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A Phase III Study of Abatacept in Japanese Subjects With Rheumatoid Arthritis

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ClinicalTrials.gov Identifier: NCT00484289
Recruitment Status : Completed
First Posted : June 8, 2007
Results First Posted : August 9, 2012
Last Update Posted : June 24, 2013
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Rheumatoid Arthritis
Intervention Drug: Abatacept
Enrollment 217
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Participants From Phase I Study (IM101-034); Abatacept 10mg/kg Participants From Phase II Study(IM101-071); Abatacept 10mg/kg New Participants With MTX Intolerance; Abatacept 10 mg/kg
Hide Arm/Group Description 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 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. 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.
Period Title: Long Term Phase
Started 13 178 26
Completed 10 [1] 142 [1] 10 [1]
Not Completed 3 36 16
Reason Not Completed
Adverse Event             1             17             5
Withdrawal by Subject             0             7             6
Inadequate response             2             7             4
Other Reason             0             5             1
[1]
Completed participants entered postmarketing phase.
Period Title: Post Marketing Phase
Started 10 142 10
Completed 10 141 10
Not Completed 0 1 0
Reason Not Completed
Adverse Event             0             1             0
Arm/Group Title Participants From Phase I Study (IM101-034); Abatacept 10mg/kg Participants From Phase II Study(IM101-071); Abatacept 10mg/kg New Participants With MTX Intolerance; Abatacept 10 mg/kg Total
Hide Arm/Group Description 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 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. 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 of all reporting groups
Overall Number of Baseline Participants 13 178 26 217
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 13 participants 178 participants 26 participants 217 participants
52.8  (11.6) 53.2  (11.5) 57.8  (10.6) 53.8  (11.4)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 13 participants 178 participants 26 participants 217 participants
20 - 29 years 1 7 0 8
30 - 39 years 2 13 1 16
40 - 49 years 0 39 5 44
50 - 59 years 6 70 7 83
≥ 60 years 4 49 13 66
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 178 participants 26 participants 217 participants
Female
12
  92.3%
146
  82.0%
19
  73.1%
177
  81.6%
Male
1
   7.7%
32
  18.0%
7
  26.9%
40
  18.4%
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 13 participants 178 participants 26 participants 217 participants
55.2  (9.7) 56.9  (9.4) 53.9  (10.8) 56.5  (9.6)
Duration of Rheumatoid Arthritis  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 13 participants 178 participants 26 participants 217 participants
<= 2 years 0 24 2 26
>2 to <= 5 years 2 45 4 51
> 5 to <= 10 years 2 57 12 71
> 10 years 9 52 8 69
American College of Rheumatology (ACR) Functional Status Classification   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 13 participants 178 participants 26 participants 217 participants
Class I 0 29 0 29
Class II 12 112 17 141
Class III 1 37 9 47
Class IV 0 0 0 0
[1]
Measure Description: ACR Classification Criteria for Determining Progression of Rheumatoid Arthritis – Class I: Completely able to perform usual activities of daily living; II: Able to perform usual self-care and vocational activities, but limited in avocational activities ; III: Able to perform usual self-care activities, but limited in vocational and avocational activities ; IV: Limited ability to perform usual self-care, vocational, and avocational activities
Number of Tender Joints   [1] 
Mean (Standard Deviation)
Unit of measure:  Joints
Number Analyzed 13 participants 178 participants 26 participants 217 participants
8.4  (5.2) 14.3  (11.2) 22.7  (13.3) 14.9  (11.6)
[1]
Measure Description: Tender joints are an indicator of Rheumatoid Arthritis. The number of tender joints in a standard 68 joint count was evaluated. The number of tender joints ranges from 0 tender joints to 68, where an increased number of tender joints indicates increasing level of disease severity.
Number of Swollen Joints   [1] 
Mean (Standard Deviation)
Unit of measure:  Joints
Number Analyzed 13 participants 178 participants 26 participants 217 participants
9.1  (4.7) 11.6  (8.7) 17.2  (10.0) 12.1  (8.9)
[1]
Measure Description: Swollen joints are an indicator of Rheumatoid Arthritis. The number of swollen joints in a standard 66 joint count was evaluated. The number of swollen joints ranges from 0 swollen joints to 66, where an increased number of swollen joints indicate increasing level of disease severity.
Participant Pain Assessment   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 13 participants 178 participants 26 participants 217 participants
43.1  (23.5) 52.3  (24.9) 80.6  (20.1) 55.1  (26.0)
[1]
Measure Description: The participant self-reported pain assessment is a core component of the ACR scoring system where increasing score indicates increasing level of severity as indicated on a 100 mm Visual Analog Scale (VAS) with 0 mm representing “no pain” and 100 mm representing the “most pain possible”.
Physical Function (Health Assessment Questionnaire [HAQ])   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 13 participants 178 participants 26 participants 217 participants
0.98  (0.57) 1.16  (0.75) 1.80  (0.90) 1.22  (0.79)
[1]
Measure Description: 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 baseline in HAQ disability Index.
Physician Global Assessment   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 13 participants 178 participants 26 participants 217 participants
56.5  (24.7) 47.5  (24.0) 75.5  (16.5) 51.4  (24.9)
[1]
Measure Description: Physician Global Assessment of the participant’s disease activity using a visual analog scale (VAS) of 0 - 100 mm with 100 mm being the worst case), a component of the ACR criteria.
Participant Global Assessment   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 13 participants 178 participants 26 participants 217 participants
47.1  (20.7) 50.8  (23.8) 77.3  (20.4) 53.7  (24.8)
[1]
Measure Description: Participants used a horizontal visual analog scale (VAS) of 100 mm for overall assessment of rheumatoid arthritis. Scale ranged from 0 (very well) to 100 (very poor). Participants were instructed to draw a vertical through a horizontal line to indicate state of rheumatoid arthritis. Distance from the "very well" end of the horizontal line to the vertical line drawn by the participant was the global disease assessment score on a scale of 1-10, where 1=controlled or equivocal rheumatoid arthritis activity, 1.1-4=mild activity, 4.1-8=moderate activity, and 8.1-10=high activity.
C-Reactive Protein (CRP) Level   [1] 
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 13 participants 178 participants 26 participants 217 participants
1.84  (2.84) 2.32  (2.18) 4.67  (3.65) 2.57  (2.55)
[1]
Measure Description: CRP is a acute phase reactant protein that is a clinical marker for Rheumatoid Arthritis (RA). Levels of CRP can be used to determine DAS 28.
Morning stiffness  
Mean (Standard Deviation)
Unit of measure:  Minutes
Number Analyzed 13 participants 178 participants 26 participants 217 participants
117.7  (201.3) 72.7  (124.9) 166.6  (195.7) 86.7  (143.0)
Rheumatoid Factor Status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 13 participants 178 participants 26 participants 217 participants
Negative (<=20 IU/mL) 1 24 4 29
Positive (>20 IU/mL) 12 154 22 188
[1]
Measure Description: 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 in itself is 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 IU/mL and considered negative if value is <20.
Methotrexate Usage at Registration   [1] 
Mean (Standard Deviation)
Unit of measure:  Mg/week
Number Analyzed 13 participants 178 participants 26 participants 217 participants
7.11  (1.45) 7.11  (1.07) NA [2]   (NA) 7.11  (1.09)
[1]
Measure Description: n=9, 175, and 0 for participants from phase I study,phase II study, and new participants with MTX, respectively.
[2]
This arm had only participants to whom MTX could not be administered for safety reasons
Oral Corticosteroids Usage at Registration   [1] 
Mean (Standard Deviation)
Unit of measure:  Mg/day
Number Analyzed 13 participants 178 participants 26 participants 217 participants
6.15  (2.37) 5.67  (2.38) 6.78  (2.48) 5.85  (2.41)
[1]
Measure Description: Dosage of oral corticosteroids was calculated using prednisolone volume. n=13, 146, and 23 for participants from phase I study, phase II study, and new participants with MTX, respectively.
1.Primary Outcome
Title Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE), and Discontinuations Due to AEs
Hide Description 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.
Time Frame 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).
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants who received at least 1 dose of the study drug.
Arm/Group Title Participants From Phase I Study (IM101-034); Abatacept 10mg/kg Participants From Phase II Study(IM101-071); Abatacept 10mg/kg New Participants With MTX Intolerance; Abatacept 10 mg/kg
Hide Arm/Group Description:
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 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.
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.
Overall Number of Participants Analyzed 13 178 26
Measure Type: Number
Unit of Measure: participants
SAEs 4 50 14
Drug-related SAEs 2 26 9
AEs 13 176 24
Drug-related AEs 13 165 24
Discontinuation due to SAEs 0 14 5
Discontinuation due to AEs 1 18 5
Deaths 0 1 0
2.Primary Outcome
Title Number of Participants With Abnormal Laboratory Changes (ALC)
Hide Description 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.
