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Study of Abatacept (BMS-188667) in Subjects With Active Rheumatoid Arthritis on Background Non-biologic DMARDS (Disease Modifying Antirheumatic Drugs) Who Have an Inadequate Response to Anti-TNF Therapy

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ClinicalTrials.gov Identifier: NCT00124982
Recruitment Status : Completed
First Posted : July 29, 2005
Results First Posted : June 2, 2011
Last Update Posted : February 27, 2012
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Rheumatoid Arthritis
Interventions Drug: Abatacept
Drug: Non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)
Drug: Anti-Tumor Necrosing Factor (TNF) Therapy
Enrollment 1286
Recruitment Details  
Pre-assignment Details Of 1286 participants enrolled in this study, 240 were not treated.
Arm/Group Title Short Term (ST) Abatacept (ABA)-Previous User ST-Current User Long-term ABA
Hide Arm/Group Description In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion. In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion. Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
Period Title: Short-term Period
Started 449 597 0
Completed 377 483 0
Not Completed 72 114 0
Reason Not Completed
Death             1             1             0
Adverse Event             17             22             0
Lack of Efficacy             32             73             0
Lost to Follow-up             8             5             0
Withdrawal of Consent             7             9             0
Poor/Non-compliance             3             1             0
No Longer Meets Study Criteria             1             2             0
Participant Decision             1             0             0
Participant Chose Own Doctor             0             1             0
Investigator Decision-No Specific AE             1             0             0
Participant Had Lymphopenia             1             0             0
Period Title: Long-term Period
Started 0 0 530 [1]
Completed 0 0 441
Not Completed 0 0 89
Reason Not Completed
Death             0             0             1
Adverse Event             0             0             17
Lack of Efficacy             0             0             46
Lost to Follow-up             0             0             4
Withdrawal by Subject             0             0             16
Pregnancy             0             0             1
Poor/Non-compliance             0             0             2
Administrative Reason by Sponsor             0             0             1
Neurologist Recommendation             0             0             1
[1]
A large number did not continue due to a rollover from study drug to commercially available drug.
Arm/Group Title ST Abatacept (ABA)-Previous User ST ABA-Current User Total
Hide Arm/Group Description In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion. In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion. Total of all reporting groups
Overall Number of Baseline Participants 449 597 1046
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 449 participants 597 participants 1046 participants
56.1  (12.5) 53.2  (12.3) 54.4  (12.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 449 participants 597 participants 1046 participants
Female
359
  80.0%
490
  82.1%
849
  81.2%
Male
90
  20.0%
107
  17.9%
197
  18.8%
Number of Tender Joints   [1] 
Mean (Standard Deviation)
Unit of measure:  Tender joints
Number Analyzed 449 participants 597 participants 1046 participants
17.8  (5.9) 17.8  (6.1) 17.8  (6.0)
[1]
Measure Description: The mean number of tender joints was evaluated based on the number of tender joints in a standard 68 joint count.
Number of Swollen Joints   [1] 
Mean (Standard Deviation)
Unit of measure:  Swollen joints
Number Analyzed 449 participants 597 participants 1046 participants
13.9  (5.6) 13.5  (5.4) 13.6  (5.5)
[1]
Measure Description: The mean number of swollen joints was evaluated based on the number of swollen joints in a standard 66 joint count.
Physical Function, Health Assessment Questionnaire Disability Index (HAQ-DI)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 449 participants 597 participants 1046 participants
1.7  (0.6) 1.7  (0.6) 1.7  (0.6)
[1]
Measure Description: The HAQ-DI includes 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1= with some difficulty, 2= with much difficulty, and 3= unable to do. HAQ-DI= sum of worst scores in each domain divided by the number of domains answered. HAQ-DI ranges from a minimum of 0 (no difficulty) to a maximum overall score of 3(unable to do).
hs-C-Reactive Protein (hs-CRP) Serum Levels   [1] 
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 449 participants 597 participants 1046 participants
2.2  (3.0) 2.1  (3.0) 2.1  (3.0)
[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 (DAS) 28 (Using CRP Levels)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 449 participants 597 participants 1046 participants
6.2  (0.7) 6.2  (0.7) 6.2  (0.7)
[1]
Measure Description: The DAS28 (CRP) is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, serum CRP level, and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thresholds that define high disease activity (> 5.1), low disease activity (< 3.2) and remission (< 2.6). A clinically significant response= decrease in DAS28 score of >1.2 from baseline.
Rheumatoid Factor (RF) Status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 449 participants 597 participants 1046 participants
Negative 138 215 353
Positive 292 349 641
Data Not Available 19 33 52
[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.
1.Primary Outcome
Title Short-term Period: Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuations, AEs, Related AEs, or AEs Leading to Discontinuations
Hide Description AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with treatment.SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.Related AE/SAE=Certain,Probable,Possible,or Missing relationship to Drug
Time Frame Days 1-169
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants
Arm/Group Title ST Abatacept (ABA)-Previous User ST ABA-Current User
Hide Arm/Group Description:
In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
Overall Number of Participants Analyzed 449 597
Measure Type: Number
Unit of Measure: participants
Death 1 1
SAEs 50 59
Related SAEs 10 16
SAEs Leading to Discontinuation 9 8
AEs 350 473
Related AEs 190 273
AEs Leading to Discontinuation 17 24
2.Primary Outcome
Title Short-term Period: Number of Participants With AEs of Special Interest
Hide Description AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs, including all infections, serious infections, and opportunistic infections; autoimmune disorders; neoplasms; acute infusional AEs (pre-specified AEs occurring within 1 hour of start of infusion) and peri-infusional AEs (pre-specified AEs occurring within 24 hours of the start of infusion).
Time Frame Days 1-169
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants
Arm/Group Title ST Abatacept (ABA)-Previous User ST ABA-Current User
Hide Arm/Group Description:
In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
Overall Number of Participants Analyzed 449 597
Measure Type: Number
Unit of Measure: participants
Infections (pre-specified) 26 38
Serious Infections (pre-specified) 6 7
Benign, malignant, and unspecified neoplasms 8 7
Autoimmune disorders (pre-specified) 4 9
Acute infusional AEs (pre-specified) 20 37
Peri-infusional AEs (pre-specified) 57 99
3.Primary Outcome
Title Short-term Period: Number of Participants With Hematology Laboratories Meeting Marked Abnormality (MA) Criteria
Hide Description Upper Normal Limit (ULN), Lower Normal Limit (LLN), Baseline (BL). Marked abnormality criteria are: Hemoglobin (HGB): >3 g/dL decrease from BL; Hematocrit: <0.75 * BL; Erythrocytes: <0.75 * BL; Platelets (PLT): <0.67 * LLN/>1.5 * ULN, or if BL < LLN then use 0.5 * BL/<100,000 mm^3; Leukocytes: <0.75 * LLN/ >1.25 * ULN, or if BL<LLN then use <0.8 * BL/>ULN, or if BL>ULN then use >1.2 * BL/<LLN; neutrophils+bands: <1.0 * 10^3 c/uL; eosinophils: >0.750 * 10^3 c/uL; basophils: > 400 mm^3; monocytes: >2000 mm^3; lymphocytes: <0.750 * 10^3 c/uL/ >7.50 * 10^3 c/uL.
