Trial Outcomes & Findings for Phase IIIB Switching From Intravenous to Subcutaneous Study (NCT NCT00663702)
NCT ID: NCT00663702
Last Updated: 2015-03-09
Results Overview
An AE is a new or worsening illness, sign, or symptom or a clinically significant abnormal laboratory test result occurring during the study, regardless of causality, and noted by the investigators. Systemic injection reaction occurring ≤ 24 hours after dosing.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
123 participants
Primary outcome timeframe
Day 1 (Baseline) through Day 85
Results posted on
2015-03-09
Participant Flow
Participants were enrolled at 3 locations and 32 sites worldwide: United States (20 sites), Canada (6 sites), and Mexico (6 sites).
A total of 126 participants were enrolled, and 3 discontinued prior to study start due to failure to continue to meet study eligibility criteria.
Participant milestones
| Measure |
Subcutaneous Abatacept, 125 mg (Prior Anti-TNF Failure)
Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor (anti-TNF) in an earlier study (NCT00048581, or Bristol-Myers Squibb \[BMS\] IM101-029), received subcutaneous abatacept, 125 mg, once weekly for 3 months (to Day 85). Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
|
Subcutaneous Abatacept, 125 mg (Prior Methotrexate Failure)
Participants with active rheumatoid arthritis, who previously received intravenous abatacept and showed an inadequate response to treatment with methotrexate in an earlier study (NCT00048568,or BMS IM101-102), received subcutaneous abatacept, 125 mg, once weekly for 3 months (to Day 85). Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
|
|---|---|---|
|
Overall Study
STARTED
|
52
|
71
|
|
Overall Study
COMPLETED
|
34
|
61
|
|
Overall Study
NOT COMPLETED
|
18
|
10
|
Reasons for withdrawal
| Measure |
Subcutaneous Abatacept, 125 mg (Prior Anti-TNF Failure)
Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor (anti-TNF) in an earlier study (NCT00048581, or Bristol-Myers Squibb \[BMS\] IM101-029), received subcutaneous abatacept, 125 mg, once weekly for 3 months (to Day 85). Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
|
Subcutaneous Abatacept, 125 mg (Prior Methotrexate Failure)
Participants with active rheumatoid arthritis, who previously received intravenous abatacept and showed an inadequate response to treatment with methotrexate in an earlier study (NCT00048568,or BMS IM101-102), received subcutaneous abatacept, 125 mg, once weekly for 3 months (to Day 85). Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
|
|---|---|---|
|
Overall Study
Adverse Event
|
8
|
4
|
|
Overall Study
Withdrawal by Subject
|
3
|
1
|
|
Overall Study
Pregnancy
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
3
|
0
|
|
Overall Study
Death
|
1
|
1
|
|
Overall Study
Lack of Efficacy
|
3
|
3
|
Baseline Characteristics
Phase IIIB Switching From Intravenous to Subcutaneous Study
Baseline characteristics by cohort
| Measure |
Subcutaneous Abatacept, 125 mg (Prior Anti-TNF Failure)
n=52 Participants
Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor (anti-TNF) in an earlier study (NCT00048581, or BMS IM101-029), received subcutaneous abatacept, 125 mg, once weekly for 3 months (to Day 85). Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
|
Subcutaneous Abatacept, 125 mg (Prior Methotrexate Failure)
n=71 Participants
Participants with active rheumatoid arthritis, who previously received intravenous abatacept and showed an inadequate response to treatment with methotrexate in an earlier study (NCT00048568,or BMS IM101-102), received subcutaneous abatacept, 125 mg, once weekly for 3 months (to Day 85). Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
|
Total
n=123 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.5 Years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
52.8 Years
STANDARD_DEVIATION 13.8 • n=7 Participants
|
54.3 Years
STANDARD_DEVIATION 12.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
101 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
47 Partcipants
n=5 Participants
|
70 Partcipants
n=7 Participants
|
117 Partcipants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
3 Partcipants
n=5 Participants
|
0 Partcipants
n=7 Participants
|
3 Partcipants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian/Alaska Native
|
1 Partcipants
n=5 Participants
|
0 Partcipants
n=7 Participants
|
1 Partcipants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Partcipants
n=5 Participants
|
1 Partcipants
n=7 Participants
|
1 Partcipants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Partcipants
n=5 Participants
|
0 Partcipants
n=7 Participants
|
1 Partcipants
n=5 Participants
|
|
Region of Enrollment
North America
|
52 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Region of Enrollment
South America
|
0 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Mean Baseline High Sensitivity C-Reactive Protein Level
|
0.94 μg/mL
STANDARD_DEVIATION 0.65 • n=5 Participants
|
0.92 μg/mL
STANDARD_DEVIATION 0.88 • n=7 Participants
|
0.93 μg/mL
STANDARD_DEVIATION 0.79 • n=5 Participants
|
|
Mean Baseline 28 Joint Disease Activity Score (DAS 28)
|
3.55 Score on a scale
STANDARD_DEVIATION 1.20 • n=5 Participants
|
3.28 Score on a scale
STANDARD_DEVIATION 1.29 • n=7 Participants
|
3.39 Score on a scale
STANDARD_DEVIATION 1.26 • n=5 Participants
|
|
Mean Number of Tender Joints at Baseline
|
9.1 Joints
STANDARD_DEVIATION 12.8 • n=5 Participants
|
8.8 Joints
STANDARD_DEVIATION 12.4 • n=7 Participants
|
8.9 Joints
STANDARD_DEVIATION 12.5 • n=5 Participants
|
|
Mean Number of Swollen Joints at Baseline
|
5.4 Joints
STANDARD_DEVIATION 6.4 • n=5 Participants
|
4.3 Joints
STANDARD_DEVIATION 5.9 • n=7 Participants
|
4.8 Joints
STANDARD_DEVIATION 6.1 • n=5 Participants
|
|
Participant Weight at Baseline
Less than 60 kilograms
|
9 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Participant Weight at Baseline
60-100 kilograms
|
30 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
|
Participant Weight at Baseline
Greater than 100 kilograms
|
10 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Participant Weight at Baseline
Missing
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 (Baseline) through Day 85Population: All participants who received at least 1 dose of study medication
An AE is a new or worsening illness, sign, or symptom or a clinically significant abnormal laboratory test result occurring during the study, regardless of causality, and noted by the investigators. Systemic injection reaction occurring ≤ 24 hours after dosing.
Outcome measures
| Measure |
Subcutaneous Abatacept, 125 mg
n=123 Participants
Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
|
Subcutaneous Abatacept, 125 mg (Prior Methotrexate Failure)
Participants with active rheumatoid arthritis, who previously received intravenous abatacept and showed an inadequate response to treatment with methotrexate in an earlier study (NCT00048568,or BMS IM101-102), received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
|
|---|---|---|
|
Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, SAEs Leading to Discontinuation, Treatment-related Adverse Events (AEs), AEs Leading to Discontinuation, and AEs of Interest (AEIs) at Day 85
Deaths
|
0 Participants
|
—
|
|
Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, SAEs Leading to Discontinuation, Treatment-related Adverse Events (AEs), AEs Leading to Discontinuation, and AEs of Interest (AEIs) at Day 85
SAEs
|
1 Participants
|
—
|
|
Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, SAEs Leading to Discontinuation, Treatment-related Adverse Events (AEs), AEs Leading to Discontinuation, and AEs of Interest (AEIs) at Day 85
Treatment-related SAEs
|
0 Participants
|
—
|
|
Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, SAEs Leading to Discontinuation, Treatment-related Adverse Events (AEs), AEs Leading to Discontinuation, and AEs of Interest (AEIs) at Day 85
SAEs leading to discontinuation
|
0 Participants
|
—
|
|
Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, SAEs Leading to Discontinuation, Treatment-related Adverse Events (AEs), AEs Leading to Discontinuation, and AEs of Interest (AEIs) at Day 85
Treatment-related AEs
|
11 Participants
|
—
|
|
Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, SAEs Leading to Discontinuation, Treatment-related Adverse Events (AEs), AEs Leading to Discontinuation, and AEs of Interest (AEIs) at Day 85
AEs leading to discontinuation
|
1 Participants
|
—
|
|
Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, SAEs Leading to Discontinuation, Treatment-related Adverse Events (AEs), AEs Leading to Discontinuation, and AEs of Interest (AEIs) at Day 85
AEIs: Infections
|
20 Participants
|
—
|
|
Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, SAEs Leading to Discontinuation, Treatment-related Adverse Events (AEs), AEs Leading to Discontinuation, and AEs of Interest (AEIs) at Day 85
AEIs: Malignancy
|
0 Participants
|
—
|
|
Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, SAEs Leading to Discontinuation, Treatment-related Adverse Events (AEs), AEs Leading to Discontinuation, and AEs of Interest (AEIs) at Day 85
AEIs: Automimmune disorders (prespecified)
|
0 Participants
|
—
|
|
Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, SAEs Leading to Discontinuation, Treatment-related Adverse Events (AEs), AEs Leading to Discontinuation, and AEs of Interest (AEIs) at Day 85
AEIs: Injection reactions (prespecified) Local
|
2 Participants
|
—
|
|
Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, SAEs Leading to Discontinuation, Treatment-related Adverse Events (AEs), AEs Leading to Discontinuation, and AEs of Interest (AEIs) at Day 85
AEIs: Injection reactions (prespecified) Systemic
|
2 Participants
|
—
|
PRIMARY outcome
Timeframe: Day 1 (Baseline) through 56 days past last day of subcutaneous injection in the cumulative study periodPopulation: All participants who received at least 1 dose of study medication
An AE is a new or worsening illness, sign, or symptom or a clinically significant abnormal laboratory test result occurring during the study, regardless of causality, and noted by the investigators.
