Trial Outcomes & Findings for Study of Abatacept (BMS-188667) in Subjects With Active Rheumatoid Arthritis on Background Non-biologic DMARDS (Disease Modifying Antirheumatic Drugs) Who Have an Inadequate Response to Anti-TNF Therapy (NCT NCT00124982)
NCT ID: NCT00124982
Last Updated: 2012-02-27
Results Overview
AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with treatment.SAE=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.Related AE/SAE=Certain,Probable,Possible,or Missing relationship to Drug
COMPLETED
PHASE3
1286 participants
Days 1-169
2012-02-27
Participant Flow
Of 1286 participants enrolled in this study, 240 were not treated.
Participant milestones
| Measure |
Short Term (ST) Abatacept (ABA)-Previous User
In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
|
ST-Current User
In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
|
Long-term ABA
Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
|
|---|---|---|---|
|
Short-term Period
STARTED
|
449
|
597
|
0
|
|
Short-term Period
COMPLETED
|
377
|
483
|
0
|
|
Short-term Period
NOT COMPLETED
|
72
|
114
|
0
|
|
Long-term Period
STARTED
|
0
|
0
|
530
|
|
Long-term Period
COMPLETED
|
0
|
0
|
441
|
|
Long-term Period
NOT COMPLETED
|
0
|
0
|
89
|
Reasons for withdrawal
| Measure |
Short Term (ST) Abatacept (ABA)-Previous User
In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
|
ST-Current User
In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
|
Long-term ABA
Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
|
|---|---|---|---|
|
Short-term Period
Death
|
1
|
1
|
0
|
|
Short-term Period
Adverse Event
|
17
|
22
|
0
|
|
Short-term Period
Lack of Efficacy
|
32
|
73
|
0
|
|
Short-term Period
Lost to Follow-up
|
8
|
5
|
0
|
|
Short-term Period
Withdrawal of Consent
|
7
|
9
|
0
|
|
Short-term Period
Poor/Non-compliance
|
3
|
1
|
0
|
|
Short-term Period
No Longer Meets Study Criteria
|
1
|
2
|
0
|
|
Short-term Period
Participant Decision
|
1
|
0
|
0
|
|
Short-term Period
Participant Chose Own Doctor
|
0
|
1
|
0
|
|
Short-term Period
Investigator Decision-No Specific AE
|
1
|
0
|
0
|
|
Short-term Period
Participant Had Lymphopenia
|
1
|
0
|
0
|
|
Long-term Period
Death
|
0
|
0
|
1
|
|
Long-term Period
Adverse Event
|
0
|
0
|
17
|
|
Long-term Period
Lack of Efficacy
|
0
|
0
|
46
|
|
Long-term Period
Lost to Follow-up
|
0
|
0
|
4
|
|
Long-term Period
Withdrawal by Subject
|
0
|
0
|
16
|
|
Long-term Period
Pregnancy
|
0
|
0
|
1
|
|
Long-term Period
Poor/Non-compliance
|
0
|
0
|
2
|
|
Long-term Period
Administrative Reason by Sponsor
|
0
|
0
|
1
|
|
Long-term Period
Neurologist Recommendation
|
0
|
0
|
1
|
Baseline Characteristics
Study of Abatacept (BMS-188667) in Subjects With Active Rheumatoid Arthritis on Background Non-biologic DMARDS (Disease Modifying Antirheumatic Drugs) Who Have an Inadequate Response to Anti-TNF Therapy
Baseline characteristics by cohort
| Measure |
ST Abatacept (ABA)-Previous User
n=449 Participants
In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
|
ST ABA-Current User
n=597 Participants
In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
|
Total
n=1046 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
56.1 years
STANDARD_DEVIATION 12.5 • n=5 Participants
|
53.2 years
STANDARD_DEVIATION 12.3 • n=7 Participants
|
54.4 years
STANDARD_DEVIATION 12.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
359 Participants
n=5 Participants
|
490 Participants
n=7 Participants
|
849 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
90 Participants
n=5 Participants
|
107 Participants
n=7 Participants
|
197 Participants
n=5 Participants
|
|
Number of Tender Joints
|
17.8 tender joints
STANDARD_DEVIATION 5.9 • n=5 Participants
|
17.8 tender joints
STANDARD_DEVIATION 6.1 • n=7 Participants
|
17.8 tender joints
STANDARD_DEVIATION 6.0 • n=5 Participants
|
|
Number of Swollen Joints
|
13.9 swollen joints
STANDARD_DEVIATION 5.6 • n=5 Participants
|
13.5 swollen joints
STANDARD_DEVIATION 5.4 • n=7 Participants
|
13.6 swollen joints
STANDARD_DEVIATION 5.5 • n=5 Participants
|
|
Physical Function, Health Assessment Questionnaire Disability Index (HAQ-DI)
|
1.7 units on a scale
STANDARD_DEVIATION 0.6 • n=5 Participants
|
1.7 units on a scale
STANDARD_DEVIATION 0.6 • n=7 Participants
|
1.7 units on a scale
STANDARD_DEVIATION 0.6 • n=5 Participants
|
|
hs-C-Reactive Protein (hs-CRP) Serum Levels
|
2.2 mg/dL
STANDARD_DEVIATION 3.0 • n=5 Participants
|
2.1 mg/dL
STANDARD_DEVIATION 3.0 • n=7 Participants
|
2.1 mg/dL
STANDARD_DEVIATION 3.0 • n=5 Participants
|
|
Disease Activity Score (DAS) 28 (Using CRP Levels)
|
6.2 units on a scale
STANDARD_DEVIATION 0.7 • n=5 Participants
|
6.2 units on a scale
STANDARD_DEVIATION 0.7 • n=7 Participants
|
6.2 units on a scale
STANDARD_DEVIATION 0.7 • n=5 Participants
|
|
Rheumatoid Factor (RF) Status
Negative
|
138 participants
n=5 Participants
|
215 participants
n=7 Participants
|
353 participants
n=5 Participants
|
|
Rheumatoid Factor (RF) Status
Positive
|
292 participants
n=5 Participants
|
349 participants
n=7 Participants
|
641 participants
n=5 Participants
|
|
Rheumatoid Factor (RF) Status
Data Not Available
|
19 participants
n=5 Participants
|
33 participants
n=7 Participants
|
52 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Days 1-169Population: All treated participants
AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with treatment.SAE=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.Related AE/SAE=Certain,Probable,Possible,or Missing relationship to Drug
Outcome measures
| Measure |
ST Abatacept (ABA)-Previous User
n=449 Participants
In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
|
ST ABA-Current User
n=597 Participants
In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
|
|---|---|---|
|
Short-term Period: Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuations, AEs, Related AEs, or AEs Leading to Discontinuations
Death
|
1 participants
|
1 participants
|
|
Short-term Period: Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuations, AEs, Related AEs, or AEs Leading to Discontinuations
SAEs
|
50 participants
|
59 participants
|
|
Short-term Period: Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuations, AEs, Related AEs, or AEs Leading to Discontinuations
Related SAEs
|
10 participants
|
16 participants
|
|
Short-term Period: Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuations, AEs, Related AEs, or AEs Leading to Discontinuations
SAEs Leading to Discontinuation
|
9 participants
|
8 participants
|
|
Short-term Period: Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuations, AEs, Related AEs, or AEs Leading to Discontinuations
AEs
|
350 participants
|
473 participants
|
|
Short-term Period: Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuations, AEs, Related AEs, or AEs Leading to Discontinuations
Related AEs
|
190 participants
|
273 participants
|
|
Short-term Period: Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuations, AEs, Related AEs, or AEs Leading to Discontinuations
AEs Leading to Discontinuation
|
17 participants
|
24 participants
|
PRIMARY outcome
Timeframe: Days 1-169Population: All treated participants
AE=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 are those AEs that may be associated with the use of immunomodulatory drugs, including all infections, serious infections, and opportunistic infections; autoimmune disorders; neoplasms; acute infusional AEs (pre-specified AEs occurring within 1 hour of start of infusion) and peri-infusional AEs (pre-specified AEs occurring within 24 hours of the start of infusion).
Outcome measures
| Measure |
ST Abatacept (ABA)-Previous User
n=449 Participants
In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
|
ST ABA-Current User
n=597 Participants
In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
|
|---|---|---|
|
Short-term Period: Number of Participants With AEs of Special Interest
Infections (pre-specified)
|
26 participants
|
38 participants
|
|
Short-term Period: Number of Participants With AEs of Special Interest
Serious Infections (pre-specified)
|
6 participants
|
7 participants
|
|
Short-term Period: Number of Participants With AEs of Special Interest
Benign, malignant, and unspecified neoplasms
|
8 participants
|
7 participants
|
|
Short-term Period: Number of Participants With AEs of Special Interest
Autoimmune disorders (pre-specified)
|
4 participants
|
9 participants
|
|
Short-term Period: Number of Participants With AEs of Special Interest
Acute infusional AEs (pre-specified)
|
20 participants
|
37 participants
|
|
Short-term Period: Number of Participants With AEs of Special Interest
Peri-infusional AEs (pre-specified)
|
57 participants
|
99 participants
|
PRIMARY outcome
Timeframe: Days 1-169Population: Participants who received at least 1 infusion of abatacept during the short-term treatment period
Upper Normal Limit (ULN), Lower Normal Limit (LLN), Baseline (BL). 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/\<100,000 mm\^3; Leukocytes: \<0.75 \* LLN/ \>1.25 \* ULN, or if BL\<LLN then use \<0.8 \* BL/\>ULN, or if BL\>ULN then use \>1.2 \* BL/\<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 |
ST Abatacept (ABA)-Previous User
n=429 Participants
In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
|
ST ABA-Current User
n=581 Participants
In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
|
|---|---|---|
|
Short-term Period: Number of Participants With Hematology Laboratories Meeting Marked Abnormality (MA) Criteria
Low HGB (n=429, n=581)
|
2 participants
|
3 participants
|
|
Short-term Period: Number of Participants With Hematology Laboratories Meeting Marked Abnormality (MA) Criteria
Low hematocrit (n=428, n=580)
|
1 participants
|
2 participants
|
|
Short-term Period: Number of Participants With Hematology Laboratories Meeting Marked Abnormality (MA) Criteria
Low erythrocytes (n=429, n=581)
|
1 participants
|
2 participants
|
|
Short-term Period: Number of Participants With Hematology Laboratories Meeting Marked Abnormality (MA) Criteria
Low PLT (n=424, n=578)
|
1 participants
|
1 participants
|
|
Short-term Period: Number of Participants With Hematology Laboratories Meeting Marked Abnormality (MA) Criteria
High PLT (n=424, n=578)
|
0 participants
|
0 participants
|
|
Short-term Period: Number of Participants With Hematology Laboratories Meeting Marked Abnormality (MA) Criteria
Low leukocytes (n=429, n=581)
|
2 participants
|
1 participants
|
|
Short-term Period: Number of Participants With Hematology Laboratories Meeting Marked Abnormality (MA) Criteria
High leukocytes (n=429, n=581)
|
3 participants
|
8 participants
|
|
Short-term Period: Number of Participants With Hematology Laboratories Meeting Marked Abnormality (MA) Criteria
Low neutrophils+bands (n=429, n=580)
|
0 participants
|
1 participants
|
|
Short-term Period: Number of Participants With Hematology Laboratories Meeting Marked Abnormality (MA) Criteria
High eosinophils (n=429, n=580)
|
2 participants
|
2 participants
|
|
Short-term Period: Number of Participants With Hematology Laboratories Meeting Marked Abnormality (MA) Criteria
High basophils (n=429, n=580)
|
0 participants
|
0 participants
|
|
Short-term Period: Number of Participants With Hematology Laboratories Meeting Marked Abnormality (MA) Criteria
High monocytes (n=429, n=580)
|
1 participants
|
0 participants
|
|
Short-term Period: Number of Participants With Hematology Laboratories Meeting Marked Abnormality (MA) Criteria
Low lymphocytes (n=429, n=580)
|
30 participants
|
27 participants
|
|
Short-term Period: Number of Participants With Hematology Laboratories Meeting Marked Abnormality (MA) Criteria
High lymphocytes (n=429, n=580)
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Days 1-169Population: All treated participants. n=number of participants with evaluable laboratory results.
Marked abnormality criteria: Alkaline phosphatase (ALP): \>2\* ULN, or if BL\>ULN then use \>3\* BL; 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; G-Glutamyl transferase (GGT): \>2\* ULN, or if BL\>ULN then use \>3\* BL; Bilirubin: \>2\* ULN, or if BL\>ULN then use \>4\* BL; blood urea nitrogen (BUN): \>2\* BL; creatinine: \>1.5\* BL
Outcome measures
| Measure |
ST Abatacept (ABA)-Previous User
n=428 Participants
In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
|
ST ABA-Current User
n=583 Participants
In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
|
|---|---|---|
|
Short-term Period: Number of Participants With Liver and Kidney Function Laboratories Meeting MA Criteria
High ALP (n=428, n=583)
|
0 participants
|
0 participants
|
|
Short-term Period: Number of Participants With Liver and Kidney Function Laboratories Meeting MA Criteria
High AST (n=426, n=583)
|
1 participants
|
2 participants
|
|
Short-term Period: Number of Participants With Liver and Kidney Function Laboratories Meeting MA Criteria
High ALT (n=426, n=583)
|
2 participants
|
1 participants
|
|
Short-term Period: Number of Participants With Liver and Kidney Function Laboratories Meeting MA Criteria
High GGT (n=427, n=583)
|
1 participants
|
5 participants
|
|
Short-term Period: Number of Participants With Liver and Kidney Function Laboratories Meeting MA Criteria
High bilirubin (n=426, n=583)
|
1 participants
|
1 participants
|
|
Short-term Period: Number of Participants With Liver and Kidney Function Laboratories Meeting MA Criteria
High BUN (n=428, n=583)
|
3 participants
|
8 participants
|
|
Short-term Period: Number of Participants With Liver and Kidney Function Laboratories Meeting MA Criteria
High creatinine (n=427, n=583)
|
8 participants
|
7 participants
|
PRIMARY outcome
Timeframe: Days 1-169Population: All treated participants. n=number of participants with evaluable laboratory results.
Marked abnormality criteria:Sodium (Na): \<0.95\* LLN/ \>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 (K): \<0.9\* LLN/\>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/\>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 (Ca): \<0.8\* LLN/\>1.2\* ULN, or if BL\<LLN then use 0.75\* BL or \>ULN, or if BL\>ULN then use\>1.25\* BL or \<LLN; phosphorous (P): \<0.75\* LLN/ \>1.25\* ULN, or if BL\<LLN then use 0.67\* BL or \>ULN, or if BL\>ULN then use\>1.33\* BL or \<LLN
Outcome measures
| Measure |
ST Abatacept (ABA)-Previous User
n=428 Participants
In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
|
ST ABA-Current User
n=583 Participants
In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
|
|---|---|---|
|
Short-term Period: Number of Participants With Electrolyte Laboratories Meeting MA Criteria
Low Na (n=428, n=583)
|
0 participants
|
2 participants
|
|
Short-term Period: Number of Participants With Electrolyte Laboratories Meeting MA Criteria
High Na (n=428, n=583)
|
0 participants
|
0 participants
|
|
Short-term Period: Number of Participants With Electrolyte Laboratories Meeting MA Criteria
Low K (n=425, n=583)
|
1 participants
|
3 participants
|
|
Short-term Period: Number of Participants With Electrolyte Laboratories Meeting MA Criteria
High K (n=425, n=583)
|
0 participants
|
0 participants
|
|
Short-term Period: Number of Participants With Electrolyte Laboratories Meeting MA Criteria
Low chloride (n=428, n=583)
|
0 participants
|
0 participants
|
|
Short-term Period: Number of Participants With Electrolyte Laboratories Meeting MA Criteria
High chloride (n=428, n=583)
|
0 participants
|
0 participants
|
|
Short-term Period: Number of Participants With Electrolyte Laboratories Meeting MA Criteria
Low Ca (n=428, n=583)
|
2 participants
|
0 participants
|
|
Short-term Period: Number of Participants With Electrolyte Laboratories Meeting MA Criteria
High Ca (n=428, n=583)
|
0 participants
|
0 participants
|
|
Short-term Period: Number of Participants With Electrolyte Laboratories Meeting MA Criteria
Low P (n=426, n=583)
|
1 participants
|
0 participants
|
|
Short-term Period: Number of Participants With Electrolyte Laboratories Meeting MA Criteria
High P (n=426, n=583)
|
3 participants
|
1 participants
|
PRIMARY outcome
Timeframe: Days 1-169Population: All treated participants. n=number of participants with evaluable laboratory results.
Marked abnormality criteria: serum glucose (Glu):\<65 mg/dL/ \>220 mg/dL; fasting serum Glu: \<0.8\* LLN/\>1.5\* ULN, or if BL\<LLN then use 0.8\* BL or \>ULN, or if BL\>ULN then use \>2.0\* BL or \<LLN; total protein: \<0.9\* LLN/\>1.1\* ULN; 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\* BL. Urinalysis (Urine protein, urine Glu, urine blood, leukocyte esterase, Red Blood Cells \[RBCs\], White Blood Cells \[WBCs\]):Use ≥2 when BL value missing or value ≥4,or when pre-dose=0 or 0.5. Use ≥3 when pre-dose=1. Use ≥4 when pre-dose=2 or 3
Outcome measures
| Measure |
ST Abatacept (ABA)-Previous User
n=428 Participants
In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
|
ST ABA-Current User
n=583 Participants
In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
|
|---|---|---|
|
Short-term Period: Number of Participants With Other Chemistry and Urinalysis Laboratories Meeting MA Criteria
Low Glu (n=427, n=583)
|
7 participants
|
17 participants
|
|
Short-term Period: Number of Participants With Other Chemistry and Urinalysis Laboratories Meeting MA Criteria
High Glu (n=427, n=583)
|
12 participants
|
21 participants
|
|
Short-term Period: Number of Participants With Other Chemistry and Urinalysis Laboratories Meeting MA Criteria
Low protein (n=428, n=583)
|
0 participants
|
0 participants
|
|
Short-term Period: Number of Participants With Other Chemistry and Urinalysis Laboratories Meeting MA Criteria
High protein (n=428, n=583)
|
0 participants
|
0 participants
|
|
Short-term Period: Number of Participants With Other Chemistry and Urinalysis Laboratories Meeting MA Criteria
Low albumin (n=428, n=583)
|
1 participants
|
2 participants
|
|
Short-term Period: Number of Participants With Other Chemistry and Urinalysis Laboratories Meeting MA Criteria
High uric acid (n=428, n=583)
|
0 participants
|
0 participants
|
|
Short-term Period: Number of Participants With Other Chemistry and Urinalysis Laboratories Meeting MA Criteria
High urine protein (n=298, n=421)
|
4 participants
|
2 participants
|
|
Short-term Period: Number of Participants With Other Chemistry and Urinalysis Laboratories Meeting MA Criteria
High urine glucose (n=298, n=421)
|
0 participants
|
4 participants
|
|
Short-term Period: Number of Participants With Other Chemistry and Urinalysis Laboratories Meeting MA Criteria
High urine blood (n=298, n=421)
|
5 participants
|
14 participants
|
|
Short-term Period: Number of Participants With Other Chemistry and Urinalysis Laboratories Meeting MA Criteria
High urine leukocyte esterase (n=297, n=491)
|
20 participants
|
17 participants
|
|
Short-term Period: Number of Participants With Other Chemistry and Urinalysis Laboratories Meeting MA Criteria
High urine RBC (n=68, n=98)
|
13 participants
|
17 participants
|
|
Short-term Period: Number of Participants With Other Chemistry and Urinalysis Laboratories Meeting MA Criteria
High urine WBC (n=80, n=117)
|
30 participants
|
36 participants
|
PRIMARY outcome
Timeframe: Day 1 (Baseline) -Day 169Population: Although mean values for systolic and diastolic blood pressure were recorded, mean changes from baseline were not summarized for these data.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Days 1-169Population: Treated participants with available serum samples for assay
Serum samples from all treated adult participants with active rheumatoid arthritis (RA) were screened for the presence of drug-specific antibodies using ELISA. Immunogenicity was defined as the presence of a positive anti-abatacept or anti-CTLA4 antibody.
Outcome measures
| Measure |
ST Abatacept (ABA)-Previous User
n=41 Participants
In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
|
ST ABA-Current User
In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
|
|---|---|---|
|
Short-term Period: Number of Participants With Positive Anti-Abatacept or Anti-Cytotoxic T-Lymphocyte Antigen 4 (CTLA4) Responses by Enzyme-Linked Immunosorbant Assay (ELISA)
Anti-CTLA4 antibodies
|
0 participants
|
—
|
|
Short-term Period: Number of Participants With Positive Anti-Abatacept or Anti-Cytotoxic T-Lymphocyte Antigen 4 (CTLA4) Responses by Enzyme-Linked Immunosorbant Assay (ELISA)
Anti-abatacept antibodies
|
12 participants
|
—
|
PRIMARY outcome
Timeframe: From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abataceptPopulation: All treated participants
AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with treatment.SAE=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.Related AE/SAE=Certain,Probable,Possible,or Missing relationship to Drug
Outcome measures
| Measure |
ST Abatacept (ABA)-Previous User
n=530 Participants
In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
|
ST ABA-Current User
In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
|
|---|---|---|
|
Long-term Period: Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuations, AEs, Related AEs, or AEs Leading to Discontinuations
Death
|
1 participants
|
—
|
|
Long-term Period: Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuations, AEs, Related AEs, or AEs Leading to Discontinuations
SAEs
|
61 participants
|
—
|
|
Long-term Period: Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuations, AEs, Related AEs, or AEs Leading to Discontinuations
Related SAEs
|
15 participants
|
—
|
|
Long-term Period: Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuations, AEs, Related AEs, or AEs Leading to Discontinuations
SAEs Leading to Discontinuation
|
11 participants
|
—
|
|
Long-term Period: Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuations, AEs, Related AEs, or AEs Leading to Discontinuations
AEs
|
328 participants
|
—
|
|
Long-term Period: Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuations, AEs, Related AEs, or AEs Leading to Discontinuations
Related AEs
|
146 participants
|
—
|
|
Long-term Period: Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuations, AEs, Related AEs, or AEs Leading to Discontinuations
AEs Leading to Discontinuation
|
15 participants
|
—
|
PRIMARY outcome
Timeframe: From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abataceptPopulation: All treated participants
AE=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 are those AEs that may be associated with the use of immunomodulatory drugs, including all infections, serious infections, and opportunistic infections; autoimmune disorders; neoplasms; acute infusional AEs (pre-specified AEs occurring within 1 hour of start of infusion) and peri-infusional AEs (pre-specified AEs occurring within 24 hours of the start of infusion).
Outcome measures
| Measure |
ST Abatacept (ABA)-Previous User
n=530 Participants
In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
|
ST ABA-Current User
In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
|
|---|---|---|
|
Long-term Period: Number of Participants With AEs of Special Interest
Infections (pre-specified)
|
177 participants
|
—
|
|
Long-term Period: Number of Participants With AEs of Special Interest
Malignant neoplasms
|
4 participants
|
—
|
|
Long-term Period: Number of Participants With AEs of Special Interest
Autoimmune disorders (pre-specified)
|
8 participants
|
—
|
|
Long-term Period: Number of Participants With AEs of Special Interest
Peri-infusional AEs (pre-specified)
|
42 participants
|
—
|
|
Long-term Period: Number of Participants With AEs of Special Interest
Acute infusional AEs (pre-specified)
|
14 participants
|
—
|
PRIMARY outcome
Timeframe: From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abataceptPopulation: Participants who received at least 1 infusion of abatacept during the long-term treatment period. n=number of participants with evaluable laboratory results.
ULN=upper limit of normal; LLN=lower limit of normal; BL=baseline. Marked abnormality criteria=Hemoglobin: \>3 g/dL decrease from BL; Hematocrit: \<0.75\*BL; Erythrocytes:\<0.75\*BL; Platelets: \<0.67\*LLN/\>1.5 \* ULN, or if BL\<LLN, use 0.5\*BL/\<100,000 mm\^3; Leukocytes: \<0.75\*LLN/\>1.25\*ULN, or if BL\<LLN, use \<0.8\*BL/\>ULN, or if BL\>ULN,use \>1.2\*BL/\<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 |
ST Abatacept (ABA)-Previous User
n=513 Participants
In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
|
ST ABA-Current User
In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
|
|---|---|---|
|
Long-term Period: Number of Participants With Hematology Laboratories Meeting Marked Abnormality (MA) Criteria
Low hemoglobin (n=513)
|
1 participants
|
—
|
|
Long-term Period: Number of Participants With Hematology Laboratories Meeting Marked Abnormality (MA) Criteria
Low hematocrit (n=510)
|
1 participants
|
—
|
|
Long-term Period: Number of Participants With Hematology Laboratories Meeting Marked Abnormality (MA) Criteria
Low erythrocytes (n=513)
|
1 participants
|
—
|
|
Long-term Period: Number of Participants With Hematology Laboratories Meeting Marked Abnormality (MA) Criteria
Low platelets (n=500)
|
0 participants
|
—
|
|
Long-term Period: Number of Participants With Hematology Laboratories Meeting Marked Abnormality (MA) Criteria
High platelets (n=500)
|
1 participants
|
—
|
|
Long-term Period: Number of Participants With Hematology Laboratories Meeting Marked Abnormality (MA) Criteria
Low leukocytes (n=513)
|
1 participants
|
—
|
|
Long-term Period: Number of Participants With Hematology Laboratories Meeting Marked Abnormality (MA) Criteria
High leukocytes (n=513)
|
8 participants
|
—
|
|
Long-term Period: Number of Participants With Hematology Laboratories Meeting Marked Abnormality (MA) Criteria
Low neutrophils+bands (510)
|
0 participants
|
—
|
|
Long-term Period: Number of Participants With Hematology Laboratories Meeting Marked Abnormality (MA) Criteria
Low lymphocytes (n=510)
|
34 participants
|
—
|
|
Long-term Period: Number of Participants With Hematology Laboratories Meeting Marked Abnormality (MA) Criteria
High lymphocytes (n=510)
|
0 participants
|
—
|
|
Long-term Period: Number of Participants With Hematology Laboratories Meeting Marked Abnormality (MA) Criteria
High monocytes (n=510)
|
2 participants
|
—
|
|
Long-term Period: Number of Participants With Hematology Laboratories Meeting Marked Abnormality (MA) Criteria
High basophils (n=510)
|
1 participants
|
—
|
|
Long-term Period: Number of Participants With Hematology Laboratories Meeting Marked Abnormality (MA) Criteria
High eosinophils (n=510)
|
13 participants
|
—
|
PRIMARY outcome
Timeframe: From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abataceptPopulation: All treated participants. n=number of participants with evaluable laboratory results.
Marked abnormality criteria: Alkaline phosphatase (ALP): \>2\*ULN, or if BL\>ULN, use \>3\*BL; aspartate aminotransferase (AST): \>3\*ULN, or if BL\>ULN,use \>4\*BL; alanine aminotransferase (ALT): \>3\*ULN, or if BL\>ULN, use \>4\*BL; G-Glutamyl transferase (GGT): \>2\*ULN, or if BL\>ULN, use \>3\*BL; bilirubin: \>2\*ULN, or if BL\>ULN, use \>4\*BL; blood urea nitrogen (BUN): \>2\*BL; creatinine: \>1.5\*BL
Outcome measures
| Measure |
ST Abatacept (ABA)-Previous User
n=514 Participants
In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
|
ST ABA-Current User
In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
|
|---|---|---|
|
Long-term Period: Number of Participants With Liver and Kidney Function Laboratories Meeting MA Criteria
High ALT (n=512)
|
5 participants
|
—
|
|
Long-term Period: Number of Participants With Liver and Kidney Function Laboratories Meeting MA Criteria
High ALP (n=514)
|
0 participants
|
—
|
|
Long-term Period: Number of Participants With Liver and Kidney Function Laboratories Meeting MA Criteria
High AST (n=512)
|
1 participants
|
—
|
|
Long-term Period: Number of Participants With Liver and Kidney Function Laboratories Meeting MA Criteria
High GGT (n=512)
|
10 participants
|
—
|
|
Long-term Period: Number of Participants With Liver and Kidney Function Laboratories Meeting MA Criteria
High bilirubin (n=513)
|
1 participants
|
—
|
|
Long-term Period: Number of Participants With Liver and Kidney Function Laboratories Meeting MA Criteria
High BUN (n=513)
|
5 participants
|
—
|
|
Long-term Period: Number of Participants With Liver and Kidney Function Laboratories Meeting MA Criteria
High creatinine (n=512)
|
8 participants
|
—
|
PRIMARY outcome
Timeframe: From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abataceptPopulation: All treated participants. n=number of participants with evaluable laboratory results.
