Trial Outcomes & Findings for A Phase III Study of Abatacept in Japanese Subjects With Rheumatoid Arthritis (NCT NCT00484289)
NCT ID: NCT00484289
Last Updated: 2013-06-24
Results Overview
AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. SAE is 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 cancer, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event. Both subjective and objective AEs and SAEs are included.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
217 participants
Primary outcome timeframe
From initiation of the study drug (31 Mar 2008) to data cutoff (27 Dec 2010). The overall mean duration of exposure to the study drug was approximately 3 years (34.3 ± 10.7 months).
Results posted on
2013-06-24
Participant Flow
Participant milestones
| Measure |
Participants From Phase I Study (IM101-034); Abatacept 10mg/kg
Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
|
Participants From Phase II Study(IM101-071); Abatacept 10mg/kg
Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
|
New Participants With MTX Intolerance; Abatacept 10 mg/kg
Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs \[excluding MTX\]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
|
|---|---|---|---|
|
Long Term Phase
STARTED
|
13
|
178
|
26
|
|
Long Term Phase
COMPLETED
|
10
|
142
|
10
|
|
Long Term Phase
NOT COMPLETED
|
3
|
36
|
16
|
|
Post Marketing Phase
STARTED
|
10
|
142
|
10
|
|
Post Marketing Phase
COMPLETED
|
10
|
141
|
10
|
|
Post Marketing Phase
NOT COMPLETED
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Participants From Phase I Study (IM101-034); Abatacept 10mg/kg
Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
|
Participants From Phase II Study(IM101-071); Abatacept 10mg/kg
Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
|
New Participants With MTX Intolerance; Abatacept 10 mg/kg
Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs \[excluding MTX\]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
|
|---|---|---|---|
|
Long Term Phase
Adverse Event
|
1
|
17
|
5
|
|
Long Term Phase
Withdrawal by Subject
|
0
|
7
|
6
|
|
Long Term Phase
Inadequate response
|
2
|
7
|
4
|
|
Long Term Phase
Other Reason
|
0
|
5
|
1
|
|
Post Marketing Phase
Adverse Event
|
0
|
1
|
0
|
Baseline Characteristics
A Phase III Study of Abatacept in Japanese Subjects With Rheumatoid Arthritis
Baseline characteristics by cohort
| Measure |
Participants From Phase I Study (IM101-034); Abatacept 10mg/kg
n=13 Participants
Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
|
Participants From Phase II Study(IM101-071); Abatacept 10mg/kg
n=178 Participants
Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
|
New Participants With MTX Intolerance; Abatacept 10 mg/kg
n=26 Participants
Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs \[excluding MTX\]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
|
Total
n=217 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
52.8 years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
53.2 years
STANDARD_DEVIATION 11.5 • n=7 Participants
|
57.8 years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
53.8 years
STANDARD_DEVIATION 11.4 • n=4 Participants
|
|
Age, Customized
20 - 29 years
|
1 participants
n=5 Participants
|
7 participants
n=7 Participants
|
0 participants
n=5 Participants
|
8 participants
n=4 Participants
|
|
Age, Customized
30 - 39 years
|
2 participants
n=5 Participants
|
13 participants
n=7 Participants
|
1 participants
n=5 Participants
|
16 participants
n=4 Participants
|
|
Age, Customized
40 - 49 years
|
0 participants
n=5 Participants
|
39 participants
n=7 Participants
|
5 participants
n=5 Participants
|
44 participants
n=4 Participants
|
|
Age, Customized
50 - 59 years
|
6 participants
n=5 Participants
|
70 participants
n=7 Participants
|
7 participants
n=5 Participants
|
83 participants
n=4 Participants
|
|
Age, Customized
≥ 60 years
|
4 participants
n=5 Participants
|
49 participants
n=7 Participants
|
13 participants
n=5 Participants
|
66 participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
146 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
177 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
|
Weight
|
55.2 kg
STANDARD_DEVIATION 9.7 • n=5 Participants
|
56.9 kg
STANDARD_DEVIATION 9.4 • n=7 Participants
|
53.9 kg
STANDARD_DEVIATION 10.8 • n=5 Participants
|
56.5 kg
STANDARD_DEVIATION 9.6 • n=4 Participants
|
|
Duration of Rheumatoid Arthritis
<= 2 years
|
0 participants
9.0 • n=5 Participants
|
24 participants
7.3 • n=7 Participants
|
2 participants
10.1 • n=5 Participants
|
26 participants
7.9 • n=4 Participants
|
|
Duration of Rheumatoid Arthritis
>2 to <= 5 years
|
2 participants
n=5 Participants
|
45 participants
n=7 Participants
|
4 participants
n=5 Participants
|
51 participants
n=4 Participants
|
|
Duration of Rheumatoid Arthritis
> 5 to <= 10 years
|
2 participants
n=5 Participants
|
57 participants
n=7 Participants
|
12 participants
n=5 Participants
|
71 participants
n=4 Participants
|
|
Duration of Rheumatoid Arthritis
> 10 years
|
9 participants
n=5 Participants
|
52 participants
n=7 Participants
|
8 participants
n=5 Participants
|
69 participants
n=4 Participants
|
|
American College of Rheumatology (ACR) Functional Status Classification
Class I
|
0 participants
n=5 Participants
|
29 participants
n=7 Participants
|
0 participants
n=5 Participants
|
29 participants
n=4 Participants
|
|
American College of Rheumatology (ACR) Functional Status Classification
Class II
|
12 participants
n=5 Participants
|
112 participants
n=7 Participants
|
17 participants
n=5 Participants
|
141 participants
n=4 Participants
|
|
American College of Rheumatology (ACR) Functional Status Classification
Class III
|
1 participants
n=5 Participants
|
37 participants
n=7 Participants
|
9 participants
n=5 Participants
|
47 participants
n=4 Participants
|
|
American College of Rheumatology (ACR) Functional Status Classification
Class IV
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
|
Number of Tender Joints
|
8.4 joints
STANDARD_DEVIATION 5.2 • n=5 Participants
|
14.3 joints
STANDARD_DEVIATION 11.2 • n=7 Participants
|
22.7 joints
STANDARD_DEVIATION 13.3 • n=5 Participants
|
14.9 joints
STANDARD_DEVIATION 11.6 • n=4 Participants
|
|
Number of Swollen Joints
|
9.1 joints
STANDARD_DEVIATION 4.7 • n=5 Participants
|
11.6 joints
STANDARD_DEVIATION 8.7 • n=7 Participants
|
17.2 joints
STANDARD_DEVIATION 10.0 • n=5 Participants
|
12.1 joints
STANDARD_DEVIATION 8.9 • n=4 Participants
|
|
Participant Pain Assessment
|
43.1 units on a scale
STANDARD_DEVIATION 23.5 • n=5 Participants
|
52.3 units on a scale
STANDARD_DEVIATION 24.9 • n=7 Participants
|
80.6 units on a scale
STANDARD_DEVIATION 20.1 • n=5 Participants
|
55.1 units on a scale
STANDARD_DEVIATION 26.0 • n=4 Participants
|
|
Physical Function (Health Assessment Questionnaire [HAQ])
|
0.98 units on a scale
STANDARD_DEVIATION 0.57 • n=5 Participants
|
1.16 units on a scale
STANDARD_DEVIATION 0.75 • n=7 Participants
|
1.80 units on a scale
STANDARD_DEVIATION 0.90 • n=5 Participants
|
1.22 units on a scale
STANDARD_DEVIATION 0.79 • n=4 Participants
|
|
Physician Global Assessment
|
56.5 Units on a scale
STANDARD_DEVIATION 24.7 • n=5 Participants
|
47.5 Units on a scale
STANDARD_DEVIATION 24.0 • n=7 Participants
|
75.5 Units on a scale
STANDARD_DEVIATION 16.5 • n=5 Participants
|
51.4 Units on a scale
STANDARD_DEVIATION 24.9 • n=4 Participants
|
|
Participant Global Assessment
|
47.1 units on a scale
STANDARD_DEVIATION 20.7 • n=5 Participants
|
50.8 units on a scale
STANDARD_DEVIATION 23.8 • n=7 Participants
|
77.3 units on a scale
STANDARD_DEVIATION 20.4 • n=5 Participants
|
53.7 units on a scale
STANDARD_DEVIATION 24.8 • n=4 Participants
|
|
C-Reactive Protein (CRP) Level
|
1.84 mg/dL
STANDARD_DEVIATION 2.84 • n=5 Participants
|
2.32 mg/dL
STANDARD_DEVIATION 2.18 • n=7 Participants
|
4.67 mg/dL
STANDARD_DEVIATION 3.65 • n=5 Participants
|
2.57 mg/dL
STANDARD_DEVIATION 2.55 • n=4 Participants
|
|
Morning stiffness
|
117.7 minutes
STANDARD_DEVIATION 201.3 • n=5 Participants
|
72.7 minutes
STANDARD_DEVIATION 124.9 • n=7 Participants
|
166.6 minutes
STANDARD_DEVIATION 195.7 • n=5 Participants
|
86.7 minutes
STANDARD_DEVIATION 143.0 • n=4 Participants
|
|
Rheumatoid Factor Status
Negative (<=20 IU/mL)
|
1 participants
n=5 Participants
|
24 participants
n=7 Participants
|
4 participants
n=5 Participants
|
29 participants
n=4 Participants
|
|
Rheumatoid Factor Status
Positive (>20 IU/mL)
|
12 participants
n=5 Participants
|
154 participants
n=7 Participants
|
22 participants
n=5 Participants
|
188 participants
n=4 Participants
|
|
Methotrexate Usage at Registration
|
7.11 mg/week
STANDARD_DEVIATION 1.45 • n=5 Participants
|
7.11 mg/week
STANDARD_DEVIATION 1.07 • n=7 Participants
|
NA mg/week
STANDARD_DEVIATION NA • n=5 Participants
|
7.11 mg/week
STANDARD_DEVIATION 1.09 • n=4 Participants
|
|
Oral Corticosteroids Usage at Registration
|
6.15 mg/day
STANDARD_DEVIATION 2.37 • n=5 Participants
|
5.67 mg/day
STANDARD_DEVIATION 2.38 • n=7 Participants
|
6.78 mg/day
STANDARD_DEVIATION 2.48 • n=5 Participants
|
5.85 mg/day
STANDARD_DEVIATION 2.41 • n=4 Participants
|
PRIMARY outcome
Timeframe: From initiation of the study drug (31 Mar 2008) to data cutoff (27 Dec 2010). The overall mean duration of exposure to the study drug was approximately 3 years (34.3 ± 10.7 months).Population: All treated participants who received at least 1 dose of the study drug.
AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. SAE is 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 cancer, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event. Both subjective and objective AEs and SAEs are included.
Outcome measures
| Measure |
Participants From Phase I Study (IM101-034); Abatacept 10mg/kg
n=13 Participants
Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
|
Participants From Phase II Study(IM101-071); Abatacept 10mg/kg
n=178 Participants
Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
|
New Participants With MTX Intolerance; Abatacept 10 mg/kg
n=26 Participants
Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs \[excluding MTX\]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
|
|---|---|---|---|
|
Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE), and Discontinuations Due to AEs
SAEs
|
4 participants
|
50 participants
|
14 participants
|
|
Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE), and Discontinuations Due to AEs
Drug-related SAEs
|
2 participants
|
26 participants
|
9 participants
|
|
Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE), and Discontinuations Due to AEs
AEs
|
13 participants
|
176 participants
|
24 participants
|
|
Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE), and Discontinuations Due to AEs
Drug-related AEs
|
13 participants
|
165 participants
|
24 participants
|
|
Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE), and Discontinuations Due to AEs
Discontinuation due to SAEs
|
0 participants
|
14 participants
|
5 participants
|
|
Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE), and Discontinuations Due to AEs
Discontinuation due to AEs
|
1 participants
|
18 participants
|
5 participants
|
|
Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE), and Discontinuations Due to AEs
Deaths
|
0 participants
|
1 participants
|
0 participants
|
PRIMARY outcome
Timeframe: From initiation of the study drug (31 Mar 2008) to data cutoff (27 Dec 2010). The overall mean duration of exposure to the study drug was approximately 3 years (34.3 ± 10.7 months).Population: All treated participants who received at least 1 dose of the study drug.
The laboratory tests were analyses included enzyme, gastrointestinal, hematology, hepatobiliary, lipid, metabolic, nutritional, blood gas, microbiology, serology, protein, chemistry, renal, urinary tract, urinalyses, water, electrolyte and mineral investigations.
Outcome measures
| Measure |
Participants From Phase I Study (IM101-034); Abatacept 10mg/kg
n=13 Participants
Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
|
Participants From Phase II Study(IM101-071); Abatacept 10mg/kg
n=178 Participants
Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
|
New Participants With MTX Intolerance; Abatacept 10 mg/kg
n=26 Participants
Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs \[excluding MTX\]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
|
|---|---|---|---|
|
Number of Participants With Abnormal Laboratory Changes (ALC)
Participants with Serious ALC
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Abnormal Laboratory Changes (ALC)
Discontinuations due Serious ALC
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Abnormal Laboratory Changes (ALC)
Participants with drug related Serious ALC
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Abnormal Laboratory Changes (ALC)
Participants with ALC
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Abnormal Laboratory Changes (ALC)
Discontinuations due ALC
|
6 participants
|
102 participants
|
13 participants
|
PRIMARY outcome
Timeframe: At week 0, 2, 4; then once every 4 weeks up to 48 months; then once in every 3 months or 12 weeks to end of study (27 Dec 2010). The overall mean duration of exposure to the study drug was approximately 3 years (34.3 ± 10.7 months).Population: All treated participants who received at least 1 dose of the study drug.