Time Frame 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).
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants who received at least 1 dose of the study drug.
Arm/Group Title Participants From Phase I Study (IM101-034); Abatacept 10mg/kg Participants From Phase II Study(IM101-071); Abatacept 10mg/kg New Participants With MTX Intolerance; Abatacept 10 mg/kg
Hide Arm/Group Description:
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 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.
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.
Overall Number of Participants Analyzed 13 178 26
Measure Type: Number
Unit of Measure: participants
Participants with Serious ALC 0 0 1
Discontinuations due Serious ALC 0 0 0
Participants with drug related Serious ALC 0 0 1
Participants with ALC 0 1 0
Discontinuations due ALC 7 125 19
Discontinuations due ALC 6 102 13
3.Primary Outcome
Title Number of Participants With Vital Signs, Physical Examinations, and Electrocardiogram Findings That Were Considered to be AEs by the Investigator
Hide Description [Not Specified]
Time Frame 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).
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants who received at least 1 dose of the study drug.
Arm/Group Title Participants From Phase I Study (IM101-034); Abatacept 10mg/kg Participants From Phase II Study(IM101-071); Abatacept 10mg/kg New Participants With MTX Intolerance; Abatacept 10 mg/kg
Hide Arm/Group Description:
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 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.
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.
Overall Number of Participants Analyzed 13 178 26
Measure Type: Number
Unit of Measure: participants
Blood pressure increased 2 27 12
Blood pressure decreased 1 11 1
Blood pressure diastolic decreased 0 7 0
Blood pressure systolic increased 0 3 2
Weight decreased 0 5 0
Weight increased 0 3 1
Body temperature decreased 0 3 0
Body temperature increased 0 2 0
Blood pressure systolic decreased 1 1 1
Blood pressure diastolic increased 0 1 0
Electrocardiogram abnormal 0 1 0
Electrocardiogram ST segment depression 0 1 0
Electrocardiogram ST-T segment abnormal 0 1 0
Heart rate increased 0 2 0
Heart rate decreased 0 1 0
4.Secondary Outcome
Title Percentage of Participants With American College of Rheumatology (ACR 20) Response Over Time
Hide Description 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.
Time Frame At weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192.
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants who received at least 1 dose of the study drug. n = number of participants assessed at given time point.
Arm/Group Title Participants From Phase I Study (IM101-034); Abatacept 10mg/kg Participants From Phase II Study(IM101-071); Abatacept 10mg/kg New Participants With MTX Intolerance; Abatacept 10 mg/kg
Hide Arm/Group Description:
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 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.
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.
Overall Number of Participants Analyzed 13 178 26
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Week 4; (n=13, 178,26)
30.8
(9.1 to 61.4)
29.2
(22.7 to 36.5)
34.6
(17.2 to 55.7)
Week 12; (n=13, 178,24)
76.9
(46.2 to 95.0)
47.2
(39.7 to 54.8)
58.3
(36.6 to 77.9)
Week 24; (n=13, 176, 23)
76.9
(46.2 to 95.0)
59.7
(52.0 to 67.0)
78.3
(56.3 to 92.5)
Week 36; (n=13, 175, 20)
69.2
(38.6 to 90.9)
61.7
(54.1 to 68.9)
90.0
(68.3 to 98.8)
Week 48; (n=13, 170, 18)
61.5
(31.6 to 86.1)
63.5
(55.8 to 70.8)
88.9
(65.3 to 98.6)
Week 60; (n=13, 165, 17)
69.2
(38.6 to 90.9)
69.7
(62.1 to 76.6)
94.1
(71.3 to 99.9)
Week 72; (n=13, 161, 17)
84.6
(54.6 to 98.1)
67.7
(59.9 to 74.8)
94.1
(71.3 to 99.9)
Week 84; (n=13, 161, 17)
61.5
(31.6 to 86.1)
67.1
(59.2 to 74.3)
100.0
(80.5 to 100.0)
Week 96; (n=13, 160, 17)
69.2
(38.6 to 90.9)
63.8
(55.8 to 71.2)
82.4
(56.6 to 96.2)
Week 108; (n=13, 156, 15)
53.8
(25.1 to 80.8)
67.9
(60.0 to 75.2)
100.0
(78.2 to 100.0)
Week 120; (n=13, 154, 15)
69.2
(38.6 to 90.9)
69.5
(61.6 to 76.6)
100.0
(78.2 to 100.0)
Week 132; (n=13, 151, 14)
61.5
(31.6 to 86.1)
68.9
(60.8 to 76.2)
100.0
(76.8 to 100.0)
Week 144; (n=12, 142, 13)
58.3
(27.7 to 84.8)
69.7
(61.5 to 77.1)
84.6
(54.6 to 98.1)
Week 156; (n=11, 113, 12)
63.6
(30.8 to 89.1)
66.4
(56.9 to 75.0)
100.0
(73.5 to 100.0)
Week 168; (n=10, 80, 8)
80.0
(44.4 to 97.5)
71.3
(60.0 to 80.8)
100.0
(63.1 to 100.0)
Week 180; (n=8, 56, 4)
62.5
(24.5 to 91.5)
69.6
(55.9 to 81.2)
100.0
(39.8 to 100.0)
Week 192; (n=3, 7, 1)
66.7
(9.4 to 99.2)
85.7
(42.1 to 99.6)
100.0
(2.5 to 100.0)
5.Secondary Outcome
Title Percentage of Participants With ACR 50 Response Over Time
Hide Description 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.
Time Frame At weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192.
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants who received at least 1 dose of the study drug. n = Number of participants assessed at given time point.
Arm/Group Title Participants From Phase I Study (IM101-034); Abatacept 10mg/kg Participants From Phase II Study(IM101-071); Abatacept 10mg/kg New Participants With MTX Intolerance; Abatacept 10 mg/kg
Hide Arm/Group Description:
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 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.
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.
Overall Number of Participants Analyzed 13 178 26
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Week 4; (n=13, 178, 26)
15.4
(1.9 to 45.4)
6.2
(3.1 to 10.8)
0
(0 to 13.2)
Week 12; (n=13, 178,24)
38.5
(13.9 to 68.4)
16.3
(11.2 to 22.6)
29.2
(12.6 to 51.1)
Week 24; (n=13, 176, 23)
30.8
(9.1 to 61.4)
25.6
(19.3 to 32.7)
47.8
(26.8 to 69.4)
Week 36; (n=13, 175, 20)
38.5
(13.9 to 68.4)
28.6
(22.0 to 35.9)
50.0
(27.2 to 72.8)
Week 48; (n=13, 170, 18)
15.4
(1.9 to 45.4)
38.8
(31.5 to 46.6)
72.2
(46.5 to 90.3)
Week 60; (n=13, 165, 17)
30.8
(9.1 to 61.4)
42.4
(34.8 to 50.3)
58.8
(32.9 to 81.6)
Week 72; (n=13, 161, 17)
46.2
(19.2 to 74.9)
43.5
(35.7 to 51.5)
70.6
(44.0 to 89.7)
Week 84; (n=13, 161, 17)
38.5
(13.9 to 68.4)
42.2
(34.5 to 50.3)
70.6
(44.0 to 89.7)
Week 96; (n=13, 160, 17)
23.1
(5.0 to 53.8)
38.1
(30.6 to 46.1)
58.8
(32.9 to 81.6)
Week 108; (n=13, 156, 15)
23.1
(5.0 to 53.8)
42.3
(34.4 to 50.5)
66.7
(38.4 to 88.2)
Week 120; (n=13, 154, 15)
46.2
(19.2 to 74.9)
45.5
(37.4 to 53.7)
93.3
(68.1 to 99.8)
Week 132; (n=13, 151, 14)
38.5
(13.9 to 68.4)
43.7
(35.7 to 52.0)
85.7
(57.2 to 98.2)
Week 144; (n=12, 142, 13)
25.0
(5.5 to 57.2)
47.2
(38.8 to 55.7)
69.2
(38.6 to 90.9)
Week 156; (n=11, 113, 12)
36.4
(10.9 to 69.2)
47.8
(38.3 to 57.4)
83.3
(51.6 to 97.9)
Week 168; (n=10, 80, 8)
30.0
(6.7 to 65.2)
47.5
(36.2 to 59.0)
87.5
(47.3 to 99.7)
Week 180; (n=8, 56, 4)
12.5
(0.3 to 52.7)
51.8
(38.0 to 65.3)
75.0
(19.4 to 99.4)
Week 192; (n=3, 7, 1)
66.7
(9.4 to 99.2)
71.4
(29.0 to 96.3)
100.0
(2.5 to 100.0)
6.Secondary Outcome
Title Percentage of Participants With ACR 70 Response Over Time
Hide Description 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.