Marked abnormality criteria:Sodium (Na): \<0.95\* LLN/ \>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 (K): \<0.9\* LLN/\>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/\>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 (Ca): \<0.8\* LLN/\>1.2\* ULN, or if BL\<LLN then use 0.75\* BL or \>ULN, or if BL\>ULN then use\>1.25\* BL or \<LLN; phosphorous (P): \<0.75\* LLN/ \>1.25\* ULN, or if BL\<LLN then use 0.67\* BL or \>ULN, or if BL\>ULN then use\>1.33\* BL or \<LLN
Outcome measures
| Measure |
ST Abatacept (ABA)-Previous User
n=513 Participants
In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
|
ST ABA-Current User
In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
|
|---|---|---|
|
Long-term Period: Number of Participants With Electrolyte Laboratories Meeting MA Criteria
Low Na (n=513)
|
1 participants
|
—
|
|
Long-term Period: Number of Participants With Electrolyte Laboratories Meeting MA Criteria
High Na (n=513)
|
3 participants
|
—
|
|
Long-term Period: Number of Participants With Electrolyte Laboratories Meeting MA Criteria
Low K (n=510)
|
4 participants
|
—
|
|
Long-term Period: Number of Participants With Electrolyte Laboratories Meeting MA Criteria
High K (n=510)
|
1 participants
|
—
|
|
Long-term Period: Number of Participants With Electrolyte Laboratories Meeting MA Criteria
Low chloride (n=513)
|
1 participants
|
—
|
|
Long-term Period: Number of Participants With Electrolyte Laboratories Meeting MA Criteria
High chloride (n=513)
|
1 participants
|
—
|
|
Long-term Period: Number of Participants With Electrolyte Laboratories Meeting MA Criteria
Low Ca (n=513)
|
0 participants
|
—
|
|
Long-term Period: Number of Participants With Electrolyte Laboratories Meeting MA Criteria
High Ca (n=513)
|
1 participants
|
—
|
|
Long-term Period: Number of Participants With Electrolyte Laboratories Meeting MA Criteria
Low P (n=512)
|
0 participants
|
—
|
|
Long-term Period: Number of Participants With Electrolyte Laboratories Meeting MA Criteria
High P (n=512)
|
3 participants
|
—
|
PRIMARY outcome
Timeframe: From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abataceptPopulation: All treated participants. n=number of participants with evaluable laboratory results.
Marked abnormality criteria: serum glucose (Glu):\<65 mg/dL/ \>220 mg/dL; fasting serum Glu: \<0.8\* LLN/\>1.5\* ULN, or if BL\<LLN then use 0.8\* BL or \>ULN, or if BL\>ULN then use \>2.0\* BL or \<LLN; total protein: \<0.9\* LLN/\>1.1\* ULN; 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\* BL. Urinalysis (Urine protein, urine Glu, urine blood, leukocyte esterase, Red Blood Cells \[RBCs\], White Blood Cells \[WBCs\]):Use ≥2 when BL value missing or value ≥4,or when pre-dose=0 or 0.5. Use ≥3 when pre-dose=1. Use ≥4 when pre-dose=2 or 3
Outcome measures
| Measure |
ST Abatacept (ABA)-Previous User
n=513 Participants
In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
|
ST ABA-Current User
In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
|
|---|---|---|
|
Long-term Period: Number of Participants With Other Chemistry and Urinalysis Laboratories Meeting MA Criteria
Low glu (n=513)
|
15 participants
|
—
|
|
Long-term Period: Number of Participants With Other Chemistry and Urinalysis Laboratories Meeting MA Criteria
High glu (n=513)
|
17 participants
|
—
|
|
Long-term Period: Number of Participants With Other Chemistry and Urinalysis Laboratories Meeting MA Criteria
Low protein (n=513)
|
1 participants
|
—
|
|
Long-term Period: Number of Participants With Other Chemistry and Urinalysis Laboratories Meeting MA Criteria
High protein (n=513)
|
0 participants
|
—
|
|
Long-term Period: Number of Participants With Other Chemistry and Urinalysis Laboratories Meeting MA Criteria
Low albumin (n=511)
|
1 participants
|
—
|
|
Long-term Period: Number of Participants With Other Chemistry and Urinalysis Laboratories Meeting MA Criteria
High uric acid (n=513)
|
0 participants
|
—
|
|
Long-term Period: Number of Participants With Other Chemistry and Urinalysis Laboratories Meeting MA Criteria
High urine protein (n=462)
|
4 participants
|
—
|
|
Long-term Period: Number of Participants With Other Chemistry and Urinalysis Laboratories Meeting MA Criteria
High urine glucose (n=462)
|
5 participants
|
—
|
|
Long-term Period: Number of Participants With Other Chemistry and Urinalysis Laboratories Meeting MA Criteria
High urine blood (n=462)
|
10 participants
|
—
|
|
Long-term Period: Number of Participants With Other Chemistry and Urinalysis Laboratories Meeting MA Criteria
High urine leukocyte esterase (n=462)
|
13 participants
|
—
|
|
Long-term Period: Number of Participants With Other Chemistry and Urinalysis Laboratories Meeting MA Criteria
High urine RBC (n=91)
|
24 participants
|
—
|
|
Long-term Period: Number of Participants With Other Chemistry and Urinalysis Laboratories Meeting MA Criteria
High urine WBC (n=91)
|
11 participants
|
—
|
PRIMARY outcome
Timeframe: BL, Day 365, Day 729Population: All treated participants in the OL. n=number of participants with evaluable laboratory results.
HGB normal range (NR)=11.6 - 16.2 g/dL, marked abnormality (MA) is \>3 g/dL decrease from BL. Total protein NR=6.0 - 8.4 g/dL, MA is \<0.9\* LLN/\>1.1\* ULN; Albumin NR=3.5 - 5.3 g/dL, MA is \<0.9\* LLN, or if BL\<LLN then use \<0.75 BL
Outcome measures
| Measure |
ST Abatacept (ABA)-Previous User
n=218 Participants
In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
|
ST ABA-Current User
In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
|
|---|---|---|
|
Long-term Period: Change From Baseline in Hemoglobin (HGB), Total Protein, and Albumin Over Time
Day 365 HGB (n=218)
|
0.40 g/dL
Standard Deviation 0.08
|
—
|
|
Long-term Period: Change From Baseline in Hemoglobin (HGB), Total Protein, and Albumin Over Time
Day 365 total protein (n=217)
|
-0.22 g/dL
Standard Deviation 0.04
|
—
|
|
Long-term Period: Change From Baseline in Hemoglobin (HGB), Total Protein, and Albumin Over Time
Day 365 albumin (n=217)
|
0.13 g/dL
Standard Deviation 0.02
|
—
|
|
Long-term Period: Change From Baseline in Hemoglobin (HGB), Total Protein, and Albumin Over Time
Day 729 HGB (n=62)
|
0.47 g/dL
Standard Deviation 0.18
|
—
|
|
Long-term Period: Change From Baseline in Hemoglobin (HGB), Total Protein, and Albumin Over Time
Day 729 total protein (n=65)
|
-0.59 g/dL
Standard Deviation 0.07
|
—
|
|
Long-term Period: Change From Baseline in Hemoglobin (HGB), Total Protein, and Albumin Over Time
Day 729 albumin (n=65)
|
0.16 g/dL
Standard Deviation 0.04
|
—
|
PRIMARY outcome
Timeframe: BL, Day 365, Day 729Population: All treated participants in the OL. n=number of participants with evaluable laboratory results.
The hematocrit value refers to the percentage of blood volume that is occupied by red blood cells. Hematocrit values for participants were expressed as percentages and were averaged to yield a group mean value (percentage) at a particular time point. The mean change from baseline in hematocrit value (expressed as a percent)= mean post-baseline value (expressed as a percent) - mean baseline value (expressed as a percent).
Outcome measures
| Measure |
ST Abatacept (ABA)-Previous User
n=213 Participants
In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
|
ST ABA-Current User
In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
|
|---|---|---|
|
Long-term Period: Change From Baseline in Hematocrit Over Time
Day 365 hematocrit (n=213)
|
1.00 percentage change
Standard Deviation 0.22
|
—
|
|
Long-term Period: Change From Baseline in Hematocrit Over Time
Day 729 HGB (n=61)
|
0.81 percentage change
Standard Deviation 0.47
|
—
|
PRIMARY outcome
Timeframe: BL, Day 365, Day 729Population: All treated participants in the OL. n=number of participants with evaluable laboratory results.
Erythrocytes NR= 3.80 - 5.50 \*10\^6 c/uL, MA is \<0.75 \* BL
Outcome measures
| Measure |
ST Abatacept (ABA)-Previous User
n=218 Participants
In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
|
ST ABA-Current User
In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
|
|---|---|---|
|
Long-term Period: Change From Baseline in Erythrocytes Over Time
Day 365 erythrocytes (n=218)
|
0.04 10^6 c/uL
Standard Deviation 0.02
|
—
|
|
Long-term Period: Change From Baseline in Erythrocytes Over Time
Day 729 erythrocytes (n=62)
|
0.06 10^6 c/uL
Standard Deviation 0.04
|
—
|
PRIMARY outcome
Timeframe: BL, Day 365, Day 729Population: All treated participants in the OL. n=number of participants with evaluable laboratory results.
Erythrocytes NR= 3.80 - 5.50 \*10\^6 c/uL, MA is \<0.75 \* BL
Outcome measures
| Measure |
ST Abatacept (ABA)-Previous User
n=214 Participants
In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
|
ST ABA-Current User
In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
|
|---|---|---|
|
Long-term Period: Change From Baseline in Platelets (PLT) Over Time
Day 365 PLT (n=214)
|
-41.2 10^9 c/L
Standard Deviation 6.24
|
—
|
|
Long-term Period: Change From Baseline in Platelets (PLT) Over Time
Day 729 PLT (n=61)
|
-67.7 10^9 c/L
Standard Deviation 11.02
|
—
|
PRIMARY outcome
Timeframe: BL, Day 365, Day 729Population: All treated participants in the OL. n=number of participants with evaluable laboratory results.
Leukocytes NR=4.1 - 12.3\*10\^3 c/uL, MA is \<0.75 \* LLN/ \>1.25 \* ULN, or if BL\<LLN then use \<0.8 \* BL/\>ULN, or if BL\>ULN then use \>1.2 \* BL/\<LLN. Neutrophils+bands MA is \<1.0 \* 10\^3 c/uL. Eosinophils MA is \>0.750 \* 10\^3 c/uL. Basophils MA is \> 400 mm\^3. Monocytes MA is \>2000 mm\^3. Lymphocytes MA is \<0.750 \* 10\^3 c/uL/ \>7.50 \* 10\^3 c/uL
Outcome measures
| Measure |
ST Abatacept (ABA)-Previous User
n=218 Participants
In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
|
ST ABA-Current User
In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
|
|---|---|---|
|
Long-term Period: Change From Baseline in White Blood Cells Over Time
Day 729 basophils (n=62)
|
0.00 10^3 c/uL
Standard Deviation 0.00
|
—
|
|
Long-term Period: Change From Baseline in White Blood Cells Over Time
Day 365 leukocytes (n=218)
|
-0.86 10^3 c/uL
Standard Deviation 0.17
|
—
|
|
Long-term Period: Change From Baseline in White Blood Cells Over Time
Day 365 neutrophils (n=215)
|
-0.83 10^3 c/uL
Standard Deviation 0.16
|
—
|
|
Long-term Period: Change From Baseline in White Blood Cells Over Time
Day 365 eosinophils (n=215)
|
-0.01 10^3 c/uL
Standard Deviation 0.01
|
—
|
|
Long-term Period: Change From Baseline in White Blood Cells Over Time
Day 365 monocytes (n=215)
|
0.00 10^3 c/uL
Standard Deviation 0.02
|
—
|
|
Long-term Period: Change From Baseline in White Blood Cells Over Time
Day 365 basophils (n=215)
|
0.00 10^3 c/uL
Standard Deviation 0.00
|
—
|
|
Long-term Period: Change From Baseline in White Blood Cells Over Time
Day 365 lymphocytes (n=215)
|
0.08 10^3 c/uL
Standard Deviation 0.05
|
—
|
|
Long-term Period: Change From Baseline in White Blood Cells Over Time
Day 729 leukocytes (n=62)
|
-1.49 10^3 c/uL
Standard Deviation 0.26
|
—
|
|
Long-term Period: Change From Baseline in White Blood Cells Over Time
Day 729 neutrophils (n=62)
|
-1.56 10^3 c/uL
Standard Deviation 0.27
|
—
|
|
Long-term Period: Change From Baseline in White Blood Cells Over Time
Day 729 eosinophils (n=62)
|
-0.02 10^3 c/uL
Standard Deviation 0.02
|
—
|
|
Long-term Period: Change From Baseline in White Blood Cells Over Time
Day 729 monocytes (n=62)
|
-0.01 10^3 c/uL
Standard Deviation 0.03
|
—
|
|
Long-term Period: Change From Baseline in White Blood Cells Over Time
Day 729 lymphocytes (n=62)
|
0.10 10^3 c/uL
Standard Deviation 0.09
|
—
|
PRIMARY outcome
Timeframe: BL, Day 365, Day 729Population: All treated participants in the OL. n=number of participants with evaluable laboratory results.
HGB normal range (NR)=11.6 - 16.2 g/dL, marked abnormality (MA) is \>3 g/dL decrease from BL. Total protein NR=6.0 - 8.4 g/dL, MA is \<0.9\* LLN/\>1.1\* ULN; Albumin NR=3.5 - 5.3 g/dL, MA is \<0.9\* LLN, or if BL\<LLN then use \<0.75 BL
Outcome measures
| Measure |
ST Abatacept (ABA)-Previous User
n=218 Participants
In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
|
ST ABA-Current User
In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
|
|---|---|---|
|
Long-term Period: Change From Baseline in Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), and G-Glutamyl Transferase (GGT) Over Time
Day 365 ALP (n=218)
|
0.81 U/L
Standard Deviation 2.64
|
—
|
|
Long-term Period: Change From Baseline in Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), and G-Glutamyl Transferase (GGT) Over Time
Day 365 AST (n=212)
|
0.64 U/L
Standard Deviation 1.09
|
—
|
|
Long-term Period: Change From Baseline in Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), and G-Glutamyl Transferase (GGT) Over Time
Day 365 ALT (n=212)
|
0.76 U/L
Standard Deviation 1.80
|
—
|
|
Long-term Period: Change From Baseline in Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), and G-Glutamyl Transferase (GGT) Over Time
Day 365 GGT (n=217)
|
2.21 U/L
Standard Deviation 3.61
|
—
|
|
Long-term Period: Change From Baseline in Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), and G-Glutamyl Transferase (GGT) Over Time
Day 729 ALP (n=64)
|
-8.44 U/L
Standard Deviation 5.82
|
—
|
|
Long-term Period: Change From Baseline in Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), and G-Glutamyl Transferase (GGT) Over Time
Day 729 AST (n=63)
|
1.35 U/L
Standard Deviation 2.38
|
—
|
|
Long-term Period: Change From Baseline in Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), and G-Glutamyl Transferase (GGT) Over Time
Day 729 ALT (n=63)
|
2.60 U/L
Standard Deviation 3.92
|
—
|
|
Long-term Period: Change From Baseline in Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), and G-Glutamyl Transferase (GGT) Over Time
Day 729 GGT (n=64)
|
0.13 U/L
Standard Deviation 2.34
|
—
|
PRIMARY outcome
Timeframe: BL, Day 365, Day 729Population: All treated participants in the OL. n=number of participants with evaluable laboratory results.
Bilirubin NR=0.2-1.2 mg/dL, MA: \>2\* ULN, or if BL\>ULN then use \>4\* BL. BUN NR=4.0-24.0 mg/dL, MA: \>2\*BL. Creatinine NR=0.4-1.2 mg/dL, MA: \>1.5\*BL. Ca NR=8.8-10.2 mg/dL, MA: \<0.8\*LLN/\>1.2\*ULN, or if BL\<LLN then use 0.75\*BL or \>ULN, or if BL\>ULN then use\>1.25\*BL or \<LLN. P NR=2.8-4.0 mg/dL, MA: \<0.75\*LLN/ \>1.25\*ULN, or if BL\<LLN then use 0.67\*BL or \>ULN, or if BL\>ULN then use\>1.33\*BL or \<LLN. Glu MA: \<65 mg/dL/ \>220 mg/dL. Uric acid MA: \>1.5\*ULN, or if BL\>ULN then use \>2\*BL.
Outcome measures
| Measure |
ST Abatacept (ABA)-Previous User
n=217 Participants
In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
|
ST ABA-Current User
In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
|
|---|---|---|
|
Long-term Period: Change From Baseline in Bilirubin, Blood Urea Nitrogen (BUN), Creatinine, Calcium (Ca), Phosphorus (P), Serum Glucose (Glu), and Uric Acid Over Time
Day 365 bilirubin (n=210)
|
0.04 mg/dL
Standard Deviation 0.01
|
—
|
|
Long-term Period: Change From Baseline in Bilirubin, Blood Urea Nitrogen (BUN), Creatinine, Calcium (Ca), Phosphorus (P), Serum Glucose (Glu), and Uric Acid Over Time
Day 365 BUN (n=217)
|
0.85 mg/dL
Standard Deviation 0.31
|
—
|
|
Long-term Period: Change From Baseline in Bilirubin, Blood Urea Nitrogen (BUN), Creatinine, Calcium (Ca), Phosphorus (P), Serum Glucose (Glu), and Uric Acid Over Time
Day 365 creatinine (n=217)
|
0.05 mg/dL
Standard Deviation 0.01
|
—
|
|
Long-term Period: Change From Baseline in Bilirubin, Blood Urea Nitrogen (BUN), Creatinine, Calcium (Ca), Phosphorus (P), Serum Glucose (Glu), and Uric Acid Over Time
Day 365 Ca (n=217)
|
0.11 mg/dL
Standard Deviation 0.03
|
—
|
|
Long-term Period: Change From Baseline in Bilirubin, Blood Urea Nitrogen (BUN), Creatinine, Calcium (Ca), Phosphorus (P), Serum Glucose (Glu), and Uric Acid Over Time
Day 365 P (n=217)
|
0.13 mg/dL
Standard Deviation 0.04
|
—
|
|
Long-term Period: Change From Baseline in Bilirubin, Blood Urea Nitrogen (BUN), Creatinine, Calcium (Ca), Phosphorus (P), Serum Glucose (Glu), and Uric Acid Over Time
Day 365 Glu (n=217)
|
0.83 mg/dL
Standard Deviation 2.26
|
—
|
|
Long-term Period: Change From Baseline in Bilirubin, Blood Urea Nitrogen (BUN), Creatinine, Calcium (Ca), Phosphorus (P), Serum Glucose (Glu), and Uric Acid Over Time
Day 365 uric acid (n=217)
|
-0.18 mg/dL
Standard Deviation 0.07
|
—
|
|
Long-term Period: Change From Baseline in Bilirubin, Blood Urea Nitrogen (BUN), Creatinine, Calcium (Ca), Phosphorus (P), Serum Glucose (Glu), and Uric Acid Over Time
Day 729 bilirubin (n=65)
|
-0.01 mg/dL
Standard Deviation 0.02
|
—
|
|
Long-term Period: Change From Baseline in Bilirubin, Blood Urea Nitrogen (BUN), Creatinine, Calcium (Ca), Phosphorus (P), Serum Glucose (Glu), and Uric Acid Over Time
Day 729 BUN (n=65)
|
0.77 mg/dL
Standard Deviation 0.54
|
—
|
|
Long-term Period: Change From Baseline in Bilirubin, Blood Urea Nitrogen (BUN), Creatinine, Calcium (Ca), Phosphorus (P), Serum Glucose (Glu), and Uric Acid Over Time
Day 729 creatinine (n=65)
|
0.04 mg/dL
Standard Deviation 0.02
|
—
|
|
Long-term Period: Change From Baseline in Bilirubin, Blood Urea Nitrogen (BUN), Creatinine, Calcium (Ca), Phosphorus (P), Serum Glucose (Glu), and Uric Acid Over Time
Day 729 Ca (n=65)
|
0.07 mg/dL
Standard Deviation 0.06
|
—
|
|
Long-term Period: Change From Baseline in Bilirubin, Blood Urea Nitrogen (BUN), Creatinine, Calcium (Ca), Phosphorus (P), Serum Glucose (Glu), and Uric Acid Over Time
Day 729 P (n=64)
|
-0.77 mg/dL
Standard Deviation 0.08
|
—
|
|
Long-term Period: Change From Baseline in Bilirubin, Blood Urea Nitrogen (BUN), Creatinine, Calcium (Ca), Phosphorus (P), Serum Glucose (Glu), and Uric Acid Over Time
Day 729 Glu (n=64)
|
1.71 mg/dL
Standard Deviation 2.94
|
—
|
|
Long-term Period: Change From Baseline in Bilirubin, Blood Urea Nitrogen (BUN), Creatinine, Calcium (Ca), Phosphorus (P), Serum Glucose (Glu), and Uric Acid Over Time
Day 729 uric acid (n=65)
|
0.11 mg/dL
Standard Deviation 0.11
|
—
|
PRIMARY outcome
Timeframe: BL, Day 365, Day 729Population: All treated participants in the OL. n=number of participants with evaluable laboratory results.
Na NR=132 - 147 mEq/L, MA is 95\* LLN/ \>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. K NR=3.3 - 5.5 mEq/L, MA is \<0.9\* LLN/\>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. Cl NR=94 - 111 mEq/L, MA is \<0.9\* LLN/\>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
Outcome measures
| Measure |
ST Abatacept (ABA)-Previous User
n=217 Participants
In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
|
ST ABA-Current User
In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
|
|---|---|---|
|
LT; Change From Baseline in Sodium (Na), Potassium (K), Chloride (Cl) Over Time
Day 365 Na (n=216)
|
-0.91 mEq/L
Standard Deviation 0.25
|
—
|
|
LT; Change From Baseline in Sodium (Na), Potassium (K), Chloride (Cl) Over Time
Day 365 K (n=210)
|
-0.08 mEq/L
Standard Deviation 0.03
|
—
|
|
LT; Change From Baseline in Sodium (Na), Potassium (K), Chloride (Cl) Over Time
Day 365 Cl (n=217)
|
-0.37 mEq/L
Standard Deviation 0.25
|
—
|
|
LT; Change From Baseline in Sodium (Na), Potassium (K), Chloride (Cl) Over Time
Day 729 Na (n=65)
|
1.23 mEq/L
Standard Deviation 0.33
|
—
|
|
LT; Change From Baseline in Sodium (Na), Potassium (K), Chloride (Cl) Over Time
Day 729 K (n=63)
|
-0.06 mEq/L
Standard Deviation 0.06
|
—
|
|
LT; Change From Baseline in Sodium (Na), Potassium (K), Chloride (Cl) Over Time
Day 729 Cl (n=65)
|
1.42 mEq/L
Standard Deviation 0.37
|
—
|
PRIMARY outcome
Timeframe: From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abataceptPopulation: All treated participants. n=number of participants with evaluable blood pressure measurements.
Measurements were taken in a seated position before and after abatacept infusion.
