Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Methotrexate-Inadequate Response Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00559585
Recruitment Status : Completed
First Posted : November 16, 2007
Results First Posted : July 6, 2011
Last Update Posted : November 9, 2015
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Rheumatoid Arthritis (RA)
Interventions Drug: Subcutaneous (SC) Abatacept
Drug: Intravenous (IV) Abatacept
Enrollment 2492
Recruitment Details During the double blind short term (ST) period of the Main study, a sub-study in RA participants was initiated to evaluate anti-tumor necrosis factor (TNF) failure population. The sub-study was terminated early due to slow recruitment and participants from the sub-study were allowed to roll into the Main study during the LT Open Label Period.
Pre-assignment Details 2492 enrolled: 2472 in Main Study:1008 not randomized: 918 no longer met criteria, 61 withdrew consent, 7 lost to follow-up, 22 other reasons. Randomized, not treated: 4 no longer met criteria, 2 withdrew consent, and 1 randomization error; 20 enrolled in Anti-TNF sub-study; 2 not randomized as no longer met criteria; 18 randomized in substudy.
Arm/Group Title Subcutaneous (SC) Abatacept Intravenous (IV) Abatacept
Hide Arm/Group Description During the Main Study Double Blind ST Period, participants received 125 mg weekly SC abatacept injections for 6 months (with an IV abatacept loading dose on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV Placebo) with the exception that on Day 1 a loading dose of IV abatacept replaced the IV Placebo treatment. During the Open Label Long Term (LT) Period, participants in both the Main Study and the Anti-TNF Failure Sub-study switched to open-label SC abatacept. The study continued until SC formulation became commercially available on a country basis or the Sponsor terminated the study. During the Main study Double Blind ST Period, participants received IV abatacept infusions on Days 1, 15, 29, and every 28 days, thereafter for 6 months. A double-dummy design was used to protect the blind, thus, participants also received SC injections of placebo (SC Placebo). During the Open Label LT Period, participants in both the Main Study and the Anti-TNF Failure Sub-study switched to open-label SC abatacept. The study continued until SC formulation became commercially available on a country basis or the Sponsor terminated the study.
Period Title: Double Blind ST Period Main Study
Started 736 [1] 721 [1]
Completed 693 676
Not Completed 43 45
Reason Not Completed
Adverse Event             17             25
Withdrawal by Subject             11             5
Lost to Follow-up             0             6
Administrative Reason By Sponsor             1             0
Death             1             1
No Longer Meets Study Criteria             2             1
Lack of Efficacy             6             1
Poor/Non-Compliance             3             0
Missed Doses             0             1
Incomplete Breast Exam             0             1
Suspended Drug Due To Surgery             0             1
Early Discontinuation             0             1
Participant Weight Gain             1             0
Participant Withdrew-Recurrent Infection             0             1
Investigator Decision             0             1
Ongoing Infection Risk             1             0
[1]
Randomized and treated
Period Title: Anti-TNF Sub-Study in ST Period
Started 8 [1] 10 [2]
Completed 7 9
Not Completed 1 1
Reason Not Completed
Lack of Efficacy             1             1
[1]
7 completed Sub-Study ST period and 6 chose to roll over into LT Period.
[2]
9 completed Sub-Study ST Period and 9 chose to over into the LT Period.
Period Title: Open Label LT Period Main + Sub-Study
Started 1373 [1] 0 [2]
Completed 945 0
Not Completed 428 0
Reason Not Completed
Adverse Event             100             0
Withdrawal by Subject             81             0
Pregnancy             16             0
Lost to Follow-up             32             0
Administrative reason by Sponsor             9             0
Death             20             0
No longer met criteria             1             0
Lack of Efficacy             89             0
Poor/non-compliance             8             0
non-specified             71             0
no end of study status page             1             0
[1]
1373 includes 15 participants from ST Period Sub-Study who rolled over into LT Period (6 SC + 9 IV).
[2]
IV administration was discontinued and abatacept was only administered SC during LT Period.
Arm/Group Title Subcutaneous (SC) Abatacept Intravenous (IV) Abatacept Total
Hide Arm/Group Description Participants received 125 mg weekly SC abatacept injections (with an intravenous [IV] abatacept loading dose on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV Placebo) with the exception that on Day 1 a loading dose of IV abatacept replaced the IV Placebo treatment. The Per Protocol (PP) Analysis Population (instead of the Intent-To-Treat Population) was used to perform primary and key secondary efficacy analyses as per regulatory guidelines for non-inferiority studies. Participants received IV abatacept infusions on Days 1, 15, 29, and every 28 days, thereafter. A double-dummy design was used to protect the blind, thus, participants also received SC injections of placebo (SC Placebo). The Per Protocol (PP) Analysis Population (instead of the Intent-To-Treat Population) was used to perform primary and key secondary efficacy analyses as per regulatory guidelines for non-inferiority studies. Total of all reporting groups
Overall Number of Baseline Participants 696 683 1379
Hide Baseline Analysis Population Description
Per-protocol Population in ST Period.
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 696 participants 683 participants 1379 participants
49.9  (13.0) 49.9  (12.7) 49.9  (12.8)
[1]
Measure Description: Since regulatory guidelines indicate use of the Per Protocol (PP) Analysis Population (instead of the Intent-To-Treat Population) for non-inferiority studies, this population was used to perform primary and key secondary efficacy analyses. Thus, Baseline continuous age data are presented for the PP Analysis Population.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 696 participants 683 participants 1379 participants
Female
586
  84.2%
549
  80.4%
1135
  82.3%
Male
110
  15.8%
134
  19.6%
244
  17.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 696 participants 683 participants 1379 participants
American Indian or Alaska Native
5
   0.7%
1
   0.1%
6
   0.4%
Asian
63
   9.1%
72
  10.5%
135
   9.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
26
   3.7%
24
   3.5%
50
   3.6%
White
516
  74.1%
505
  73.9%
1021
  74.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
86
  12.4%
81
  11.9%
167
  12.1%
Region Of Enrollment  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 696 participants 683 participants 1379 participants
North America 129 111 240
South America 338 340 678
Europe 123 123 246
Rest of the World 106 109 215
Baseline Weight Category  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 696 participants 683 participants 1379 participants
<60 kg 175 171 346
60 to 100 kg 464 465 929
>100 kg 57 47 104
Duration of RA Disease  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 696 participants 683 participants 1379 participants
7.6  (8.0) 7.7  (7.9) 7.7  (7.9)
Duration of Disease Category  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 696 participants 683 participants 1379 participants
≤2 Years 229 206 435
2 - ≤5 yrs 144 145 289
5 - ≤10 yrs 134 155 289
> 10 yrs 189 177 366
Number of Tender Joints   [1] 
Mean (Standard Deviation)
Unit of measure:  Tender joints
Number Analyzed 696 participants 683 participants 1379 participants
30  (14.1) 29.2  (13.1) 29.6  (13.6)
[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:  Swollen joints
Number Analyzed 696 participants 683 participants 1379 participants
20.5  (9.4) 19.6  (8.5) 20.0  (9.0)
[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 indicates increasing level of disease severity.
Participant Pain Assessment   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 696 participants 683 participants 1379 participants
68.0  (20.0) 66.9  (20.5) 67.5  (20.3)
[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. For each post-baseline visit in the DB, time-matched baseline Participant Pain Assessment values were presented and represent the mean baseline value for only that cohort of participants with assessments available at that visit.
Physical Function (Health Assessment Questionnaire Disability Index [HAQ-DI])   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 696 participants 683 participants 1379 participants
1.73  (0.68) 1.69  (0.67) 1.71  (0.67)
[1]
Measure Description: The disability section of the full HAQ includes 20 questions to assess physical The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain divided by the number of domains answered. HAQ-DI overall score ranges from a minimum of 0 to a maximum of 3.0.
Participant Global Assessment   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 696 participants 683 participants 1379 participants
67.2  (20.1) 65.2  (19.9) 66.2  (20.0)
[1]
Measure Description: Participants used a horizontal 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, 4-8=moderate activity, and 8.1-10=high activity.
Physician Global Assessment   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 696 participants 683 participants 1379 participants
64.3  (16.5) 63.4  (16.3) 63.9  (16.4)
[1]
Measure Description: Physician global rheumatoid arthritis assessment core component of the ACR scoring system where increasing score indicates increasing level of severity as indicated on a 100 mm Visual Analog Scale, with 0 mm representing no pain and 100 mm representing the most pain possible.
High Sensitivity C-Reactive Protein (hsCRP) Level   [1] 
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 696 participants 683 participants 1379 participants
2.65  (2.91) 2.72  (2.91) 2.69  (2.91)
[1]
Measure Description: hs-CRP is a acute phase reactant protein that is a clinical marker for Rheumatoid Arthritis (RA). Levels of hs-CRP can be used to determine DAS28.
Disease Activity Score (CRP)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 696 participants 683 participants 1379 participants
6.25  (0.84) 6.22  (0.83) 6.24  (0.83)
[1]
Measure Description: The DAS28 index measures disease activity in rheumatoid arthritis and is a composite derived from the number of swollen/tender joints, laboratory tests of inflammation (C-reactive protein measured in mg/L), and participant assessment of global health (by marking a 100 mm line from "very good" to "very bad"). A higher DAS28 score indicates worse control of disease. High disease activity is > 5.1, low disease activity is < 3.2 and remission is < 2.6.
Rheumatoid Factor Status   [1] 
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 696 participants 683 participants 1379 participants
Negative 102 91 193
Positive 582 583 1165
Unknown 12 9 21
[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 is itself an antibody. RF and IgG join to form immune complexes which contribute to the disease process. A positive value for RF was >20 IU/mL; a negative value for RF was ≤ 20 IU/mL.
Baseline Methotrexate (MTX) Dose  
Mean (Standard Deviation)
Unit of measure:  Mg/wk
Number Analyzed 696 participants 683 participants 1379 participants
16.3  (3.6) 16.5  (3.7) 16.4  (3.6)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 696 participants 683 participants 1379 participants
72.1  (18.1) 71.5  (17.5) 71.8  (17.8)
1.Primary Outcome
Title Double-blind Period: Number of Participants Achieving American College of Rheumatology (ACR) 20 Response at Day 169
Hide Description The ACR 20 definition of improvement is a 20% improvement from baseline in the number of tender and swollen joints, and a 20% improvement from baseline in 3 of the remaining 5 core set measures: participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function and acute phase reactant value (C-reactive protein).
Time Frame Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol (PP) population, defined as participants who are compliant with the study criteria.
Arm/Group Title Subcutaneous Abatacept Intravenous Abatacept
Hide Arm/Group Description:
Participants received weekly injections of 125 mg subcutaneous abatacept (with a loading dose of intravenous (IV) abatacept on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV placebo) with the exception that on Day 1, a loading dose of IV abatacept replaced the IV placebo treatment.
Participants received IV abatacept infusions on Days 1, 15, and 29 and every 28 days thereafter. A double-dummy design was used to protect the blind, thus, participants also received subcutaneous injections of placebo (subcutaneous placebo).
Overall Number of Participants Analyzed 693 678
Measure Type: Number
Unit of Measure: participants
527 514
2.Primary Outcome
Title Anti-TNF Failure Sub-Study Double Blind Period : Number of Participants With Positive Anti-abatacept or Anti-Cytotoxic T Lymphocyte Antigen 4-T Cell (CTLA4-T) Response in Anti-TNF Failure Population
Hide Description Serum samples from all treated adult participants with active rheumatoid arthritis who were from the Anti-TNF failure population were screened for the presence of drug-specific antibodies using Enzyme Linked Immunoabsorbant Assay (ELISA). The number of participants who had the presence of anti-abatacept antibodies or anti-CTLA-4 antibodies present in their serum are summarized.
Time Frame Days 85, and 169 and postvisits on Days 28, 56, and 85
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants in the Anti-TNF Failure Sub-study who received at least 1 dose of study medication. n=Number of participants with at least 1 assessment available.