Time Frame At weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192.
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants who received at least 1 dose of the study drug. n = Number of participants assessed at given time point.
Arm/Group Title Participants From Phase I Study (IM101-034); Abatacept 10mg/kg Participants From Phase II Study(IM101-071); Abatacept 10mg/kg New Participants With MTX Intolerance; Abatacept 10 mg/kg
Hide Arm/Group Description:
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 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.
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.
Overall Number of Participants Analyzed 13 178 26
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Week 4; (n=13, 178, 26)
7.7
(0.2 to 36.0)
0
(0 to 2.1)
0
(0 to 13.2)
Week 12; (n=13, 178, 24)
7.7
(0.2 to 36.0)
5.6
(2.7 to 10.1)
8.3
(1.0 to 27.0)
Week 24; (n=13, 176, 23)
7.7
(0.2 to 36.0)
10.8
(6.6 to 16.3)
21.7
(7.5 to 43.7)
Week 36; (n=13, 175, 20)
15.4
(1.9 to 45.4)
11.4
(7.1 to 17.1)
20.0
(5.7 to 43.7)
Week 48; (n=13, 170, 18)
15.4
(1.9 to 45.4)
15.3
(10.2 to 21.6)
27.8
(9.7 to 53.5)
Week 60; (n=13, 165, 17)
15.4
(1.9 to 45.4)
19.4
(13.7 to 26.3)
29.4
(10.3 to 56.0)
Week 72; (n=13, 161, 17)
15.4
(1.9 to 45.4)
18.6
(12.9 to 25.5)
23.5
(6.8 to 49.9)
Week 84; (n=13, 161, 17)
7.7
(0.2 to 36.0)
17.4
(11.9 to 24.1)
23.5
(6.8 to 49.9)
Week 96; (n=13, 160, 17)
7.7
(0.2 to 36.0)
19.4
(13.6 to 26.4)
23.5
(6.8 to 49.9)
Week 108; (n=13, 156, 15)
7.7
(0.2 to 36.0)
15.4
(10.1 to 22.0)
33.3
(11.8 to 61.6)
Week 120; (n=13, 154, 15)
7.7
(0.2 to 36.0)
19.5
(13.5 to 26.6)
46.7
(21.3 to 73.4)
Week 132; (n=13, 151, 14)
0
(0 to 24.7)
20.5
(14.4 to 27.9)
42.9
(17.7 to 71.1)
Week 144; (n=12, 142, 13)
0
(0 to 26.5)
21.8
(15.3 to 29.5)
23.1
(5.0 to 53.8)
Week 156; (n=11, 113, 12)
0
(0 to 28.5)
25.7
(17.9 to 34.7)
33.3
(9.9 to 65.1)
Week 168; (n=10, 80, 8)
0
(0 to 30.8)
27.5
(18.1 to 38.6)
62.5
(24.5 to 91.5)
Week 180; (n=8, 56, 4)
0
(0 to 36.9)
33.9
(21.8 to 47.8)
50.0
(6.8 to 93.2)
Week 192; (n=3, 7, 1)
0
(0 to 70.8)
14.3
(0.4 to 57.9)
100.0
(2.5 to 100.0)
7.Secondary Outcome
Title Baseline (BL) and Postbaseline (PBL) Disease Activity Scores (DAS 28)
Hide Description 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.
Time Frame At BL (week 0), week 24, 48, 96, 144, and 192.
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Participants From Phase I Study (IM101-034); Abatacept 10mg/kg Participants From Phase II Study(IM101-071); Abatacept 10mg/kg New Participants With MTX Intolerance; Abatacept 10 mg/kg
Hide Arm/Group Description:
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 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.
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.
Overall Number of Participants Analyzed 13 178 26
Mean (Standard Deviation)
Unit of Measure: Units on a Scale
Week 24- BL (n=13, 176, 21) 4.4  (1.0) 4.8  (1.4) 6.3  (1.0)
Week 24- PBL (n=13, 176, 21) 3.0  (1.1) 3.2  (1.1) 4.0  (1.9)
Week 48- BL (n=13, 168, 18) 4.4  (1.0) 4.8  (1.4) 6.3  (1.0)
Week 48- PBL (n=13, 168, 18) 3.0  (1.1) 2.9  (1.1) 3.5  (1.4)
Week 96- BL (n=13, 159, 17) 4.4  (1.0) 4.8  (1.4) 6.2  (1.0)
Week 96- PBL (n=13, 159, 17) 3.3  (1.0) 2.8  (1.0) 3.2  (1.0)
Week 144- BL (n=12, 142, 13) 4.3  (0.9) 4.9  (1.4) 6.3  (1.0)
Week 144- PBL (n=12, 142, 13) 3.0  (0.9) 2.8  (1.0) 3.2  (1.2)
Week 192- BL (n=3, 7, 1) 4.6  (1.6) 5.4  (0.9) 7.9 [1]   (NA)
Week 192- PBL (n=3, 7, 1) 2.6  (1.2) 3.1  (1.4) 1.9 [1]   (NA)
[1]
Not applicable as there was only 1 participant in the group with both BL and PBL values.
8.Secondary Outcome
Title Change From Baseline in DAS 28 Scores at Week 24, 48, 96, 144, and 192
Hide Description 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.
Time Frame At BL (week 0), weeks 24, 48, 96, 144, and 192.
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Participants From Phase I Study (IM101-034); Abatacept 10mg/kg Participants From Phase II Study(IM101-071); Abatacept 10mg/kg New Participants With MTX Intolerance; Abatacept 10 mg/kg
Hide Arm/Group Description:
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 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.
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.
Overall Number of Participants Analyzed 13 178 26
Mean (95% Confidence Interval)
Unit of Measure: Units on a Scale
Week 24 (n=13, 176, 21)
-1.4
(-2.0 to -0.8)
-1.7
(-1.8 to -1.5)
-2.3
(-2.9 to -1.7)
Week 48 (n=13, 168, 18)
-1.4
(-2.0 to -0.9)
-1.9
(-2.1 to -1.7)
-2.8
(-3.3 to -2.3)
Week 96 (n=13, 159, 17)
-1.1
(-1.7 to -0.6)
-2.0
(-2.3 to -1.8)
-3.0
(-3.6 to -2.4)
Week 144 (n=12, 142, 13)
-1.3
(-1.8 to -0.8)
-2.1
(-2.3 to -1.9)
-3.1
(-4.0 to -2.2)
Week 192 (n=3, 7, 1)
-2.0
(-3.4 to -0.6)
-2.3
(-3.6 to -1.1)
-6.0 [1] 
(NA to NA)
[1]
Not applicable as there was only 1 participant in the group with both BL and PBL values.
9.Secondary Outcome
Title Number of Participants With DAS 28 Score Change ≥ 1.2 From Baseline at Weeks 24, 48, 96, 144, and 192
Hide Description

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.

Time Frame At BL (week 0), weeks 24, 48, 96, 144, and 192.
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Participants From Phase I Study (IM101-034); Abatacept 10mg/kg Participants From Phase II Study(IM101-071); Abatacept 10mg/kg New Participants With MTX Intolerance; Abatacept 10 mg/kg
Hide Arm/Group Description:
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 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.
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.
Overall Number of Participants Analyzed 13 178 26
Measure Type: Number
Unit of Measure: participants
Week 24 (n=13, 176, 21) 9 113 17
Week 48 (n=13, 168, 18) 8 114 16
Week 96 (n=13, 159, 17) 7 111 16
Week 144 (n=12, 142, 13) 6 107 12
Week 192 (n=3, 7, 1) 3 5 1
10.Secondary Outcome
Title Number of Participants With Low Disease Activity Score (DAS 28 Score ≤ 3.2) at Weeks 24, 48, 96, 144, 192
Hide Description 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.
Time Frame At weeks 24, 48, 96, 144, and 192.
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants who received at least 1 dose of the study drug. n = participants with available scores at the given time point.
Arm/Group Title Participants From Phase I Study (IM101-034); Abatacept 10mg/kg Participants From Phase II Study(IM101-071); Abatacept 10mg/kg New Participants With MTX Intolerance; Abatacept 10 mg/kg
Hide Arm/Group Description:
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 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.
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.