Outcome measures
| Measure |
ST Abatacept (ABA)-Previous User
n=482 Participants
In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
|
ST ABA-Current User
In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
|
|---|---|---|
|
Long-term Period: Mean Sitting Systolic Blood Pressure (SBP) Over Time
Day 169 SBP pre-infusion (n=482)
|
125.1 mm Hg
Standard Deviation 16.02
|
—
|
|
Long-term Period: Mean Sitting Systolic Blood Pressure (SBP) Over Time
Day 169 SBP post-infusion (n=478)
|
125.3 mm Hg
Standard Deviation 16.03
|
—
|
|
Long-term Period: Mean Sitting Systolic Blood Pressure (SBP) Over Time
Day 197 SBP pre-infusion (n=414)
|
124.4 mm Hg
Standard Deviation 16.98
|
—
|
|
Long-term Period: Mean Sitting Systolic Blood Pressure (SBP) Over Time
Day 197 SBP post-infusion (n=415)
|
123.9 mm Hg
Standard Deviation 16.84
|
—
|
|
Long-term Period: Mean Sitting Systolic Blood Pressure (SBP) Over Time
Day 225 SBP pre-infusion (n=340)
|
123.9 mm Hg
Standard Deviation 16.33
|
—
|
|
Long-term Period: Mean Sitting Systolic Blood Pressure (SBP) Over Time
Day 225 SBP post-infusion (n=338)
|
123.4 mm Hg
Standard Deviation 16.59
|
—
|
|
Long-term Period: Mean Sitting Systolic Blood Pressure (SBP) Over Time
Day 253 SBP pre-infusion (n=251)
|
124.0 mm Hg
Standard Deviation 17.47
|
—
|
|
Long-term Period: Mean Sitting Systolic Blood Pressure (SBP) Over Time
Day 253 SBP post-infusion (n=251)
|
124.9 mm Hg
Standard Deviation 16.57
|
—
|
|
Long-term Period: Mean Sitting Systolic Blood Pressure (SBP) Over Time
Day 281 SBP pre-infusion (n=203)
|
124.2 mm Hg
Standard Deviation 17.25
|
—
|
|
Long-term Period: Mean Sitting Systolic Blood Pressure (SBP) Over Time
Day 281 SBP post-infusion (n=202)
|
124.8 mm Hg
Standard Deviation 16.62
|
—
|
|
Long-term Period: Mean Sitting Systolic Blood Pressure (SBP) Over Time
Day 309 SBP pre-infusion (n=160)
|
124.1 mm Hg
Standard Deviation 18.09
|
—
|
|
Long-term Period: Mean Sitting Systolic Blood Pressure (SBP) Over Time
Day 309 SBP post-infusion (n=159)
|
123.8 mm Hg
Standard Deviation 17.58
|
—
|
|
Long-term Period: Mean Sitting Systolic Blood Pressure (SBP) Over Time
Day 337 SBP pre-infusion (n=128)
|
124.8 mm Hg
Standard Deviation 16.84
|
—
|
|
Long-term Period: Mean Sitting Systolic Blood Pressure (SBP) Over Time
Day 337 SBP post-infusion (n=128)
|
124.0 mm Hg
Standard Deviation 18.84
|
—
|
|
Long-term Period: Mean Sitting Systolic Blood Pressure (SBP) Over Time
Day 365 SBP pre-infusion (n=118)
|
126.2 mm Hg
Standard Deviation 17.47
|
—
|
|
Long-term Period: Mean Sitting Systolic Blood Pressure (SBP) Over Time
Day 365 SBP post-infusion (n=120)
|
125.0 mm Hg
Standard Deviation 15.85
|
—
|
|
Long-term Period: Mean Sitting Systolic Blood Pressure (SBP) Over Time
Day 393 SBP pre-infusion (n=101)
|
123.0 mm Hg
Standard Deviation 18.74
|
—
|
|
Long-term Period: Mean Sitting Systolic Blood Pressure (SBP) Over Time
Day 393 SBP post-infusion (n=99)
|
124.1 mm Hg
Standard Deviation 17.06
|
—
|
|
Long-term Period: Mean Sitting Systolic Blood Pressure (SBP) Over Time
Day 421 SBP post-infusion (n=93)
|
124.4 mm Hg
Standard Deviation 15.84
|
—
|
|
Long-term Period: Mean Sitting Systolic Blood Pressure (SBP) Over Time
Day 449 SBP pre-infusion (n=82)
|
125.8 mm Hg
Standard Deviation 18.29
|
—
|
|
Long-term Period: Mean Sitting Systolic Blood Pressure (SBP) Over Time
Day 449 SBP post-infusion (n=82)
|
124.0 mm Hg
Standard Deviation 17.25
|
—
|
|
Long-term Period: Mean Sitting Systolic Blood Pressure (SBP) Over Time
Day 477 SBP pre-infusion (n=75)
|
125.3 mm Hg
Standard Deviation 19.03
|
—
|
|
Long-term Period: Mean Sitting Systolic Blood Pressure (SBP) Over Time
Day 477 SBP post-infusion (n=75)
|
122.9 mm Hg
Standard Deviation 16.36
|
—
|
|
Long-term Period: Mean Sitting Systolic Blood Pressure (SBP) Over Time
Day 505 SBP pre-infusion (n=72)
|
124.3 mm Hg
Standard Deviation 20.88
|
—
|
|
Long-term Period: Mean Sitting Systolic Blood Pressure (SBP) Over Time
Day 505 SBP post-infusion (n=73)
|
122.7 mm Hg
Standard Deviation 17.08
|
—
|
|
Long-term Period: Mean Sitting Systolic Blood Pressure (SBP) Over Time
Day 533 SBP pre-infusion (n=67)
|
125.4 mm Hg
Standard Deviation 16.73
|
—
|
|
Long-term Period: Mean Sitting Systolic Blood Pressure (SBP) Over Time
Day 533 SBP post-infusion (n=66)
|
125.2 mm Hg
Standard Deviation 17.57
|
—
|
|
Long-term Period: Mean Sitting Systolic Blood Pressure (SBP) Over Time
Day 561 SBP pre-infusion (n=63)
|
121.6 mm Hg
Standard Deviation 18.36
|
—
|
|
Long-term Period: Mean Sitting Systolic Blood Pressure (SBP) Over Time
Day 561 SBP post-infusion (n=63)
|
120.6 mm Hg
Standard Deviation 18.94
|
—
|
|
Long-term Period: Mean Sitting Systolic Blood Pressure (SBP) Over Time
Day 589 SBP pre-infusion (n=57)
|
119.6 mm Hg
Standard Deviation 15.98
|
—
|
|
Long-term Period: Mean Sitting Systolic Blood Pressure (SBP) Over Time
Day 589 SBP post-infusion (n=57)
|
121.1 mm Hg
Standard Deviation 18.49
|
—
|
|
Long-term Period: Mean Sitting Systolic Blood Pressure (SBP) Over Time
Day 617 SBP pre-infusion (n=56)
|
122.1 mm Hg
Standard Deviation 15.62
|
—
|
|
Long-term Period: Mean Sitting Systolic Blood Pressure (SBP) Over Time
Day 617 SBP post-infusion (n=56)
|
122.3 mm Hg
Standard Deviation 18.57
|
—
|
|
Long-term Period: Mean Sitting Systolic Blood Pressure (SBP) Over Time
Day 645 SBP pre-infusion (n=44)
|
120.0 mm Hg
Standard Deviation 18.78
|
—
|
|
Long-term Period: Mean Sitting Systolic Blood Pressure (SBP) Over Time
Day 645 SBP post-infusion (n=43)
|
121.8 mm Hg
Standard Deviation 18.33
|
—
|
|
Long-term Period: Mean Sitting Systolic Blood Pressure (SBP) Over Time
Day 673 SBP pre-infusion (n=40)
|
123.4 mm Hg
Standard Deviation 18.53
|
—
|
|
Long-term Period: Mean Sitting Systolic Blood Pressure (SBP) Over Time
Day 673 SBP post-infusion (n=41)
|
123.6 mm Hg
Standard Deviation 17.90
|
—
|
|
Long-term Period: Mean Sitting Systolic Blood Pressure (SBP) Over Time
Day 701 SBP pre-infusion (n=35)
|
119.4 mm Hg
Standard Deviation 16.82
|
—
|
|
Long-term Period: Mean Sitting Systolic Blood Pressure (SBP) Over Time
Day 701 SBP post-infusion (n=36)
|
117.6 mm Hg
Standard Deviation 15.57
|
—
|
|
Long-term Period: Mean Sitting Systolic Blood Pressure (SBP) Over Time
Day 729 SBP pre-infusion (n=32)
|
121.5 mm Hg
Standard Deviation 21.43
|
—
|
|
Long-term Period: Mean Sitting Systolic Blood Pressure (SBP) Over Time
Day 729 SBP post-infusion (n=32)
|
121.9 mm Hg
Standard Deviation 17.48
|
—
|
|
Long-term Period: Mean Sitting Systolic Blood Pressure (SBP) Over Time
Day 757 SBP pre-infusion (n=30)
|
121.1 mm Hg
Standard Deviation 16.36
|
—
|
|
Long-term Period: Mean Sitting Systolic Blood Pressure (SBP) Over Time
Day 757 SBP post-infusion (n=29)
|
118.3 mm Hg
Standard Deviation 19.11
|
—
|
|
Long-term Period: Mean Sitting Systolic Blood Pressure (SBP) Over Time
Day 785 SBP pre-infusion (n=25)
|
119.1 mm Hg
Standard Deviation 19.97
|
—
|
|
Long-term Period: Mean Sitting Systolic Blood Pressure (SBP) Over Time
Day 785 SBP post-infusion (n=25)
|
117.3 mm Hg
Standard Deviation 18.64
|
—
|
|
Long-term Period: Mean Sitting Systolic Blood Pressure (SBP) Over Time
Day 813 SBP pre-infusion (n=23)
|
118.4 mm Hg
Standard Deviation 12.24
|
—
|
|
Long-term Period: Mean Sitting Systolic Blood Pressure (SBP) Over Time
Day 813 SBP post-infusion (n=22)
|
123.0 mm Hg
Standard Deviation 14.08
|
—
|
|
Long-term Period: Mean Sitting Systolic Blood Pressure (SBP) Over Time
Day 841 SBP pre-infusion (n=19)
|
115.3 mm Hg
Standard Deviation 15.92
|
—
|
|
Long-term Period: Mean Sitting Systolic Blood Pressure (SBP) Over Time
Day 841 SBP post-infusion (n=19)
|
119.1 mm Hg
Standard Deviation 18.52
|
—
|
|
Long-term Period: Mean Sitting Systolic Blood Pressure (SBP) Over Time
Day 869 SBP pre-infusion (n=18)
|
117.6 mm Hg
Standard Deviation 14.84
|
—
|
|
Long-term Period: Mean Sitting Systolic Blood Pressure (SBP) Over Time
Day 869 SBP post-infusion (n=18)
|
117.6 mm Hg
Standard Deviation 14.22
|
—
|
|
Long-term Period: Mean Sitting Systolic Blood Pressure (SBP) Over Time
Day 897 SBP pre-infusion (n=19)
|
116.4 mm Hg
Standard Deviation 14.18
|
—
|
|
Long-term Period: Mean Sitting Systolic Blood Pressure (SBP) Over Time
Day 897 SBP post-infusion (n=19)
|
115.4 mm Hg
Standard Deviation 12.81
|
—
|
|
Long-term Period: Mean Sitting Systolic Blood Pressure (SBP) Over Time
Day 925 SBP pre-infusion (n=19)
|
116.4 mm Hg
Standard Deviation 16.33
|
—
|
|
Long-term Period: Mean Sitting Systolic Blood Pressure (SBP) Over Time
Day 925 SBP post-infusion (n=19)
|
118.2 mm Hg
Standard Deviation 18.78
|
—
|
|
Long-term Period: Mean Sitting Systolic Blood Pressure (SBP) Over Time
Day 953 SBP pre-infusion (n=19)
|
116.8 mm Hg
Standard Deviation 15.97
|
—
|
|
Long-term Period: Mean Sitting Systolic Blood Pressure (SBP) Over Time
Day 953 SBP post-infusion (n=19)
|
119.5 mm Hg
Standard Deviation 20.01
|
—
|
|
Long-term Period: Mean Sitting Systolic Blood Pressure (SBP) Over Time
Day 981 SBP pre-infusion (n=18)
|
115.6 mm Hg
Standard Deviation 16.18
|
—
|
|
Long-term Period: Mean Sitting Systolic Blood Pressure (SBP) Over Time
Day 981 SBP post-infusion (n=18)
|
118.4 mm Hg
Standard Deviation 18.75
|
—
|
|
Long-term Period: Mean Sitting Systolic Blood Pressure (SBP) Over Time
Day 1009 SBP pre-infusion (n=19)
|
116.8 mm Hg
Standard Deviation 20.57
|
—
|
|
Long-term Period: Mean Sitting Systolic Blood Pressure (SBP) Over Time
Day 1009 SBP post-infusion (n=19)
|
118.9 mm Hg
Standard Deviation 13.70
|
—
|
|
Long-term Period: Mean Sitting Systolic Blood Pressure (SBP) Over Time
Day 1037 SBP pre-infusion (n=15)
|
113.5 mm Hg
Standard Deviation 16.51
|
—
|
|
Long-term Period: Mean Sitting Systolic Blood Pressure (SBP) Over Time
Day 1037 SBP post-infusion (n=15)
|
115.3 mm Hg
Standard Deviation 15.39
|
—
|
|
Long-term Period: Mean Sitting Systolic Blood Pressure (SBP) Over Time
Day 1065 SBP pre-infusion (n=14)
|
123.1 mm Hg
Standard Deviation 24.47
|
—
|
|
Long-term Period: Mean Sitting Systolic Blood Pressure (SBP) Over Time
Day 1065 SBP post-infusion (n=14)
|
119.4 mm Hg
Standard Deviation 16.84
|
—
|
|
Long-term Period: Mean Sitting Systolic Blood Pressure (SBP) Over Time
Day 1093 SBP pre-infusion (n=10)
|
116.5 mm Hg
Standard Deviation 18.31
|
—
|
|
Long-term Period: Mean Sitting Systolic Blood Pressure (SBP) Over Time
Day 1093 SBP post-infusion (n=10)
|
113.5 mm Hg
Standard Deviation 14.54
|
—
|
|
Long-term Period: Mean Sitting Systolic Blood Pressure (SBP) Over Time
Day 1121 SBP pre-infusion (n=7)
|
118.3 mm Hg
Standard Deviation 20.93
|
—
|
|
Long-term Period: Mean Sitting Systolic Blood Pressure (SBP) Over Time
Day 1121 SBP post-infusion (n=7)
|
115.1 mm Hg
Standard Deviation 11.87
|
—
|
|
Long-term Period: Mean Sitting Systolic Blood Pressure (SBP) Over Time
Day 1149 SBP pre-infusion (n=7)
|
116.9 mm Hg
Standard Deviation 13.91
|
—
|
|
Long-term Period: Mean Sitting Systolic Blood Pressure (SBP) Over Time
Day 1149 SBP post-infusion (n=7)
|
116.4 mm Hg
Standard Deviation 8.98
|
—
|
|
Long-term Period: Mean Sitting Systolic Blood Pressure (SBP) Over Time
Day 1177 SBP pre-infusion (n=7)
|
114.6 mm Hg
Standard Deviation 12.43
|
—
|
|
Long-term Period: Mean Sitting Systolic Blood Pressure (SBP) Over Time
Day 1177 SBP post-infusion (n=7)
|
114.6 mm Hg
Standard Deviation 7.72
|
—
|
PRIMARY outcome
Timeframe: From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abataceptPopulation: All treated participants. n=number of participants with evaluable blood pressure readings.
Measurements were taken in a seated position before and after abatacept infusion.
Outcome measures
| Measure |
ST Abatacept (ABA)-Previous User
n=481 Participants
In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
|
ST ABA-Current User
In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
|
|---|---|---|
|
Long-term Period: Mean Sitting Diastolic Blood Pressure (DBP) Over Time
Day 673 DBP post-infusion (n=41)
|
75.1 mm Hg
Standard Deviation 10.41
|
—
|
|
Long-term Period: Mean Sitting Diastolic Blood Pressure (DBP) Over Time
Day 701 DBP pre-infusion (n=35)
|
72.0 mm Hg
Standard Deviation 9.39
|
—
|
|
Long-term Period: Mean Sitting Diastolic Blood Pressure (DBP) Over Time
Day 701 DBP post-infusion (n=36)
|
72.3 mm Hg
Standard Deviation 8.70
|
—
|
|
Long-term Period: Mean Sitting Diastolic Blood Pressure (DBP) Over Time
Day 729 DBP pre-infusion (n=32)
|
76.7 mm Hg
Standard Deviation 11.66
|
—
|
|
Long-term Period: Mean Sitting Diastolic Blood Pressure (DBP) Over Time
Day 729 DBP post-infusion (n=32)
|
74.8 mm Hg
Standard Deviation 10.34
|
—
|
|
Long-term Period: Mean Sitting Diastolic Blood Pressure (DBP) Over Time
Day 757 DBP pre-infusion (n=30)
|
75.0 mm Hg
Standard Deviation 9.34
|
—
|
|
Long-term Period: Mean Sitting Diastolic Blood Pressure (DBP) Over Time
Day 757 DBP post-infusion (n=29)
|
73.8 mm Hg
Standard Deviation 10.07
|
—
|
|
Long-term Period: Mean Sitting Diastolic Blood Pressure (DBP) Over Time
Day 785 DBP pre-infusion (n=24)
|
73.5 mm Hg
Standard Deviation 10.46
|
—
|
|
Long-term Period: Mean Sitting Diastolic Blood Pressure (DBP) Over Time
Day 785 DBP post-infusion (n=25)
|
72.7 mm Hg
Standard Deviation 9.32
|
—
|
|
Long-term Period: Mean Sitting Diastolic Blood Pressure (DBP) Over Time
Day 813 DBP pre-infusion (n=22)
|
75.2 mm Hg
Standard Deviation 8.05
|
—
|
|
Long-term Period: Mean Sitting Diastolic Blood Pressure (DBP) Over Time
Day 813 DBP post-infusion (n=22)
|
73.9 mm Hg
Standard Deviation 10.95
|
—
|
|
Long-term Period: Mean Sitting Diastolic Blood Pressure (DBP) Over Time
Day 841 DBP pre-infusion (n=19)
|
72.4 mm Hg
Standard Deviation 8.41
|
—
|
|
Long-term Period: Mean Sitting Diastolic Blood Pressure (DBP) Over Time
Day 841 DBP post-infusion (n=19)
|
73.2 mm Hg
Standard Deviation 10.87
|
—
|
|
Long-term Period: Mean Sitting Diastolic Blood Pressure (DBP) Over Time
Day 869 DBP pre-infusion (n=19)
|
72.7 mm Hg
Standard Deviation 10.61
|
—
|
|
Long-term Period: Mean Sitting Diastolic Blood Pressure (DBP) Over Time
Day 869 DBP post-infusion (n=18)
|
71.1 mm Hg
Standard Deviation 9.86
|
—
|
|
Long-term Period: Mean Sitting Diastolic Blood Pressure (DBP) Over Time
Day 897 DBP pre-infusion (n=19)
|
68.8 mm Hg
Standard Deviation 7.44
|
—
|
|
Long-term Period: Mean Sitting Diastolic Blood Pressure (DBP) Over Time
Day 897 DBP post-infusion (n=19)
|
67.9 mm Hg
Standard Deviation 7.69
|
—
|
|
Long-term Period: Mean Sitting Diastolic Blood Pressure (DBP) Over Time
Day 925 DBP pre-infusion (n=19)
|
73.5 mm Hg
Standard Deviation 9.96
|
—
|
|
Long-term Period: Mean Sitting Diastolic Blood Pressure (DBP) Over Time
Day 925 DBP post-infusion (n=19)
|
71.8 mm Hg
Standard Deviation 10.77
|
—
|
|
Long-term Period: Mean Sitting Diastolic Blood Pressure (DBP) Over Time
Day 953 DBP pre-infusion (n=19)
|
68.7 mm Hg
Standard Deviation 10.91
|
—
|
|
Long-term Period: Mean Sitting Diastolic Blood Pressure (DBP) Over Time
Day 953 DBP post-infusion (n=19)
|
72.5 mm Hg
Standard Deviation 10.74
|
—
|
|
Long-term Period: Mean Sitting Diastolic Blood Pressure (DBP) Over Time
Day 981 DBP pre-infusion (n=18)
|
69.7 mm Hg
Standard Deviation 11.05
|
—
|
|
Long-term Period: Mean Sitting Diastolic Blood Pressure (DBP) Over Time
Day 981 DBP post-infusion (n=18)
|
69.7 mm Hg
Standard Deviation 11.45
|
—
|
|
Long-term Period: Mean Sitting Diastolic Blood Pressure (DBP) Over Time
Day 1009 DBP pre-infusion (n=19)
|
71.6 mm Hg
Standard Deviation 9.78
|
—
|
|
Long-term Period: Mean Sitting Diastolic Blood Pressure (DBP) Over Time
Day 1009 DBP post-infusion (n=19)
|
70.3 mm Hg
Standard Deviation 9.16
|
—
|
|
Long-term Period: Mean Sitting Diastolic Blood Pressure (DBP) Over Time
Day 1037 DBP pre-infusion (n=15)
|
71.3 mm Hg
Standard Deviation 11.15
|
—
|
|
Long-term Period: Mean Sitting Diastolic Blood Pressure (DBP) Over Time
Day 1037 DBP post-infusion (n=15)
|
71.2 mm Hg
Standard Deviation 8.48
|
—
|
|
Long-term Period: Mean Sitting Diastolic Blood Pressure (DBP) Over Time
Day 1065 DBP pre-infusion (n=13)
|
71.5 mm Hg
Standard Deviation 7.18
|
—
|
|
Long-term Period: Mean Sitting Diastolic Blood Pressure (DBP) Over Time
Day 1065 DBP post-infusion (n=14)
|
72.4 mm Hg
Standard Deviation 7.53
|
—
|
|
Long-term Period: Mean Sitting Diastolic Blood Pressure (DBP) Over Time
Day 1093 DBP pre-infusion (n=10)
|
71.8 mm Hg
Standard Deviation 6.07
|
—
|
|
Long-term Period: Mean Sitting Diastolic Blood Pressure (DBP) Over Time
Day 1093 DBP post-infusion (n=10)
|
76.3 mm Hg
Standard Deviation 5.58
|
—
|
|
Long-term Period: Mean Sitting Diastolic Blood Pressure (DBP) Over Time
Day 1121 DBP pre-infusion (n=7)
|
75.1 mm Hg
Standard Deviation 5.64
|
—
|
|
Long-term Period: Mean Sitting Diastolic Blood Pressure (DBP) Over Time
Day 1121 DBP post-infusion (n=7)
|
72.6 mm Hg
Standard Deviation 4.08
|
—
|
|
Long-term Period: Mean Sitting Diastolic Blood Pressure (DBP) Over Time
Day 1149 DBP pre-infusion (n=7)
|
72.6 mm Hg
Standard Deviation 4.16
|
—
|
|
Long-term Period: Mean Sitting Diastolic Blood Pressure (DBP) Over Time
Day 1149 DBP post-infusion (n=7)
|
72.4 mm Hg
Standard Deviation 3.99
|
—
|
|
Long-term Period: Mean Sitting Diastolic Blood Pressure (DBP) Over Time
Day 1177 DBP pre-infusion (n=7)
|
69.1 mm Hg
Standard Deviation 9.32
|
—
|
|
Long-term Period: Mean Sitting Diastolic Blood Pressure (DBP) Over Time
Day 1177 DBP post-infusion (n=7)
|
73.4 mm Hg
Standard Deviation 7.35
|
—
|
|
Long-term Period: Mean Sitting Diastolic Blood Pressure (DBP) Over Time
Day 169 DBP pre-infusion (n=481)
|
75.1 mm Hg
Standard Deviation 10.09
|
—
|
|
Long-term Period: Mean Sitting Diastolic Blood Pressure (DBP) Over Time
Day 169 DBP post-infusion (n=477)
|
74.9 mm Hg
Standard Deviation 9.60
|
—
|
|
Long-term Period: Mean Sitting Diastolic Blood Pressure (DBP) Over Time
Day 197 DBP pre-infusion (n=414)
|
74.0 mm Hg
Standard Deviation 10.09
|
—
|
|
Long-term Period: Mean Sitting Diastolic Blood Pressure (DBP) Over Time
Day 197 DBP post-infusion (n=415)
|
74.4 mm Hg
Standard Deviation 10.27
|
—
|
|
Long-term Period: Mean Sitting Diastolic Blood Pressure (DBP) Over Time
Day 225 DBP pre-infusion (n=340)
|
73.9 mm Hg
Standard Deviation 10.28
|
—
|
|
Long-term Period: Mean Sitting Diastolic Blood Pressure (DBP) Over Time
Day 225 DBP post-infusion (n=338)
|
73.7 mm Hg
Standard Deviation 9.53
|
—
|
|
Long-term Period: Mean Sitting Diastolic Blood Pressure (DBP) Over Time
Day 253 DBP pre-infusion (n=251)
|
74.5 mm Hg
Standard Deviation 10.60
|
—
|
|
Long-term Period: Mean Sitting Diastolic Blood Pressure (DBP) Over Time
Day 253 DBP post-infusion (n=251)
|
74.5 mm Hg
Standard Deviation 10.04
|
—
|
|
Long-term Period: Mean Sitting Diastolic Blood Pressure (DBP) Over Time
Day 281 DBP pre-infusion (n=203)
|
74.7 mm Hg
Standard Deviation 10.16
|
—
|
|
Long-term Period: Mean Sitting Diastolic Blood Pressure (DBP) Over Time
Day 281 DBP post-infusion (n=202)
|
75.3 mm Hg
Standard Deviation 9.94
|
—
|
|
Long-term Period: Mean Sitting Diastolic Blood Pressure (DBP) Over Time
Day 309 DBP pre-infusion (n=160)
|
75.4 mm Hg
Standard Deviation 10.36
|
—
|
|
Long-term Period: Mean Sitting Diastolic Blood Pressure (DBP) Over Time
Day 309 DBP post-infusion (n=159)
|
75.6 mm Hg
Standard Deviation 10.73
|
—
|
|
Long-term Period: Mean Sitting Diastolic Blood Pressure (DBP) Over Time
Day 337 DBP pre-infusion (n=128)
|
74.5 mm Hg
Standard Deviation 10.42
|
—
|
|
Long-term Period: Mean Sitting Diastolic Blood Pressure (DBP) Over Time
Day 337 DBP post-infusion (n=128)
|
74.5 mm Hg
Standard Deviation 10.48
|
—
|
|
Long-term Period: Mean Sitting Diastolic Blood Pressure (DBP) Over Time
Day 365 DBP pre-infusion (n=118)
|
76.4 mm Hg
Standard Deviation 10.88
|
—
|
|
Long-term Period: Mean Sitting Diastolic Blood Pressure (DBP) Over Time
Day 365 DBP post-infusion (n=120)
|
75.0 mm Hg
Standard Deviation 10.27
|
—
|
|
Long-term Period: Mean Sitting Diastolic Blood Pressure (DBP) Over Time
Day 393 DBP pre-infusion (n=101)
|
75.3 mm Hg
Standard Deviation 12.13
|
—
|
|
Long-term Period: Mean Sitting Diastolic Blood Pressure (DBP) Over Time
Day 393 DBP post-infusion (n=99)
|
74.7 mm Hg
Standard Deviation 10.77
|
—
|
|
Long-term Period: Mean Sitting Diastolic Blood Pressure (DBP) Over Time
Day 421 DBP post-infusion (n=93)
|
75.5 mm Hg
Standard Deviation 10.48
|
—
|
|
Long-term Period: Mean Sitting Diastolic Blood Pressure (DBP) Over Time
Day 449 DBP pre-infusion (n=82)
|
75.8 mm Hg
Standard Deviation 10.82
|
—
|
|
Long-term Period: Mean Sitting Diastolic Blood Pressure (DBP) Over Time
Day 449 DBP post-infusion (n=82)
|
76.6 mm Hg
Standard Deviation 11.73
|
—
|
|
Long-term Period: Mean Sitting Diastolic Blood Pressure (DBP) Over Time
Day 477 DBP pre-infusion (n=75)
|
76.4 mm Hg
Standard Deviation 13.25
|
—
|
|
Long-term Period: Mean Sitting Diastolic Blood Pressure (DBP) Over Time
Day 477 DBP post-infusion (n=75)
|
75.2 mm Hg
Standard Deviation 11.56
|
—
|
|
Long-term Period: Mean Sitting Diastolic Blood Pressure (DBP) Over Time
Day 505 DBP pre-infusion (n=72)
|
75.3 mm Hg
Standard Deviation 12.80
|
—
|
|
Long-term Period: Mean Sitting Diastolic Blood Pressure (DBP) Over Time
Day 505 DBP post-infusion (n=73)
|
75.9 mm Hg
Standard Deviation 13.62
|
—
|
|
Long-term Period: Mean Sitting Diastolic Blood Pressure (DBP) Over Time
Day 533 DBP pre-infusion (n=67)
|
75.6 mm Hg
Standard Deviation 11.36
|
—
|
|
Long-term Period: Mean Sitting Diastolic Blood Pressure (DBP) Over Time
Day 533 DBP post-infusion (n=66)
|
77.0 mm Hg
Standard Deviation 11.57
|
—
|
|
Long-term Period: Mean Sitting Diastolic Blood Pressure (DBP) Over Time
Day 561 DBP pre-infusion (n=63)
|
74.9 mm Hg
Standard Deviation 12.10
|
—
|
|
Long-term Period: Mean Sitting Diastolic Blood Pressure (DBP) Over Time
Day 561 DBP post-infusion (n=63)
|
73.2 mm Hg
Standard Deviation 12.32
|
—
|
|
Long-term Period: Mean Sitting Diastolic Blood Pressure (DBP) Over Time
Day 589 DBP pre-infusion (n=57)
|
72.8 mm Hg
Standard Deviation 12.0
|
—
|
|
Long-term Period: Mean Sitting Diastolic Blood Pressure (DBP) Over Time
Day 589 DBP post-infusion (n=57)
|
74.7 mm Hg
Standard Deviation 11.20
|
—
|
|
Long-term Period: Mean Sitting Diastolic Blood Pressure (DBP) Over Time
Day 617 DBP pre-infusion (n=56)
|
74.4 mm Hg
Standard Deviation 10.92
|
—
|
|
Long-term Period: Mean Sitting Diastolic Blood Pressure (DBP) Over Time
Day 617 DBP post-infusion (n=55)
|
74.7 mm Hg
Standard Deviation 12.53
|
—
|
|
Long-term Period: Mean Sitting Diastolic Blood Pressure (DBP) Over Time
Day 645 DBP pre-infusion (n=44)
|
73.8 mm Hg
Standard Deviation 10.68
|
—
|
|
Long-term Period: Mean Sitting Diastolic Blood Pressure (DBP) Over Time
Day 645 DBP post-infusion (n=43)
|
76.2 mm Hg
Standard Deviation 11.01
|
—
|
|
Long-term Period: Mean Sitting Diastolic Blood Pressure (DBP) Over Time
Day 673 DBP pre-infusion (n=40)
|
76.3 mm Hg
Standard Deviation 10.32
|
—
|
PRIMARY outcome
Timeframe: From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abataceptPopulation: All treated participants. n=number of participants with evaluable heart rate readings.