Arm/Group Title Subcutaneous Abatacept Intravenous Abatacept
Hide Arm/Group Description:
Participants received weekly injections of 125 mg subcutaneous abatacept (with a loading dose of intravenous (IV) abatacept on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV placebo) with the exception that on Day 1, a loading dose of IV abatacept replaced the IV placebo treatment. An Anti-TNF Failure Sub-study was initiated using the same treatment as the Main study in order to assess the immunogenicity and safety in the Anti-TNF Failure population.
Participants received IV abatacept infusions on Days 1, 15, and 29 and every 28 days thereafter. A double-dummy design was used to protect the blind, thus, participants also received subcutaneous injections of placebo (subcutaneous placebo). An Anti-TNF Failure Sub-study was initiated using the same treatment as the Main study in order to assess the immunogenicity and safety in the Anti-TNF Failure population.
Overall Number of Participants Analyzed 8 10
Measure Type: Number
Unit of Measure: participants
Day 85 Anti-abatacept (n=8,10) 0 0
Day 85 Anti-CTLA4-T (n=8,10) 0 0
Day 169 Anti-abatacept (n=6,9) 0 0
Day 169 Anti-CTLA4-T(n=6,9) 1 0
Overall Treatment Anti-abatacept (n=8,10) 0 0
Overall on Treatment Anti-CTLA4-T(n=8,10) 1 0
28 days post Anti-abatacept (n=1,1) 0 0
28 days post Anti-CTLA4-T (n=1,1) 0 0
56 days post Anti-abatacept (n=0,1) 0 0
56 days post Anti-CTLA4-T (n=0,1) 0 0
85 days post Anti-abatacept (n=0,1) 0 0
85 days post Anti-CTLA4-T (n=0,1) 0 0
3.Secondary Outcome
Title Double-blind Period: Number of Participants Achieving ACR 50 and ACR 70 Responses at Day 169
Hide Description The ACR 50 definition of improvement is a 50% improvement from baseline in the number of tender and swollen joint counts, and a 50% improvement from baseline in 3 of the remaining 5 core set measures: participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function and acute phase reactant value (C-reactive protein). ACR 70 is defined similarly with 70% improvements from baseline for tender and swollen joint counts and 3 out of 5 core measures.
Time Frame Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
PP population, defined as participants who are compliant with the study criteria.
Arm/Group Title Subcutaneous Abatacept Intravenous Abatacept
Hide Arm/Group Description:
Participants received weekly injections of 125 mg subcutaneous abatacept (with a loading dose of IV abatacept on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV placebo) with the exception that on Day 1, a loading dose of IV abatacept replaced the IV placebo treatment.
Participants received IV abatacept infusions on Days 1, 15, and 29 and every 28 days thereafter. A double-dummy design was used to protect the blind, thus, participants also received subcutaneous injections of placebo (subcutaneous placebo).
Overall Number of Participants Analyzed 693 678
Measure Type: Number
Unit of Measure: participants
ACR 50 357 341
ACR 70 183 170
4.Secondary Outcome
Title Double-blind Period: Mean Baseline Health Assessment Questionnaire Disability Index (HAQ-DI) for Participants With Assessments at Day 169
Hide Description The disability section of the full HAQ-DI 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.
Time Frame Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of study medication at any time and had HAD-QI scores available.
Arm/Group Title Subcutaneous Abatacept Intravenous Abatacept
Hide Arm/Group Description:
Participants received weekly injections of 125 mg subcutaneous abatacept (with a loading dose of IV abatacept on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV placebo) with the exception that on Day 1, a loading dose of IV abatacept replaced the IV placebo treatment.
Participants received IV abatacept infusions on Days 1, 15, and 29 and every 28 days thereafter. A double-dummy design was used to protect the blind, thus, participants also received subcutaneous injections of placebo (subcutaneous placebo).
Overall Number of Participants Analyzed 729 711
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.72  (0.68) 1.67  (0.67)
5.Secondary Outcome
Title Double-blind Period: Adjusted Mean Change From Baseline to Day 169 in HAQ-DI
Hide Description The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain divided by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0.
Time Frame Baseline to Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of study medication at any time and had HAD-QI scores available.
Arm/Group Title Subcutaneous Abatacept Intravenous Abatacept
Hide Arm/Group Description:
Participants received weekly injections of 125 mg subcutaneous abatacept (with a loading dose of IV abatacept on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV placebo) with the exception that on Day 1, a loading dose of IV abatacept replaced the IV placebo treatment.
Participants received IV abatacept infusions on Days 1, 15, and 29 and every 28 days thereafter. A double-dummy design was used to protect the blind, thus, participants also received subcutaneous injections of placebo (Subcutaneous placebo placebo).
Overall Number of Participants Analyzed 729 711
Mean (Standard Error)
Unit of Measure: units on a scale
-0.69  (0.02) -0.70  (0.02)
6.Secondary Outcome
Title Double-blind Period: Number of Participants Achieving Clinically Meaningful HAQ-DI Response at Day 169
Hide Description The disability section of the full HAQ-DI 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-DI response=an improvement of at least 0.3 units from baseline in HAQ-DI.
Time Frame Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of study medication at any time and had HAD-QI scores available
Arm/Group Title Subcutaneous Abatacept Intravenous Abatacept
Hide Arm/Group Description:
Participants received weekly injections of 125 mg subcutaneous abatacept (with an IV abatacept loading dose on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV Placebo) with the exception that on Day 1 a loading dose of IV abatacept replaced the IV Placebo treatment.
Participants received IV abatacept infusions on Days 1, 15, 29, and every 28 days, thereafter. A double-dummy design was used to protect the blind, thus, participants also received SC injections of placebo (SC Placebo).
Overall Number of Participants Analyzed 729 711
Measure Type: Number
Unit of Measure: participants
483 442
7.Secondary Outcome
Title Double-blind Period: Number of Participants With Death As Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, SAEs Leading to Discontinuation, Adverse Events (AEs), Treatment-related AEs, or AEs Leading to Discontinuation
Hide Description AE=any new untoward medical event or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event. Treatment-related SAE=possibly, probably, or certainly related to study drug
Time Frame Day 1 to 56 days after last dose in short-term or first dose in the long-term, whichever occurs first.
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study medication.
Arm/Group Title Subcutaneous Abatacept Intravenous Abatacept
Hide Arm/Group Description:
Participants received weekly injections of 125 mg subcutaneous abatacept (with a loading dose of IV abatacept on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV placebo) with the exception
Participants received IV abatacept infusions on Days 1, 15, and 29 and every 28 days thereafter. A double-dummy design was used to protect the blind, thus, participants also received subcutaneous injections of placebo (subcutaneous placebo).
Overall Number of Participants Analyzed 736 721
Measure Type: Number
Unit of Measure: participants
Deaths 2 5
SAEs 31 35
Treatment-related SAEs 5 12
SAEs Leading to Discontinuation 8 14
AEs 493 470
Treatment-related AEs 204 210
AEs Leading to Discontinuation 15 25
8.Secondary Outcome
Title Anti-TNF Failure Sub-study Double-blind Period: Number of Participants With SAEs, AEs Leading to Discontinuation or Who Died
Hide Description AE=any new untoward medical event or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.
Time Frame Day 1 to 56 days after last dose in short-term or first dose in the long-term, whichever occurs first.
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study medication.
Arm/Group Title Subcutaneous (SC) Abatacept Intravenous (IV) Abatacept
Hide Arm/Group Description:
During the Double Blind ST Period, participants received 125 mg weekly SC abatacept injections for 6 months (with an intravenous [IV] abatacept loading dose on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV Placebo) with the exception that on Day 1 a loading dose of IV abatacept replaced the IV Placebo treatment. An Anti-TNF Failure Sub-study was initiated using the same treatment as the Main study in order to assess the immunogenicity and safety in the Anti-TNF Failure population.
During the Double Blind ST Period, participants received IV abatacept infusions on Days 1, 15, 29, and every 28 days, thereafter for 6 months. A double-dummy design was used to protect the blind, thus, participants also received SC injections of placebo (SC Placebo). An Anti-TNF Failure Sub-study was initiated using the same treatment as the Main study in order to assess the immunogenicity and safety in the Anti-TNF Failure population.
Overall Number of Participants Analyzed 8 10
Measure Type: Number
Unit of Measure: participants
Deaths 0 0
SAEs 0 0
AEs Leading to Discontinuation 0 0
9.Secondary Outcome
Title Double-blind Period: Number of Participants With AEs of Special Interest
Hide Description AE=any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs: all infections,serious infections,and opportunistic infections; autoimmune disorders; malignancies; acute infusional AEs (prespecified AEs occurring within 1 hr of start of infusion), peri-infusional AEs (prespecified AEs occurring within 24 hrs of the start of infusion), system injection reactions, and local injection site reactions
Time Frame Day 1 up to 56 days post last dose in short- term period or first dose in the long -term period, whichever occurs first.
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study medication.
Arm/Group Title Subcutaneous Abatacept Intravenous Abatacept
Hide Arm/Group Description:
Participants received weekly injections of 125 mg subcutaneous abatacept (with a loading dose of IV abatacept on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV placebo) with the exception that on Day 1, a loading dose of IV abatacept replaced the IV placebo treatment.
Participants received IV abatacept infusions on Days 1, 15, and 29 and every 28 days thereafter. A double-dummy design was used to protect the blind, thus, participants also received subcutaneous injections of placebo (subcutaneous placebo).
Overall Number of Participants Analyzed 736 721
Measure Type: Number
Unit of Measure: participants
Infections 234 221
Malignancies 3 5
Autoimmune Disorders 7 6
Acute Infusional AEs 20 16
Peri-infusional AEs 59 59
Local Injection Site Reactions 19 18
Systemic Injection Reactions 56 56
10.Secondary Outcome
Title Double-blind Period: Number of Participants With Clinically Significant Abnormalities in Vital Sign Measurements
Hide Description Vital sign measurements were performed for participants before and after infusion/subcutaneous injection of study medication at each visit and included seated systolic blood pressure, seated diastolic blood pressure, temperature, and heart rate. Abnormalities were determined to be clinically significant by the investigator.
Time Frame Day 1 through end of short-term period (Day 169)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study medication.
Arm/Group Title Subcutaneous Abatacept Intravenous Abatacept
Hide Arm/Group Description:
Participants received weekly injections of 125 mg subcutaneous abatacept (with a loading dose of IV abatacept on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV placebo) with the exception that on Day 1, a loading dose of IV abatacept replaced the IV placebo treatment.
Participants received weekly injections of 125 mg subcutaneous abatacept (with a loading dose of IV abatacept on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV placebo) with the exception that on Day 1, a loading dose of IV abatacept replaced the IV placebo treatment.
Overall Number of Participants Analyzed 736 721
Measure Type: Number
Unit of Measure: participants
0 0
11.Secondary Outcome
Title Double-blind Period: Number of Participants With Hematology Laboratory Test Results Meeting the Criteria for Marked Abnormality
Hide Description ULN=upper limit of normal; LLN=lower limit of normal; BL= baseline. Marked abnormality criteria: Hemoglobin: >3 g/dL decrease from BL; hematocrit: <0.75*BL; erythrocytes: <0.75*BL; platelets: <0.67*LLN/>1.5*ULN, or if BL<LLN, use <0.5*BL and <100,000 mm^3; leukocytes: <0.75*LLN/>1.25*ULN, or if BL<LLN use <0.8*BL or >ULN, or if BL>ULN, use >1.2*BL or <LLN; neutrophils+bands: <1.0*10^3 c/uL; eosinophils: >0.750*10^3 c/uL; basophils: >400 mm^3; monocytes: >2000 mm^3; lymphocytes: <0.750*10^3 c/uL/>7.50*10^3 c/uL.
Time Frame Day 1 through end of short-term period (Day 169)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study medication. n=Number of participants with assessments available.
Arm/Group Title Subcutaneous Abatacept Intravenous Abatacept
Hide Arm/Group Description:
Participants received weekly injections of 125 mg subcutaneous abatacept (with a loading dose of IV abatacept on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV placebo) with the exception that on Day 1, a loading dose of IV abatacept replaced the IV placebo treatment.
