 Cohort of Participants Continuing in the OL Period
Activities (n=369, 160)
|
1.87 Units on a Scale
Standard Deviation 0.79
|
1.86 Units on a Scale
Standard Deviation 0.82
|
SECONDARY outcome
Timeframe: BL (Day 0), Day 365Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.
Outcome measures
| Measure |
ABA + MTX DB
n=376 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=160 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 365 for Participants Continuing in the OL Period
Gripping (n=371, 160)
|
-0.63 Units on a Scale
Standard Error 0.05
|
-0.49 Units on a Scale
Standard Error 0.07
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 365 for Participants Continuing in the OL Period
Activities (n=369, 160)
|
-0.66 Units on a Scale
Standard Error 0.05
|
-0.47 Units on a Scale
Standard Error 0.07
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 365 for Participants Continuing in the OL Period
HAQ DI (n=369, 160)
|
-0.68 Units on a Scale
Standard Error 0.03
|
-0.51 Units on a Scale
Standard Error 0.05
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 365 for Participants Continuing in the OL Period
Dressing and Grooming (n=372, 160)
|
-0.77 Units on a Scale
Standard Error 0.04
|
-0.62 Units on a Scale
Standard Error 0.06
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 365 for Participants Continuing in the OL Period
Arising (n=372, 160)
|
-0.75 Units on a Scale
Standard Error 0.05
|
-0.59 Units on a Scale
Standard Error 0.07
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 365 for Participants Continuing in the OL Period
Eating (n=372, 160)
|
-0.80 Units on a Scale
Standard Error 0.05
|
-0.46 Units on a Scale
Standard Error 0.07
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 365 for Participants Continuing in the OL Period
Walking (n=372, 158)
|
-0.62 Units on a Scale
Standard Error 0.04
|
-0.48 Units on a Scale
Standard Error 0.06
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 365 for Participants Continuing in the OL Period
Hygiene (n=370, 160)
|
-0.54 Units on a Scale
Standard Error 0.05
|
-0.36 Units on a Scale
Standard Error 0.08
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 365 for Participants Continuing in the OL Period
Reaching (n=370, 160)
|
-0.71 Units on a Scale
Standard Error 0.05
|
-0.60 Units on a Scale
Standard Error 0.07
|
SECONDARY outcome
Timeframe: BL (Day 0), Day 449Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.
Outcome measures
| Measure |
ABA + MTX DB
n=376 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=160 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) for the Day 449 Cohort of Participants Continuing in the OL Period
HAQ DI (n=366, 157)
|
1.69 Units on a Scale
Standard Deviation 0.64
|
1.71 Units on a Scale
Standard Deviation 0.59
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) for the Day 449 Cohort of Participants Continuing in the OL Period
Dressing and Grooming (n=367, 157)
|
1.48 Units on a Scale
Standard Deviation 0.75
|
1.49 Units on a Scale
Standard Deviation 0.73
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) for the Day 449 Cohort of Participants Continuing in the OL Period
Arising (n=367, 157)
|
1.42 Units on a Scale
Standard Deviation 0.83
|
1.46 Units on a Scale
Standard Deviation 0.79
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) for the Day 449 Cohort of Participants Continuing in the OL Period
Eating (n=367, 157)
|
1.64 Units on a Scale
Standard Deviation 0.97
|
1.67 Units on a Scale
Standard Deviation 0.84
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) for the Day 449 Cohort of Participants Continuing in the OL Period
Walking (n=367, 155)
|
1.40 Units on a Scale
Standard Deviation 0.83
|
1.37 Units on a Scale
Standard Deviation 0.76
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) for the Day 449 Cohort of Participants Continuing in the OL Period
Hygiene (n=367, 157)
|
1.93 Units on a Scale
Standard Deviation 0.90
|
1.92 Units on a Scale
Standard Deviation 0.89
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) for the Day 449 Cohort of Participants Continuing in the OL Period
Reaching (n= 367, 157)
|
1.94 Units on a Scale
Standard Deviation 0.86
|
1.97 Units on a Scale
Standard Deviation 0.80
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) for the Day 449 Cohort of Participants Continuing in the OL Period
Gripping (n=368, 157)
|
1.81 Units on a Scale
Standard Deviation 0.75
|
1.90 Units on a Scale
Standard Deviation 0.67
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) for the Day 449 Cohort of Participants Continuing in the OL Period
Activities (n=367, 157)
|
1.87 Units on a Scale
Standard Deviation 0.79
|
1.87 Units on a Scale
Standard Deviation 0.82
|
SECONDARY outcome
Timeframe: BL (Day 0), Day 449Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.
Outcome measures
| Measure |
ABA + MTX DB
n=376 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=160 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 449 for Participants Continuing in the OL Period
HAQ DI (n=366, 157)
|
-0.70 Units on a Scale
Standard Error 0.03
|
-0.71 Units on a Scale
Standard Error 0.05
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 449 for Participants Continuing in the OL Period
Dressing and Grooming (n=367, 157)
|
-0.78 Units on a Scale
Standard Error 0.04
|
-0.85 Units on a Scale
Standard Error 0.06
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 449 for Participants Continuing in the OL Period
Arising (n=367, 157)
|
-0.72 Units on a Scale
Standard Error 0.05
|
-0.86 Units on a Scale
Standard Error 0.07
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 449 for Participants Continuing in the OL Period
Eating (n=367, 157)
|
-0.82 Units on a Scale
Standard Error 0.05
|
-0.63 Units on a Scale
Standard Error 0.07
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 449 for Participants Continuing in the OL Period
Walking (n=367, 155)
|
-0.60 Units on a Scale
Standard Error 0.05
|
-0.61 Units on a Scale
Standard Error 0.06
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 449 for Participants Continuing in the OL Period
Hygiene (n=367, 157)
|
-0.57 Units on a Scale
Standard Error 0.05
|
-0.59 Units on a Scale
Standard Error 0.08
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 449 for Participants Continuing in the OL Period
Reaching (n= 367, 157)
|
-0.75 Units on a Scale
Standard Error 0.05
|
-0.76 Units on a Scale
Standard Error 0.07
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 449 for Participants Continuing in the OL Period
Gripping (n=368, 157)
|
-0.67 Units on a Scale
Standard Error 0.05
|
-0.73 Units on a Scale
Standard Error 0.08
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 449 for Participants Continuing in the OL Period
Activities (n=367, 157)
|
-0.70 Units on a Scale
Standard Error 0.05
|
-0.65 Units on a Scale
Standard Error 0.08
|
SECONDARY outcome
Timeframe: BL (Day 0), Day 533Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.
Outcome measures
| Measure |
ABA + MTX DB
n=376 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=160 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) for the Day 533 Cohort of Participants Continuing in the OL Period
HAQ DI (n=354, 157)
|
1.69 Units on a Scale
Standard Deviation 0.64
|
1.71 Units on a Scale
Standard Deviation 0.58
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) for the Day 533 Cohort of Participants Continuing in the OL Period
Dressing and Grooming (n=355, 156)
|
1.47 Units on a Scale
Standard Deviation 0.75
|
1.49 Units on a Scale
Standard Deviation 0.73
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) for the Day 533 Cohort of Participants Continuing in the OL Period
Arising (n=355, 157)
|
1.42 Units on a Scale
Standard Deviation 0.84
|
1.45 Units on a Scale
Standard Deviation .078
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) for the Day 533 Cohort of Participants Continuing in the OL Period
Eating (n=355, 156)
|
1.64 Units on a Scale
Standard Deviation 0.98
|
1.67 Units on a Scale
Standard Deviation 0.84
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) for the Day 533 Cohort of Participants Continuing in the OL Period
Walking (n=351, 156)
|
1.40 Units on a Scale
Standard Deviation 0.84
|
1.37 Units on a Scale
Standard Deviation 0.78
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) for the Day 533 Cohort of Participants Continuing in the OL Period
Hygiene (n=354, 157)
|
1.94 Units on a Scale
Standard Deviation 0.91
|
1.92 Units on a Scale
Standard Deviation 0.88
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) for the Day 533 Cohort of Participants Continuing in the OL Period
Reaching (n=354, 157)
|
1.95 Units on a Scale
Standard Deviation 0.86
|
1.97 Units on a Scale
Standard Deviation 0.80
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) for the Day 533 Cohort of Participants Continuing in the OL Period
Gripping (n=354, 157)
|
1.81 Units on a Scale
Standard Deviation 0.76
|
1.91 Units on a Scale
Standard Deviation 0.66
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) for the Day 533 Cohort of Participants Continuing in the OL Period
Activities (n=354, 157)
|
1.88 Units on a Scale
Standard Deviation 0.79
|
1.87 Units on a Scale
Standard Deviation 0.82
|
SECONDARY outcome
Timeframe: BL (Day 0), Day 533Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.
Outcome measures
| Measure |
ABA + MTX DB
n=376 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=160 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 533 for Participants Continuing in the OL Period
Reaching (n=354, 157)
|
-0.77 Units on a Scale
Standard Error 0.05
|
-0.57 Units on a Scale
Standard Error 0.08
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 533 for Participants Continuing in the OL Period
Gripping (n=354, 157)
|
-0.68 Units on a Scale
Standard Error 0.05
|
-0.74 Units on a Scale
Standard Error 0.08
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 533 for Participants Continuing in the OL Period
HAQ DI (n=354, 157)
|
-0.73 Units on a Scale
Standard Error 0.04
|
-0.73 Units on a Scale
Standard Error 0.05
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 533 for Participants Continuing in the OL Period
Dressing and Grooming (n=355, 156)
|
-0.81 Units on a Scale
Standard Error 0.05
|
-0.85 Units on a Scale
Standard Error 0.06
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 533 for Participants Continuing in the OL Period
Arising (n=355, 157)
|
-0.76 Units on a Scale
Standard Error 0.05
|
-0.86 Units on a Scale
Standard Error 0.07
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 533 for Participants Continuing in the OL Period
Eating (n=355, 156)
|
-0.83 Units on a Scale
Standard Error 0.05
|
-0.74 Units on a Scale
Standard Error 0.07
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 533 for Participants Continuing in the OL Period
Walking (n=351, 156)
|
-0.64 Units on a Scale
Standard Error 0.05
|
-0.69 Units on a Scale
Standard Error 0.07
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 533 for Participants Continuing in the OL Period
Hygiene (n=354, 157)
|
-0.64 Units on a Scale
Standard Error 0.05
|
-0.57 Units on a Scale
Standard Error 0.08
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 533 for Participants Continuing in the OL Period
Activities (n=354, 157)
|
-0.70 Units on a Scale
Standard Error 0.05
|
-0.68 Units on a Scale
Standard Error 0.08
|
SECONDARY outcome
Timeframe: BL (Day 0), Day 617Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.
Outcome measures
| Measure |
ABA + MTX DB
n=376 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=160 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 617 Cohort of Participants Continuing in the OL Period
Walking (n=348, 154)
|
1.40 Units on a Scale
Standard Deviation 0.83
|
1.37 Units on a Scale
Standard Deviation 0.78
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 617 Cohort of Participants Continuing in the OL Period
Hygiene (n=348, 155)
|
1.93 Units on a Scale
Standard Deviation 0.90
|
1.92 Units on a Scale
Standard Deviation 0.89
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 617 Cohort of Participants Continuing in the OL Period
Reaching (n=348, 155)
|
1.96 Units on a Scale
Standard Deviation 0.86
|
1.97 Units on a Scale
Standard Deviation 0.81
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 617 Cohort of Participants Continuing in the OL Period
Gripping (n=348, 154)
|
1.82 Units on a Scale
Standard Deviation 0.75
|
1.91 Units on a Scale
Standard Deviation 0.67
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 617 Cohort of Participants Continuing in the OL Period
Activities (n=348, 155)
|
1.88 Units on a Scale
Standard Deviation 0.79
|
1.87 Units on a Scale
Standard Deviation 0.83
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 617 Cohort of Participants Continuing in the OL Period
HAQ DI (n=348, 154)
|
1.69 Units on a Scale
Standard Deviation 0.64
|
1.71 Units on a Scale
Standard Deviation 0.59
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 617 Cohort of Participants Continuing in the OL Period
Dressing and Grooming (n=348, 155)
|
1.47 Units on a Scale
Standard Deviation 0.75
|
1.50 Units on a Scale
Standard Deviation 0.73
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 617 Cohort of Participants Continuing in the OL Period
Arising (n=348, 155)
|
1.42 Units on a Scale
Standard Deviation 0.84
|
1.46 Units on a Scale
Standard Deviation 0.79
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 617 Cohort of Participants Continuing in the OL Period
Eating (n=348, 155)
|
1.64 Units on a Scale
Standard Deviation 0.97
|
1.68 Units on a Scale
Standard Deviation 0.84
|
SECONDARY outcome
Timeframe: BL (Day 0), Day 617Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.