Outcome measures
| Measure |
ST Abatacept (ABA)-Previous User
n=481 Participants
In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
|
ST ABA-Current User
In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
|
|---|---|---|
|
Long-term Period: Mean Heart Rate (HR) Over Time
Day 169 HR pre-infusion (n=481)
|
74.4 beats per minute
Standard Deviation 11.08
|
—
|
|
Long-term Period: Mean Heart Rate (HR) Over Time
Day 169 HR post-infusion (n=481)
|
73.0 beats per minute
Standard Deviation 10.22
|
—
|
|
Long-term Period: Mean Heart Rate (HR) Over Time
Day 197 HR pre-infusion (n=414)
|
74.4 beats per minute
Standard Deviation 11.58
|
—
|
|
Long-term Period: Mean Heart Rate (HR) Over Time
Day 197 HR post-infusion (n=416)
|
72.8 beats per minute
Standard Deviation 10.65
|
—
|
|
Long-term Period: Mean Heart Rate (HR) Over Time
Day 225 HR pre-infusion (n=340)
|
74.7 beats per minute
Standard Deviation 10.43
|
—
|
|
Long-term Period: Mean Heart Rate (HR) Over Time
Day 225 HR post-infusion (n=338)
|
72.5 beats per minute
Standard Deviation 9.88
|
—
|
|
Long-term Period: Mean Heart Rate (HR) Over Time
Day 253 HR pre-infusion (n=252)
|
73.9 beats per minute
Standard Deviation 11.72
|
—
|
|
Long-term Period: Mean Heart Rate (HR) Over Time
Day 253 HR post-infusion (n=252)
|
72.1 beats per minute
Standard Deviation 10.96
|
—
|
|
Long-term Period: Mean Heart Rate (HR) Over Time
Day 281 HR pre-infusion (n=203)
|
73.8 beats per minute
Standard Deviation 11.39
|
—
|
|
Long-term Period: Mean Heart Rate (HR) Over Time
Day 281 HR post-infusion (n=202)
|
72.4 beats per minute
Standard Deviation 10.17
|
—
|
|
Long-term Period: Mean Heart Rate (HR) Over Time
Day 309 HR pre-infusion (n=160)
|
73.9 beats per minute
Standard Deviation 9.62
|
—
|
|
Long-term Period: Mean Heart Rate (HR) Over Time
Day 309 HR post-infusion (n=159)
|
72.0 beats per minute
Standard Deviation 9.85
|
—
|
|
Long-term Period: Mean Heart Rate (HR) Over Time
Day 337 HR pre-infusion (n=128)
|
74.1 beats per minute
Standard Deviation 11.71
|
—
|
|
Long-term Period: Mean Heart Rate (HR) Over Time
Day 337 HR post-infusion (n=129)
|
70.9 beats per minute
Standard Deviation 8.78
|
—
|
|
Long-term Period: Mean Heart Rate (HR) Over Time
Day 365 HR pre-infusion (n=118)
|
73.7 beats per minute
Standard Deviation 12.20
|
—
|
|
Long-term Period: Mean Heart Rate (HR) Over Time
Day 365 HR post-infusion (n=120)
|
73.1 beats per minute
Standard Deviation 10.21
|
—
|
|
Long-term Period: Mean Heart Rate (HR) Over Time
Day 393 HR pre-infusion (n=101)
|
73.0 beats per minute
Standard Deviation 10.26
|
—
|
|
Long-term Period: Mean Heart Rate (HR) Over Time
Day 393 HR post-infusion (n=99)
|
72.4 beats per minute
Standard Deviation 9.88
|
—
|
|
Long-term Period: Mean Heart Rate (HR) Over Time
Day 421 HR post-infusion (n=93)
|
71.6 beats per minute
Standard Deviation 8.63
|
—
|
|
Long-term Period: Mean Heart Rate (HR) Over Time
Day 449 HR pre-infusion (n=82)
|
74.2 beats per minute
Standard Deviation 10.67
|
—
|
|
Long-term Period: Mean Heart Rate (HR) Over Time
Day 449 HR post-infusion (n=82)
|
73.7 beats per minute
Standard Deviation 9.81
|
—
|
|
Long-term Period: Mean Heart Rate (HR) Over Time
Day 477 HR pre-infusion (n=74)
|
75.4 beats per minute
Standard Deviation 12.48
|
—
|
|
Long-term Period: Mean Heart Rate (HR) Over Time
Day 477 HR post-infusion (n=75)
|
72.9 beats per minute
Standard Deviation 10.89
|
—
|
|
Long-term Period: Mean Heart Rate (HR) Over Time
Day 505 HR pre-infusion (n=72)
|
73.8 beats per minute
Standard Deviation 11.41
|
—
|
|
Long-term Period: Mean Heart Rate (HR) Over Time
Day 505 HR post-infusion (n=73)
|
73.0 beats per minute
Standard Deviation 8.90
|
—
|
|
Long-term Period: Mean Heart Rate (HR) Over Time
Day 533 HR pre-infusion (n=66)
|
73.2 beats per minute
Standard Deviation 11.57
|
—
|
|
Long-term Period: Mean Heart Rate (HR) Over Time
Day 533 HR post-infusion (n=66)
|
75.7 beats per minute
Standard Deviation 12.21
|
—
|
|
Long-term Period: Mean Heart Rate (HR) Over Time
Day 561 HR pre-infusion (n=63)
|
73.8 beats per minute
Standard Deviation 10.09
|
—
|
|
Long-term Period: Mean Heart Rate (HR) Over Time
Day 561 HR post-infusion (n=63)
|
72.3 beats per minute
Standard Deviation 10.18
|
—
|
|
Long-term Period: Mean Heart Rate (HR) Over Time
Day 589 HR pre-infusion (n=57)
|
73.0 beats per minute
Standard Deviation 9.83
|
—
|
|
Long-term Period: Mean Heart Rate (HR) Over Time
Day 589 HR post-infusion (n=57)
|
71.5 beats per minute
Standard Deviation 9.66
|
—
|
|
Long-term Period: Mean Heart Rate (HR) Over Time
Day 617 HR pre-infusion (n=56)
|
72.9 beats per minute
Standard Deviation 10.89
|
—
|
|
Long-term Period: Mean Heart Rate (HR) Over Time
Day 617 HR post-infusion (n=55)
|
71.7 beats per minute
Standard Deviation 9.40
|
—
|
|
Long-term Period: Mean Heart Rate (HR) Over Time
Day 645 HR pre-infusion (n=44)
|
76.6 beats per minute
Standard Deviation 13.40
|
—
|
|
Long-term Period: Mean Heart Rate (HR) Over Time
Day 645 HR post-infusion (n=43)
|
76.1 beats per minute
Standard Deviation 13.00
|
—
|
|
Long-term Period: Mean Heart Rate (HR) Over Time
Day 673 HR pre-infusion (n=40)
|
73.5 beats per minute
Standard Deviation 11.67
|
—
|
|
Long-term Period: Mean Heart Rate (HR) Over Time
Day 673 HR post-infusion (n=41)
|
73.3 beats per minute
Standard Deviation 10.74
|
—
|
|
Long-term Period: Mean Heart Rate (HR) Over Time
Day 701 HR pre-infusion (n=35)
|
72.1 beats per minute
Standard Deviation 12.13
|
—
|
|
Long-term Period: Mean Heart Rate (HR) Over Time
Day 701 HR post-infusion (n=36)
|
73.3 beats per minute
Standard Deviation 10.23
|
—
|
|
Long-term Period: Mean Heart Rate (HR) Over Time
Day 729 HR pre-infusion (n=32)
|
70.7 beats per minute
Standard Deviation 11.24
|
—
|
|
Long-term Period: Mean Heart Rate (HR) Over Time
Day 729 HR post-infusion (n=32)
|
71.7 beats per minute
Standard Deviation 11.38
|
—
|
|
Long-term Period: Mean Heart Rate (HR) Over Time
Day 757 HR pre-infusion (n=30)
|
74.1 beats per minute
Standard Deviation 9.60
|
—
|
|
Long-term Period: Mean Heart Rate (HR) Over Time
Day 757 HR post-infusion (n=30)
|
73.2 beats per minute
Standard Deviation 9.35
|
—
|
|
Long-term Period: Mean Heart Rate (HR) Over Time
Day 785 HR pre-infusion (n=25)
|
76.5 beats per minute
Standard Deviation 8.78
|
—
|
|
Long-term Period: Mean Heart Rate (HR) Over Time
Day 785 HR post-infusion (n=25)
|
73.4 beats per minute
Standard Deviation 8.61
|
—
|
|
Long-term Period: Mean Heart Rate (HR) Over Time
Day 813 HR pre-infusion (n=23)
|
73.9 beats per minute
Standard Deviation 11.23
|
—
|
|
Long-term Period: Mean Heart Rate (HR) Over Time
Day 813 HR post-infusion (n=22)
|
71.4 beats per minute
Standard Deviation 10.90
|
—
|
|
Long-term Period: Mean Heart Rate (HR) Over Time
Day 841 HR pre-infusion (n=19)
|
74.2 beats per minute
Standard Deviation 10.95
|
—
|
|
Long-term Period: Mean Heart Rate (HR) Over Time
Day 841 HR post-infusion (n=19)
|
71.4 beats per minute
Standard Deviation 9.15
|
—
|
|
Long-term Period: Mean Heart Rate (HR) Over Time
Day 869 HR pre-infusion (n=19)
|
72.4 beats per minute
Standard Deviation 12.21
|
—
|
|
Long-term Period: Mean Heart Rate (HR) Over Time
Day 869 HR post-infusion (n=18)
|
72.3 beats per minute
Standard Deviation 11.98
|
—
|
|
Long-term Period: Mean Heart Rate (HR) Over Time
Day 897 HR pre-infusion (n=19)
|
71.7 beats per minute
Standard Deviation 9.16
|
—
|
|
Long-term Period: Mean Heart Rate (HR) Over Time
Day 897 HR post-infusion (n=19)
|
70.9 beats per minute
Standard Deviation 9.10
|
—
|
|
Long-term Period: Mean Heart Rate (HR) Over Time
Day 925 HR pre-infusion (n=19)
|
76.7 beats per minute
Standard Deviation 7.75
|
—
|
|
Long-term Period: Mean Heart Rate (HR) Over Time
Day 925 HR post-infusion (n=19)
|
73.0 beats per minute
Standard Deviation 7.86
|
—
|
|
Long-term Period: Mean Heart Rate (HR) Over Time
Day 953 HR pre-infusion (n=19)
|
75.5 beats per minute
Standard Deviation 10.57
|
—
|
|
Long-term Period: Mean Heart Rate (HR) Over Time
Day 953 HR post-infusion (n=19)
|
73.8 beats per minute
Standard Deviation 7.49
|
—
|
|
Long-term Period: Mean Heart Rate (HR) Over Time
Day 981 HR pre-infusion (n=18)
|
75.7 beats per minute
Standard Deviation 13.05
|
—
|
|
Long-term Period: Mean Heart Rate (HR) Over Time
Day 981 HR post-infusion (n=18)
|
72.8 beats per minute
Standard Deviation 8.76
|
—
|
|
Long-term Period: Mean Heart Rate (HR) Over Time
Day 1009 HR pre-infusion (n=19)
|
76.1 beats per minute
Standard Deviation 10.68
|
—
|
|
Long-term Period: Mean Heart Rate (HR) Over Time
Day 1009 HR post-infusion (n=18)
|
73.6 beats per minute
Standard Deviation 7.94
|
—
|
|
Long-term Period: Mean Heart Rate (HR) Over Time
Day 1037 HR pre-infusion (n=15)
|
74.6 beats per minute
Standard Deviation 11.36
|
—
|
|
Long-term Period: Mean Heart Rate (HR) Over Time
Day 1037 HR post-infusion (n=15)
|
75.1 beats per minute
Standard Deviation 10.53
|
—
|
|
Long-term Period: Mean Heart Rate (HR) Over Time
Day 1065 HR pre-infusion (n=14)
|
74.3 beats per minute
Standard Deviation 8.90
|
—
|
|
Long-term Period: Mean Heart Rate (HR) Over Time
Day 1065 HR post-infusion (n=14)
|
75.1 beats per minute
Standard Deviation 9.05
|
—
|
|
Long-term Period: Mean Heart Rate (HR) Over Time
Day 1093 HR pre-infusion (n=10)
|
70.6 beats per minute
Standard Deviation 9.54
|
—
|
|
Long-term Period: Mean Heart Rate (HR) Over Time
Day 1093 HR post-infusion (n=10)
|
70.3 beats per minute
Standard Deviation 8.03
|
—
|
|
Long-term Period: Mean Heart Rate (HR) Over Time
Day 1121 HR pre-infusion (n=7)
|
72.4 beats per minute
Standard Deviation 4.89
|
—
|
|
Long-term Period: Mean Heart Rate (HR) Over Time
Day 1121 HR post-infusion (n=7)
|
69.1 beats per minute
Standard Deviation 3.80
|
—
|
|
Long-term Period: Mean Heart Rate (HR) Over Time
Day 1149 HR pre-infusion (n=7)
|
71.0 beats per minute
Standard Deviation 1.83
|
—
|
|
Long-term Period: Mean Heart Rate (HR) Over Time
Day 1149 HR post-infusion (n=7)
|
69.9 beats per minute
Standard Deviation 4.85
|
—
|
|
Long-term Period: Mean Heart Rate (HR) Over Time
Day 1177 HR pre-infusion (n=7)
|
75.0 beats per minute
Standard Deviation 8.85
|
—
|
|
Long-term Period: Mean Heart Rate (HR) Over Time
Day 1177 HR post-infusion (n=7)
|
69.1 beats per minute
Standard Deviation 10.71
|
—
|
PRIMARY outcome
Timeframe: From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abataceptPopulation: All treated participants. n=number of participants with evaluable temperature readings.
Outcome measures
| Measure |
ST Abatacept (ABA)-Previous User
n=482 Participants
In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
|
ST ABA-Current User
In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
|
|---|---|---|
|
Long-term Period: Mean Temperature (T) Over Time
Day 897 T post-infusion (n=18)
|
36.3 degrees Celsius
Standard Deviation 0.64
|
—
|
|
Long-term Period: Mean Temperature (T) Over Time
Day 925 T pre-infusion (n=19)
|
36.1 degrees Celsius
Standard Deviation 0.36
|
—
|
|
Long-term Period: Mean Temperature (T) Over Time
Day 169 T pre-infusion (n=482)
|
36.5 degrees Celsius
Standard Deviation 0.45
|
—
|
|
Long-term Period: Mean Temperature (T) Over Time
Day 169 T post-infusion (n=478)
|
36.5 degrees Celsius
Standard Deviation 0.45
|
—
|
|
Long-term Period: Mean Temperature (T) Over Time
Day 197 T pre-infusion (n=415)
|
36.6 degrees Celsius
Standard Deviation 0.44
|
—
|
|
Long-term Period: Mean Temperature (T) Over Time
Day 197 T post-infusion (n=413)
|
36.5 degrees Celsius
Standard Deviation 0.43
|
—
|
|
Long-term Period: Mean Temperature (T) Over Time
Day 225 T pre-infusion (n=340)
|
36.5 degrees Celsius
Standard Deviation 0.48
|
—
|
|
Long-term Period: Mean Temperature (T) Over Time
Day 225 T post-infusion (n=335)
|
36.5 degrees Celsius
Standard Deviation 0.46
|
—
|
|
Long-term Period: Mean Temperature (T) Over Time
Day 253 T pre-infusion (n=251)
|
36.5 degrees Celsius
Standard Deviation 0.48
|
—
|
|
Long-term Period: Mean Temperature (T) Over Time
Day 253 T post-infusion (n=251)
|
36.5 degrees Celsius
Standard Deviation 0.45
|
—
|
|
Long-term Period: Mean Temperature (T) Over Time
Day 281 T pre-infusion (n=202)
|
36.4 degrees Celsius
Standard Deviation 0.47
|
—
|
|
Long-term Period: Mean Temperature (T) Over Time
Day 281 T post-infusion (n=202)
|
36.5 degrees Celsius
Standard Deviation 0.45
|
—
|
|
Long-term Period: Mean Temperature (T) Over Time
Day 309 T pre-infusion (n=158)
|
36.4 degrees Celsius
Standard Deviation 0.48
|
—
|
|
Long-term Period: Mean Temperature (T) Over Time
Day 309 T post-infusion (n=158)
|
36.4 degrees Celsius
Standard Deviation 0.50
|
—
|
|
Long-term Period: Mean Temperature (T) Over Time
Day 337 T pre-infusion (n=129)
|
36.3 degrees Celsius
Standard Deviation 0.51
|
—
|
|
Long-term Period: Mean Temperature (T) Over Time
Day 337 T post-infusion (n=128)
|
36.4 degrees Celsius
Standard Deviation 0.49
|
—
|
|
Long-term Period: Mean Temperature (T) Over Time
Day 365 T pre-infusion (n=118)
|
36.4 degrees Celsius
Standard Deviation 0.54
|
—
|
|
Long-term Period: Mean Temperature (T) Over Time
Day 365 T post-infusion (n=119)
|
36.4 degrees Celsius
Standard Deviation 0.55
|
—
|
|
Long-term Period: Mean Temperature (T) Over Time
Day 393 T pre-infusion (n=101)
|
36.4 degrees Celsius
Standard Deviation 0.47
|
—
|
|
Long-term Period: Mean Temperature (T) Over Time
Day 393 T post-infusion (n=96)
|
36.4 degrees Celsius
Standard Deviation 0.50
|
—
|
|
Long-term Period: Mean Temperature (T) Over Time
Day 421 T post-infusion (n=93)
|
36.4 degrees Celsius
Standard Deviation 0.45
|
—
|
|
Long-term Period: Mean Temperature (T) Over Time
Day 449 T pre-infusion (n=82)
|
36.4 degrees Celsius
Standard Deviation 0.44
|
—
|
|
Long-term Period: Mean Temperature (T) Over Time
Day 449 T post-infusion (n=82)
|
36.4 degrees Celsius
Standard Deviation 0.48
|
—
|
|
Long-term Period: Mean Temperature (T) Over Time
Day 477 T pre-infusion (n=75)
|
36.4 degrees Celsius
Standard Deviation 0.51
|
—
|
|
Long-term Period: Mean Temperature (T) Over Time
Day 477 T post-infusion (n=75)
|
36.4 degrees Celsius
Standard Deviation 0.53
|
—
|
|
Long-term Period: Mean Temperature (T) Over Time
Day 505 T pre-infusion (n=71)
|
36.5 degrees Celsius
Standard Deviation 0.44
|
—
|
|
Long-term Period: Mean Temperature (T) Over Time
Day 505 T post-infusion (n=72)
|
36.5 degrees Celsius
Standard Deviation 0.55
|
—
|
|
Long-term Period: Mean Temperature (T) Over Time
Day 533 T pre-infusion (n=67)
|
36.4 degrees Celsius
Standard Deviation 0.57
|
—
|
|
Long-term Period: Mean Temperature (T) Over Time
Day 533 T post-infusion (n=64)
|
36.4 degrees Celsius
Standard Deviation 0.42
|
—
|
|
Long-term Period: Mean Temperature (T) Over Time
Day 561 T pre-infusion (n=63)
|
36.4 degrees Celsius
Standard Deviation 0.41
|
—
|
|
Long-term Period: Mean Temperature (T) Over Time
Day 561 T post-infusion (n=62)
|
36.5 degrees Celsius
Standard Deviation 0.43
|
—
|
|
Long-term Period: Mean Temperature (T) Over Time
Day 589 T pre-infusion (n=57)
|
36.4 degrees Celsius
Standard Deviation 0.50
|
—
|
|
Long-term Period: Mean Temperature (T) Over Time
Day 589 T post-infusion (n=57)
|
36.4 degrees Celsius
Standard Deviation 0.47
|
—
|
|
Long-term Period: Mean Temperature (T) Over Time
Day 617 T pre-infusion (n=56)
|
36.4 degrees Celsius
Standard Deviation 0.51
|
—
|
|
Long-term Period: Mean Temperature (T) Over Time
Day 617 T post-infusion (n=54)
|
36.4 degrees Celsius
Standard Deviation 0.43
|
—
|
|
Long-term Period: Mean Temperature (T) Over Time
Day 645 T pre-infusion (n=44)
|
36.3 degrees Celsius
Standard Deviation 0.47
|
—
|
|
Long-term Period: Mean Temperature (T) Over Time
Day 645 T post-infusion (n=42)
|
36.3 degrees Celsius
Standard Deviation 0.63
|
—
|
|
Long-term Period: Mean Temperature (T) Over Time
Day 673 T pre-infusion (n=40)
|
36.3 degrees Celsius
Standard Deviation 0.56
|
—
|
|
Long-term Period: Mean Temperature (T) Over Time
Day 673 T post-infusion (n=41)
|
36.3 degrees Celsius
Standard Deviation 0.50
|
—
|
|
Long-term Period: Mean Temperature (T) Over Time
Day 701 T pre-infusion (n=35)
|
36.3 degrees Celsius
Standard Deviation 0.49
|
—
|
|
Long-term Period: Mean Temperature (T) Over Time
Day 701 T post-infusion (n=35)
|
36.3 degrees Celsius
Standard Deviation 0.44
|
—
|
|
Long-term Period: Mean Temperature (T) Over Time
Day 729 T pre-infusion (n=31)
|
36.1 degrees Celsius
Standard Deviation 0.51
|
—
|
|
Long-term Period: Mean Temperature (T) Over Time
Day 729 T post-infusion (n=32)
|
36.2 degrees Celsius
Standard Deviation 0.42
|
—
|
|
Long-term Period: Mean Temperature (T) Over Time
Day 757 T pre-infusion (n=30)
|
36.2 degrees Celsius
Standard Deviation 0.52
|
—
|
|
Long-term Period: Mean Temperature (T) Over Time
Day 757 T post-infusion (n=30)
|
36.2 degrees Celsius
Standard Deviation 0.53
|
—
|
|
Long-term Period: Mean Temperature (T) Over Time
Day 785 T pre-infusion (n=25)
|
36.2 degrees Celsius
Standard Deviation 0.40
|
—
|
|
Long-term Period: Mean Temperature (T) Over Time
Day 785 T post-infusion (n=24)
|
36.2 degrees Celsius
Standard Deviation 0.37
|
—
|
|
Long-term Period: Mean Temperature (T) Over Time
Day 813 T pre-infusion (n=23)
|
36.1 degrees Celsius
Standard Deviation 0.43
|
—
|
|
Long-term Period: Mean Temperature (T) Over Time
Day 813 T post-infusion (n=22)
|
36.0 degrees Celsius
Standard Deviation 0.34
|
—
|
|
Long-term Period: Mean Temperature (T) Over Time
Day 841 T pre-infusion (n=19)
|
36.1 degrees Celsius
Standard Deviation 0.40
|
—
|
|
Long-term Period: Mean Temperature (T) Over Time
Day 841 T post-infusion (n=19)
|
36.2 degrees Celsius
Standard Deviation 0.46
|
—
|
|
Long-term Period: Mean Temperature (T) Over Time
Day 869 T pre-infusion (n=19)
|
36.1 degrees Celsius
Standard Deviation 0.66
|
—
|
|
Long-term Period: Mean Temperature (T) Over Time
Day 869 T post-infusion (n=18)
|
36.1 degrees Celsius
Standard Deviation 0.57
|
—
|
|
Long-term Period: Mean Temperature (T) Over Time
Day 897 T pre-infusion (n=18)
|
36.2 degrees Celsius
Standard Deviation 0.62
|
—
|
|
Long-term Period: Mean Temperature (T) Over Time
Day 925 T post-infusion (n=19)
|
36.1 degrees Celsius
Standard Deviation 0.43
|
—
|
|
Long-term Period: Mean Temperature (T) Over Time
Day 953 T pre-infusion (n=19)
|
36.1 degrees Celsius
Standard Deviation 0.54
|
—
|
|
Long-term Period: Mean Temperature (T) Over Time
Day 953 T post-infusion (n=18)
|
36.1 degrees Celsius
Standard Deviation 0.52
|
—
|
|
Long-term Period: Mean Temperature (T) Over Time
Day 981 T pre-infusion (n=17)
|
36.2 degrees Celsius
Standard Deviation 0.48
|
—
|
|
Long-term Period: Mean Temperature (T) Over Time
Day 981 T post-infusion (n=17)
|
36.0 degrees Celsius
Standard Deviation 0.68
|
—
|
|
Long-term Period: Mean Temperature (T) Over Time
Day 1009 T pre-infusion (n=19)
|
36.1 degrees Celsius
Standard Deviation 0.40
|
—
|
|
Long-term Period: Mean Temperature (T) Over Time
Day 1009 T post-infusion (n=17)
|
36.3 degrees Celsius
Standard Deviation 0.44
|
—
|
|
Long-term Period: Mean Temperature (T) Over Time
Day 1037 T pre-infusion (n=15)
|
36.1 degrees Celsius
Standard Deviation 0.38
|
—
|
|
Long-term Period: Mean Temperature (T) Over Time
Day 1037 T post-infusion (n=15)
|
36.1 degrees Celsius
Standard Deviation 0.41
|
—
|
|
Long-term Period: Mean Temperature (T) Over Time
Day 1065 T pre-infusion (n=14)
|
36.1 degrees Celsius
Standard Deviation 0.80
|
—
|
|
Long-term Period: Mean Temperature (T) Over Time
Day 1065 T post-infusion (n=14)
|
36.3 degrees Celsius
Standard Deviation 0.58
|
—
|
|
Long-term Period: Mean Temperature (T) Over Time
Day 1093 T pre-infusion (n=10)
|
36.1 degrees Celsius
Standard Deviation 0.59
|
—
|
|
Long-term Period: Mean Temperature (T) Over Time
Day 1093 T post-infusion (n=10)
|
36.2 degrees Celsius
Standard Deviation 0.47
|
—
|
|
Long-term Period: Mean Temperature (T) Over Time
Day 1121 T pre-infusion (n=7)
|
36.3 degrees Celsius
Standard Deviation 0.40
|
—
|
|
Long-term Period: Mean Temperature (T) Over Time
Day 1121 T post-infusion (n=7)
|
36.4 degrees Celsius
Standard Deviation 0.33
|
—
|
|
Long-term Period: Mean Temperature (T) Over Time
Day 1149 T pre-infusion (n=7)
|
36.3 degrees Celsius
Standard Deviation 0.43
|
—
|
|
Long-term Period: Mean Temperature (T) Over Time
Day 1149 T post-infusion (n=7)
|
36.3 degrees Celsius
Standard Deviation 0.35
|
—
|
|
Long-term Period: Mean Temperature (T) Over Time
Day 1177 T pre-infusion (n=7)
|
36.1 degrees Celsius
Standard Deviation 0.54
|
—
|
|
Long-term Period: Mean Temperature (T) Over Time
Day 1177 T post-infusion (n=7)
|
36.2 degrees Celsius
Standard Deviation 0.38
|
—
|
SECONDARY outcome
Timeframe: BL, Day 169Population: All treated participants.
The DAS 28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR or CRP, and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thresholds that define high disease activity (\> 5.1), low disease activity (\< 3.2) and remission (\< 2.6). A clinically significant response= decrease in DAS28 score of \>1.2 from baseline.
Outcome measures
| Measure |
ST Abatacept (ABA)-Previous User
n=449 Participants
In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
|
ST ABA-Current User
n=597 Participants
In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
|
|---|---|---|
|
Short-term Period: Number of Participants With Clinically Meaningful Improvement (CMI) in Disease Activity Score (DAS 28), Low Disease Activity (LDAS), or Remission at Day 169
CMI
|
267 participants
|
320 participants
|
|
Short-term Period: Number of Participants With Clinically Meaningful Improvement (CMI) in Disease Activity Score (DAS 28), Low Disease Activity (LDAS), or Remission at Day 169
LDAS
|
101 participants
|
133 participants
|
|
Short-term Period: Number of Participants With Clinically Meaningful Improvement (CMI) in Disease Activity Score (DAS 28), Low Disease Activity (LDAS), or Remission at Day 169
Remission
|
54 participants
|
82 participants
|
SECONDARY outcome
Timeframe: BL (Day 0), Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169Population: All treated participants. n=number of evaluable participants.
The DAS 28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR or CRP, and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thresholds that define high disease activity (\> 5.1), low disease activity (\< 3.2) and remission (\< 2.6). Time-matched baseline (Day 0) values and post-baseline values were presented for each post-baseline visit, and represent only that cohort of participants with measurements available at that post-baseline visit.