Overall Number of Participants Analyzed 13 178 26
Measure Type: Number
Unit of Measure: participants
Week 24 (n=13, 176, 21) 9 95 6
Week 48 (n=13, 168, 18) 9 105 7
Week 96 (n=13, 159, 17) 6 101 6
Week 144 (n=12, 142, 13) 6 95 7
Week 192 (n=3, 7, 1) 2 3 1
11.Secondary Outcome
Title Number of Participants in Remission (DAS 28 Score < 2.6) at Weeks 24, 48, 96, 144, 192
Hide Description

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.

Time Frame At weeks 24, 48, 96, 144, and 192.
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants who received at least 1 dose of the study drug. n = participants with available scores at the given time point.
Arm/Group Title Participants From Phase I Study (IM101-034); Abatacept 10mg/kg Participants From Phase II Study(IM101-071); Abatacept 10mg/kg New Participants With MTX Intolerance; Abatacept 10 mg/kg
Hide Arm/Group Description:
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 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.
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.
Overall Number of Participants Analyzed 13 178 26
Measure Type: Number
Unit of Measure: participants
Week 24 (n=13, 176, 21) 6 60 6
Week 48 (n=13, 168, 18) 4 75 5
Week 96 (n=13, 159, 17) 3 75 5
Week 144 (n=12, 142, 13) 4 71 3
Week 192 (n=3, 7, 1) 2 2 1
12.Secondary Outcome
Title 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
Hide Description 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.
Time Frame At BL (week 0), weeks 24, 48, 96, 144, and 192.
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Participants From Phase I Study (IM101-034); Abatacept 10mg/kg Participants From Phase II Study(IM101-071); Abatacept 10mg/kg New Participants With MTX Intolerance; Abatacept 10 mg/kg
Hide Arm/Group Description:
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 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.
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.
Overall Number of Participants Analyzed 13 178 26
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Week 24 (n=13, 176, 23)
38.5
(13.9 to 68.4)
39.2
(31.9 to 46.8)
52.2
(30.6 to 73.2)
Week 48 (n=13, 170, 18)
30.8
(9.1 to 61.4)
41.2
(33.7 to 49.0)
77.8
(52.4 to 93.6)
Week 96 (n=13, 160, 17)
46.2
(19.2 to 74.9)
47.5
(39.6 to 55.5)
76.5
(50.1 to 93.2)
Week 144 (n=12, 142, 13)
50.0
(21.1 to 78.9)
48.6
(40.1 to 57.1)
69.2
(38.6 to 90.9)
Week 192 (n=3, 7, 1)
100.0
(29.2 to 100.0)
85.7
(42.1 to 99.6)
100.0
(2.5 to 100.0)
13.Secondary Outcome
Title Baseline and Postbaseline Physical Component Summary (PCS) of Health-Related Quality of Life (SF-36) Scores
Hide Description 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.
Time Frame At BL (week 0), weeks 24, 48, 96, 144, and 192.
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Participants From Phase I Study (IM101-034); Abatacept 10mg/kg Participants From Phase II Study(IM101-071); Abatacept 10mg/kg New Participants With MTX Intolerance; Abatacept 10 mg/kg
Hide Arm/Group Description:
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 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.
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.
Overall Number of Participants Analyzed 13 178 26
Mean (Standard Deviation)
Unit of Measure: Units on a Scale
Week 24- BL (n=13, 176, 23) 34.2  (14.5) 30.3  (15.2) 19.0  (12.5)
Week 24- PBL (n=13, 176, 23) 40.6  (12.6) 38.5  (14.3) 30.3  (17.1)
Week 48- BL (n=13, 170, 18) 34.2  (14.5) 30.4  (15.2) 20.1  (12.4)
Week 48- PBL (n=13, 170, 18) 40.9  (11.1) 40.1  (13.7) 37.1  (14.0)
Week 96- BL (n=13, 160, 17) 34.2  (14.5) 29.8  (15.2) 19.9  (12.7)
Week 96- PBL (n=13, 160, 17) 38.7  (12.6) 40.3  (13.2) 37.5  (13.5)
Week 144- BL (n=12, 142, 13) 32.9  (14.4) 30.6  (15.1) 21.1  (14.0)
Week 144- PBL (n=12, 142, 13) 37.8  (14.5) 39.2  (13.7) 32.9  (14.2)
Week 192- BL (n=3, 7, 1) 24.6  (10.9) 22.8  (12.2) 12.5 [1]   (NA)
Week 192- PBL (n=3, 7, 1) 30.4  (24.8) 38.5  (16.1) 37.0 [1]   (NA)
[1]
Not applicable as there was only 1 participant in the group with both BL and PBL values.
14.Secondary Outcome
Title 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
Hide Description 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.
Time Frame At baseline (week 0), weeks 24, 48, 96, 144, and 192.
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Participants From Phase I Study (IM101-034); Abatacept 10mg/kg Participants From Phase II Study(IM101-071); Abatacept 10mg/kg New Participants With MTX Intolerance; Abatacept 10 mg/kg
Hide Arm/Group Description:
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 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.
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.
Overall Number of Participants Analyzed 13 178 26
Mean (95% Confidence Interval)
Unit of Measure: Units on a Scale
Week 24 (n=13, 176, 23)
6.5
(0 to 13.0)
8.2
(6.4 to 10.0)
11.3
(5.2 to 17.5)
Week 48 (n=13, 170, 18)
6.7
(0.3 to 13.1)
9.7
(7.7 to 11.7)
17.1
(11.1 to 23.0)
Week 96 (n=13, 160, 17)
4.5
(-4.5 to 13.6)
10.4
(8.5 to 12.4)
17.6
(9.7 to 25.5)
Week 144 (n=12, 142, 13)
4.8
(-5.3 to 14.9)
8.6
(6.6 to 10.6)
11.8
(4.4 to 19.1)
Week 192 (n=3, 7, 1)
5.7
(-79.9 to 91.4)
15.7
(0.7 to 30.8)
24.6 [1] 
(NA to NA)
[1]
Not applicable as there was only 1 participant in the group with both BL and PBL values.
15.Secondary Outcome
Title Baseline and Postbaseline Mental Component Summary (MCS) of Health-Related Quality of Life (SF-36) Scores
Hide Description 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.
Time Frame At BL (week 0), weeks 24, 48, 96, 144, and 192.
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Participants From Phase I Study (IM101-034); Abatacept 10mg/kg Participants From Phase II Study(IM101-071); Abatacept 10mg/kg New Participants With MTX Intolerance; Abatacept 10 mg/kg
Hide Arm/Group Description:
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 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.
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.
Overall Number of Participants Analyzed 13 178 26
Mean (Standard Deviation)
Unit of Measure: Units on a Scale
Week 24- BL (n=13, 176, 23) 41.6  (12.4) 48.6  (8.5) 41.7  (9.8)
Week 24- PBL (n=13, 176, 23) 45.2  (8.9) 51.2  (7.5) 49.5  (10.5)
Week 48- BL (n=13, 170, 18) 41.6  (12.4) 48.6  (8.5) 43.2  (9.6)
Week 48- PBL (n=13, 170, 18) 49.0  (8.0) 51.6  (8.1) 49.9  (7.5)
Week 96- BL (n=13, 160, 17) 41.6  (12.4) 48.6  (8.5) 43.6  (9.8)
Week 96- PBL (n=13, 160, 17) 49.9  (7.2) 50.6  (7.5) 51.6  (8.2)
Week 144- BL (n=12, 142, 13) 41.6  (13.0) 48.5  (8.6) 42.2  (9.4)
Week 144- PBL (n=12, 142, 13) 51.1  (7.6) 50.6  (7.3) 51.1  (8.4)
Week 192- BL (n=3, 7, 1) 45.7  (20.4) 45.4  (8.1) 37.1 [1]   (NA)
Week 192- PBL (n=3, 7, 1) 60.7  (6.1) 52.4  (12.5) 69.3 [1]   (NA)
[1]
Not applicable as there was only 1 participant in the group with both BL and PBL values.
16.Secondary Outcome
Title 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
Hide Description 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.
Time Frame At BL (Week 0), weeks 24, 48, 96, 144, and 192.
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Participants From Phase I Study (IM101-034); Abatacept 10mg/kg Participants From Phase II Study(IM101-071); Abatacept 10mg/kg New Participants With MTX Intolerance; Abatacept 10 mg/kg
Hide Arm/Group Description:
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 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.
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.