Outcome measures
| Measure |
Participants From Phase I Study (IM101-034); Abatacept 10mg/kg
n=13 Participants
Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
|
Participants From Phase II Study(IM101-071); Abatacept 10mg/kg
n=178 Participants
Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
|
New Participants With MTX Intolerance; Abatacept 10 mg/kg
n=26 Participants
Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs \[excluding MTX\]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
|
|---|---|---|---|
|
Number of Participants With Vital Signs, Physical Examinations, and Electrocardiogram Findings That Were Considered to be AEs by the Investigator
Blood pressure increased
|
2 participants
|
27 participants
|
12 participants
|
|
Number of Participants With Vital Signs, Physical Examinations, and Electrocardiogram Findings That Were Considered to be AEs by the Investigator
Blood pressure decreased
|
1 participants
|
11 participants
|
1 participants
|
|
Number of Participants With Vital Signs, Physical Examinations, and Electrocardiogram Findings That Were Considered to be AEs by the Investigator
Blood pressure diastolic decreased
|
0 participants
|
7 participants
|
0 participants
|
|
Number of Participants With Vital Signs, Physical Examinations, and Electrocardiogram Findings That Were Considered to be AEs by the Investigator
Blood pressure systolic increased
|
0 participants
|
3 participants
|
2 participants
|
|
Number of Participants With Vital Signs, Physical Examinations, and Electrocardiogram Findings That Were Considered to be AEs by the Investigator
Weight decreased
|
0 participants
|
5 participants
|
0 participants
|
|
Number of Participants With Vital Signs, Physical Examinations, and Electrocardiogram Findings That Were Considered to be AEs by the Investigator
Weight increased
|
0 participants
|
3 participants
|
1 participants
|
|
Number of Participants With Vital Signs, Physical Examinations, and Electrocardiogram Findings That Were Considered to be AEs by the Investigator
Body temperature decreased
|
0 participants
|
3 participants
|
0 participants
|
|
Number of Participants With Vital Signs, Physical Examinations, and Electrocardiogram Findings That Were Considered to be AEs by the Investigator
Body temperature increased
|
0 participants
|
2 participants
|
0 participants
|
|
Number of Participants With Vital Signs, Physical Examinations, and Electrocardiogram Findings That Were Considered to be AEs by the Investigator
Blood pressure systolic decreased
|
1 participants
|
1 participants
|
1 participants
|
|
Number of Participants With Vital Signs, Physical Examinations, and Electrocardiogram Findings That Were Considered to be AEs by the Investigator
Blood pressure diastolic increased
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Vital Signs, Physical Examinations, and Electrocardiogram Findings That Were Considered to be AEs by the Investigator
Electrocardiogram abnormal
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Vital Signs, Physical Examinations, and Electrocardiogram Findings That Were Considered to be AEs by the Investigator
Electrocardiogram ST segment depression
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Vital Signs, Physical Examinations, and Electrocardiogram Findings That Were Considered to be AEs by the Investigator
Electrocardiogram ST-T segment abnormal
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Vital Signs, Physical Examinations, and Electrocardiogram Findings That Were Considered to be AEs by the Investigator
Heart rate increased
|
0 participants
|
2 participants
|
0 participants
|
|
Number of Participants With Vital Signs, Physical Examinations, and Electrocardiogram Findings That Were Considered to be AEs by the Investigator
Heart rate decreased
|
0 participants
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: At weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192.Population: All treated participants who received at least 1 dose of the study drug. n = number of participants assessed at given time point.
ACR 20 response requires a participant to have a 20% reduction in the number of swollen and tender joints, and a reduction of 20% in three of the following five parameters: physician global assessment of disease activity, participant global assessment of disease activity, participant global assessment of pain, C-reactive protein, and degree of disability in Health Assessment Questionnaire score.
Outcome measures
| Measure |
Participants From Phase I Study (IM101-034); Abatacept 10mg/kg
n=13 Participants
Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
|
Participants From Phase II Study(IM101-071); Abatacept 10mg/kg
n=178 Participants
Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
|
New Participants With MTX Intolerance; Abatacept 10 mg/kg
n=26 Participants
Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs \[excluding MTX\]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
|
|---|---|---|---|
|
Percentage of Participants With American College of Rheumatology (ACR 20) Response Over Time
Week 4; (n=13, 178,26)
|
30.8 percentage of participants
Interval 9.1 to 61.4
|
29.2 percentage of participants
Interval 22.7 to 36.5
|
34.6 percentage of participants
Interval 17.2 to 55.7
|
|
Percentage of Participants With American College of Rheumatology (ACR 20) Response Over Time
Week 12; (n=13, 178,24)
|
76.9 percentage of participants
Interval 46.2 to 95.0
|
47.2 percentage of participants
Interval 39.7 to 54.8
|
58.3 percentage of participants
Interval 36.6 to 77.9
|
|
Percentage of Participants With American College of Rheumatology (ACR 20) Response Over Time
Week 24; (n=13, 176, 23)
|
76.9 percentage of participants
Interval 46.2 to 95.0
|
59.7 percentage of participants
Interval 52.0 to 67.0
|
78.3 percentage of participants
Interval 56.3 to 92.5
|
|
Percentage of Participants With American College of Rheumatology (ACR 20) Response Over Time
Week 36; (n=13, 175, 20)
|
69.2 percentage of participants
Interval 38.6 to 90.9
|
61.7 percentage of participants
Interval 54.1 to 68.9
|
90.0 percentage of participants
Interval 68.3 to 98.8
|
|
Percentage of Participants With American College of Rheumatology (ACR 20) Response Over Time
Week 48; (n=13, 170, 18)
|
61.5 percentage of participants
Interval 31.6 to 86.1
|
63.5 percentage of participants
Interval 55.8 to 70.8
|
88.9 percentage of participants
Interval 65.3 to 98.6
|
|
Percentage of Participants With American College of Rheumatology (ACR 20) Response Over Time
Week 60; (n=13, 165, 17)
|
69.2 percentage of participants
Interval 38.6 to 90.9
|
69.7 percentage of participants
Interval 62.1 to 76.6
|
94.1 percentage of participants
Interval 71.3 to 99.9
|
|
Percentage of Participants With American College of Rheumatology (ACR 20) Response Over Time
Week 72; (n=13, 161, 17)
|
84.6 percentage of participants
Interval 54.6 to 98.1
|
67.7 percentage of participants
Interval 59.9 to 74.8
|
94.1 percentage of participants
Interval 71.3 to 99.9
|
|
Percentage of Participants With American College of Rheumatology (ACR 20) Response Over Time
Week 84; (n=13, 161, 17)
|
61.5 percentage of participants
Interval 31.6 to 86.1
|
67.1 percentage of participants
Interval 59.2 to 74.3
|
100.0 percentage of participants
Interval 80.5 to 100.0
|
|
Percentage of Participants With American College of Rheumatology (ACR 20) Response Over Time
Week 96; (n=13, 160, 17)
|
69.2 percentage of participants
Interval 38.6 to 90.9
|
63.8 percentage of participants
Interval 55.8 to 71.2
|
82.4 percentage of participants
Interval 56.6 to 96.2
|
|
Percentage of Participants With American College of Rheumatology (ACR 20) Response Over Time
Week 108; (n=13, 156, 15)
|
53.8 percentage of participants
Interval 25.1 to 80.8
|
67.9 percentage of participants
Interval 60.0 to 75.2
|
100.0 percentage of participants
Interval 78.2 to 100.0
|
|
Percentage of Participants With American College of Rheumatology (ACR 20) Response Over Time
Week 120; (n=13, 154, 15)
|
69.2 percentage of participants
Interval 38.6 to 90.9
|
69.5 percentage of participants
Interval 61.6 to 76.6
|
100.0 percentage of participants
Interval 78.2 to 100.0
|
|
Percentage of Participants With American College of Rheumatology (ACR 20) Response Over Time
Week 132; (n=13, 151, 14)
|
61.5 percentage of participants
Interval 31.6 to 86.1
|
68.9 percentage of participants
Interval 60.8 to 76.2
|
100.0 percentage of participants
Interval 76.8 to 100.0
|
|
Percentage of Participants With American College of Rheumatology (ACR 20) Response Over Time
Week 144; (n=12, 142, 13)
|
58.3 percentage of participants
Interval 27.7 to 84.8
|
69.7 percentage of participants
Interval 61.5 to 77.1
|
84.6 percentage of participants
Interval 54.6 to 98.1
|
|
Percentage of Participants With American College of Rheumatology (ACR 20) Response Over Time
Week 156; (n=11, 113, 12)
|
63.6 percentage of participants
Interval 30.8 to 89.1
|
66.4 percentage of participants
Interval 56.9 to 75.0
|
100.0 percentage of participants
Interval 73.5 to 100.0
|
|
Percentage of Participants With American College of Rheumatology (ACR 20) Response Over Time
Week 180; (n=8, 56, 4)
|
62.5 percentage of participants
Interval 24.5 to 91.5
|
69.6 percentage of participants
Interval 55.9 to 81.2
|
100.0 percentage of participants
Interval 39.8 to 100.0
|
|
Percentage of Participants With American College of Rheumatology (ACR 20) Response Over Time
Week 192; (n=3, 7, 1)
|
66.7 percentage of participants
Interval 9.4 to 99.2
|
85.7 percentage of participants
Interval 42.1 to 99.6
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
|
Percentage of Participants With American College of Rheumatology (ACR 20) Response Over Time
Week 168; (n=10, 80, 8)
|
80.0 percentage of participants
Interval 44.4 to 97.5
|
71.3 percentage of participants
Interval 60.0 to 80.8
|
100.0 percentage of participants
Interval 63.1 to 100.0
|
SECONDARY outcome
Timeframe: At weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192.Population: All treated participants who received at least 1 dose of the study drug. n = Number of participants assessed at given time point.
ACR 50 response requires a participant to have a 50% reduction in the number of swollen and tender joints, and a reduction of 50% in three of the following five parameters: physician global assessment of disease activity, participant global assessment of disease activity, participant global assessment of pain, C-reactive protein, and degree of disability in Health Assessment Questionnaire score.