Participants received IV abatacept infusions on Days 1, 15, and 29 and every 28 days thereafter. A double-dummy design was used to protect the blind, thus, participants also received subcutaneous injections of placebo (subcutaneous placebo).
Overall Number of Participants Analyzed 736 721
Measure Type: Number
Unit of Measure: participants
Low hemoglobin (LLN=11.5 g/dL); n=729, 713 2 5
Low hematocrit (LLN=34%); n=726, 713 2 4
Low erythrocytes(LLN=3.8 x10*6c/uL);n=729, 713 2 3
Low platelets (LLN=140*10^9 c/L); n=725, 709 1 0
High platelets (ULN=450*10^9 c/L); n=725, 709 0 0
Low leukocytes (LLN= 3.8*10^3 c/uL); n=729, 713 6 2
High leukocytes (ULN = 10.6*10^3 c/uL);n=729, 713 25 18
Low neutrophils+bands(LLN=1.8*10^3 c/uL);n=730,713 0 0
High eosinophils (ULN= 7*10^3 c/uL); n=730, 712 22 16
High basophils (ULN= 0.2*10^3 c/uL); n=730, 712 0 0
High monocytes (ULN=1*10^3 c/uL); n=730, 712 0 1
Low lymphocytes (LLN= 0.7*10^3 c/uL);n=730,712 40 42
High lymphocytes(ULN=4.5*10^3 c/uL);n=730,712 40 42
12.Secondary Outcome
Title Double-blind Period: Number of Participants With Liver Function Laboratory Test Results Meeting the Criteria for Marked Abnormality
Hide Description Marked abnormality criteria: Alkaline phosphatase (ALP): >2*ULN, or if BL>ULN, use >3*BL; aspartate aminotransferase (AST): >3*ULN, or if BL>ULN, use >4*BL; alanine aminotransferase (ALT): >3*ULN, or if BL>ULN, use >4*BL; G-glutamyl transferase (GGT): >2* ULN, or if BL>ULN, use >3*BL; bilirubin: >2* ULN, or if BL>ULN, use >4*BL; blood urea nitrogen: >2* BL; creatinine: >1.5*BL
Time Frame Day 1 through end of short-term period (Day 169)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study medication. n=Number of participants with assessments available.
Arm/Group Title Subcutaneous Abatacept Intravenous Abatacept
Hide Arm/Group Description:
Participants received weekly injections of 125 mg subcutaneous abatacept (with a loading dose of IV abatacept on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV placebo) with the exception that on Day 1, a loading dose of IV abatacept replaced the IV placebo treatment.
Participants received IV abatacept infusions on Days 1, 15, and 29 and every 28 days thereafter. A double-dummy design was used to protect the blind, thus, participants also received subcutaneous injections of placebo (subcutaneous placebo).
Overall Number of Participants Analyzed 736 721
Measure Type: Number
Unit of Measure: participants
High ALP (ULN=400 U/L); n=730, 713 1 3
High AST (ULN=44 U/L); n=729, 713 5 5
High ALT (ULN=55 U/L);n=729, 713 12 16
High GGT (ULN=65 U/L); n=730, 713 8 14
High bilirubin (ULN=1.2 mg/dL); n=730, 713 1 0
High blood urea nitrogen (26 mg/dL); n=730, 713 21 27
High creatinine (ULN=1.5 mg/dL); n=730, 713 19 30
13.Secondary Outcome
Title Double-blind Period: Number of Participants With Electrolyte Laboratory Test Results Meeting the Criteria for Marked Abnormality
Hide Description Marked abnormality criteria: Sodium: <0.95*LLN/>1.05*ULN, or if BL<LLN, use <0.95* BL or >ULN, or if BL>ULN, use>1.05* BL or <LLN; potassium: <0.9* LLN/>1.1*ULN, or if BL<LLN then use <0.9* BL or >ULN, or if BL>ULN, use>1.1* BL or <LLN; chlorine: <0.9*LLN/>1.1* ULN, or if BL<LLN, use <0.9*BL or >ULN, or if BL>ULN, use>1.1*BL or <LLN; calcium: <0.8* LLN/>1.2* ULN, or if BL<LLN, use <0.75*BL or >ULN, or if BL>ULN, use>1.25* BL or <LLN; phosphorous: <0.75* LLN/>1.25*ULN, or if BL<LLN, use 0.67*BL or >ULN, or if BL>ULN, use>1.33* BL or <LLN
Time Frame Day 1 through end of short-term period (Day 169)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study medication. N=number of participants with assessments available.
Arm/Group Title Subcutaneous Abatacept Intravenous Abatacept
Hide Arm/Group Description:
Participants received weekly injections of 125 mg subcutaneous abatacept (with a loading dose of IV abatacept on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV placebo) with the exception that on Day 1, a loading dose of IV abatacept replaced the IV placebo treatment.
Participants received IV abatacept infusions on Days 1, 15, and 29 and every 28 days thereafter. A double-dummy design was used to protect the blind, thus, participants also received subcutaneous injections of placebo (subcutaneous placebo).
Overall Number of Participants Analyzed 736 721
Measure Type: Number
Unit of Measure: participants
Low sodium (LLN=135 mEq/L) 2 0
High sodium (ULN=148 mEq/L) 0 0
Low potassium (LLN=3.5 mEq/L) 9 9
High potassium (ULN=5.5 mEq/L) 1 0
Low chlorine (LLN= 96 mEq/L) 0 0
High chlorine (ULN=109 mEq/L) 0 0
Low calcium (LLN=8.4 mg/dL) 1 0
High calcium (ULN=10.6 mg/dL) 1 0
Low phosphorous (LLN=0.8 mg/dL) 1 2
High phosphorous (ULN=5.6 mg/dL) 0 1
14.Secondary Outcome
Title Double-blind Period: Minimum Observed Serum Concentration of Abatacept
Hide Description [Not Specified]
Time Frame Days 57, 85, 113, 120, 127, 134, 141, and 169
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 dose of study medication and from whom at least 1 pharmacokinetic (PK) sample was collected and reported (N). Only participants with adequate PK profiles were included in the summary statistics and statistical analysis (n).
Arm/Group Title Subcutaneous Abatacept Intravenous Abatacept
Hide Arm/Group Description:
Participants received weekly injections of 125 mg subcutaneous abatacept (with a loading dose of IV abatacept on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV placebo) with the exception that on Day 1, a loading dose of IV abatacept replaced the IV placebo treatment.
Participants received IV abatacept infusions on Days 1, 15, and 29 and every 28 days thereafter. A double-dummy design was used to protect the blind, thus, participants also received subcutaneous injections of placebo (subcutaneous placebo).
Overall Number of Participants Analyzed 630 649
Geometric Mean (Standard Deviation)
Unit of Measure: µg/mL
Day 57 (n=25, n=16) 31.60  (21.483) 23.14  (14.008)
Day 85 (n=630, n=649) 28.30  (21.692) 20.00  (13.441)
Day 113 (n=44, n=29) 26.49  (16.569) 18.76  (16.322)
Day 120 (n=27) 25.10  (14.933) NA [1]   (NA)
Day 127 (n=28) 29.16  (14.780) NA [2]   (NA)
Day 134 (n=27) 25.10  (15.753) NA [3]   (NA)
Day 141 (n=26, n=26) 25.79  (14.264) 18.10  (17.717)
Day 169 (n=530, n=521) 24.91  (14.989) 18.10  (17.94)
[1]
PK values were not sampled for IV abatacept group on Day 120
[2]
PK values were not sampled for IV abatacept group on Day 127
[3]
PK values were not sampled for IV abatacept group on Day 134
15.Secondary Outcome
Title Anti-TNF Failure Sub-study Double-blind Period: Minimum Observed Serum Concentration (Cmin) of Abatacept
Hide Description Serum concentrations of abatacept were analyzed using a validated ELISA. Steady-state trough observed concentration in serum (Cminss) was measured in μg/mL. Samples were obtained on Days 57, 85, 113, 120, 127, 134, 141, and 169.
Time Frame Days 57, 85, 113, 120, 127, 134, 141, and 169 (ST Period)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 dose of study medication and who had adequate PK profiles were analyzed. n= number of participants available at each specific time point.
Arm/Group Title Subcutaneous (SC) Abatacept Intravenous (IV) Abatacept
Hide Arm/Group Description:
During the Double Blind ST Period, participants received 125 mg weekly SC abatacept injections for 6 months (with an intravenous [IV] abatacept loading dose on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV Placebo) with the exception that on Day 1 a loading dose of IV abatacept replaced the IV Placebo treatment. An Anti-TNF Failure Sub-study was initiated using the same treatment as the Main study in order to assess the immunogenicity and safety in the Anti-TNF Failure population.
During the Double Blind ST Period, participants received IV abatacept infusions on Days 1, 15, 29, and every 28 days, thereafter for 6 months. A double-dummy design was used to protect the blind, thus, participants also received SC injections of placebo (SC Placebo). An Anti-TNF Failure Sub-study was initiated using the same treatment as the Main study in order to assess the immunogenicity and safety in the Anti-TNF Failure population.
Overall Number of Participants Analyzed 6 9
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: μg/mL
Day 57 (n=3,4)
25.53
(16%)
15.51
(25%)
Day 85 (n=6,9)
21.51
(26%)
12.50
(48%)
Day 113 (n=6,6)
23.14
(27%)
11.10
(31%)
Day 120 (n=4)
25.75
(17%)
NA [1] 
(NA%)
Day 127 (n=3)
25.42
(9%)
NA [2] 
(NA%)
Day 134 (n=3)
25.55
(13%)
NA [3] 
(NA%)
Day 141 (n=4,6)
20.85
(24%)
8.34
(44%)
Day 169 (n=5,7)
19.66
(25%)
9.00
(53%)
[1]
PK values were not sampled for IV abatacept group on Day 120.
[2]
PK values were not sampled for IV abatacept group on Day 127.
[3]
PK values were not sampled for IV abatacept group on Day 134.
16.Secondary Outcome
Title Double-blind Period: Maximum Observed Serum Concentration of Abatacept
Hide Description [Not Specified]
Time Frame End of infusion on Days 1 and 113 for IV infusion and in the dosing interval of Days 113 to 120 for subcutaneous
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 dose of study medication and who had adequate PK profiles for analysis
Arm/Group Title Subcutaneous Abatacept Intravenous Abatacept
Hide Arm/Group Description:
Participants received weekly injections of 125 mg subcutaneous abatacept (with a loading dose of IV abatacept on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV placebo) with the exception that on Day 1, a loading dose of IV abatacept replaced the IV placebo treatment.
Participants received IV abatacept infusions on Days 1, 15, and 29 and every 28 days thereafter. A double-dummy design was used to protect the blind, thus, participants also received subcutaneous injections of placebo (subcutaneous placebo).
Overall Number of Participants Analyzed 39 39
Geometric Mean (Standard Deviation)
Unit of Measure: µg/mL
40.39  (30.148) 222.35  (71.920)
17.Secondary Outcome
Title Anti-TNF Failure Substudy Double Blind Period: Geometric Mean Maximum Observed Serum Concentration of Abatacept
Hide Description Serum concentrations of abatacept were analyzed using a validated enzyme-linked immunosorbent assay (ELISA). Samples were obtained on Days 57, 85, 113, 120, 127, 134, 141, and 169. Cmax was measured in micrograms per milliliter (μg/mL).
Time Frame End of infusion on Days 1 and 113 for IV infusion and in the dosing interval of Days 113 to 120 for subcutaneous
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Sub-study who received at least 1 dose of study medication and who had adequate PK profiles were analyzed
Arm/Group Title Subcutaneous (SC) Abatacept Intravenous (IV) Abatacept
Hide Arm/Group Description:
During the Double Blind ST Period, participants received 125 mg weekly SC abatacept injections for 6 months (with an intravenous [IV] abatacept loading dose on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV Placebo) with the exception that on Day 1 a loading dose of IV abatacept replaced the IV Placebo treatment. An Anti-TNF Failure Sub-study was initiated using the same treatment as the Main study in order to assess the immunogenicity and safety in the Anti-TNF Failure population.