Outcome measures
| Measure |
ABA + MTX DB
n=376 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=160 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 617 for Participants Continuing in the OL Period
HAQ DI (n=348, 154)
|
-0.73 Units on a Scale
Standard Error 0.04
|
-0.74 Units on a Scale
Standard Error 0.06
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 617 for Participants Continuing in the OL Period
Dressing and Grooming (n=348, 155)
|
-0.76 Units on a Scale
Standard Error 0.05
|
-0.82 Units on a Scale
Standard Error 0.07
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 617 for Participants Continuing in the OL Period
Arising (n=348, 155)
|
-0.84 Units on a Scale
Standard Error 0.05
|
-0.81 Units on a Scale
Standard Error 0.07
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 617 for Participants Continuing in the OL Period
Eating (n=348, 155)
|
-0.80 Units on a Scale
Standard Error 0.05
|
-0.75 Units on a Scale
Standard Error 0.07
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 617 for Participants Continuing in the OL Period
Walking (n=348, 154)
|
-0.66 Units on a Scale
Standard Error 0.05
|
-0.67 Units on a Scale
Standard Error 0.07
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 617 for Participants Continuing in the OL Period
Hygiene (n=348, 155)
|
-0.56 Units on a Scale
Standard Error 0.05
|
-0.66 Units on a Scale
Standard Error 0.08
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 617 for Participants Continuing in the OL Period
Reaching (n=348, 155)
|
-0.81 Units on a Scale
Standard Error 0.05
|
-0.80 Units on a Scale
Standard Error 0.08
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 617 for Participants Continuing in the OL Period
Gripping (n=348, 154)
|
-0.75 Units on a Scale
Standard Error 0.05
|
-0.68 Units on a Scale
Standard Error 0.08
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 617 for Participants Continuing in the OL Period
Activities (n=348, 155)
|
-0.71 Units on a Scale
Standard Error 0.05
|
-0.76 Units on a Scale
Standard Error 0.09
|
SECONDARY outcome
Timeframe: BL (Day 0), Day 729Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.
Outcome measures
| Measure |
ABA + MTX DB
n=376 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=160 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 729 Cohort of Participants Continuing in the OL Period
HAQ DI (n=337, 148)
|
1.69 Units on a Scale
Standard Deviation 0.64
|
1.72 Units on a Scale
Standard Deviation 0.60
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 729 Cohort of Participants Continuing in the OL Period
Dressing and Grooming (n=337, 148)
|
1.48 Units on a Scale
Standard Deviation 0.76
|
1.51 Units on a Scale
Standard Deviation 0.74
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 729 Cohort of Participants Continuing in the OL Period
Arising (n=338, 148)
|
1.41 Units on a Scale
Standard Deviation 0.83
|
1.45 Units on a Scale
Standard Deviation 0.79
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 729 Cohort of Participants Continuing in the OL Period
Eating (n= 337, 148)
|
1.63 Units on a Scale
Standard Deviation 0.98
|
1.72 Units on a Scale
Standard Deviation 0.83
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 729 Cohort of Participants Continuing in the OL Period
Walking (n=338, 147)
|
1.41 Units on a Scale
Standard Deviation 0.84
|
1.37 Units on a Scale
Standard Deviation 0.78
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 729 Cohort of Participants Continuing in the OL Period
Hygiene (n=338, 148)
|
1.93 Units on a Scale
Standard Deviation 0.89
|
1.93 Units on a Scale
Standard Deviation 0.89
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 729 Cohort of Participants Continuing in the OL Period
Reaching (n=336, 148)
|
1.95 Units on a Scale
Standard Deviation 0.87
|
1.97 Units on a Scale
Standard Deviation 0.81
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 729 Cohort of Participants Continuing in the OL Period
Gripping (n=338, 148)
|
1.81 Units on a Scale
Standard Deviation 0.77
|
1.92 Units on a Scale
Standard Deviation 0.65
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 729 Cohort of Participants Continuing in the OL Period
Activities (n=338, 148)
|
1.86 Units on a Scale
Standard Deviation 0.79
|
1.89 Units on a Scale
Standard Deviation 0.83
|
SECONDARY outcome
Timeframe: BL (Day 0), Day 729Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.
Outcome measures
| Measure |
ABA + MTX DB
n=376 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=160 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 729 for Participants Continuing in the OL Period
HAQ DI (n=337, 148)
|
-0.74 Units on a Scale
Standard Error 0.04
|
-0.72 Units on a Scale
Standard Error 0.06
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 729 for Participants Continuing in the OL Period
Dressing and Grooming (n=337, 148)
|
-0.82 Units on a Scale
Standard Error 0.05
|
-0.91 Units on a Scale
Standard Error 0.07
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 729 for Participants Continuing in the OL Period
Arising (n=338, 148)
|
-0.80 Units on a Scale
Standard Error 0.05
|
-0.82 Units on a Scale
Standard Error 0.08
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 729 for Participants Continuing in the OL Period
Eating (n= 337, 148)
|
-0.81 Units on a Scale
Standard Error 0.05
|
-0.72 Units on a Scale
Standard Error 0.08
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 729 for Participants Continuing in the OL Period
Walking (n=338, 147)
|
-0.68 Units on a Scale
Standard Error 0.05
|
-0.63 Units on a Scale
Standard Error 0.07
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 729 for Participants Continuing in the OL Period
Hygiene (n=338, 148)
|
-0.53 Units on a Scale
Standard Error 0.05
|
-0.62 Units on a Scale
Standard Error 0.09
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 729 for Participants Continuing in the OL Period
Reaching (n=336, 148)
|
-0.79 Units on a Scale
Standard Error 0.05
|
-0.73 Units on a Scale
Standard Error 0.08
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 729 for Participants Continuing in the OL Period
Gripping (n=338, 148)
|
-0.75 Units on a Scale
Standard Error 0.05
|
-0.62 Units on a Scale
Standard Error 0.08
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 729 for Participants Continuing in the OL Period
Activities (n=338, 148)
|
-0.72 Units on a Scale
Standard Error 0.05
|
-0.72 Units on a Scale
Standard Error 0.09
|
SECONDARY outcome
Timeframe: BL (Day 0), Day 813Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.
Outcome measures
| Measure |
ABA + MTX DB
n=376 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=160 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 813 Cohort of Participants Continuing in the OL Period
HAQ DI (n=325, 146)
|
1.70 Units on a Scale
Standard Deviation 0.64
|
1.72 Units on a Scale
Standard Deviation 0.60
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 813 Cohort of Participants Continuing in the OL Period
Dressing and Grooming (n=325, 147)
|
1.48 Units on a Scale
Standard Deviation 0.75
|
1.51 Units on a Scale
Standard Deviation 0.74
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 813 Cohort of Participants Continuing in the OL Period
Arising (n=325, 147)
|
1.42 Units on a Scale
Standard Deviation 0.83
|
1.46 Units on a Scale
Standard Deviation 0.80
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 813 Cohort of Participants Continuing in the OL Period
Eating (n=325, 147)
|
1.65 Units on a Scale
Standard Deviation 0.98
|
1.70 Units on a Scale
Standard Deviation 0.83
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 813 Cohort of Participants Continuing in the OL Period
Walking (n=324, 146)
|
1.42 Units on a Scale
Standard Deviation 0.83
|
1.38 Units on a Scale
Standard Deviation 0.78
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 813 Cohort of Participants Continuing in the OL Period
Hygiene (n=325, 146)
|
1.95 Units on a Scale
Standard Deviation 0.89
|
1.94 Units on a Scale
Standard Deviation 0.90
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 813 Cohort of Participants Continuing in the OL Period
Reaching (n=324, 146)
|
1.97 Units on a Scale
Standard Deviation 0.87
|
1.97 Units on a Scale
Standard Deviation 0.82
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 813 Cohort of Participants Continuing in the OL Period
Gripping (n=325, 146)
|
1.81 Units on a Scale
Standard Deviation 0.77
|
1.92 Units on a Scale
Standard Deviation 0.66
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 813 Cohort of Participants Continuing in the OL Period
Activities (n=324, 146)
|
1.87 Units on a Scale
Standard Deviation 0.79
|
1.87 Units on a Scale
Standard Deviation 0.84
|
SECONDARY outcome
Timeframe: BL (Day 0), Day 813Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.
Outcome measures
| Measure |
ABA + MTX DB
n=376 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=160 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 813 for Participants Continuing in the OL Period
HAQ DI (n=325, 146)
|
-0.77 Units on a Scale
Standard Error 0.04
|
-0.71 Units on a Scale
Standard Error 0.06
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 813 for Participants Continuing in the OL Period
Dressing and Grooming (n=325, 147)
|
-0.82 Units on a Scale
Standard Error 0.06
|
-0.87 Units on a Scale
Standard Error 0.07
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 813 for Participants Continuing in the OL Period
Arising (n=325, 147)
|
-0.80 Units on a Scale
Standard Error 0.05
|
-0.78 Units on a Scale
Standard Error 0.08
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 813 for Participants Continuing in the OL Period
Eating (n=325, 147)
|
-0.88 Units on a Scale
Standard Error 0.06
|
-0.72 Units on a Scale
Standard Error 0.08
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 813 for Participants Continuing in the OL Period
Walking (n=324, 146)
|
-0.69 Units on a Scale
Standard Error 0.05
|
-0.66 Units on a Scale
Standard Error 0.07
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 813 for Participants Continuing in the OL Period
Hygiene (n=325, 146)
|
-0.58 Units on a Scale
Standard Error 0.06
|
-0.53 Units on a Scale
Standard Error 0.09
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 813 for Participants Continuing in the OL Period
Reaching (n=324, 146)
|
-0.85 Units on a Scale
Standard Error 0.05
|
-0.72 Units on a Scale
Standard Error 0.08
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 813 for Participants Continuing in the OL Period
Gripping (n=325, 146)
|
-0.76 Units on a Scale
Standard Error 0.05
|
-0.77 Units on a Scale
Standard Error 0.08
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 813 for Participants Continuing in the OL Period
Activities (n=324, 146)
|
-0.76 Units on a Scale
Standard Error 0.05
|
-0.71 Units on a Scale
Standard Error 0.08
|
SECONDARY outcome
Timeframe: BL (Day 0), Day 897Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.