Outcome measures
| Measure |
Subcutaneous Abatacept, 125 mg
n=123 Participants
Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
|
Subcutaneous Abatacept, 125 mg (Prior Methotrexate Failure)
Participants with active rheumatoid arthritis, who previously received intravenous abatacept and showed an inadequate response to treatment with methotrexate in an earlier study (NCT00048568,or BMS IM101-102), received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
|
|---|---|---|
|
Number of Participants With Death As Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, SAEs Leading to Discontinuation, Treatment-related Adverse Events (AEs), and AEs Leading to Discontinuation
Treatment-related SAEs
|
11 Participants
|
—
|
|
Number of Participants With Death As Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, SAEs Leading to Discontinuation, Treatment-related Adverse Events (AEs), and AEs Leading to Discontinuation
Deaths
|
4 Participants
|
—
|
|
Number of Participants With Death As Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, SAEs Leading to Discontinuation, Treatment-related Adverse Events (AEs), and AEs Leading to Discontinuation
SAEs
|
43 Participants
|
—
|
|
Number of Participants With Death As Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, SAEs Leading to Discontinuation, Treatment-related Adverse Events (AEs), and AEs Leading to Discontinuation
SAEs leading to discontinuation
|
8 Participants
|
—
|
|
Number of Participants With Death As Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, SAEs Leading to Discontinuation, Treatment-related Adverse Events (AEs), and AEs Leading to Discontinuation
Treatment-related AEs
|
60 Participants
|
—
|
|
Number of Participants With Death As Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, SAEs Leading to Discontinuation, Treatment-related Adverse Events (AEs), and AEs Leading to Discontinuation
AEs leading to discontinuation
|
11 Participants
|
—
|
PRIMARY outcome
Timeframe: Day 1 (Baseline) through 56 days past last day of subcutaneous injection in the cumulative study periodPopulation: All participants who received at least 1 dose of study medication. n=patients evaluable
LLN=lower limit of normal; ULN=upper limit of normal; preRx=pretreatment. Marked abnormality criteria: Hemoglobin (g/dL) \>3 decrease from preRx. Hematocrit (%)\<0.75\*preRx. Erythrocytes (\*10\^6 c/uL) \<0.75\*preRx. Platelet count (\*10\^9 c/L) \<0.67\*LLN or 1.5\*ULN or, if preRx\<LLN, use \<0.5\*preRx and \<100,000 mm\^3. Leukocytes (\*10\^3 c/uL) \<0.75\*LLN or \>1.25\*ULN or, if preRx\<LLN, use \<0.8\*preRx or \>ULN or, if preRx\>ULN, use \>1.2\*preRx or \<LLN. Eosinophils \>0.750\*10\^3 c/uL. Lymphocytes \<0.750\*10\^3 c/uL or \>7.50\*10\^3 c/uL.
Outcome measures
| Measure |
Subcutaneous Abatacept, 125 mg
n=123 Participants
Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
|
Subcutaneous Abatacept, 125 mg (Prior Methotrexate Failure)
Participants with active rheumatoid arthritis, who previously received intravenous abatacept and showed an inadequate response to treatment with methotrexate in an earlier study (NCT00048568,or BMS IM101-102), received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
|
|---|---|---|
|
Number of Participants With Hematology Laboratory Values Meeting the Criteria for Marked Abnormality
Hemoglobin, low (n=120)
|
7 Participants
|
—
|
|
Number of Participants With Hematology Laboratory Values Meeting the Criteria for Marked Abnormality
Hematocrit, low (n=119)
|
4 Participants
|
—
|
|
Number of Participants With Hematology Laboratory Values Meeting the Criteria for Marked Abnormality
Erythrocytes, low (n=120)
|
4 Participants
|
—
|
|
Number of Participants With Hematology Laboratory Values Meeting the Criteria for Marked Abnormality
Platelet count, low (n=120)
|
2 Participants
|
—
|
|
Number of Participants With Hematology Laboratory Values Meeting the Criteria for Marked Abnormality
Leukocytes, low (n=120)
|
2 Participants
|
—
|
|
Number of Participants With Hematology Laboratory Values Meeting the Criteria for Marked Abnormality
Leukocytes, high (n=120)
|
3 Participants
|
—
|
|
Number of Participants With Hematology Laboratory Values Meeting the Criteria for Marked Abnormality
Eosinophils (absolute), high (n=122)
|
12 Participants
|
—
|
|
Number of Participants With Hematology Laboratory Values Meeting the Criteria for Marked Abnormality
Lymphocytes (absolute), low (n=122)
|
15 Participants
|
—
|
PRIMARY outcome
Timeframe: Day 1 (Baseline) through 56 days past last day of subcutaneous injection in the cumulative study periodPopulation: All participants who received at least 1 dose of study medication. n=patients evaluable
LLN=lower limit of normal; ULN=upper limit of normal; preRx=pretreatment. Marked abnormality criteria: Alkaline phosphatase (U/L) \>2\*ULN or if preRx\>ULN, use 3\*preRx. Alanine aminotransferase (U/L)\>3\*ULN or if preRx\>ULN, use \>4\*preRx. G-glutamyl transferase (U/L)\>2\*ULN or if preRx\>ULN, use \>3\*preRx. Blood urea nitrogen (mg/dL)\>2\*preRx. Creatinine (mg/dL)\>1.5\*preRx.
Outcome measures
| Measure |
Subcutaneous Abatacept, 125 mg
n=123 Participants
Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
|
Subcutaneous Abatacept, 125 mg (Prior Methotrexate Failure)
Participants with active rheumatoid arthritis, who previously received intravenous abatacept and showed an inadequate response to treatment with methotrexate in an earlier study (NCT00048568,or BMS IM101-102), received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
|
|---|---|---|
|
Number of Participants With Liver and Kidney Function Laboratory Values Meeting the Criteria for Marked Abnormality
Alkaline phosphatase, high (n=120)
|
1 Participants
|
—
|
|
Number of Participants With Liver and Kidney Function Laboratory Values Meeting the Criteria for Marked Abnormality
Aspartate aminotransferase, high (n=120)
|
3 Participants
|
—
|
|
Number of Participants With Liver and Kidney Function Laboratory Values Meeting the Criteria for Marked Abnormality
Alanine aminotransferase, high (n=120)
|
6 Participants
|
—
|
|
Number of Participants With Liver and Kidney Function Laboratory Values Meeting the Criteria for Marked Abnormality
G-glutamyl transferase, high (n=120)
|
7 Participants
|
—
|
|
Number of Participants With Liver and Kidney Function Laboratory Values Meeting the Criteria for Marked Abnormality
Blood urea nitrogen, high (n=120)
|
5 Participants
|
—
|
|
Number of Participants With Liver and Kidney Function Laboratory Values Meeting the Criteria for Marked Abnormality
Creatinine, high (n=120)
|
11 Participants
|
—
|
PRIMARY outcome
Timeframe: Day 1 (Baseline) through 56 days past last day of subcutaneous injection in the cumulative study periodPopulation: All participants who received at least 1 dose of study medication. n=patients evaluable
LLN=lower limit of normal; ULN=upper limit of normal; preRx=pretreatment. Sodium: \<0.95\*LLN or \>1.05\*ULN or if preRx\<LLN, \<0.95\*preRx or \>ULN, or if preRx\>ULN,\>1.05\*preRx or \<LLN. Potassium,serum: \<0.9\*LLN or \>1.1\*ULN or if preRx\<LLN, use \<0.9\*preRx or \>ULN or if preRx\>ULN, 1.1\*preRx or \<LLN. Phosphorus: 0.75\*LLN or 1.25\*ULN or, if preRx\<LLN, \<0.67\*preRx or \>ULN or, if preRx\>ULN, \<LLN.