During the Double Blind ST Period, participants received IV abatacept infusions on Days 1, 15, 29, and every 28 days, thereafter for 6 months. A double-dummy design was used to protect the blind, thus, participants also received SC injections of placebo (SC Placebo). An Anti-TNF Failure Sub-study was initiated using the same treatment as the Main study in order to assess the immunogenicity and safety in the Anti-TNF Failure population.
Overall Number of Participants Analyzed 5 5
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: μg/mL
35.84
(24%)
229.88
(26%)
18.Secondary Outcome
Title Double-blind Period: Area Under The Curve In A Dose Interval (AUC TAU) of Abatacept
Hide Description [Not Specified]
Time Frame Dosing interval between Days 113 and 141 (TAU=28 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 dose of study medication and who had adequate PK profiles for analysis
Arm/Group Title Subcutaneous Abatacept Intravenous Abatacept
Hide Arm/Group Description:
Participants received weekly injections of 125 mg subcutaneous abatacept (with a loading dose of IV abatacept on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV placebo) with the exception that on Day 1, a loading dose of IV abatacept replaced the IV placebo treatment.
Participants received IV abatacept infusions on Days 1, 15, and 29 and every 28 days thereafter. A double-dummy design was used to protect the blind, thus, participants also received subcutaneous injections of placebo (subcutaneous placebo).
Overall Number of Participants Analyzed 39 39
Geometric Mean (Standard Deviation)
Unit of Measure: µg*h/mL
5182.37  (2854.136) 39587.08  (15444.743)
19.Secondary Outcome
Title Anti-TNF Failure Sub-study Double Blind Period: Area Under The Curve In A Dose Interval (AUC TAU) of Abatacept
Hide Description Serum concentrations of abatacept were analyzed using a validated ELISA. AUC(TAU) was measured as μg*h/mL. Samples for AUC (TAU) were obtained on Days 113, 120, 127, 134, and 141.
Time Frame Dosing Interval between Days 113 and 141 (TAU=28 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the sub-study who received at least 1 dose of study medication and who had adequate PK profiles for analysis
Arm/Group Title Subcutaneous (SC) Abatacept Intravenous (IV) Abatacept
Hide Arm/Group Description:
During the Double Blind ST Period, participants received 125 mg weekly SC abatacept injections for 6 months (with an intravenous [IV] abatacept loading dose on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV Placebo) with the exception that on Day 1 a loading dose of IV abatacept replaced the IV Placebo treatment. An Anti-TNF Failure Sub-study was initiated using the same treatment as the Main study in order to assess the immunogenicity and safety in the Anti-TNF Failure population.
During the Double Blind ST Period, participants received IV abatacept infusions on Days 1, 15, 29, and every 28 days, thereafter for 6 months. A double-dummy design was used to protect the blind, thus, participants also received SC injections of placebo (SC Placebo). An Anti-TNF Failure Sub-study was initiated using the same treatment as the Main study in order to assess the immunogenicity and safety in the Anti-TNF Failure population.
Overall Number of Participants Analyzed 5 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: μg*h/mL
4384.80
(17%)
34260.55
(35%)
20.Secondary Outcome
Title Double-blind Period: Number of Participants With Positive Anti-abatacept or Anti-Cytotoxic T Lymphocyte Antigen 4-T Cell (CTLA4-T) Responses Over Time by Enzyme Linked Immunoabsorbant Assay (ELISA)
Hide Description Serum samples from all treated adult participants with active rheumatoid arthritis were screened for the presence of drug-specific antibodies using ELISA. Immunogenicity was defined as the presence of a positive anti-abatacept (anti-ABA) or anti-CTLA4 antibody (anti-CTLA4).
Time Frame Days 85, and 169 and postvisits on Days 28, 56, and 85
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study medication. n=Number of participants with at least 1 assessment available.
Arm/Group Title Subcutaneous Abatacept Intravenous Abatacept
Hide Arm/Group Description:
Participants received weekly injections of 125 mg subcutaneous abatacept (with a loading dose of IV abatacept on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV placebo) with the exception that on Day 1, a loading dose of IV abatacept replaced the IV placebo treatment.
Participants received IV abatacept infusions on Days 1, 15, and 29 and every 28 days thereafter. A double-dummy design was used to protect the blind, thus, participants also received subcutaneous injections of placebo (subcutaneous placebo).
Overall Number of Participants Analyzed 736 721
Measure Type: Number
Unit of Measure: participants
Day 85 anti-ABA (n=700, n=682) 0 2
Day 85 anti-CTLA4 (n=705, n=689 0 0
Day 85 total (n=706, n=689) 0 2
Day 169 anti-ABA (n=671, n=648) 3 4
Day 169 anti-CTLA4 (n=681, n=658) 2 4
Day 169 total (n=681, n=658) 5 8
Overall on-treatment visits anti-ABA (n=707, 691) 3 5
Overall on-treatment visits anti-CTLA4 (n=716,702) 2 4
Overall on-treatment visits total (n=716, 702) 5 9
28 days post last dose anti-ABA (n=18, n=25) 0 0
28 days post last dose anti-CTLA4 (n=20, n=27) 0 2
28 days post last dose total (n=20, n=27) 0 2
56 days post last dose anti-ABA (n=19, n=22) 0 0
56 days post last dose anti-CTLA4 (n=19, n=23) 1 1
56 days post last dose total (n=19, n=23) 1 1
85 days post last dose anti-ABA (n=12, n=15) 0 0
85 days post last dose anti-CTLA4 (n=13, n=15) 2 5
85 days post last dose total (n=13, n=15) 2 5
Overall post visits anti-ABA (n=26, n=29) 0 0
Overall post visits anti-CTLA4 (n=28, n=31) 3 7
Overall post visits total (n=28, n=31) 3 7
Overall anti-ABA (n=714, n=698) 3 5
Overall anti-CTLA4 (n=725, n=710) 5 11
Overall total (n=725, n=710) 8 16
21.Secondary Outcome
Title Double-blind Period: Time-matched Median Percent Change From Baseline in Levels of Serum C-reactive Protein Over the Short-term Period
Hide Description C-reactive protein is an acute phase reactant protein that is a clinical marker for rheumatoid arthritis. Time-matched median percent change from baseline= (time-matched baseline value - Post-baseline value)/time-matched baseline value*100, where the time-matched baseline value represents the median baseline value for only that cohort of participants with measurements available at that visit.
Time Frame Baseline to Days 15, 29, 57, 85, 113, 141, and 169
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study medication. n=Number of participants with at least 1 assessment available.
Arm/Group Title Subcutaneous Abatacept Intravenous Abatacept
Hide Arm/Group Description:
Participants received weekly injections of 125 mg subcutaneous abatacept (with a loading dose of IV abatacept on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV placebo) with the exception that on Day 1, a loading dose of IV abatacept replaced the IV placebo treatment.
Participants received IV abatacept infusions on Days 1, 15, and 29 and every 28 days thereafter. A double-dummy design was used to protect the blind, thus, participants also received subcutaneous injections of placebo (subcutaneous placebo).
Overall Number of Participants Analyzed 736 721
Median (Inter-Quartile Range)
Unit of Measure: percent change
Day 15 (n=720, n=703)
34.16
(-11.11 to 58.80)
33.74
(-6.24 to 58.41)
Day 29 (n=727, n=711)
39.74
(3.83 to 66.99)
42.52
(0.42 to 68.66)
Day 57 (n=727, n=711)
47.88
(6.84 to 73.53)
51.42
(7.53 to 74.95)
Day 85 (n=727, n=711)
52.90
(8.70 to 78.25)
53.65
(11.05 to 79.42)
Day 113 (n=727, n=711)
53.33
(7.09 to 80.29)
58.12
(11.21 to 81.26)
Day 141 (n=727, n=711)
56.12
(5.28 to 83.24)
58.39
(16.14 to 81.52)
Day 169 (n=727, n=711)
57.18
(11.18 to 83.28)
56.81
(17.92 to 82.70)
22.Secondary Outcome
Title Double-blind Period: Number of Participants With Positive Anti-abatacept Responses Over Time by Electrochemiluminescence Immunoassay Among the First 10% of Participants Randomized
Hide Description An electrochemiluminescence immunoassay screened sera for drug-specific antibodies, immunocompetition was used to identify specific anti-abatacept reactivity. CTLA4 and Possibly Ig category=reactivity against extracellular domain of human CTLA4, constant regions of human IgG1, or both (CTLA4Ig; abatacept molecule). Ig and/or Junction (JNCT) category=reactivity against constant regions and/or hinge region of human IgG1. Drug-induced seropositivity was defined as a postbaseline titer higher than Baseline, or any postbaseline positivity if Baseline value was missing. Trt=treatment.
Time Frame Days 85, and 169 and postvisits on Days 28, 56, and 85
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of abatacept and had at least 1 immunogenicity result reported during the short-term period.
Arm/Group Title Subcutaneous Abatacept Intravenous Abatacept
Hide Arm/Group Description:
Participants received weekly injections of 125 mg subcutaneous abatacept (with a loading dose of IV abatacept on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV placebo) with the exception that on Day 1, a loading dose of IV abatacept replaced the IV placebo treatment.
Participants received IV abatacept infusions on Days 1, 15, and 29 and every 28 days thereafter. A double-dummy design was used to protect the blind, thus, participants also received subcutaneous injections of placebo (subcutaneous placebo).
Overall Number of Participants Analyzed 82 71
Measure Type: Number
Unit of Measure: participants
Day 85 CTLA4 + possibly Ig (n=78, n=67) 0 0
Day 85 Ig +/- JNCT (n=78, n=67) 0 0
Day 85 total (n=78, n=67) 0 0
Day 169 CTLA4 + possibly Ig (n=75, n=67) 0 1
Day 169 Ig +/- JNCT (n=75, n=67) 0 0
Day 169 total (n=75, n=67) 0 1
Overall on-TRT CTLA4 + possibly Ig (n=79, 70) 0 1
Overall on-TRT Ig +/- JNCT (n=79, 70) 0 0
Overall on-TRT total (n=79, 70) 0 1
28 days post last dose CTLA4+possibly Ig (n=2,n=2) 0 0
28 days post last dose Ig +/- JNCT (n=2, n=2) 0 0
28 days post last dose Total (n=2, n=2) 0 0
56 days post last dose CTLA4+possibly Ig (n=2,n=2) 0 0
56 days post last dose Ig +/- JNCT (n=2, n=2) 0 0
56 days post last dose total (n=2, n=2) 0 0
85 days post last dose CTLA4+possibly Ig (n=1,n=1) 0 0
85 days post last dose Ig +/- JNCT (n=1, n=1) 0 0
85 days post last dose total (n=1, n=1) 0 0
Overall post visits CTLA4+possibly Ig (n=3, n=2) 0 0
Overall post visits Ig +/- JNCT (n=3, n=2) 0 0
Overall post visits total (n=3, n=2) 0 0
Overall CTLA4+possibly Ig (n=82, n=71) 0 1
Overall Ig +/- JNCT (n=82, n=71) 0 0
Overall total (n=82, n=71) 0 1
23.Secondary Outcome
Title Double-blind Period: Number of Participants Seroconverting by Day 169 According to Status (Negative or Positive) at Baseline
Hide Description Rheumatoid factor (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.
Time Frame Baseline to Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study medication. n=Number of participants with at least 1 assessment available.
Arm/Group Title Subcutaneous Abatacept Intravenous Abatacept
Hide Arm/Group Description:
Participants received weekly injections of 125 mg subcutaneous abatacept (with a loading dose of IV abatacept on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV placebo) with the exception that on Day 1, a loading dose of IV abatacept replaced the IV placebo treatment.
Participants received IV abatacept infusions on Days 1, 15, and 29 and every 28 days thereafter. A double-dummy design was used to protect the blind, thus, participants also received subcutaneous injections of placebo (subcutaneous placebo).