Time Frame Days 1-169
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 infusion of abatacept during the short-term treatment period
Arm/Group Title ST Abatacept (ABA)-Previous User ST ABA-Current User
Hide Arm/Group Description:
In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
Overall Number of Participants Analyzed 429 581
Measure Type: Number
Unit of Measure: participants
Low HGB (n=429, n=581) 2 3
Low hematocrit (n=428, n=580) 1 2
Low erythrocytes (n=429, n=581) 1 2
Low PLT (n=424, n=578) 1 1
High PLT (n=424, n=578) 0 0
Low leukocytes (n=429, n=581) 2 1
High leukocytes (n=429, n=581) 3 8
Low neutrophils+bands (n=429, n=580) 0 1
High eosinophils (n=429, n=580) 2 2
High basophils (n=429, n=580) 0 0
High monocytes (n=429, n=580) 1 0
Low lymphocytes (n=429, n=580) 30 27
High lymphocytes (n=429, n=580) 0 0
4.Primary Outcome
Title Short-term Period: Number of Participants With Liver and Kidney Function Laboratories Meeting MA Criteria
Hide Description Marked abnormality criteria: Alkaline phosphatase (ALP): >2* ULN, or if BL>ULN then use >3* BL; aspartate aminotransferase (AST): >3* ULN, or if BL>ULN then use >4* BL; alanine aminotransferase (ALT): >3* ULN, or if BL>ULN then use >4* BL; G-Glutamyl transferase (GGT): >2* ULN, or if BL>ULN then use >3* BL; Bilirubin: >2* ULN, or if BL>ULN then use >4* BL; blood urea nitrogen (BUN): >2* BL; creatinine: >1.5* BL
Time Frame Days 1-169
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants. n=number of participants with evaluable laboratory results.
Arm/Group Title ST Abatacept (ABA)-Previous User ST ABA-Current User
Hide Arm/Group Description:
In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
Overall Number of Participants Analyzed 428 583
Measure Type: Number
Unit of Measure: participants
High ALP (n=428, n=583) 0 0
High AST (n=426, n=583) 1 2
High ALT (n=426, n=583) 2 1
High GGT (n=427, n=583) 1 5
High bilirubin (n=426, n=583) 1 1
High BUN (n=428, n=583) 3 8
High creatinine (n=427, n=583) 8 7
5.Primary Outcome
Title Short-term Period: Number of Participants With Electrolyte Laboratories Meeting MA Criteria
Hide Description Marked abnormality criteria:Sodium (Na): <0.95* LLN/ >1.05* ULN,or if BL<LLN then use 0.95* BL or >ULN,or if BL>ULN then use>1.05* BL or <LLN; potassium (K): <0.9* LLN/>1.1* ULN,or if BL<LLN then use 0.9* BL or >ULN, or if BL>ULN then use>1.1* BL or <LLN; chloride: <0.9* LLN/>1.1* ULN, or if BL<LLN then use 0.9* BL or >ULN, or if BL>ULN then use>1.1* BL or <LLN; calcium (Ca): <0.8* LLN/>1.2* ULN, or if BL<LLN then use 0.75* BL or >ULN, or if BL>ULN then use>1.25* BL or <LLN; phosphorous (P): <0.75* LLN/ >1.25* ULN, or if BL<LLN then use 0.67* BL or >ULN, or if BL>ULN then use>1.33* BL or <LLN
Time Frame Days 1-169
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants. n=number of participants with evaluable laboratory results.
Arm/Group Title ST Abatacept (ABA)-Previous User ST ABA-Current User
Hide Arm/Group Description:
In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
Overall Number of Participants Analyzed 428 583
Measure Type: Number
Unit of Measure: participants
Low Na (n=428, n=583) 0 2
High Na (n=428, n=583) 0 0
Low K (n=425, n=583) 1 3
High K (n=425, n=583) 0 0
Low chloride (n=428, n=583) 0 0
High chloride (n=428, n=583) 0 0
Low Ca (n=428, n=583) 2 0
High Ca (n=428, n=583) 0 0
Low P (n=426, n=583) 1 0
High P (n=426, n=583) 3 1
6.Primary Outcome
Title Short-term Period: Number of Participants With Other Chemistry and Urinalysis Laboratories Meeting MA Criteria
Hide Description Marked abnormality criteria: serum glucose (Glu):<65 mg/dL/ >220 mg/dL; fasting serum Glu: <0.8* LLN/>1.5* ULN, or if BL<LLN then use 0.8* BL or >ULN, or if BL>ULN then use >2.0* BL or <LLN; total protein: <0.9* LLN/>1.1* ULN; albumin: <0.9* LLN,or if BL<LLN then use <0.75 BL; uric acid: >1.5* ULN, or if BL>ULN then use >2* BL. Urinalysis (Urine protein, urine Glu, urine blood, leukocyte esterase, Red Blood Cells [RBCs], White Blood Cells [WBCs]):Use ≥2 when BL value missing or value ≥4,or when pre-dose=0 or 0.5. Use ≥3 when pre-dose=1. Use ≥4 when pre-dose=2 or 3
Time Frame Days 1-169
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants. n=number of participants with evaluable laboratory results.
Arm/Group Title ST Abatacept (ABA)-Previous User ST ABA-Current User
Hide Arm/Group Description:
In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
Overall Number of Participants Analyzed 428 583
Measure Type: Number
Unit of Measure: participants
Low Glu (n=427, n=583) 7 17
High Glu (n=427, n=583) 12 21
Low protein (n=428, n=583) 0 0
High protein (n=428, n=583) 0 0
Low albumin (n=428, n=583) 1 2
High uric acid (n=428, n=583) 0 0
High urine protein (n=298, n=421) 4 2
High urine glucose (n=298, n=421) 0 4
High urine blood (n=298, n=421) 5 14
High urine leukocyte esterase (n=297, n=491) 20 17
High urine RBC (n=68, n=98) 13 17
High urine WBC (n=80, n=117) 30 36
7.Primary Outcome
Title Short-term Period: Mean Change From Baseline in Systolic and Diastolic Blood Pressure
Hide Description [Not Specified]
Time Frame Day 1 (Baseline) -Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
Although mean values for systolic and diastolic blood pressure were recorded, mean changes from baseline were not summarized for these data.
Arm/Group Title ST Abatacept (ABA)-Previous User ST ABA-Current User
Hide Arm/Group Description:
In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
8.Primary Outcome
Title Short-term Period: Number of Participants With Positive Anti-Abatacept or Anti-Cytotoxic T-Lymphocyte Antigen 4 (CTLA4) Responses by Enzyme-Linked Immunosorbant Assay (ELISA)
Hide Description Serum samples from all treated adult participants with active rheumatoid arthritis (RA) were screened for the presence of drug-specific antibodies using ELISA. Immunogenicity was defined as the presence of a positive anti-abatacept or anti-CTLA4 antibody.