Outcome measures
| Measure |
Subcutaneous Abatacept, 125 mg
n=123 Participants
Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
|
Subcutaneous Abatacept, 125 mg (Prior Methotrexate Failure)
Participants with active rheumatoid arthritis, who previously received intravenous abatacept and showed an inadequate response to treatment with methotrexate in an earlier study (NCT00048568,or BMS IM101-102), received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
|
|---|---|---|
|
Number of Participants With Electrolyte Laboratory Values Meeting the Criteria for Marked Abnormality
Sodium, serum, low (mEq/L) (n=120)
|
2 Participants
|
—
|
|
Number of Participants With Electrolyte Laboratory Values Meeting the Criteria for Marked Abnormality
Potassium, serum, low (mEq/L) (n=120)
|
6 Participants
|
—
|
|
Number of Participants With Electrolyte Laboratory Values Meeting the Criteria for Marked Abnormality
Phosphorus, inorganic, low (mg/dL) (n=120)
|
2 Participants
|
—
|
PRIMARY outcome
Timeframe: Day 1 (Baseline) to up to 56 days past the last day of subcutaneous injection in the cumulative study periodPopulation: All participants who received at least 1 dose of study medication. n=patients evaluable
LLN=lower limit of normal; ULN=upper limit of normal; preRX=pretreatment. Criteria for marked abnormality: .
Outcome measures
| Measure |
Subcutaneous Abatacept, 125 mg
n=123 Participants
Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
|
Subcutaneous Abatacept, 125 mg (Prior Methotrexate Failure)
Participants with active rheumatoid arthritis, who previously received intravenous abatacept and showed an inadequate response to treatment with methotrexate in an earlier study (NCT00048568,or BMS IM101-102), received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
|
|---|---|---|
|
Number of Participants With Chemistry Laboratory Values Meeting the Criteria for Marked Abnormality
Glucose, serum, low (n=122)
|
17 Participants
|
—
|
|
Number of Participants With Chemistry Laboratory Values Meeting the Criteria for Marked Abnormality
Glucose, serum, fasting, low (n=59)
|
5 Participants
|
—
|
|
Number of Participants With Chemistry Laboratory Values Meeting the Criteria for Marked Abnormality
Glucose, serum, high (n=122)
|
12 Participants
|
—
|
|
Number of Participants With Chemistry Laboratory Values Meeting the Criteria for Marked Abnormality
Glucose, serum, fasting, high (n=59)
|
3 Participants
|
—
|
|
Number of Participants With Chemistry Laboratory Values Meeting the Criteria for Marked Abnormality
Protein, total, low (n=120)
|
1 Participants
|
—
|
|
Number of Participants With Chemistry Laboratory Values Meeting the Criteria for Marked Abnormality
Protein, total, high (n=120)
|
1 Participants
|
—
|
|
Number of Participants With Chemistry Laboratory Values Meeting the Criteria for Marked Abnormality
Albumin, low (n=120)
|
3 Participants
|
—
|
PRIMARY outcome
Timeframe: Day 1 (Baseline) through 56 days past last day of subcutaneous injection in the cumulative study periodPopulation: All participants who received at least 1 dose of study medication. n=patients evaluable
preRX=pretreatment. For all values analyzed (protein, urine; glucose, urine; blood, urine: leukocyte esterase, urine; white blood cells, urine; red blood cells, urine): If missing preRx, use \>=2 or, if value \>= 4, or if preRx=0 or 0.5, use \>=2 or, if preRx= 1, use \>=3 or, if preRx=2 or 3, use \>=4.
Outcome measures
| Measure |
Subcutaneous Abatacept, 125 mg
n=123 Participants
Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
|
Subcutaneous Abatacept, 125 mg (Prior Methotrexate Failure)
Participants with active rheumatoid arthritis, who previously received intravenous abatacept and showed an inadequate response to treatment with methotrexate in an earlier study (NCT00048568,or BMS IM101-102), received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
|
|---|---|---|
|
Participants With Urinalysis Values Meeting the Criteria for Marked Abnormality
Protein, urine, high (n=122)
|
12 Participants
|
—
|
|
Participants With Urinalysis Values Meeting the Criteria for Marked Abnormality
Glucose, urine, high (n=122)
|
8 Participants
|
—
|
|
Participants With Urinalysis Values Meeting the Criteria for Marked Abnormality
Blood, urine, high (n=122)
|
28 Participants
|
—
|
|
Participants With Urinalysis Values Meeting the Criteria for Marked Abnormality
Leukocyte esterase, urine, high (n=95)
|
32 Participants
|
—
|
|
Participants With Urinalysis Values Meeting the Criteria for Marked Abnormality
White blood cells, urine, high (n=103)
|
64 Participants
|
—
|
|
Participants With Urinalysis Values Meeting the Criteria for Marked Abnormality
Red blood cells, urine, high (n=91)
|
33 Participants
|
—
|
PRIMARY outcome
Timeframe: Day 1 (Baseline) to up to 56 days past the last day of subcutaneous injection in the cumulative study periodPopulation: All participants who received at least 1 dose of study medication.
AEs of special interest are AEs that may be associated with the use of immunomodulatory drugs, such as infections, malignancies, autoimmune disorders, and injection reactions (defined as local injection site reactions and systemic injection reactions occurring within 24 hours of subcutaneous injection).
Outcome measures
| Measure |
Subcutaneous Abatacept, 125 mg
n=123 Participants
Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
|
Subcutaneous Abatacept, 125 mg (Prior Methotrexate Failure)
Participants with active rheumatoid arthritis, who previously received intravenous abatacept and showed an inadequate response to treatment with methotrexate in an earlier study (NCT00048568,or BMS IM101-102), received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
|
|---|---|---|
|
Number of Participants With Adverse Events of Special Interest
Infections
|
96 Participants
|
—
|
|
Number of Participants With Adverse Events of Special Interest
Malignancies
|
7 Participants
|
—
|
|
Number of Participants With Adverse Events of Special Interest
Prespecified autoimmune disorders
|
7 Participants
|
—
|
|
Number of Participants With Adverse Events of Special Interest
Prespecified systemic injection reactions
|
14 Participants
|
—
|
PRIMARY outcome
Timeframe: Before injection on Days 1, 29, 57, 85, 169, 253, 365, 449, 533, 617, 729, 813, 897, 981, 1093, 1177, 1261, 1345, 1457, 1541, 1625, 1709, and 1821Population: All participants who received at least 1 dose of study medication. n=patients evaluable
BP was measured after the patient had been seated quietly for at least 5 minutes and recorded during the screening visit, during every office visit prior to administration of subcutaneous injections, and at study discharge or 7 days after the last dose for patients who terminated early.
Outcome measures
| Measure |
Subcutaneous Abatacept, 125 mg
n=123 Participants
Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
|
Subcutaneous Abatacept, 125 mg (Prior Methotrexate Failure)