Overall Number of Participants Analyzed 736 721
Measure Type: Number
Unit of Measure: participants
Baseline RF negative 106 93
Baseline RF negative; Day 169 RF positive 2 3
Baseline RF positive 586 582
Baseline RF positive ; Day 169 RF negative 33 40
24.Secondary Outcome
Title Open-Label LT Period: Number of Participants Achieving ACR 20 Response at Days 169, 729, 1261, and 1821
Hide Description The ACR 20 definition of improvement is a 20% improvement from baseline in the number of tender and swollen joints, and a 20% improvement from baseline in 3 of the remaining 5 core set measures: participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function and acute phase reactant value (C-reactive protein).
Time Frame Days 169, 729, 1261, 1821
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who entered the LT period and received at least 1 dose of study drug during the LT period were summarized.
Arm/Group Title Open-Label SC Abatacept Long Term Period
Hide Arm/Group Description:
During the Open-Label LT Period, participants could either continue with or switch to 125 mg weekly SC abatacept injections until the SC formulation became commercially available on a country basis or the Sponsor terminated the study. The Anti-TNF Sub-study terminated due to low recruitment and participants were permitted to roll into the LT Open Label Period.
Overall Number of Participants Analyzed 1357
Measure Type: Number
Unit of Measure: participants
Day 169 (n=1357) 1087
Day 729 (n=1187) 973
Day 1261 (n=1068) 904
Day 1821 (n=421) 356
25.Secondary Outcome
Title Open-Label LT Period: Number of Participants Achieving ACR 50 and ACR 70 Responses at Days 169, 729, 1261, 1821
Hide Description The ACR 50 definition of improvement is a 50% improvement from baseline in the number of tender and swollen joint counts, and a 50% improvement from baseline in 3 of the remaining 5 core set measures: participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function and acute phase reactant value (C-reactive protein). ACR 70 is defined similarly with 70% improvements from baseline for tender and swollen joint counts and 3 out of 5 core measures.
Time Frame Days 169, 729, 1261, 1821
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who entered the LT period and received at least 1 dose of study drug during the LT period were summarized.
Arm/Group Title Open-Label SC Abatacept Long Term Period
Hide Arm/Group Description:
During the Open-Label LT Period, participants could either continue with or switch to 125 mg weekly SC abatacept injections until the SC formulation became commercially available on a country basis or the Sponsor terminated the study. The Anti-TNF Sub-study terminated due to low recruitment and participants were permitted to roll into the LT Open Label Period.
Overall Number of Participants Analyzed 1362
Measure Type: Number
Unit of Measure: participants
Day 169 ACR 50 (n=1362) 724
Day 729 ACR 50 (n=1185) 720
Day 1261 ACR 50(n=1069) 672
Day 1821 ACR 50 (n=423) 277
Day 169 ACR 70 (n=1362) 371
Day 729 ACR 70 (n=1186) 443
Day 1261 ACR 70 (n=1070) 438
Day 1821 ACR 70 (n=425) 191
26.Secondary Outcome
Title Open-Label LT Period: Mean Change From Baseline in Disease Activity Score in 28 Joints (DAS28) Using C-reactive Protein (CRP) at Days 169, 729, 1261, 1821
Hide Description The DAS28 index measures disease activity in rheumatoid arthritis and is a composite derived from the number of swollen/tender joints, laboratory tests of inflammation (C-reactive protein measured in mg/L), and participant assessment of global health (by marking a visual analog scale 100 mm line from "very good" to "very bad"). A higher DAS28 score indicates worse control of disease. High disease activity is > 5.1, low disease activity is < 3.2 and remission is < 2.6. A clinically significant response= decrease in DAS28 score of >1.2 from baseline.
Time Frame Days 169, 729, 1261, 1821
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who entered the LT period and received at least 1 dose of study drug during the LT period were summarized.
Arm/Group Title Open-Label SC Abatacept Long Term Period
Hide Arm/Group Description:
During the Open-Label LT Period, participants could either continue with or switch to 125 mg weekly SC abatacept injections until the SC formulation became commercially available on a country basis or the Sponsor terminated the study. The Anti-TNF Sub-study terminated due to low recruitment and participants were permitted to roll into the LT Open Label Period.
Overall Number of Participants Analyzed 1353
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Day 169 (n=1353)
-2.65
(-2.71 to -2.58)
Day 729 (n=1181)
-2.94
(-3.01 to -2.86)
Day 1261 (n=1063)
-3.09
(-3.17 to -3.00)
Day 1821 (n=413)
-3.24
(-3.38 to -3.11)
27.Secondary Outcome
Title Open-Label LT Period: Number of Participants Achieving DAS 28 Remission at Days 169, 729, 1261, 1821
Hide Description The DAS28 index measures disease activity in rheumatoid arthritis and is a composite derived from the number of swollen/tender joints, laboratory tests of inflammation (C-reactive protein measured in mg/L), and participant assessment of global health (by marking a visual analog scale 100 mm line from "very good" to "very bad"). A higher DAS28 score indicates worse control of disease. High disease activity is > 5.1, low disease activity is < 3.2 and remission is < 2.6.
Time Frame Days 169, 729, 1261, 1821
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who entered the LT period and received at least 1 dose of study drug during the LT period were summarized.
Arm/Group Title Open-Label SC Abatacept Long Term Period
Hide Arm/Group Description:
During the Open-Label LT Period, participants could either continue with or switch to 125 mg weekly SC abatacept injections until the SC formulation became commercially available on a country basis or the Sponsor terminated the study. The Anti-TNF Sub-study terminated due to low recruitment and participants were permitted to roll into the LT Open Label Period.
Overall Number of Participants Analyzed 1355
Measure Type: Number
Unit of Measure: participants
Day 169 (n=1355) 334
Day 729 (n=1183) 411
Day 1261 (n=1064) 425
Day 1821 (n=413) 169
28.Secondary Outcome
Title Open-Label LT Period: Number of Participants Achieving DAS 28 Low Disease Activity (LDA) at Days 169, 729, 1261, 1821
Hide Description The DAS28 index measures disease activity in rheumatoid arthritis and is a composite derived from the number of swollen/tender joints, laboratory tests of inflammation (C-reactive protein measured in mg/L), and participant assessment of global health (by marking a visual analog scale 100 mm line from "very good" to "very bad"). A higher DAS28 score indicates worse control of disease. High disease activity is > 5.1, low disease activity is < 3.2 and remission is < 2.6.
Time Frame Days 169, 729, 1261, 1821
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who entered the LT period and received at least 1 dose of study drug during the LT period were summarized.
Arm/Group Title Open-Label SC Abatacept Long Term Period
Hide Arm/Group Description:
During the Open-Label LT Period, participants could either continue with or switch to 125 mg weekly SC abatacept injections until the SC formulation became commercially available on a country basis or the Sponsor terminated the study. The Anti-TNF Sub-study terminated due to low recruitment and participants were permitted to roll into the LT Open Label Period.
Overall Number of Participants Analyzed 1355
Measure Type: Number
Unit of Measure: participants
Day 169 (n=1355) 553
Day 729 (n=1183) 600
Day 1261 (n=1064) 585
Day 1821 (n=413) 238
29.Secondary Outcome
Title Open-Label LT Period: Number of Participants With HAQ-DI Response at Days 169, 729, 1261, 1821
Hide Description The disability section of the full HAQ includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain divided by the number of domains answered. HAQ-DI overall score ranges from a minimum of 0 to a maximum of 3.0. HAQ response was defined as an improvement (reduction) from baseline (Day 1) of at least 0.3 units in the HAQ score.
Time Frame Days 169, 729, 1261, 1821
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who entered the LT period, received at least 1 dose of study drug during the LT period, and had HAD-QI scores at baseline and at specified days were summarized.
Arm/Group Title Open-Label SC Abatacept Long Term Period
Hide Arm/Group Description:
During the Open-Label LT Period, participants could either continue with or switch to 125 mg weekly SC abatacept injections until the SC formulation became commercially available on a country basis or the Sponsor terminated the study. The Anti-TNF Sub-study terminated due to low recruitment and participants were permitted to roll into the LT Open Label Period.
Overall Number of Participants Analyzed 1364
Measure Type: Number
Unit of Measure: participants
Day 169 (n=1364) 962
Day 729 (n=1190) 853
Day 1261 (n=1068) 780
Day 1821 (n=427) 315
30.Secondary Outcome
Title Open-Label LT Period: Number of Participants With Death As Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, SAEs Leading to Discontinuation, Adverse Events (AEs), Treatment-related AEs, or AEs Leading to Discontinuation
Hide Description AE=any new untoward medical event or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event. Treatment-related SAE=possibly, probably, or certainly related to study drug
Time Frame End of ST Period (Day 169) to last dose plus 85 days, up to 5 years (September 2014)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who entered the LT Period and received at least 1 dose of study drug during the LT Period.
Arm/Group Title Open-Label SC Abatacept Long Term Period
Hide Arm/Group Description:
During the Open-Label LT Period, participants could either continue with or switch to 125 mg weekly SC abatacept injections until the SC formulation became commercially available on a country basis or the Sponsor terminated the study. The Anti-TNF Sub-study terminated due to low recruitment and participants were permitted to roll into the LT Open Label Period.
Overall Number of Participants Analyzed 1373
Measure Type: Number
Unit of Measure: participants
Death 41
SAE 353
Treatment-related SAE 88
SAEs leading to Discontinuation 73
Treatment-related AEs 632
AEs leading to Discontinuation 97
31.Secondary Outcome
Title Open-Label LT Period: Number of Participants With AEs of Special Interest
Hide Description AE=any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs: all infections, serious infections, and opportunistic infections; autoimmune disorders; malignancies; system injection reactions, and local injection site reactions.
Time Frame End of ST Period (Day 169) to last dose plus 85 days, up to 5 years (September 2014)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who entered the LT Period and received at least 1 dose of study drug during the LT Period.
Arm/Group Title Open-Label SC Abatacept Long Term Period
Hide Arm/Group Description:
During the Open-Label LT Period, participants could either continue with or switch to 125 mg weekly SC abatacept injections until the SC formulation became commercially available on a country basis or the Sponsor terminated the study. The Anti-TNF Sub-study terminated due to low recruitment and participants were permitted to roll into the LT Open Label Period.
Overall Number of Participants Analyzed 1373
Measure Type: Number
Unit of Measure: participants
All Infections 962
Serious Infections 85
Infections leading to Discontinuation 25
Serious Infections leading to Discontinuation 16
Malignancies 56
Autoimmune Disorders 67
Local Injection Site Reactions 33
Systemic Injection Reactions 161
32.Secondary Outcome
Title Open-Label LT Period: Number of Participants With Clinically Significant Abnormalities in Vital Sign Measurements
Hide Description Vital sign assessments were performed in the LT period at 12-week intervals and at a yearly visit (at 16-week intervals) and, for participants who withdrew from the study prematurely, 7 days after the last dose of SC abatacept. Vital signs included seated systolic blood pressure, seated diastolic blood pressure, temperature, and heart rate. Abnormalities were determined to be clinically significant by the investigator.
Time Frame End of ST Period (Day 169) to last dose plus 7 days, up to 5 years (September 2014)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who entered the LT Period and received at least 1 dose of study drug during the LT Period.
Arm/Group Title Open-Label SC Abatacept Long Term Period
Hide Arm/Group Description:
During the Open-Label LT Period, participants could either continue with or switch to 125 mg weekly SC abatacept injections until the SC formulation became commercially available on a country basis or the Sponsor terminated the study. The Anti-TNF Sub-study terminated due to low recruitment and participants were permitted to roll into the LT Open Label Period.
Overall Number of Participants Analyzed 1373
Measure Type: Number
Unit of Measure: participants
0
33.Secondary Outcome
Title Open-Label LT Period: Number of Participants With Clinically Significant Laboratory Abnormalities
Hide Description Laboratory assessments were performed in the LT period at 12-week intervals and at a yearly visit and, for participants who withdrew from the study prematurely, 7 days after the last dose of SC abatacept. Abnormalities were determined to be clinically significant by the investigator.