Outcome measures
| Measure |
Participants From Phase I Study (IM101-034); Abatacept 10mg/kg
n=13 Participants
Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
|
Participants From Phase II Study(IM101-071); Abatacept 10mg/kg
n=178 Participants
Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
|
New Participants With MTX Intolerance; Abatacept 10 mg/kg
n=26 Participants
Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs \[excluding MTX\]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
|
|---|---|---|---|
|
Percentage of Participants With ACR 50 Response Over Time
Week 24; (n=13, 176, 23)
|
30.8 percentage of participants
Interval 9.1 to 61.4
|
25.6 percentage of participants
Interval 19.3 to 32.7
|
47.8 percentage of participants
Interval 26.8 to 69.4
|
|
Percentage of Participants With ACR 50 Response Over Time
Week 36; (n=13, 175, 20)
|
38.5 percentage of participants
Interval 13.9 to 68.4
|
28.6 percentage of participants
Interval 22.0 to 35.9
|
50.0 percentage of participants
Interval 27.2 to 72.8
|
|
Percentage of Participants With ACR 50 Response Over Time
Week 48; (n=13, 170, 18)
|
15.4 percentage of participants
Interval 1.9 to 45.4
|
38.8 percentage of participants
Interval 31.5 to 46.6
|
72.2 percentage of participants
Interval 46.5 to 90.3
|
|
Percentage of Participants With ACR 50 Response Over Time
Week 60; (n=13, 165, 17)
|
30.8 percentage of participants
Interval 9.1 to 61.4
|
42.4 percentage of participants
Interval 34.8 to 50.3
|
58.8 percentage of participants
Interval 32.9 to 81.6
|
|
Percentage of Participants With ACR 50 Response Over Time
Week 72; (n=13, 161, 17)
|
46.2 percentage of participants
Interval 19.2 to 74.9
|
43.5 percentage of participants
Interval 35.7 to 51.5
|
70.6 percentage of participants
Interval 44.0 to 89.7
|
|
Percentage of Participants With ACR 50 Response Over Time
Week 84; (n=13, 161, 17)
|
38.5 percentage of participants
Interval 13.9 to 68.4
|
42.2 percentage of participants
Interval 34.5 to 50.3
|
70.6 percentage of participants
Interval 44.0 to 89.7
|
|
Percentage of Participants With ACR 50 Response Over Time
Week 96; (n=13, 160, 17)
|
23.1 percentage of participants
Interval 5.0 to 53.8
|
38.1 percentage of participants
Interval 30.6 to 46.1
|
58.8 percentage of participants
Interval 32.9 to 81.6
|
|
Percentage of Participants With ACR 50 Response Over Time
Week 108; (n=13, 156, 15)
|
23.1 percentage of participants
Interval 5.0 to 53.8
|
42.3 percentage of participants
Interval 34.4 to 50.5
|
66.7 percentage of participants
Interval 38.4 to 88.2
|
|
Percentage of Participants With ACR 50 Response Over Time
Week 120; (n=13, 154, 15)
|
46.2 percentage of participants
Interval 19.2 to 74.9
|
45.5 percentage of participants
Interval 37.4 to 53.7
|
93.3 percentage of participants
Interval 68.1 to 99.8
|
|
Percentage of Participants With ACR 50 Response Over Time
Week 132; (n=13, 151, 14)
|
38.5 percentage of participants
Interval 13.9 to 68.4
|
43.7 percentage of participants
Interval 35.7 to 52.0
|
85.7 percentage of participants
Interval 57.2 to 98.2
|
|
Percentage of Participants With ACR 50 Response Over Time
Week 144; (n=12, 142, 13)
|
25.0 percentage of participants
Interval 5.5 to 57.2
|
47.2 percentage of participants
Interval 38.8 to 55.7
|
69.2 percentage of participants
Interval 38.6 to 90.9
|
|
Percentage of Participants With ACR 50 Response Over Time
Week 156; (n=11, 113, 12)
|
36.4 percentage of participants
Interval 10.9 to 69.2
|
47.8 percentage of participants
Interval 38.3 to 57.4
|
83.3 percentage of participants
Interval 51.6 to 97.9
|
|
Percentage of Participants With ACR 50 Response Over Time
Week 168; (n=10, 80, 8)
|
30.0 percentage of participants
Interval 6.7 to 65.2
|
47.5 percentage of participants
Interval 36.2 to 59.0
|
87.5 percentage of participants
Interval 47.3 to 99.7
|
|
Percentage of Participants With ACR 50 Response Over Time
Week 180; (n=8, 56, 4)
|
12.5 percentage of participants
Interval 0.3 to 52.7
|
51.8 percentage of participants
Interval 38.0 to 65.3
|
75.0 percentage of participants
Interval 19.4 to 99.4
|
|
Percentage of Participants With ACR 50 Response Over Time
Week 192; (n=3, 7, 1)
|
66.7 percentage of participants
Interval 9.4 to 99.2
|
71.4 percentage of participants
Interval 29.0 to 96.3
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
|
Percentage of Participants With ACR 50 Response Over Time
Week 4; (n=13, 178, 26)
|
15.4 percentage of participants
Interval 1.9 to 45.4
|
6.2 percentage of participants
Interval 3.1 to 10.8
|
0 percentage of participants
Interval 0.0 to 13.2
|
|
Percentage of Participants With ACR 50 Response Over Time
Week 12; (n=13, 178,24)
|
38.5 percentage of participants
Interval 13.9 to 68.4
|
16.3 percentage of participants
Interval 11.2 to 22.6
|
29.2 percentage of participants
Interval 12.6 to 51.1
|
SECONDARY outcome
Timeframe: At weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192.Population: All treated participants who received at least 1 dose of the study drug. n = Number of participants assessed at given time point.
ACR 70 response requires a participant to have a 70% reduction in the number of swollen and tender joints, and a reduction of 70% in three of the following five parameters: physician global assessment of disease activity, participant global assessment of disease activity, participant global assessment of pain, C-reactive protein, and degree of disability in Health Assessment Questionnaire score.
Outcome measures
| Measure |
Participants From Phase I Study (IM101-034); Abatacept 10mg/kg
n=13 Participants
Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
|
Participants From Phase II Study(IM101-071); Abatacept 10mg/kg
n=178 Participants
Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
|
New Participants With MTX Intolerance; Abatacept 10 mg/kg
n=26 Participants
Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs \[excluding MTX\]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
|
|---|---|---|---|
|
Percentage of Participants With ACR 70 Response Over Time
Week 4; (n=13, 178, 26)
|
7.7 percentage of participants
Interval 0.2 to 36.0
|
0 percentage of participants
Interval 0.0 to 2.1
|
0 percentage of participants
Interval 0.0 to 13.2
|
|
Percentage of Participants With ACR 70 Response Over Time
Week 12; (n=13, 178, 24)
|
7.7 percentage of participants
Interval 0.2 to 36.0
|
5.6 percentage of participants
Interval 2.7 to 10.1
|
8.3 percentage of participants
Interval 1.0 to 27.0
|
|
Percentage of Participants With ACR 70 Response Over Time
Week 24; (n=13, 176, 23)
|
7.7 percentage of participants
Interval 0.2 to 36.0
|
10.8 percentage of participants
Interval 6.6 to 16.3
|
21.7 percentage of participants
Interval 7.5 to 43.7
|
|
Percentage of Participants With ACR 70 Response Over Time
Week 36; (n=13, 175, 20)
|
15.4 percentage of participants
Interval 1.9 to 45.4
|
11.4 percentage of participants
Interval 7.1 to 17.1
|
20.0 percentage of participants
Interval 5.7 to 43.7
|
|
Percentage of Participants With ACR 70 Response Over Time
Week 48; (n=13, 170, 18)
|
15.4 percentage of participants
Interval 1.9 to 45.4
|
15.3 percentage of participants
Interval 10.2 to 21.6
|
27.8 percentage of participants
Interval 9.7 to 53.5
|
|
Percentage of Participants With ACR 70 Response Over Time
Week 60; (n=13, 165, 17)
|
15.4 percentage of participants
Interval 1.9 to 45.4
|
19.4 percentage of participants
Interval 13.7 to 26.3
|
29.4 percentage of participants
Interval 10.3 to 56.0
|
|
Percentage of Participants With ACR 70 Response Over Time
Week 72; (n=13, 161, 17)
|
15.4 percentage of participants
Interval 1.9 to 45.4
|
18.6 percentage of participants
Interval 12.9 to 25.5
|
23.5 percentage of participants
Interval 6.8 to 49.9
|
|
Percentage of Participants With ACR 70 Response Over Time
Week 96; (n=13, 160, 17)
|
7.7 percentage of participants
Interval 0.2 to 36.0
|
19.4 percentage of participants
Interval 13.6 to 26.4
|
23.5 percentage of participants
Interval 6.8 to 49.9
|
|
Percentage of Participants With ACR 70 Response Over Time
Week 144; (n=12, 142, 13)
|
0 percentage of participants
Interval 0.0 to 26.5
|
21.8 percentage of participants
Interval 15.3 to 29.5
|
23.1 percentage of participants
Interval 5.0 to 53.8
|
|
Percentage of Participants With ACR 70 Response Over Time
Week 156; (n=11, 113, 12)
|
0 percentage of participants
Interval 0.0 to 28.5
|
25.7 percentage of participants
Interval 17.9 to 34.7
|
33.3 percentage of participants
Interval 9.9 to 65.1
|
|
Percentage of Participants With ACR 70 Response Over Time
Week 168; (n=10, 80, 8)
|
0 percentage of participants
Interval 0.0 to 30.8
|
27.5 percentage of participants
Interval 18.1 to 38.6
|
62.5 percentage of participants
Interval 24.5 to 91.5
|
|
Percentage of Participants With ACR 70 Response Over Time
Week 84; (n=13, 161, 17)
|
7.7 percentage of participants
Interval 0.2 to 36.0
|
17.4 percentage of participants
Interval 11.9 to 24.1
|
23.5 percentage of participants
Interval 6.8 to 49.9
|
|
Percentage of Participants With ACR 70 Response Over Time
Week 108; (n=13, 156, 15)
|
7.7 percentage of participants
Interval 0.2 to 36.0
|
15.4 percentage of participants
Interval 10.1 to 22.0
|
33.3 percentage of participants
Interval 11.8 to 61.6
|
|
Percentage of Participants With ACR 70 Response Over Time
Week 120; (n=13, 154, 15)
|
7.7 percentage of participants
Interval 0.2 to 36.0
|
19.5 percentage of participants
Interval 13.5 to 26.6
|
46.7 percentage of participants
Interval 21.3 to 73.4
|
|
Percentage of Participants With ACR 70 Response Over Time
Week 132; (n=13, 151, 14)
|
0 percentage of participants
Interval 0.0 to 24.7
|
20.5 percentage of participants
Interval 14.4 to 27.9
|
42.9 percentage of participants
Interval 17.7 to 71.1
|
|
Percentage of Participants With ACR 70 Response Over Time
Week 180; (n=8, 56, 4)
|
0 percentage of participants
Interval 0.0 to 36.9
|
33.9 percentage of participants
Interval 21.8 to 47.8
|
50.0 percentage of participants
Interval 6.8 to 93.2
|
|
Percentage of Participants With ACR 70 Response Over Time
Week 192; (n=3, 7, 1)
|
0 percentage of participants
Interval 0.0 to 70.8
|
14.3 percentage of participants
Interval 0.4 to 57.9
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
SECONDARY outcome
Timeframe: At BL (week 0), week 24, 48, 96, 144, and 192.Population: All treated participants who received at least 1 dose of the study drug. n = participants with both BL and PBL measurement at a given time point.
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, CRP levels, and participant assessment of disease activity measure on a visual analogue scale of 100 mm. The DAS28 has numeric thresholds that define high disease activity (change of \> 5.1), low disease activity (change of ≤ 3.2) and remission (\< 2.6). Please see outcome 8 for change from BL data.
Outcome measures
| Measure |
Participants From Phase I Study (IM101-034); Abatacept 10mg/kg
n=13 Participants
Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
|
Participants From Phase II Study(IM101-071); Abatacept 10mg/kg
n=178 Participants
Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
|
New Participants With MTX Intolerance; Abatacept 10 mg/kg
n=26 Participants
Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs \[excluding MTX\]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
|
|---|---|---|---|
|
Baseline (BL) and Postbaseline (PBL) Disease Activity Scores (DAS 28)
Week 24- BL (n=13, 176, 21)
|
4.4 Units on a Scale
Standard Deviation 1.0
|
4.8 Units on a Scale
Standard Deviation 1.4
|
6.3 Units on a Scale
Standard Deviation 1.0
|
|
Baseline (BL) and Postbaseline (PBL) Disease Activity Scores (DAS 28)
Week 24- PBL (n=13, 176, 21)
|
3.0 Units on a Scale
Standard Deviation 1.1
|
3.2 Units on a Scale
Standard Deviation 1.1
|
4.0 Units on a Scale
Standard Deviation 1.9
|
|
Baseline (BL) and Postbaseline (PBL) Disease Activity Scores (DAS 28)
Week 96- PBL (n=13, 159, 17)
|
3.3 Units on a Scale
Standard Deviation 1.0
|
2.8 Units on a Scale
Standard Deviation 1.0
|
3.2 Units on a Scale
Standard Deviation 1.0
|
|
Baseline (BL) and Postbaseline (PBL) Disease Activity Scores (DAS 28)
Week 144- BL (n=12, 142, 13)
|
4.3 Units on a Scale
Standard Deviation 0.9
|
4.9 Units on a Scale
Standard Deviation 1.4
|
6.3 Units on a Scale
Standard Deviation 1.0
|
|
Baseline (BL) and Postbaseline (PBL) Disease Activity Scores (DAS 28)
Week 144- PBL (n=12, 142, 13)
|
3.0 Units on a Scale
Standard Deviation 0.9
|
2.8 Units on a Scale
Standard Deviation 1.0
|
3.2 Units on a Scale
Standard Deviation 1.2
|
|
Baseline (BL) and Postbaseline (PBL) Disease Activity Scores (DAS 28)
Week 192- BL (n=3, 7, 1)
|
4.6 Units on a Scale
Standard Deviation 1.6
|
5.4 Units on a Scale
Standard Deviation 0.9
|
7.9 Units on a Scale
Standard Deviation NA
Not applicable as there was only 1 participant in the group with both BL and PBL values.
|
|
Baseline (BL) and Postbaseline (PBL) Disease Activity Scores (DAS 28)
Week 192- PBL (n=3, 7, 1)
|
2.6 Units on a Scale
Standard Deviation 1.2
|
3.1 Units on a Scale
Standard Deviation 1.4
|
1.9 Units on a Scale
Standard Deviation NA
Not applicable as there was only 1 participant in the group with both BL and PBL values.
|
|
Baseline (BL) and Postbaseline (PBL) Disease Activity Scores (DAS 28)
Week 48- BL (n=13, 168, 18)
|
4.4 Units on a Scale
Standard Deviation 1.0
|
4.8 Units on a Scale
Standard Deviation 1.4
|
6.3 Units on a Scale
Standard Deviation 1.0
|
|
Baseline (BL) and Postbaseline (PBL) Disease Activity Scores (DAS 28)
Week 48- PBL (n=13, 168, 18)
|
3.0 Units on a Scale
Standard Deviation 1.1
|
2.9 Units on a Scale
Standard Deviation 1.1
|
3.5 Units on a Scale
Standard Deviation 1.4
|
|
Baseline (BL) and Postbaseline (PBL) Disease Activity Scores (DAS 28)
Week 96- BL (n=13, 159, 17)
|
4.4 Units on a Scale
Standard Deviation 1.0
|
4.8 Units on a Scale
Standard Deviation 1.4
|
6.2 Units on a Scale
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: At BL (week 0), weeks 24, 48, 96, 144, and 192.Population: All treated participants who received at least 1 dose of the study drug. n = participants with both BL and PBL measurement at a given time point.