Participants with active rheumatoid arthritis, who previously received intravenous abatacept and showed an inadequate response to treatment with methotrexate in an earlier study (NCT00048568,or BMS IM101-102), received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
|
|---|---|---|
|
Mean Sitting Systolic and Diastolic Blood Pressure (BP)
Sitting Systolic BP Day 449 (n=111)
|
123.9 mm Hg
Standard Deviation 15.80
|
—
|
|
Mean Sitting Systolic and Diastolic Blood Pressure (BP)
Sitting Systolic BP Day 1
|
121.6 mm Hg
Standard Deviation 16.15
|
—
|
|
Mean Sitting Systolic and Diastolic Blood Pressure (BP)
Sitting Systolic BP Day 29 (n=120)
|
123.6 mm Hg
Standard Deviation 16.08
|
—
|
|
Mean Sitting Systolic and Diastolic Blood Pressure (BP)
Sitting Systolic BP Day 57 (n=120)
|
123.9 mm Hg
Standard Deviation 16.95
|
—
|
|
Mean Sitting Systolic and Diastolic Blood Pressure (BP)
Sitting Systolic BP Day 85 (n=120)
|
124.3 mm Hg
Standard Deviation 16.62
|
—
|
|
Mean Sitting Systolic and Diastolic Blood Pressure (BP)
Sitting Systolic BP Day 169 (n=116)
|
124.0 mm Hg
Standard Deviation 15.09
|
—
|
|
Mean Sitting Systolic and Diastolic Blood Pressure (BP)
Sitting Systolic BP Day 253 (n=114)
|
122.3 mm Hg
Standard Deviation 14.58
|
—
|
|
Mean Sitting Systolic and Diastolic Blood Pressure (BP)
Sitting Systolic BP Day 365 (n=114)
|
124.1 mm Hg
Standard Deviation 15.0
|
—
|
|
Mean Sitting Systolic and Diastolic Blood Pressure (BP)
Sitting Systolic BP Day 533 (n=108)
|
123.5 mm Hg
Standard Deviation 15.08
|
—
|
|
Mean Sitting Systolic and Diastolic Blood Pressure (BP)
Sitting Systolic BP Day 617 (n=109)
|
124.4 mm Hg
Standard Deviation 16.03
|
—
|
|
Mean Sitting Systolic and Diastolic Blood Pressure (BP)
Sitting Systolic BP Day 729 (n=108)
|
125.2 mm Hg
Standard Deviation 16.09
|
—
|
|
Mean Sitting Systolic and Diastolic Blood Pressure (BP)
Sitting Systolic BP Day 813 (n=105)
|
125.6 mm Hg
Standard Deviation 16.04
|
—
|
|
Mean Sitting Systolic and Diastolic Blood Pressure (BP)
Sitting Systolic BP Day 897 (n=102)
|
122.8 mm Hg
Standard Deviation 13.15
|
—
|
|
Mean Sitting Systolic and Diastolic Blood Pressure (BP)
Sitting Systolic BP Day 981 (n=101)
|
123.5 mm Hg
Standard Deviation 15.44
|
—
|
|
Mean Sitting Systolic and Diastolic Blood Pressure (BP)
Sitting Systolic BP Day 1093 (n=98)
|
122.9 mm Hg
Standard Deviation 13.46
|
—
|
|
Mean Sitting Systolic and Diastolic Blood Pressure (BP)
Sitting Systolic BP Day 1177 (n=84)
|
124.4 mm Hg
Standard Deviation 13.66
|
—
|
|
Mean Sitting Systolic and Diastolic Blood Pressure (BP)
Sitting Systolic BP Day 1261 (n=73)
|
123.0 mm Hg
Standard Deviation 15.29
|
—
|
|
Mean Sitting Systolic and Diastolic Blood Pressure (BP)
Sitting Systolic BP Day 1345 (n=64)
|
120.6 mm Hg
Standard Deviation 12.27
|
—
|
|
Mean Sitting Systolic and Diastolic Blood Pressure (BP)
Sitting Systolic BP Day 1457 (n=64)
|
124.5 mm Hg
Standard Deviation 13.17
|
—
|
|
Mean Sitting Systolic and Diastolic Blood Pressure (BP)
Sitting Systolic BP Day 1541 (n=64)
|
121.0 mm Hg
Standard Deviation 13.75
|
—
|
|
Mean Sitting Systolic and Diastolic Blood Pressure (BP)
Sitting Systolic BP Day 1625 (n=64)
|
123.4 mm Hg
Standard Deviation 14.71
|
—
|
|
Mean Sitting Systolic and Diastolic Blood Pressure (BP)
Sitting Systolic BP Day 1709 (n=48)
|
122.7 mm Hg
Standard Deviation 15.55
|
—
|
|
Mean Sitting Systolic and Diastolic Blood Pressure (BP)
Sitting Systolic BP Day 1821 (n=3)
|
123.7 mm Hg
Standard Deviation 15.18
|
—
|
|
Mean Sitting Systolic and Diastolic Blood Pressure (BP)
Sitting Diastolic BP Day 1 (n=123)
|
73.9 mm Hg
Standard Deviation 8.83
|
—
|
|
Mean Sitting Systolic and Diastolic Blood Pressure (BP)
Sitting Diastolic BP Day 29 (n=120)
|
75.6 mm Hg
Standard Deviation 9.28
|
—
|
|
Mean Sitting Systolic and Diastolic Blood Pressure (BP)
Sitting Diastolic BP Day 57 (n=120)
|
74.3 mm Hg
Standard Deviation 8.82
|
—
|
|
Mean Sitting Systolic and Diastolic Blood Pressure (BP)
Sitting Diastolic BP Day 85 (n=120)
|
74.9 mm Hg
Standard Deviation 10.37
|
—
|
|
Mean Sitting Systolic and Diastolic Blood Pressure (BP)
Sitting Diastolic BP Day 169 (n=116)
|
74.3 mm Hg
Standard Deviation 9.19
|
—
|
|
Mean Sitting Systolic and Diastolic Blood Pressure (BP)
Sitting Diastolic BP Day 253 (n=114)
|
73.9 mm Hg
Standard Deviation 9.96
|
—
|
|
Mean Sitting Systolic and Diastolic Blood Pressure (BP)
Sitting Diastolic BP Day 365 (n=114)
|
74.0 mm Hg
Standard Deviation 9.98
|
—
|
|
Mean Sitting Systolic and Diastolic Blood Pressure (BP)
Sitting Diastolic BP Day 449 (n=111)
|
74.4 mm Hg
Standard Deviation 9.53
|
—
|
|
Mean Sitting Systolic and Diastolic Blood Pressure (BP)
Sitting Diastolic BP Day 533 (n=108)
|
74.8 mm Hg
Standard Deviation 10.08
|
—
|
|
Mean Sitting Systolic and Diastolic Blood Pressure (BP)
Sitting Diastolic BP Day 617 (n=109)
|
74.9 mm Hg
Standard Deviation 9.72
|
—
|
|
Mean Sitting Systolic and Diastolic Blood Pressure (BP)
Sitting Diastolic BP Day 79 (n=108)
|
75.5 mm Hg
Standard Deviation 9.83
|
—
|
|
Mean Sitting Systolic and Diastolic Blood Pressure (BP)
Sitting Diastolic BP Day 813 (n=105)
|
75.8 mm Hg
Standard Deviation 10.20
|
—
|
|
Mean Sitting Systolic and Diastolic Blood Pressure (BP)
Sitting Diastolic BP Day 897 (n=102)
|
75.0 mm Hg
Standard Deviation 10.23
|
—
|
|
Mean Sitting Systolic and Diastolic Blood Pressure (BP)
Sitting Diastolic BP Day 981 (n=101)
|
75.2 mm Hg
Standard Deviation 9.35
|
—
|
|
Mean Sitting Systolic and Diastolic Blood Pressure (BP)
Sitting Diastolic BP Day 1093 (n=98)
|
76.2 mm Hg
Standard Deviation 10.78
|
—
|
|
Mean Sitting Systolic and Diastolic Blood Pressure (BP)
Sitting Diastolic BP Day1177 (n=84)
|
77.6 mm Hg
Standard Deviation 9.04
|
—
|
|
Mean Sitting Systolic and Diastolic Blood Pressure (BP)
Sitting Diastolic BP Day 1261 (n=73)
|
76.3 mm Hg
Standard Deviation 9.94
|
—
|
|
Mean Sitting Systolic and Diastolic Blood Pressure (BP)
Sitting Diastolic BP Day 1345 (n=64)
|
75.4 mm Hg
Standard Deviation 8.21
|
—
|
|
Mean Sitting Systolic and Diastolic Blood Pressure (BP)
Sitting Diastolic BP Day 1457 (n=64)
|
76.8 mm Hg
Standard Deviation 7.14
|
—
|
|
Mean Sitting Systolic and Diastolic Blood Pressure (BP)
Sitting Diastolic BP Day 1541 (n=64)
|
75.6 mm Hg
Standard Deviation 9.53
|
—
|
|
Mean Sitting Systolic and Diastolic Blood Pressure (BP)
Sitting Diastolic BP Day 1625 (n=64)
|
75.6 mm Hg
Standard Deviation 9.36
|
—
|
|
Mean Sitting Systolic and Diastolic Blood Pressure (BP)
Sitting Diastolic BP Day 1709 (n=48)
|
75.2 mm Hg
Standard Deviation 9.74
|
—
|
|
Mean Sitting Systolic and Diastolic Blood Pressure (BP)
Sitting Diastolic BP Day 1821 (n=3)
|
69.3 mm Hg
Standard Deviation 8.14
|
—
|
PRIMARY outcome
Timeframe: Before injection on Days 1, 29, 57, 85, 169, 253, 365, 449, 533, 617, 729, 813, 897, 981, 1093, 1177, 1261, 1345, 1457, 1541, 1625, 1709, and 1821Population: All participants who received at least 1 dose of study medication. n=patients evaluable
Heart rate was measured after the patient had been seated quietly for at least 5 minutes and recorded during the screening visit, during every office visit prior to administration of subcutaneous injections, and at study discharge or 7 days after the last dose for patients who terminated early.