Time Frame Days 1-169
Hide Outcome Measure Data
Hide Analysis Population Description
Treated participants with available serum samples for assay
Arm/Group Title All Treated Participants
Hide Arm/Group Description:
Open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
Overall Number of Participants Analyzed 41
Measure Type: Number
Unit of Measure: participants
Anti-abatacept antibodies 12
Anti-CTLA4 antibodies 0
9.Primary Outcome
Title Long-term Period: Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuations, AEs, Related AEs, or AEs Leading to Discontinuations
Hide Description AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with treatment.SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.Related AE/SAE=Certain,Probable,Possible,or Missing relationship to Drug
Time Frame From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants
Arm/Group Title Long-term ABA
Hide Arm/Group Description:
Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
Overall Number of Participants Analyzed 530
Measure Type: Number
Unit of Measure: participants
Death 1
SAEs 61
Related SAEs 15
SAEs Leading to Discontinuation 11
AEs 328
Related AEs 146
AEs Leading to Discontinuation 15
10.Primary Outcome
Title Long-term Period: Number of Participants With AEs of Special Interest
Hide Description AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs, including all infections, serious infections, and opportunistic infections; autoimmune disorders; neoplasms; acute infusional AEs (pre-specified AEs occurring within 1 hour of start of infusion) and peri-infusional AEs (pre-specified AEs occurring within 24 hours of the start of infusion).
Time Frame From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants
Arm/Group Title Long-term ABA
Hide Arm/Group Description:
Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
Overall Number of Participants Analyzed 530
Measure Type: Number
Unit of Measure: participants
Infections (pre-specified) 177
Malignant neoplasms 4
Autoimmune disorders (pre-specified) 8
Peri-infusional AEs (pre-specified) 42
Acute infusional AEs (pre-specified) 14
11.Primary Outcome
Title Long-term Period: Number of Participants With Hematology Laboratories Meeting Marked Abnormality (MA) Criteria
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/<100,000 mm^3; Leukocytes: <0.75*LLN/>1.25*ULN, or if BL<LLN, use <0.8*BL/>ULN, or if BL>ULN,use >1.2*BL/<LLN; neutrophils+bands: <1.0*10^3 c/uL; eosinophils: >0.750*10^3 c/uL; basophils: >400 mm^3; monocytes: >2000 mm^3; lymphocytes: <0.750*10^3 c/uL/>7.50*10^3 c/uL.
Time Frame From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 infusion of abatacept during the long-term treatment period. n=number of participants with evaluable laboratory results.
Arm/Group Title Long-term ABA
Hide Arm/Group Description:
Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
Overall Number of Participants Analyzed 513
Measure Type: Number
Unit of Measure: participants
Low hemoglobin (n=513) 1
Low hematocrit (n=510) 1
Low erythrocytes (n=513) 1
Low platelets (n=500) 0
High platelets (n=500) 1
Low leukocytes (n=513) 1
High leukocytes (n=513) 8
Low neutrophils+bands (510) 0
Low lymphocytes (n=510) 34
High lymphocytes (n=510) 0
High monocytes (n=510) 2
High basophils (n=510) 1
High eosinophils (n=510) 13
12.Primary Outcome
Title Long-term Period: Number of Participants With Liver and Kidney Function Laboratories Meeting MA Criteria
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 (BUN): >2*BL; creatinine: >1.5*BL
Time Frame From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants. n=number of participants with evaluable laboratory results.
Arm/Group Title Long-term ABA
Hide Arm/Group Description:
Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
Overall Number of Participants Analyzed 514
Measure Type: Number
Unit of Measure: participants
High ALP (n=514) 0
High AST (n=512) 1
High ALT (n=512) 5
High GGT (n=512) 10
High bilirubin (n=513) 1
High BUN (n=513) 5
High creatinine (n=512) 8
13.Primary Outcome
Title Long-term Period: Number of Participants With Electrolyte Laboratories Meeting MA Criteria
Hide Description Marked abnormality criteria:Sodium (Na): <0.95* LLN/ >1.05* ULN,or if BL<LLN then use 0.95* BL or >ULN,or if BL>ULN then use>1.05* BL or <LLN; potassium (K): <0.9* LLN/>1.1* ULN,or if BL<LLN then use 0.9* BL or >ULN, or if BL>ULN then use>1.1* BL or <LLN; chloride: <0.9* LLN/>1.1* ULN, or if BL<LLN then use 0.9* BL or >ULN, or if BL>ULN then use>1.1* BL or <LLN; calcium (Ca): <0.8* LLN/>1.2* ULN, or if BL<LLN then use 0.75* BL or >ULN, or if BL>ULN then use>1.25* BL or <LLN; phosphorous (P): <0.75* LLN/ >1.25* ULN, or if BL<LLN then use 0.67* BL or >ULN, or if BL>ULN then use>1.33* BL or <LLN
Time Frame From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants. n=number of participants with evaluable laboratory results.
Arm/Group Title Long-term ABA
Hide Arm/Group Description:
Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
Overall Number of Participants Analyzed 513
Measure Type: Number
Unit of Measure: participants
Low Na (n=513) 1
High Na (n=513) 3
Low K (n=510) 4
High K (n=510) 1
Low chloride (n=513) 1
High chloride (n=513) 1
Low Ca (n=513) 0
High Ca (n=513) 1
Low P (n=512) 0
High P (n=512) 3
14.Primary Outcome
Title Long-term Period: Number of Participants With Other Chemistry and Urinalysis Laboratories Meeting MA Criteria
Hide Description Marked abnormality criteria: serum glucose (Glu):<65 mg/dL/ >220 mg/dL; fasting serum Glu: <0.8* LLN/>1.5* ULN, or if BL<LLN then use 0.8* BL or >ULN, or if BL>ULN then use >2.0* BL or <LLN; total protein: <0.9* LLN/>1.1* ULN; albumin: <0.9* LLN,or if BL<LLN then use <0.75 BL; uric acid: >1.5* ULN, or if BL>ULN then use >2* BL. Urinalysis (Urine protein, urine Glu, urine blood, leukocyte esterase, Red Blood Cells [RBCs], White Blood Cells [WBCs]):Use ≥2 when BL value missing or value ≥4,or when pre-dose=0 or 0.5. Use ≥3 when pre-dose=1. Use ≥4 when pre-dose=2 or 3
Time Frame From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants. n=number of participants with evaluable laboratory results.
Arm/Group Title Long-term ABA
Hide Arm/Group Description:
Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
Overall Number of Participants Analyzed 513
Measure Type: Number
Unit of Measure: participants
Low glu (n=513) 15
High glu (n=513) 17
Low protein (n=513) 1
High protein (n=513) 0
Low albumin (n=511) 1
High uric acid (n=513) 0
High urine protein (n=462) 4
High urine glucose (n=462) 5
High urine blood (n=462) 10
High urine leukocyte esterase (n=462) 13
High urine RBC (n=91) 24
High urine WBC (n=91) 11
15.Primary Outcome
Title Long-term Period: Change From Baseline in Hemoglobin (HGB), Total Protein, and Albumin Over Time
Hide Description HGB normal range (NR)=11.6 – 16.2 g/dL, marked abnormality (MA) is >3 g/dL decrease from BL. Total protein NR=6.0 – 8.4 g/dL, MA is <0.9* LLN/>1.1* ULN; Albumin NR=3.5 – 5.3 g/dL, MA is <0.9* LLN, or if BL<LLN then use <0.75 BL
Time Frame BL, Day 365, Day 729
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants in the OL. n=number of participants with evaluable laboratory results.