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, CRP levels, and participant assessment of disease activity measure on a visual analogue scale of 100 mm. The DAS28 has numeric thresholds that define high disease activity (\> 5.1), low disease activity (≤ 3.2) and remission (\< 2.6). Please refer to outcome 7 for BL and PBL values.
Outcome measures
| Measure |
Participants From Phase I Study (IM101-034); Abatacept 10mg/kg
n=13 Participants
Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
|
Participants From Phase II Study(IM101-071); Abatacept 10mg/kg
n=178 Participants
Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
|
New Participants With MTX Intolerance; Abatacept 10 mg/kg
n=26 Participants
Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs \[excluding MTX\]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
|
|---|---|---|---|
|
Change From Baseline in DAS 28 Scores at Week 24, 48, 96, 144, and 192
Week 24 (n=13, 176, 21)
|
-1.4 Units on a Scale
Interval -2.0 to -0.8
|
-1.7 Units on a Scale
Interval -1.8 to -1.5
|
-2.3 Units on a Scale
Interval -2.9 to -1.7
|
|
Change From Baseline in DAS 28 Scores at Week 24, 48, 96, 144, and 192
Week 48 (n=13, 168, 18)
|
-1.4 Units on a Scale
Interval -2.0 to -0.9
|
-1.9 Units on a Scale
Interval -2.1 to -1.7
|
-2.8 Units on a Scale
Interval -3.3 to -2.3
|
|
Change From Baseline in DAS 28 Scores at Week 24, 48, 96, 144, and 192
Week 96 (n=13, 159, 17)
|
-1.1 Units on a Scale
Interval -1.7 to -0.6
|
-2.0 Units on a Scale
Interval -2.3 to -1.8
|
-3.0 Units on a Scale
Interval -3.6 to -2.4
|
|
Change From Baseline in DAS 28 Scores at Week 24, 48, 96, 144, and 192
Week 144 (n=12, 142, 13)
|
-1.3 Units on a Scale
Interval -1.8 to -0.8
|
-2.1 Units on a Scale
Interval -2.3 to -1.9
|
-3.1 Units on a Scale
Interval -4.0 to -2.2
|
|
Change From Baseline in DAS 28 Scores at Week 24, 48, 96, 144, and 192
Week 192 (n=3, 7, 1)
|
-2.0 Units on a Scale
Interval -3.4 to -0.6
|
-2.3 Units on a Scale
Interval -3.6 to -1.1
|
-6.0 Units on a Scale
Not applicable as there was only 1 participant in the group with both BL and PBL values.
|
SECONDARY outcome
Timeframe: At BL (week 0), weeks 24, 48, 96, 144, and 192.Population: All treated participants who received at least 1 dose of the study drug. n = participants with both BL and PBL measurement at a given time point.
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, CRP levels, and participant assessment of disease activity measure on a visual analogue scale. Participants with DAS 28 score change ≥ 1.2 from BL were considered to have improvement.
Outcome measures
| Measure |
Participants From Phase I Study (IM101-034); Abatacept 10mg/kg
n=13 Participants
Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
|
Participants From Phase II Study(IM101-071); Abatacept 10mg/kg
n=178 Participants
Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
|
New Participants With MTX Intolerance; Abatacept 10 mg/kg
n=26 Participants
Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs \[excluding MTX\]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
|
|---|---|---|---|
|
Number of Participants With DAS 28 Score Change ≥ 1.2 From Baseline at Weeks 24, 48, 96, 144, and 192
Week 24 (n=13, 176, 21)
|
9 participants
|
113 participants
|
17 participants
|
|
Number of Participants With DAS 28 Score Change ≥ 1.2 From Baseline at Weeks 24, 48, 96, 144, and 192
Week 48 (n=13, 168, 18)
|
8 participants
|
114 participants
|
16 participants
|
|
Number of Participants With DAS 28 Score Change ≥ 1.2 From Baseline at Weeks 24, 48, 96, 144, and 192
Week 96 (n=13, 159, 17)
|
7 participants
|
111 participants
|
16 participants
|
|
Number of Participants With DAS 28 Score Change ≥ 1.2 From Baseline at Weeks 24, 48, 96, 144, and 192
Week 144 (n=12, 142, 13)
|
6 participants
|
107 participants
|
12 participants
|
|
Number of Participants With DAS 28 Score Change ≥ 1.2 From Baseline at Weeks 24, 48, 96, 144, and 192
Week 192 (n=3, 7, 1)
|
3 participants
|
5 participants
|
1 participants
|
SECONDARY outcome
Timeframe: At weeks 24, 48, 96, 144, and 192.Population: All treated participants who received at least 1 dose of the study drug. n = participants with available scores at the given time point.
The DAS28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, CRP levels, and participant assessment of disease activity measure on a visual analogue scale. Participants with DAS 28 score ≤ 3.2 were considered to have low disease activity.
Outcome measures
| Measure |
Participants From Phase I Study (IM101-034); Abatacept 10mg/kg
n=13 Participants
Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
|
Participants From Phase II Study(IM101-071); Abatacept 10mg/kg
n=178 Participants
Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
|
New Participants With MTX Intolerance; Abatacept 10 mg/kg
n=26 Participants
Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs \[excluding MTX\]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
|
|---|---|---|---|
|
Number of Participants With Low Disease Activity Score (DAS 28 Score ≤ 3.2) at Weeks 24, 48, 96, 144, 192
Week 24 (n=13, 176, 21)
|
9 participants
|
95 participants
|
6 participants
|
|
Number of Participants With Low Disease Activity Score (DAS 28 Score ≤ 3.2) at Weeks 24, 48, 96, 144, 192
Week 48 (n=13, 168, 18)
|
9 participants
|
105 participants
|
7 participants
|
|
Number of Participants With Low Disease Activity Score (DAS 28 Score ≤ 3.2) at Weeks 24, 48, 96, 144, 192
Week 96 (n=13, 159, 17)
|
6 participants
|
101 participants
|
6 participants
|
|
Number of Participants With Low Disease Activity Score (DAS 28 Score ≤ 3.2) at Weeks 24, 48, 96, 144, 192
Week 144 (n=12, 142, 13)
|
6 participants
|
95 participants
|
7 participants
|
|
Number of Participants With Low Disease Activity Score (DAS 28 Score ≤ 3.2) at Weeks 24, 48, 96, 144, 192
Week 192 (n=3, 7, 1)
|
2 participants
|
3 participants
|
1 participants
|
SECONDARY outcome
Timeframe: At weeks 24, 48, 96, 144, and 192.Population: All treated participants who received at least 1 dose of the study drug. n = participants with available scores at the given time point.
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, CRP levels, and participant assessment of disease activity measure on a visual analogue scale. Participants with DAS 28 score \< 2.6 were considered to be in remission.
Outcome measures
| Measure |
Participants From Phase I Study (IM101-034); Abatacept 10mg/kg
n=13 Participants
Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
|
Participants From Phase II Study(IM101-071); Abatacept 10mg/kg
n=178 Participants
Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
|
New Participants With MTX Intolerance; Abatacept 10 mg/kg
n=26 Participants
Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs \[excluding MTX\]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
|
|---|---|---|---|
|
Number of Participants in Remission (DAS 28 Score < 2.6) at Weeks 24, 48, 96, 144, 192
Week 24 (n=13, 176, 21)
|
6 participants
|
60 participants
|
6 participants
|
|
Number of Participants in Remission (DAS 28 Score < 2.6) at Weeks 24, 48, 96, 144, 192
Week 48 (n=13, 168, 18)
|
4 participants
|
75 participants
|
5 participants
|
|
Number of Participants in Remission (DAS 28 Score < 2.6) at Weeks 24, 48, 96, 144, 192
Week 96 (n=13, 159, 17)
|
3 participants
|
75 participants
|
5 participants
|
|
Number of Participants in Remission (DAS 28 Score < 2.6) at Weeks 24, 48, 96, 144, 192
Week 144 (n=12, 142, 13)
|
4 participants
|
71 participants
|
3 participants
|
|
Number of Participants in Remission (DAS 28 Score < 2.6) at Weeks 24, 48, 96, 144, 192
Week 192 (n=3, 7, 1)
|
2 participants
|
2 participants
|
1 participants
|
SECONDARY outcome
Timeframe: At BL (week 0), weeks 24, 48, 96, 144, and 192.Population: All treated participants who received at least 1 dose of the study drug. n = participants with both BL and PBL measurement at a given time point.
The disability section of the full HAQ includes 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. The 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. Higher scores= greater dysfunction. A disability index was calculated by summing the worst scores in each domain and dividing by the number of domains answered. Clinically meaningful HAQ response=an improvement of at least 0.3 units from BL in HAQ.
Outcome measures
| Measure |
Participants From Phase I Study (IM101-034); Abatacept 10mg/kg
n=13 Participants
Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
|
Participants From Phase II Study(IM101-071); Abatacept 10mg/kg
n=178 Participants
Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
|
New Participants With MTX Intolerance; Abatacept 10 mg/kg
n=26 Participants
Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs \[excluding MTX\]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
|
|---|---|---|---|
|
Percentage of Participants Who Achieved a Reduction of At Least 0.3 Units From Baseline in Health Assessment Questionnaire (HAQ) at Weeks 24, 48, 96, 144, 192
Week 24 (n=13, 176, 23)
|
38.5 percentage of participants
Interval 13.9 to 68.4
|
39.2 percentage of participants
Interval 31.9 to 46.8
|
52.2 percentage of participants
Interval 30.6 to 73.2
|
|
Percentage of Participants Who Achieved a Reduction of At Least 0.3 Units From Baseline in Health Assessment Questionnaire (HAQ) at Weeks 24, 48, 96, 144, 192
Week 48 (n=13, 170, 18)
|
30.8 percentage of participants
Interval 9.1 to 61.4
|
41.2 percentage of participants
Interval 33.7 to 49.0
|
77.8 percentage of participants
Interval 52.4 to 93.6
|
|
Percentage of Participants Who Achieved a Reduction of At Least 0.3 Units From Baseline in Health Assessment Questionnaire (HAQ) at Weeks 24, 48, 96, 144, 192
Week 96 (n=13, 160, 17)
|
46.2 percentage of participants
Interval 19.2 to 74.9
|
47.5 percentage of participants
Interval 39.6 to 55.5
|
76.5 percentage of participants
Interval 50.1 to 93.2
|
|
Percentage of Participants Who Achieved a Reduction of At Least 0.3 Units From Baseline in Health Assessment Questionnaire (HAQ) at Weeks 24, 48, 96, 144, 192
Week 144 (n=12, 142, 13)
|
50.0 percentage of participants
Interval 21.1 to 78.9
|
48.6 percentage of participants
Interval 40.1 to 57.1
|
69.2 percentage of participants
Interval 38.6 to 90.9
|
|
Percentage of Participants Who Achieved a Reduction of At Least 0.3 Units From Baseline in Health Assessment Questionnaire (HAQ) at Weeks 24, 48, 96, 144, 192
Week 192 (n=3, 7, 1)
|
100.0 percentage of participants
Interval 29.2 to 100.0
|
85.7 percentage of participants
Interval 42.1 to 99.6
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
SECONDARY outcome
Timeframe: At BL (week 0), weeks 24, 48, 96, 144, and 192.Population: All treated participants who received at least 1 dose of the study drug. n = participants with both BL and PBL measurement at a given point time point.
The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role functioning \[physical\], bodily pain, and general health) and 4 mental subscales (vitality, social function, role emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from 0 to 100, with a higher score indicating better quality of life. Improvements of \> 3 points were considered clinically meaningful.Please see outcome 14 for change from BL data.