Outcome measures
| Measure |
ST Abatacept (ABA)-Previous User
n=429 Participants
In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
|
ST ABA-Current User
n=580 Participants
In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
|
|---|---|---|
|
Short-term Period: Mean Time-matched Baseline (Day 0) DAS 28 and DAS 28 for Post-Baseline Visits Through 6 Month Open-Label
BL (Day 0) for Day 15 cohort (n=429,570)
|
6.21 units on a scale
Standard Deviation 0.73
|
6.17 units on a scale
Standard Deviation 0.72
|
|
Short-term Period: Mean Time-matched Baseline (Day 0) DAS 28 and DAS 28 for Post-Baseline Visits Through 6 Month Open-Label
Day 15 visit (n=429,570)
|
5.46 units on a scale
Standard Deviation 1.05
|
5.49 units on a scale
Standard Deviation 1.12
|
|
Short-term Period: Mean Time-matched Baseline (Day 0) DAS 28 and DAS 28 for Post-Baseline Visits Through 6 Month Open-Label
BL (Day 0) for Day 29 cohort (n=426,580)
|
6.22 units on a scale
Standard Deviation 0.72
|
6.17 units on a scale
Standard Deviation 0.71
|
|
Short-term Period: Mean Time-matched Baseline (Day 0) DAS 28 and DAS 28 for Post-Baseline Visits Through 6 Month Open-Label
Day 29 visit (n=426,580)
|
5.05 units on a scale
Standard Deviation 1.20
|
5.09 units on a scale
Standard Deviation 1.25
|
|
Short-term Period: Mean Time-matched Baseline (Day 0) DAS 28 and DAS 28 for Post-Baseline Visits Through 6 Month Open-Label
BL (Day 0) for Day 57 cohort (n=425,563)
|
6.22 units on a scale
Standard Deviation 0.74
|
6.16 units on a scale
Standard Deviation 0.71
|
|
Short-term Period: Mean Time-matched Baseline (Day 0) DAS 28 and DAS 28 for Post-Baseline Visits Through 6 Month Open-Label
Day 57 visit (n=425,563)
|
4.65 units on a scale
Standard Deviation 1.27
|
4.72 units on a scale
Standard Deviation 1.30
|
|
Short-term Period: Mean Time-matched Baseline (Day 0) DAS 28 and DAS 28 for Post-Baseline Visits Through 6 Month Open-Label
BL (Day 0) for Day 85 cohort (n=403,542)
|
6.21 units on a scale
Standard Deviation 0.73
|
6.16 units on a scale
Standard Deviation 0.72
|
|
Short-term Period: Mean Time-matched Baseline (Day 0) DAS 28 and DAS 28 for Post-Baseline Visits Through 6 Month Open-Label
Day 85 visit (n=403,542)
|
4.44 units on a scale
Standard Deviation 1.37
|
4.57 units on a scale
Standard Deviation 1.35
|
|
Short-term Period: Mean Time-matched Baseline (Day 0) DAS 28 and DAS 28 for Post-Baseline Visits Through 6 Month Open-Label
BL (Day 0) for Day 113 cohort (n=393,516)
|
6.20 units on a scale
Standard Deviation 0.73
|
6.15 units on a scale
Standard Deviation 0.71
|
|
Short-term Period: Mean Time-matched Baseline (Day 0) DAS 28 and DAS 28 for Post-Baseline Visits Through 6 Month Open-Label
Day 113 visit (n=393,516)
|
4.24 units on a scale
Standard Deviation 1.36
|
4.39 units on a scale
Standard Deviation 1.41
|
|
Short-term Period: Mean Time-matched Baseline (Day 0) DAS 28 and DAS 28 for Post-Baseline Visits Through 6 Month Open-Label
BL (Day 0) for Day 141 cohort (n=372,493)
|
6.19 units on a scale
Standard Deviation 0.74
|
6.16 units on a scale
Standard Deviation 0.73
|
|
Short-term Period: Mean Time-matched Baseline (Day 0) DAS 28 and DAS 28 for Post-Baseline Visits Through 6 Month Open-Label
Day 141 visit (n=372,493)
|
4.19 units on a scale
Standard Deviation 1.38
|
4.27 units on a scale
Standard Deviation 1.39
|
|
Short-term Period: Mean Time-matched Baseline (Day 0) DAS 28 and DAS 28 for Post-Baseline Visits Through 6 Month Open-Label
BL (Day 0) for Day 169 cohort(n=369,468)
|
6.19 units on a scale
Standard Deviation 0.73
|
6.15 units on a scale
Standard Deviation 0.73
|
|
Short-term Period: Mean Time-matched Baseline (Day 0) DAS 28 and DAS 28 for Post-Baseline Visits Through 6 Month Open-Label
Day 169 visit (n=369,468)
|
4.16 units on a scale
Standard Deviation 1.43
|
4.14 units on a scale
Standard Deviation 1.47
|
SECONDARY outcome
Timeframe: BL (Day 0), Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169Population: All treated participants. n=number of evaluable participants.
The DAS28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR or CRP, and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thresholds that define high disease activity (\> 5.1), low disease activity (\< 3.2) and remission (\< 2.6). Time-matched mean change from BL= Post-BL value - time-matched BL value, where the time-matched BL value represents the mean BL (Day 0) value for only that cohort of participants with measurements available at that post-BL visit.
Outcome measures
| Measure |
ST Abatacept (ABA)-Previous User
n=429 Participants
In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
|
ST ABA-Current User
n=580 Participants
In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
|
|---|---|---|
|
Short-term Period: Mean Time-matched Change From Baseline (Day 0) in DAS 28 Through 6 Month Open-Label
Change from BL (Day 0) to Day 15 visit (n=429,570)
|
-0.75 units on a scale
Standard Deviation 0.04
|
-0.68 units on a scale
Standard Deviation 0.04
|
|
Short-term Period: Mean Time-matched Change From Baseline (Day 0) in DAS 28 Through 6 Month Open-Label
Change from BL (Day 0) to Day 29 visit (n=426,580)
|
-1.18 units on a scale
Standard Deviation 0.05
|
-1.07 units on a scale
Standard Deviation 0.05
|
|
Short-term Period: Mean Time-matched Change From Baseline (Day 0) in DAS 28 Through 6 Month Open-Label
Change from BL (Day 0) to Day 57 visit (n=425,563)
|
-1.57 units on a scale
Standard Deviation 0.06
|
-1.44 units on a scale
Standard Deviation 0.05
|
|
Short-term Period: Mean Time-matched Change From Baseline (Day 0) in DAS 28 Through 6 Month Open-Label
Change from BL (Day 0) to Day 85 visit (n=403,542)
|
-1.76 units on a scale
Standard Deviation 0.06
|
-1.60 units on a scale
Standard Deviation 0.05
|
|
Short-term Period: Mean Time-matched Change From Baseline (Day 0) in DAS 28 Through 6 Month Open-Label
Change from BL (Day 0) to Day 113 visit(n=393,516)
|
-1.96 units on a scale
Standard Deviation 0.07
|
-1.76 units on a scale
Standard Deviation 0.06
|
|
Short-term Period: Mean Time-matched Change From Baseline (Day 0) in DAS 28 Through 6 Month Open-Label
Change from BL (Day 0) to Day 141 visit(n=372,493)
|
-2.00 units on a scale
Standard Deviation 0.07
|
-1.90 units on a scale
Standard Deviation 0.06
|
|
Short-term Period: Mean Time-matched Change From Baseline (Day 0) in DAS 28 Through 6 Month Open-Label
Change from BL (Day 0) to Day 169 visit(n=369,468)
|
-2.02 units on a scale
Standard Deviation 0.07
|
-2.01 units on a scale
Standard Deviation 0.07
|
SECONDARY outcome
Timeframe: BL, Day 169Population: All treated participants
hs-CRP is a acute phase reactant protein that is a clinical marker for Rheumatoid Arthritis (RA). Levels of hs-CRP can be used to determine DAS28.
Outcome measures
| Measure |
ST Abatacept (ABA)-Previous User
n=376 Participants
In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
|
ST ABA-Current User
n=476 Participants
In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
|
|---|---|---|
|
Short-term Period: Mean Change From Baseline to Day 169 in High Sensitivity C-Reactive Protein (Hs-CRP)
|
-0.88 mg/dL
Standard Deviation 0.13
|
-0.68 mg/dL
Standard Deviation 0.13
|
SECONDARY outcome
Timeframe: BL, Day 169Population: All treated participants
RF is an autoantibody (antibody directed against an organism's own tissues) most relevant in rheumatoid arthritis. It is an antibody against the Fc portion of Immunoglobulin (Ig)G, which is itself an antibody. RF and IgG join to form immune complexes which contribute to the disease process.
Outcome measures
| Measure |
ST Abatacept (ABA)-Previous User
n=376 Participants
In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
|
ST ABA-Current User
n=476 Participants
In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
|
|---|---|---|
|
Short-term Period: Mean Change From Baseline to Day 169 in Rheumatoid Factor (RF)
|
-32.2 IU/mL
Standard Deviation 11.33
|
-22.8 IU/mL
Standard Deviation 10.19
|
SECONDARY outcome
Timeframe: BL, Day 169Population: All treated participants
The HAQ-DI includes 20 questions to assess physical functions 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, and 3= unable to do. HAQ-DI= sum of worst scores in each domain divided by the number of domains answered. HAQ-DI ranges from a minimum of 0 (no difficulty) to a maximum overall score of 3(unable to do).
Outcome measures
| Measure |
ST Abatacept (ABA)-Previous User
n=366 Participants
In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
|
ST ABA-Current User
n=475 Participants
In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
|
|---|---|---|
|
Short-term Period: Mean Change From Baseline to Day 169 in the Health Assessment Questionnaire Disability Index (HAQ-DI)
|
-0.34 units on a scale
Standard Deviation 0.03
|
-0.41 units on a scale
Standard Deviation 0.03
|
SECONDARY outcome
Timeframe: BL, Day 169Population: All treated participants
HAQ-DI includes 20 questions to assess physical functions 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, and 3= unable to do. HAQ-DI= sum of worst scores in each domain divided by the number of domains answered. HAQ-DI ranges from a minimum of 0 (no difficulty) to a maximum overall score of 3(unable to do). Clinically meaningful HAQ response=an improvement of at least 0.3 units from baseline in HAQ disability Index.
Outcome measures
| Measure |
ST Abatacept (ABA)-Previous User
n=449 Participants
In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
|
ST ABA-Current User
n=597 Participants
In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
|
|---|---|---|
|
Short-term Period: Number of Participants Achieving a Clinically Meaningful HAQ Response
|
208 participants
|
281 participants
|
SECONDARY outcome
Timeframe: BLPopulation: All treated participants. n=number of evaluable participants.
The SF-36 is a validated instrument measuring health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores (1) physical component summary=physical functioning, role-physical, bodily pain, and general health; (2) mental component summary=vitality, social functioning, role-emotional, and mental health. There is no total overall score; scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Change from Baseline= post-Baseline - Baseline value.
Outcome measures
| Measure |
ST Abatacept (ABA)-Previous User
n=370 Participants
In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
|
ST ABA-Current User
n=475 Participants
In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
|
|---|---|---|
|
Short-term Period: Mean Baseline Short Form 36 (SF-36) Quality of Life Physical Component Summary (PCS), Mental Component Summary (MCS), and SF-36 Individual Component Scores
PCS (n=360, n=466)
|
28.81 units on a scale
Standard Deviation 7.74
|
28.75 units on a scale
Standard Deviation 7.47
|
|
Short-term Period: Mean Baseline Short Form 36 (SF-36) Quality of Life Physical Component Summary (PCS), Mental Component Summary (MCS), and SF-36 Individual Component Scores
MCS (n=360, n=466)
|
42.45 units on a scale
Standard Deviation 12.98
|
42.43 units on a scale
Standard Deviation 12.43
|
|
Short-term Period: Mean Baseline Short Form 36 (SF-36) Quality of Life Physical Component Summary (PCS), Mental Component Summary (MCS), and SF-36 Individual Component Scores
Physical Function Scale Component (n=367, n=473)
|
27.72 units on a scale
Standard Deviation 9.87
|
28.22 units on a scale
Standard Deviation 9.54
|
|
Short-term Period: Mean Baseline Short Form 36 (SF-36) Quality of Life Physical Component Summary (PCS), Mental Component Summary (MCS), and SF-36 Individual Component Scores
Role-Physical Scale Component (n=364, n=473)
|
32.06 units on a scale
Standard Deviation 7.95
|
31.38 units on a scale
Standard Deviation 7.11
|
|
Short-term Period: Mean Baseline Short Form 36 (SF-36) Quality of Life Physical Component Summary (PCS), Mental Component Summary (MCS), and SF-36 Individual Component Scores
Bodily Pain Scale Component (n=367, n=472)
|
31.73 units on a scale
Standard Deviation 7.17
|
31.13 units on a scale
Standard Deviation 7.26
|
|
Short-term Period: Mean Baseline Short Form 36 (SF-36) Quality of Life Physical Component Summary (PCS), Mental Component Summary (MCS), and SF-36 Individual Component Scores
General Health Scale Component (n=369, n=475)
|
35.70 units on a scale
Standard Deviation 9.40
|
35.71 units on a scale
Standard Deviation 9.22
|
|
Short-term Period: Mean Baseline Short Form 36 (SF-36) Quality of Life Physical Component Summary (PCS), Mental Component Summary (MCS), and SF-36 Individual Component Scores
Vitality Scale Component (n=369, n=472)
|
35.95 units on a scale
Standard Deviation 9.21
|
36.62 units on a scale
Standard Deviation 9.11
|
|
Short-term Period: Mean Baseline Short Form 36 (SF-36) Quality of Life Physical Component Summary (PCS), Mental Component Summary (MCS), and SF-36 Individual Component Scores
Social Functioning Scale Component (n=370, n=475)
|
34.76 units on a scale
Standard Deviation 11.86
|
34.13 units on a scale
Standard Deviation 10.99
|
|
Short-term Period: Mean Baseline Short Form 36 (SF-36) Quality of Life Physical Component Summary (PCS), Mental Component Summary (MCS), and SF-36 Individual Component Scores
Role-Emotional Scale Component (n=365, n=471)
|
37.21 units on a scale
Standard Deviation 13.99
|
36.98 units on a scale
Standard Deviation 14.03
|
|
Short-term Period: Mean Baseline Short Form 36 (SF-36) Quality of Life Physical Component Summary (PCS), Mental Component Summary (MCS), and SF-36 Individual Component Scores
Mental Health Scale Component (n=369, n=472)
|
41.79 units on a scale
Standard Deviation 12.79
|
41.92 units on a scale
Standard Deviation 11.95
|
SECONDARY outcome
Timeframe: BL, Day 169Population: All treated participants. n=number of evaluable participants.
The SF-36 is a validated instrument measuring health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores (1) physical component summary=physical functioning, role-physical, bodily pain, and general health; (2) mental component summary=vitality, social functioning, role-emotional, and mental health. There is no total overall score; scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Change from Baseline= post-Baseline - Baseline value.
Outcome measures
| Measure |
ST Abatacept (ABA)-Previous User
n=370 Participants
In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
|
ST ABA-Current User
n=475 Participants
In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
|
|---|---|---|
|
Short-term Period: Mean Change From Baseline to Day 169 in SF-36 PCS, MCS, and SF-36 Individual Component Scores
PCS (n=360, n=466)
|
5.50 units on a scale
Standard Deviation 0.44
|
6.08 units on a scale
Standard Deviation 0.43
|
|
Short-term Period: Mean Change From Baseline to Day 169 in SF-36 PCS, MCS, and SF-36 Individual Component Scores
MCS (n=360, n=466)
|
4.79 units on a scale
Standard Deviation 0.59
|
5.43 units on a scale
Standard Deviation 0.52
|
|
Short-term Period: Mean Change From Baseline to Day 169 in SF-36 PCS, MCS, and SF-36 Individual Component Scores
Physical Function Scale Component (n=367, n=473)
|
4.31 units on a scale
Standard Deviation 0.52
|
4.66 units on a scale
Standard Deviation 0.49
|
|
Short-term Period: Mean Change From Baseline to Day 169 in SF-36 PCS, MCS, and SF-36 Individual Component Scores
Role-Physical Scale Component (n=364, n=473)
|
5.85 units on a scale
Standard Deviation 0.59
|
6.82 units on a scale
Standard Deviation 0.55
|
|
Short-term Period: Mean Change From Baseline to Day 169 in SF-36 PCS, MCS, and SF-36 Individual Component Scores
Bodily Pain Scale Component (n=367, n=472)
|
8.20 units on a scale
Standard Deviation 0.45
|
8.72 units on a scale
Standard Deviation 0.45
|
|
Short-term Period: Mean Change From Baseline to Day 169 in SF-36 PCS, MCS, and SF-36 Individual Component Scores
General Health Scale Component (n=369, n=475)
|
2.85 units on a scale
Standard Deviation 0.38
|
3.83 units on a scale
Standard Deviation 0.38
|
|
Short-term Period: Mean Change From Baseline to Day 169 in SF-36 PCS, MCS, and SF-36 Individual Component Scores
Vitality Scale Component (n=369, n=472)
|
6.32 units on a scale
Standard Deviation 0.51
|
6.37 units on a scale
Standard Deviation 0.50
|
|
Short-term Period: Mean Change From Baseline to Day 169 in SF-36 PCS, MCS, and SF-36 Individual Component Scores
Social Functioning Scale Component (n=370, n=475)
|
6.44 units on a scale
Standard Deviation 0.58
|
7.18 units on a scale
Standard Deviation 0.54
|
|
Short-term Period: Mean Change From Baseline to Day 169 in SF-36 PCS, MCS, and SF-36 Individual Component Scores
Role-Emotional Scale Component (n=365, n=471)
|
5.30 units on a scale
Standard Deviation 0.76
|
5.85 units on a scale
Standard Deviation 0.71
|
|
Short-term Period: Mean Change From Baseline to Day 169 in SF-36 PCS, MCS, and SF-36 Individual Component Scores
Mental Health Scale Component (n=369, n=472)
|
3.74 units on a scale
Standard Deviation 0.52
|
4.41 units on a scale
Standard Deviation 0.46
|
SECONDARY outcome
Timeframe: BLPopulation: All treated participants
The VAS for Fatigue (VAS-F) consists of a 100 mm line, with 0 (No Fatigue) on 1 end and 100 (Extreme Fatigue) on the other end, which a participant marks to indicate how much fatigue he or she feels. The marked point in mm is converted into a numeric value from 0 to 100, where 0=no fatigue and 100=maximum fatigue. Increasing numbers=increasing fatigue.
Outcome measures
| Measure |
ST Abatacept (ABA)-Previous User
n=376 Participants
In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
|
ST ABA-Current User
n=476 Participants
In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
|
|---|---|---|
|
Short-term Period: Mean Baseline Fatigue Visual Analog Scale (VAS)
|
73.33 units on a scale
Standard Deviation 19.67
|
72.70 units on a scale
Standard Deviation 20.75
|
SECONDARY outcome
Timeframe: BL, Day 169Population: All treated participants
The VAS for Fatigue (VAS-F) consists of a 100 mm line, with 0 (No Fatigue) on 1 end and 100 (Extreme Fatigue) on the other end, which a participant marks to indicate how much fatigue he or she feels. The marked point in mm is converted into a numeric value from 0 to 100, where 0=no fatigue and 100=maximum fatigue. Increasing numbers=increasing fatigue.
Outcome measures
| Measure |
ST Abatacept (ABA)-Previous User
n=376 Participants
In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
|
ST ABA-Current User
n=476 Participants
In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
|
|---|---|---|
|
Short-term Period: Mean Change From Baseline to Day 169 in Fatigue Visual Analog Scale (VAS)
|
-18.3 units on a scale
Standard Deviation 1.35
|
-20.2 units on a scale
Standard Deviation 1.25
|
SECONDARY outcome
Timeframe: BL, Days 365, 449, 533, 617, 729, 813Population: All treated participants. n=number of evaluable participants.
The DAS28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR or CRP, and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thresholds that define high disease activity (\> 5.1), low disease activity (\< 3.2) and remission (\< 2.6). A clinically significant response= decrease in DAS28 score of \>1.2 from baseline.
Outcome measures
| Measure |
ST Abatacept (ABA)-Previous User
n=213 Participants
In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
|
ST ABA-Current User
In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
|
|---|---|---|
|
Long-term Period: Number of Participants With Clinically Meaningful Improvement in DAS 28, Low Disease Activity, or Remission Over Time
Day 729 Remission (n=60)
|
12 participants
|
—
|
|
Long-term Period: Number of Participants With Clinically Meaningful Improvement in DAS 28, Low Disease Activity, or Remission Over Time
Day 365 CMI (n=212)
|
163 participants
|
—
|
|
Long-term Period: Number of Participants With Clinically Meaningful Improvement in DAS 28, Low Disease Activity, or Remission Over Time
Day 365 LDAS (n=213)
|
70 participants
|
—
|
|
Long-term Period: Number of Participants With Clinically Meaningful Improvement in DAS 28, Low Disease Activity, or Remission Over Time
Day 365 Remission (n=213)
|
31 participants
|
—
|
|
Long-term Period: Number of Participants With Clinically Meaningful Improvement in DAS 28, Low Disease Activity, or Remission Over Time
Day 449 CMI (n=119)
|
105 participants
|
—
|
|
Long-term Period: Number of Participants With Clinically Meaningful Improvement in DAS 28, Low Disease Activity, or Remission Over Time
Day 449 LDAS (n=120)
|
43 participants
|
—
|
|
Long-term Period: Number of Participants With Clinically Meaningful Improvement in DAS 28, Low Disease Activity, or Remission Over Time
Day 449 Remission (n=120)
|
25 participants
|
—
|
|
Long-term Period: Number of Participants With Clinically Meaningful Improvement in DAS 28, Low Disease Activity, or Remission Over Time
Day 533 CMI (n=102)
|
91 participants
|
—
|
|
Long-term Period: Number of Participants With Clinically Meaningful Improvement in DAS 28, Low Disease Activity, or Remission Over Time
Day 533 LDAS (n=102)
|
38 participants
|
—
|
|
Long-term Period: Number of Participants With Clinically Meaningful Improvement in DAS 28, Low Disease Activity, or Remission Over Time
Day 533 Remission (n=102)
|
25 participants
|
—
|
|
Long-term Period: Number of Participants With Clinically Meaningful Improvement in DAS 28, Low Disease Activity, or Remission Over Time
Day 617 CMI (n=78)
|
69 participants
|
—
|
|
Long-term Period: Number of Participants With Clinically Meaningful Improvement in DAS 28, Low Disease Activity, or Remission Over Time
Day 617 LDAS (n=79)
|
38 participants
|
—
|
|
Long-term Period: Number of Participants With Clinically Meaningful Improvement in DAS 28, Low Disease Activity, or Remission Over Time
Day 617 Remission (79)
|
17 participants
|
—
|
|
Long-term Period: Number of Participants With Clinically Meaningful Improvement in DAS 28, Low Disease Activity, or Remission Over Time
Day 729 CMI (n=59)
|
51 participants
|
—
|
|
Long-term Period: Number of Participants With Clinically Meaningful Improvement in DAS 28, Low Disease Activity, or Remission Over Time
Day 729 LDAS (n=60)
|
23 participants
|
—
|
|
Long-term Period: Number of Participants With Clinically Meaningful Improvement in DAS 28, Low Disease Activity, or Remission Over Time
Day 813 CMI (n=38)
|
34 participants
|
—
|
|
Long-term Period: Number of Participants With Clinically Meaningful Improvement in DAS 28, Low Disease Activity, or Remission Over Time
Day 813 LDAS (n=38)
|
21 participants
|
—
|
|
Long-term Period: Number of Participants With Clinically Meaningful Improvement in DAS 28, Low Disease Activity, or Remission Over Time
Day 813 Remission (n=38)
|
12 participants
|
—
|
SECONDARY outcome
Timeframe: BL (Day 0), Days 365, 449, 533, 617, 729, 813Population: All treated participants analyzed in the LT. N=the total number of participants analyzed, n=the number of participants at that time point with available measurements. Mean time-matched baseline values reflect changing n-values over time
The DAS28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR or CRP, and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thresholds that define high disease activity (\> 5.1), low disease activity (\< 3.2) and remission (\< 2.6). Time-matched baseline (Day 0)values and post-baseline values were presented for each post-baseline visit, and represent only that cohort of participants with measurements available at that post-baseline visit.
Outcome measures
| Measure |
ST Abatacept (ABA)-Previous User
n=212 Participants
In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
|
ST ABA-Current User
In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
|
|---|---|---|
|
Long-term Period: Mean Time-matched Baseline (Day 0) DAS 28 and DAS 28 for Post-Baseline Visits Over the Long Term
BL (Day 0) for Day 365 cohort (n=212)
|
6.18 units on a scale
Standard Deviation 0.73
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) DAS 28 and DAS 28 for Post-Baseline Visits Over the Long Term
Day 365 visit (n=212)
|
3.90 units on a scale
Standard Deviation 1.32
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) DAS 28 and DAS 28 for Post-Baseline Visits Over the Long Term
BL (Day 0) for Day 449 cohort (n=212)
|
6.16 units on a scale
Standard Deviation 0.70
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) DAS 28 and DAS 28 for Post-Baseline Visits Over the Long Term
Day 449 visit (n=212)
|
3.55 units on a scale
Standard Deviation 1.11
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) DAS 28 and DAS 28 for Post-Baseline Visits Over the Long Term
BL (Day 0) for Day 533 cohort (n=102)
|
6.16 units on a scale
Standard Deviation 0.73
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) DAS 28 and DAS 28 for Post-Baseline Visits Over the Long Term
Day 533 visit (n=102)
|
3.52 units on a scale
Standard Deviation 1.09
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) DAS 28 and DAS 28 for Post-Baseline Visits Over the Long Term
BL (Day 0) for Day 617 cohort (n=78)
|
6.15 units on a scale
Standard Deviation 0.68
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) DAS 28 and DAS 28 for Post-Baseline Visits Over the Long Term
Day 617 visit (n=78)
|
3.44 units on a scale
Standard Deviation 1.12
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) DAS 28 and DAS 28 for Post-Baseline Visits Over the Long Term
BL (Day 0) for Day 729 cohort (n=59)
|
6.16 units on a scale
Standard Deviation 0.69
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) DAS 28 and DAS 28 for Post-Baseline Visits Over the Long Term
Day 729 visit (n=59)
|
3.49 units on a scale
Standard Deviation 1.18
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) DAS 28 and DAS 28 for Post-Baseline Visits Over the Long Term
BL (Day 0) for Day 813 cohort (n=38)
|
6.26 units on a scale
Standard Deviation 0.67
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) DAS 28 and DAS 28 for Post-Baseline Visits Over the Long Term
Day 813 visit (n=38)
|
3.28 units on a scale
Standard Deviation 1.07
|
—
|
SECONDARY outcome
Timeframe: BL (Day 0), Days 365, 449, 533, 617, 729, 813Population: All treated participants analyzed in the LT. N=the total number of participants analyzed, n=the number of participants at that time point with available measurements. Mean time-matched baseline values reflect changing n-values over time
The DAS28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR or CRP, and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thresholds that define high disease activity (\> 5.1), low disease activity (\< 3.2) and remission (\< 2.6). Time-matched mean change from BL= Post-BL value - time-matched BL value, where the time-matched BL value represents the mean BL(Day 0)value for only that cohort of participants with measurements available at that post-BL visit.
Outcome measures
| Measure |
ST Abatacept (ABA)-Previous User
n=212 Participants
In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
|
ST ABA-Current User
In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
|
|---|---|---|
|
Long-term Period: Mean Time-matched Change From Baseline (Day 0) in DAS 28 Over The Long Term
Change from BL (Day 0) to Day 365 visit (n=212)
|
-2.28 units on a scale
Standard Error 0.10
|
—
|
|
Long-term Period: Mean Time-matched Change From Baseline (Day 0) in DAS 28 Over The Long Term
Change from BL (Day 0) to Day 449 visit (n=212)
|
-2.62 units on a scale
Standard Error 0.11
|
—
|
|
Long-term Period: Mean Time-matched Change From Baseline (Day 0) in DAS 28 Over The Long Term
Change from BL (Day 0) to Day 533 visit (n=102)
|
-2.64 units on a scale
Standard Error 0.13
|
—
|
|
Long-term Period: Mean Time-matched Change From Baseline (Day 0) in DAS 28 Over The Long Term
Change from BL (Day 0) to Day 617 visit (n=78)
|
-2.72 units on a scale
Standard Error 0.15
|
—
|
|
Long-term Period: Mean Time-matched Change From Baseline (Day 0) in DAS 28 Over The Long Term
Change from BL (Day 0) to Day 729 visit (n=59)
|
-2.66 units on a scale
Standard Error 0.19
|
—
|
|
Long-term Period: Mean Time-matched Change From Baseline (Day 0) in DAS 28 Over The Long Term
Change from BL (Day 0) to Day 813 visit (n=38)
|
-2.97 units on a scale
Standard Error 0.22
|
—
|
SECONDARY outcome
Timeframe: BL (Day 0), Days 365, 449, 533, 617, 729, 813Population: All treated participants analyzed in the LT. N=the total number of participants analyzed, n=the number of participants at that time point with available measurements. Mean time-matched baseline values reflect changing n-values over time
The mean number of tender joints was evaluated based on the number of tender joints in a standard 68 joint count. Time-matched baseline (Day 0) values and post-baseline values were presented for each post-baseline visit, and represent only that cohort of participants with measurements available at that post-baseline visit.