Outcome measures
| Measure |
Subcutaneous Abatacept, 125 mg
n=123 Participants
Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
|
Subcutaneous Abatacept, 125 mg (Prior Methotrexate Failure)
Participants with active rheumatoid arthritis, who previously received intravenous abatacept and showed an inadequate response to treatment with methotrexate in an earlier study (NCT00048568,or BMS IM101-102), received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
|
|---|---|---|
|
Mean Heart Rate
Day 533 (n=109)
|
72.7 Beats per minute
Standard Deviation 8.41
|
—
|
|
Mean Heart Rate
Day 1
|
74.2 Beats per minute
Standard Deviation 9.56
|
—
|
|
Mean Heart Rate
Day 29 (n=120)
|
74.9 Beats per minute
Standard Deviation 8.35
|
—
|
|
Mean Heart Rate
Day 57 (n=120)
|
74.6 Beats per minute
Standard Deviation 8.63
|
—
|
|
Mean Heart Rate
Day 85 (n=120)
|
74.5 Beats per minute
Standard Deviation 8.90
|
—
|
|
Mean Heart Rate
Day 169 (n=119)
|
73.6 Beats per minute
Standard Deviation 9.05
|
—
|
|
Mean Heart Rate
Day 253 (n=115)
|
73.9 Beats per minute
Standard Deviation 9.74
|
—
|
|
Mean Heart Rate
Day 365 (n=114)
|
73.8 Beats per minute
Standard Deviation 9.37
|
—
|
|
Mean Heart Rate
Day 449 (n=111)
|
73.5 Beats per minute
Standard Deviation 9.12
|
—
|
|
Mean Heart Rate
Day 617 (n=109)
|
73.6 Beats per minute
Standard Deviation 9.83
|
—
|
|
Mean Heart Rate
Day 729 (n=108)
|
74.2 Beats per minute
Standard Deviation 9.71
|
—
|
|
Mean Heart Rate
Day 813 (n=105)
|
72.8 Beats per minute
Standard Deviation 7.76
|
—
|
|
Mean Heart Rate
Day 897 (n=102)
|
72.4 Beats per minute
Standard Deviation 10.05
|
—
|
|
Mean Heart Rate
Day 981 (n=101)
|
73.0 Beats per minute
Standard Deviation 8.90
|
—
|
|
Mean Heart Rate
Day 1093 (n=98)
|
71.9 Beats per minute
Standard Deviation 9.07
|
—
|
|
Mean Heart Rate
Day 1177 (n=84)
|
72.6 Beats per minute
Standard Deviation 8.33
|
—
|
|
Mean Heart Rate
Day 1261 (n=73)
|
72.3 Beats per minute
Standard Deviation 9.41
|
—
|
|
Mean Heart Rate
Day 1345 (n=64)
|
72.6 Beats per minute
Standard Deviation 8.02
|
—
|
|
Mean Heart Rate
Day 1457 (n=64)
|
72.1 Beats per minute
Standard Deviation 7.78
|
—
|
|
Mean Heart Rate
Day 1541 (n=64)
|
72.7 Beats per minute
Standard Deviation 8.90
|
—
|
|
Mean Heart Rate
Day 1625 (n=64)
|
72.5 Beats per minute
Standard Deviation 8.73
|
—
|
|
Mean Heart Rate
Day 1709 (n=48)
|
74.0 Beats per minute
Standard Deviation 9.78
|
—
|
|
Mean Heart Rate
Day 1821 (n=3)
|
74.0 Beats per minute
Standard Deviation 6.24
|
—
|
PRIMARY outcome
Timeframe: Before injection on Days 1, 29, 57, 85, 169, 253, 365, 449, 533, 617, 729, 813, 897, 981, 1093, 1177, 1261, 1345, 1457, 1541, 1625, 1709, and 1821Population: All participants who received at least 1 dose of study medication. n=patients evaluable
Temperature was measured after the patient had been seated quietly for at least 5 minutes and recorded during the screening visit, during every office visit prior to administration of subcutaneous injections, and at study discharge or 7 days after the last dose for patients who terminated early.
Outcome measures
| Measure |
Subcutaneous Abatacept, 125 mg
n=123 Participants
Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
|
Subcutaneous Abatacept, 125 mg (Prior Methotrexate Failure)
Participants with active rheumatoid arthritis, who previously received intravenous abatacept and showed an inadequate response to treatment with methotrexate in an earlier study (NCT00048568,or BMS IM101-102), received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
|
|---|---|---|
|
Mean Temperature
Day 1
|
36.4 Degrees Celsius
Standard Deviation 0.49
|
—
|
|
Mean Temperature
Day 29 (n=120)
|
36.4 Degrees Celsius
Standard Deviation 0.43
|
—
|
|
Mean Temperature
Day 57 (n=120)
|
36.3 Degrees Celsius
Standard Deviation 0.40
|
—
|
|
Mean Temperature
Day 85 (n=120)
|
36.4 Degrees Celsius
Standard Deviation 0.43
|
—
|
|
Mean Temperature
Day 169 (n=119)
|
36.4 Degrees Celsius
Standard Deviation 0.41
|
—
|
|
Mean Temperature
Day 253 (n=115)
|
36.4 Degrees Celsius
Standard Deviation 0.38
|
—
|
|
Mean Temperature
Day 365 (n=114)
|
36.3 Degrees Celsius
Standard Deviation 0.39
|
—
|
|
Mean Temperature
Day 449 (n=111)
|
36.4 Degrees Celsius
Standard Deviation 0.46
|
—
|
|
Mean Temperature
Day 533 (n=109)
|
36.4 Degrees Celsius
Standard Deviation 0.38
|
—
|
|
Mean Temperature
Day 617 (n=109)
|
36.4 Degrees Celsius
Standard Deviation 0.41
|
—
|
|
Mean Temperature
Day 729 (n=108)
|
36.3 Degrees Celsius
Standard Deviation 0.33
|
—
|
|
Mean Temperature
Day 813 (n=105)
|
36.3 Degrees Celsius
Standard Deviation 0.48
|
—
|
|
Mean Temperature
Day 897 (n=102)
|
36.4 Degrees Celsius
Standard Deviation 0.36
|
—
|
|
Mean Temperature
Day 981 (n=101)
|
36.4 Degrees Celsius
Standard Deviation 0.44
|
—
|
|
Mean Temperature
Day 1093 (n=98)
|
36.3 Degrees Celsius
Standard Deviation 0.43
|
—
|
|
Mean Temperature
Day 1177 (n=84)
|
36.3 Degrees Celsius
Standard Deviation 0.39
|
—
|
|
Mean Temperature
Day 1261 (n=73)
|
36.3 Degrees Celsius
Standard Deviation 0.41
|
—
|
|
Mean Temperature
Day 1345 (n=64)
|
36.3 Degrees Celsius
Standard Deviation 0.33
|
—
|
|
Mean Temperature
Day 1457 (n=64)
|
36.3 Degrees Celsius
Standard Deviation 0.39
|
—
|
|
Mean Temperature
Day 1541 (n=64)
|
36.2 Degrees Celsius
Standard Deviation 0.36
|
—
|
|
Mean Temperature
Day 1625 (n=64)
|
36.2 Degrees Celsius
Standard Deviation 0.43
|
—
|
|
Mean Temperature
Day 1709 (n=48)
|
36.2 Degrees Celsius
Standard Deviation 0.37
|
—
|
|
Mean Temperature
Day 1821 (n=3)
|
36.7 Degrees Celsius
Standard Deviation 0.21
|
—
|
SECONDARY outcome
Timeframe: Days 29, 85, 57, and 85Population: All participants who received at least 1 dose of study medication. n=patients who had at least 1 pharmacokinetic sample drawn postbaseline
Cmin of abatacept was determined from serum samples.
Outcome measures
| Measure |
Subcutaneous Abatacept, 125 mg
n=123 Participants
Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
|
Subcutaneous Abatacept, 125 mg (Prior Methotrexate Failure)
Participants with active rheumatoid arthritis, who previously received intravenous abatacept and showed an inadequate response to treatment with methotrexate in an earlier study (NCT00048568,or BMS IM101-102), received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
|
|---|---|---|
|
Mean Trough Serum Concentration (Cmin) of Abatacept
Day 29 (n=116)
|
34.31 μg/mL
Geometric Coefficient of Variation 46
|
—
|
|
Mean Trough Serum Concentration (Cmin) of Abatacept
Day 57 (n=117)
|
34.25 μg/mL
Geometric Coefficient of Variation 48
|
—
|
|
Mean Trough Serum Concentration (Cmin) of Abatacept
Day 85 (n=118)
|
33.78 μg/mL
Geometric Coefficient of Variation 48
|
—
|
SECONDARY outcome
Timeframe: Day 1 (Baseline) through Day 85Population: All participants who received at least 1 subcutaneous abatacept injection and who had at least 1 immunogenicity result reported (on the corresponding assay) on subcutaneous abatacept treatment. n=patients evaluable
Using the ELISA, any positive (titer of 400 or greater) postbaseline sample was classified as positive immunogenicity. The percentage of participants with at least 1 positive antibody response (anti-abatacept and/or anti-CTLA4-T) during the 85 days was tabulated by antibody specificity and overall.