Outcome measures
| Measure |
Participants From Phase I Study (IM101-034); Abatacept 10mg/kg
n=13 Participants
Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
|
Participants From Phase II Study(IM101-071); Abatacept 10mg/kg
n=178 Participants
Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
|
New Participants With MTX Intolerance; Abatacept 10 mg/kg
n=26 Participants
Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs \[excluding MTX\]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
|
|---|---|---|---|
|
Baseline and Postbaseline Physical Component Summary (PCS) of Health-Related Quality of Life (SF-36) Scores
Week 24- BL (n=13, 176, 23)
|
34.2 Units on a Scale
Standard Deviation 14.5
|
30.3 Units on a Scale
Standard Deviation 15.2
|
19.0 Units on a Scale
Standard Deviation 12.5
|
|
Baseline and Postbaseline Physical Component Summary (PCS) of Health-Related Quality of Life (SF-36) Scores
Week 24- PBL (n=13, 176, 23)
|
40.6 Units on a Scale
Standard Deviation 12.6
|
38.5 Units on a Scale
Standard Deviation 14.3
|
30.3 Units on a Scale
Standard Deviation 17.1
|
|
Baseline and Postbaseline Physical Component Summary (PCS) of Health-Related Quality of Life (SF-36) Scores
Week 48- BL (n=13, 170, 18)
|
34.2 Units on a Scale
Standard Deviation 14.5
|
30.4 Units on a Scale
Standard Deviation 15.2
|
20.1 Units on a Scale
Standard Deviation 12.4
|
|
Baseline and Postbaseline Physical Component Summary (PCS) of Health-Related Quality of Life (SF-36) Scores
Week 48- PBL (n=13, 170, 18)
|
40.9 Units on a Scale
Standard Deviation 11.1
|
40.1 Units on a Scale
Standard Deviation 13.7
|
37.1 Units on a Scale
Standard Deviation 14.0
|
|
Baseline and Postbaseline Physical Component Summary (PCS) of Health-Related Quality of Life (SF-36) Scores
Week 96- BL (n=13, 160, 17)
|
34.2 Units on a Scale
Standard Deviation 14.5
|
29.8 Units on a Scale
Standard Deviation 15.2
|
19.9 Units on a Scale
Standard Deviation 12.7
|
|
Baseline and Postbaseline Physical Component Summary (PCS) of Health-Related Quality of Life (SF-36) Scores
Week 96- PBL (n=13, 160, 17)
|
38.7 Units on a Scale
Standard Deviation 12.6
|
40.3 Units on a Scale
Standard Deviation 13.2
|
37.5 Units on a Scale
Standard Deviation 13.5
|
|
Baseline and Postbaseline Physical Component Summary (PCS) of Health-Related Quality of Life (SF-36) Scores
Week 144- BL (n=12, 142, 13)
|
32.9 Units on a Scale
Standard Deviation 14.4
|
30.6 Units on a Scale
Standard Deviation 15.1
|
21.1 Units on a Scale
Standard Deviation 14.0
|
|
Baseline and Postbaseline Physical Component Summary (PCS) of Health-Related Quality of Life (SF-36) Scores
Week 144- PBL (n=12, 142, 13)
|
37.8 Units on a Scale
Standard Deviation 14.5
|
39.2 Units on a Scale
Standard Deviation 13.7
|
32.9 Units on a Scale
Standard Deviation 14.2
|
|
Baseline and Postbaseline Physical Component Summary (PCS) of Health-Related Quality of Life (SF-36) Scores
Week 192- BL (n=3, 7, 1)
|
24.6 Units on a Scale
Standard Deviation 10.9
|
22.8 Units on a Scale
Standard Deviation 12.2
|
12.5 Units on a Scale
Standard Deviation NA
Not applicable as there was only 1 participant in the group with both BL and PBL values.
|
|
Baseline and Postbaseline Physical Component Summary (PCS) of Health-Related Quality of Life (SF-36) Scores
Week 192- PBL (n=3, 7, 1)
|
30.4 Units on a Scale
Standard Deviation 24.8
|
38.5 Units on a Scale
Standard Deviation 16.1
|
37.0 Units on a Scale
Standard Deviation NA
Not applicable as there was only 1 participant in the group with both BL and PBL values.
|
SECONDARY outcome
Timeframe: At baseline (week 0), weeks 24, 48, 96, 144, and 192.Population: All treated participants who received at least 1 dose of the study drug. n = participants with both BL and PBL measurement at a given point time point.
The SF-36 covers 8 health dimensions including 4 physical (physical function, role functioning \[physical\], bodily pain, and general health) and 4 mental subscales (vitality, social function, role emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, higher score indicating better quality of life. Improvements of \>3 points were considered clinically meaningful. Please see outcome 13 for BL and PBL values.
Outcome measures
| Measure |
Participants From Phase I Study (IM101-034); Abatacept 10mg/kg
n=13 Participants
Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
|
Participants From Phase II Study(IM101-071); Abatacept 10mg/kg
n=178 Participants
Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
|
New Participants With MTX Intolerance; Abatacept 10 mg/kg
n=26 Participants
Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs \[excluding MTX\]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
|
|---|---|---|---|
|
Change From Baseline in Physical Component Summary (PCS) of Health-Related Quality of Life (SF-36) Score at Weeks 24, 48, 96, 144, and 192
Week 24 (n=13, 176, 23)
|
6.5 Units on a Scale
Interval 0.0 to 13.0
|
8.2 Units on a Scale
Interval 6.4 to 10.0
|
11.3 Units on a Scale
Interval 5.2 to 17.5
|
|
Change From Baseline in Physical Component Summary (PCS) of Health-Related Quality of Life (SF-36) Score at Weeks 24, 48, 96, 144, and 192
Week 48 (n=13, 170, 18)
|
6.7 Units on a Scale
Interval 0.3 to 13.1
|
9.7 Units on a Scale
Interval 7.7 to 11.7
|
17.1 Units on a Scale
Interval 11.1 to 23.0
|
|
Change From Baseline in Physical Component Summary (PCS) of Health-Related Quality of Life (SF-36) Score at Weeks 24, 48, 96, 144, and 192
Week 96 (n=13, 160, 17)
|
4.5 Units on a Scale
Interval -4.5 to 13.6
|
10.4 Units on a Scale
Interval 8.5 to 12.4
|
17.6 Units on a Scale
Interval 9.7 to 25.5
|
|
Change From Baseline in Physical Component Summary (PCS) of Health-Related Quality of Life (SF-36) Score at Weeks 24, 48, 96, 144, and 192
Week 144 (n=12, 142, 13)
|
4.8 Units on a Scale
Interval -5.3 to 14.9
|
8.6 Units on a Scale
Interval 6.6 to 10.6
|
11.8 Units on a Scale
Interval 4.4 to 19.1
|
|
Change From Baseline in Physical Component Summary (PCS) of Health-Related Quality of Life (SF-36) Score at Weeks 24, 48, 96, 144, and 192
Week 192 (n=3, 7, 1)
|
5.7 Units on a Scale
Interval -79.9 to 91.4
|
15.7 Units on a Scale
Interval 0.7 to 30.8
|
24.6 Units on a Scale
Not applicable as there was only 1 participant in the group with both BL and PBL values.
|
SECONDARY outcome
Timeframe: At BL (week 0), weeks 24, 48, 96, 144, and 192.Population: All treated participants who received at least 1 dose of the study drug. n = participants with both BL and PBL measurement at a given point time point.
The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role functioning \[physical\], bodily pain, and general health) and 4 mental subscales (vitality, social function, role emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from 0 to 100, with a higher score indicating better quality of life. Improvements of \> 3 points were considered clinically meaningful. Please see outcome 14 for change from BL data.
Outcome measures
| Measure |
Participants From Phase I Study (IM101-034); Abatacept 10mg/kg
n=13 Participants
Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
|
Participants From Phase II Study(IM101-071); Abatacept 10mg/kg
n=178 Participants
Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
|
New Participants With MTX Intolerance; Abatacept 10 mg/kg
n=26 Participants
Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs \[excluding MTX\]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
|
|---|---|---|---|
|
Baseline and Postbaseline Mental Component Summary (MCS) of Health-Related Quality of Life (SF-36) Scores
Week 24- BL (n=13, 176, 23)
|
41.6 Units on a Scale
Standard Deviation 12.4
|
48.6 Units on a Scale
Standard Deviation 8.5
|
41.7 Units on a Scale
Standard Deviation 9.8
|
|
Baseline and Postbaseline Mental Component Summary (MCS) of Health-Related Quality of Life (SF-36) Scores
Week 24- PBL (n=13, 176, 23)
|
45.2 Units on a Scale
Standard Deviation 8.9
|
51.2 Units on a Scale
Standard Deviation 7.5
|
49.5 Units on a Scale
Standard Deviation 10.5
|
|
Baseline and Postbaseline Mental Component Summary (MCS) of Health-Related Quality of Life (SF-36) Scores
Week 144- PBL (n=12, 142, 13)
|
51.1 Units on a Scale
Standard Deviation 7.6
|
50.6 Units on a Scale
Standard Deviation 7.3
|
51.1 Units on a Scale
Standard Deviation 8.4
|
|
Baseline and Postbaseline Mental Component Summary (MCS) of Health-Related Quality of Life (SF-36) Scores
Week 48- BL (n=13, 170, 18)
|
41.6 Units on a Scale
Standard Deviation 12.4
|
48.6 Units on a Scale
Standard Deviation 8.5
|
43.2 Units on a Scale
Standard Deviation 9.6
|
|
Baseline and Postbaseline Mental Component Summary (MCS) of Health-Related Quality of Life (SF-36) Scores
Week 48- PBL (n=13, 170, 18)
|
49.0 Units on a Scale
Standard Deviation 8.0
|
51.6 Units on a Scale
Standard Deviation 8.1
|
49.9 Units on a Scale
Standard Deviation 7.5
|
|
Baseline and Postbaseline Mental Component Summary (MCS) of Health-Related Quality of Life (SF-36) Scores
Week 96- PBL (n=13, 160, 17)
|
49.9 Units on a Scale
Standard Deviation 7.2
|
50.6 Units on a Scale
Standard Deviation 7.5
|
51.6 Units on a Scale
Standard Deviation 8.2
|
|
Baseline and Postbaseline Mental Component Summary (MCS) of Health-Related Quality of Life (SF-36) Scores
Week 144- BL (n=12, 142, 13)
|
41.6 Units on a Scale
Standard Deviation 13.0
|
48.5 Units on a Scale
Standard Deviation 8.6
|
42.2 Units on a Scale
Standard Deviation 9.4
|
|
Baseline and Postbaseline Mental Component Summary (MCS) of Health-Related Quality of Life (SF-36) Scores
Week 192- BL (n=3, 7, 1)
|
45.7 Units on a Scale
Standard Deviation 20.4
|
45.4 Units on a Scale
Standard Deviation 8.1
|
37.1 Units on a Scale
Standard Deviation NA
Not applicable as there was only 1 participant in the group with both BL and PBL values.
|
|
Baseline and Postbaseline Mental Component Summary (MCS) of Health-Related Quality of Life (SF-36) Scores
Week 192- PBL (n=3, 7, 1)
|
60.7 Units on a Scale
Standard Deviation 6.1
|
52.4 Units on a Scale
Standard Deviation 12.5
|
69.3 Units on a Scale
Standard Deviation NA
Not applicable as there was only 1 participant in the group with both BL and PBL values.
|
|
Baseline and Postbaseline Mental Component Summary (MCS) of Health-Related Quality of Life (SF-36) Scores
Week 96- BL (n=13, 160, 17)
|
41.6 Units on a Scale
Standard Deviation 12.4
|
48.6 Units on a Scale
Standard Deviation 8.5
|
43.6 Units on a Scale
Standard Deviation 9.8
|
SECONDARY outcome
Timeframe: At BL (Week 0), weeks 24, 48, 96, 144, and 192.Population: All treated participants who received at least 1 dose of the study drug. n = participants with both BL and PBL measurement at a given point time point.
The SF-36 covers 8 health dimensions including 4 physical (physical function, role functioning \[physical\], bodily pain, and general health) and 4 mental subscales (vitality, social function, role emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, higher score indicating better quality of life. Improvements of \> 3 points were considered clinically meaningful.Please see outcome 15 for BL and PBL values.
Outcome measures
| Measure |
Participants From Phase I Study (IM101-034); Abatacept 10mg/kg
n=13 Participants
Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
|
Participants From Phase II Study(IM101-071); Abatacept 10mg/kg
n=178 Participants
Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
|
New Participants With MTX Intolerance; Abatacept 10 mg/kg
n=26 Participants
Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs \[excluding MTX\]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
|
|---|---|---|---|
|
Change From Baseline in Mental Component Summary (MCS) of Health-Related Quality of Life (SF-36) Score at Weeks 24, 48, 96, 144, and 192
Week 24 (n=13, 176, 23)
|
3.6 Units on a Scale
Interval -1.3 to 8.6
|
2.6 Units on a Scale
Interval 1.5 to 3.7
|
7.7 Units on a Scale
Interval 1.7 to 13.8
|
|
Change From Baseline in Mental Component Summary (MCS) of Health-Related Quality of Life (SF-36) Score at Weeks 24, 48, 96, 144, and 192
Week 96 (n=13, 160, 17)
|
8.3 Units on a Scale
Interval 2.0 to 14.6
|
2.1 Units on a Scale
Interval 0.7 to 3.4
|
8.0 Units on a Scale
Interval 1.9 to 14.2
|
|
Change From Baseline in Mental Component Summary (MCS) of Health-Related Quality of Life (SF-36) Score at Weeks 24, 48, 96, 144, and 192
Week 144 (n=12, 142, 13)
|
9.5 Units on a Scale
Interval 3.4 to 15.6
|
2.1 Units on a Scale
Interval 0.8 to 3.5
|
8.9 Units on a Scale
Interval 1.9 to 15.9
|
|
Change From Baseline in Mental Component Summary (MCS) of Health-Related Quality of Life (SF-36) Score at Weeks 24, 48, 96, 144, and 192
Week 192 (n=3, 7, 1)
|
15.0 Units on a Scale
Interval -49.5 to 79.6
|
7.0 Units on a Scale
Interval -5.2 to 19.3
|
32.1 Units on a Scale
Not applicable as there was only 1 participant in the group with both BL and PBL values.
|
|
Change From Baseline in Mental Component Summary (MCS) of Health-Related Quality of Life (SF-36) Score at Weeks 24, 48, 96, 144, and 192
Week 48 (n=13, 170, 18)
|
7.4 Units on a Scale
Interval 2.5 to 12.3
|
3.0 Units on a Scale
Interval 1.7 to 4.3
|
6.7 Units on a Scale
Interval 1.4 to 11.9
|
SECONDARY outcome
Timeframe: At BL (week 0), weeks 24, 48, 96, 144, and 192.Population: All treated participants who received at least 1 dose of the study drug. n = number of participants with both BL and PBL measurement at a given point time point.