Outcome measures
| Measure |
ABA + MTX DB
n=376 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=160 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 897 Cohort of Participants Continuing in the OL Period
HAQ DI (n=318, 140)
|
1.69 Units on a Scale
Standard Deviation 0.64
|
1.72 Units on a Scale
Standard Deviation 0.60
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 897 Cohort of Participants Continuing in the OL Period
Dressing and Grooming (n=319, 140)
|
1.47 Units on a Scale
Standard Deviation 0.76
|
1.52 Units on a Scale
Standard Deviation 0.75
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 897 Cohort of Participants Continuing in the OL Period
Arising (n=319, 140)
|
1.43 Units on a Scale
Standard Deviation 0.84
|
1.46 Units on a Scale
Standard Deviation 0.80
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 897 Cohort of Participants Continuing in the OL Period
Eating (n=319, 140)
|
1.63 Units on a Scale
Standard Deviation 0.99
|
1.71 Units on a Scale
Standard Deviation 0.84
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 897 Cohort of Participants Continuing in the OL Period
Walking (n=319, 138)
|
1.41 Units on a Scale
Standard Deviation 0.84
|
1.38 Units on a Scale
Standard Deviation 0.79
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 897 Cohort of Participants Continuing in the OL Period
Hygiene (n=319, 140)
|
1.95 Units on a Scale
Standard Deviation 0.90
|
1.94 Units on a Scale
Standard Deviation 0.90
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 897 Cohort of Participants Continuing in the OL Period
Reaching (n=319, 140)
|
1.96 Units on a Scale
Standard Deviation 0.87
|
2.01 Units on a Scale
Standard Deviation 0.80
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 897 Cohort of Participants Continuing in the OL Period
Gripping (n=319, 140)
|
1.80 Units on a Scale
Standard Deviation 0.76
|
1.92 Units on a Scale
Standard Deviation 0.67
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 897 Cohort of Participants Continuing in the OL Period
Activities (n=319, 140)
|
1.87 Units on a Scale
Standard Deviation 0.79
|
1.87 Units on a Scale
Standard Deviation 0.85
|
SECONDARY outcome
Timeframe: BL (Day 0), Day 897Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.
Outcome measures
| Measure |
ABA + MTX DB
n=376 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=160 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 897 for Participants Continuing in the OL Period
HAQ DI (n=318, 140)
|
-0.76 Units on a Scale
Standard Error 0.04
|
-0.74 Units on a Scale
Standard Error 0.06
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 897 for Participants Continuing in the OL Period
Dressing and Grooming (n=319, 140)
|
-0.86 Units on a Scale
Standard Error 0.05
|
-0.90 Units on a Scale
Standard Error 0.08
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 897 for Participants Continuing in the OL Period
Arising (n=319, 140)
|
-0.81 Units on a Scale
Standard Error 0.05
|
-0.87 Units on a Scale
Standard Error 0.07
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 897 for Participants Continuing in the OL Period
Eating (n=319, 140)
|
-0.88 Units on a Scale
Standard Error 0.05
|
-0.78 Units on a Scale
Standard Error 0.08
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 897 for Participants Continuing in the OL Period
Walking (n=319, 138)
|
-0.69 Units on a Scale
Standard Error 0.05
|
-0.67 Units on a Scale
Standard Error 0.07
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 897 for Participants Continuing in the OL Period
Hygiene (n=319, 140)
|
-0.60 Units on a Scale
Standard Error 0.06
|
-0.54 Units on a Scale
Standard Error 0.09
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 897 for Participants Continuing in the OL Period
Reaching (n=319, 140)
|
-0.82 Units on a Scale
Standard Error 0.06
|
-0.74 Units on a Scale
Standard Error 0.08
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 897 for Participants Continuing in the OL Period
Gripping (n=319, 140)
|
-0.74 Units on a Scale
Standard Error 0.06
|
-0.74 Units on a Scale
Standard Error 0.08
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 897 for Participants Continuing in the OL Period
Activities (n=319, 140)
|
-0.69 Units on a Scale
Standard Error 0.05
|
-0.71 Units on a Scale
Standard Error 0.09
|
SECONDARY outcome
Timeframe: BL (Day 0), Day 981Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.
Outcome measures
| Measure |
ABA + MTX DB
n=376 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=160 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 981 Cohort of Participants Continuing in the OL Period
HAQ DI (n=312, 137)
|
1.69 Units on a Scale
Standard Deviation 0.65
|
1.72 Units on a Scale
Standard Deviation 0.60
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 981 Cohort of Participants Continuing in the OL Period
Dressing and Grooming (n=312, 137)
|
1.47 Units on a Scale
Standard Deviation 0.76
|
1.52 Units on a Scale
Standard Deviation 0.75
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 981 Cohort of Participants Continuing in the OL Period
Arising (n=312, 137)
|
1.42 Units on a Scale
Standard Deviation 0.84
|
1.45 Units on a Scale
Standard Deviation 0.79
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 981 Cohort of Participants Continuing in the OL Period
Eating (n=312, 137)
|
1.63 Units on a Scale
Standard Deviation 0.99
|
1.70 Units on a Scale
Standard Deviation 0.83
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 981 Cohort of Participants Continuing in the OL Period
Walking (n=308, 136)
|
1.41 Units on a Scale
Standard Deviation 0.84
|
1.37 Units on a Scale
Standard Deviation 0.79
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 981 Cohort of Participants Continuing in the OL Period
Hygiene (n=312, 137)
|
1.94 Units on a Scale
Standard Deviation 0.89
|
1.93 Units on a Scale
Standard Deviation 0.90
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 981 Cohort of Participants Continuing in the OL Period
Reaching (n=312, 137)
|
1.97 Units on a Scale
Standard Deviation 0.86
|
1.99 Units on a Scale
Standard Deviation 0.80
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 981 Cohort of Participants Continuing in the OL Period
Gripping (n=312, 137)
|
1.80 Units on a Scale
Standard Deviation 0.78
|
1.92 Units on a Scale
Standard Deviation 0.68
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 981 Cohort of Participants Continuing in the OL Period
Activities (n=312, 137)
|
1.87 Units on a Scale
Standard Deviation 0.79
|
1.85 Units on a Scale
Standard Deviation 0.84
|
SECONDARY outcome
Timeframe: BL (Day 0), Day 981Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis.
The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.
Outcome measures
| Measure |
ABA + MTX DB
n=376 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=160 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 981 for Participants Continuing in the OL Period
HAQ DI (n=312, 137)
|
-0.74 Units on a Scale
Standard Error 0.04
|
-0.69 Units on a Scale
Standard Error 0.06
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 981 for Participants Continuing in the OL Period
Dressing and Grooming (n=312, 137)
|
-0.80 Units on a Scale
Standard Error 0.05
|
-0.86 Units on a Scale
Standard Error 0.08
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 981 for Participants Continuing in the OL Period
Arising (n=312, 137)
|
-0.82 Units on a Scale
Standard Error 0.05
|
-0.77 Units on a Scale
Standard Error 0.08
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 981 for Participants Continuing in the OL Period
Eating (n=312, 137)
|
-0.84 Units on a Scale
Standard Error 0.06
|
-0.64 Units on a Scale
Standard Error 0.08
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 981 for Participants Continuing in the OL Period
Walking (n=308, 136)
|
-0.66 Units on a Scale
Standard Error 0.05
|
-0.63 Units on a Scale
Standard Error 0.08
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 981 for Participants Continuing in the OL Period
Hygiene (n=312, 137)
|
-0.54 Units on a Scale
Standard Error 0.06
|
-0.49 Units on a Scale
Standard Error 0.09
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 981 for Participants Continuing in the OL Period
Reaching (n=312, 137)
|
-0.82 Units on a Scale
Standard Error 0.05
|
-0.75 Units on a Scale
Standard Error 0.09
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 981 for Participants Continuing in the OL Period
Gripping (n=312, 137)
|
-0.68 Units on a Scale
Standard Error 0.06
|
-0.74 Units on a Scale
Standard Error 0.08
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 981 for Participants Continuing in the OL Period
Activities (n=312, 137)
|
-0.74 Units on a Scale
Standard Error 0.05
|
-0.64 Units on a Scale
Standard Error 0.09
|
SECONDARY outcome
Timeframe: BL (Day 0), Day 1,093Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.
Outcome measures
| Measure |
ABA + MTX DB
n=376 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=160 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,093 Cohort of Participants Continuing in the OL Period
HAQ DI (n=308, 137)
|
1.69 Units on a Scale
Standard Error 0.64
|
1.72 Units on a Scale
Standard Error 0.60
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,093 Cohort of Participants Continuing in the OL Period
Dressing and Grooming (n=310, 138)
|
1.47 Units on a Scale
Standard Error 0.75
|
1.51 Units on a Scale
Standard Error 0.75
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,093 Cohort of Participants Continuing in the OL Period
Arising (n=309, 138)
|
1.41 Units on a Scale
Standard Error 0.84
|
1.45 Units on a Scale
Standard Error 0.79
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,093 Cohort of Participants Continuing in the OL Period
Eating (n=309, 138)
|
1.62 Units on a Scale
Standard Error 0.98
|
1.69 Units on a Scale
Standard Error 0.84
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,093 Cohort of Participants Continuing in the OL Period
Walking (n=308, 137)
|
1.41 Units on a Scale
Standard Error 0.83
|
1.36 Units on a Scale
Standard Error 0.78
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,093 Cohort of Participants Continuing in the OL Period
Hygiene (n=310, 137)
|
1.94 Units on a Scale
Standard Error 0.89
|
1.92 Units on a Scale
Standard Error 0.90
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,093 Cohort of Participants Continuing in the OL Period
Reaching (n=310, 137)
|
1.96 Units on a Scale
Standard Error 0.87
|
1.99 Units on a Scale
Standard Error 0.80
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,093 Cohort of Participants Continuing in the OL Period
Gripping (n=310, 137)
|
1.79 Units on a Scale
Standard Error 0.77
|
1.92 Units on a Scale
Standard Error 0.68
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,093 Cohort of Participants Continuing in the OL Period
Activities (n=310, 137)
|
1.87 Units on a Scale
Standard Error 0.79
|
1.85 Units on a Scale
Standard Error 0.84
|
SECONDARY outcome
Timeframe: BL (Day 0), Day 1,093Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.
Outcome measures
| Measure |
ABA + MTX DB
n=376 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=160 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,093 for Participants Continuing in the OL Period
HAQ DI (n=308, 137)
|
-0.74 Units on a Scale
Standard Error 0.04
|
-0.76 Units on a Scale
Standard Error 0.06
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,093 for Participants Continuing in the OL Period
Dressing and Grooming (n=310, 138)
|
-0.80 Units on a Scale
Standard Error 0.05
|
-0.91 Units on a Scale
Standard Error 0.07
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,093 for Participants Continuing in the OL Period
Arising (n=309, 138)
|
-0.82 Units on a Scale
Standard Error 0.05
|
-0.87 Units on a Scale
Standard Error 0.08
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,093 for Participants Continuing in the OL Period
Eating (n=309, 138)
|
-0.81 Units on a Scale
Standard Error 0.06
|
-0.70 Units on a Scale
Standard Error 0.08
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,093 for Participants Continuing in the OL Period
Walking (n=308, 137)
|
-0.70 Units on a Scale
Standard Error 0.05
|
-0.69 Units on a Scale
Standard Error 0.08
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,093 for Participants Continuing in the OL Period
Hygiene (n=310, 137)
|
-0.58 Units on a Scale
Standard Error 0.05
|
-0.59 Units on a Scale
Standard Error 0.09
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,093 for Participants Continuing in the OL Period
Reaching (n=310, 137)
|
-0.79 Units on a Scale
Standard Error 0.05
|
-0.81 Units on a Scale
Standard Error 0.08
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,093 for Participants Continuing in the OL Period
Gripping (n=310, 137)
|
-0.71 Units on a Scale
Standard Error 0.06
|
-0.74 Units on a Scale
Standard Error 0.08
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,093 for Participants Continuing in the OL Period
Activities (n=310, 137)
|
-0.71 Units on a Scale
Standard Error 0.05
|
-0.73 Units on a Scale
Standard Error 0.09
|
SECONDARY outcome
Timeframe: BL (Day 0), Day 1,177Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.