Outcome measures
| Measure |
Subcutaneous Abatacept, 125 mg
n=122 Participants
Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
|
Subcutaneous Abatacept, 125 mg (Prior Methotrexate Failure)
Participants with active rheumatoid arthritis, who previously received intravenous abatacept and showed an inadequate response to treatment with methotrexate in an earlier study (NCT00048568,or BMS IM101-102), received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
|
|---|---|---|
|
Percentage of Participants With A Positive Anti-abatacept Response (Based on Enzyme-linked Immunosorbent Assay [ELISA]) at Day 85
Anti-abatacept (n=85)
|
8.2 Percentage of participants
|
—
|
|
Percentage of Participants With A Positive Anti-abatacept Response (Based on Enzyme-linked Immunosorbent Assay [ELISA]) at Day 85
Anti-CTLA4-T9 (n=122)
|
0.8 Percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Day 1 (Baseline) through Day 85Population: All participants who received at least 1 subcutaneous abatacept injection and who had at least 1 immunogenicity result reported (on the corresponding assay) on subcutaneous abatacept treatment. n=patients evaluable
Number of participants was tabulated using ECL assay with at least 1 positive abatacept-induced immunogenic response (CTLA4 and possibly Ig, Ig and/or Junction Region) in the first 85 days. Positive response (titers \>10) included: * A missing baseline immunogenicity measurement and a positive immunogenicity response postbaseline * A negative baseline immunogenicity response and a positive immunogenicity response postbaseline * A positive baseline immunogenicity response and a positive immunogenicity response postbaseline that has a titer value strictly greater than the baseline titer value
Outcome measures
| Measure |
Subcutaneous Abatacept, 125 mg
n=122 Participants
Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
|
Subcutaneous Abatacept, 125 mg (Prior Methotrexate Failure)
Participants with active rheumatoid arthritis, who previously received intravenous abatacept and showed an inadequate response to treatment with methotrexate in an earlier study (NCT00048568,or BMS IM101-102), received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
|
|---|---|---|
|
Percentage of Participants With A Positive Anti-abatacept Response (Based on Electrochemiluminescence [ECL] Immunoassay) at Day 85
|
0 Percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Day 1 (Baseline) through Day 1093Population: All participants who received at least 1 dose of study medication
The DAS 28-CRP is a measure of disease activity in rheumatoid arthritis (RA) and assesses the 28 joints RA commonly affects; the score includes the number of tender and swollen joints (out of 28), C-reactive protein level (a measure of inflammation in the blood), and the patient's global assessment of health (ranging from very good to very bad). DAS-CRP scores range from 0 to 10, with higher values indicating greater disease activity. Individual measures are fed into a complex mathematical formula to produce the overall DAS (a score greater than 5.1 implies active disease; less than 3.2, well controlled disease; and less than 2.6, remission.)
Outcome measures
| Measure |
Subcutaneous Abatacept, 125 mg
n=52 Participants
Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
|
Subcutaneous Abatacept, 125 mg (Prior Methotrexate Failure)
n=71 Participants
Participants with active rheumatoid arthritis, who previously received intravenous abatacept and showed an inadequate response to treatment with methotrexate in an earlier study (NCT00048568,or BMS IM101-102), received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
|
|---|---|---|
|
Mean Disease Activity Score 28 Based on C-reactive Protein (DAS 28-CRP) Scores Over Time
Day 29 (n=50, 69)
|
3.60 Units on a scale
Standard Deviation 1.24
|
2.95 Units on a scale
Standard Deviation 1.31
|
|
Mean Disease Activity Score 28 Based on C-reactive Protein (DAS 28-CRP) Scores Over Time
Day 57 (n=49, 69)
|
3.36 Units on a scale
Standard Deviation 1.11
|
2.96 Units on a scale
Standard Deviation 1.37
|
|
Mean Disease Activity Score 28 Based on C-reactive Protein (DAS 28-CRP) Scores Over Time
Day 85 (n=49, 70)
|
3.44 Units on a scale
Standard Deviation 1.14
|
2.91 Units on a scale
Standard Deviation 1.30
|
|
Mean Disease Activity Score 28 Based on C-reactive Protein (DAS 28-CRP) Scores Over Time
Day 169 (n=48, 71)
|
3.45 Units on a scale
Standard Deviation 1.10
|
2.93 Units on a scale
Standard Deviation 1.29
|
|
Mean Disease Activity Score 28 Based on C-reactive Protein (DAS 28-CRP) Scores Over Time
Day 253 (n=46, 71)
|
3.60 Units on a scale
Standard Deviation 1.33
|
3.01 Units on a scale
Standard Deviation 1.21
|
|
Mean Disease Activity Score 28 Based on C-reactive Protein (DAS 28-CRP) Scores Over Time
Day 365 (n=45, 70)
|
3.51 Units on a scale
Standard Deviation 1.32
|
3.09 Units on a scale
Standard Deviation 1.25
|
|
Mean Disease Activity Score 28 Based on C-reactive Protein (DAS 28-CRP) Scores Over Time
Day 449 (n=43, 69)
|
3.58 Units on a scale
Standard Deviation 1.33
|
3.21 Units on a scale
Standard Deviation 1.35
|
|
Mean Disease Activity Score 28 Based on C-reactive Protein (DAS 28-CRP) Scores Over Time
Day 533 (n=43, 68)
|
3.51 Units on a scale
Standard Deviation 1.23
|
3.08 Units on a scale
Standard Deviation 1.43
|
|
Mean Disease Activity Score 28 Based on C-reactive Protein (DAS 28-CRP) Scores Over Time
Day 617 (n=41, 67)
|
3.31 Units on a scale
Standard Deviation 1.20
|
3.16 Units on a scale
Standard Deviation 1.37
|
|
Mean Disease Activity Score 28 Based on C-reactive Protein (DAS 28-CRP) Scores Over Time
Day 729 (n=41, 67)
|
3.30 Units on a scale
Standard Deviation 1.12
|
3.15 Units on a scale
Standard Deviation 1.26
|
|
Mean Disease Activity Score 28 Based on C-reactive Protein (DAS 28-CRP) Scores Over Time
Day 813 (n=39, 65)
|
3.38 Units on a scale
Standard Deviation 1.17
|
2.81 Units on a scale
Standard Deviation 1.05
|
|
Mean Disease Activity Score 28 Based on C-reactive Protein (DAS 28-CRP) Scores Over Time
Day 897 (n=38, 65)
|
3.41 Units on a scale
Standard Deviation 1.46
|
3.02 Units on a scale
Standard Deviation 1.19
|
|
Mean Disease Activity Score 28 Based on C-reactive Protein (DAS 28-CRP) Scores Over Time
Day 981 (n=38, 65)
|
3.32 Units on a scale
Standard Deviation 1.37
|
3.02 Units on a scale
Standard Deviation 1.28
|
|
Mean Disease Activity Score 28 Based on C-reactive Protein (DAS 28-CRP) Scores Over Time
Day 1093 (n=34, 65)
|
3.21 Units on a scale
Standard Deviation 1.26
|
3.10 Units on a scale
Standard Deviation 1.37
|
SECONDARY outcome
Timeframe: Day 1 (Baseline) through Day 1093Population: All participants who received at least 1 dose of study medication
LDAS is defined as DAS 28-CRP ≤3.2. DAS 28-CRP remission is defined as DAS 28-CRP \<2.6. The DAS 28-CRP is a measure of disease activity in rheumatoid arthritis (RA) and assesses the 28 joints RA commonly affects; the score includes the number of tender and swollen joints (out of 28), C-reactive protein level (a measure of inflammation in the blood), and the patient's global assessment of health (ranging from very good to very bad). DAS-CRP scores range from 0 to 10, with higher values indicating greater disease activity. Individual measures are fed into a complex mathematical formula to produce the overall DAS (a score greater than 5.1 implies active disease; less than 3.2, well controlled disease; and less than 2.6, remission.)