Outcome measures
| Measure |
ST Abatacept (ABA)-Previous User
n=221 Participants
In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
|
ST ABA-Current User
In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
|
|---|---|---|
|
Long-term Period: Mean Time-matched Baseline (Day 0) Number of Tender Joints and Number of Tender Joints for Post-Baseline Visits Over the Long Term
BL (Day 0) for Day 365 cohort (n=221)
|
16.90 tender joints
Standard Deviation 5.82
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) Number of Tender Joints and Number of Tender Joints for Post-Baseline Visits Over the Long Term
Day 365 visit (n=221)
|
6.04 tender joints
Standard Deviation 6.75
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) Number of Tender Joints and Number of Tender Joints for Post-Baseline Visits Over the Long Term
BL (Day 0) for Day 449 cohort (n=221)
|
16.57 tender joints
Standard Deviation 5.68
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) Number of Tender Joints and Number of Tender Joints for Post-Baseline Visits Over the Long Term
Day 449 visit (n=221)
|
4.39 tender joints
Standard Deviation 5.17
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) Number of Tender Joints and Number of Tender Joints for Post-Baseline Visits Over the Long Term
BL (Day 0) for Day 533 cohort (n=107)
|
16.14 tender joints
Standard Deviation 5.81
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) Number of Tender Joints and Number of Tender Joints for Post-Baseline Visits Over the Long Term
Day 533 visit (n=107)
|
4.34 tender joints
Standard Deviation 4.83
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) Number of Tender Joints and Number of Tender Joints for Post-Baseline Visits Over the Long Term
BL (Day 0) for Day 617 cohort (n=87)
|
16.29 tender joints
Standard Deviation 5.75
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) Number of Tender Joints and Number of Tender Joints for Post-Baseline Visits Over the Long Term
Day 617 visit (n=87)
|
3.75 tender joints
Standard Deviation 4.75
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) Number of Tender Joints and Number of Tender Joints for Post-Baseline Visits Over the Long Term
BL (Day 0) for Day 729 cohort (n=63)
|
16.40 tender joints
Standard Deviation 5.97
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) Number of Tender Joints and Number of Tender Joints for Post-Baseline Visits Over the Long Term
Day 729 visit (n=63)
|
4.02 tender joints
Standard Deviation 5.08
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) Number of Tender Joints and Number of Tender Joints for Post-Baseline Visits Over the Long Term
BL (Day 0) for Day 813 cohort (n=43)
|
17.42 tender joints
Standard Deviation 5.57
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) Number of Tender Joints and Number of Tender Joints for Post-Baseline Visits Over the Long Term
Day 813 visit (n=43)
|
3.67 tender joints
Standard Deviation 4.04
|
—
|
SECONDARY outcome
Timeframe: BL (Day 0), Days 365, 449, 533, 617, 729, 813Population: All treated participants analyzed in the LT. N=the total number of participants analyzed, n=the number of participants at that time point with available measurements. Mean time-matched baseline values reflect changing n-values over time
The mean number of tender joints was evaluated based on the number of tender joints in a standard 68 joint count. Time-matched mean change from baseline = Post-baseline value - time-matched baseline value, where the time-matched baseline value represents the mean baseline (Day 0) value for only that cohort of participants with measurements available at that post-baseline visit.
Outcome measures
| Measure |
ST Abatacept (ABA)-Previous User
n=221 Participants
In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
|
ST ABA-Current User
In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
|
|---|---|---|
|
Long-term Period: Mean Time-matched Change From Baseline (Day 0) in Number of Tender Joints Over the Long Term
Change from BL (Day 0) to Day 365 visit (n=221)
|
-10.9 tender joints
Standard Error 0.51
|
—
|
|
Long-term Period: Mean Time-matched Change From Baseline (Day 0) in Number of Tender Joints Over the Long Term
Change from BL (Day 0) to Day 449 visit (n=221)
|
-12.2 tender joints
Standard Error 0.58
|
—
|
|
Long-term Period: Mean Time-matched Change From Baseline (Day 0) in Number of Tender Joints Over the Long Term
Change from BL (Day 0) to Day 533 visit (n=107)
|
-11.8 tender joints
Standard Error 0.70
|
—
|
|
Long-term Period: Mean Time-matched Change From Baseline (Day 0) in Number of Tender Joints Over the Long Term
Change from BL (Day 0) to Day 617 visit (n=87)
|
-12.5 tender joints
Standard Error 0.75
|
—
|
|
Long-term Period: Mean Time-matched Change From Baseline (Day 0) in Number of Tender Joints Over the Long Term
Change from BL (Day 0) to Day 729 visit (n=63)
|
-12.4 tender joints
Standard Error 0.98
|
—
|
|
Long-term Period: Mean Time-matched Change From Baseline (Day 0) in Number of Tender Joints Over the Long Term
Change from BL (Day 0) to Day 813 visit (n=43)
|
-13.7 tender joints
Standard Error 1.12
|
—
|
SECONDARY outcome
Timeframe: BL (Day 0), Days 365, 449, 533, 617, 729, 813Population: All treated participants analyzed in the LT. N=the total number of participants analyzed, n=the number of participants at that time point with available measurements. Mean time-matched baseline values reflect changing n-values over time
The mean number of swollen joints was evaluated based on the number of swollen joints in a standard 66 joint count. Time-matched baseline (Day 0) values and post-baseline values were presented for each post-baseline visit, and represent only that cohort of participants with measurements available at that post-baseline visit.
Outcome measures
| Measure |
ST Abatacept (ABA)-Previous User
n=221 Participants
In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
|
ST ABA-Current User
In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
|
|---|---|---|
|
Long-term Period: Mean Time-matched Baseline (Day 0) Number of Swollen Joints And Post-Baseline Number of Swollen Joints Over the Long Term
BL (Day 0) for Day 365 cohort (n=221)
|
12.72 swollen joints
Standard Deviation 5.37
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) Number of Swollen Joints And Post-Baseline Number of Swollen Joints Over the Long Term
Day 365 visit (n=221)
|
4.56 swollen joints
Standard Deviation 4.83
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) Number of Swollen Joints And Post-Baseline Number of Swollen Joints Over the Long Term
BL (Day 0) for Day 449 cohort (n=221)
|
12.50 swollen joints
Standard Deviation 4.95
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) Number of Swollen Joints And Post-Baseline Number of Swollen Joints Over the Long Term
Day 449 visit (n=221)
|
3.63 swollen joints
Standard Deviation 3.99
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) Number of Swollen Joints And Post-Baseline Number of Swollen Joints Over the Long Term
BL (Day 0) for Day 533 cohort (n=107)
|
11.91 swollen joints
Standard Deviation 5.01
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) Number of Swollen Joints And Post-Baseline Number of Swollen Joints Over the Long Term
Day 533 visit (n=107)
|
2.81 swollen joints
Standard Deviation 2.67
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) Number of Swollen Joints And Post-Baseline Number of Swollen Joints Over the Long Term
BL (Day 0) for Day 617 cohort (n=87)
|
11.98 swollen joints
Standard Deviation 4.91
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) Number of Swollen Joints And Post-Baseline Number of Swollen Joints Over the Long Term
Day 617 visit (n=87)
|
2.97 swollen joints
Standard Deviation 3.40
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) Number of Swollen Joints And Post-Baseline Number of Swollen Joints Over the Long Term
BL (Day 0) for Day 729 cohort (n=63)
|
11.57 swollen joints
Standard Deviation 4.74
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) Number of Swollen Joints And Post-Baseline Number of Swollen Joints Over the Long Term
Day 729 visit (n=63)
|
3.02 swollen joints
Standard Deviation 4.05
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) Number of Swollen Joints And Post-Baseline Number of Swollen Joints Over the Long Term
BL (Day 0) for Day 813 cohort (n=43)
|
12.40 swollen joints
Standard Deviation 4.14
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) Number of Swollen Joints And Post-Baseline Number of Swollen Joints Over the Long Term
Day 813 visit (n=43)
|
2.14 swollen joints
Standard Deviation 3.10
|
—
|
SECONDARY outcome
Timeframe: BL (Day 0), Days 365, 449, 533, 617, 729, 813Population: All treated participants analyzed in the LT. N=the total number of participants analyzed, n=the number of participants at that time point with available measurements. Mean time-matched baseline values reflect changing n-values over time
The mean number of swollen joints was evaluated based on the number of swollen joints in a standard 66 joint count. Time-matched mean change from baseline = Post-baseline value - time-matched baseline value, where the time-matched baseline value represents the mean baseline (Day 0) value for only that cohort of participants with measurements available at that post-baseline visit.
Outcome measures
| Measure |
ST Abatacept (ABA)-Previous User
n=221 Participants
In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
|
ST ABA-Current User
In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
|
|---|---|---|
|
Long-term Period: Mean Time-Matched Change From Baseline (Day 0) in Number of Swollen Joints Over the Long Term
Change from BL (Day 0) to Day 365 visit (n=221)
|
-8.16 swollen joints
Standard Error 0.40
|
—
|
|
Long-term Period: Mean Time-Matched Change From Baseline (Day 0) in Number of Swollen Joints Over the Long Term
Change from BL (Day 0) to Day 449 visit (n=221)
|
-8.87 swollen joints
Standard Error 0.48
|
—
|
|
Long-term Period: Mean Time-Matched Change From Baseline (Day 0) in Number of Swollen Joints Over the Long Term
Change from BL (Day 0) to Day 533 visit (n=107)
|
-9.09 swollen joints
Standard Error 0.50
|
—
|
|
Long-term Period: Mean Time-Matched Change From Baseline (Day 0) in Number of Swollen Joints Over the Long Term
Change from BL (Day 0) to Day 617 visit (n=87)
|
-9.01 swollen joints
Standard Error 0.60
|
—
|
|
Long-term Period: Mean Time-Matched Change From Baseline (Day 0) in Number of Swollen Joints Over the Long Term
Change from BL (Day 0) to Day 729 visit (n=63)
|
-8.56 swollen joints
Standard Error 0.81
|
—
|
|
Long-term Period: Mean Time-Matched Change From Baseline (Day 0) in Number of Swollen Joints Over the Long Term
Change from BL (Day 0) to Day 813 visit (n=43)
|
-10.3 swollen joints
Standard Error 0.76
|
—
|
SECONDARY outcome
Timeframe: BL (Day 0), Days 365, 449, 533, 617, 729, 813Population: All treated participants analyzed in the LT. N=the total number of participants analyzed, n=the number of participants at that time point with available measurements. Mean time-matched baseline values reflect changing n-values over time
hs-CRP is a acute phase reactant protein that is a clinical marker for Rheumatoid Arthritis (RA). Levels of hs-CRP can be used to determine DAS28. Time-matched baseline (Day 0) values and post-baseline values were presented for each post-baseline visit, and represent only that cohort of participants with measurements available at that post-baseline visit.
Outcome measures
| Measure |
ST Abatacept (ABA)-Previous User
n=216 Participants
In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
|
ST ABA-Current User
In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
|
|---|---|---|
|
Long-term Period: Mean Time-matched Baseline (Day 0) Hs-CRP Levels and Hs-CRP Levels for Post-Baseline Over the Long Term
BL (Day 0) for Day 365 cohort (n=216)
|
2.36 mg/dL
Standard Deviation 2.90
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) Hs-CRP Levels and Hs-CRP Levels for Post-Baseline Over the Long Term
Day 365 visit (n=216)
|
1.24 mg/dL
Standard Deviation 1.78
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) Hs-CRP Levels and Hs-CRP Levels for Post-Baseline Over the Long Term
BL (Day 0) for Day 449 cohort (n=125)
|
2.48 mg/dL
Standard Deviation 2.89
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) Hs-CRP Levels and Hs-CRP Levels for Post-Baseline Over the Long Term
Day 449 visit (n=125)
|
0.97 mg/dL
Standard Deviation 1.59
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) Hs-CRP Levels and Hs-CRP Levels for Post-Baseline Over the Long Term
BL (Day 0) for Day 533 cohort (n=106)
|
2.65 mg/dL
Standard Deviation 2.99
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) Hs-CRP Levels and Hs-CRP Levels for Post-Baseline Over the Long Term
Day 533 visit (n=106)
|
0.93 mg/dL
Standard Deviation 1.39
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) Hs-CRP Levels and Hs-CRP Levels for Post-Baseline Over the Long Term
BL (Day 0) for Day 617 cohort (n=80)
|
2.82 mg/dL
Standard Deviation 3.22
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) Hs-CRP Levels and Hs-CRP Levels for Post-Baseline Over the Long Term
Day 617 visit (n=80)
|
0.81 mg/dL
Standard Deviation 1.21
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) Hs-CRP Levels and Hs-CRP Levels for Post-Baseline Over the Long Term
BL (Day 0) for Day 729 cohort (n=61)
|
2.47 mg/dL
Standard Deviation 3.21
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) Hs-CRP Levels and Hs-CRP Levels for Post-Baseline Over the Long Term
Day 729 visit (n=61)
|
0.98 mg/dL
Standard Deviation 1.57
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) Hs-CRP Levels and Hs-CRP Levels for Post-Baseline Over the Long Term
BL (Day 0) for Day 813 cohort (n=43)
|
2.60 mg/dL
Standard Deviation 2.80
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) Hs-CRP Levels and Hs-CRP Levels for Post-Baseline Over the Long Term
Day 813 visit (n=43)
|
0.68 mg/dL
Standard Deviation 0.96
|
—
|
SECONDARY outcome
Timeframe: BL (Day 0), Days 365, 449, 533, 617, 729, 813Population: All treated participants analyzed in the LT. N=the total number of participants analyzed, n=the number of participants at that time point with available measurements. Mean time-matched baseline values reflect changing n-values over time
hs-CRP is a acute phase reactant protein that is a clinical marker for Rheumatoid Arthritis (RA). Levels of hs-CRP can be used to determine DAS28. Time-matched mean change from baseline = Post-baseline value - time-matched baseline value, where the time-matched baseline value represents the mean baseline (Day 0) value for only that cohort of participants with measurements available at that post-baseline visit.
Outcome measures
| Measure |
ST Abatacept (ABA)-Previous User
n=216 Participants
In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
|
ST ABA-Current User
In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
|
|---|---|---|
|
Long-term Period: Mean Time-matched Change From Baseline (Day 0) in Hs-CRP Level Over the Long Term
Change from BL (Day 0) to Day 365 visit (n=216)
|
-1.12 mg/dL
Standard Error 0.19
|
—
|
|
Long-term Period: Mean Time-matched Change From Baseline (Day 0) in Hs-CRP Level Over the Long Term
Change from BL (Day 0) to Day 449 visit (n=125)
|
-1.51 mg/dL
Standard Error 0.22
|
—
|
|
Long-term Period: Mean Time-matched Change From Baseline (Day 0) in Hs-CRP Level Over the Long Term
Change from BL (Day 0) to Day 533 visit (n=106)
|
-1.72 mg/dL
Standard Error 0.26
|
—
|
|
Long-term Period: Mean Time-matched Change From Baseline (Day 0) in Hs-CRP Level Over the Long Term
Change from BL (Day 0) to Day 617 visit (n=80)
|
-2.02 mg/dL
Standard Error 0.32
|
—
|
|
Long-term Period: Mean Time-matched Change From Baseline (Day 0) in Hs-CRP Level Over the Long Term
Change from BL (Day 0) to Day 729 visit (n=61)
|
-1.49 mg/dL
Standard Error 0.36
|
—
|
|
Long-term Period: Mean Time-matched Change From Baseline (Day 0) in Hs-CRP Level Over the Long Term
Change from BL (Day 0) to Day 813 visit (n=43)
|
-1.92 mg/dL
Standard Error 0.43
|
—
|
SECONDARY outcome
Timeframe: BL (Day 0), Days 365, 449, 533, 617, 729, 813Population: All treated participants analyzed in the LT. N=the total number of participants analyzed, n=the number of participants at that time point with available measurements. Mean time-matched baseline values reflect changing n-values over time
The VAS for Fatigue (VAS-F) consists of a 100 mm line, with 0 (No Fatigue) on 1 end and 100 (Extreme Fatigue) on the other end, which a participant marks to indicate how much fatigue he or she feels. The marked point in mm is converted into a numeric value from 0 to 100, where 0=no fatigue and 100=maximum fatigue. Increasing numbers=increasing fatigue. Time-matched baseline (Day 0) values and post-baseline values were presented for each post-baseline visit, and represent only that cohort of participants with measurements available at that post-baseline visit.
Outcome measures
| Measure |
ST Abatacept (ABA)-Previous User
n=216 Participants
In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
|
ST ABA-Current User
In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
|
|---|---|---|
|
Long-term Period: Mean Time-matched Baseline (Day 0) Visual Analog Scale (VAS) and VAS for Post-Baseline Visits Over the Long Term
BL (Day 0) for Day 365 cohort (n=220)
|
74.05 units on a scale
Standard Deviation 16.28
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) Visual Analog Scale (VAS) and VAS for Post-Baseline Visits Over the Long Term
Day 365 visit (n=220)
|
40.61 units on a scale
Standard Deviation 24.76
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) Visual Analog Scale (VAS) and VAS for Post-Baseline Visits Over the Long Term
BL (Day 0) for Day 449 cohort (n=121)
|
73.20 units on a scale
Standard Deviation 15.46
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) Visual Analog Scale (VAS) and VAS for Post-Baseline Visits Over the Long Term
Day 449 visit (n=121)
|
38.74 units on a scale
Standard Deviation 24.18
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) Visual Analog Scale (VAS) and VAS for Post-Baseline Visits Over the Long Term
BL (Day 0) for Day 533 cohort (n=104)
|
73.41 units on a scale
Standard Deviation 15.51
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) Visual Analog Scale (VAS) and VAS for Post-Baseline Visits Over the Long Term
Day 533 visit (n=104)
|
39.27 units on a scale
Standard Deviation 23.23
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) Visual Analog Scale (VAS) and VAS for Post-Baseline Visits Over the Long Term
BL (Day 0) for Day 617 cohort (n=85)
|
73.59 units on a scale
Standard Deviation 14.75
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) Visual Analog Scale (VAS) and VAS for Post-Baseline Visits Over the Long Term
Day 617 visit (n=85)
|
42.16 units on a scale
Standard Deviation 22.75
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) Visual Analog Scale (VAS) and VAS for Post-Baseline Visits Over the Long Term
BL (Day 0) for Day 729 cohort (n=61)
|
73.48 units on a scale
Standard Deviation 16.71
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) Visual Analog Scale (VAS) and VAS for Post-Baseline Visits Over the Long Term
Day 729 visit (n=61)
|
42.90 units on a scale
Standard Deviation 23.09
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) Visual Analog Scale (VAS) and VAS for Post-Baseline Visits Over the Long Term
BL (Day 0) for Day 813 cohort (n=38)
|
74.47 units on a scale
Standard Deviation 16.68
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) Visual Analog Scale (VAS) and VAS for Post-Baseline Visits Over the Long Term
Day 813 visit (n=38)
|
39.61 units on a scale
Standard Deviation 22.13
|
—
|
SECONDARY outcome
Timeframe: BL (Day 0), Days 365, 449, 533, 617, 729, 813Population: All treated participants analyzed in the LT. N=the total number of participants analyzed, n=the number of participants at that time point with available measurements. Mean time-matched baseline values reflect changing n-values over time
The VAS for Fatigue (VAS-F) consists of a 100 mm line, with 0 (No Fatigue) on 1 end and 100 (Extreme Fatigue) on the other end, which a participant marks to indicate how much fatigue he or she feels. The marked point in mm is converted into a numeric value from 0 to 100, where 0=no fatigue and 100=maximum fatigue. Increasing numbers=increasing fatigue. Time-matched mean change from BL = Post-BL value - time-matched BL value, where the time-matched BL value represents the mean BL (Day 0) value for only that cohort of participants with data available at that post-BL visit.
Outcome measures
| Measure |
ST Abatacept (ABA)-Previous User
n=216 Participants
In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
|
ST ABA-Current User
In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
|
|---|---|---|
|
Long-term Period: Mean Time-matched Change From Baseline (Day 0) in VAS Over the Long Term
Change from BL (Day 0) to Day 365 visit (n=220)
|
-33.4 units on a scale
Standard Error 1.88
|
—
|
|
Long-term Period: Mean Time-matched Change From Baseline (Day 0) in VAS Over the Long Term
Change from BL (Day 0) to Day 449 visit (n=121)
|
-34.5 units on a scale
Standard Error 2.43
|
—
|
|
Long-term Period: Mean Time-matched Change From Baseline (Day 0) in VAS Over the Long Term
Change from BL (Day 0) to Day 533 visit (n=104)
|
-34.1 units on a scale
Standard Error 2.82
|
—
|
|
Long-term Period: Mean Time-matched Change From Baseline (Day 0) in VAS Over the Long Term
Change from BL (Day 0) to Day 617 visit (n=85)
|
-31.4 units on a scale
Standard Error 2.91
|
—
|
|
Long-term Period: Mean Time-matched Change From Baseline (Day 0) in VAS Over the Long Term
Change from BL (Day 0) to Day 729 visit (n=61)
|
-30.6 units on a scale
Standard Error 3.65
|
—
|
|
Long-term Period: Mean Time-matched Change From Baseline (Day 0) in VAS Over the Long Term
Change from BL (Day 0) to Day 813 visit (n=38)
|
-34.9 units on a scale
Standard Error 4.03
|
—
|
SECONDARY outcome
Timeframe: BL (Day 0)Population: All treated participants analyzed in the LT. N=the total number of participants analyzed, n=the number of participants at that time point with available measurements. Mean time-matched baseline values reflect changing n-values over time
HAQ-DI includes 20 questions to assess physical functions in 8 domains:dressing, arising,eating,walking, hygiene, reach, grip and common activities. Domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do. HAQ-DI= sum of worst scores in each domain divided by number of domains answered. HAQ-DI minimum=0 (no difficulty), max overall score=3(unable to do). Time-matched BL(Day 0)values presented for each post-BL visit represent only that cohort of participants with measurements available at that post-BL visit.
Outcome measures
| Measure |
ST Abatacept (ABA)-Previous User
n=216 Participants
In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
|
ST ABA-Current User
In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
|
|---|---|---|
|
Long-term Period: Mean Time-matched Baseline (Day 0) HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 729 HAQ gripping (n=63)
|
1.90 units on a scale
Standard Deviation 0.73
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 729 HAQ activities (n=63)
|
2.03 units on a scale
Standard Deviation 0.80
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 813 HAQ-DI (n=39)
|
2.01 units on a scale
Standard Deviation 0.62
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 813 HAQ dressing and grooming (n=39)
|
1.92 units on a scale
Standard Deviation 0.84
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 813 HAQ arising (n=39)
|
1.59 units on a scale
Standard Deviation 0.75
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 813 HAQ eating (n=39)
|
2.18 units on a scale
Standard Deviation 0.94
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 365 HAQ-DI (n=215)
|
1.80 units on a scale
Standard Deviation 0.62
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 365 HAQ dressing and grooming (n=215)
|
1.62 units on a scale
Standard Deviation 0.86
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 365 HAQ arising (n=215)
|
1.39 units on a scale
Standard Deviation 0.76
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 365 HAQ eating (n=215)
|
1.84 units on a scale
Standard Deviation 0.92
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 365 HAQ walking (n=215)
|
1.43 units on a scale
Standard Deviation 0.78
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 365 HAQ hygiene (n=214)
|
2.08 units on a scale
Standard Deviation 0.77
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 365 HAQ reaching (n=215)
|
2.12 units on a scale
Standard Deviation 0.80
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 365 HAQ gripping (n=216)
|
1.94 units on a scale
Standard Deviation 0.70
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 365 HAQ activities (n=216)
|
2.00 units on a scale
Standard Deviation 0.80
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 449 HAQ-DI (n=116)
|
1.89 units on a scale
Standard Deviation 0.60
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 449 HAQ dressing and grooming (n=116)
|
1.77 units on a scale
Standard Deviation 0.81
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 449 HAQ arising (n=116)
|
1.45 units on a scale
Standard Deviation 0.74
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 449 HAQ eating (n=116)
|
2.01 units on a scale
Standard Deviation 0.90
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 449 HAQ walking (n=116)
|
1.53 units on a scale
Standard Deviation 0.76
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 449 HAQ hygiene (n=117)
|
2.11 units on a scale
Standard Deviation 0.77
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 449 HAQ reaching (n=117)
|
2.23 units on a scale
Standard Deviation 0.77
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 449 HAQ gripping (n=117)
|
1.97 units on a scale
Standard Deviation 0.68
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 449 HAQ activities (n=117)
|
2.05 units on a scale
Standard Deviation 0.76
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 533 HAQ-DI (n=101)
|
1.87 units on a scale
Standard Deviation 0.62
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 533 HAQ dressing and grooming (n=102)
|
1.78 units on a scale
Standard Deviation 0.83
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 533 HAQ arising (n=102)
|
1.41 units on a scale
Standard Deviation 0.76
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 533 HAQ eating (n=102)
|
1.96 units on a scale
Standard Deviation 0.92
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 533 HAQ walking (n=102)
|
1.56 units on a scale
Standard Deviation 0.74
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 533 HAQ hygiene (n=101)
|
2.07 units on a scale
Standard Deviation 0.78
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 533 HAQ reaching (n=101)
|
2.22 units on a scale
Standard Deviation 0.78
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 533 HAQ gripping (n=101)
|
1.96 units on a scale
Standard Deviation 0.68
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 533 HAQ activities (n=101)
|
2.03 units on a scale
Standard Deviation 0.79
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 617 HAQ-DI (n=83)
|
1.86 units on a scale
Standard Deviation 0.61
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 617 HAQ dressing and grooming (n=83)
|
1.78 units on a scale
Standard Deviation 0.81
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 617 HAQ arising (n=83)
|
1.40 units on a scale
Standard Deviation 0.75
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 617 HAQ eating (n=83)
|
1.94 units on a scale
Standard Deviation 0.90
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 617 HAQ walking (n=83)
|
1.54 units on a scale
Standard Deviation 0.72
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 617 HAQ hygiene (n=83)
|
2.02 units on a scale
Standard Deviation 0.76
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 617 HAQ reaching (n=83)
|
2.20 units on a scale
Standard Deviation 0.78
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 617 HAQ gripping (n=83)
|
1.94 units on a scale
Standard Deviation 0.69
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 617 HAQ activities (n=83)
|
2.04 units on a scale
Standard Deviation 0.83
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 729 HAQ-DI (n=63)
|
1.86 units on a scale
Standard Deviation 0.61
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 729 HAQ dressing and grooming (n=63)
|
1.75 units on a scale
Standard Deviation 0.82
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 729 HAQ arising (n=63)
|
1.40 units on a scale
Standard Deviation 0.75
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 729 HAQ eating (n=63)
|
1.95 units on a scale
Standard Deviation 0.92
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 729 HAQ walking (n=63)
|
1.57 units on a scale
Standard Deviation 0.67
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 729 HAQ hygiene (n=63)
|
2.00 units on a scale
Standard Deviation 0.78
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 729 HAQ reaching (n=63)
|
2.24 units on a scale
Standard Deviation 0.71
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 813 HAQ walking (n=39)
|
1.69 units on a scale
Standard Deviation 0.66
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 813 HAQ hygiene (n=39)
|
2.10 units on a scale
Standard Deviation 0.82
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 813 HAQ reaching (n=39)
|
2.41 units on a scale
Standard Deviation 0.64
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 813 HAQ gripping (n=39)
|
2.00 units on a scale
Standard Deviation 0.79
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 813 HAQ activities (n=39)
|
2.18 units on a scale
Standard Deviation 0.79
|
—
|
SECONDARY outcome
Timeframe: Days 365, 449, 533, 617, 729, 813Population: All treated participants analyzed in the LT. N=the total number of participants analyzed, n=the number of participants at that time point with available measurements. Mean post-baseline values reflect changing n-values over time
HAQ-DI includes 20 questions to assess physical functions in 8 domains:dressing, arising, eating, walking, hygiene, reach, grip and common activities. Domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do. HAQ-DI= sum of worst scores in each domain divided by number of domains answered. HAQ-DI minimum=0(no difficulty), max overall score=3(unable to do). Post-BL values presented for each visit represent only that cohort of participants with measurements available at that post-BL visit.