Arm/Group Title Long-term ABA
Hide Arm/Group Description:
Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
Overall Number of Participants Analyzed 218
Mean (Standard Deviation)
Unit of Measure: g/dL
Day 365 HGB (n=218) 0.40  (0.08)
Day 365 total protein (n=217) -0.22  (0.04)
Day 365 albumin (n=217) 0.13  (0.02)
Day 729 HGB (n=62) 0.47  (0.18)
Day 729 total protein (n=65) -0.59  (0.07)
Day 729 albumin (n=65) 0.16  (0.04)
16.Primary Outcome
Title Long-term Period: Change From Baseline in Hematocrit Over Time
Hide Description The hematocrit value refers to the percentage of blood volume that is occupied by red blood cells. Hematocrit values for participants were expressed as percentages and were averaged to yield a group mean value (percentage) at a particular time point. The mean change from baseline in hematocrit value (expressed as a percent)= mean post-baseline value (expressed as a percent) - mean baseline value (expressed as a percent).
Time Frame BL, Day 365, Day 729
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants in the OL. n=number of participants with evaluable laboratory results.
Arm/Group Title Long-term ABA
Hide Arm/Group Description:
Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
Overall Number of Participants Analyzed 213
Mean (Standard Deviation)
Unit of Measure: percentage change
Day 365 hematocrit (n=213) 1.00  (0.22)
Day 729 HGB (n=61) 0.81  (0.47)
17.Primary Outcome
Title Long-term Period: Change From Baseline in Erythrocytes Over Time
Hide Description Erythrocytes NR= 3.80 – 5.50 *10^6 c/uL, MA is <0.75 * BL
Time Frame BL, Day 365, Day 729
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants in the OL. n=number of participants with evaluable laboratory results.
Arm/Group Title Long-term ABA
Hide Arm/Group Description:
Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
Overall Number of Participants Analyzed 218
Mean (Standard Deviation)
Unit of Measure: 10^6 c/uL
Day 365 erythrocytes (n=218) 0.04  (0.02)
Day 729 erythrocytes (n=62) 0.06  (0.04)
18.Primary Outcome
Title Long-term Period: Change From Baseline in Platelets (PLT) Over Time
Hide Description Erythrocytes NR= 3.80 - 5.50 *10^6 c/uL, MA is <0.75 * BL
Time Frame BL, Day 365, Day 729
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants in the OL. n=number of participants with evaluable laboratory results.
Arm/Group Title Long-term ABA
Hide Arm/Group Description:
Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
Overall Number of Participants Analyzed 214
Mean (Standard Deviation)
Unit of Measure: 10^9 c/L
Day 365 PLT (n=214) -41.2  (6.24)
Day 729 PLT (n=61) -67.7  (11.02)
19.Primary Outcome
Title Long-term Period: Change From Baseline in White Blood Cells Over Time
Hide Description Leukocytes NR=4.1 - 12.3*10^3 c/uL, MA is <0.75 * LLN/ >1.25 * ULN, or if BL<LLN then use <0.8 * BL/>ULN, or if BL>ULN then use >1.2 * BL/<LLN. Neutrophils+bands MA is <1.0 * 10^3 c/uL. Eosinophils MA is >0.750 * 10^3 c/uL. Basophils MA is > 400 mm^3. Monocytes MA is >2000 mm^3. Lymphocytes MA is <0.750 * 10^3 c/uL/ >7.50 * 10^3 c/uL
Time Frame BL, Day 365, Day 729
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants in the OL. n=number of participants with evaluable laboratory results.
Arm/Group Title Long-term ABA
Hide Arm/Group Description:
Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
Overall Number of Participants Analyzed 218
Mean (Standard Deviation)
Unit of Measure: 10^3 c/uL
Day 365 leukocytes (n=218) -0.86  (0.17)
Day 365 neutrophils (n=215) -0.83  (0.16)
Day 365 eosinophils (n=215) -0.01  (0.01)
Day 365 monocytes (n=215) 0.00  (0.02)
Day 365 basophils (n=215) 0.00  (0.00)
Day 365 lymphocytes (n=215) 0.08  (0.05)
Day 729 leukocytes (n=62) -1.49  (0.26)
Day 729 neutrophils (n=62) -1.56  (0.27)
Day 729 eosinophils (n=62) -0.02  (0.02)
Day 729 monocytes (n=62) -0.01  (0.03)
Day 729 basophils (n=62) 0.00  (0.00)
Day 729 lymphocytes (n=62) 0.10  (0.09)
20.Primary Outcome
Title Long-term Period: Change From Baseline in Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), and G-Glutamyl Transferase (GGT) Over Time
Hide Description HGB normal range (NR)=11.6 - 16.2 g/dL, marked abnormality (MA) is >3 g/dL decrease from BL. Total protein NR=6.0 - 8.4 g/dL, MA is <0.9* LLN/>1.1* ULN; Albumin NR=3.5 - 5.3 g/dL, MA is <0.9* LLN, or if BL<LLN then use <0.75 BL
Time Frame BL, Day 365, Day 729
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants in the OL. n=number of participants with evaluable laboratory results.
Arm/Group Title Long-term ABA
Hide Arm/Group Description:
Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
Overall Number of Participants Analyzed 218
Mean (Standard Deviation)
Unit of Measure: U/L
Day 365 ALP (n=218) 0.81  (2.64)
Day 365 AST (n=212) 0.64  (1.09)
Day 365 ALT (n=212) 0.76  (1.80)
Day 365 GGT (n=217) 2.21  (3.61)
Day 729 ALP (n=64) -8.44  (5.82)
Day 729 AST (n=63) 1.35  (2.38)
Day 729 ALT (n=63) 2.60  (3.92)
Day 729 GGT (n=64) 0.13  (2.34)
21.Primary Outcome
Title Long-term Period: Change From Baseline in Bilirubin, Blood Urea Nitrogen (BUN), Creatinine, Calcium (Ca), Phosphorus (P), Serum Glucose (Glu), and Uric Acid Over Time
Hide Description Bilirubin NR=0.2–1.2 mg/dL, MA: >2* ULN, or if BL>ULN then use >4* BL. BUN NR=4.0–24.0 mg/dL, MA: >2*BL. Creatinine NR=0.4–1.2 mg/dL, MA: >1.5*BL. Ca NR=8.8–10.2 mg/dL, MA: <0.8*LLN/>1.2*ULN, or if BL<LLN then use 0.75*BL or >ULN, or if BL>ULN then use>1.25*BL or <LLN. P NR=2.8–4.0 mg/dL, MA: <0.75*LLN/ >1.25*ULN, or if BL<LLN then use 0.67*BL or >ULN, or if BL>ULN then use>1.33*BL or <LLN. Glu MA: <65 mg/dL/ >220 mg/dL. Uric acid MA: >1.5*ULN, or if BL>ULN then use >2*BL.
Time Frame BL, Day 365, Day 729
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants in the OL. n=number of participants with evaluable laboratory results.