Time Frame End of ST Period (Day 169) to last dose plus 7 days, up to 5 years (September 2014)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who entered the LT Period and received at least 1 dose of study drug during the LT Period.
Arm/Group Title Open-Label SC Abatacept Long Term Period
Hide Arm/Group Description:
During the Open-Label LT Period, participants could either continue with or switch to 125 mg weekly SC abatacept injections until the SC formulation became commercially available on a country basis or the Sponsor terminated the study. The Anti-TNF Sub-study terminated due to low recruitment and participants were permitted to roll into the LT Open Label Period.
Overall Number of Participants Analyzed 1373
Measure Type: Number
Unit of Measure: participants
0
Time Frame First dose (Day 1) in ST period to last dose in LT period plus 85 days, up to 5 years (September 2014).
Adverse Event Reporting Description Population includes both Main Study and Anti-TNF Failure Sub-study. Sub-study was terminated early and participants could enter LT Period of Main study.
 
Arm/Group Title IV Abatacept SC Abatacept
Hide Arm/Group Description During the Main study Double Blind ST Period, participants received IV abatacept infusions on Days 1, 15, 29, and every 28 days, thereafter for 6 months. A double-dummy design was used to protect the blind, thus, participants also received SC injections of placebo (SC Placebo). An Anti-TNF Failure Sub-study was initiated (recruited separately from Main study) using the same treatment as the Main study in order to assess the immunogenicity and safety in the Anti-TNF Failure population. The Sub-study terminated due to low recruitment and participants were permitted to roll into the LT Open Label Period. During the Open Label LT Period, participants in both the Main Study and the Anti-TNF Failure Sub-study could switch to SC abatacept until the SC formulation became commercially available on a country basis or the Sponsor terminated the study. During the Main Study Double Blind ST Period, participants received 125 mg weekly SC abatacept injections for 6 months (with an IV abatacept loading dose on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV Placebo) with the exception that on Day 1 a loading dose of IV abatacept replaced the IV Placebo treatment. An Anti-TNF Failure Sub-study was initiated (recruited separately from Main study) using the same treatment as the Main study in order to assess the immunogenicity and safety in the Anti-TNF Failure population. The Sub-study terminated due to low recruitment and participants were permitted to roll into the LT Open Label Period. During the Open Label LT Period, participants in both the Main Study and the Anti-TNF Failure Sub-study could continue SC abatacept until the SC formulation became commercially available on a country basis or the Sponsor terminated the study.
All-Cause Mortality
IV Abatacept SC Abatacept
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
IV Abatacept SC Abatacept
Affected / at Risk (%) Affected / at Risk (%)
Total   206/731 (28.18%)   199/744 (26.75%) 
Blood and lymphatic system disorders     
Hypersplenism † 1  1/731 (0.14%)  0/744 (0.00%) 
Splenomegaly † 1  1/731 (0.14%)  0/744 (0.00%) 
Anaemia † 1  2/731 (0.27%)  3/744 (0.40%) 
Necrotising granulomatous lymphadenitis † 1  0/731 (0.00%)  1/744 (0.13%) 
Autoimmune haemolytic anaemia † 1  0/731 (0.00%)  1/744 (0.13%) 
Iron deficiency anaemia † 1  0/731 (0.00%)  1/744 (0.13%) 
Pancytopenia † 1  2/731 (0.27%)  0/744 (0.00%) 
Cardiac disorders     
Acute coronary syndrome † 1  1/731 (0.14%)  2/744 (0.27%) 
Bradycardia † 1  2/731 (0.27%)  0/744 (0.00%) 
Cardiac arrest † 1  1/731 (0.14%)  0/744 (0.00%) 
Ventricular tachycardia † 1  0/731 (0.00%)  1/744 (0.13%) 
Atrial fibrillation † 1  1/731 (0.14%)  3/744 (0.40%) 
Atrial flutter † 1  1/731 (0.14%)  1/744 (0.13%) 
Pericarditis † 1  2/731 (0.27%)  1/744 (0.13%) 
Angina pectoris † 1  1/731 (0.14%)  1/744 (0.13%) 
Sinus tachycardia † 1  1/731 (0.14%)  0/744 (0.00%) 
Angina unstable † 1  1/731 (0.14%)  0/744 (0.00%) 
Cardio-respiratory arrest † 1  0/731 (0.00%)  1/744 (0.13%) 
Coronary artery disease † 1  2/731 (0.27%)  0/744 (0.00%) 
Coronary artery occlusion † 1  0/731 (0.00%)  1/744 (0.13%) 
Acute left ventricular failure † 1  0/731 (0.00%)  1/744 (0.13%) 
Cardiac failure † 1  0/731 (0.00%)  2/744 (0.27%) 
Cardiopulmonary failure † 1  1/731 (0.14%)  0/744 (0.00%) 
Acute myocardial infarction † 1  1/731 (0.14%)  5/744 (0.67%) 
Myocardial infarction † 1  5/731 (0.68%)  11/744 (1.48%) 
Myocardial ischaemia † 1  1/731 (0.14%)  3/744 (0.40%) 
Tachycardia † 1  1/731 (0.14%)  2/744 (0.27%) 
Congenital, familial and genetic disorders     
Metatarsus primus varus † 1  1/731 (0.14%)  0/744 (0.00%) 
Atrial septal defect † 1  2/731 (0.27%)  0/744 (0.00%) 
Ear and labyrinth disorders     
Deafness † 1  1/731 (0.14%)  0/744 (0.00%) 
Vertigo † 1  1/731 (0.14%)  0/744 (0.00%) 
Meniere's disease † 1  2/731 (0.27%)  0/744 (0.00%) 
Eye disorders     
Keratitis † 1  1/731 (0.14%)  0/744 (0.00%) 
Macular fibrosis † 1  0/731 (0.00%)  1/744 (0.13%) 
Blindness † 1  0/731 (0.00%)  1/744 (0.13%) 
Uveitis † 1  0/731 (0.00%)  1/744 (0.13%) 
Retinal infarction † 1  1/731 (0.14%)  0/744 (0.00%) 
Cataract † 1  0/731 (0.00%)  1/744 (0.13%) 
Gastrointestinal disorders     
Abdominal pain † 1  2/731 (0.27%)  4/744 (0.54%) 
Gastric ulcer haemorrhage † 1  1/731 (0.14%)  0/744 (0.00%) 
Pancreatic cyst † 1  0/731 (0.00%)  1/744 (0.13%) 
Abdominal pain upper † 1  1/731 (0.14%)  0/744 (0.00%) 
Colitis † 1  1/731 (0.14%)  0/744 (0.00%) 
Colitis ischaemic † 1  1/731 (0.14%)  0/744 (0.00%) 
Incarcerated inguinal hernia † 1  1/731 (0.14%)  0/744 (0.00%) 
Large intestine perforation † 1  0/731 (0.00%)  1/744 (0.13%) 
Pancreatitis acute † 1  1/731 (0.14%)  1/744 (0.13%) 
Upper gastrointestinal haemorrhage † 1  1/731 (0.14%)  1/744 (0.13%) 
Abdominal distension † 1  0/731 (0.00%)  1/744 (0.13%) 
Gastric ulcer † 1  0/731 (0.00%)  1/744 (0.13%) 
Gastritis † 1  2/731 (0.27%)  0/744 (0.00%) 
Gastrointestinal ischaemia † 1  0/731 (0.00%)  1/744 (0.13%) 
Gastrooesophageal reflux disease † 1  1/731 (0.14%)  0/744 (0.00%) 
Haemorrhoids † 1  1/731 (0.14%)  0/744 (0.00%) 
Vomiting † 1  2/731 (0.27%)  1/744 (0.13%) 
Gastrointestinal angiodysplasia haemorrhagic † 1  0/731 (0.00%)  1/744 (0.13%) 
Mouth ulceration † 1  0/731 (0.00%)  1/744 (0.13%) 
Small intestinal obstruction † 1  0/731 (0.00%)  1/744 (0.13%) 
Dysphagia † 1  0/731 (0.00%)  1/744 (0.13%) 
Haematochezia † 1  1/731 (0.14%)  0/744 (0.00%) 
Inguinal hernia † 1  0/731 (0.00%)  3/744 (0.40%) 
Nausea † 1  2/731 (0.27%)  0/744 (0.00%) 
Acute abdomen † 1  1/731 (0.14%)  0/744 (0.00%) 
Aphthous stomatitis † 1  0/731 (0.00%)  1/744 (0.13%) 
Crohn's disease † 1  1/731 (0.14%)  0/744 (0.00%) 
Diarrhoea † 1  1/731 (0.14%)  1/744 (0.13%) 
Enterocele † 1  0/731 (0.00%)  1/744 (0.13%) 
Colitis ulcerative † 1  1/731 (0.14%)  0/744 (0.00%) 
Hernial eventration † 1  1/731 (0.14%)  1/744 (0.13%) 
Intestinal infarction † 1  1/731 (0.14%)  0/744 (0.00%) 
Pancreatitis † 1  1/731 (0.14%)  0/744 (0.00%) 
General disorders     
Chest pain † 1  6/731 (0.82%)  4/744 (0.54%) 
Oedema peripheral † 1  0/731 (0.00%)  1/744 (0.13%) 
Adhesion † 1  1/731 (0.14%)  0/744 (0.00%) 
Non-cardiac chest pain † 1  0/731 (0.00%)  1/744 (0.13%) 
Chest discomfort † 1  0/731 (0.00%)  1/744 (0.13%) 
Embedded device † 1  1/731 (0.14%)  0/744 (0.00%) 
Asthenia † 1  1/731 (0.14%)  1/744 (0.13%) 
Sudden death † 1  1/731 (0.14%)  0/744 (0.00%) 
Device failure † 1  0/731 (0.00%)  1/744 (0.13%) 
Device malfunction † 1  0/731 (0.00%)  1/744 (0.13%) 
Incarcerated hernia † 1  0/731 (0.00%)  1/744 (0.13%) 
Multi-organ failure † 1  0/731 (0.00%)  1/744 (0.13%) 
Pyrexia † 1  0/731 (0.00%)  1/744 (0.13%) 
Pacemaker generated arrhythmia † 1  1/731 (0.14%)  0/744 (0.00%) 
Sudden cardiac death † 1  0/731 (0.00%)  1/744 (0.13%) 
Hepatobiliary disorders     
Jaundice hepatocellular † 1  0/731 (0.00%)  1/744 (0.13%) 
Cholecystitis acute † 1  3/731 (0.41%)  0/744 (0.00%) 
Cholecystitis chronic † 1  1/731 (0.14%)  4/744 (0.54%) 