Outcome measures
| Measure |
Subcutaneous Abatacept, 125 mg
n=52 Participants
Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
|
Subcutaneous Abatacept, 125 mg (Prior Methotrexate Failure)
n=71 Participants
Participants with active rheumatoid arthritis, who previously received intravenous abatacept and showed an inadequate response to treatment with methotrexate in an earlier study (NCT00048568,or BMS IM101-102), received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
|
|---|---|---|
|
Percentage of Participants With Low Disease Activity Score (LDAS) and Disease Activity Score 28 Based on C-reactive Protein (DAS 28-CRP) Remission Over Time:
LDAS Day 29 (n=50, 69)
|
40.0 Percentage of participants
Interval 26.4 to 53.6
|
68.1 Percentage of participants
Interval 57.1 to 79.1
|
|
Percentage of Participants With Low Disease Activity Score (LDAS) and Disease Activity Score 28 Based on C-reactive Protein (DAS 28-CRP) Remission Over Time:
Remission Day 29 (n=50, 69)
|
24.0 Percentage of participants
Interval 12.2 to 35.8
|
50.7 Percentage of participants
Interval 38.9 to 62.5
|
|
Percentage of Participants With Low Disease Activity Score (LDAS) and Disease Activity Score 28 Based on C-reactive Protein (DAS 28-CRP) Remission Over Time:
LDAS Day 57 (n=49, 69)
|
44.9 Percentage of participants
Interval 31.0 to 58.8
|
60.9 Percentage of participants
Interval 49.4 to 72.4
|
|
Percentage of Participants With Low Disease Activity Score (LDAS) and Disease Activity Score 28 Based on C-reactive Protein (DAS 28-CRP) Remission Over Time:
Remission Day 57 (n=49, 69)
|
26.5 Percentage of participants
Interval 14.2 to 38.9
|
47.8 Percentage of participants
Interval 36.0 to 59.6
|
|
Percentage of Participants With Low Disease Activity Score (LDAS) and Disease Activity Score 28 Based on C-reactive Protein (DAS 28-CRP) Remission Over Time:
LDAS Day 85 (n=49, 70)
|
40.8 Percentage of participants
Interval 27.1 to 54.6
|
64.3 Percentage of participants
Interval 53.1 to 75.5
|
|
Percentage of Participants With Low Disease Activity Score (LDAS) and Disease Activity Score 28 Based on C-reactive Protein (DAS 28-CRP) Remission Over Time:
Remission Day 85 (n=49, 70)
|
24.5 Percentage of participants
Interval 12.4 to 36.5
|
48.6 Percentage of participants
Interval 36.9 to 60.3
|
|
Percentage of Participants With Low Disease Activity Score (LDAS) and Disease Activity Score 28 Based on C-reactive Protein (DAS 28-CRP) Remission Over Time:
LDAS Day 169 (n=48, 71)
|
39.6 Percentage of participants
Interval 25.7 to 53.4
|
59.2 Percentage of participants
Interval 47.7 to 70.6
|
|
Percentage of Participants With Low Disease Activity Score (LDAS) and Disease Activity Score 28 Based on C-reactive Protein (DAS 28-CRP) Remission Over Time:
Remission Day 169 (n=48, 71)
|
25.0 Percentage of participants
Interval 12.8 to 37.2
|
49.3 Percentage of participants
Interval 37.7 to 60.9
|
|
Percentage of Participants With Low Disease Activity Score (LDAS) and Disease Activity Score 28 Based on C-reactive Protein (DAS 28-CRP) Remission Over Time:
LDAS Day 253 (n=46, 71)
|
39.1 Percentage of participants
Interval 25.0 to 53.2
|
66.2 Percentage of participants
Interval 55.2 to 77.2
|
|
Percentage of Participants With Low Disease Activity Score (LDAS) and Disease Activity Score 28 Based on C-reactive Protein (DAS 28-CRP) Remission Over Time:
Remission Day 253 (n=46, 71)
|
30.4 Percentage of participants
Interval 17.1 to 43.7
|
42.3 Percentage of participants
Interval 30.8 to 53.7
|
|
Percentage of Participants With Low Disease Activity Score (LDAS) and Disease Activity Score 28 Based on C-reactive Protein (DAS 28-CRP) Remission Over Time:
LDAS Day 365 (n=45, 70)
|
40.0 Percentage of participants
Interval 25.7 to 54.3
|
57.1 Percentage of participants
Interval 45.5 to 68.7
|
|
Percentage of Participants With Low Disease Activity Score (LDAS) and Disease Activity Score 28 Based on C-reactive Protein (DAS 28-CRP) Remission Over Time:
Remission Day 365 (n=45, 70)
|
33.3 Percentage of participants
Interval 19.6 to 47.1
|
42.9 Percentage of participants
Interval 31.3 to 54.5
|
|
Percentage of Participants With Low Disease Activity Score (LDAS) and Disease Activity Score 28 Based on C-reactive Protein (DAS 28-CRP) Remission Over Time:
LDAS Day 449 (n=43, 69)
|
41.9 Percentage of participants
Interval 27.1 to 56.6
|
53.6 Percentage of participants
Interval 41.9 to 65.4
|
|
Percentage of Participants With Low Disease Activity Score (LDAS) and Disease Activity Score 28 Based on C-reactive Protein (DAS 28-CRP) Remission Over Time:
Remission Day 449 (n=43, 69)
|
30.2 Percentage of participants
Interval 16.5 to 44.0
|
43.5 Percentage of participants
Interval 31.8 to 55.2
|
|
Percentage of Participants With Low Disease Activity Score (LDAS) and Disease Activity Score 28 Based on C-reactive Protein (DAS 28-CRP) Remission Over Time:
LDAS Day 533 (n=43, 68)
|
37.2 Percentage of participants
Interval 22.8 to 51.7
|
60.3 Percentage of participants
Interval 48.7 to 71.9
|
|
Percentage of Participants With Low Disease Activity Score (LDAS) and Disease Activity Score 28 Based on C-reactive Protein (DAS 28-CRP) Remission Over Time:
Remission Day 533 (n=43, 68)
|
23.3 Percentage of participants
Interval 10.6 to 35.9
|
48.5 Percentage of participants
Interval 36.7 to 60.4
|
|
Percentage of Participants With Low Disease Activity Score (LDAS) and Disease Activity Score 28 Based on C-reactive Protein (DAS 28-CRP) Remission Over Time:
LDAS Day 617 (n=41, 67)
|
46.3 Percentage of participants
Interval 31.1 to 61.6
|
53.7 Percentage of participants
Interval 41.8 to 65.7
|
|
Percentage of Participants With Low Disease Activity Score (LDAS) and Disease Activity Score 28 Based on C-reactive Protein (DAS 28-CRP) Remission Over Time:
Remission Day 617 (n=41, 67)
|
29.3 Percentage of participants
Interval 15.3 to 43.2
|
43.3 Percentage of participants
Interval 31.4 to 55.1
|
|
Percentage of Participants With Low Disease Activity Score (LDAS) and Disease Activity Score 28 Based on C-reactive Protein (DAS 28-CRP) Remission Over Time:
LDAS Day 729 (n=41, 67)
|
41.5 Percentage of participants
Interval 26.4 to 56.5
|
59.7 Percentage of participants
Interval 48.0 to 71.4
|
|
Percentage of Participants With Low Disease Activity Score (LDAS) and Disease Activity Score 28 Based on C-reactive Protein (DAS 28-CRP) Remission Over Time:
Remission Day 729 (n=41, 67)
|
29.3 Percentage of participants
Interval 15.3 to 43.2
|
34.3 Percentage of participants
Interval 23.0 to 45.7
|
|
Percentage of Participants With Low Disease Activity Score (LDAS) and Disease Activity Score 28 Based on C-reactive Protein (DAS 28-CRP) Remission Over Time:
LDAS Day 813 (n=39, 65)
|
43.6 Percentage of participants
Interval 28.0 to 59.2
|
69.2 Percentage of participants
Interval 58.0 to 80.5
|
|
Percentage of Participants With Low Disease Activity Score (LDAS) and Disease Activity Score 28 Based on C-reactive Protein (DAS 28-CRP) Remission Over Time:
Remission Day 813 (n=39, 65)
|
25.6 Percentage of participants
Interval 11.9 to 39.3
|
46.2 Percentage of participants
Interval 34.0 to 58.3
|
|
Percentage of Participants With Low Disease Activity Score (LDAS) and Disease Activity Score 28 Based on C-reactive Protein (DAS 28-CRP) Remission Over Time:
LDAS Day 897 (n=38, 65)
|
50.0 Percentage of participants
Interval 34.1 to 65.9
|
60.0 Percentage of participants
Interval 48.1 to 71.9
|
|
Percentage of Participants With Low Disease Activity Score (LDAS) and Disease Activity Score 28 Based on C-reactive Protein (DAS 28-CRP) Remission Over Time:
Remission Day 897 (n=38, 65)
|
34.2 Percentage of participants
Interval 19.1 to 49.3
|
43.1 Percentage of participants
Interval 31.0 to 55.1
|
|
Percentage of Participants With Low Disease Activity Score (LDAS) and Disease Activity Score 28 Based on C-reactive Protein (DAS 28-CRP) Remission Over Time:
DLAS Day 981 (n=38, 65)
|
50.0 Percentage of participants
Interval 34.1 to 65.9
|
64.6 Percentage of participants
Interval 53.0 to 76.2
|
|
Percentage of Participants With Low Disease Activity Score (LDAS) and Disease Activity Score 28 Based on C-reactive Protein (DAS 28-CRP) Remission Over Time:
Remission Day 981 (n=38, 65)
|
42.1 Percentage of participants
Interval 26.4 to 57.8
|
46.2 Percentage of participants
Interval 34.0 to 58.3
|
|
Percentage of Participants With Low Disease Activity Score (LDAS) and Disease Activity Score 28 Based on C-reactive Protein (DAS 28-CRP) Remission Over Time:
LDAS Day 1093 (n=34, 65)
|
52.9 Percentage of participants
Interval 36.2 to 69.7
|
58.5 Percentage of participants
Interval 46.5 to 70.4
|
|
Percentage of Participants With Low Disease Activity Score (LDAS) and Disease Activity Score 28 Based on C-reactive Protein (DAS 28-CRP) Remission Over Time:
Remission Day 1093 (n=34, 65)
|
41.2 Percentage of participants
Interval 24.6 to 57.7
|
50.8 Percentage of participants
Interval 38.6 to 62.9
|
SECONDARY outcome
Timeframe: Day 1 (Baseline) to Day 1093Population: All participants who received at least 1 dose of study medication
The HAQ-DI assesses patients' functional ability by rating their abilities over the previous week. At least 2 questions are asked from each of 8 categories: dressing and grooming, hygiene, arising, reach, eating, grip, walking, and common daily activities. Patients rate difficulty performing specific tasks: 0=without difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do. The sum of the categories is divided by the number of categories answered, yielding a score from 0-3.