CRP is an acute phase reactant protein that is a clinical marker for Rheumatoid Arthritis (RA) and is a core component of the ACR scoring system. CRP was evaluated from serum samples. Increasing levels indicate increasing level of disease. Please see outcome 18 for change from BL data.
Outcome measures
| Measure |
Participants From Phase I Study (IM101-034); Abatacept 10mg/kg
n=13 Participants
Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
|
Participants From Phase II Study(IM101-071); Abatacept 10mg/kg
n=178 Participants
Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
|
New Participants With MTX Intolerance; Abatacept 10 mg/kg
n=26 Participants
Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs \[excluding MTX\]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
|
|---|---|---|---|
|
Baseline and Postbaseline C-reactive Protein (CRP) Levels
Week 24- BL (n=13, 176, 21)
|
1.8 mg/dL
Standard Deviation 2.8
|
2.3 mg/dL
Standard Deviation 2.2
|
3.9 mg/dL
Standard Deviation 3.1
|
|
Baseline and Postbaseline C-reactive Protein (CRP) Levels
Week 24- PBL (n=13, 176, 21)
|
0.7 mg/dL
Standard Deviation 0.7
|
0.8 mg/dL
Standard Deviation 1.3
|
1.9 mg/dL
Standard Deviation 2.5
|
|
Baseline and Postbaseline C-reactive Protein (CRP) Levels
Week 48- BL (n=13, 168, 18)
|
1.8 mg/dL
Standard Deviation 2.8
|
2.2 mg/dL
Standard Deviation 2.1
|
4.1 mg/dL
Standard Deviation 3.1
|
|
Baseline and Postbaseline C-reactive Protein (CRP) Levels
Week 48- PBL (n=13, 168, 18)
|
1.1 mg/dL
Standard Deviation 2.1
|
0.6 mg/dL
Standard Deviation 1.1
|
0.9 mg/dL
Standard Deviation 1.3
|
|
Baseline and Postbaseline C-reactive Protein (CRP) Levels
Week 96- BL (n=13, 159, 17)
|
1.8 mg/dL
Standard Deviation 2.8
|
2.3 mg/dL
Standard Deviation 2.2
|
4.1 mg/dL
Standard Deviation 3.2
|
|
Baseline and Postbaseline C-reactive Protein (CRP) Levels
Week 96- PBL (n=13, 159, 17)
|
0.9 mg/dL
Standard Deviation 1.3
|
0.5 mg/dL
Standard Deviation 0.9
|
1.0 mg/dL
Standard Deviation 1.0
|
|
Baseline and Postbaseline C-reactive Protein (CRP) Levels
Week 144- BL (n=12, 142, 13)
|
1.9 mg/dL
Standard Deviation 2.9
|
2.4 mg/dL
Standard Deviation 2.2
|
4.2 mg/dL
Standard Deviation 3.4
|
|
Baseline and Postbaseline C-reactive Protein (CRP) Levels
Week 144- PBL (n=12, 142, 13)
|
1.2 mg/dL
Standard Deviation 1.4
|
0.6 mg/dL
Standard Deviation 1.5
|
0.6 mg/dL
Standard Deviation 0.6
|
|
Baseline and Postbaseline C-reactive Protein (CRP) Levels
Week 192- BL (n=3, 7, 1)
|
4.6 mg/dL
Standard Deviation 5.4
|
1.7 mg/dL
Standard Deviation 1.2
|
8.4 mg/dL
Standard Deviation NA
Not applicable as there was only 1 participant in the group with both BL and PBL values.
|
|
Baseline and Postbaseline C-reactive Protein (CRP) Levels
Week 192- PBL (n=3, 7, 1)
|
1.4 mg/dL
Standard Deviation 1.7
|
0.8 mg/dL
Standard Deviation 1.6
|
0.2 mg/dL
Standard Deviation NA
Not applicable as there was only 1 participant in the group with both BL and PBL values.
|
SECONDARY outcome
Timeframe: At BL (week 0), weeks 24, 48, 96, 144, and 192.Population: All treated participants who received at least 1 dose of the study drug. n = participants with both BL and PBL measurement at a given point time point.
CRP is an acute phase reactant protein that is a clinical marker for Rheumatoid Arthritis (RA) and is a core component of the ACR scoring system. CRP was evaluated from serum samples. Increasing levels indicate increasing level of disease, negative values indicate improvement. Percentage improvement from BL = (BL - PBL value) / BL value \* 100. Please refer to outcome 17 for BL and PBL values.
Outcome measures
| Measure |
Participants From Phase I Study (IM101-034); Abatacept 10mg/kg
n=13 Participants
Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
|
Participants From Phase II Study(IM101-071); Abatacept 10mg/kg
n=178 Participants
Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
|
New Participants With MTX Intolerance; Abatacept 10 mg/kg
n=26 Participants
Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs \[excluding MTX\]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
|
|---|---|---|---|
|
Percentage Decrease in C-reactive Protein Levels From Baseline at Weeks 24, 48, 96, 144, and 192
Week 24 (n=13, 176, 21)
|
-18.4 percentage improvement
Interval -147.8 to 111.1
|
30.5 percentage improvement
Interval -0.4 to 61.4
|
60.2 percentage improvement
Interval 42.7 to 77.7
|
|
Percentage Decrease in C-reactive Protein Levels From Baseline at Weeks 24, 48, 96, 144, and 192
Week 48 (n=13, 168, 18)
|
12.0 percentage improvement
Interval -35.9 to 59.9
|
31.9 percentage improvement
Interval 8.7 to 55.1
|
77.8 percentage improvement
Interval 65.2 to 90.3
|
|
Percentage Decrease in C-reactive Protein Levels From Baseline at Weeks 24, 48, 96, 144, and 192
Week 96 (n=13, 159, 17)
|
-3.3 percentage improvement
Interval -77.9 to 71.3
|
40.5 percentage improvement
Interval 21.8 to 59.1
|
70.1 percentage improvement
Interval 51.0 to 89.2
|
|
Percentage Decrease in C-reactive Protein Levels From Baseline at Weeks 24, 48, 96, 144, and 192
Week 144 (n=12, 142, 13)
|
-71.9 percentage improvement
Interval -188.7 to 44.9
|
-39.3 percentage improvement
Interval -191.5 to 113.0
|
79.9 percentage improvement
Interval 68.0 to 91.7
|
|
Percentage Decrease in C-reactive Protein Levels From Baseline at Weeks 24, 48, 96, 144, and 192
Week 192 (n=3, 7, 1)
|
67.9 percentage improvement
Interval 52.0 to 83.7
|
39.7 percentage improvement
Interval -83.2 to 162.6
|
97.4 percentage improvement
Not applicable as there was only 1 participant in the group with both baseline and postbaseline values.
|
SECONDARY outcome
Timeframe: At BL (week 0), weeks 24, 48, 96, 144, and 192.Population: All treated participants who received at least 1 dose of the study drug. n = participants with both BL and PBL measurement at a given point time point.
Rheumatoid factor (RF or RhF) 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. RF levels are considered positive if value is \>20 and considered negative if value is \<20. Please see outcome 20 for change from BL data.
Outcome measures
| Measure |
Participants From Phase I Study (IM101-034); Abatacept 10mg/kg
n=13 Participants
Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
|
Participants From Phase II Study(IM101-071); Abatacept 10mg/kg
n=178 Participants
Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
|
New Participants With MTX Intolerance; Abatacept 10 mg/kg
n=26 Participants
Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs \[excluding MTX\]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
|
|---|---|---|---|
|
Baseline and Postbaseline Rheumatoid Factor Levels
Week 24- BL (n=13, 176, 21)
|
200.2 IU/mL
Standard Deviation 343.8
|
214.3 IU/mL
Standard Deviation 383.3
|
630.8 IU/mL
Standard Deviation 873.4
|
|
Baseline and Postbaseline Rheumatoid Factor Levels
Week 24- PBL (n=13, 176, 21)
|
127.5 IU/mL
Standard Deviation 191.6
|
141.0 IU/mL
Standard Deviation 289.2
|
573.9 IU/mL
Standard Deviation 897.2
|
|
Baseline and Postbaseline Rheumatoid Factor Levels
Week 48- BL (n=13, 168, 18)
|
200.2 IU/mL
Standard Deviation 343.8
|
217.3 IU/mL
Standard Deviation 389.7
|
560.9 IU/mL
Standard Deviation 893.0
|
|
Baseline and Postbaseline Rheumatoid Factor Levels
Week 48- PBL (n=13, 168, 18)
|
139.9 IU/mL
Standard Deviation 241.8
|
149.5 IU/mL
Standard Deviation 288.4
|
288.3 IU/mL
Standard Deviation 482.8
|
|
Baseline and Postbaseline Rheumatoid Factor Levels
Week 96- BL (n=13, 159, 17)
|
200.2 IU/mL
Standard Deviation 343.8
|
215.9 IU/mL
Standard Deviation 393.9
|
590.9 IU/mL
Standard Deviation 911.1
|
|
Baseline and Postbaseline Rheumatoid Factor Levels
Week 96- PBL (n=13, 159, 17)
|
186.9 IU/mL
Standard Deviation 339.4
|
151.0 IU/mL
Standard Deviation 285.8
|
216.8 IU/mL
Standard Deviation 329.2
|
|
Baseline and Postbaseline Rheumatoid Factor Levels
Week 144- BL (n=12, 142, 13)
|
205.6 IU/mL
Standard Deviation 358.5
|
229.0 IU/mL
Standard Deviation 412.6
|
639.4 IU/mL
Standard Deviation 990.8
|
|
Baseline and Postbaseline Rheumatoid Factor Levels
Week 144- PBL (n=12, 142, 13)
|
211.3 IU/mL
Standard Deviation 359.8
|
173.7 IU/mL
Standard Deviation 360.8
|
361.6 IU/mL
Standard Deviation 663.9
|
|
Baseline and Postbaseline Rheumatoid Factor Levels
Week 192- BL (n=3, 7, 1)
|
314.3 IU/mL
Standard Deviation 455.3
|
253.7 IU/mL
Standard Deviation 307.6
|
2800.0 IU/mL
Standard Deviation NA
Not applicable as there was only 1 participant in the group with both BL and PBL values.
|
|
Baseline and Postbaseline Rheumatoid Factor Levels
Week 192- PBL (n=3, 7, 1)
|
315.0 IU/mL
Standard Deviation 307.0
|
348.4 IU/mL
Standard Deviation 521.6
|
197.0 IU/mL
Standard Deviation NA
Not applicable as there was only 1 participant in the group with both BL and PBL values.
|
SECONDARY outcome
Timeframe: At BL (week 0), weeks 24, 48, 96, 144, and 192.Population: All treated participants who received at least 1 dose of the study drug. n = participants with both BL and PBL measurement at a given point time point.
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. RF levels are considered positive if value is \>20 and considered negative if value is \<20. Please refer to outcome 19 for BL and PBL values.
Outcome measures
| Measure |
Participants From Phase I Study (IM101-034); Abatacept 10mg/kg
n=13 Participants
Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
|
Participants From Phase II Study(IM101-071); Abatacept 10mg/kg
n=178 Participants
Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
|
New Participants With MTX Intolerance; Abatacept 10 mg/kg
n=26 Participants
Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs \[excluding MTX\]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
|
|---|---|---|---|
|
Change From Baseline in Rheumatoid Factor Levels at Weeks 24, 48, 96, 144, and 192
Week 24 (n=13, 176, 21)
|
-72.6 IU/mL
Interval -197.5 to 52.2
|
-73.2 IU/mL
Interval -102.8 to -43.7
|
-56.9 IU/mL
Interval -149.5 to 35.7
|
|
Change From Baseline in Rheumatoid Factor Levels at Weeks 24, 48, 96, 144, and 192
Week 48 (n=13, 168, 18)
|
-60.2 IU/mL
Interval -137.9 to 17.4
|
-67.8 IU/mL
Interval -100.4 to -35.2
|
-272.6 IU/mL
Interval -494.0 to -51.2
|
|
Change From Baseline in Rheumatoid Factor Levels at Weeks 24, 48, 96, 144, and 192
Week 96 (n=13, 159, 17)
|
-13.2 IU/mL
Interval -63.3 to 36.8
|
-64.9 IU/mL
Interval -103.3 to -26.6
|
-374.1 IU/mL
Interval -704.9 to -43.2
|
|
Change From Baseline in Rheumatoid Factor Levels at Weeks 24, 48, 96, 144, and 192
Week 144 (n=12, 142, 13)
|
5.7 IU/mL
Interval -43.0 to 54.4
|
-55.3 IU/mL
Interval -97.2 to -13.3
|
-277.8 IU/mL
Interval -708.2 to 152.7
|
|
Change From Baseline in Rheumatoid Factor Levels at Weeks 24, 48, 96, 144, and 192
Week 192 (n=3, 7, 1)
|
0.7 IU/mL
Interval -471.3 to 472.7
|
94.7 IU/mL
Interval -122.5 to 311.9
|
-2603 IU/mL
Not applicable as there was only 1 participant with both BL and BL measurements.
|
SECONDARY outcome
Timeframe: At BL (week 0), weeks 24, 48, 72, 96, 120, 144, 168, and 192.Population: All participants who received study treatment, and had BL and at least one PBL measurement for immunogenicity.