Hepatic steatosis † 1  1/731 (0.14%)  1/744 (0.13%) 
Drug-induced liver injury † 1  0/731 (0.00%)  1/744 (0.13%) 
Biliary colic † 1  0/731 (0.00%)  1/744 (0.13%) 
Cholelithiasis † 1  4/731 (0.55%)  2/744 (0.27%) 
Cholecystitis † 1  2/731 (0.27%)  2/744 (0.27%) 
Immune system disorders     
Anaphylactic reaction † 1  1/731 (0.14%)  1/744 (0.13%) 
Infections and infestations     
Appendicitis perforated † 1  1/731 (0.14%)  1/744 (0.13%) 
Arthritis infective † 1  0/731 (0.00%)  1/744 (0.13%) 
Breast abscess † 1  1/731 (0.14%)  0/744 (0.00%) 
Diverticulitis † 1  0/731 (0.00%)  1/744 (0.13%) 
Gastroenteritis viral † 1  1/731 (0.14%)  1/744 (0.13%) 
Infective tenosynovitis † 1  2/731 (0.27%)  0/744 (0.00%) 
Pelvic inflammatory disease † 1  0/731 (0.00%)  1/744 (0.13%) 
Salpingitis † 1  0/731 (0.00%)  2/744 (0.27%) 
Staphylococcal sepsis † 1  0/731 (0.00%)  1/744 (0.13%) 
Urosepsis † 1  1/731 (0.14%)  1/744 (0.13%) 
Encephalitis † 1  1/731 (0.14%)  0/744 (0.00%) 
Localised infection † 1  1/731 (0.14%)  0/744 (0.00%) 
Peritoneal tuberculosis † 1  0/731 (0.00%)  1/744 (0.13%) 
Peritonitis † 1  1/731 (0.14%)  0/744 (0.00%) 
Appendicitis † 1  3/731 (0.41%)  3/744 (0.40%) 
Bacteraemia † 1  0/731 (0.00%)  1/744 (0.13%) 
Cellulitis † 1  1/731 (0.14%)  2/744 (0.27%) 
Erysipelas † 1  1/731 (0.14%)  0/744 (0.00%) 
Gastroenteritis † 1  3/731 (0.41%)  2/744 (0.27%) 
H1N1 influenza † 1  1/731 (0.14%)  0/744 (0.00%) 
Lobar pneumonia † 1  0/731 (0.00%)  2/744 (0.27%) 
Mastitis † 1  1/731 (0.14%)  0/744 (0.00%) 
Tuberculosis † 1  1/731 (0.14%)  0/744 (0.00%) 
Varicella † 1  1/731 (0.14%)  0/744 (0.00%) 
Abdominal sepsis † 1  0/731 (0.00%)  1/744 (0.13%) 
Abscess oral † 1  1/731 (0.14%)  0/744 (0.00%) 
Arthritis bacterial † 1  2/731 (0.27%)  1/744 (0.13%) 
Atypical pneumonia † 1  1/731 (0.14%)  1/744 (0.13%) 
Bronchopneumonia † 1  0/731 (0.00%)  1/744 (0.13%) 
Infectious pleural effusion † 1  0/731 (0.00%)  2/744 (0.27%) 
Ludwig angina † 1  0/731 (0.00%)  1/744 (0.13%) 
Oral candidiasis † 1  0/731 (0.00%)  1/744 (0.13%) 
Septic shock † 1  1/731 (0.14%)  1/744 (0.13%) 
Viral hepatitis carrier † 1  1/731 (0.14%)  0/744 (0.00%) 
Pneumonia † 1  12/731 (1.64%)  8/744 (1.08%) 
Pneumonia staphylococcal † 1  1/731 (0.14%)  0/744 (0.00%) 
Sinusitis † 1  0/731 (0.00%)  2/744 (0.27%) 
Wound infection † 1  1/731 (0.14%)  0/744 (0.00%) 
Bronchitis † 1  2/731 (0.27%)  3/744 (0.40%) 
Gastrointestinal infection † 1  0/731 (0.00%)  1/744 (0.13%) 
Herpes zoster † 1  2/731 (0.27%)  2/744 (0.27%) 
Respiratory tract infection † 1  1/731 (0.14%)  2/744 (0.27%) 
Sinusitis fungal † 1  0/731 (0.00%)  1/744 (0.13%) 
Soft tissue infection † 1  1/731 (0.14%)  0/744 (0.00%) 
Staphylococcal infection † 1  0/731 (0.00%)  1/744 (0.13%) 
Urinary tract infection † 1  7/731 (0.96%)  1/744 (0.13%) 
Chronic sinusitis † 1  0/731 (0.00%)  1/744 (0.13%) 
Pulmonary tuberculosis † 1  0/731 (0.00%)  3/744 (0.40%) 
Sepsis † 1  1/731 (0.14%)  3/744 (0.40%) 
Osteomyelitis † 1  1/731 (0.14%)  1/744 (0.13%) 
Pelvic abscess † 1  1/731 (0.14%)  0/744 (0.00%) 
Pyelonephritis acute † 1  2/731 (0.27%)  1/744 (0.13%) 
Subcutaneous abscess † 1  1/731 (0.14%)  1/744 (0.13%) 
Tetanus † 1  1/731 (0.14%)  0/744 (0.00%) 
Upper respiratory tract infection † 1  1/731 (0.14%)  0/744 (0.00%) 
Viral infection † 1  1/731 (0.14%)  0/744 (0.00%) 
Injury, poisoning and procedural complications     
Ankle fracture † 1  0/731 (0.00%)  1/744 (0.13%) 
Cervical vertebral fracture † 1  0/731 (0.00%)  1/744 (0.13%) 
Contusion † 1  0/731 (0.00%)  1/744 (0.13%) 
Fall † 1  1/731 (0.14%)  1/744 (0.13%) 
Humerus fracture † 1  1/731 (0.14%)  1/744 (0.13%) 
Joint injury † 1  0/731 (0.00%)  1/744 (0.13%) 
Wound † 1  1/731 (0.14%)  0/744 (0.00%) 
Dislocation of vertebra † 1  1/731 (0.14%)  0/744 (0.00%) 
Joint dislocation † 1  1/731 (0.14%)  0/744 (0.00%) 
Laceration † 1  1/731 (0.14%)  0/744 (0.00%) 
Limb traumatic amputation † 1  0/731 (0.00%)  1/744 (0.13%) 
Lumbar vertebral fracture † 1  1/731 (0.14%)  0/744 (0.00%) 
Stress fracture † 1  1/731 (0.14%)  1/744 (0.13%) 
Median nerve injury † 1  1/731 (0.14%)  0/744 (0.00%) 
Overdose † 1  1/731 (0.14%)  0/744 (0.00%) 
Road traffic accident † 1  3/731 (0.41%)  0/744 (0.00%) 
Multiple injuries † 1  1/731 (0.14%)  0/744 (0.00%) 
Procedural pain † 1  1/731 (0.14%)  0/744 (0.00%) 
Pubis fracture † 1  0/731 (0.00%)  1/744 (0.13%) 
Tibia fracture † 1  0/731 (0.00%)  2/744 (0.27%) 
Post-traumatic neck syndrome † 1  0/731 (0.00%)  1/744 (0.13%) 
Thoracic vertebral fracture † 1  0/731 (0.00%)  1/744 (0.13%) 
Upper limb fracture † 1  2/731 (0.27%)  0/744 (0.00%) 
Femoral neck fracture † 1  3/731 (0.41%)  2/744 (0.27%) 
Femur fracture † 1  1/731 (0.14%)  1/744 (0.13%) 
Foot fracture † 1  1/731 (0.14%)  1/744 (0.13%) 
Spinal compression fracture † 1  1/731 (0.14%)  0/744 (0.00%) 
Alcohol poisoning † 1  0/731 (0.00%)  1/744 (0.13%) 
Hip fracture † 1  0/731 (0.00%)  1/744 (0.13%) 
Limb injury † 1  0/731 (0.00%)  1/744 (0.13%) 
Lower limb fracture † 1  2/731 (0.27%)  1/744 (0.13%) 
Ulna fracture † 1  0/731 (0.00%)  1/744 (0.13%) 
Animal bite † 1  0/731 (0.00%)  1/744 (0.13%) 
Cardiac function disturbance postoperative † 1  1/731 (0.14%)  0/744 (0.00%) 
Incisional hernia † 1  0/731 (0.00%)  1/744 (0.13%) 
Spinal fracture † 1  1/731 (0.14%)  0/744 (0.00%) 
Wrist fracture † 1  1/731 (0.14%)  0/744 (0.00%) 
Investigations     
Enterococcus test positive † 1  0/731 (0.00%)  1/744 (0.13%) 
Hepatic enzyme increased † 1  1/731 (0.14%)  0/744 (0.00%) 
Metabolism and nutrition disorders     
Diabetic ketoacidosis † 1  0/731 (0.00%)  1/744 (0.13%) 
Obesity † 1  2/731 (0.27%)  0/744 (0.00%) 
Dehydration † 1  1/731 (0.14%)  2/744 (0.27%) 
Hypokalaemia † 1  0/731 (0.00%)  1/744 (0.13%) 
Hyponatraemia † 1  0/731 (0.00%)  1/744 (0.13%) 
Metabolic acidosis † 1  0/731 (0.00%)  1/744 (0.13%) 
Diabetes mellitus † 1  1/731 (0.14%)  1/744 (0.13%) 
Musculoskeletal and connective tissue disorders     
Facet joint syndrome † 1  0/731 (0.00%)  1/744 (0.13%) 
Ligament disorder † 1  0/731 (0.00%)  1/744 (0.13%) 
Joint contracture † 1  1/731 (0.14%)  0/744 (0.00%) 
Spinal osteoarthritis † 1  1/731 (0.14%)  1/744 (0.13%) 
Pain in extremity † 1  0/731 (0.00%)  1/744 (0.13%) 
Intervertebral disc protrusion † 1  2/731 (0.27%)  2/744 (0.27%) 
Lumbar spinal stenosis † 1  1/731 (0.14%)  1/744 (0.13%) 
Musculoskeletal pain † 1  0/731 (0.00%)  1/744 (0.13%) 
Osteoporotic fracture † 1  0/731 (0.00%)  1/744 (0.13%) 
Spinal column stenosis † 1  1/731 (0.14%)  2/744 (0.27%) 
Costochondritis † 1  0/731 (0.00%)  1/744 (0.13%) 
Arthralgia † 1  1/731 (0.14%)  2/744 (0.27%) 
Foot deformity † 1  3/731 (0.41%)  1/744 (0.13%) 
Osteoarthritis † 1  12/731 (1.64%)  16/744 (2.15%) 
Pathological fracture † 1  0/731 (0.00%)  1/744 (0.13%) 
Synovitis † 1  0/731 (0.00%)  1/744 (0.13%) 
Arthritis † 1  1/731 (0.14%)  3/744 (0.40%) 
Joint range of motion decreased † 1  0/731 (0.00%)  1/744 (0.13%) 
Neck pain † 1  1/731 (0.14%)  0/744 (0.00%) 
Rotator cuff syndrome † 1  1/731 (0.14%)  0/744 (0.00%) 
Back pain † 1  2/731 (0.27%)  3/744 (0.40%) 
Osteonecrosis † 1  2/731 (0.27%)  1/744 (0.13%) 
Rheumatoid arthritis † 1  12/731 (1.64%)  14/744 (1.88%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Cervix carcinoma stage 0 † 1  2/731 (0.27%)  1/744 (0.13%) 
Colon cancer metastatic † 1  1/731 (0.14%)  0/744 (0.00%) 
Intraductal proliferative breast lesion † 1  0/731 (0.00%)  1/744 (0.13%) 
Invasive ductal breast carcinoma † 1  2/731 (0.27%)  0/744 (0.00%) 
Lung neoplasm malignant † 1  1/731 (0.14%)  0/744 (0.00%) 
Metastases to peritoneum † 1  0/731 (0.00%)  1/744 (0.13%) 
Ovarian epithelial cancer † 1  0/731 (0.00%)  1/744 (0.13%) 
Squamous cell carcinoma † 1  2/731 (0.27%)  1/744 (0.13%) 
Anal cancer † 1  1/731 (0.14%)  0/744 (0.00%) 
Breast cancer † 1  1/731 (0.14%)  3/744 (0.40%) 
Renal cell carcinoma † 1  0/731 (0.00%)  1/744 (0.13%) 
Small cell lung cancer † 1  1/731 (0.14%)  0/744 (0.00%) 
B-cell lymphoma † 1  0/731 (0.00%)  1/744 (0.13%) 
Fibrous histiocytoma † 1  0/731 (0.00%)  1/744 (0.13%) 
Invasive lobular breast carcinoma † 1  0/731 (0.00%)  1/744 (0.13%) 
Lung adenocarcinoma † 1  1/731 (0.14%)  0/744 (0.00%) 