Arm/Group Title Long-term ABA
Hide Arm/Group Description:
Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
Overall Number of Participants Analyzed 217
Mean (Standard Deviation)
Unit of Measure: mg/dL
Day 365 bilirubin (n=210) 0.04  (0.01)
Day 365 BUN (n=217) 0.85  (0.31)
Day 365 creatinine (n=217) 0.05  (0.01)
Day 365 Ca (n=217) 0.11  (0.03)
Day 365 P (n=217) 0.13  (0.04)
Day 365 Glu (n=217) 0.83  (2.26)
Day 365 uric acid (n=217) -0.18  (0.07)
Day 729 bilirubin (n=65) -0.01  (0.02)
Day 729 BUN (n=65) 0.77  (0.54)
Day 729 creatinine (n=65) 0.04  (0.02)
Day 729 Ca (n=65) 0.07  (0.06)
Day 729 P (n=64) -0.77  (0.08)
Day 729 Glu (n=64) 1.71  (2.94)
Day 729 uric acid (n=65) 0.11  (0.11)
22.Primary Outcome
Title LT; Change From Baseline in Sodium (Na), Potassium (K), Chloride (Cl) Over Time
Hide Description Na NR=132 – 147 mEq/L, MA is 95* LLN/ >1.05* ULN, or if BL<LLN then use 0.95* BL or >ULN, or if BL>ULN then use>1.05* BL or <LLN. K NR=3.3 – 5.5 mEq/L, MA is <0.9* LLN/>1.1* ULN,or if BL<LLN then use 0.9* BL or >ULN, or if BL>ULN then use>1.1* BL or <LLN. Cl NR=94 – 111 mEq/L, MA is <0.9* LLN/>1.1* ULN, or if BL<LLN then use 0.9* BL or >ULN, or if BL>ULN then use>1.1* BL or <LLN
Time Frame BL, Day 365, Day 729
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants in the OL. n=number of participants with evaluable laboratory results.
Arm/Group Title Long-term ABA
Hide Arm/Group Description:
Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
Overall Number of Participants Analyzed 217
Mean (Standard Deviation)
Unit of Measure: mEq/L
Day 365 Na (n=216) -0.91  (0.25)
Day 365 K (n=210) -0.08  (0.03)
Day 365 Cl (n=217) -0.37  (0.25)
Day 729 Na (n=65) 1.23  (0.33)
Day 729 K (n=63) -0.06  (0.06)
Day 729 Cl (n=65) 1.42  (0.37)
23.Primary Outcome
Title Long-term Period: Mean Sitting Systolic Blood Pressure (SBP) Over Time
Hide Description Measurements were taken in a seated position before and after abatacept infusion.
Time Frame From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants. n=number of participants with evaluable blood pressure measurements.
Arm/Group Title Long-term ABA
Hide Arm/Group Description:
Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
Overall Number of Participants Analyzed 482
Mean (Standard Deviation)
Unit of Measure: mm Hg
Day 169 SBP pre-infusion (n=482) 125.1  (16.02)
Day 169 SBP post-infusion (n=478) 125.3  (16.03)
Day 197 SBP pre-infusion (n=414) 124.4  (16.98)
Day 197 SBP post-infusion (n=415) 123.9  (16.84)
Day 225 SBP pre-infusion (n=340) 123.9  (16.33)
Day 225 SBP post-infusion (n=338) 123.4  (16.59)
Day 253 SBP pre-infusion (n=251) 124.0  (17.47)
Day 253 SBP post-infusion (n=251) 124.9  (16.57)
Day 281 SBP pre-infusion (n=203) 124.2  (17.25)
Day 281 SBP post-infusion (n=202) 124.8  (16.62)
Day 309 SBP pre-infusion (n=160) 124.1  (18.09)
Day 309 SBP post-infusion (n=159) 123.8  (17.58)
Day 337 SBP pre-infusion (n=128) 124.8  (16.84)
Day 337 SBP post-infusion (n=128) 124.0  (18.84)
Day 365 SBP pre-infusion (n=118) 126.2  (17.47)
Day 365 SBP post-infusion (n=120) 125.0  (15.85)
Day 393 SBP pre-infusion (n=101) 123.0  (18.74)
Day 393 SBP post-infusion (n=99) 124.1  (17.06)
Day 421 SBP post-infusion (n=93) 125.5  (19.44)
Day 421 SBP post-infusion (n=93) 124.4  (15.84)
Day 449 SBP pre-infusion (n=82) 125.8  (18.29)
Day 449 SBP post-infusion (n=82) 124.0  (17.25)
Day 477 SBP pre-infusion (n=75) 125.3  (19.03)
Day 477 SBP post-infusion (n=75) 122.9  (16.36)
Day 505 SBP pre-infusion (n=72) 124.3  (20.88)
Day 505 SBP post-infusion (n=73) 122.7  (17.08)
Day 533 SBP pre-infusion (n=67) 125.4  (16.73)
Day 533 SBP post-infusion (n=66) 125.2  (17.57)
Day 561 SBP pre-infusion (n=63) 121.6  (18.36)
Day 561 SBP post-infusion (n=63) 120.6  (18.94)
Day 589 SBP pre-infusion (n=57) 119.6  (15.98)
Day 589 SBP post-infusion (n=57) 121.1  (18.49)
Day 617 SBP pre-infusion (n=56) 122.1  (15.62)
Day 617 SBP post-infusion (n=56) 122.3  (18.57)
Day 645 SBP pre-infusion (n=44) 120.0  (18.78)
Day 645 SBP post-infusion (n=43) 121.8  (18.33)
Day 673 SBP pre-infusion (n=40) 123.4  (18.53)
Day 673 SBP post-infusion (n=41) 123.6  (17.90)
Day 701 SBP pre-infusion (n=35) 119.4  (16.82)
Day 701 SBP post-infusion (n=36) 117.6  (15.57)
Day 729 SBP pre-infusion (n=32) 121.5  (21.43)
Day 729 SBP post-infusion (n=32) 121.9  (17.48)
Day 757 SBP pre-infusion (n=30) 121.1  (16.36)
Day 757 SBP post-infusion (n=29) 118.3  (19.11)
Day 785 SBP pre-infusion (n=25) 119.1  (19.97)
Day 785 SBP post-infusion (n=25) 117.3  (18.64)
Day 813 SBP pre-infusion (n=23) 118.4  (12.24)
Day 813 SBP post-infusion (n=22) 123.0  (14.08)
Day 841 SBP pre-infusion (n=19) 115.3  (15.92)
Day 841 SBP post-infusion (n=19) 119.1  (18.52)
Day 869 SBP pre-infusion (n=18) 117.6  (14.84)
Day 869 SBP post-infusion (n=18) 117.6  (14.22)
Day 897 SBP pre-infusion (n=19) 116.4  (14.18)
Day 897 SBP post-infusion (n=19) 115.4  (12.81)
Day 925 SBP pre-infusion (n=19) 116.4  (16.33)
Day 925 SBP post-infusion (n=19) 118.2  (18.78)
Day 953 SBP pre-infusion (n=19) 116.8  (15.97)
Day 953 SBP post-infusion (n=19) 119.5  (20.01)
Day 981 SBP pre-infusion (n=18) 115.6  (16.18)
Day 981 SBP post-infusion (n=18) 118.4  (18.75)
Day 1009 SBP pre-infusion (n=19) 116.8  (20.57)
Day 1009 SBP post-infusion (n=19) 118.9  (13.70)
Day 1037 SBP pre-infusion (n=15) 113.5  (16.51)
Day 1037 SBP post-infusion (n=15) 115.3  (15.39)
Day 1065 SBP pre-infusion (n=14) 123.1  (24.47)
Day 1065 SBP post-infusion (n=14) 119.4  (16.84)
Day 1093 SBP pre-infusion (n=10) 116.5  (18.31)
Day 1093 SBP post-infusion (n=10) 113.5  (14.54)
Day 1121 SBP pre-infusion (n=7) 118.3  (20.93)
Day 1121 SBP post-infusion (n=7) 115.1  (11.87)
Day 1149 SBP pre-infusion (n=7) 116.9  (13.91)
Day 1149 SBP post-infusion (n=7) 116.4  (8.98)
Day 1177 SBP pre-infusion (n=7) 114.6  (12.43)
Day 1177 SBP post-infusion (n=7) 114.6  (7.72)
24.Primary Outcome
Title Long-term Period: Mean Sitting Diastolic Blood Pressure (DBP) Over Time
Hide Description Measurements were taken in a seated position before and after abatacept infusion.