Outcome measures
| Measure |
ABA + MTX DB
n=376 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=160 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,177 Cohort of Participants Continuing in the OL Period
HAQ DI (n=274, 125)
|
1.69 Units on a Scale
Standard Deviation 0.63
|
1.71 Units on a Scale
Standard Deviation 0.61
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,177 Cohort of Participants Continuing in the OL Period
Dressing and Grooming (n=274, 125)
|
1.47 Units on a Scale
Standard Deviation 0.76
|
1.53 Units on a Scale
Standard Deviation 0.77
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,177 Cohort of Participants Continuing in the OL Period
Arising (n=274, 125)
|
1.39 Units on a Scale
Standard Deviation 0.81
|
1.45 Units on a Scale
Standard Deviation 0.80
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,177 Cohort of Participants Continuing in the OL Period
Eating (n=274, 125)
|
1.68 Units on a Scale
Standard Deviation 0.97
|
1.70 Units on a Scale
Standard Deviation 0.85
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,177 Cohort of Participants Continuing in the OL Period
Walking (n=272, 122)
|
1.37 Units on a Scale
Standard Deviation 0.83
|
1.37 Units on a Scale
Standard Deviation 0.78
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,177 Cohort of Participants Continuing in the OL Period
Hygiene (n=275, 124)
|
1.94 Units on a Scale
Standard Deviation 0.89
|
1.90 Units on a Scale
Standard Deviation 0.91
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,177 Cohort of Participants Continuing in the OL Period
Reaching (n=275, 125)
|
1.96 Units on a Scale
Standard Deviation 0.85
|
1.99 Units on a Scale
Standard Deviation 0.80
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,177 Cohort of Participants Continuing in the OL Period
Gripping (n=275, 125)
|
1.83 Units on a Scale
Standard Deviation 0.75
|
1.91 Units on a Scale
Standard Deviation 0.68
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,177 Cohort of Participants Continuing in the OL Period
Activities (n=275, 125)
|
1.87 Units on a Scale
Standard Deviation 0.80
|
1.85 Units on a Scale
Standard Deviation 0.86
|
SECONDARY outcome
Timeframe: BL (Day 0), Day 1,177Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.
Outcome measures
| Measure |
ABA + MTX DB
n=376 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=160 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,177 for Participants Continuing in the OL Period
HAQ DI (n=274, 125)
|
-0.76 Units on a Scale
Standard Error 0.04
|
-0.74 Units on a Scale
Standard Error 0.07
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,177 for Participants Continuing in the OL Period
Dressing and Grooming (n=274, 125)
|
-0.82 Units on a Scale
Standard Error 0.05
|
-0.86 Units on a Scale
Standard Error 0.09
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,177 for Participants Continuing in the OL Period
Arising (n=274, 125)
|
-0.74 Units on a Scale
Standard Error 0.06
|
-0.79 Units on a Scale
Standard Error 0.09
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,177 for Participants Continuing in the OL Period
Eating (n=274, 125)
|
-0.92 Units on a Scale
Standard Error 0.06
|
-0.74 Units on a Scale
Standard Error 0.09
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,177 for Participants Continuing in the OL Period
Walking (n=272, 122)
|
-0.63 Units on a Scale
Standard Error 0.06
|
-0.66 Units on a Scale
Standard Error 0.08
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,177 for Participants Continuing in the OL Period
Hygiene (n=275, 124)
|
-0.57 Units on a Scale
Standard Error 0.06
|
-0.48 Units on a Scale
Standard Error 0.10
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,177 for Participants Continuing in the OL Period
Reaching (n=275, 125)
|
-0.82 Units on a Scale
Standard Error 0.06
|
-0.84 Units on a Scale
Standard Error 0.09
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,177 for Participants Continuing in the OL Period
Gripping (n=275, 125)
|
-0.80 Units on a Scale
Standard Error 0.06
|
-0.80 Units on a Scale
Standard Error 0.09
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,177 for Participants Continuing in the OL Period
Activities (n=275, 125)
|
-0.75 Units on a Scale
Standard Error 0.06
|
-0.76 Units on a Scale
Standard Error 0.10
|
SECONDARY outcome
Timeframe: BL (Day 0), Day 1,261Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.
Outcome measures
| Measure |
ABA + MTX DB
n=376 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=160 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,261 Cohort of Participants Continuing in the OL Period
HAQ DI (n=292, 134)
|
1.69 Units on a Scale
Standard Error 0.65
|
1.70 Units on a Scale
Standard Error 0.60
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,261 Cohort of Participants Continuing in the OL Period
Dressing and Grooming (n=292, 135)
|
1.47 Units on a Scale
Standard Error 0.77
|
1.51 Units on a Scale
Standard Error 0.75
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,261 Cohort of Participants Continuing in the OL Period
Arising (n=292, 135)
|
1.42 Units on a Scale
Standard Error 0.85
|
1.44 Units on a Scale
Standard Error 0.79
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,261 Cohort of Participants Continuing in the OL Period
Eating (n=292, 135)
|
1.64 Units on a Scale
Standard Error 1.00
|
1.69 Units on a Scale
Standard Error 0.83
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,261 Cohort of Participants Continuing in the OL Period
Walking (n=290, 134)
|
1.40 Units on a Scale
Standard Error 0.83
|
1.36 Units on a Scale
Standard Error 0.79
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,261 Cohort of Participants Continuing in the OL Period
Hygiene (n=292, 134)
|
1.96 Units on a Scale
Standard Error 0.90
|
1.92 Units on a Scale
Standard Error 0.90
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,261 Cohort of Participants Continuing in the OL Period
Reaching (n=292, 134)
|
1.97 Units on a Scale
Standard Error 0.87
|
1.97 Units on a Scale
Standard Error 0.79
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,261 Cohort of Participants Continuing in the OL Period
Gripping (n=292, 134)
|
1.79 Units on a Scale
Standard Error 0.77
|
1.91 Units on a Scale
Standard Error 0.68
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,261 Cohort of Participants Continuing in the OL Period
Activities (n=292, 133)
|
1.87 Units on a Scale
Standard Error 0.81
|
1.83 Units on a Scale
Standard Error 0.85
|
SECONDARY outcome
Timeframe: BL (Day 0), Day 1,261Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.
Outcome measures
| Measure |
ABA + MTX DB
n=376 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=160 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,261 for Participants Continuing in the OL Period
HAQ DI (n=292, 134)
|
-0.74 Units on a Scale
Standard Error 0.04
|
-0.73 Units on a Scale
Standard Error 0.06
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,261 for Participants Continuing in the OL Period
Dressing and Grooming (n=292, 135)
|
-0.81 Units on a Scale
Standard Error 0.05
|
-0.91 Units on a Scale
Standard Error 0.08
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,261 for Participants Continuing in the OL Period
Arising (n=292, 135)
|
-0.82 Units on a Scale
Standard Error 0.05
|
-0.82 Units on a Scale
Standard Error 0.08
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,261 for Participants Continuing in the OL Period
Eating (n=292, 135)
|
-0.85 Units on a Scale
Standard Error 0.06
|
-0.73 Units on a Scale
Standard Error 0.08
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,261 for Participants Continuing in the OL Period
Walking (n=290, 134)
|
-0.66 Units on a Scale
Standard Error 0.06
|
-0.63 Units on a Scale
Standard Error 0.08
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,261 for Participants Continuing in the OL Period
Hygiene (n=292, 134)
|
-0.52 Units on a Scale
Standard Error 0.06
|
-0.54 Units on a Scale
Standard Error 0.09
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,261 for Participants Continuing in the OL Period
Reaching (n=292, 134)
|
-0.83 Units on a Scale
Standard Error 0.06
|
-0.80 Units on a Scale
Standard Error 0.09
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,261 for Participants Continuing in the OL Period
Gripping (n=292, 134)
|
-0.68 Units on a Scale
Standard Error 0.06
|
-0.70 Units on a Scale
Standard Error 0.09
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,261 for Participants Continuing in the OL Period
Activities (n=292, 133)
|
-0.75 Units on a Scale
Standard Error 0.05
|
-0.68 Units on a Scale
Standard Error 0.10
|
SECONDARY outcome
Timeframe: BL (Day 0), Day 1,345Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.
Outcome measures
| Measure |
ABA + MTX DB
n=376 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=160 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,345 Cohort of Participants Continuing in the OL Period
HAQ DI (n=152, 62)
|
1.65 Units on a Scale
Standard Deviation 0.63
|
1.73 Units on a Scale
Standard Deviation 0.58
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,345 Cohort of Participants Continuing in the OL Period
Dressing and Grooming (n=152, 62)
|
1.45 Units on a Scale
Standard Deviation 0.73
|
1.50 Units on a Scale
Standard Deviation 0.70
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,345 Cohort of Participants Continuing in the OL Period
Arising (n=152, 62)
|
1.34 Units on a Scale
Standard Deviation 0.79
|
1.44 Units on a Scale
Standard Deviation 0.74
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,345 Cohort of Participants Continuing in the OL Period
Eating (n=152, 62)
|
1.63 Units on a Scale
Standard Deviation 0.97
|
1.69 Units on a Scale
Standard Deviation 0.84
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,345 Cohort of Participants Continuing in the OL Period
Walking (n=151, 62)
|
1.32 Units on a Scale
Standard Deviation 0.80
|
1.35 Units on a Scale
Standard Deviation 0.79
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,345 Cohort of Participants Continuing in the OL Period
Hygiene (n=152, 62)
|
1.82 Units on a Scale
Standard Deviation 0.89
|
2.05 Units on a Scale
Standard Deviation 0.86
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,345 Cohort of Participants Continuing in the OL Period
Reaching (n=152, 62)
|
1.98 Units on a Scale
Standard Deviation 0.82
|
2.06 Units on a Scale
Standard Deviation 0.74
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,345 Cohort of Participants Continuing in the OL Period
Gripping (n=152, 62)
|
1.77 Units on a Scale
Standard Deviation 0.74
|
1.94 Units on a Scale
Standard Deviation 0.60
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,345 Cohort of Participants Continuing in the OL Period
Activities (n=152, 62)
|
1.88 Units on a Scale
Standard Deviation 0.79
|
1.79 Units on a Scale
Standard Deviation 0.77
|
SECONDARY outcome
Timeframe: BL (Day 0), Day 1,345Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.
Outcome measures
| Measure |
ABA + MTX DB
n=376 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=160 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,345 for Participants Continuing in the OL Period
HAQ DI (n=152, 62)
|
-0.69 Units on a Scale
Standard Error 0.06
|
-0.73 Units on a Scale
Standard Error 0.09
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,345 for Participants Continuing in the OL Period
Dressing and Grooming (n=152, 62)
|
-0.74 Units on a Scale
Standard Error 0.07
|
-0.81 Units on a Scale
Standard Error 0.11
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,345 for Participants Continuing in the OL Period
Arising (n=152, 62)
|
-0.68 Units on a Scale
Standard Error 0.08
|
-0.84 Units on a Scale
Standard Error 0.12
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,345 for Participants Continuing in the OL Period
Eating (n=152, 62)
|
-0.84 Units on a Scale
Standard Error 0.08
|
-0.68 Units on a Scale
Standard Error 0.13
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,345 for Participants Continuing in the OL Period
Walking (n=151, 62)
|
-0.61 Units on a Scale
Standard Error 0.07
|
-0.60 Units on a Scale
Standard Error 0.13
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,345 for Participants Continuing in the OL Period
Hygiene (n=152, 62)
|
-0.46 Units on a Scale
Standard Error 0.09
|
-0.71 Units on a Scale
Standard Error 0.13
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,345 for Participants Continuing in the OL Period
Reaching (n=152, 62)
|
-0.84 Units on a Scale
Standard Error 0.08
|
-0.76 Units on a Scale
Standard Error 0.13
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,345 for Participants Continuing in the OL Period
Gripping (n=152, 62)
|
-0.63 Units on a Scale
Standard Error 0.08
|
-0.82 Units on a Scale
Standard Error 0.11
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,345 for Participants Continuing in the OL Period
Activities (n=152, 62)
|
-0.73 Units on a Scale
Standard Error 0.08
|
-0.60 Units on a Scale
Standard Error 0.12
|
SECONDARY outcome
Timeframe: BL (Day 0), Day 1,457Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.