Overall Number of Participants Analyzed 13 178 26
Mean (95% Confidence Interval)
Unit of Measure: Units on a Scale
Week 24 (n=13, 176, 23)
3.6
(-1.3 to 8.6)
2.6
(1.5 to 3.7)
7.7
(1.7 to 13.8)
Week 48 (n=13, 170, 18)
7.4
(2.5 to 12.3)
3.0
(1.7 to 4.3)
6.7
(1.4 to 11.9)
Week 96 (n=13, 160, 17)
8.3
(2.0 to 14.6)
2.1
(0.7 to 3.4)
8.0
(1.9 to 14.2)
Week 144 (n=12, 142, 13)
9.5
(3.4 to 15.6)
2.1
(0.8 to 3.5)
8.9
(1.9 to 15.9)
Week 192 (n=3, 7, 1)
15.0
(-49.5 to 79.6)
7.0
(-5.2 to 19.3)
32.1 [1] 
(NA to NA)
[1]
Not applicable as there was only 1 participant in the group with both BL and PBL values.
17.Secondary Outcome
Title Baseline and Postbaseline C-reactive Protein (CRP) Levels
Hide Description 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.
Time Frame At BL (week 0), weeks 24, 48, 96, 144, and 192.
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Participants From Phase I Study (IM101-034); Abatacept 10mg/kg Participants From Phase II Study(IM101-071); Abatacept 10mg/kg New Participants With MTX Intolerance; Abatacept 10 mg/kg
Hide Arm/Group Description:
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 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.
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.
Overall Number of Participants Analyzed 13 178 26
Mean (Standard Deviation)
Unit of Measure: mg/dL
Week 24- BL (n=13, 176, 21) 1.8  (2.8) 2.3  (2.2) 3.9  (3.1)
Week 24- PBL (n=13, 176, 21) 0.7  (0.7) 0.8  (1.3) 1.9  (2.5)
Week 48- BL (n=13, 168, 18) 1.8  (2.8) 2.2  (2.1) 4.1  (3.1)
Week 48- PBL (n=13, 168, 18) 1.1  (2.1) 0.6  (1.1) 0.9  (1.3)
Week 96- BL (n=13, 159, 17) 1.8  (2.8) 2.3  (2.2) 4.1  (3.2)
Week 96- PBL (n=13, 159, 17) 0.9  (1.3) 0.5  (0.9) 1.0  (1.0)
Week 144- BL (n=12, 142, 13) 1.9  (2.9) 2.4  (2.2) 4.2  (3.4)
Week 144- PBL (n=12, 142, 13) 1.2  (1.4) 0.6  (1.5) 0.6  (0.6)
Week 192- BL (n=3, 7, 1) 4.6  (5.4) 1.7  (1.2) 8.4 [1]   (NA)
Week 192- PBL (n=3, 7, 1) 1.4  (1.7) 0.8  (1.6) 0.2 [1]   (NA)
[1]
Not applicable as there was only 1 participant in the group with both BL and PBL values.
18.Secondary Outcome
Title Percentage Decrease in C-reactive Protein Levels From Baseline at Weeks 24, 48, 96, 144, and 192
Hide Description 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.
Time Frame At BL (week 0), weeks 24, 48, 96, 144, and 192.
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Participants From Phase I Study (IM101-034); Abatacept 10mg/kg Participants From Phase II Study(IM101-071); Abatacept 10mg/kg New Participants With MTX Intolerance; Abatacept 10 mg/kg
Hide Arm/Group Description:
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 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.
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.
Overall Number of Participants Analyzed 13 178 26
Mean (95% Confidence Interval)
Unit of Measure: percentage improvement
Week 24 (n=13, 176, 21)
-18.4
(-147.8 to 111.1)
30.5
(-0.4 to 61.4)
60.2
(42.7 to 77.7)
Week 48 (n=13, 168, 18)
12.0
(-35.9 to 59.9)
31.9
(8.7 to 55.1)
77.8
(65.2 to 90.3)
Week 96 (n=13, 159, 17)
-3.3
(-77.9 to 71.3)
40.5
(21.8 to 59.1)
70.1
(51.0 to 89.2)
Week 144 (n=12, 142, 13)
-71.9
(-188.7 to 44.9)
-39.3
(-191.5 to 113.0)
79.9
(68.0 to 91.7)
Week 192 (n=3, 7, 1)
67.9
(52.0 to 83.7)
39.7
(-83.2 to 162.6)
97.4 [1] 
(NA to NA)
[1]
Not applicable as there was only 1 participant in the group with both baseline and postbaseline values.
19.Secondary Outcome
Title Baseline and Postbaseline Rheumatoid Factor Levels
Hide Description 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.
Time Frame At BL (week 0), weeks 24, 48, 96, 144, and 192.
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Participants From Phase I Study (IM101-034); Abatacept 10mg/kg Participants From Phase II Study(IM101-071); Abatacept 10mg/kg New Participants With MTX Intolerance; Abatacept 10 mg/kg
Hide Arm/Group Description:
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 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.
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.
Overall Number of Participants Analyzed 13 178 26
Mean (Standard Deviation)
Unit of Measure: IU/mL
Week 24- BL (n=13, 176, 21) 200.2  (343.8) 214.3  (383.3) 630.8  (873.4)
Week 24- PBL (n=13, 176, 21) 127.5  (191.6) 141.0  (289.2) 573.9  (897.2)
Week 48- BL (n=13, 168, 18) 200.2  (343.8) 217.3  (389.7) 560.9  (893.0)
Week 48- PBL (n=13, 168, 18) 139.9  (241.8) 149.5  (288.4) 288.3  (482.8)
Week 96- BL (n=13, 159, 17) 200.2  (343.8) 215.9  (393.9) 590.9  (911.1)
Week 96- PBL (n=13, 159, 17) 186.9  (339.4) 151.0  (285.8) 216.8  (329.2)
Week 144- BL (n=12, 142, 13) 205.6  (358.5) 229.0  (412.6) 639.4  (990.8)
Week 144- PBL (n=12, 142, 13) 211.3  (359.8) 173.7  (360.8) 361.6  (663.9)
Week 192- BL (n=3, 7, 1) 314.3  (455.3) 253.7  (307.6) 2800.0 [1]   (NA)
Week 192- PBL (n=3, 7, 1) 315.0  (307.0) 348.4  (521.6) 197.0 [1]   (NA)
[1]
Not applicable as there was only 1 participant in the group with both BL and PBL values.
20.Secondary Outcome
Title Change From Baseline in Rheumatoid Factor Levels at Weeks 24, 48, 96, 144, and 192
Hide Description 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.
Time Frame At BL (week 0), weeks 24, 48, 96, 144, and 192.
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Participants From Phase I Study (IM101-034); Abatacept 10mg/kg Participants From Phase II Study(IM101-071); Abatacept 10mg/kg New Participants With MTX Intolerance; Abatacept 10 mg/kg
Hide Arm/Group Description:
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 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.
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.
Overall Number of Participants Analyzed 13 178 26
Mean (95% Confidence Interval)
Unit of Measure: IU/mL
Week 24 (n=13, 176, 21)
-72.6
(-197.5 to 52.2)
-73.2
(-102.8 to -43.7)
-56.9
(-149.5 to 35.7)
Week 48 (n=13, 168, 18)
-60.2
(-137.9 to 17.4)
-67.8
(-100.4 to -35.2)
-272.6
(-494.0 to -51.2)
Week 96 (n=13, 159, 17)
-13.2
(-63.3 to 36.8)
-64.9
(-103.3 to -26.6)
-374.1
(-704.9 to -43.2)
Week 144 (n=12, 142, 13)
5.7
(-43.0 to 54.4)
-55.3
(-97.2 to -13.3)
-277.8
(-708.2 to 152.7)
Week 192 (n=3, 7, 1)
0.7
(-471.3 to 472.7)
94.7
(-122.5 to 311.9)
-2603 [1] 
(NA to NA)
[1]
Not applicable as there was only 1 participant with both BL and BL measurements.
21.Secondary Outcome
Title Number of Participants Who Were Positive for Anti-abatacept and Anti-CTLA4-T Antibodies
Hide Description 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.
Time Frame At BL (week 0), weeks 24, 48, 72, 96, 120, 144, 168, and 192.
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received study treatment, and had BL and at least one PBL measurement for immunogenicity.
Arm/Group Title Participants From Phase I Study (IM101-034); Abatacept 10mg/kg Participants From Phase II Study(IM101-071); Abatacept 10mg/kg New Participants With MTX Intolerance; Abatacept 10 mg/kg
Hide Arm/Group Description:
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 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.
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.
Overall Number of Participants Analyzed 13 178 26
Measure Type: Number
Unit of Measure: participants
Positive for anti-abatacept antibody 2 19 2
Positive for anti-CTLA4-T antibody 0 19 1
22.Secondary Outcome
Title Abatacept PK Parameter: Total Body Clearance
Hide Description 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.