Time Frame From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants. n=number of participants with evaluable blood pressure readings.
Arm/Group Title Long-term ABA
Hide Arm/Group Description:
Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
Overall Number of Participants Analyzed 481
Mean (Standard Deviation)
Unit of Measure: mm Hg
Day 169 DBP pre-infusion (n=481) 75.1  (10.09)
Day 169 DBP post-infusion (n=477) 74.9  (9.60)
Day 197 DBP pre-infusion (n=414) 74.0  (10.09)
Day 197 DBP post-infusion (n=415) 74.4  (10.27)
Day 225 DBP pre-infusion (n=340) 73.9  (10.28)
Day 225 DBP post-infusion (n=338) 73.7  (9.53)
Day 253 DBP pre-infusion (n=251) 74.5  (10.60)
Day 253 DBP post-infusion (n=251) 74.5  (10.04)
Day 281 DBP pre-infusion (n=203) 74.7  (10.16)
Day 281 DBP post-infusion (n=202) 75.3  (9.94)
Day 309 DBP pre-infusion (n=160) 75.4  (10.36)
Day 309 DBP post-infusion (n=159) 75.6  (10.73)
Day 337 DBP pre-infusion (n=128) 74.5  (10.42)
Day 337 DBP post-infusion (n=128) 74.5  (10.48)
Day 365 DBP pre-infusion (n=118) 76.4  (10.88)
Day 365 DBP post-infusion (n=120) 75.0  (10.27)
Day 393 DBP pre-infusion (n=101) 75.3  (12.13)
Day 393 DBP post-infusion (n=99) 74.7  (10.77)
Day 421 DBP post-infusion (n=93) 77.1  (11.66)
Day 421 DBP post-infusion (n=93) 75.5  (10.48)
Day 449 DBP pre-infusion (n=82) 75.8  (10.82)
Day 449 DBP post-infusion (n=82) 76.6  (11.73)
Day 477 DBP pre-infusion (n=75) 76.4  (13.25)
Day 477 DBP post-infusion (n=75) 75.2  (11.56)
Day 505 DBP pre-infusion (n=72) 75.3  (12.80)
Day 505 DBP post-infusion (n=73) 75.9  (13.62)
Day 533 DBP pre-infusion (n=67) 75.6  (11.36)
Day 533 DBP post-infusion (n=66) 77.0  (11.57)
Day 561 DBP pre-infusion (n=63) 74.9  (12.10)
Day 561 DBP post-infusion (n=63) 73.2  (12.32)
Day 589 DBP pre-infusion (n=57) 72.8  (12.0)
Day 589 DBP post-infusion (n=57) 74.7  (11.20)
Day 617 DBP pre-infusion (n=56) 74.4  (10.92)
Day 617 DBP post-infusion (n=55) 74.7  (12.53)
Day 645 DBP pre-infusion (n=44) 73.8  (10.68)
Day 645 DBP post-infusion (n=43) 76.2  (11.01)
Day 673 DBP pre-infusion (n=40) 76.3  (10.32)
Day 673 DBP post-infusion (n=41) 75.1  (10.41)
Day 701 DBP pre-infusion (n=35) 72.0  (9.39)
Day 701 DBP post-infusion (n=36) 72.3  (8.70)
Day 729 DBP pre-infusion (n=32) 76.7  (11.66)
Day 729 DBP post-infusion (n=32) 74.8  (10.34)
Day 757 DBP pre-infusion (n=30) 75.0  (9.34)
Day 757 DBP post-infusion (n=29) 73.8  (10.07)
Day 785 DBP pre-infusion (n=24) 73.5  (10.46)
Day 785 DBP post-infusion (n=25) 72.7  (9.32)
Day 813 DBP pre-infusion (n=22) 75.2  (8.05)
Day 813 DBP post-infusion (n=22) 73.9  (10.95)
Day 841 DBP pre-infusion (n=19) 72.4  (8.41)
Day 841 DBP post-infusion (n=19) 73.2  (10.87)
Day 869 DBP pre-infusion (n=19) 72.7  (10.61)
Day 869 DBP post-infusion (n=18) 71.1  (9.86)
Day 897 DBP pre-infusion (n=19) 68.8  (7.44)
Day 897 DBP post-infusion (n=19) 67.9  (7.69)
Day 925 DBP pre-infusion (n=19) 73.5  (9.96)
Day 925 DBP post-infusion (n=19) 71.8  (10.77)
Day 953 DBP pre-infusion (n=19) 68.7  (10.91)
Day 953 DBP post-infusion (n=19) 72.5  (10.74)
Day 981 DBP pre-infusion (n=18) 69.7  (11.05)
Day 981 DBP post-infusion (n=18) 69.7  (11.45)
Day 1009 DBP pre-infusion (n=19) 71.6  (9.78)
Day 1009 DBP post-infusion (n=19) 70.3  (9.16)
Day 1037 DBP pre-infusion (n=15) 71.3  (11.15)
Day 1037 DBP post-infusion (n=15) 71.2  (8.48)
Day 1065 DBP pre-infusion (n=13) 71.5  (7.18)
Day 1065 DBP post-infusion (n=14) 72.4  (7.53)
Day 1093 DBP pre-infusion (n=10) 71.8  (6.07)
Day 1093 DBP post-infusion (n=10) 76.3  (5.58)
Day 1121 DBP pre-infusion (n=7) 75.1  (5.64)
Day 1121 DBP post-infusion (n=7) 72.6  (4.08)
Day 1149 DBP pre-infusion (n=7) 72.6  (4.16)
Day 1149 DBP post-infusion (n=7) 72.4  (3.99)
Day 1177 DBP pre-infusion (n=7) 69.1  (9.32)
Day 1177 DBP post-infusion (n=7) 73.4  (7.35)
25.Primary Outcome
Title Long-term Period: Mean Heart Rate (HR) Over Time
Hide Description [Not Specified]
Time Frame From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants. n=number of participants with evaluable heart rate readings.