Outcome measures
| Measure |
ABA + MTX DB
n=376 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=160 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,457 Cohort of Participants Continuing in the OL Period
HAQ DI (n=289, 129)
|
1.70 Units on a Scale
Standard Deviation 0.65
|
1.71 Units on a Scale
Standard Deviation 0.60
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,457 Cohort of Participants Continuing in the OL Period
Dressing and Grooming (n=289, 129)
|
1.48 Units on a Scale
Standard Deviation 0.76
|
1.51 Units on a Scale
Standard Deviation 0.74
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,457 Cohort of Participants Continuing in the OL Period
Arising (n=289, 129)
|
1.43 Units on a Scale
Standard Deviation 0.85
|
1.44 Units on a Scale
Standard Deviation 0.78
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,457 Cohort of Participants Continuing in the OL Period
Eating (n=289, 129)
|
1.64 Units on a Scale
Standard Deviation 1.00
|
1.70 Units on a Scale
Standard Deviation 0.83
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,457 Cohort of Participants Continuing in the OL Period
Walking (n=287, 126)
|
1.42 Units on a Scale
Standard Deviation 0.83
|
1.37 Units on a Scale
Standard Deviation 0.78
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,457 Cohort of Participants Continuing in the OL Period
Hygiene (n=289, 129)
|
1.95 Units on a Scale
Standard Deviation 0.89
|
1.91 Units on a Scale
Standard Deviation 0.91
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,457 Cohort of Participants Continuing in the OL Period
Reaching (n=289, 129)
|
1.97 Units on a Scale
Standard Deviation 0.86
|
1.99 Units on a Scale
Standard Deviation 0.79
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,457 Cohort of Participants Continuing in the OL Period
Gripping (n=289, 129)
|
1.80 Units on a Scale
Standard Deviation 0.77
|
1.91 Units on a Scale
Standard Deviation 0.69
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,457 Cohort of Participants Continuing in the OL Period
Activities (n=289, 129)
|
1.88 Units on a Scale
Standard Deviation 0.80
|
1.84 Units on a Scale
Standard Deviation 0.84
|
SECONDARY outcome
Timeframe: BL (Day 0), Day 1,457Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.
Outcome measures
| Measure |
ABA + MTX DB
n=376 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=160 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,457 for Participants Continuing in the OL Period
HAQ DI (n=289, 129)
|
-0.77 Units on a Scale
Standard Error 0.04
|
-0.74 Units on a Scale
Standard Error 0.06
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,457 for Participants Continuing in the OL Period
Dressing and Grooming (n=289, 129)
|
-0.85 Units on a Scale
Standard Error 0.06
|
-0.91 Units on a Scale
Standard Error 0.08
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,457 for Participants Continuing in the OL Period
Arising (n=289, 129)
|
-0.80 Units on a Scale
Standard Error 0.05
|
-0.82 Units on a Scale
Standard Error 0.08
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,457 for Participants Continuing in the OL Period
Eating (n=289, 129)
|
-0.89 Units on a Scale
Standard Error 0.06
|
-0.81 Units on a Scale
Standard Error 0.08
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,457 for Participants Continuing in the OL Period
Walking (n=287, 126)
|
-0.68 Units on a Scale
Standard Error 0.05
|
-0.63 Units on a Scale
Standard Error 0.08
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,457 for Participants Continuing in the OL Period
Hygiene (n=289, 129)
|
-0.57 Units on a Scale
Standard Error 0.06
|
-0.59 Units on a Scale
Standard Error 0.10
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,457 for Participants Continuing in the OL Period
Reaching (n=289, 129)
|
-0.84 Units on a Scale
Standard Error 0.06
|
-0.76 Units on a Scale
Standard Error 0.09
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,457 for Participants Continuing in the OL Period
Gripping (n=289, 129)
|
-0.77 Units on a Scale
Standard Error 0.06
|
-0.71 Units on a Scale
Standard Error 0.09
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,457 for Participants Continuing in the OL Period
Activities (n=289, 129)
|
-0.77 Units on a Scale
Standard Error 0.06
|
-0.74 Units on a Scale
Standard Error 0.09
|
SECONDARY outcome
Timeframe: BL (Day 0), Day 1,625Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.
Outcome measures
| Measure |
ABA + MTX DB
n=376 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=160 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,625 Cohort of Participants Continuing in the OL Period
HAQ DI (n=280, 126)
|
1.69 Units on a Scale
Standard Deviation 0.65
|
1.72 Units on a Scale
Standard Deviation 0.59
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,625 Cohort of Participants Continuing in the OL Period
Dressing and Grooming (n=280, 126)
|
1.46 Units on a Scale
Standard Deviation 0.77
|
1.52 Units on a Scale
Standard Deviation 0.73
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,625 Cohort of Participants Continuing in the OL Period
Arising (n=280, 126)
|
1.42 Units on a Scale
Standard Deviation 0.85
|
1.45 Units on a Scale
Standard Deviation 0.75
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,625 Cohort of Participants Continuing in the OL Period
Eating (n=280, 126)
|
1.63 Units on a Scale
Standard Deviation 0.99
|
1.69 Units on a Scale
Standard Deviation 0.83
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,625 Cohort of Participants Continuing in the OL Period
Walking (n=279, 125)
|
1.43 Units on a Scale
Standard Deviation 0.84
|
1.37 Units on a Scale
Standard Deviation 0.78
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,625 Cohort of Participants Continuing in the OL Period
Hygiene (n=280, 126)
|
1.94 Units on a Scale
Standard Deviation 0.90
|
1.93 Units on a Scale
Standard Deviation 0.89
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,625 Cohort of Participants Continuing in the OL Period
Reaching (n=280, 126)
|
1.96 Units on a Scale
Standard Deviation 0.85
|
2.00 Units on a Scale
Standard Deviation 0.78
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,625 Cohort of Participants Continuing in the OL Period
Gripping (n=280, 126)
|
1.80 Units on a Scale
Standard Deviation 0.77
|
1.93 Units on a Scale
Standard Deviation 0.67
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,625 Cohort of Participants Continuing in the OL Period
Activities (n=280, 126)
|
1.88 Units on a Scale
Standard Deviation 0.80
|
1.87 Units on a Scale
Standard Deviation 0.83
|
SECONDARY outcome
Timeframe: BL (Day 0), Day 1,625Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.
Outcome measures
| Measure |
ABA + MTX DB
n=376 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=160 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,625 for Participants Continuing in the OL Period
HAQ DI (n=280, 126)
|
-0.76 Units on a Scale
Standard Error 0.04
|
-0.78 Units on a Scale
Standard Error 0.06
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,625 for Participants Continuing in the OL Period
Dressing and Grooming (n=280, 126)
|
-0.84 Units on a Scale
Standard Error 0.06
|
-0.98 Units on a Scale
Standard Error 0.08
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,625 for Participants Continuing in the OL Period
Arising (n=280, 126)
|
-0.79 Units on a Scale
Standard Error 0.06
|
-0.84 Units on a Scale
Standard Error 0.08
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,625 for Participants Continuing in the OL Period
Eating (n=280, 126)
|
-0.83 Units on a Scale
Standard Error 0.06
|
-0.79 Units on a Scale
Standard Error 0.09
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,625 for Participants Continuing in the OL Period
Walking (n=279, 125)
|
-0.70 Units on a Scale
Standard Error 0.06
|
-0.74 Units on a Scale
Standard Error 0.08
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,625 for Participants Continuing in the OL Period
Hygiene (n=280, 126)
|
-0.56 Units on a Scale
Standard Error 0.06
|
-0.57 Units on a Scale
Standard Error 0.10
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,625 for Participants Continuing in the OL Period
Reaching (n=280, 126)
|
-0.83 Units on a Scale
Standard Error 0.06
|
-0.81 Units on a Scale
Standard Error 0.09
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,625 for Participants Continuing in the OL Period
Gripping (n=280, 126)
|
-0.80 Units on a Scale
Standard Error 0.06
|
-0.76 Units on a Scale
Standard Error 0.09
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,625 for Participants Continuing in the OL Period
Activities (n=280, 126)
|
-0.78 Units on a Scale
Standard Error 0.06
|
-0.76 Units on a Scale
Standard Error 0.09
|
SECONDARY outcome
Timeframe: BL (Day 0), Day 1,821Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.
Outcome measures
| Measure |
ABA + MTX DB
n=376 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=160 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,821 Cohort of Participants Continuing in the OL Period
HAQ DI (n=273, 125)
|
1.69 Units on a Scale
Standard Deviation 0.65
|
1.69 Units on a Scale
Standard Deviation 0.60
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,821 Cohort of Participants Continuing in the OL Period
Dressing and Grooming (n=273, 125)
|
1.47 Units on a Scale
Standard Deviation 0.77
|
1.49 Units on a Scale
Standard Deviation 0.74
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,821 Cohort of Participants Continuing in the OL Period
Arising (n=273, 125)
|
1.41 Units on a Scale
Standard Deviation 0.83
|
1.42 Units on a Scale
Standard Deviation 0.76
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,821 Cohort of Participants Continuing in the OL Period
Eating (n=273, 124)
|
1.63 Units on a Scale
Standard Deviation 1.00
|
1.67 Units on a Scale
Standard Deviation 0.83
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,821 Cohort of Participants Continuing in the OL Period
Walking (n=271, 122)
|
1.43 Units on a Scale
Standard Deviation 0.84
|
1.34 Units on a Scale
Standard Deviation 0.78
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,821 Cohort of Participants Continuing in the OL Period
Hygiene (n=273, 125)
|
1.93 Units on a Scale
Standard Deviation 0.90
|
1.88 Units on a Scale
Standard Deviation 0.91
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,821 Cohort of Participants Continuing in the OL Period
Reaching (n=273, 125)
|
1.97 Units on a Scale
Standard Deviation 0.86
|
1.97 Units on a Scale
Standard Deviation 0.78
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,821 Cohort of Participants Continuing in the OL Period
Gripping (n=273, 125)
|
1.79 Units on a Scale
Standard Deviation 0.78
|
1.90 Units on a Scale
Standard Deviation 0.70
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,821 Cohort of Participants Continuing in the OL Period
Activities (n=273, 125)
|
1.88 Units on a Scale
Standard Deviation 0.81
|
1.82 Units on a Scale
Standard Deviation 0.85
|
SECONDARY outcome
Timeframe: BL (Day 0), Day 1,821Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.
Outcome measures
| Measure |
ABA + MTX DB
n=376 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=160 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,821 for Participants Continuing in the OL Period
HAQ DI (n=273, 125)
|
-0.77 Units on a Scale
Standard Error 0.44
|
-0.72 Units on a Scale
Standard Error 0.06
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,821 for Participants Continuing in the OL Period
Dressing and Grooming (n=273, 125)
|
-0.82 Units on a Scale
Standard Error 0.06
|
-0.86 Units on a Scale
Standard Error 0.08
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,821 for Participants Continuing in the OL Period
Arising (n=273, 125)
|
-0.83 Units on a Scale
Standard Error 0.06
|
-0.90 Units on a Scale
Standard Error 0.08
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,821 for Participants Continuing in the OL Period
Eating (n=273, 124)
|
-0.86 Units on a Scale
Standard Error 0.07
|
-0.78 Units on a Scale
Standard Error 0.09
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,821 for Participants Continuing in the OL Period
Walking (n=271, 122)
|
-0.68 Units on a Scale
Standard Error 0.06
|
-0.61 Units on a Scale
Standard Error 0.08
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,821 for Participants Continuing in the OL Period
Hygiene (n=273, 125)
|
-0.56 Units on a Scale
Standard Error 0.07
|
-0.53 Units on a Scale
Standard Error 0.10
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,821 for Participants Continuing in the OL Period
Reaching (n=273, 125)
|
-0.83 Units on a Scale
Standard Error 0.06
|
-0.74 Units on a Scale
Standard Error 0.09
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,821 for Participants Continuing in the OL Period
Gripping (n=273, 125)
|
-0.79 Units on a Scale
Standard Error 0.06
|
-0.80 Units on a Scale
Standard Error 0.09
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,821 for Participants Continuing in the OL Period
Activities (n=273, 125)
|
-0.76 Units on a Scale
Standard Error 0.06
|
-0.61 Units on a Scale
Standard Error 0.09
|
SECONDARY outcome
Timeframe: BL (Day 0), Day 1,989Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.