Validated enzyme-linked immunoassay (ELISA) method was used to measure anti-abatacept and anti-CTLA4-T antibody levels. For anti-abatacept antibody ELISA, a sample was considered seropositive if it had a titer of 400 or greater and if immunodepletion was observed. The responses that were negative in initial screen were reported as seronegative with a value of \< 400. A sample was considered positive in CTLA4-T antibody ELISA if it had a titer of 25 or greater and if immunodepletion was observed.
Outcome measures
| Measure |
Participants From Phase I Study (IM101-034); Abatacept 10mg/kg
n=13 Participants
Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
|
Participants From Phase II Study(IM101-071); Abatacept 10mg/kg
n=178 Participants
Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
|
New Participants With MTX Intolerance; Abatacept 10 mg/kg
n=26 Participants
Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs \[excluding MTX\]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
|
|---|---|---|---|
|
Number of Participants Who Were Positive for Anti-abatacept and Anti-CTLA4-T Antibodies
Positive for anti-abatacept antibody
|
2 participants
|
19 participants
|
2 participants
|
|
Number of Participants Who Were Positive for Anti-abatacept and Anti-CTLA4-T Antibodies
Positive for anti-CTLA4-T antibody
|
0 participants
|
19 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Samples were collected predose at week 8, 12, 16, 24; end of infusion at week 12; and at week 13-15 visits.Population: All participants who received abatacept and had blood samples for assay.
Total body clearance is the rate and extent at which the drug is eliminated from the body. The clearance of a drug is used to understand the processes involved in drug elimination, distribution and metabolism.
Outcome measures
| Measure |
Participants From Phase I Study (IM101-034); Abatacept 10mg/kg
n=113 Participants
Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
|
Participants From Phase II Study(IM101-071); Abatacept 10mg/kg
Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
|
New Participants With MTX Intolerance; Abatacept 10 mg/kg
Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs \[excluding MTX\]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
|
|---|---|---|---|
|
Abatacept PK Parameter: Total Body Clearance
|
0.306 L/day
Full Range 0.098 • Interval 0.149 to 0.668
|
—
|
—
|
SECONDARY outcome
Timeframe: Samples were collected predose at week 8, 12, 16, 24; end of infusion at week 12; and at week 13-15 visits.Population: All participants who received abatacept and had blood samples for assay.
Area under the plasma concentration-time curve (AUCss) at steady state for each dosing interval was determined using the linear trapezoidal rule.
Outcome measures
| Measure |
Participants From Phase I Study (IM101-034); Abatacept 10mg/kg
n=113 Participants
Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
|
Participants From Phase II Study(IM101-071); Abatacept 10mg/kg
Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
|
New Participants With MTX Intolerance; Abatacept 10 mg/kg
Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs \[excluding MTX\]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
|
|---|---|---|---|
|
Abatacept PK Parameter: Area Under the Serum Concentration-time Curve at Steady State
|
42959.94 µg*h/mL
Full Range 12763.45 • Interval 17971.87 to 80321.29
|
—
|
—
|
SECONDARY outcome
Timeframe: Samples were collected predose at week 8, 12, 16, 24; end of infusion at week 12; and at week 13-15 visits.Population: All participants who received abatacept and had blood samples for assay.
Maximum plasma concentration is the maximum observed serum drug concentration at steady state (Css max).
Outcome measures
| Measure |
Participants From Phase I Study (IM101-034); Abatacept 10mg/kg
n=113 Participants
Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
|
Participants From Phase II Study(IM101-071); Abatacept 10mg/kg
Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
|
New Participants With MTX Intolerance; Abatacept 10 mg/kg
Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs \[excluding MTX\]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
|
|---|---|---|---|
|
Abatacept PK Parameter: Maximum Serum Concentration at Steady State
|
241.62 µg/mL
Full Range 73.96 • Interval 68.15 to 434.55
|
—
|
—
|
SECONDARY outcome
Timeframe: Samples were collected predose at week 8, 12, 16, 24; end of infusion at week 12; and at week 13-15 visits.Population: All participants who received abatacept and had blood samples for assay.
Minimum Plasma Concentration (Cmin) is the minimum observed serum drug concentration at steady state.
Outcome measures
| Measure |
Participants From Phase I Study (IM101-034); Abatacept 10mg/kg
n=113 Participants
Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
|
Participants From Phase II Study(IM101-071); Abatacept 10mg/kg
Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
|
New Participants With MTX Intolerance; Abatacept 10 mg/kg
Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs \[excluding MTX\]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
|
|---|---|---|---|
|
Abatacept PK Parameter: Minimum Plasma Concentration at Steady State
|
26.14 µg/mL
Full Range 23.10 • Interval 0.15 to 127.5
|
—
|
—
|
Adverse Events
Participants From Phase I Study (IM101-034); Abatacept 10mg/kg
Serious events: 4 serious events
Other events: 13 other events
Deaths: 0 deaths
Participants From Phase II Study(IM101-071); Abatacept 10mg/kg
Serious events: 50 serious events
Other events: 176 other events
Deaths: 0 deaths
New Participants With MTX Intolerance; Abatacept 10 mg/kg
Serious events: 14 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Participants From Phase I Study (IM101-034); Abatacept 10mg/kg
n=13 participants at risk
Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
|
Participants From Phase II Study(IM101-071); Abatacept 10mg/kg
n=178 participants at risk
Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
|
New Participants With MTX Intolerance; Abatacept 10 mg/kg
n=26 participants at risk
Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs \[excluding MTX\]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
0.00%
0/13
|
0.56%
1/178
|
0.00%
0/26
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/13
|
0.56%
1/178
|
3.8%
1/26
|
|
Surgical and medical procedures
Bunion operation
|
0.00%
0/13
|
0.56%
1/178
|
0.00%
0/26
|
|
Surgical and medical procedures
Gastric polypectomy
|
0.00%
0/13
|
0.56%
1/178
|
0.00%
0/26
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.00%
0/13
|
0.56%
1/178
|
0.00%
0/26
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/13
|
0.56%
1/178
|
0.00%
0/26
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/13
|
0.56%
1/178
|
0.00%
0/26
|
|
Cardiac disorders
Mitral valve incompetence
|
0.00%
0/13
|
0.56%
1/178
|
0.00%
0/26
|
|
Cardiac disorders
Prinzmetal angina
|
0.00%
0/13
|
0.56%
1/178
|
0.00%
0/26
|
|
Ear and labyrinth disorders
Deafness
|
0.00%
0/13
|
0.00%
0/178
|
3.8%
1/26
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/13
|
0.56%
1/178
|
0.00%
0/26
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/13
|
0.56%
1/178
|
0.00%
0/26
|
|
Eye disorders
Cataract
|
0.00%
0/13
|
0.56%
1/178
|
3.8%
1/26
|
|
Gastrointestinal disorders
Anal fistula
|
0.00%
0/13
|
0.56%
1/178
|
0.00%
0/26
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/13
|
0.00%
0/178
|
3.8%
1/26
|
|
Gastrointestinal disorders
Inflammatory bowel disease
|
0.00%
0/13
|
0.00%
0/178
|
3.8%
1/26
|
|
Gastrointestinal disorders
Radicular cyst
|
0.00%
0/13
|
0.56%
1/178
|
0.00%
0/26
|
|
Gastrointestinal disorders
Volvulus
|
0.00%
0/13
|
0.56%
1/178
|
0.00%
0/26
|
|
General disorders
Feeling abnormal
|
0.00%
0/13
|
0.56%
1/178
|
0.00%
0/26
|
|
General disorders
Pyrexia
|
0.00%
0/13
|
0.56%
1/178
|
0.00%
0/26
|
|
Hepatobiliary disorders
Cholelithiasis
|
7.7%
1/13
|
0.56%
1/178
|
0.00%
0/26
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/13
|
0.56%
1/178
|
0.00%
0/26
|
|
Infections and infestations
Appendicitis
|
0.00%
0/13
|
0.56%
1/178
|
0.00%
0/26
|
|
Infections and infestations
Arthritis bacterial
|
7.7%
1/13
|
0.00%
0/178
|
0.00%
0/26
|
|
Infections and infestations
Bronchitis
|
0.00%
0/13
|
0.56%
1/178
|
0.00%
0/26
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/13
|
0.56%
1/178
|
0.00%
0/26
|
|
Infections and infestations
Cellulitis
|
0.00%
0/13
|
1.1%
2/178
|
3.8%
1/26
|
|
Infections and infestations
Fungal infection
|
0.00%
0/13
|
0.00%
0/178
|
3.8%
1/26
|
|
Infections and infestations
Gastroenteritis
|
7.7%
1/13
|
0.56%
1/178
|
0.00%
0/26
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/13
|
0.00%
0/178
|
3.8%
1/26
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/13
|
0.56%
1/178
|
0.00%
0/26
|
|
Infections and infestations
Otitis media chronic
|
0.00%
0/13
|
0.00%
0/178
|
3.8%
1/26
|
|
Infections and infestations
Pharyngeal abscess
|
0.00%
0/13
|
0.56%
1/178
|
0.00%
0/26
|
|
Infections and infestations
Pneumonia
|
0.00%
0/13
|
1.1%
2/178
|
0.00%
0/26
|
|
Infections and infestations
Sepsis
|
0.00%
0/13
|
0.56%
1/178
|
0.00%
0/26
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/13
|
0.56%
1/178
|
0.00%
0/26
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/13
|
0.56%
1/178
|
0.00%
0/26
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/13
|
0.56%
1/178
|
3.8%
1/26
|
|
Injury, poisoning and procedural complications
Femur fracture
|
7.7%
1/13
|
0.56%
1/178
|
0.00%
0/26
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/13
|
0.56%
1/178
|
0.00%
0/26
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/13
|
1.1%
2/178
|
0.00%
0/26
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/13
|
0.56%
1/178
|
0.00%
0/26
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/13
|
0.56%
1/178
|
0.00%
0/26
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
0.00%
0/13
|
0.56%
1/178
|
0.00%
0/26
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.00%
0/13
|
1.1%
2/178
|
0.00%
0/26
|
|
Injury, poisoning and procedural complications
Rib fracture
|
7.7%
1/13
|
0.00%
0/178
|
0.00%
0/26
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/13
|
1.1%
2/178
|
3.8%
1/26
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/13
|
0.56%
1/178
|
3.8%
1/26
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.00%
0/13
|
0.56%
1/178
|
0.00%
0/26
|
|
Investigations
C-reactive protein increased
|
0.00%
0/13
|
0.00%
0/178
|
3.8%
1/26
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/13
|
0.56%
1/178
|
0.00%
0/26
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.7%
1/13
|
0.00%
0/178
|
0.00%
0/26
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/13
|
1.1%
2/178
|
0.00%
0/26
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
7.7%
1/13
|
2.2%
4/178
|
0.00%
0/26
|
|
Musculoskeletal and connective tissue disorders
Head deformity
|
0.00%
0/13
|
0.00%
0/178
|
3.8%
1/26
|
|
Musculoskeletal and connective tissue disorders
Joint destruction
|
0.00%
0/13
|
2.8%
5/178
|
3.8%
1/26
|
|
Musculoskeletal and connective tissue disorders
Knee deformity
|
0.00%
0/13
|
0.56%
1/178
|
0.00%
0/26
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/13
|
0.56%
1/178
|
0.00%
0/26
|
|
Musculoskeletal and connective tissue disorders
Osteitis
|
0.00%
0/13
|
0.56%
1/178
|
0.00%
0/26
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
7.7%
1/13
|
0.56%
1/178
|
7.7%
2/26
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.00%