Arm/Group Title Long-term ABA
Hide Arm/Group Description:
Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
Overall Number of Participants Analyzed 481
Mean (Standard Deviation)
Unit of Measure: beats per minute
Day 169 HR pre-infusion (n=481) 74.4  (11.08)
Day 169 HR post-infusion (n=481) 73.0  (10.22)
Day 197 HR pre-infusion (n=414) 74.4  (11.58)
Day 197 HR post-infusion (n=416) 72.8  (10.65)
Day 225 HR pre-infusion (n=340) 74.7  (10.43)
Day 225 HR post-infusion (n=338) 72.5  (9.88)
Day 253 HR pre-infusion (n=252) 73.9  (11.72)
Day 253 HR post-infusion (n=252) 72.1  (10.96)
Day 281 HR pre-infusion (n=203) 73.8  (11.39)
Day 281 HR post-infusion (n=202) 72.4  (10.17)
Day 309 HR pre-infusion (n=160) 73.9  (9.62)
Day 309 HR post-infusion (n=159) 72.0  (9.85)
Day 337 HR pre-infusion (n=128) 74.1  (11.71)
Day 337 HR post-infusion (n=129) 70.9  (8.78)
Day 365 HR pre-infusion (n=118) 73.7  (12.20)
Day 365 HR post-infusion (n=120) 73.1  (10.21)
Day 393 HR pre-infusion (n=101) 73.0  (10.26)
Day 393 HR post-infusion (n=99) 72.4  (9.88)
Day 421 HR post-infusion (n=93) 74.2  (10.32)
Day 421 HR post-infusion (n=93) 71.6  (8.63)
Day 449 HR pre-infusion (n=82) 74.2  (10.67)
Day 449 HR post-infusion (n=82) 73.7  (9.81)
Day 477 HR pre-infusion (n=74) 75.4  (12.48)
Day 477 HR post-infusion (n=75) 72.9  (10.89)
Day 505 HR pre-infusion (n=72) 73.8  (11.41)
Day 505 HR post-infusion (n=73) 73.0  (8.90)
Day 533 HR pre-infusion (n=66) 73.2  (11.57)
Day 533 HR post-infusion (n=66) 75.7  (12.21)
Day 561 HR pre-infusion (n=63) 73.8  (10.09)
Day 561 HR post-infusion (n=63) 72.3  (10.18)
Day 589 HR pre-infusion (n=57) 73.0  (9.83)
Day 589 HR post-infusion (n=57) 71.5  (9.66)
Day 617 HR pre-infusion (n=56) 72.9  (10.89)
Day 617 HR post-infusion (n=55) 71.7  (9.40)
Day 645 HR pre-infusion (n=44) 76.6  (13.40)
Day 645 HR post-infusion (n=43) 76.1  (13.00)
Day 673 HR pre-infusion (n=40) 73.5  (11.67)
Day 673 HR post-infusion (n=41) 73.3  (10.74)
Day 701 HR pre-infusion (n=35) 72.1  (12.13)
Day 701 HR post-infusion (n=36) 73.3  (10.23)
Day 729 HR pre-infusion (n=32) 70.7  (11.24)
Day 729 HR post-infusion (n=32) 71.7  (11.38)
Day 757 HR pre-infusion (n=30) 74.1  (9.60)
Day 757 HR post-infusion (n=30) 73.2  (9.35)
Day 785 HR pre-infusion (n=25) 76.5  (8.78)
Day 785 HR post-infusion (n=25) 73.4  (8.61)
Day 813 HR pre-infusion (n=23) 73.9  (11.23)
Day 813 HR post-infusion (n=22) 71.4  (10.90)
Day 841 HR pre-infusion (n=19) 74.2  (10.95)
Day 841 HR post-infusion (n=19) 71.4  (9.15)
Day 869 HR pre-infusion (n=19) 72.4  (12.21)
Day 869 HR post-infusion (n=18) 72.3  (11.98)
Day 897 HR pre-infusion (n=19) 71.7  (9.16)
Day 897 HR post-infusion (n=19) 70.9  (9.10)
Day 925 HR pre-infusion (n=19) 76.7  (7.75)
Day 925 HR post-infusion (n=19) 73.0  (7.86)
Day 953 HR pre-infusion (n=19) 75.5  (10.57)
Day 953 HR post-infusion (n=19) 73.8  (7.49)
Day 981 HR pre-infusion (n=18) 75.7  (13.05)
Day 981 HR post-infusion (n=18) 72.8  (8.76)
Day 1009 HR pre-infusion (n=19) 76.1  (10.68)
Day 1009 HR post-infusion (n=18) 73.6  (7.94)
Day 1037 HR pre-infusion (n=15) 74.6  (11.36)
Day 1037 HR post-infusion (n=15) 75.1  (10.53)
Day 1065 HR pre-infusion (n=14) 74.3  (8.90)
Day 1065 HR post-infusion (n=14) 75.1  (9.05)
Day 1093 HR pre-infusion (n=10) 70.6  (9.54)
Day 1093 HR post-infusion (n=10) 70.3  (8.03)
Day 1121 HR pre-infusion (n=7) 72.4  (4.89)
Day 1121 HR post-infusion (n=7) 69.1  (3.80)
Day 1149 HR pre-infusion (n=7) 71.0  (1.83)
Day 1149 HR post-infusion (n=7) 69.9  (4.85)
Day 1177 HR pre-infusion (n=7) 75.0  (8.85)
Day 1177 HR post-infusion (n=7) 69.1  (10.71)
26.Primary Outcome
Title Long-term Period: Mean Temperature (T) Over Time
Hide Description [Not Specified]
Time Frame From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants. n=number of participants with evaluable temperature readings.