Outcome measures
| Measure |
ABA + MTX DB
n=376 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=160 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,989 Cohort of Participants Continuing in the OL Period
HAQ DI (n=119, 55)
|
1.72 Units on a Scale
Standard Deviation 0.61
|
1.67 Units on a Scale
Standard Deviation 0.62
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,989 Cohort of Participants Continuing in the OL Period
Dressing and Grooming (n=119, 55)
|
1.51 Units on a Scale
Standard Deviation 0.72
|
1.49 Units on a Scale
Standard Deviation 0.69
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,989 Cohort of Participants Continuing in the OL Period
Arising (n=119, 55)
|
1.36 Units on a Scale
Standard Deviation 0.78
|
1.38 Units on a Scale
Standard Deviation 0.78
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,989 Cohort of Participants Continuing in the OL Period
Eating (n=119, 55)
|
1.66 Units on a Scale
Standard Deviation 0.99
|
1.62 Units on a Scale
Standard Deviation 0.85
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,989 Cohort of Participants Continuing in the OL Period
Walking (n=117, 54)
|
1.45 Units on a Scale
Standard Deviation 0.79
|
1.30 Units on a Scale
Standard Deviation 0.84
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,989 Cohort of Participants Continuing in the OL Period
Hygiene (n=119, 55)
|
1.87 Units on a Scale
Standard Deviation 0.94
|
1.89 Units on a Scale
Standard Deviation 0.92
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,989 Cohort of Participants Continuing in the OL Period
Reaching (n=119, 55)
|
2.08 Units on a Scale
Standard Deviation 0.81
|
1.98 Units on a Scale
Standard Deviation 0.76
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,989 Cohort of Participants Continuing in the OL Period
Gripping (n=119, 55)
|
1.85 Units on a Scale
Standard Deviation 0.74
|
1.87 Units on a Scale
Standard Deviation 0.67
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,989 Cohort of Participants Continuing in the OL Period
Activities (n=119, 55)
|
1.97 Units on a Scale
Standard Deviation 0.81
|
1.84 Units on a Scale
Standard Deviation 0.74
|
SECONDARY outcome
Timeframe: BL (Day 0), Day 1,989Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.
Outcome measures
| Measure |
ABA + MTX DB
n=376 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=160 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,989 for Participants Continuing in the OL Period
HAQ DI (n=119, 55)
|
-0.81 Units on a Scale
Standard Error 0.07
|
-0.70 Units on a Scale
Standard Error 0.10
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,989 for Participants Continuing in the OL Period
Dressing and Grooming (n=119, 55)
|
-0.84 Units on a Scale
Standard Error 0.09
|
-0.76 Units on a Scale
Standard Error 0.11
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,989 for Participants Continuing in the OL Period
Arising (n=119, 55)
|
-0.86 Units on a Scale
Standard Error 0.08
|
-0.84 Units on a Scale
Standard Error 0.12
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,989 for Participants Continuing in the OL Period
Eating (n=119, 55)
|
-0.83 Units on a Scale
Standard Error 0.10
|
-0.62 Units on a Scale
Standard Error 0.14
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,989 for Participants Continuing in the OL Period
Walking (n=117, 54)
|
-0.77 Units on a Scale
Standard Error 0.09
|
-0.67 Units on a Scale
Standard Error 0.12
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,989 for Participants Continuing in the OL Period
Hygiene (n=119, 55)
|
-0.56 Units on a Scale
Standard Error 0.11
|
-0.58 Units on a Scale
Standard Error 0.13
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,989 for Participants Continuing in the OL Period
Reaching (n=119, 55)
|
-0.89 Units on a Scale
Standard Error 0.10
|
-0.75 Units on a Scale
Standard Error 0.14
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,989 for Participants Continuing in the OL Period
Gripping (n=119, 55)
|
-0.88 Units on a Scale
Standard Error 0.10
|
-0.67 Units on a Scale
Standard Error 0.12
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,989 for Participants Continuing in the OL Period
Activities (n=119, 55)
|
-0.84 Units on a Scale
Standard Error 0.10
|
-0.71 Units on a Scale
Standard Error 0.13
|
SECONDARY outcome
Timeframe: BL (Day 0), Day 2,185Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.
Outcome measures
| Measure |
ABA + MTX DB
n=376 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=160 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 2,185 Cohort of Participants Continuing in the OL Period
HAQ DI (n=85, 38)
|
1.73 Units on a Scale
Standard Deviation 0.55
|
1.69 Units on a Scale
Standard Deviation 0.49
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 2,185 Cohort of Participants Continuing in the OL Period
Dressing and Grooming (n=85, 37)
|
1.54 Units on a Scale
Standard Deviation 0.70
|
1.54 Units on a Scale
Standard Deviation 0.65
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 2,185 Cohort of Participants Continuing in the OL Period
Arising (n=85, 38)
|
1.36 Units on a Scale
Standard Deviation 0.72
|
1.37 Units on a Scale
Standard Deviation 0.59
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 2,185 Cohort of Participants Continuing in the OL Period
Eating (n=85, 38)
|
1.64 Units on a Scale
Standard Deviation 0.96
|
1.58 Units on a Scale
Standard Deviation 0.79
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 2,185 Cohort of Participants Continuing in the OL Period
Walking (n=84, 38)
|
1.39 Units on a Scale
Standard Deviation 0.73
|
1.37 Units on a Scale
Standard Deviation 0.71
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 2,185 Cohort of Participants Continuing in the OL Period
Hygiene (n=85, 38)
|
1.86 Units on a Scale
Standard Deviation 0.91
|
1.97 Units on a Scale
Standard Deviation 0.82
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 2,185 Cohort of Participants Continuing in the OL Period
Reaching (n=85, 38)
|
2.11 Units on a Scale
Standard Deviation 0.79
|
2.03 Units on a Scale
Standard Deviation 0.68
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 2,185 Cohort of Participants Continuing in the OL Period
Gripping (n=85, 38)
|
1.86 Units on a Scale
Standard Deviation 0.73
|
1.84 Units on a Scale
Standard Deviation 0.55
|
|
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 2,185 Cohort of Participants Continuing in the OL Period
Activities (n=85, 38)
|
2.04 Units on a Scale
Standard Deviation 0.70
|
1.84 Units on a Scale
Standard Deviation 0.59
|
SECONDARY outcome
Timeframe: BL (Day 0), Day 2,185Population: All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.
The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.
Outcome measures
| Measure |
ABA + MTX DB
n=376 Participants
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
MTX + Placebo DB
n=160 Participants
Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
|---|---|---|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 2,185 for Participants Continuing in the OL Period
HAQ DI (n=85, 38)
|
-0.70 Units on a Scale
Standard Error 0.08
|
-0.68 Units on a Scale
Standard Error 0.10
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 2,185 for Participants Continuing in the OL Period
Dressing and Grooming (n=85, 37)
|
-0.68 Units on a Scale
Standard Error 0.10
|
-0.78 Units on a Scale
Standard Error 0.13
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 2,185 for Participants Continuing in the OL Period
Arising (n=85, 38)
|
-0.66 Units on a Scale
Standard Error 0.11
|
-0.82 Units on a Scale
Standard Error 0.12
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 2,185 for Participants Continuing in the OL Period
Eating (n=85, 38)
|
-0.82 Units on a Scale
Standard Error 0.11
|
-0.74 Units on a Scale
Standard Error 0.16
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 2,185 for Participants Continuing in the OL Period
Walking (n=84, 38)
|
-0.67 Units on a Scale
Standard Error 0.11
|
-0.58 Units on a Scale
Standard Error 0.14
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 2,185 for Participants Continuing in the OL Period
Hygiene (n=85, 38)
|
-0.55 Units on a Scale
Standard Error 0.13
|
-0.68 Units on a Scale
Standard Error 0.15
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 2,185 for Participants Continuing in the OL Period
Reaching (n=85, 38)
|
-0.88 Units on a Scale
Standard Error 0.12
|
-0.66 Units on a Scale
Standard Error 0.17
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 2,185 for Participants Continuing in the OL Period
Gripping (n=85, 38)
|
-0.64 Units on a Scale
Standard Error 0.11
|
-0.47 Units on a Scale
Standard Error 0.12
|
|
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 2,185 for Participants Continuing in the OL Period
Activities (n=85, 38)
|
-0.68 Units on a Scale
Standard Error 0.10
|
-0.68 Units on a Scale
Standard Error 0.13
|
Adverse Events
ABA + MTX OL
Serious events: 215 serious events
Other events: 466 other events
Deaths: 0 deaths
ABA + MTX DB
Serious events: 68 serious events
Other events: 320 other events
Deaths: 0 deaths
MTX + Placebo DB
Serious events: 27 serious events
Other events: 144 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ABA + MTX OL
n=539 participants at risk
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
ABA + MTX DB
n=433 participants at risk
Abatacept was dosed intravenously by weight with participants weighing \< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of \< 10 mg/wk were acceptable if due to toxicity.