0/13
|
0.56%
1/178
|
3.8%
1/26
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis stenosans
|
0.00%
0/13
|
0.56%
1/178
|
0.00%
0/26
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
0.00%
0/13
|
0.56%
1/178
|
0.00%
0/26
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/13
|
0.56%
1/178
|
0.00%
0/26
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma stage 0
|
0.00%
0/13
|
0.56%
1/178
|
0.00%
0/26
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large B-cell lymphoma
|
0.00%
0/13
|
0.56%
1/178
|
0.00%
0/26
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.00%
0/13
|
0.00%
0/178
|
3.8%
1/26
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.00%
0/13
|
0.56%
1/178
|
0.00%
0/26
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm
|
0.00%
0/13
|
0.56%
1/178
|
0.00%
0/26
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.00%
0/13
|
0.56%
1/178
|
0.00%
0/26
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pinealoma
|
0.00%
0/13
|
0.56%
1/178
|
0.00%
0/26
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
T-cell lymphoma
|
0.00%
0/13
|
0.56%
1/178
|
0.00%
0/26
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/13
|
0.56%
1/178
|
0.00%
0/26
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/13
|
0.56%
1/178
|
0.00%
0/26
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/13
|
0.56%
1/178
|
3.8%
1/26
|
|
Nervous system disorders
Encephalitis
|
0.00%
0/13
|
0.56%
1/178
|
0.00%
0/26
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/13
|
0.56%
1/178
|
0.00%
0/26
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/13
|
0.56%
1/178
|
0.00%
0/26
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/13
|
0.00%
0/178
|
3.8%
1/26
|
|
Nervous system disorders
Sensory disturbance
|
0.00%
0/13
|
0.56%
1/178
|
0.00%
0/26
|
|
Nervous system disorders
Thalamus haemorrhage
|
0.00%
0/13
|
0.00%
0/178
|
3.8%
1/26
|
|
Nervous system disorders
VIIth nerve paralysis
|
0.00%
0/13
|
0.00%
0/178
|
3.8%
1/26
|
Other adverse events
| Measure |
Participants From Phase I Study (IM101-034); Abatacept 10mg/kg
n=13 participants at risk
Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
|
Participants From Phase II Study(IM101-071); Abatacept 10mg/kg
n=178 participants at risk
Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
|
New Participants With MTX Intolerance; Abatacept 10 mg/kg
n=26 participants at risk
Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs \[excluding MTX\]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/13
|
5.1%
9/178
|
3.8%
1/26
|
|
Cardiac disorders
Cardiac failure
|
7.7%
1/13
|
0.00%
0/178
|
0.00%
0/26
|
|
Cardiac disorders
Cardiomegaly
|
7.7%
1/13
|
1.1%
2/178
|
0.00%
0/26
|
|
Cardiac disorders
Tachycardia
|
7.7%
1/13
|
1.7%
3/178
|
0.00%
0/26
|
|
Ear and labyrinth disorders
Vertigo
|
7.7%
1/13
|
3.9%
7/178
|
7.7%
2/26
|
|
Eye disorders
Blepharitis
|
7.7%
1/13
|
0.56%
1/178
|
0.00%
0/26
|
|
Eye disorders
Cataract
|
0.00%
0/13
|
2.2%
4/178
|
11.5%
3/26
|
|
Eye disorders
Dry eye
|
0.00%
0/13
|
5.1%
9/178
|
3.8%
1/26
|
|
Eye disorders
Eye discharge
|
7.7%
1/13
|
0.00%
0/178
|
0.00%
0/26
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/13
|
5.6%
10/178
|
3.8%
1/26
|
|
Gastrointestinal disorders
Abdominal pain upper
|
7.7%
1/13
|
6.2%
11/178
|
3.8%
1/26
|
|
Gastrointestinal disorders
Colonic polyp
|
7.7%
1/13
|
1.1%
2/178
|
0.00%
0/26
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/13
|
11.8%
21/178
|
19.2%
5/26
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/13
|
11.8%
21/178
|
0.00%
0/26
|
|
Gastrointestinal disorders
Diarrhoea
|
7.7%
1/13
|
5.6%
10/178
|
7.7%
2/26
|
|
Gastrointestinal disorders
Enterocolitis
|
7.7%
1/13
|
1.7%
3/178
|
3.8%
1/26
|
|
Gastrointestinal disorders
Gastric polyps
|
7.7%
1/13
|
3.9%
7/178
|
3.8%
1/26
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/13
|
1.1%
2/178
|
7.7%
2/26
|
|
Gastrointestinal disorders
Gastritis
|
7.7%
1/13
|
10.1%
18/178
|
3.8%
1/26
|
|
Gastrointestinal disorders
Gastrointestinal motility disorder
|
7.7%
1/13
|
0.00%
0/178
|
0.00%
0/26
|
|
Gastrointestinal disorders
Haemorrhoids
|
15.4%
2/13
|
1.7%
3/178
|
7.7%
2/26
|
|
Gastrointestinal disorders
Inguinal hernia
|
7.7%
1/13
|
0.00%
0/178
|
0.00%
0/26
|
|
Gastrointestinal disorders
Nausea
|
15.4%
2/13
|
7.9%
14/178
|
7.7%
2/26
|
|
Gastrointestinal disorders
Periodontitis
|
0.00%
0/13
|
2.8%
5/178
|
7.7%
2/26
|
|
Gastrointestinal disorders
Stomatitis
|
30.8%
4/13
|
25.8%
46/178
|
11.5%
3/26
|
|
Gastrointestinal disorders
Toothache
|
7.7%
1/13
|
1.1%
2/178
|
0.00%
0/26
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/13
|
4.5%
8/178
|
11.5%
3/26
|
|
General disorders
Malaise
|
7.7%
1/13
|
4.5%
8/178
|
3.8%
1/26
|
|
General disorders
Pyrexia
|
7.7%
1/13
|
6.2%
11/178
|
15.4%
4/26
|
|
General disorders
Thirst
|
0.00%
0/13
|
1.1%
2/178
|
7.7%
2/26
|
|
Immune system disorders
Seasonal allergy
|
7.7%
1/13
|
7.9%
14/178
|
7.7%
2/26
|
|
Infections and infestations
Bronchitis
|
15.4%
2/13
|
8.4%
15/178
|
3.8%
1/26
|
|
Infections and infestations
Cystitis
|
30.8%
4/13
|
6.2%
11/178
|
0.00%
0/26
|
|
Infections and infestations
Dermatitis infected
|
7.7%
1/13
|
0.00%
0/178
|
0.00%
0/26
|
|
Infections and infestations
Diverticulitis
|
7.7%
1/13
|
0.00%
0/178
|
0.00%
0/26
|
|
Infections and infestations
Folliculitis
|
7.7%
1/13
|
2.2%
4/178
|
0.00%
0/26
|
|
Infections and infestations
Gastroenteritis
|
15.4%
2/13
|
9.0%
16/178
|
11.5%
3/26
|
|
Infections and infestations
Herpes simplex
|
7.7%
1/13
|
0.56%
1/178
|
3.8%
1/26
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/13
|
5.1%
9/178
|
3.8%
1/26
|
|
Infections and infestations
Nasopharyngitis
|
61.5%
8/13
|
57.9%
103/178
|
46.2%
12/26
|
|
Infections and infestations
Oesophageal candidiasis
|
7.7%
1/13
|
0.00%
0/178
|
0.00%
0/26
|
|
Infections and infestations
Onychomycosis
|
7.7%
1/13
|
2.8%
5/178
|
0.00%
0/26
|
|
Infections and infestations
Oral herpes
|
7.7%
1/13
|
4.5%
8/178
|
3.8%
1/26
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/13
|
13.5%
24/178
|
15.4%
4/26
|
|
Infections and infestations
Rhinitis
|
0.00%
0/13
|
5.1%
9/178
|
0.00%
0/26
|
|
Infections and infestations
Sinusitis
|
0.00%
0/13
|
6.2%
11/178
|
7.7%
2/26
|
|
Infections and infestations
Tinea pedis
|
7.7%
1/13
|
5.6%
10/178
|
3.8%
1/26
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
15.4%
2/13
|
2.8%
5/178
|
0.00%
0/26
|
|
Injury, poisoning and procedural complications
Contusion
|
15.4%
2/13
|
5.1%
9/178
|
3.8%
1/26
|
|
Injury, poisoning and procedural complications
Excoriation
|
7.7%
1/13
|
1.7%
3/178
|
3.8%
1/26
|
|
Injury, poisoning and procedural complications
Muscle strain
|
15.4%
2/13
|
0.56%
1/178
|
0.00%
0/26
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
7.7%
1/13
|
0.00%
0/178
|
7.7%
2/26
|
|
Injury, poisoning and procedural complications
Thermal burn
|
7.7%
1/13
|
1.7%
3/178
|
0.00%
0/26
|
|
Investigations
Alanine aminotransferase increased
|
15.4%
2/13
|
16.3%
29/178
|
7.7%
2/26
|
|
Investigations
Aspartate aminotransferase increased
|
7.7%
1/13
|
12.9%
23/178
|
3.8%
1/26
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/13
|
3.9%
7/178
|
11.5%
3/26
|
|
Investigations
Blood glucose increased
|
7.7%
1/13
|
5.1%
9/178
|
11.5%
3/26
|
|
Investigations
Blood pressure decreased
|
7.7%
1/13
|
6.2%
11/178
|
3.8%
1/26
|
|
Investigations
Blood pressure increased
|
15.4%
2/13
|
15.2%
27/178
|
46.2%
12/26
|
|
Investigations
Blood pressure systolic decreased
|
7.7%
1/13
|
0.56%
1/178
|
3.8%
1/26
|
|
Investigations
Blood pressure systolic increased
|
0.00%
0/13
|
1.7%
3/178
|
7.7%
2/26
|
|
Investigations
Blood urea increased
|
7.7%
1/13
|
3.4%
6/178
|
0.00%
0/26
|
|
Investigations
Blood urine present
|
7.7%
1/13
|
7.9%
14/178
|
3.8%
1/26
|
|
Investigations
Brain natriuretic peptide increased
|
7.7%
1/13
|
0.00%
0/178
|
0.00%
0/26
|
|
Investigations
Eosinophil count increased
|
0.00%
0/13
|
5.1%
9/178
|
15.4%
4/26
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/13
|
8.4%
15/178
|
3.8%
1/26
|
|
Investigations
Glucose urine present
|
0.00%
0/13
|
6.2%
11/178
|
7.7%
2/26
|
|
Investigations
Lymphocyte count decreased
|
7.7%
1/13
|
19.7%
35/178
|
19.2%
5/26
|
|
Investigations
Protein total decreased
|
0.00%
0/13
|
2.2%
4/178
|
7.7%
2/26
|
|
Investigations
Red blood cells urine positive
|
7.7%
1/13
|
7.3%
13/178
|
7.7%
2/26
|
|
Investigations
White blood cell count increased
|
7.7%
1/13
|
16.3%
29/178
|
26.9%
7/26
|
|
Investigations
White blood cells urine positive
|
23.1%
3/13
|
10.1%
18/178
|
11.5%
3/26
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/13
|
2.2%
4/178
|
7.7%
2/26
|
|
Musculoskeletal and connective tissue disorders
Atlantoaxial instability
|
7.7%
1/13
|
0.56%
1/178
|
0.00%
0/26
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.7%
1/13
|
12.4%
22/178
|
11.5%
3/26
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
7.7%
1/13
|
3.4%
6/178
|
3.8%
1/26
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
7.7%
1/13
|
3.4%
6/178
|
0.00%
0/26
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
15.4%
2/13
|
2.2%
4/178
|
0.00%
0/26
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
7.7%
1/13
|
6.7%
12/178
|
7.7%
2/26
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
7.7%
1/13
|
1.7%
3/178
|
3.8%
1/26
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
7.7%
1/13
|
4.5%
8/178
|
3.8%
1/26
|
|
Musculoskeletal and connective tissue disorders
Tendon disorder
|
7.7%
1/13
|
0.00%
0/178
|
0.00%
0/26
|
|
Nervous system disorders
Dizziness
|
0.00%
0/13
|
5.1%
9/178
|
11.5%
3/26
|
|
Nervous system disorders
Headache
|
0.00%
0/13
|
8.4%
15/178
|
11.5%
3/26
|
|
Nervous system disorders
Hypoaesthesia
|
7.7%
1/13
|
3.9%
7/178
|
0.00%
0/26
|
|
Nervous system disorders
Sciatica
|
7.7%
1/13
|
1.7%
3/178
|
3.8%
1/26
|
|
Nervous system disorders
Syncope
|
7.7%
1/13
|
0.00%
0/178
|
0.00%
0/26
|
|
Psychiatric disorders
Insomnia
|
15.4%
2/13
|
11.2%
20/178
|
15.4%
4/26
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.7%
1/13
|
11.8%
21/178
|
0.00%
0/26
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal discomfort
|
7.7%
1/13
|
0.56%
1/178
|
0.00%
0/26
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
15.4%
2/13
|
5.1%
9/178
|
0.00%
0/26
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal erythema
|
7.7%
1/13
|
1.1%
2/178
|
3.8%
1/26
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
15.4%
2/13
|
6.2%
11/178
|
3.8%
1/26
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
38.5%
5/13
|
15.7%
28/178
|
7.7%
2/26
|
|
Skin and subcutaneous tissue disorders
Acne
|
7.7%
1/13
|
0.56%
1/178
|
3.8%
1/26
|
|
Skin and subcutaneous tissue disorders
Eczema
|
7.7%
1/13
|
16.3%
29/178
|
7.7%
2/26
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.00%
0/13
|
8.4%
15/178
|
7.7%
2/26
|
|
Skin and subcutaneous tissue disorders
Rash
|
15.4%
2/13
|
8.4%
15/178
|
15.4%
4/26
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
7.7%
1/13
|
0.00%
0/178
|
0.00%
0/26
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/13
|
1.1%
2/178
|
7.7%
2/26
|
|
Vascular disorders
Hypertension
|
15.4%
2/13
|
7.3%
13/178
|
3.8%
1/26
|
|
Metabolism and nutrition disorders
Decreased appetite
|
7.7%
1/13
|
0.56%
1/178
|
0.00%
0/26
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/13
|
2.2%
4/178
|
7.7%
2/26
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
7.7%
1/13
|
0.56%
1/178
|
0.00%
0/26
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
15.4%
2/13
|
0.56%
1/178
|
0.00%
0/26
|
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