Time Frame Samples were collected predose at week 8, 12, 16, 24; end of infusion at week 12; and at week 13-15 visits.
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received abatacept and had blood samples for assay.
Arm/Group Title All Participants From IM101-129 Study
Hide Arm/Group Description:
Participants with rheumatoid arthritis (RA) who participated in studies IM101-034 and IM101-071. Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Weeks 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
Overall Number of Participants Analyzed 113
Median (Full Range)
Unit of Measure: L/day
0.306
(0.149 to 0.668)
23.Secondary Outcome
Title Abatacept PK Parameter: Area Under the Serum Concentration-time Curve at Steady State
Hide Description Area under the plasma concentration-time curve (AUCss) at steady state for each dosing interval was determined using the linear trapezoidal rule.
Time Frame Samples were collected predose at week 8, 12, 16, 24; end of infusion at week 12; and at week 13-15 visits.
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received abatacept and had blood samples for assay.
Arm/Group Title All Participants From IM101-129 Study
Hide Arm/Group Description:
Participants with rheumatoid arthritis (RA) who participated in studies IM101-034 and IM101-071. Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Weeks 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
Overall Number of Participants Analyzed 113
Median (Full Range)
Unit of Measure: µg*h/mL
42959.94
(17971.87 to 80321.29)
24.Secondary Outcome
Title Abatacept PK Parameter: Maximum Serum Concentration at Steady State
Hide Description Maximum plasma concentration is the maximum observed serum drug concentration at steady state (Css max).
Time Frame Samples were collected predose at week 8, 12, 16, 24; end of infusion at week 12; and at week 13-15 visits.
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received abatacept and had blood samples for assay.
Arm/Group Title All Participants From IM101-129 Study
Hide Arm/Group Description:
Participants with rheumatoid arthritis (RA) who participated in studies IM101-034 and IM101-071. Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Weeks 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
Overall Number of Participants Analyzed 113
Median (Full Range)
Unit of Measure: µg/mL
241.62
(68.15 to 434.55)
25.Secondary Outcome
Title Abatacept PK Parameter: Minimum Plasma Concentration at Steady State
Hide Description Minimum Plasma Concentration (Cmin) is the minimum observed serum drug concentration at steady state.
Time Frame Samples were collected predose at week 8, 12, 16, 24; end of infusion at week 12; and at week 13-15 visits.
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received abatacept and had blood samples for assay.
Arm/Group Title All Participants From IM101-129 Study
Hide Arm/Group Description:
Participants with rheumatoid arthritis (RA) who participated in studies IM101-034 and IM101-071. Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Weeks 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
Overall Number of Participants Analyzed 113
Median (Full Range)
Unit of Measure: µg/mL
26.14
(0.15 to 127.50)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Participants From Phase I Study (IM101-034); Abatacept 10mg/kg Participants From Phase II Study(IM101-071); Abatacept 10mg/kg New Participants With MTX Intolerance; Abatacept 10 mg/kg
Hide Arm/Group Description 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 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. 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.
All-Cause Mortality
Participants From Phase I Study (IM101-034); Abatacept 10mg/kg Participants From Phase II Study(IM101-071); Abatacept 10mg/kg New Participants With MTX Intolerance; Abatacept 10 mg/kg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Participants From Phase I Study (IM101-034); Abatacept 10mg/kg Participants From Phase II Study(IM101-071); Abatacept 10mg/kg New Participants With MTX Intolerance; Abatacept 10 mg/kg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   4/13 (30.77%)   50/178 (28.09%)   14/26 (53.85%) 
Cardiac disorders       
Atrial fibrillation  1  0/13 (0.00%)  1/178 (0.56%)  0/26 (0.00%) 
Cardiac failure  2  0/13 (0.00%)  1/178 (0.56%)  0/26 (0.00%) 
Mitral valve incompetence  2  0/13 (0.00%)  1/178 (0.56%)  0/26 (0.00%) 
Prinzmetal angina  2  0/13 (0.00%)  1/178 (0.56%)  0/26 (0.00%) 
Ear and labyrinth disorders       
Deafness  2  0/13 (0.00%)  0/178 (0.00%)  1/26 (3.85%) 
Vertigo  2  0/13 (0.00%)  1/178 (0.56%)  0/26 (0.00%) 
Vertigo positional  2  0/13 (0.00%)  1/178 (0.56%)  0/26 (0.00%) 
Eye disorders       
Cataract  2  0/13 (0.00%)  1/178 (0.56%)  1/26 (3.85%) 
Gastrointestinal disorders       
Anal fistula  2  0/13 (0.00%)  1/178 (0.56%)  0/26 (0.00%) 
Gastric ulcer  2  0/13 (0.00%)  0/178 (0.00%)  1/26 (3.85%) 
Inflammatory bowel disease  2  0/13 (0.00%)  0/178 (0.00%)  1/26 (3.85%) 
Radicular cyst  2  0/13 (0.00%)  1/178 (0.56%)  0/26 (0.00%) 
Volvulus  2  0/13 (0.00%)  1/178 (0.56%)  0/26 (0.00%) 
General disorders       
Feeling abnormal  2  0/13 (0.00%)  1/178 (0.56%)  0/26 (0.00%) 
Pyrexia  2  0/13 (0.00%)  1/178 (0.56%)  0/26 (0.00%) 
Hepatobiliary disorders       
Cholelithiasis  2  1/13 (7.69%)  1/178 (0.56%)  0/26 (0.00%) 
Infections and infestations       
Acute sinusitis  2  0/13 (0.00%)  1/178 (0.56%)  0/26 (0.00%) 
Appendicitis  2  0/13 (0.00%)  1/178 (0.56%)  0/26 (0.00%) 
Arthritis bacterial  2  1/13 (7.69%)  0/178 (0.00%)  0/26 (0.00%) 
Bronchitis  2  0/13 (0.00%)  1/178 (0.56%)  0/26 (0.00%) 
Bronchopneumonia  2  0/13 (0.00%)  1/178 (0.56%)  0/26 (0.00%) 
Cellulitis  2  0/13 (0.00%)  2/178 (1.12%)  1/26 (3.85%) 
Fungal infection  2  0/13 (0.00%)  0/178 (0.00%)  1/26 (3.85%) 
Gastroenteritis  2  1/13 (7.69%)  1/178 (0.56%)  0/26 (0.00%) 
Gastroenteritis viral  2  0/13 (0.00%)  0/178 (0.00%)  1/26 (3.85%) 
Osteomyelitis  2  0/13 (0.00%)  1/178 (0.56%)  0/26 (0.00%) 
Otitis media chronic  2  0/13 (0.00%)  0/178 (0.00%)  1/26 (3.85%) 
Pharyngeal abscess  2  0/13 (0.00%)  1/178 (0.56%)  0/26 (0.00%) 