Outcome measures
| Measure |
ST Abatacept (ABA)-Previous User
n=216 Participants
In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
|
ST ABA-Current User
In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
|
|---|---|---|
|
Long-term Period: Mean HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Post-baseline Visits Over the Long Term
Day 813 HAQ eating (n=39)
|
1.46 units on a scale
Standard Deviation 0.94
|
—
|
|
Long-term Period: Mean HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Post-baseline Visits Over the Long Term
Day 365 HAQ-DI (n=215)
|
1.34 units on a scale
Standard Deviation 0.75
|
—
|
|
Long-term Period: Mean HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Post-baseline Visits Over the Long Term
Day 365 HAQ dressing and grooming (n=215)
|
1.15 units on a scale
Standard Deviation 0.93
|
—
|
|
Long-term Period: Mean HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Post-baseline Visits Over the Long Term
Day 365 HAQ arising (n=215)
|
0.85 units on a scale
Standard Deviation 0.80
|
—
|
|
Long-term Period: Mean HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Post-baseline Visits Over the Long Term
Day 365 HAQ eating (n=215)
|
1.26 units on a scale
Standard Deviation 1.00
|
—
|
|
Long-term Period: Mean HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Post-baseline Visits Over the Long Term
Day 365 HAQ walking (n=215)
|
1.03 units on a scale
Standard Deviation 0.86
|
—
|
|
Long-term Period: Mean HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Post-baseline Visits Over the Long Term
Day 365 HAQ hygiene (n=214)
|
1.70 units on a scale
Standard Deviation 1.06
|
—
|
|
Long-term Period: Mean HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Post-baseline Visits Over the Long Term
Day 365 HAQ reaching (n=215)
|
1.73 units on a scale
Standard Deviation 1.01
|
—
|
|
Long-term Period: Mean HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Post-baseline Visits Over the Long Term
Day 365 HAQ gripping (n=216)
|
1.45 units on a scale
Standard Deviation 0.90
|
—
|
|
Long-term Period: Mean HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Post-baseline Visits Over the Long Term
Day 365 HAQ activities (n=216)
|
1.52 units on a scale
Standard Deviation 1.01
|
—
|
|
Long-term Period: Mean HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Post-baseline Visits Over the Long Term
Day 449 HAQ-DI (n=116)
|
1.37 units on a scale
Standard Deviation 0.75
|
—
|
|
Long-term Period: Mean HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Post-baseline Visits Over the Long Term
Day 449 HAQ dressing and grooming (n=116)
|
1.17 units on a scale
Standard Deviation 0.94
|
—
|
|
Long-term Period: Mean HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Post-baseline Visits Over the Long Term
Day 449 HAQ arising (n=116)
|
0.84 units on a scale
Standard Deviation 0.80
|
—
|
|
Long-term Period: Mean HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Post-baseline Visits Over the Long Term
Day 449 HAQ eating (n=116)
|
1.35 units on a scale
Standard Deviation 1.03
|
—
|
|
Long-term Period: Mean HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Post-baseline Visits Over the Long Term
Day 449 HAQ walking (n=116)
|
1.02 units on a scale
Standard Deviation 0.85
|
—
|
|
Long-term Period: Mean HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Post-baseline Visits Over the Long Term
Day 449 HAQ hygiene (n=117)
|
1.67 units on a scale
Standard Deviation 1.02
|
—
|
|
Long-term Period: Mean HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Post-baseline Visits Over the Long Term
Day 449 HAQ reaching (n=117)
|
1.79 units on a scale
Standard Deviation 0.96
|
—
|
|
Long-term Period: Mean HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Post-baseline Visits Over the Long Term
Day 449 HAQ gripping (n=117)
|
1.50 units on a scale
Standard Deviation 0.91
|
—
|
|
Long-term Period: Mean HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Post-baseline Visits Over the Long Term
Day 449 HAQ activities (n=117)
|
1.61 units on a scale
Standard Deviation 1.01
|
—
|
|
Long-term Period: Mean HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Post-baseline Visits Over the Long Term
Day 533 HAQ-DI (n=101)
|
1.33 units on a scale
Standard Deviation 0.74
|
—
|
|
Long-term Period: Mean HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Post-baseline Visits Over the Long Term
Day 533 HAQ dressing and grooming (n=102)
|
1.15 units on a scale
Standard Deviation 0.95
|
—
|
|
Long-term Period: Mean HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Post-baseline Visits Over the Long Term
Day 533 HAQ arising (n=102)
|
0.82 units on a scale
Standard Deviation 0.80
|
—
|
|
Long-term Period: Mean HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Post-baseline Visits Over the Long Term
Day 533 HAQ eating (n=102)
|
1.30 units on a scale
Standard Deviation 0.97
|
—
|
|
Long-term Period: Mean HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Post-baseline Visits Over the Long Term
Day 533 HAQ walking (n=102)
|
0.98 units on a scale
Standard Deviation 0.87
|
—
|
|
Long-term Period: Mean HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Post-baseline Visits Over the Long Term
Day 533 HAQ hygiene (n=101)
|
1.57 units on a scale
Standard Deviation 1.04
|
—
|
|
Long-term Period: Mean HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Post-baseline Visits Over the Long Term
Day 533 HAQ reaching (n=101)
|
1.81 units on a scale
Standard Deviation 0.94
|
—
|
|
Long-term Period: Mean HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Post-baseline Visits Over the Long Term
Day 533 HAQ gripping (n=101)
|
1.48 units on a scale
Standard Deviation 0.97
|
—
|
|
Long-term Period: Mean HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Post-baseline Visits Over the Long Term
Day 533 HAQ activities (n=101)
|
1.58 units on a scale
Standard Deviation 0.94
|
—
|
|
Long-term Period: Mean HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Post-baseline Visits Over the Long Term
Day 617 HAQ-DI (n=83)
|
1.27 units on a scale
Standard Deviation 0.68
|
—
|
|
Long-term Period: Mean HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Post-baseline Visits Over the Long Term
Day 617 HAQ dressing and grooming (n=83)
|
0.98 units on a scale
Standard Deviation 0.88
|
—
|
|
Long-term Period: Mean HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Post-baseline Visits Over the Long Term
Day 617 HAQ arising (n=83)
|
0.73 units on a scale
Standard Deviation 0.81
|
—
|
|
Long-term Period: Mean HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Post-baseline Visits Over the Long Term
Day 617 HAQ eating (n=83)
|
1.33 units on a scale
Standard Deviation 0.88
|
—
|
|
Long-term Period: Mean HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Post-baseline Visits Over the Long Term
Day 617 HAQ walking (n=83)
|
0.96 units on a scale
Standard Deviation 0.76
|
—
|
|
Long-term Period: Mean HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Post-baseline Visits Over the Long Term
Day 617 HAQ hygiene (n=83)
|
1.48 units on a scale
Standard Deviation 0.95
|
—
|
|
Long-term Period: Mean HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Post-baseline Visits Over the Long Term
Day 617 HAQ reaching (n=83)
|
1.70 units on a scale
Standard Deviation 0.85
|
—
|
|
Long-term Period: Mean HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Post-baseline Visits Over the Long Term
Day 617 HAQ gripping (n=83)
|
1.43 units on a scale
Standard Deviation 0.84
|
—
|
|
Long-term Period: Mean HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Post-baseline Visits Over the Long Term
Day 617 HAQ activities (n=83)
|
1.57 units on a scale
Standard Deviation 0.93
|
—
|
|
Long-term Period: Mean HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Post-baseline Visits Over the Long Term
Day 729 HAQ-DI (n=63)
|
1.34 units on a scale
Standard Deviation 0.74
|
—
|
|
Long-term Period: Mean HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Post-baseline Visits Over the Long Term
Day 729 HAQ dressing and grooming (n=63)
|
1.03 units on a scale
Standard Deviation 0.95
|
—
|
|
Long-term Period: Mean HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Post-baseline Visits Over the Long Term
Day 729 HAQ arising (n=63)
|
0.81 units on a scale
Standard Deviation 0.82
|
—
|
|
Long-term Period: Mean HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Post-baseline Visits Over the Long Term
Day 729 HAQ eating (n=63)
|
1.33 units on a scale
Standard Deviation 0.97
|
—
|
|
Long-term Period: Mean HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Post-baseline Visits Over the Long Term
Day 729 HAQ walking (n=63)
|
1.11 units on a scale
Standard Deviation 0.94
|
—
|
|
Long-term Period: Mean HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Post-baseline Visits Over the Long Term
Day 729 HAQ hygiene (n=63)
|
1.48 units on a scale
Standard Deviation 1.03
|
—
|
|
Long-term Period: Mean HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Post-baseline Visits Over the Long Term
Day 729 HAQ reaching (n=63)
|
1.73 units on a scale
Standard Deviation 0.81
|
—
|
|
Long-term Period: Mean HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Post-baseline Visits Over the Long Term
Day 729 HAQ gripping (n=63)
|
1.57 units on a scale
Standard Deviation 0.91
|
—
|
|
Long-term Period: Mean HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Post-baseline Visits Over the Long Term
Day 729 HAQ activities (n=63)
|
1.68 units on a scale
Standard Deviation 0.96
|
—
|
|
Long-term Period: Mean HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Post-baseline Visits Over the Long Term
Day 813 HAQ-DI (n=39)
|
1.38 units on a scale
Standard Deviation 0.69
|
—
|
|
Long-term Period: Mean HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Post-baseline Visits Over the Long Term
Day 813 HAQ dressing and grooming (n=39)
|
1.18 units on a scale
Standard Deviation 0.97
|
—
|
|
Long-term Period: Mean HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Post-baseline Visits Over the Long Term
Day 813 HAQ arising (n=39)
|
0.82 units on a scale
Standard Deviation 0.79
|
—
|
|
Long-term Period: Mean HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Post-baseline Visits Over the Long Term
Day 813 HAQ walking (n=39)
|
1.10 units on a scale
Standard Deviation 0.79
|
—
|
|
Long-term Period: Mean HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Post-baseline Visits Over the Long Term
Day 813 HAQ hygiene (n=39)
|
1.59 units on a scale
Standard Deviation 0.88
|
—
|
|
Long-term Period: Mean HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Post-baseline Visits Over the Long Term
Day 813 HAQ reaching (n=39)
|
1.72 units on a scale
Standard Deviation 0.76
|
—
|
|
Long-term Period: Mean HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Post-baseline Visits Over the Long Term
Day 813 HAQ gripping (n=39)
|
1.36 units on a scale
Standard Deviation 0.96
|
—
|
|
Long-term Period: Mean HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Post-baseline Visits Over the Long Term
Day 813 HAQ activities (n=39)
|
1.77 units on a scale
Standard Deviation 0.93
|
—
|
SECONDARY outcome
Timeframe: BL (Day 0), Days 365, 449, 533, 617, 729, 813Population: All treated participants analyzed in the LT. N=the total number of participants analyzed, n=the number of participants at that time point with available measurements. Mean time-matched baseline values reflect changing n-values over time
HAQ-DI includes 20 questions assessing physical functions in 8 domains:dressing,arising,eating,walking,hygiene,reach,grip and common activities.Domain questions evaluated on 4-point scale: 0=without any difficulty,1=with some difficulty,2=with much difficulty,and 3=unable to do. HAQ-DI=sum of worst scores in each domain ÷ number of domains answered. HAQ-DI minimum=0 (no difficulty), max overall score=3(unable to do). Time-matched mean change from BL= Post-BL value - time-matched BL value. Time-matched BL value=mean BL (Day 0)value for only that cohort with data available at that post-BL visit.
Outcome measures
| Measure |
ST Abatacept (ABA)-Previous User
n=216 Participants
In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
|
ST ABA-Current User
In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
|
|---|---|---|
|
Long-term Period: Mean Time-matched Change From Baseline (Day 0) in HAQ-DI and HAQ-DI Components For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 365 HAQ-DI (n=215)
|
-0.46 units on a scale
Standard Error 0.04
|
—
|
|
Long-term Period: Mean Time-matched Change From Baseline (Day 0) in HAQ-DI and HAQ-DI Components For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 365 HAQ dressing and grooming (n=215)
|
-0.47 units on a scale
Standard Error 0.06
|
—
|
|
Long-term Period: Mean Time-matched Change From Baseline (Day 0) in HAQ-DI and HAQ-DI Components For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 365 HAQ arising (n=215)
|
-0.54 units on a scale
Standard Error 0.06
|
—
|
|
Long-term Period: Mean Time-matched Change From Baseline (Day 0) in HAQ-DI and HAQ-DI Components For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 365 HAQ eating (n=215)
|
-0.58 units on a scale
Standard Error 0.06
|
—
|
|
Long-term Period: Mean Time-matched Change From Baseline (Day 0) in HAQ-DI and HAQ-DI Components For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 365 HAQ walking (n=215)
|
-0.39 units on a scale
Standard Error 0.05
|
—
|
|
Long-term Period: Mean Time-matched Change From Baseline (Day 0) in HAQ-DI and HAQ-DI Components For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 365 HAQ hygiene (n=214)
|
-0.38 units on a scale
Standard Error 0.06
|
—
|
|
Long-term Period: Mean Time-matched Change From Baseline (Day 0) in HAQ-DI and HAQ-DI Components For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 365 HAQ reaching (n=215)
|
-0.38 units on a scale
Standard Error 0.05
|
—
|
|
Long-term Period: Mean Time-matched Change From Baseline (Day 0) in HAQ-DI and HAQ-DI Components For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 365 HAQ gripping (n=216)
|
-0.49 units on a scale
Standard Error 0.06
|
—
|
|
Long-term Period: Mean Time-matched Change From Baseline (Day 0) in HAQ-DI and HAQ-DI Components For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 365 HAQ activities (n=216)
|
-0.47 units on a scale
Standard Error 0.06
|
—
|
|
Long-term Period: Mean Time-matched Change From Baseline (Day 0) in HAQ-DI and HAQ-DI Components For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 449 HAQ-DI (n=116)
|
-0.52 units on a scale
Standard Error 0.05
|
—
|
|
Long-term Period: Mean Time-matched Change From Baseline (Day 0) in HAQ-DI and HAQ-DI Components For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 449 HAQ dressing and grooming (n=116)
|
-0.59 units on a scale
Standard Error 0.08
|
—
|
|
Long-term Period: Mean Time-matched Change From Baseline (Day 0) in HAQ-DI and HAQ-DI Components For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 449 HAQ arising (n=116)
|
-0.60 units on a scale
Standard Error 0.07
|
—
|
|
Long-term Period: Mean Time-matched Change From Baseline (Day 0) in HAQ-DI and HAQ-DI Components For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 449 HAQ eating (n=116)
|
-0.66 units on a scale
Standard Error 0.08
|
—
|
|
Long-term Period: Mean Time-matched Change From Baseline (Day 0) in HAQ-DI and HAQ-DI Components For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 449 HAQ walking (n=116)
|
-0.52 units on a scale
Standard Error 0.07
|
—
|
|
Long-term Period: Mean Time-matched Change From Baseline (Day 0) in HAQ-DI and HAQ-DI Components For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 449 HAQ hygiene (n=117)
|
-0.44 units on a scale
Standard Error 0.08
|
—
|
|
Long-term Period: Mean Time-matched Change From Baseline (Day 0) in HAQ-DI and HAQ-DI Components For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 449 HAQ reaching (n=117)
|
-0.44 units on a scale
Standard Error 0.07
|
—
|
|
Long-term Period: Mean Time-matched Change From Baseline (Day 0) in HAQ-DI and HAQ-DI Components For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 449 HAQ gripping (n=117)
|
-0.47 units on a scale
Standard Error 0.08
|
—
|
|
Long-term Period: Mean Time-matched Change From Baseline (Day 0) in HAQ-DI and HAQ-DI Components For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 449 HAQ activities (n=117)
|
-0.44 units on a scale
Standard Error 0.08
|
—
|
|
Long-term Period: Mean Time-matched Change From Baseline (Day 0) in HAQ-DI and HAQ-DI Components For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 533 HAQ-DI (n=101)
|
-0.54 units on a scale
Standard Error 0.06
|
—
|
|
Long-term Period: Mean Time-matched Change From Baseline (Day 0) in HAQ-DI and HAQ-DI Components For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 533 HAQ dressing and grooming (n=102)
|
-0.64 units on a scale
Standard Error 0.10
|
—
|
|
Long-term Period: Mean Time-matched Change From Baseline (Day 0) in HAQ-DI and HAQ-DI Components For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 533 HAQ arising (n=102)
|
-0.59 units on a scale
Standard Error 0.08
|
—
|
|
Long-term Period: Mean Time-matched Change From Baseline (Day 0) in HAQ-DI and HAQ-DI Components For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 533 HAQ eating (n=102)
|
-0.66 units on a scale
Standard Error 0.10
|
—
|
|
Long-term Period: Mean Time-matched Change From Baseline (Day 0) in HAQ-DI and HAQ-DI Components For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 533 HAQ walking (n=102)
|
-0.58 units on a scale
Standard Error 0.07
|
—
|
|
Long-term Period: Mean Time-matched Change From Baseline (Day 0) in HAQ-DI and HAQ-DI Components For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 533 HAQ hygiene (n=101)
|
-0.50 units on a scale
Standard Error 0.09
|
—
|
|
Long-term Period: Mean Time-matched Change From Baseline (Day 0) in HAQ-DI and HAQ-DI Components For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 533 HAQ reaching (n=101)
|
-0.41 units on a scale
Standard Error 0.09
|
—
|
|
Long-term Period: Mean Time-matched Change From Baseline (Day 0) in HAQ-DI and HAQ-DI Components For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 533 HAQ gripping (n=101)
|
-0.49 units on a scale
Standard Error 0.10
|
—
|
|
Long-term Period: Mean Time-matched Change From Baseline (Day 0) in HAQ-DI and HAQ-DI Components For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 533 HAQ activities (n=101)
|
-0.45 units on a scale
Standard Error 0.09
|
—
|
|
Long-term Period: Mean Time-matched Change From Baseline (Day 0) in HAQ-DI and HAQ-DI Components For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 617 HAQ-DI (n=83)
|
-0.59 units on a scale
Standard Error 0.07
|
—
|
|
Long-term Period: Mean Time-matched Change From Baseline (Day 0) in HAQ-DI and HAQ-DI Components For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 617 HAQ dressing and grooming (n=83)
|
-0.81 units on a scale
Standard Error 0.10
|
—
|
|
Long-term Period: Mean Time-matched Change From Baseline (Day 0) in HAQ-DI and HAQ-DI Components For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 617 HAQ arising (n=83)
|
-0.66 units on a scale
Standard Error 0.10
|
—
|
|
Long-term Period: Mean Time-matched Change From Baseline (Day 0) in HAQ-DI and HAQ-DI Components For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 617 HAQ eating (n=83)
|
-0.61 units on a scale
Standard Error 0.11
|
—
|
|
Long-term Period: Mean Time-matched Change From Baseline (Day 0) in HAQ-DI and HAQ-DI Components For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 617 HAQ walking (n=83)
|
-0.58 units on a scale
Standard Error 0.09
|
—
|
|
Long-term Period: Mean Time-matched Change From Baseline (Day 0) in HAQ-DI and HAQ-DI Components For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 617 HAQ hygiene (n=83)
|
-0.54 units on a scale
Standard Error 0.10
|
—
|
|
Long-term Period: Mean Time-matched Change From Baseline (Day 0) in HAQ-DI and HAQ-DI Components For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 617 HAQ reaching (n=83)
|
-0.51 units on a scale
Standard Error 0.09
|
—
|
|
Long-term Period: Mean Time-matched Change From Baseline (Day 0) in HAQ-DI and HAQ-DI Components For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 617 HAQ gripping (n=83)
|
-0.51 units on a scale
Standard Error 0.10
|
—
|
|
Long-term Period: Mean Time-matched Change From Baseline (Day 0) in HAQ-DI and HAQ-DI Components For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 617 HAQ activities (n=83)
|
-0.47 units on a scale
Standard Error 0.10
|
—
|
|
Long-term Period: Mean Time-matched Change From Baseline (Day 0) in HAQ-DI and HAQ-DI Components For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 729 HAQ-DI (n=63)
|
-0.51 units on a scale
Standard Error 0.09
|
—
|
|
Long-term Period: Mean Time-matched Change From Baseline (Day 0) in HAQ-DI and HAQ-DI Components For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 729 HAQ dressing and grooming (n=63)
|
-0.71 units on a scale
Standard Error 0.13
|
—
|
|
Long-term Period: Mean Time-matched Change From Baseline (Day 0) in HAQ-DI and HAQ-DI Components For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 729 HAQ arising (n=63)
|
-0.59 units on a scale
Standard Error 0.12
|
—
|
|
Long-term Period: Mean Time-matched Change From Baseline (Day 0) in HAQ-DI and HAQ-DI Components For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 729 HAQ eating (n=63)
|
-0.62 units on a scale
Standard Error 0.13
|
—
|
|
Long-term Period: Mean Time-matched Change From Baseline (Day 0) in HAQ-DI and HAQ-DI Components For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 729 HAQ walking (n=63)
|
-0.46 units on a scale
Standard Error 0.11
|
—
|
|
Long-term Period: Mean Time-matched Change From Baseline (Day 0) in HAQ-DI and HAQ-DI Components For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 729 HAQ hygiene (n=63)
|
-0.52 units on a scale
Standard Error 0.13
|
—
|
|
Long-term Period: Mean Time-matched Change From Baseline (Day 0) in HAQ-DI and HAQ-DI Components For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 729 HAQ reaching (n=63)
|
-0.51 units on a scale
Standard Error 0.10
|
—
|
|
Long-term Period: Mean Time-matched Change From Baseline (Day 0) in HAQ-DI and HAQ-DI Components For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 729 HAQ gripping (n=63)
|
-0.33 units on a scale
Standard Error 0.10
|
—
|
|
Long-term Period: Mean Time-matched Change From Baseline (Day 0) in HAQ-DI and HAQ-DI Components For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 729 HAQ activities (n=63)
|
-0.35 units on a scale
Standard Error 0.11
|
—
|
|
Long-term Period: Mean Time-matched Change From Baseline (Day 0) in HAQ-DI and HAQ-DI Components For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 813 HAQ-DI (n=39)
|
-0.63 units on a scale
Standard Error 0.11
|
—
|
|
Long-term Period: Mean Time-matched Change From Baseline (Day 0) in HAQ-DI and HAQ-DI Components For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 813 HAQ dressing and grooming (n=39)
|
-0.74 units on a scale
Standard Error 0.18
|
—
|
|
Long-term Period: Mean Time-matched Change From Baseline (Day 0) in HAQ-DI and HAQ-DI Components For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 813 HAQ arising (n=39)
|
-0.77 units on a scale
Standard Error 0.16
|
—
|
|
Long-term Period: Mean Time-matched Change From Baseline (Day 0) in HAQ-DI and HAQ-DI Components For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 813 HAQ eating (n=39)
|
-0.72 units on a scale
Standard Error 0.18
|
—
|
|
Long-term Period: Mean Time-matched Change From Baseline (Day 0) in HAQ-DI and HAQ-DI Components For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 813 HAQ walking (n=39)
|
-0.59 units on a scale
Standard Error 0.12
|
—
|
|
Long-term Period: Mean Time-matched Change From Baseline (Day 0) in HAQ-DI and HAQ-DI Components For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 813 HAQ hygiene (n=39)
|
-0.51 units on a scale
Standard Error 0.17
|
—
|
|
Long-term Period: Mean Time-matched Change From Baseline (Day 0) in HAQ-DI and HAQ-DI Components For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 813 HAQ reaching (n=39)
|
-0.69 units on a scale
Standard Error 0.13
|
—
|
|
Long-term Period: Mean Time-matched Change From Baseline (Day 0) in HAQ-DI and HAQ-DI Components For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 813 HAQ gripping (n=39)
|
-0.64 units on a scale
Standard Error 0.14
|
—
|
|
Long-term Period: Mean Time-matched Change From Baseline (Day 0) in HAQ-DI and HAQ-DI Components For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 813 HAQ activities (n=39)
|
-0.41 units on a scale
Standard Error 0.13
|
—
|
SECONDARY outcome
Timeframe: BL, Days 365, 449, 533, 617, 729, 813Population: All treated participants. N=the total number of participants analyzed, n=the number of participants at that time point with available measurements.
HAQ-DI includes 20 questions to assess physical functions 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, and 3= unable to do. HAQ-DI= sum of worst scores in each domain divided by the number of domains answered. HAQ-DI ranges from a minimum of 0 (no difficulty) to a maximum overall score of 3(unable to do). Clinically meaningful HAQ response=an improvement of at least 0.3 units from baseline in HAQ disability Index.
Outcome measures
| Measure |
ST Abatacept (ABA)-Previous User
n=215 Participants
In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
|
ST ABA-Current User
In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
|
|---|---|---|
|
Long-term Period: Number of Participants Achieving Clinically Meaningful HAQ Response Over Time
Day 365 (n=215)
|
124 participants
|
—
|
|
Long-term Period: Number of Participants Achieving Clinically Meaningful HAQ Response Over Time
Day 449 (n=116)
|
69 participants
|
—
|
|
Long-term Period: Number of Participants Achieving Clinically Meaningful HAQ Response Over Time
Day 533 (n=101)
|
62 participants
|
—
|
|
Long-term Period: Number of Participants Achieving Clinically Meaningful HAQ Response Over Time
Day 617 (n=83)
|
53 participants
|
—
|
|
Long-term Period: Number of Participants Achieving Clinically Meaningful HAQ Response Over Time
Day 729 (n=63)
|
38 participants
|
—
|
|
Long-term Period: Number of Participants Achieving Clinically Meaningful HAQ Response Over Time
Day 813 (n=39)
|
26 participants
|
—
|
SECONDARY outcome
Timeframe: BL (Day 0)Population: All treated participants analyzed in the LT. N=the total number of participants analyzed, n=the number of participants at that time point with available measurements. Mean time-matched baseline values reflect changing n-values over time
SF-36 has 36 questions with 8 subscale scores and 2 summary scores (1) physical component summary=physical functioning, role-physical, bodily pain, and general health;(2) mental component summary=vitality,social functioning,role-emotional, and mental health. There is no total overall score; scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score and 100=best score. Time-matched BL (Day 0) values presented for each post-BL visit represent only that cohort of participants with measurements available at that post-BL visit
Outcome measures
| Measure |
ST Abatacept (ABA)-Previous User
n=306 Participants
In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
|
ST ABA-Current User
In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
|
|---|---|---|
|
Long-term Period: Mean Time-matched Baseline (Day 0) SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 365 PCS (n=297)
|
28.96 units on a scale
Standard Deviation 7.22
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 365 MCS (n=297)
|
41.09 units on a scale
Standard Deviation 12.90
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 365 Physical Function Scale Component (n=306)
|
28.04 units on a scale
Standard Deviation 9.88
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 365 Role-Physical Scale Component (n=300)
|
31.17 units on a scale
Standard Deviation 7.16
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 365 Bodily Pain Scale Component (n=305)
|
31.07 units on a scale
Standard Deviation 7.39
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 365 General Health Scale Component (n=308)
|
35.04 units on a scale
Standard Deviation 9.59
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 365 Vitality Scale Component (n=308)
|
35.96 units on a scale
Standard Deviation 9.11
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 365 Social Functioning Scale Component (n=308)
|
34.31 units on a scale
Standard Deviation 11.53
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 365 Role-Emotional Scale Component (n=300)
|
35.80 units on a scale
Standard Deviation 13.80
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 365 Mental Health Scale Component (n=308)
|
39.89 units on a scale
Standard Deviation 12.86
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 729 PCS (n=83)
|
29.76 units on a scale
Standard Deviation 6.50
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 729 MCS (n=83)
|
36.06 units on a scale
Standard Deviation 13.36
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 729 Physical Function Scale Component (n=89)
|
26.66 units on a scale
Standard Deviation 9.46
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 729 Role-Physical Scale Component (n=85)
|
30.87 units on a scale
Standard Deviation 6.75
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 729 Bodily Pain Scale Component (n=86)
|
29.35 units on a scale
Standard Deviation 7.09
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 729 General Health Scale Component (n=90)
|
33.23 units on a scale
Standard Deviation 9.30
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 729 Vitality Scale Component (n=90)
|
36.77 units on a scale
Standard Deviation 9.38
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 729 Social Functioning Scale Component (n=90)
|
32.59 units on a scale
Standard Deviation 12.27
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 729 Role-Emotional Scale Component (n=85)
|
30.30 units on a scale
Standard Deviation 11.61
|
—
|
|
Long-term Period: Mean Time-matched Baseline (Day 0) SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 729 Mental Health Scale Component (n=89)
|
33.67 units on a scale
Standard Deviation 13.17
|
—
|
SECONDARY outcome
Timeframe: Days 365 and 729Population: All treated participants analyzed in the LT. N=the total number of participants analyzed, n=the number of participants at that time point with available measurements. Mean post-baseline values reflect changing n-values over time
SF-36 measures health-related quality of life and has 36 questions with 8 subscale scores and 2 summary scores (1)physical component summary=physical functioning,role-physical,bodily pain,and general health; (2)mental component summary=vitality,social functioning,role-emotional,and mental health. There is no total overall score; scoring is done for both subscores and summary scores. For subscores and summary scores, 0=worst score and 100=best score. Post-BL values presented for each post-BL visit represent only that cohort of participants with measurements available at that post-BL visit.