Non-Hodgkin's lymphoma † 1  0/731 (0.00%)  1/744 (0.13%) 
Basal cell carcinoma † 1  7/731 (0.96%)  2/744 (0.27%) 
Cervix carcinoma † 1  1/731 (0.14%)  0/744 (0.00%) 
Fibroadenoma of breast † 1  0/731 (0.00%)  2/744 (0.27%) 
Mucoepidermoid carcinoma of salivary gland † 1  1/731 (0.14%)  0/744 (0.00%) 
Non-small cell lung cancer † 1  2/731 (0.27%)  0/744 (0.00%) 
Pancreatic carcinoma † 1  0/731 (0.00%)  1/744 (0.13%) 
Uterine leiomyoma † 1  2/731 (0.27%)  4/744 (0.54%) 
Biliary cancer metastatic † 1  1/731 (0.14%)  0/744 (0.00%) 
Chronic myelomonocytic leukaemia † 1  1/731 (0.14%)  0/744 (0.00%) 
Thyroid neoplasm † 1  1/731 (0.14%)  0/744 (0.00%) 
Adenosquamous cell lung cancer † 1  1/731 (0.14%)  0/744 (0.00%) 
Bladder cancer † 1  1/731 (0.14%)  0/744 (0.00%) 
Colon cancer † 1  1/731 (0.14%)  0/744 (0.00%) 
Diffuse large B-cell lymphoma † 1  0/731 (0.00%)  1/744 (0.13%) 
Neuroma † 1  0/731 (0.00%)  1/744 (0.13%) 
Gallbladder cancer metastatic † 1  1/731 (0.14%)  0/744 (0.00%) 
Papillary thyroid cancer † 1  1/731 (0.14%)  0/744 (0.00%) 
Prostate cancer † 1  2/731 (0.27%)  0/744 (0.00%) 
Renal cancer † 1  1/731 (0.14%)  0/744 (0.00%) 
Squamous cell carcinoma of skin † 1  2/731 (0.27%)  1/744 (0.13%) 
Uterine cancer † 1  0/731 (0.00%)  1/744 (0.13%) 
Nervous system disorders     
Brain stem stroke † 1  1/731 (0.14%)  0/744 (0.00%) 
Multiple sclerosis † 1  1/731 (0.14%)  0/744 (0.00%) 
Sciatica † 1  0/731 (0.00%)  1/744 (0.13%) 
Transient ischaemic attack † 1  2/731 (0.27%)  4/744 (0.54%) 
Basilar migraine † 1  0/731 (0.00%)  1/744 (0.13%) 
Coma † 1  1/731 (0.14%)  0/744 (0.00%) 
Hypoxic-ischaemic encephalopathy † 1  1/731 (0.14%)  0/744 (0.00%) 
Subarachnoid haemorrhage † 1  2/731 (0.27%)  0/744 (0.00%) 
Cerebral artery embolism † 1  0/731 (0.00%)  1/744 (0.13%) 
Cerebrovascular disorder † 1  0/731 (0.00%)  1/744 (0.13%) 
Quadriparesis † 1  1/731 (0.14%)  0/744 (0.00%) 
Syncope † 1  2/731 (0.27%)  0/744 (0.00%) 
Carotid artery aneurysm † 1  0/731 (0.00%)  1/744 (0.13%) 
Demyelinating polyneuropathy † 1  0/731 (0.00%)  1/744 (0.13%) 
Epilepsy † 1  1/731 (0.14%)  0/744 (0.00%) 
Headache † 1  3/731 (0.41%)  1/744 (0.13%) 
Polyneuropathy † 1  0/731 (0.00%)  1/744 (0.13%) 
Cerebrovascular accident † 1  2/731 (0.27%)  2/744 (0.27%) 
Cerebral ischaemia † 1  0/731 (0.00%)  1/744 (0.13%) 
Loss of consciousness † 1  1/731 (0.14%)  1/744 (0.13%) 
Encephalopathy † 1  1/731 (0.14%)  0/744 (0.00%) 
Hydrocephalus † 1  1/731 (0.14%)  0/744 (0.00%) 
Hypoaesthesia † 1  0/731 (0.00%)  1/744 (0.13%) 
Radiculitis lumbosacral † 1  0/731 (0.00%)  1/744 (0.13%) 
Amyotrophic lateral sclerosis † 1  1/731 (0.14%)  0/744 (0.00%) 
Cervical cord compression † 1  1/731 (0.14%)  0/744 (0.00%) 
Convulsion † 1  1/731 (0.14%)  1/744 (0.13%) 
Psychiatric disorders     
Mental status changes † 1  0/731 (0.00%)  1/744 (0.13%) 
Drug abuse † 1  0/731 (0.00%)  1/744 (0.13%) 
Anxiety † 1  0/731 (0.00%)  1/744 (0.13%) 
Schizophrenia † 1  0/731 (0.00%)  1/744 (0.13%) 
Suicidal ideation † 1  0/731 (0.00%)  1/744 (0.13%) 
Renal and urinary disorders     
Hydronephrosis † 1  0/731 (0.00%)  1/744 (0.13%) 
Nephrolithiasis † 1  3/731 (0.41%)  1/744 (0.13%) 
Renal injury † 1  1/731 (0.14%)  0/744 (0.00%) 
Renal failure acute † 1  3/731 (0.41%)  2/744 (0.27%) 
Stress urinary incontinence † 1  0/731 (0.00%)  1/744 (0.13%) 
Bladder prolapse † 1  1/731 (0.14%)  1/744 (0.13%) 
Calculus bladder † 1  0/731 (0.00%)  1/744 (0.13%) 
Renal impairment † 1  0/731 (0.00%)  1/744 (0.13%) 
Renal failure † 1  0/731 (0.00%)  1/744 (0.13%) 
Reproductive system and breast disorders     
Pelvic haematoma † 1  1/731 (0.14%)  0/744 (0.00%) 
Adenomyosis † 1  0/731 (0.00%)  1/744 (0.13%) 
Endometriosis † 1  1/731 (0.14%)  0/744 (0.00%) 
Metrorrhagia † 1  2/731 (0.27%)  1/744 (0.13%) 
Rectocele † 1  1/731 (0.14%)  2/744 (0.27%) 
Uterine prolapse † 1  1/731 (0.14%)  2/744 (0.27%) 
Endometrial hyperplasia † 1  0/731 (0.00%)  1/744 (0.13%) 
Menorrhagia † 1  1/731 (0.14%)  0/744 (0.00%) 
Ovarian mass † 1  1/731 (0.14%)  0/744 (0.00%) 
Cervical dysplasia † 1  0/731 (0.00%)  1/744 (0.13%) 
Vaginal prolapse † 1  2/731 (0.27%)  2/744 (0.27%) 
Cystocele † 1  2/731 (0.27%)  3/744 (0.40%) 
Ovarian cyst † 1  1/731 (0.14%)  2/744 (0.27%) 
Respiratory, thoracic and mediastinal disorders     
Pulmonary toxicity † 1  0/731 (0.00%)  1/744 (0.13%) 
Acute respiratory failure † 1  1/731 (0.14%)  0/744 (0.00%) 
Chronic obstructive pulmonary disease † 1  1/731 (0.14%)  0/744 (0.00%) 
Epistaxis † 1  0/731 (0.00%)  1/744 (0.13%) 
Pneumothorax † 1  1/731 (0.14%)  0/744 (0.00%) 
Pulmonary bulla † 1  1/731 (0.14%)  0/744 (0.00%) 
Interstitial lung disease † 1  0/731 (0.00%)  1/744 (0.13%) 
Pulmonary embolism † 1  2/731 (0.27%)  1/744 (0.13%) 
Respiratory failure † 1  0/731 (0.00%)  2/744 (0.27%) 
Haemoptysis † 1  0/731 (0.00%)  1/744 (0.13%) 
Pulmonary fibrosis † 1  1/731 (0.14%)  0/744 (0.00%) 
Asthma † 1  2/731 (0.27%)  1/744 (0.13%) 
Aspiration † 1  1/731 (0.14%)  0/744 (0.00%) 
Pulmonary oedema † 1  0/731 (0.00%)  1/744 (0.13%) 
Dyspnoea † 1  2/731 (0.27%)  6/744 (0.81%) 
Pleural effusion † 1  1/731 (0.14%)  1/744 (0.13%) 
Bronchitis chronic † 1  1/731 (0.14%)  0/744 (0.00%) 
Haemothorax † 1  0/731 (0.00%)  1/744 (0.13%) 
Lung disorder † 1  1/731 (0.14%)  0/744 (0.00%) 
Oropharyngeal pain † 1  1/731 (0.14%)  0/744 (0.00%) 
Tracheal stenosis † 1  0/731 (0.00%)  1/744 (0.13%) 
Skin and subcutaneous tissue disorders     
Skin wrinkling † 1  0/731 (0.00%)  1/744 (0.13%) 
Psoriasis † 1  1/731 (0.14%)  0/744 (0.00%) 
Urticaria † 1  1/731 (0.14%)  0/744 (0.00%) 
Surgical and medical procedures     
Mammoplasty † 1  1/731 (0.14%)  0/744 (0.00%) 
Vascular disorders     
Hypertensive crisis † 1  2/731 (0.27%)  0/744 (0.00%) 
Hypertensive emergency † 1  0/731 (0.00%)  1/744 (0.13%) 
Iliac artery occlusion † 1  1/731 (0.14%)  0/744 (0.00%) 
Hypertension † 1  0/731 (0.00%)  1/744 (0.13%) 
Angiopathy † 1  1/731 (0.14%)  0/744 (0.00%) 
Deep vein thrombosis † 1  1/731 (0.14%)  3/744 (0.40%) 
Venous thrombosis † 1  0/731 (0.00%)  1/744 (0.13%) 
Aortic aneurysm † 1  2/731 (0.27%)  0/744 (0.00%) 
Vasculitis † 1  2/731 (0.27%)  0/744 (0.00%) 
Circulatory collapse † 1  0/731 (0.00%)  1/744 (0.13%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
IV Abatacept SC Abatacept
Affected / at Risk (%) Affected / at Risk (%)
Total   544/731 (74.42%)   567/744 (76.21%) 
Blood and lymphatic system disorders     
Anaemia † 1  26/731 (3.56%)  55/744 (7.39%) 
Gastrointestinal disorders     
Abdominal pain † 1  27/731 (3.69%)  39/744 (5.24%) 
Abdominal pain upper † 1  47/731 (6.43%)  43/744 (5.78%) 
Gastritis † 1  30/731 (4.10%)  40/744 (5.38%) 
Nausea † 1  53/731 (7.25%)  79/744 (10.62%) 
Diarrhoea † 1  89/731 (12.18%)  96/744 (12.90%) 
Infections and infestations     
Pharyngitis † 1  80/731 (10.94%)  74/744 (9.95%) 
Gastroenteritis † 1  48/731 (6.57%)  60/744 (8.06%) 
Nasopharyngitis † 1  143/731 (19.56%)  149/744 (20.03%) 
Influenza † 1  55/731 (7.52%)  51/744 (6.85%) 
Sinusitis † 1  50/731 (6.84%)  69/744 (9.27%) 
Bronchitis † 1  120/731 (16.42%)  109/744 (14.65%) 
Urinary tract infection † 1  133/731 (18.19%)  150/744 (20.16%) 
Upper respiratory tract infection † 1  131/731 (17.92%)  130/744 (17.47%) 
Musculoskeletal and connective tissue disorders     
Back pain † 1  76/731 (10.40%)  76/744 (10.22%) 
Nervous system disorders     
Dizziness † 1  40/731 (5.47%)  37/744 (4.97%) 
Headache † 1  88/731 (12.04%)  86/744 (11.56%) 
Psychiatric disorders     
Depression † 1  40/731 (5.47%)  37/744 (4.97%) 
Respiratory, thoracic and mediastinal disorders     
Cough † 1  74/731 (10.12%)  72/744 (9.68%) 
Vascular disorders     
Hypertension † 1  85/731 (11.63%)  96/744 (12.90%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.1
[Not Specified]
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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00559585    
Other Study ID Numbers: IM101-174
EUDRACT # 2007-005434-37
First Submitted: November 15, 2007
First Posted: November 16, 2007
Results First Submitted: April 29, 2011
Results First Posted: July 6, 2011
Last Update Posted: November 9, 2015