Pneumonia  2  0/13 (0.00%)  2/178 (1.12%)  0/26 (0.00%) 
Sepsis  2  0/13 (0.00%)  1/178 (0.56%)  0/26 (0.00%) 
Subcutaneous abscess  2  0/13 (0.00%)  1/178 (0.56%)  0/26 (0.00%) 
Injury, poisoning and procedural complications       
Contusion  2  0/13 (0.00%)  1/178 (0.56%)  0/26 (0.00%) 
Femoral neck fracture  2  0/13 (0.00%)  1/178 (0.56%)  1/26 (3.85%) 
Femur fracture  2  1/13 (7.69%)  1/178 (0.56%)  0/26 (0.00%) 
Humerus fracture  2  0/13 (0.00%)  1/178 (0.56%)  0/26 (0.00%) 
Joint dislocation  2  0/13 (0.00%)  2/178 (1.12%)  0/26 (0.00%) 
Joint injury  2  0/13 (0.00%)  1/178 (0.56%)  0/26 (0.00%) 
Lower limb fracture  2  0/13 (0.00%)  1/178 (0.56%)  0/26 (0.00%) 
Meniscus lesion  2  0/13 (0.00%)  1/178 (0.56%)  0/26 (0.00%) 
Patella fracture  2  0/13 (0.00%)  2/178 (1.12%)  0/26 (0.00%) 
Rib fracture  2  1/13 (7.69%)  0/178 (0.00%)  0/26 (0.00%) 
Spinal compression fracture  2  0/13 (0.00%)  2/178 (1.12%)  1/26 (3.85%) 
Tendon rupture  2  0/13 (0.00%)  1/178 (0.56%)  1/26 (3.85%) 
Ulna fracture  2  0/13 (0.00%)  1/178 (0.56%)  0/26 (0.00%) 
Investigations       
C-reactive protein increased  2  0/13 (0.00%)  0/178 (0.00%)  1/26 (3.85%) 
Metabolism and nutrition disorders       
Diabetes mellitus  2  0/13 (0.00%)  1/178 (0.56%)  0/26 (0.00%) 
Musculoskeletal and connective tissue disorders       
Arthralgia  2  1/13 (7.69%)  0/178 (0.00%)  0/26 (0.00%) 
Arthritis  2  0/13 (0.00%)  2/178 (1.12%)  0/26 (0.00%) 
Foot deformity  2  1/13 (7.69%)  4/178 (2.25%)  0/26 (0.00%) 
Head deformity  2  0/13 (0.00%)  0/178 (0.00%)  1/26 (3.85%) 
Joint destruction  2  0/13 (0.00%)  5/178 (2.81%)  1/26 (3.85%) 
Knee deformity  2  0/13 (0.00%)  1/178 (0.56%)  0/26 (0.00%) 
Musculoskeletal stiffness  2  0/13 (0.00%)  1/178 (0.56%)  0/26 (0.00%) 
Osteitis  2  0/13 (0.00%)  1/178 (0.56%)  0/26 (0.00%) 
Osteoarthritis  2  1/13 (7.69%)  1/178 (0.56%)  2/26 (7.69%) 
Spinal column stenosis  2  0/13 (0.00%)  1/178 (0.56%)  1/26 (3.85%) 
Tenosynovitis stenosans  2  0/13 (0.00%)  1/178 (0.56%)  0/26 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
B-cell lymphoma  2  0/13 (0.00%)  1/178 (0.56%)  0/26 (0.00%) 
Breast cancer  2  0/13 (0.00%)  1/178 (0.56%)  0/26 (0.00%) 
Cervix carcinoma stage 0  2  0/13 (0.00%)  1/178 (0.56%)  0/26 (0.00%) 
Diffuse large B-cell lymphoma  2  0/13 (0.00%)  1/178 (0.56%)  0/26 (0.00%) 
Endometrial cancer  2  0/13 (0.00%)  0/178 (0.00%)  1/26 (3.85%) 
Gastric cancer  2  0/13 (0.00%)  1/178 (0.56%)  0/26 (0.00%) 
Neoplasm  2  0/13 (0.00%)  1/178 (0.56%)  0/26 (0.00%) 
Pancreatic carcinoma  2  0/13 (0.00%)  1/178 (0.56%)  0/26 (0.00%) 
Pinealoma  2  0/13 (0.00%)  1/178 (0.56%)  0/26 (0.00%) 
T-cell lymphoma  2  0/13 (0.00%)  1/178 (0.56%)  0/26 (0.00%) 
Uterine leiomyoma  2  0/13 (0.00%)  1/178 (0.56%)  0/26 (0.00%) 
Nervous system disorders       
Cerebral haemorrhage  2  0/13 (0.00%)  1/178 (0.56%)  0/26 (0.00%) 
Cerebral infarction  2  0/13 (0.00%)  1/178 (0.56%)  1/26 (3.85%) 
Encephalitis  2  0/13 (0.00%)  1/178 (0.56%)  0/26 (0.00%) 
Hydrocephalus  2  0/13 (0.00%)  1/178 (0.56%)  0/26 (0.00%) 
Hypoaesthesia  2  0/13 (0.00%)  1/178 (0.56%)  0/26 (0.00%) 
Neuropathy peripheral  2  0/13 (0.00%)  0/178 (0.00%)  1/26 (3.85%) 
Sensory disturbance  2  0/13 (0.00%)  1/178 (0.56%)  0/26 (0.00%) 
Thalamus haemorrhage  2  0/13 (0.00%)  0/178 (0.00%)  1/26 (3.85%) 
VIIth nerve paralysis  2  0/13 (0.00%)  0/178 (0.00%)  1/26 (3.85%) 
Respiratory, thoracic and mediastinal disorders       
Bronchitis chronic  2  0/13 (0.00%)  1/178 (0.56%)  0/26 (0.00%) 
Interstitial lung disease  2  0/13 (0.00%)  1/178 (0.56%)  1/26 (3.85%) 
Surgical and medical procedures       
Bunion operation  2  0/13 (0.00%)  1/178 (0.56%)  0/26 (0.00%) 
Gastric polypectomy  2  0/13 (0.00%)  1/178 (0.56%)  0/26 (0.00%) 
Knee arthroplasty  2  0/13 (0.00%)  1/178 (0.56%)  0/26 (0.00%) 
Indicates events were collected by systematic assessment
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Term from vocabulary, MedDRA Version. 13.1
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Term from vocabulary, MedDRA 13.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Participants From Phase I Study (IM101-034); Abatacept 10mg/kg Participants From Phase II Study(IM101-071); Abatacept 10mg/kg New Participants With MTX Intolerance; Abatacept 10 mg/kg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   13/13 (100.00%)   176/178 (98.88%)   24/26 (92.31%) 
Blood and lymphatic system disorders       
Anaemia  1  0/13 (0.00%)  9/178 (5.06%)  1/26 (3.85%) 
Cardiac disorders       
Cardiac failure  1  1/13 (7.69%)  0/178 (0.00%)  0/26 (0.00%) 
Cardiomegaly  1  1/13 (7.69%)  2/178 (1.12%)  0/26 (0.00%) 
Tachycardia  1  1/13 (7.69%)  3/178 (1.69%)  0/26 (0.00%) 
Ear and labyrinth disorders       
Vertigo  1  1/13 (7.69%)  7/178 (3.93%)  2/26 (7.69%) 
Eye disorders       
Blepharitis  1  1/13 (7.69%)  1/178 (0.56%)  0/26 (0.00%) 
Cataract  1  0/13 (0.00%)  4/178 (2.25%)  3/26 (11.54%) 
Dry eye  1  0/13 (0.00%)  9/178 (5.06%)  1/26 (3.85%) 
Eye discharge  1  1/13 (7.69%)  0/178 (0.00%)  0/26 (0.00%) 
Gastrointestinal disorders       
Abdominal discomfort  1  0/13 (0.00%)  10/178 (5.62%)  1/26 (3.85%) 
Abdominal pain upper  1  1/13 (7.69%)  11/178 (6.18%)  1/26 (3.85%) 
Colonic polyp  1  1/13 (7.69%)  2/178 (1.12%)  0/26 (0.00%) 
Constipation  1  0/13 (0.00%)  21/178 (11.80%)  5/26 (19.23%) 
Dental caries  1  0/13 (0.00%)  21/178 (11.80%)  0/26 (0.00%) 
Diarrhoea  1  1/13 (7.69%)  10/178 (5.62%)  2/26 (7.69%) 
Enterocolitis  1  1/13 (7.69%)  3/178 (1.69%)  1/26 (3.85%) 
Gastric polyps  1  1/13 (7.69%)  7/178 (3.93%)  1/26 (3.85%) 
Gastric ulcer  1  0/13 (0.00%)  2/178 (1.12%)  2/26 (7.69%) 
Gastritis  1  1/13 (7.69%)  18/178 (10.11%)  1/26 (3.85%) 
Gastrointestinal motility disorder  1  1/13 (7.69%)  0/178 (0.00%)  0/26 (0.00%) 
Haemorrhoids  1  2/13 (15.38%)  3/178 (1.69%)  2/26 (7.69%) 
Inguinal hernia  1  1/13 (7.69%)  0/178 (0.00%)  0/26 (0.00%) 
Nausea  1  2/13 (15.38%)  14/178 (7.87%)  2/26 (7.69%) 
Periodontitis  1  0/13 (0.00%)  5/178 (2.81%)  2/26 (7.69%) 
Stomatitis  1  4/13 (30.77%)  46/178 (25.84%)  3/26 (11.54%) 