Outcome measures
| Measure |
ST Abatacept (ABA)-Previous User
n=306 Participants
In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
|
ST ABA-Current User
In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
|
|---|---|---|
|
Long-term Period: Mean SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participant Cohorts at Each Post-baseline Visits Over the Long Term
Day 365 PCS (n=297)
|
35.00 units on a scale
Standard Deviation 10.09
|
—
|
|
Long-term Period: Mean SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participant Cohorts at Each Post-baseline Visits Over the Long Term
Day 365 MCS (n=297)
|
47.15 units on a scale
Standard Deviation 12.80
|
—
|
|
Long-term Period: Mean SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participant Cohorts at Each Post-baseline Visits Over the Long Term
Day 365 Physical Function Scale Component (n=306)
|
33.33 units on a scale
Standard Deviation 11.45
|
—
|
|
Long-term Period: Mean SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participant Cohorts at Each Post-baseline Visits Over the Long Term
Day 365 Role-Physical Scale Component (n=300)
|
37.85 units on a scale
Standard Deviation 11.68
|
—
|
|
Long-term Period: Mean SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participant Cohorts at Each Post-baseline Visits Over the Long Term
Day 365 Bodily Pain Scale Component (n=305)
|
39.78 units on a scale
Standard Deviation 9.87
|
—
|
|
Long-term Period: Mean SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participant Cohorts at Each Post-baseline Visits Over the Long Term
Day 365 General Health Scale Component (n=308)
|
38.58 units on a scale
Standard Deviation 10.20
|
—
|
|
Long-term Period: Mean SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participant Cohorts at Each Post-baseline Visits Over the Long Term
Day 365 Vitality Scale Component (n=308)
|
42.82 units on a scale
Standard Deviation 11.27
|
—
|
|
Long-term Period: Mean SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participant Cohorts at Each Post-baseline Visits Over the Long Term
Day 365 Social Functioning Scale Component (n=308)
|
41.24 units on a scale
Standard Deviation 11.81
|
—
|
|
Long-term Period: Mean SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participant Cohorts at Each Post-baseline Visits Over the Long Term
Day 365 Role-Emotional Scale Component (n=300)
|
42.63 units on a scale
Standard Deviation 14.32
|
—
|
|
Long-term Period: Mean SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participant Cohorts at Each Post-baseline Visits Over the Long Term
Day 365 Mental Health Scale Component (n=308)
|
45.00 units on a scale
Standard Deviation 12.82
|
—
|
|
Long-term Period: Mean SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participant Cohorts at Each Post-baseline Visits Over the Long Term
Day 729 PCS (n=83)
|
36.92 units on a scale
Standard Deviation 9.30
|
—
|
|
Long-term Period: Mean SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participant Cohorts at Each Post-baseline Visits Over the Long Term
Day 729 MCS (n=83)
|
42.06 units on a scale
Standard Deviation 12.46
|
—
|
|
Long-term Period: Mean SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participant Cohorts at Each Post-baseline Visits Over the Long Term
Day 729 Physical Function Scale Component (n=89)
|
33.91 units on a scale
Standard Deviation 11.15
|
—
|
|
Long-term Period: Mean SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participant Cohorts at Each Post-baseline Visits Over the Long Term
Day 729 Role-Physical Scale Component (n=85)
|
37.61 units on a scale
Standard Deviation 11.59
|
—
|
|
Long-term Period: Mean SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participant Cohorts at Each Post-baseline Visits Over the Long Term
Day 729 Bodily Pain Scale Component (n=86)
|
38.89 units on a scale
Standard Deviation 10.26
|
—
|
|
Long-term Period: Mean SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participant Cohorts at Each Post-baseline Visits Over the Long Term
Day 729 General Health Scale Component (n=90)
|
36.99 units on a scale
Standard Deviation 9.79
|
—
|
|
Long-term Period: Mean SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participant Cohorts at Each Post-baseline Visits Over the Long Term
Day 729 Vitality Scale Component (n=90)
|
42.94 units on a scale
Standard Deviation 10.45
|
—
|
|
Long-term Period: Mean SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participant Cohorts at Each Post-baseline Visits Over the Long Term
Day 729 Social Functioning Scale Component (n=90)
|
39.28 units on a scale
Standard Deviation 11.66
|
—
|
|
Long-term Period: Mean SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participant Cohorts at Each Post-baseline Visits Over the Long Term
Day 729 Role-Emotional Scale Component (n=85)
|
37.37 units on a scale
Standard Deviation 14.61
|
—
|
|
Long-term Period: Mean SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participant Cohorts at Each Post-baseline Visits Over the Long Term
Day 729 Mental Health Scale Component (n=89)
|
40.02 units on a scale
Standard Deviation 11.80
|
—
|
SECONDARY outcome
Timeframe: BL (Day 0), Days 365, 729Population: All treated participants analyzed in the LT. N=the total number of participants analyzed, n=the number of participants at that time point with available measurements. Mean time-matched baseline values reflect changing n-values over time
SF-36 has 36 questions with 8 subscale scores and 2 summary scores (1)physical component summary=physical functioning,role-physical,bodily pain,and general health; (2)mental component summary=vitality,social functioning,role-emotional,and mental health. There is no total overall score; scoring is done for both subscores and summary scores. For subscores and summary scores, 0=worst score and 100=best score. Time-matched mean change from BL= Post-BL value - time-matched BL value. Time-matched BL value=mean BL (Day 0)value for only that cohort with data available at that post-baseline visit.
Outcome measures
| Measure |
ST Abatacept (ABA)-Previous User
n=306 Participants
In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
|
ST ABA-Current User
In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
|
|---|---|---|
|
Long-term Period: Mean Time-matched Change From Baseline (Day 0) in SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 365 PCS (n=297)
|
6.04 units on a scale
Standard Error 0.55
|
—
|
|
Long-term Period: Mean Time-matched Change From Baseline (Day 0) in SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 365 MCS (n=297)
|
6.06 units on a scale
Standard Error 0.63
|
—
|
|
Long-term Period: Mean Time-matched Change From Baseline (Day 0) in SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 365 Physical Function Scale Component (n=306)
|
5.29 units on a scale
Standard Error 0.64
|
—
|
|
Long-term Period: Mean Time-matched Change From Baseline (Day 0) in SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 365 Role-Physical Scale Component (n=300)
|
6.69 units on a scale
Standard Error 0.68
|
—
|
|
Long-term Period: Mean Time-matched Change From Baseline (Day 0) in SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 365 Bodily Pain Scale Component (n=305)
|
8.70 units on a scale
Standard Error 0.56
|
—
|
|
Long-term Period: Mean Time-matched Change From Baseline (Day 0) in SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 365 General Health Scale Component (n=308)
|
3.54 units on a scale
Standard Error 0.46
|
—
|
|
Long-term Period: Mean Time-matched Change From Baseline (Day 0) in SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 365 Vitality Scale Component (n=308)
|
6.86 units on a scale
Standard Error 0.61
|
—
|
|
Long-term Period: Mean Time-matched Change From Baseline (Day 0) in SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 365 Social Functioning Scale Component (n=308)
|
6.93 units on a scale
Standard Error 0.67
|
—
|
|
Long-term Period: Mean Time-matched Change From Baseline (Day 0) in SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 365 Role-Emotional Scale Component (n=300)
|
6.83 units on a scale
Standard Error 0.84
|
—
|
|
Long-term Period: Mean Time-matched Change From Baseline (Day 0) in SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 365 Mental Health Scale Component (n=308)
|
5.11 units on a scale
Standard Error 0.55
|
—
|
|
Long-term Period: Mean Time-matched Change From Baseline (Day 0) in SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 729 PCS (n=83)
|
7.17 units on a scale
Standard Error 1.07
|
—
|
|
Long-term Period: Mean Time-matched Change From Baseline (Day 0) in SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 729 MCS (n=83)
|
5.99 units on a scale
Standard Error 1.27
|
—
|
|
Long-term Period: Mean Time-matched Change From Baseline (Day 0) in SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 729 Physical Function Scale Component (n=89)
|
7.25 units on a scale
Standard Error 1.31
|
—
|
|
Long-term Period: Mean Time-matched Change From Baseline (Day 0) in SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 729 Role-Physical Scale Component (n=85)
|
6.74 units on a scale
Standard Error 1.25
|
—
|
|
Long-term Period: Mean Time-matched Change From Baseline (Day 0) in SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 729 Bodily Pain Scale Component (n=86)
|
9.54 units on a scale
Standard Error 1.12
|
—
|
|
Long-term Period: Mean Time-matched Change From Baseline (Day 0) in SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 729 General Health Scale Component (n=90)
|
3.76 units on a scale
Standard Error 0.99
|
—
|
|
Long-term Period: Mean Time-matched Change From Baseline (Day 0) in SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 729 Vitality Scale Component (n=90)
|
6.16 units on a scale
Standard Error 1.09
|
—
|
|
Long-term Period: Mean Time-matched Change From Baseline (Day 0) in SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 729 Social Functioning Scale Component (n=90)
|
6.69 units on a scale
Standard Error 1.47
|
—
|
|
Long-term Period: Mean Time-matched Change From Baseline (Day 0) in SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 729 Role-Emotional Scale Component (n=85)
|
7.06 units on a scale
Standard Error 1.50
|
—
|
|
Long-term Period: Mean Time-matched Change From Baseline (Day 0) in SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Day 729 Mental Health Scale Component (n=89)
|
6.35 units on a scale
Standard Error 1.16
|
—
|
SECONDARY outcome
Timeframe: Days 1-813Population: Treated participants with available serum samples for assay
Serum samples from all treated adult participants with active rheumatoid arthritis (RA) were screened for the presence of drug-specific antibodies using ELISA. Immunogenicity was defined as the presence of a positive anti-abatacept or anti-CTLA4 antibody.
Outcome measures
| Measure |
ST Abatacept (ABA)-Previous User
n=25 Participants
In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
|
ST ABA-Current User
In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
|
|---|---|---|
|
LT; Number of Participants With Positive Anti-Abatacept or Anti-Cytotoxic T-Lymphocyte Antigen 4 (CTLA4) Responses by ELISA
Anti-abatacept antibodies
|
0 participants
|
—
|
|
LT; Number of Participants With Positive Anti-Abatacept or Anti-Cytotoxic T-Lymphocyte Antigen 4 (CTLA4) Responses by ELISA
Anti-CTLA4 antibodies
|
0 participants
|
—
|
Adverse Events
Abatacept (LT)
Abatacept (ST)
Serious adverse events
| Measure |
Abatacept (LT)
n=530 participants at risk
|
Abatacept (ST)
n=1046 participants at risk
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
ASTHMA
|
0.00%
0/530
|
0.10%
1/1046
|
|
Investigations
MEDICAL OBSERVATION
|
0.00%
0/530
|
0.19%
2/1046
|
|
Investigations
BLOOD SODIUM DECREASED
|
0.19%
1/530
|
0.00%
0/1046
|
|
Investigations
WHITE BLOOD CELL COUNT DECREASED
|
0.00%
0/530
|
0.10%
1/1046
|
|
Cardiac disorders
ARRHYTHMIA
|
0.00%
0/530
|
0.10%
1/1046
|
|
Cardiac disorders
CARDIOMEGALY
|
0.00%
0/530
|
0.10%
1/1046
|
|
Cardiac disorders
CARDIAC ARREST
|
0.00%
0/530
|
0.10%
1/1046
|
|
Cardiac disorders
ANGINA UNSTABLE
|
0.00%
0/530
|
0.10%
1/1046
|
|
Cardiac disorders
SINOATRIAL BLOCK
|
0.19%
1/530
|
0.00%
0/1046
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.00%
0/530
|
0.19%
2/1046
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
0.19%
1/530
|
0.29%
3/1046
|
|
Cardiac disorders
ACUTE CORONARY SYNDROME
|
0.19%
1/530
|
0.00%
0/1046
|
|
Cardiac disorders
CORONARY ARTERY DISEASE
|
0.00%
0/530
|
0.10%
1/1046
|
|
Cardiac disorders
CORONARY ARTERY STENOSIS
|
0.19%
1/530
|
0.00%
0/1046
|
|
Cardiac disorders
AORTIC VALVE INCOMPETENCE
|
0.00%
0/530
|
0.10%
1/1046
|
|
Cardiac disorders
CORONARY ARTERY OCCLUSION
|
0.00%
0/530
|
0.10%
1/1046
|
|
Cardiac disorders
CARDIAC FAILURE CONGESTIVE
|
0.00%
0/530
|
0.10%
1/1046
|
|
Cardiac disorders
ACUTE MYOCARDIAL INFARCTION
|
0.19%
1/530
|
0.00%
0/1046
|
|
Vascular disorders
SHOCK
|
0.00%
0/530
|
0.10%
1/1046
|
|
Vascular disorders
HYPERTENSION
|
0.19%
1/530
|
0.10%
1/1046
|
|
Vascular disorders
AORTIC STENOSIS
|
0.00%
0/530
|
0.10%
1/1046
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
0.00%
0/530
|
0.10%
1/1046
|
|
Psychiatric disorders
SUICIDAL BEHAVIOUR
|
0.00%
0/530
|
0.10%
1/1046
|
|
Hepatobiliary disorders
CHOLANGITIS
|
0.00%
0/530
|
0.10%
1/1046
|
|
Hepatobiliary disorders
CHOLELITHIASIS
|
0.00%
0/530
|
0.10%
1/1046
|
|
Hepatobiliary disorders
HEPATOTOXICITY
|
0.00%
0/530
|
0.10%
1/1046
|
|
Hepatobiliary disorders
CHOLECYSTITIS ACUTE
|
0.00%
0/530
|
0.10%
1/1046
|
|
Hepatobiliary disorders
CHOLECYSTITIS CHRONIC
|
0.00%
0/530
|
0.10%
1/1046
|
|
Hepatobiliary disorders
GALLBLADDER ENLARGEMENT
|
0.00%
0/530
|
0.10%
1/1046
|
|
Immune system disorders
ANAPHYLACTIC REACTION
|
0.00%
0/530
|
0.10%
1/1046
|
|
Nervous system disorders
SYNCOPE
|
0.00%
0/530
|
0.10%
1/1046
|
|
Nervous system disorders
HEADACHE
|
0.00%
0/530
|
0.10%
1/1046
|
|
Nervous system disorders
MIGRAINE
|
0.00%
0/530
|
0.10%
1/1046
|
|
Nervous system disorders
SCIATICA
|
0.19%
1/530
|
0.00%
0/1046
|
|
Nervous system disorders
DIZZINESS
|
0.00%
0/530
|
0.10%
1/1046
|
|
Nervous system disorders
CERVICAL ROOT PAIN
|
0.19%
1/530
|
0.00%
0/1046
|
|
Nervous system disorders
LUMBAR RADICULOPATHY
|
0.00%
0/530
|
0.10%
1/1046
|
|
Nervous system disorders
CEREBELLAR INFARCTION
|
0.00%
0/530
|
0.10%
1/1046
|
|
Nervous system disorders
CARPAL TUNNEL SYNDROME
|
0.00%
0/530
|
0.19%
2/1046
|
|
Nervous system disorders
CEREBROVASCULAR ACCIDENT
|
0.00%
0/530
|
0.10%
1/1046
|
|
Gastrointestinal disorders
NAUSEA
|
0.00%
0/530
|
0.19%
2/1046
|
|
Gastrointestinal disorders
COLITIS
|
0.00%
0/530
|
0.10%
1/1046
|
|
Gastrointestinal disorders
MELAENA
|
0.19%
1/530
|
0.00%
0/1046
|
|
Gastrointestinal disorders
RETCHING
|
0.00%
0/530
|
0.10%
1/1046
|
|
Gastrointestinal disorders
VOMITING
|
0.19%
1/530
|
0.19%
2/1046
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.19%
1/530
|
0.00%
0/1046
|
|
Gastrointestinal disorders
GASTRITIS
|
0.19%
1/530
|
0.10%
1/1046
|
|
Gastrointestinal disorders
STOMATITIS
|
0.19%
1/530
|
0.00%
0/1046
|
|
Gastrointestinal disorders
PANCREATITIS
|
0.19%
1/530
|
0.00%
0/1046
|
|
Gastrointestinal disorders
GASTRIC ULCER
|
0.00%
0/530
|
0.10%
1/1046
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.19%
1/530
|
0.10%
1/1046
|
|
Gastrointestinal disorders
MOUTH ULCERATION
|
0.00%
0/530
|
0.10%
1/1046
|
|
Gastrointestinal disorders
UMBILICAL HERNIA
|
0.19%
1/530
|
0.00%
0/1046
|
|
Gastrointestinal disorders
COLITIS ISCHAEMIC
|
0.00%
0/530
|
0.19%
2/1046
|
|
Gastrointestinal disorders
RECTAL HAEMORRHAGE
|
0.00%
0/530
|
0.10%
1/1046
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
0.00%
0/530
|
0.10%
1/1046
|
|
Gastrointestinal disorders
PROCTITIS ULCERATIVE
|
0.19%
1/530
|
0.00%
0/1046
|
|
Gastrointestinal disorders
OESOPHAGEAL OBSTRUCTION
|
0.00%
0/530
|
0.10%
1/1046
|
|
Gastrointestinal disorders
GASTROINTESTINAL HAEMORRHAGE
|
0.00%
0/530
|
0.10%
1/1046
|
|
Ear and labyrinth disorders
DEAFNESS
|
0.00%
0/530
|
0.10%
1/1046
|
|
Infections and infestations
PNEUMONIA
|
0.38%
2/530
|
0.38%
4/1046
|
|
Infections and infestations
UROSEPSIS
|
0.00%
0/530
|
0.10%
1/1046
|
|
Infections and infestations
BRONCHITIS
|
0.00%
0/530
|
0.29%
3/1046
|
|
Infections and infestations
BACTERAEMIA
|
0.19%
1/530
|
0.00%
0/1046
|
|
Infections and infestations
PHARYNGITIS
|
0.19%
1/530
|
0.00%
0/1046
|
|
Infections and infestations
APPENDICITIS
|
0.19%
1/530
|
0.00%
0/1046
|
|
Infections and infestations
SEPTIC SHOCK
|
0.00%
0/530
|
0.10%
1/1046
|
|
Infections and infestations
HERPES ZOSTER
|
0.19%
1/530
|
0.00%
0/1046
|
|
Infections and infestations
DIVERTICULITIS
|
0.00%
0/530
|
0.10%
1/1046
|
|
Infections and infestations
PYELONEPHRITIS
|
0.19%
1/530
|
0.10%
1/1046
|
|
Infections and infestations
ACUTE SINUSITIS
|
0.00%
0/530
|
0.10%
1/1046
|
|
Infections and infestations
GASTROENTERITIS
|
0.57%
3/530
|
0.10%
1/1046
|
|
Infections and infestations
LOBAR PNEUMONIA
|
0.00%
0/530
|
0.19%
2/1046
|
|
Infections and infestations
TOOTH INFECTION
|
0.00%
0/530
|
0.10%
1/1046
|
|
Infections and infestations
VIRAL INFECTION
|
0.19%
1/530
|
0.00%
0/1046
|
|
Infections and infestations
TRACHEOBRONCHITIS
|
0.00%
0/530
|
0.10%
1/1046
|
|
Infections and infestations
ABSCESS INTESTINAL
|
0.00%
0/530
|
0.10%
1/1046
|
|
Infections and infestations
ESCHERICHIA SEPSIS
|
0.00%
0/530
|
0.10%
1/1046
|
|
Infections and infestations
ARTHRITIS BACTERIAL
|
0.00%
0/530
|
0.10%
1/1046
|
|
Infections and infestations
ARTHRITIS INFECTIVE
|
0.00%
0/530
|
0.10%
1/1046
|
|
Infections and infestations
HAEMOPHILUS INFECTION
|
0.00%
0/530
|
0.10%
1/1046
|
|
Infections and infestations
PNEUMONIA PNEUMOCOCCAL
|
0.00%
0/530
|
0.10%
1/1046
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.19%
1/530
|
0.10%
1/1046
|
|
Infections and infestations
STAPHYLOCOCCAL INFECTION
|
0.19%
1/530
|
0.00%
0/1046
|
|
Infections and infestations
GASTROENTERITIS NOROVIRUS
|
0.00%
0/530
|
0.10%
1/1046
|
|
Infections and infestations
GASTROENTERITIS SALMONELLA
|
0.00%
0/530
|
0.10%
1/1046
|
|
Infections and infestations
POSTOPERATIVE WOUND INFECTION
|
0.00%
0/530
|
0.10%
1/1046
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
0.19%
1/530
|
0.10%
1/1046
|
|
Renal and urinary disorders
NEPHROLITHIASIS
|
0.19%
1/530
|
0.10%
1/1046
|
|
Renal and urinary disorders
RENAL FAILURE ACUTE
|
0.00%
0/530
|
0.19%
2/1046
|
|
Renal and urinary disorders
STRESS URINARY INCONTINENCE
|
0.19%
1/530
|
0.00%
0/1046
|
|
Renal and urinary disorders
MESANGIOPROLIFERATIVE GLOMERULONEPHRITIS
|
0.19%
1/530
|
0.00%
0/1046
|
|
Metabolism and nutrition disorders
OBESITY
|
0.19%
1/530
|
0.00%
0/1046
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.19%
1/530
|
0.00%
0/1046
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
0.00%
0/530
|
0.19%
2/1046
|
|
Metabolism and nutrition disorders
DIABETIC KETOACIDOSIS
|
0.00%
0/530
|
0.10%
1/1046
|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.19%
1/530
|
0.19%
2/1046
|
|
Blood and lymphatic system disorders
COAGULOPATHY
|
0.00%
0/530
|
0.10%
1/1046
|
|
Blood and lymphatic system disorders
MICROCYTIC ANAEMIA
|
0.19%
1/530
|
0.00%
0/1046
|
|
Skin and subcutaneous tissue disorders
URTICARIA
|
0.19%
1/530
|
0.00%
0/1046
|
|
Skin and subcutaneous tissue disorders
ANGIOEDEMA
|
0.00%
0/530
|
0.10%
1/1046
|
|
Reproductive system and breast disorders
MENORRHAGIA
|
0.00%
0/530
|
0.10%
1/1046
|
|
Reproductive system and breast disorders
OVARIAN CYST
|
0.00%
0/530
|
0.10%
1/1046
|
|
Reproductive system and breast disorders
POLYMENORRHOEA
|
0.00%
0/530
|
0.10%
1/1046
|
|
Reproductive system and breast disorders
UTERINE PROLAPSE
|
0.19%
1/530
|
0.10%
1/1046
|
|
Injury, poisoning and procedural complications
FALL
|
0.19%
1/530
|
0.00%
0/1046
|
|
Injury, poisoning and procedural complications
WOUND
|
0.19%
1/530
|
0.00%
0/1046
|
|
Injury, poisoning and procedural complications
OVERDOSE
|
0.00%
0/530
|
0.10%
1/1046
|
|
Injury, poisoning and procedural complications
ANKLE FRACTURE
|
0.00%
0/530
|
0.10%
1/1046
|
|
Injury, poisoning and procedural complications
FEMUR FRACTURE
|
0.00%
0/530
|
0.10%
1/1046
|
|
Injury, poisoning and procedural complications
FIBULA FRACTURE
|
0.19%
1/530
|
0.00%
0/1046
|
|
Injury, poisoning and procedural complications
RADIUS FRACTURE
|
0.19%
1/530
|
0.00%
0/1046
|
|
Injury, poisoning and procedural complications
UPPER LIMB FRACTURE
|
0.19%
1/530
|
0.00%
0/1046
|
|
Injury, poisoning and procedural complications
FEMORAL NECK FRACTURE
|
0.00%
0/530
|
0.10%
1/1046
|
|
Injury, poisoning and procedural complications
ROAD TRAFFIC ACCIDENT
|
0.19%
1/530
|
0.00%
0/1046
|
|
Injury, poisoning and procedural complications
MEDICAL DEVICE COMPLICATION
|
0.19%
1/530
|
0.10%
1/1046
|
|
Musculoskeletal and connective tissue disorders
BURSITIS
|
0.19%
1/530
|
0.00%
0/1046
|
|
Musculoskeletal and connective tissue disorders
ARTHRITIS
|
0.00%
0/530
|
0.19%
2/1046
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.19%
1/530
|
0.19%
2/1046
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
0.38%
2/530
|
0.19%
2/1046
|
|
Musculoskeletal and connective tissue disorders
METATARSALGIA
|
0.19%
1/530
|
0.00%
0/1046
|
|
Musculoskeletal and connective tissue disorders
OSTEONECROSIS
|
0.19%
1/530
|
0.00%
0/1046
|
|
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS
|
0.94%
5/530
|
0.48%
5/1046
|
|
Musculoskeletal and connective tissue disorders
COSTOCHONDRITIS
|
0.00%
0/530
|
0.10%
1/1046
|
|
Musculoskeletal and connective tissue disorders
TENDON DISORDER
|
0.19%
1/530
|
0.00%
0/1046
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
0.00%
0/530
|
0.10%
1/1046
|
|
Musculoskeletal and connective tissue disorders
RHEUMATOID ARTHRITIS
|
2.8%
15/530
|
1.6%
17/1046
|
|
Musculoskeletal and connective tissue disorders
ROTATOR CUFF SYNDROME
|
0.00%
0/530
|
0.10%
1/1046
|
|
Musculoskeletal and connective tissue disorders
SPINAL OSTEOARTHRITIS
|
0.00%
0/530
|
0.10%
1/1046
|
|
Musculoskeletal and connective tissue disorders
SPINAL COLUMN STENOSIS
|
0.19%
1/530
|
0.10%
1/1046
|
|
Musculoskeletal and connective tissue disorders
INTERVERTEBRAL DISC PROTRUSION
|
0.19%
1/530
|
0.29%
3/1046
|
|
Musculoskeletal and connective tissue disorders
INTERVERTEBRAL DISC DEGENERATION
|
0.00%
0/530
|
0.10%
1/1046
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
0.19%
1/530
|
0.00%
0/1046
|
|
Respiratory, thoracic and mediastinal disorders
NASAL POLYPS
|
0.00%
0/530
|
0.10%
1/1046
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMOTHORAX
|
0.00%
0/530
|
0.10%
1/1046
|
|
Respiratory, thoracic and mediastinal disorders
LUNG DISORDER
|
0.00%
0/530
|
0.10%
1/1046
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY BULLA
|
0.00%
0/530
|
0.10%
1/1046
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
0.00%
0/530
|
0.10%
1/1046
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
0.38%
2/530
|
0.00%
0/1046
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
0.00%
0/530
|
0.10%
1/1046
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY THROMBOSIS
|
0.00%
0/530
|
0.10%
1/1046
|
|
Respiratory, thoracic and mediastinal disorders
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
|
0.19%
1/530
|
0.00%
0/1046
|
|
General disorders
ULCER
|
0.19%
1/530
|
0.00%
0/1046
|
|
General disorders
PYREXIA
|
0.19%
1/530
|
0.00%
0/1046
|
|
General disorders
ASTHENIA
|
0.19%
1/530
|
0.00%
0/1046
|
|
General disorders
CHEST PAIN
|
0.57%
3/530
|
0.38%
4/1046
|
|
General disorders
CHEST DISCOMFORT
|
0.00%
0/530
|
0.19%
2/1046
|
|
General disorders
IMPAIRED HEALING
|
0.00%
0/530
|
0.10%
1/1046
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LYMPHOMA
|
0.19%
1/530
|
0.00%
0/1046
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
HAEMANGIOMA
|
0.00%
0/530
|
0.10%
1/1046
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BREAST CANCER
|
0.00%
0/530
|
0.19%
2/1046
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
UTERINE CANCER
|
0.00%
0/530
|
0.10%
1/1046
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LUNG ADENOCARCINOMA
|
0.00%
0/530
|
0.10%
1/1046
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BASAL CELL CARCINOMA
|
0.19%
1/530
|
0.29%
3/1046
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BLADDER CANCER RECURRENT
|
0.19%
1/530
|
0.00%
0/1046
|
Other adverse events
| Measure |
Abatacept (LT)
n=530 participants at risk
|
Abatacept (ST)
n=1046 participants at risk
|
|---|---|---|
|
Nervous system disorders
HEADACHE
|
4.7%
25/530
|
9.8%
102/1046
|
|
Gastrointestinal disorders
NAUSEA
|
4.9%
26/530
|
8.6%
90/1046
|
|
Gastrointestinal disorders
DIARRHOEA
|
4.5%
24/530
|
5.5%
58/1046
|
|
Infections and infestations
SINUSITIS
|
4.5%
24/530
|
6.0%
63/1046
|
|
Infections and infestations
BRONCHITIS
|
5.7%
30/530
|
4.7%
49/1046
|
|
Infections and infestations
NASOPHARYNGITIS
|
6.4%
34/530
|
3.1%
32/1046
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
4.7%
25/530
|
7.9%
83/1046
|
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