|
MTX + Placebo DB
n=219 participants at risk
Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of \< 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
|
|---|---|---|---|
|
Infections and infestations
LOWER RESPIRATORY TRACT INFECTION
|
0.37%
2/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Infections and infestations
ESCHERICHIA URINARY TRACT INFECTION
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Eye disorders
CATARACT
|
0.56%
3/539
|
0.00%
0/433
|
0.46%
1/219
|
|
Eye disorders
STRABISMUS
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Eye disorders
VITREOUS DETACHMENT
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Investigations
ARTERIOGRAM
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Investigations
WEIGHT DECREASED
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Investigations
LABORATORY TEST ABNORMAL
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Investigations
ELECTROCARDIOGRAM ST SEGMENT ABNORMAL
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Cardiac disorders
ARRHYTHMIA
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Cardiac disorders
BRADYCARDIA
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Cardiac disorders
CARDIAC ARREST
|
0.56%
3/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Cardiac disorders
ANGINA UNSTABLE
|
0.37%
2/539
|
0.23%
1/433
|
0.00%
0/219
|
|
Cardiac disorders
CARDIAC FAILURE
|
0.19%
1/539
|
0.23%
1/433
|
0.46%
1/219
|
|
Cardiac disorders
CARDIOGENIC SHOCK
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.00%
0/539
|
0.00%
0/433
|
0.46%
1/219
|
|
Cardiac disorders
MYOCARDIAL ISCHAEMIA
|
0.37%
2/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Cardiac disorders
PERICARDIAL EFFUSION
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
0.74%
4/539
|
0.23%
1/433
|
0.00%
0/219
|
|
Cardiac disorders
TACHYCARDIA PAROXYSMAL
|
0.00%
0/539
|
0.23%
1/433
|
0.00%
0/219
|
|
Cardiac disorders
CORONARY ARTERY DISEASE
|
0.37%
2/539
|
0.23%
1/433
|
0.00%
0/219
|
|
Cardiac disorders
VENTRICULAR FIBRILLATION
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Cardiac disorders
CARDIAC FAILURE CONGESTIVE
|
0.00%
0/539
|
0.00%
0/433
|
0.46%
1/219
|
|
Cardiac disorders
SUPRAVENTRICULAR TACHYCARDIA
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Cardiac disorders
ATRIOVENTRICULAR BLOCK COMPLETE
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Vascular disorders
HYPERTENSION
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Vascular disorders
VARICOSE VEIN
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Vascular disorders
AORTIC ANEURYSM
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Vascular disorders
THROMBOPHLEBITIS
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Vascular disorders
ARTERIAL DISORDER
|
0.00%
0/539
|
0.00%
0/433
|
0.46%
1/219
|
|
Vascular disorders
VENOUS THROMBOSIS
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Vascular disorders
HYPOVOLAEMIC SHOCK
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Vascular disorders
PERIPHERAL ISCHAEMIA
|
0.00%
0/539
|
0.23%
1/433
|
0.00%
0/219
|
|
Vascular disorders
AORTIC ANEURYSM RUPTURE
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Vascular disorders
ARTERIAL THROMBOSIS LIMB
|
0.00%
0/539
|
0.23%
1/433
|
0.00%
0/219
|
|
Psychiatric disorders
DELIRIUM
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Psychiatric disorders
DEPRESSION
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Hepatobiliary disorders
CHOLELITHIASIS
|
1.1%
6/539
|
0.23%
1/433
|
0.00%
0/219
|
|
Hepatobiliary disorders
BILE DUCT STONE
|
0.56%
3/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Hepatobiliary disorders
CHOLECYSTITIS ACUTE
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Hepatobiliary disorders
CHOLECYSTITIS CHRONIC
|
0.37%
2/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Nervous system disorders
APHASIA
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Nervous system disorders
SYNCOPE
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Nervous system disorders
MIGRAINE
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Nervous system disorders
DIZZINESS
|
0.00%
0/539
|
0.00%
0/433
|
0.46%
1/219
|
|
Nervous system disorders
HYPOAESTHESIA
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Nervous system disorders
OPTIC NEURITIS
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Nervous system disorders
POLYNEUROPATHY
|
0.37%
2/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Nervous system disorders
TENSION HEADACHE
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Nervous system disorders
NERVE COMPRESSION
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Nervous system disorders
CEREBRAL INFARCTION
|
0.00%
0/539
|
0.00%
0/433
|
0.46%
1/219
|
|
Nervous system disorders
CERVICAL MYELOPATHY
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Nervous system disorders
LOSS OF CONSCIOUSNESS
|
0.00%
0/539
|
0.23%
1/433
|
0.46%
1/219
|
|
Nervous system disorders
CARPAL TUNNEL SYNDROME
|
0.00%
0/539
|
0.23%
1/433
|
0.46%
1/219
|
|
Nervous system disorders
CAROTID ARTERY STENOSIS
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Nervous system disorders
CEREBROVASCULAR ACCIDENT
|
0.74%
4/539
|
0.23%
1/433
|
0.00%
0/219
|
|
Nervous system disorders
TRANSIENT ISCHAEMIC ATTACK
|
0.37%
2/539
|
0.23%
1/433
|
0.00%
0/219
|
|
Nervous system disorders
COMPLEX REGIONAL PAIN SYNDROME
|
0.00%
0/539
|
0.23%
1/433
|
0.00%
0/219
|
|
Gastrointestinal disorders
VOMITING
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Gastrointestinal disorders
GASTRITIS
|
0.19%
1/539
|
0.00%
0/433
|
0.46%
1/219
|
|
Gastrointestinal disorders
PERITONITIS
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Gastrointestinal disorders
HAEMORRHOIDS
|
0.00%
0/539
|
0.00%
0/433
|
0.46%
1/219
|
|
Gastrointestinal disorders
OESOPHAGITIS
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Gastrointestinal disorders
PEPTIC ULCER
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Gastrointestinal disorders
RECTAL POLYP
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Gastrointestinal disorders
ENTEROCOLITIS
|
0.19%
1/539
|
0.00%
0/433
|
0.46%
1/219
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.37%
2/539
|
0.00%
0/433
|
0.46%
1/219
|
|
Gastrointestinal disorders
ABDOMINAL HERNIA
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Gastrointestinal disorders
ANAL HAEMORRHAGE
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Gastrointestinal disorders
GASTRODUODENITIS
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Gastrointestinal disorders
UMBILICAL HERNIA
|
0.56%
3/539
|
0.46%
2/433
|
0.00%
0/219
|
|
Gastrointestinal disorders
COLITIS ULCERATIVE
|
0.37%
2/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Gastrointestinal disorders
RECTAL HAEMORRHAGE
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Gastrointestinal disorders
ABDOMINAL DISCOMFORT
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Gastrointestinal disorders
HAEMORRHOIDAL HAEMORRHAGE
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Gastrointestinal disorders
RETROPERITONEAL HAEMORRHAGE
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Gastrointestinal disorders
ABDOMINAL HERNIA OBSTRUCTIVE
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Gastrointestinal disorders
GASTROINTESTINAL HAEMORRHAGE
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Gastrointestinal disorders
SMALL INTESTINAL OBSTRUCTION
|
0.37%
2/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Gastrointestinal disorders
ABDOMINAL STRANGULATED HERNIA
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Gastrointestinal disorders
MESENTERIC VASCULAR INSUFFICIENCY
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Infections and infestations
SEPSIS
|
0.19%
1/539
|
0.23%
1/433
|
0.46%
1/219
|
|
Infections and infestations
ABSCESS
|
0.00%
0/539
|
0.23%
1/433
|
0.00%
0/219
|
|
Infections and infestations
CYSTITIS
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Infections and infestations
RHINITIS
|
0.00%
0/539
|
0.00%
0/433
|
0.46%
1/219
|
|
Infections and infestations
PNEUMONIA
|
1.3%
7/539
|
0.92%
4/433
|
0.46%
1/219
|
|
Infections and infestations
SINUSITIS
|
0.37%
2/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Infections and infestations
BRONCHITIS
|
0.74%
4/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Infections and infestations
CELLULITIS
|
0.93%
5/539
|
0.23%
1/433
|
0.46%
1/219
|
|
Infections and infestations
ERYSIPELAS
|
0.37%
2/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Infections and infestations
PARONYCHIA
|
0.00%
0/539
|
0.23%
1/433
|
0.00%
0/219
|
|
Infections and infestations
ABSCESS JAW
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Infections and infestations
BACTERAEMIA
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Infections and infestations
PHARYNGITIS
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Infections and infestations
ABSCESS LIMB
|
0.19%
1/539
|
0.00%
0/433
|
0.46%
1/219
|
|
Infections and infestations
APPENDICITIS
|
0.19%
1/539
|
0.00%
0/433
|
0.46%
1/219
|
|
Infections and infestations
SEPTIC SHOCK
|
0.37%
2/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Infections and infestations
TUBERCULOSIS
|
0.00%
0/539
|
0.23%
1/433
|
0.00%
0/219
|
|
Infections and infestations
DACRYOCYSTITIS
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Infections and infestations
DIVERTICULITIS
|
0.19%
1/539
|
0.46%
2/433
|
0.00%
0/219
|
|
Infections and infestations
LUNG INFECTION
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Infections and infestations
PYELONEPHRITIS
|
0.37%
2/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Infections and infestations
GASTROENTERITIS
|
0.37%
2/539
|
0.23%
1/433
|
0.00%
0/219
|
|
Infections and infestations
LOBAR PNEUMONIA
|
0.37%
2/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Infections and infestations
NASOPHARYNGITIS
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Infections and infestations
WOUND INFECTION
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Infections and infestations
BRONCHOPNEUMONIA
|
0.00%
0/539
|
0.46%
2/433
|
0.00%
0/219
|
|
Infections and infestations
DOUGLAS' ABSCESS
|
0.00%
0/539
|
0.00%
0/433
|
0.46%
1/219
|
|
Infections and infestations
HERPES DERMATITIS
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Infections and infestations
ESCHERICHIA SEPSIS
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Infections and infestations
PERIRECTAL ABSCESS
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Infections and infestations
ARTHRITIS BACTERIAL
|
0.19%
1/539
|
0.23%
1/433
|
0.00%
0/219
|
|
Infections and infestations
LOCALISED INFECTION
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Infections and infestations
OSTEOMYELITIS ACUTE
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Infections and infestations
PERINEPHRIC ABSCESS
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Infections and infestations
PYELONEPHRITIS ACUTE
|
0.19%
1/539
|
0.23%
1/433
|
0.00%
0/219
|
|
Infections and infestations
SUBCUTANEOUS ABSCESS
|
0.37%
2/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Infections and infestations
TUBERCULOUS PLEURISY
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Infections and infestations
SOFT TISSUE INFECTION
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Infections and infestations
ABDOMINAL WALL ABSCESS
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Infections and infestations
ENDOCARDITIS BACTERIAL
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Infections and infestations
HERPES VIRUS INFECTION
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Infections and infestations
PULMONARY TUBERCULOSIS
|
0.37%
2/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Infections and infestations
INCISION SITE INFECTION
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.93%
5/539
|
0.46%
2/433
|
0.00%
0/219
|
|
Infections and infestations
POST PROCEDURAL INFECTION
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Infections and infestations
RESPIRATORY TRACT INFECTION
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Infections and infestations
CLOSTRIDIUM DIFFICILE COLITIS
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Infections and infestations
POSTOPERATIVE WOUND INFECTION
|
0.37%
2/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Infections and infestations
STAPHYLOCOCCAL SKIN INFECTION
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Infections and infestations
BRONCHOPULMONARY ASPERGILLOSIS
|
0.00%
0/539
|
0.23%
1/433
|
0.00%
0/219
|
|
Renal and urinary disorders
RENAL COLIC
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Renal and urinary disorders
RENAL FAILURE
|
0.37%
2/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Renal and urinary disorders
NEPHROLITHIASIS
|
0.37%
2/539
|
0.23%
1/433
|
0.00%
0/219
|
|
Renal and urinary disorders
CALCULUS BLADDER
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Renal and urinary disorders
URINARY RETENTION
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Renal and urinary disorders
RENAL FAILURE ACUTE
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Renal and urinary disorders
URINARY INCONTINENCE
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Renal and urinary disorders
RENAL FAILURE CHRONIC
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Metabolism and nutrition disorders
OBESITY
|
0.37%
2/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.37%
2/539
|
0.46%
2/433
|
0.00%
0/219
|
|
Metabolism and nutrition disorders
DIABETES MELLITUS
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.74%
4/539
|
0.23%
1/433
|
0.00%
0/219
|
|
Blood and lymphatic system disorders
HAEMORRHAGIC ANAEMIA
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Blood and lymphatic system disorders
DISSEMINATED INTRAVASCULAR COAGULATION
|
0.00%
0/539
|
0.23%
1/433
|
0.00%
0/219
|
|
Skin and subcutaneous tissue disorders
INGROWING NAIL
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Skin and subcutaneous tissue disorders
DERMATOMYOSITIS
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Reproductive system and breast disorders