Toothache  1  1/13 (7.69%)  2/178 (1.12%)  0/26 (0.00%) 
Vomiting  1  0/13 (0.00%)  8/178 (4.49%)  3/26 (11.54%) 
General disorders       
Malaise  1  1/13 (7.69%)  8/178 (4.49%)  1/26 (3.85%) 
Pyrexia  1  1/13 (7.69%)  11/178 (6.18%)  4/26 (15.38%) 
Thirst  1  0/13 (0.00%)  2/178 (1.12%)  2/26 (7.69%) 
Immune system disorders       
Seasonal allergy  1  1/13 (7.69%)  14/178 (7.87%)  2/26 (7.69%) 
Infections and infestations       
Bronchitis  1  2/13 (15.38%)  15/178 (8.43%)  1/26 (3.85%) 
Cystitis  1  4/13 (30.77%)  11/178 (6.18%)  0/26 (0.00%) 
Dermatitis infected  1  1/13 (7.69%)  0/178 (0.00%)  0/26 (0.00%) 
Diverticulitis  1  1/13 (7.69%)  0/178 (0.00%)  0/26 (0.00%) 
Folliculitis  1  1/13 (7.69%)  4/178 (2.25%)  0/26 (0.00%) 
Gastroenteritis  1  2/13 (15.38%)  16/178 (8.99%)  3/26 (11.54%) 
Herpes simplex  1  1/13 (7.69%)  1/178 (0.56%)  1/26 (3.85%) 
Herpes zoster  1  0/13 (0.00%)  9/178 (5.06%)  1/26 (3.85%) 
Nasopharyngitis  1  8/13 (61.54%)  103/178 (57.87%)  12/26 (46.15%) 
Oesophageal candidiasis  1  1/13 (7.69%)  0/178 (0.00%)  0/26 (0.00%) 
Onychomycosis  1  1/13 (7.69%)  5/178 (2.81%)  0/26 (0.00%) 
Oral herpes  1  1/13 (7.69%)  8/178 (4.49%)  1/26 (3.85%) 
Pharyngitis  1  0/13 (0.00%)  24/178 (13.48%)  4/26 (15.38%) 
Rhinitis  1  0/13 (0.00%)  9/178 (5.06%)  0/26 (0.00%) 
Sinusitis  1  0/13 (0.00%)  11/178 (6.18%)  2/26 (7.69%) 
Tinea pedis  1  1/13 (7.69%)  10/178 (5.62%)  1/26 (3.85%) 
Injury, poisoning and procedural complications       
Arthropod sting  1  2/13 (15.38%)  5/178 (2.81%)  0/26 (0.00%) 
Contusion  1  2/13 (15.38%)  9/178 (5.06%)  1/26 (3.85%) 
Excoriation  1  1/13 (7.69%)  3/178 (1.69%)  1/26 (3.85%) 
Muscle strain  1  2/13 (15.38%)  1/178 (0.56%)  0/26 (0.00%) 
Tendon rupture  1  1/13 (7.69%)  0/178 (0.00%)  2/26 (7.69%) 
Thermal burn  1  1/13 (7.69%)  3/178 (1.69%)  0/26 (0.00%) 
Investigations       
Alanine aminotransferase increased  1  2/13 (15.38%)  29/178 (16.29%)  2/26 (7.69%) 
Aspartate aminotransferase increased  1  1/13 (7.69%)  23/178 (12.92%)  1/26 (3.85%) 
Blood alkaline phosphatase increased  1  0/13 (0.00%)  7/178 (3.93%)  3/26 (11.54%) 
Blood glucose increased  1  1/13 (7.69%)  9/178 (5.06%)  3/26 (11.54%) 
Blood pressure decreased  1  1/13 (7.69%)  11/178 (6.18%)  1/26 (3.85%) 
Blood pressure increased  1  2/13 (15.38%)  27/178 (15.17%)  12/26 (46.15%) 
Blood pressure systolic decreased  1  1/13 (7.69%)  1/178 (0.56%)  1/26 (3.85%) 
Blood pressure systolic increased  1  0/13 (0.00%)  3/178 (1.69%)  2/26 (7.69%) 
Blood urea increased  1  1/13 (7.69%)  6/178 (3.37%)  0/26 (0.00%) 
Blood urine present  1  1/13 (7.69%)  14/178 (7.87%)  1/26 (3.85%) 
Brain natriuretic peptide increased  1  1/13 (7.69%)  0/178 (0.00%)  0/26 (0.00%) 
Eosinophil count increased  1  0/13 (0.00%)  9/178 (5.06%)  4/26 (15.38%) 
Gamma-glutamyltransferase increased  1  0/13 (0.00%)  15/178 (8.43%)  1/26 (3.85%) 
Glucose urine present  1  0/13 (0.00%)  11/178 (6.18%)  2/26 (7.69%) 
Lymphocyte count decreased  1  1/13 (7.69%)  35/178 (19.66%)  5/26 (19.23%) 
Protein total decreased  1  0/13 (0.00%)  4/178 (2.25%)  2/26 (7.69%) 
Red blood cells urine positive  1  1/13 (7.69%)  13/178 (7.30%)  2/26 (7.69%) 
White blood cell count increased  1  1/13 (7.69%)  29/178 (16.29%)  7/26 (26.92%) 
White blood cells urine positive  1  3/13 (23.08%)  18/178 (10.11%)  3/26 (11.54%) 
Metabolism and nutrition disorders       
Decreased appetite  1  1/13 (7.69%)  1/178 (0.56%)  0/26 (0.00%) 
Hypercholesterolaemia  1  0/13 (0.00%)  4/178 (2.25%)  2/26 (7.69%) 
Hyperlipidaemia  1  1/13 (7.69%)  1/178 (0.56%)  0/26 (0.00%) 
Hyperuricaemia  1  2/13 (15.38%)  1/178 (0.56%)  0/26 (0.00%) 
Musculoskeletal and connective tissue disorders       
Arthralgia  1  0/13 (0.00%)  4/178 (2.25%)  2/26 (7.69%) 
Atlantoaxial instability  1  1/13 (7.69%)  1/178 (0.56%)  0/26 (0.00%) 
Back pain  1  1/13 (7.69%)  22/178 (12.36%)  3/26 (11.54%) 
Intervertebral disc protrusion  1  1/13 (7.69%)  6/178 (3.37%)  1/26 (3.85%) 
Muscle spasms  1  1/13 (7.69%)  6/178 (3.37%)  0/26 (0.00%) 
Myalgia  1  2/13 (15.38%)  4/178 (2.25%)  0/26 (0.00%) 
Osteoporosis  1  1/13 (7.69%)  12/178 (6.74%)  2/26 (7.69%) 
Spinal column stenosis  1  1/13 (7.69%)  3/178 (1.69%)  1/26 (3.85%) 
Spinal osteoarthritis  1  1/13 (7.69%)  8/178 (4.49%)  1/26 (3.85%) 
Tendon disorder  1  1/13 (7.69%)  0/178 (0.00%)  0/26 (0.00%) 
Nervous system disorders       
Dizziness  1  0/13 (0.00%)  9/178 (5.06%)  3/26 (11.54%) 
Headache  1  0/13 (0.00%)  15/178 (8.43%)  3/26 (11.54%) 
Hypoaesthesia  1  1/13 (7.69%)  7/178 (3.93%)  0/26 (0.00%) 
Sciatica  1  1/13 (7.69%)  3/178 (1.69%)  1/26 (3.85%) 
Syncope  1  1/13 (7.69%)  0/178 (0.00%)  0/26 (0.00%) 
Psychiatric disorders       
Insomnia  1  2/13 (15.38%)  20/178 (11.24%)  4/26 (15.38%) 
Respiratory, thoracic and mediastinal disorders       
Cough  1  1/13 (7.69%)  21/178 (11.80%)  0/26 (0.00%) 
Oropharyngeal discomfort  1  1/13 (7.69%)  1/178 (0.56%)  0/26 (0.00%) 
Oropharyngeal pain  1  2/13 (15.38%)  9/178 (5.06%)  0/26 (0.00%) 
Pharyngeal erythema  1  1/13 (7.69%)  2/178 (1.12%)  1/26 (3.85%) 
Rhinitis allergic  1  2/13 (15.38%)  11/178 (6.18%)  1/26 (3.85%) 
Upper respiratory tract inflammation  1  5/13 (38.46%)  28/178 (15.73%)  2/26 (7.69%) 
Skin and subcutaneous tissue disorders       
Acne  1  1/13 (7.69%)  1/178 (0.56%)  1/26 (3.85%) 
Eczema  1  1/13 (7.69%)  29/178 (16.29%)  2/26 (7.69%) 
Hyperkeratosis  1  0/13 (0.00%)  15/178 (8.43%)  2/26 (7.69%) 
Rash  1  2/13 (15.38%)  15/178 (8.43%)  4/26 (15.38%) 
Skin exfoliation  1  1/13 (7.69%)  0/178 (0.00%)  0/26 (0.00%) 
Urticaria  1  0/13 (0.00%)  2/178 (1.12%)  2/26 (7.69%) 
Vascular disorders       
Hypertension  1  2/13 (15.38%)  13/178 (7.30%)  1/26 (3.85%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: BMS Study Director
Organization: Bristol-Myers Squibb
EMail: Clinical.Trials@bms.com
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00484289     History of Changes
Other Study ID Numbers: IM101-129
First Submitted: June 7, 2007
First Posted: June 8, 2007
Results First Submitted: May 25, 2012
Results First Posted: August 9, 2012
Last Update Posted: June 24, 2013