Outcome measures
| Measure |
Subcutaneous Abatacept, 125 mg
n=52 Participants
Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
|
Subcutaneous Abatacept, 125 mg (Prior Methotrexate Failure)
n=71 Participants
Participants with active rheumatoid arthritis, who previously received intravenous abatacept and showed an inadequate response to treatment with methotrexate in an earlier study (NCT00048568,or BMS IM101-102), received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
|
|---|---|---|
|
Mean Health Assessment Questionnaire-Disability Index (HAQ-DI) Scores Over Time
Day 29 (n=51, 69)
|
0.98 Units on a scale
Standard Deviation 0.70
|
0.80 Units on a scale
Standard Deviation 0.67
|
|
Mean Health Assessment Questionnaire-Disability Index (HAQ-DI) Scores Over Time
Day 57 (n=50, 71)
|
0.92 Units on a scale
Standard Deviation 0.68
|
0.80 Units on a scale
Standard Deviation 0.67
|
|
Mean Health Assessment Questionnaire-Disability Index (HAQ-DI) Scores Over Time
Day 85 (n=49, 71)
|
0.92 Units on a scale
Standard Deviation 0.67
|
0.82 Units on a scale
Standard Deviation 0.69
|
|
Mean Health Assessment Questionnaire-Disability Index (HAQ-DI) Scores Over Time
Day 169 (n=49, 71)
|
0.97 Units on a scale
Standard Deviation 0.67
|
0.87 Units on a scale
Standard Deviation 0.74
|
|
Mean Health Assessment Questionnaire-Disability Index (HAQ-DI) Scores Over Time
Day 253 (n=48, 71)
|
0.97 Units on a scale
Standard Deviation 0.69
|
0.87 Units on a scale
Standard Deviation 0.73
|
|
Mean Health Assessment Questionnaire-Disability Index (HAQ-DI) Scores Over Time
Day 365 (n=46, 70)
|
0.96 Units on a scale
Standard Deviation 0.66
|
0.85 Units on a scale
Standard Deviation 0.69
|
|
Mean Health Assessment Questionnaire-Disability Index (HAQ-DI) Scores Over Time
Day 449 (n=43, 69)
|
0.97 Units on a scale
Standard Deviation 0.75
|
0.89 Units on a scale
Standard Deviation 0.69
|
|
Mean Health Assessment Questionnaire-Disability Index (HAQ-DI) Scores Over Time
Day 533 (n=43, 68)
|
1.07 Units on a scale
Standard Deviation 0.71
|
0.94 Units on a scale
Standard Deviation 0.71
|
|
Mean Health Assessment Questionnaire-Disability Index (HAQ-DI) Scores Over Time
Day 617 (n=42, 67)
|
0.99 Units on a scale
Standard Deviation 0.74
|
0.87 Units on a scale
Standard Deviation 0.69
|
|
Mean Health Assessment Questionnaire-Disability Index (HAQ-DI) Scores Over Time
Day 729 (n=42, 67)
|
0.98 Units on a scale
Standard Deviation 0.74
|
0.90 Units on a scale
Standard Deviation 0.71
|
|
Mean Health Assessment Questionnaire-Disability Index (HAQ-DI) Scores Over Time
Day 813 (n=40, 66)
|
1.02 Units on a scale
Standard Deviation 0.74
|
0.88 Units on a scale
Standard Deviation 0.68
|
|
Mean Health Assessment Questionnaire-Disability Index (HAQ-DI) Scores Over Time
Day 897 (n=39, 65)
|
1.06 Units on a scale
Standard Deviation 0.75
|
0.89 Units on a scale
Standard Deviation 0.73
|
|
Mean Health Assessment Questionnaire-Disability Index (HAQ-DI) Scores Over Time
Day 981 (n=39, 65)
|
1.02 Units on a scale
Standard Deviation 0.76
|
0.91 Units on a scale
Standard Deviation 0.69
|
|
Mean Health Assessment Questionnaire-Disability Index (HAQ-DI) Scores Over Time
Day 1093 (n=34, 65)
|
0.96 Units on a scale
Standard Deviation 0.74
|
0.92 Units on a scale
Standard Deviation 0.74
|
Adverse Events
Subcutaneous Abatacept, 125 mg
Serious events: 43 serious events
Other events: 101 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Subcutaneous Abatacept, 125 mg
n=123 participants at risk
Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
|
|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.81%
1/123
|
|
Nervous system disorders
Cerebrovascular accident
|
0.81%
1/123
|
|
Gastrointestinal disorders
Colonic fistula
|
0.81%
1/123
|
|
Infections and infestations
Diverticulitis
|
0.81%
1/123
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma metastatic
|
0.81%
1/123
|
|
Cardiac disorders
Pericardial effusion
|
0.81%
1/123
|
|
Cardiac disorders
Angina pectoris
|
0.81%
1/123
|
|
Nervous system disorders
Aphasia
|
0.81%
1/123
|
|
Cardiac disorders
Cardiac failure congestive
|
0.81%
1/123
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.81%
1/123
|
|
Cardiac disorders
Myocardial ischaemia
|
0.81%
1/123
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.81%
1/123
|
|
Renal and urinary disorders
Renal colic
|
0.81%
1/123
|
|
Infections and infestations
Bronchitis
|
0.81%
1/123
|
|
Gastrointestinal disorders
Colitis
|
0.81%
1/123
|
|
Cardiac disorders
Coronary artery disease
|
0.81%
1/123
|
|
Gastrointestinal disorders
Hiatus hernia
|
1.6%
2/123
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.81%
1/123
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm benign
|
0.81%
1/123
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.81%
1/123
|
|
Infections and infestations
Appendicitis
|
0.81%
1/123
|
|
General disorders
Chest pain
|
1.6%
2/123
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.81%
1/123
|
|
Infections and infestations
Dengue fever
|
0.81%
1/123
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.81%
1/123
|
|
Infections and infestations
Pneumonia
|
3.3%
4/123
|
|
Infections and infestations
Soft tissue infection
|
0.81%
1/123
|
|
Cardiac disorders
Coronary artery occlusion
|
0.81%
1/123
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.81%
1/123
|
|
Gastrointestinal disorders
Gastric polyps
|
0.81%
1/123
|
|
Injury, poisoning and procedural complications
Hip fracture
|
1.6%
2/123
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.81%
1/123
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.81%
1/123
|
|
Immune system disorders
Sarcoidosis
|
0.81%
1/123
|
|
Infections and infestations
Urosepsis
|
0.81%
1/123
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine cancer
|
0.81%
1/123
|
|
Cardiac disorders
Angina unstable
|
0.81%
1/123
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.81%
1/123
|
|
Infections and infestations
Cholecystitis infective
|
0.81%
1/123
|
|
Hepatobiliary disorders
Cholelithiasis
|
1.6%
2/123
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer
|
0.81%
1/123
|
|
General disorders
Device failure
|
0.81%
1/123
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gallbladder adenocarcinoma
|
0.81%
1/123
|
|
Infections and infestations
Gastroenteritis
|
0.81%
1/123
|
|
Cardiac disorders
Bundle branch block left
|
0.81%
1/123
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.81%
1/123
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
3.3%
4/123
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.81%
1/123
|
|
Blood and lymphatic system disorders
Pancytopenia
|
1.6%
2/123
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.81%
1/123
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.81%
1/123
|
Other adverse events
| Measure |
Subcutaneous Abatacept, 125 mg
n=123 participants at risk
Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
|
|---|---|
|
Eye disorders
Cataract
|
5.7%
7/123
|
|
Gastrointestinal disorders
Diarrhoea
|
5.7%
7/123
|
|
Injury, poisoning and procedural complications
Fall
|
7.3%
9/123
|
|
Vascular disorders
Hypertension
|
8.1%
10/123
|
|
Infections and infestations
Bronchitis
|
11.4%
14/123
|
|
Gastrointestinal disorders
Gastritis
|
5.7%
7/123
|
|
Infections and infestations
Nasopharyngitis
|
27.6%
34/123
|
|
Gastrointestinal disorders
Nausea
|
7.3%
9/123
|
|
General disorders
Oedema peripheral
|
7.3%
9/123
|
|
Psychiatric disorders
Depression
|
5.7%
7/123
|
|
Infections and infestations
Pharyngitis
|
5.7%
7/123
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.6%
13/123
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
13.8%
17/123
|
|
Nervous system disorders
Headache
|
8.1%
10/123
|
|
General disorders
Influenza like illness
|
6.5%
8/123
|
|
Infections and infestations
Sinusitis
|
8.1%
10/123
|
|
Infections and infestations
Urinary tract infection
|
19.5%
24/123
|
|
Infections and infestations
Conjunctivitis
|
7.3%
9/123
|
|
Nervous system disorders
Dizziness
|
8.1%
10/123
|
|
Infections and infestations
Gastroenteritis
|
7.3%
9/123
|
|
Blood and lymphatic system disorders
Anaemia
|
7.3%
9/123
|
|
Infections and infestations
Upper respiratory tract infection
|
24.4%
30/123
|
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