CYSTOCELE
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Reproductive system and breast disorders
RECTOCELE
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Reproductive system and breast disorders
METRORRHAGIA
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Reproductive system and breast disorders
OVARIAN CYST
|
0.00%
0/539
|
0.23%
1/433
|
0.00%
0/219
|
|
Reproductive system and breast disorders
ENDOMETRIOSIS
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Reproductive system and breast disorders
UTERINE POLYP
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Reproductive system and breast disorders
UTERINE PROLAPSE
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Reproductive system and breast disorders
BREAST CALCIFICATIONS
|
0.00%
0/539
|
0.23%
1/433
|
0.00%
0/219
|
|
Reproductive system and breast disorders
BENIGN PROSTATIC HYPERPLASIA
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Injury, poisoning and procedural complications
FALL
|
0.56%
3/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Injury, poisoning and procedural complications
OVERDOSE
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Injury, poisoning and procedural complications
EYE INJURY
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Injury, poisoning and procedural complications
HIP FRACTURE
|
0.56%
3/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Injury, poisoning and procedural complications
FOOT FRACTURE
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Injury, poisoning and procedural complications
ULNA FRACTURE
|
0.37%
2/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Injury, poisoning and procedural complications
ANKLE FRACTURE
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Injury, poisoning and procedural complications
FEMUR FRACTURE
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Injury, poisoning and procedural complications
GUN SHOT WOUND
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Injury, poisoning and procedural complications
WRIST FRACTURE
|
0.00%
0/539
|
0.23%
1/433
|
0.00%
0/219
|
|
Injury, poisoning and procedural complications
MENISCUS LESION
|
0.00%
0/539
|
0.23%
1/433
|
0.00%
0/219
|
|
Injury, poisoning and procedural complications
PROCEDURAL PAIN
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Injury, poisoning and procedural complications
SPINAL FRACTURE
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Injury, poisoning and procedural complications
WOUND DEHISCENCE
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Injury, poisoning and procedural complications
ALCOHOL POISONING
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Injury, poisoning and procedural complications
JOINT DISLOCATION
|
0.74%
4/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Injury, poisoning and procedural complications
FAILURE OF IMPLANT
|
0.00%
0/539
|
0.23%
1/433
|
0.00%
0/219
|
|
Injury, poisoning and procedural complications
TRAUMATIC FRACTURE
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Injury, poisoning and procedural complications
ACCIDENTAL OVERDOSE
|
0.37%
2/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Injury, poisoning and procedural complications
LOWER LIMB FRACTURE
|
0.00%
0/539
|
0.23%
1/433
|
0.00%
0/219
|
|
Injury, poisoning and procedural complications
PROCEDURAL VOMITING
|
0.00%
0/539
|
0.23%
1/433
|
0.00%
0/219
|
|
Injury, poisoning and procedural complications
UPPER LIMB FRACTURE
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Injury, poisoning and procedural complications
FEMORAL NECK FRACTURE
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Injury, poisoning and procedural complications
VASCULAR PSEUDOANEURYSM
|
0.00%
0/539
|
0.46%
2/433
|
0.00%
0/219
|
|
Injury, poisoning and procedural complications
INCORRECT DOSE ADMINISTERED
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Injury, poisoning and procedural complications
MEDICAL DEVICE COMPLICATION
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Injury, poisoning and procedural complications
POST PROCEDURAL COMPLICATION
|
0.37%
2/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Injury, poisoning and procedural complications
DISLOCATION OF JOINT PROSTHESIS
|
0.37%
2/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Musculoskeletal and connective tissue disorders
BURSITIS
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Musculoskeletal and connective tissue disorders
ARTHRITIS
|
1.3%
7/539
|
0.69%
3/433
|
0.46%
1/219
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.37%
2/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Musculoskeletal and connective tissue disorders
BONE CYST
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Musculoskeletal and connective tissue disorders
SYNOVITIS
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Musculoskeletal and connective tissue disorders
MONARTHRITIS
|
0.37%
2/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Musculoskeletal and connective tissue disorders
METATARSALGIA
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Musculoskeletal and connective tissue disorders
OSTEONECROSIS
|
0.56%
3/539
|
0.46%
2/433
|
0.00%
0/219
|
|
Musculoskeletal and connective tissue disorders
SYNOVIAL CYST
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Musculoskeletal and connective tissue disorders
FOOT DEFORMITY
|
0.56%
3/539
|
0.00%
0/433
|
0.46%
1/219
|
|
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS
|
3.7%
20/539
|
0.46%
2/433
|
0.91%
2/219
|
|
Musculoskeletal and connective tissue disorders
RHEUMATOID NODULE
|
0.00%
0/539
|
0.46%
2/433
|
0.00%
0/219
|
|
Musculoskeletal and connective tissue disorders
SPONDYLOLISTHESIS
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Musculoskeletal and connective tissue disorders
MUSCLE HAEMORRHAGE
|
0.00%
0/539
|
0.23%
1/433
|
0.00%
0/219
|
|
Musculoskeletal and connective tissue disorders
RHEUMATOID ARTHRITIS
|
6.7%
36/539
|
3.0%
13/433
|
2.7%
6/219
|
|
Musculoskeletal and connective tissue disorders
SOFT TISSUE NECROSIS
|
0.00%
0/539
|
0.00%
0/433
|
0.46%
1/219
|
|
Musculoskeletal and connective tissue disorders
OSTEOPOROTIC FRACTURE
|
0.00%
0/539
|
0.23%
1/433
|
0.00%
0/219
|
|
Musculoskeletal and connective tissue disorders
SPINAL COLUMN STENOSIS
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Musculoskeletal and connective tissue disorders
SYSTEMIC LUPUS ERYTHEMATOSUS
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Musculoskeletal and connective tissue disorders
INTERVERTEBRAL DISC PROTRUSION
|
0.37%
2/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Respiratory, thoracic and mediastinal disorders
ASTHMA
|
0.00%
0/539
|
0.23%
1/433
|
0.00%
0/219
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXIA
|
0.00%
0/539
|
0.00%
0/433
|
0.46%
1/219
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
0.19%
1/539
|
0.00%
0/433
|
0.46%
1/219
|
|
Respiratory, thoracic and mediastinal disorders
ATELECTASIS
|
0.00%
0/539
|
0.00%
0/433
|
0.46%
1/219
|
|
Respiratory, thoracic and mediastinal disorders
HAEMOPTYSIS
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONITIS
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMOTHORAX
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY OEDEMA
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
0.37%
2/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Respiratory, thoracic and mediastinal disorders
SLEEP APNOEA SYNDROME
|
0.00%
0/539
|
0.23%
1/433
|
0.00%
0/219
|
|
Respiratory, thoracic and mediastinal disorders
TONSILLAR INFLAMMATION
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Respiratory, thoracic and mediastinal disorders
INTERSTITIAL LUNG DISEASE
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Respiratory, thoracic and mediastinal disorders
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
|
0.19%
1/539
|
0.23%
1/433
|
0.00%
0/219
|
|
General disorders
PYREXIA
|
0.37%
2/539
|
0.00%
0/433
|
0.00%
0/219
|
|
General disorders
CHEST PAIN
|
0.93%
5/539
|
0.23%
1/433
|
0.00%
0/219
|
|
General disorders
IMPAIRED HEALING
|
0.56%
3/539
|
0.23%
1/433
|
0.00%
0/219
|
|
General disorders
HERNIA OBSTRUCTIVE
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
General disorders
MULTI-ORGAN FAILURE
|
0.00%
0/539
|
0.00%
0/433
|
0.46%
1/219
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LYMPHOMA
|
0.19%
1/539
|
0.23%
1/433
|
0.00%
0/219
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
NEOPLASM
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LEIOMYOMA
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
COLON CANCER
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LUNG NEOPLASM
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
CARDIAC MYXOMA
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PROSTATE CANCER
|
0.37%
2/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
THYROID NEOPLASM
|
0.00%
0/539
|
0.23%
1/433
|
0.00%
0/219
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
UTERINE LEIOMYOMA
|
0.56%
3/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ENDOMETRIAL CANCER
|
0.19%
1/539
|
0.00%
0/433
|
0.46%
1/219
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTATIC NEOPLASM
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BASAL CELL CARCINOMA
|
1.5%
8/539
|
0.92%
4/433
|
0.46%
1/219
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BENIGN BREAST NEOPLASM
|
0.37%
2/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
FIBROADENOMA OF BREAST
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LUNG NEOPLASM MALIGNANT
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SQUAMOUS CELL CARCINOMA
|
0.56%
3/539
|
0.23%
1/433
|
0.00%
0/219
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MYELODYSPLASTIC SYNDROME
|
0.00%
0/539
|
0.23%
1/433
|
0.00%
0/219
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
NEUROENDOCRINE CARCINOMA
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
GASTROINTESTINAL NEOPLASM
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MALIGNANT MELANOMA IN SITU
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ACUTE LYMPHOCYTIC LEUKAEMIA
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BRONCHIOLOALVEOLAR CARCINOMA
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LYMPHOPROLIFERATIVE DISORDER
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTATIC MALIGNANT MELANOMA
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SQUAMOUS CELL CARCINOMA OF SKIN
|
0.74%
4/539
|
0.00%
0/433
|
0.46%
1/219
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
EXTRANODAL MARGINAL ZONE B-CELL LYMPHOMA (MALT TYPE)
|
0.19%
1/539
|
0.00%
0/433
|
0.00%
0/219
|
Other adverse events
| Measure |
ABA + MTX OL
n=539 participants at risk
Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
|
ABA + MTX DB
n=433 participants at risk
Abatacept was dosed intravenously by weight with participants weighing \< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of \< 10 mg/wk were acceptable if due to toxicity.
|
MTX + Placebo DB
n=219 participants at risk
Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of \< 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
|
|---|---|---|---|
|
Eye disorders
CONJUNCTIVITIS
|
6.9%
37/539
|
0.92%
4/433
|
0.91%
2/219
|
|
Vascular disorders
HYPERTENSION
|
16.0%
86/539
|
6.0%
26/433
|
1.8%
4/219
|
|
Psychiatric disorders
ANXIETY
|
5.0%
27/539
|
3.5%
15/433
|
2.7%
6/219
|
|
Psychiatric disorders
INSOMNIA
|
9.5%
51/539
|
2.8%
12/433
|
2.7%
6/219
|
|
Psychiatric disorders
DEPRESSION
|
7.6%
41/539
|
3.5%
15/433
|
3.2%
7/219
|
|
Nervous system disorders
HEADACHE
|
18.4%
99/539
|
17.8%
77/433
|
11.9%
26/219
|
|
Nervous system disorders
DIZZINESS
|
10.0%
54/539
|
9.5%
41/433
|
7.3%
16/219
|
|
Gastrointestinal disorders
NAUSEA
|
9.8%
53/539
|
12.2%
53/433
|
11.4%
25/219
|
|
Gastrointestinal disorders
VOMITING
|
5.6%
30/539
|
3.9%
17/433
|
3.7%
8/219
|
|
Gastrointestinal disorders
DIARRHOEA
|
15.4%
83/539
|
11.1%
48/433
|
10.0%
22/219
|
|
Gastrointestinal disorders
DYSPEPSIA
|
13.4%
72/539
|
6.5%
28/433
|
4.6%
10/219
|
|
Gastrointestinal disorders
GASTRITIS
|
5.4%
29/539
|
2.1%
9/433
|
2.7%
6/219
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
6.1%
33/539
|
2.8%
12/433
|
3.2%
7/219
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
9.3%
50/539
|
4.4%
19/433
|
5.9%
13/219
|
|
Infections and infestations
RHINITIS
|
7.8%
42/539
|
3.5%
15/433
|
3.2%
7/219
|
|
Infections and infestations
INFLUENZA
|
14.1%
76/539
|
6.9%
30/433
|
5.5%
12/219
|
|
Infections and infestations
SINUSITIS
|
11.9%
64/539
|
4.4%
19/433
|
6.8%
15/219
|
|
Infections and infestations
BRONCHITIS
|
17.6%
95/539
|
8.5%
37/433
|
7.3%
16/219
|
|
Infections and infestations
PHARYNGITIS
|
13.0%
70/539
|
6.2%
27/433
|
4.6%
10/219
|
|
Infections and infestations
GASTROENTERITIS
|
7.8%
42/539
|
2.3%
10/433
|
4.1%
9/219
|
|
Infections and infestations
NASOPHARYNGITIS
|
25.4%
137/539
|
15.2%
66/433
|
11.4%
25/219
|
|
Infections and infestations
URINARY TRACT INFECTION
|
21.9%
118/539
|
4.8%
21/433
|
5.0%
11/219
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
24.3%
131/539
|
10.9%
47/433
|
9.6%
21/219
|
|
Blood and lymphatic system disorders
ANAEMIA
|
6.5%
35/539
|
2.1%
9/433
|
3.7%
8/219
|
|
Skin and subcutaneous tissue disorders
RASH
|
5.6%
30/539
|
4.4%
19/433
|
0.46%
1/219
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
20.4%
110/539
|
9.2%
40/433
|
5.9%
13/219
|
|
Musculoskeletal and connective tissue disorders
TENDONITIS
|
5.4%
29/539
|
0.23%
1/433
|
1.4%
3/219
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
15.4%
83/539
|
7.2%
31/433
|
6.8%
15/219
|
|
Respiratory, thoracic and mediastinal disorders
RHINITIS ALLERGIC
|
5.4%
29/539
|
0.69%
3/433
|
1.8%
4/219
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
5.8%
31/539
|
2.5%
11/433
|
3.2%
7/219
|
|
General disorders
FATIGUE
|
5.9%
32/539
|
5.5%
24/433
|
6.8%
15/219
|
|
General disorders
CHEST PAIN
|
7.1%
38/539
|
1.6%
7/433
|
2.3%
5/219
|
|
General disorders
OEDEMA PERIPHERAL
|
7.1%
38/539
|
3.0%
13/433
|
3.2%
7/219
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
- Publication restrictions are in place
Restriction type: OTHER