Arm/Group Title Long-term ABA
Hide Arm/Group Description:
Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
Overall Number of Participants Analyzed 482
Mean (Standard Deviation)
Unit of Measure: degrees Celsius
Day 169 T pre-infusion (n=482) 36.5  (0.45)
Day 169 T post-infusion (n=478) 36.5  (0.45)
Day 197 T pre-infusion (n=415) 36.6  (0.44)
Day 197 T post-infusion (n=413) 36.5  (0.43)
Day 225 T pre-infusion (n=340) 36.5  (0.48)
Day 225 T post-infusion (n=335) 36.5  (0.46)
Day 253 T pre-infusion (n=251) 36.5  (0.48)
Day 253 T post-infusion (n=251) 36.5  (0.45)
Day 281 T pre-infusion (n=202) 36.4  (0.47)
Day 281 T post-infusion (n=202) 36.5  (0.45)
Day 309 T pre-infusion (n=158) 36.4  (0.48)
Day 309 T post-infusion (n=158) 36.4  (0.50)
Day 337 T pre-infusion (n=129) 36.3  (0.51)
Day 337 T post-infusion (n=128) 36.4  (0.49)
Day 365 T pre-infusion (n=118) 36.4  (0.54)
Day 365 T post-infusion (n=119) 36.4  (0.55)
Day 393 T pre-infusion (n=101) 36.4  (0.47)
Day 393 T post-infusion (n=96) 36.4  (0.50)
Day 421 T post-infusion (n=93) 36.4  (0.47)
Day 421 T post-infusion (n=93) 36.4  (0.45)
Day 449 T pre-infusion (n=82) 36.4  (0.44)
Day 449 T post-infusion (n=82) 36.4  (0.48)
Day 477 T pre-infusion (n=75) 36.4  (0.51)
Day 477 T post-infusion (n=75) 36.4  (0.53)
Day 505 T pre-infusion (n=71) 36.5  (0.44)
Day 505 T post-infusion (n=72) 36.5  (0.55)
Day 533 T pre-infusion (n=67) 36.4  (0.57)
Day 533 T post-infusion (n=64) 36.4  (0.42)
Day 561 T pre-infusion (n=63) 36.4  (0.41)
Day 561 T post-infusion (n=62) 36.5  (0.43)
Day 589 T pre-infusion (n=57) 36.4  (0.50)
Day 589 T post-infusion (n=57) 36.4  (0.47)
Day 617 T pre-infusion (n=56) 36.4  (0.51)
Day 617 T post-infusion (n=54) 36.4  (0.43)
Day 645 T pre-infusion (n=44) 36.3  (0.47)
Day 645 T post-infusion (n=42) 36.3  (0.63)
Day 673 T pre-infusion (n=40) 36.3  (0.56)
Day 673 T post-infusion (n=41) 36.3  (0.50)
Day 701 T pre-infusion (n=35) 36.3  (0.49)
Day 701 T post-infusion (n=35) 36.3  (0.44)
Day 729 T pre-infusion (n=31) 36.1  (0.51)
Day 729 T post-infusion (n=32) 36.2  (0.42)
Day 757 T pre-infusion (n=30) 36.2  (0.52)
Day 757 T post-infusion (n=30) 36.2  (0.53)
Day 785 T pre-infusion (n=25) 36.2  (0.40)
Day 785 T post-infusion (n=24) 36.2  (0.37)
Day 813 T pre-infusion (n=23) 36.1  (0.43)
Day 813 T post-infusion (n=22) 36.0  (0.34)
Day 841 T pre-infusion (n=19) 36.1  (0.40)
Day 841 T post-infusion (n=19) 36.2  (0.46)
Day 869 T pre-infusion (n=19) 36.1  (0.66)
Day 869 T post-infusion (n=18) 36.1  (0.57)
Day 897 T pre-infusion (n=18) 36.2  (0.62)
Day 897 T post-infusion (n=18) 36.3  (0.64)
Day 925 T pre-infusion (n=19) 36.1  (0.36)
Day 925 T post-infusion (n=19) 36.1  (0.43)
Day 953 T pre-infusion (n=19) 36.1  (0.54)
Day 953 T post-infusion (n=18) 36.1  (0.52)
Day 981 T pre-infusion (n=17) 36.2  (0.48)
Day 981 T post-infusion (n=17) 36.0  (0.68)
Day 1009 T pre-infusion (n=19) 36.1  (0.40)
Day 1009 T post-infusion (n=17) 36.3  (0.44)
Day 1037 T pre-infusion (n=15) 36.1  (0.38)
Day 1037 T post-infusion (n=15) 36.1  (0.41)
Day 1065 T pre-infusion (n=14) 36.1  (0.80)
Day 1065 T post-infusion (n=14) 36.3  (0.58)
Day 1093 T pre-infusion (n=10) 36.1  (0.59)
Day 1093 T post-infusion (n=10) 36.2  (0.47)
Day 1121 T pre-infusion (n=7) 36.3  (0.40)
Day 1121 T post-infusion (n=7) 36.4  (0.33)
Day 1149 T pre-infusion (n=7) 36.3  (0.43)
Day 1149 T post-infusion (n=7) 36.3  (0.35)
Day 1177 T pre-infusion (n=7) 36.1  (0.54)
Day 1177 T post-infusion (n=7) 36.2  (0.38)
27.Secondary Outcome
Title Short-term Period: Number of Participants With Clinically Meaningful Improvement (CMI) in Disease Activity Score (DAS 28), Low Disease Activity (LDAS), or Remission at Day 169
Hide Description The DAS 28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR or CRP, and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thresholds that define high disease activity (> 5.1), low disease activity (< 3.2) and remission (< 2.6). A clinically significant response= decrease in DAS28 score of >1.2 from baseline.
Time Frame BL, Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants.
Arm/Group Title ST Abatacept (ABA)-Previous User ST ABA-Current User
Hide Arm/Group Description:
In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
Overall Number of Participants Analyzed 449 597
Measure Type: Number
Unit of Measure: participants
CMI 267 320
LDAS 101 133
Remission 54 82
28.Secondary Outcome
Title Short-term Period: Mean Time-matched Baseline (Day 0) DAS 28 and DAS 28 for Post-Baseline Visits Through 6 Month Open-Label
Hide Description The DAS 28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR or CRP, and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thresholds that define high disease activity (> 5.1), low disease activity (< 3.2) and remission (< 2.6). Time-matched baseline (Day 0) values and post-baseline values were presented for each post-baseline visit, and represent only that cohort of participants with measurements available at that post-baseline visit.
Time Frame BL (Day 0), Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants. n=number of evaluable participants.
Arm/Group Title ST Abatacept (ABA)-Previous User ST ABA-Current User
Hide Arm/Group Description:
In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
Overall Number of Participants Analyzed 429 580
Mean (Standard Deviation)
Unit of Measure: units on a scale
BL (Day 0) for Day 15 cohort (n=429,570) 6.21  (0.73) 6.17  (0.72)
Day 15 visit (n=429,570) 5.46  (1.05) 5.49  (1.12)
BL (Day 0) for Day 29 cohort (n=426,580) 6.22  (0.72) 6.17  (0.71)
Day 29 visit (n=426,580) 5.05  (1.20) 5.09  (1.25)
BL (Day 0) for Day 57 cohort (n=425,563) 6.22  (0.74) 6.16  (0.71)
Day 57 visit (n=425,563) 4.65  (1.27) 4.72  (1.30)
BL (Day 0) for Day 85 cohort (n=403,542) 6.21  (0.73) 6.16  (0.72)
Day 85 visit (n=403,542) 4.44  (1.37) 4.57  (1.35)
BL (Day 0) for Day 113 cohort (n=393,516) 6.20  (0.73) 6.15  (0.71)
Day 113 visit (n=393,516) 4.24  (1.36) 4.39  (1.41)
BL (Day 0) for Day 141 cohort (n=372,493) 6.19  (0.74) 6.16  (0.73)
Day 141 visit (n=372,493) 4.19  (1.38) 4.27  (1.39)
BL (Day 0) for Day 169 cohort(n=369,468) 6.19  (0.73) 6.15  (0.73)
Day 169 visit (n=369,468) 4.16  (1.43) 4.14  (1.47)
29.Secondary Outcome
Title Short-term Period: Mean Time-matched Change From Baseline (Day 0) in DAS 28 Through 6 Month Open-Label
Hide Description The DAS28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR or CRP, and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thresholds that define high disease activity (> 5.1), low disease activity (< 3.2) and remission (< 2.6). Time-matched mean change from BL= Post-BL value - time-matched BL value, where the time-matched BL value represents the mean BL (Day 0) value for only that cohort of participants with measurements available at that post-BL visit.
Time Frame BL (Day 0), Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants. n=number of evaluable participants.
Arm/Group Title ST Abatacept (ABA)-Previous User ST ABA-Current User
Hide Arm/Group Description:
In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
Overall Number of Participants Analyzed 429 580
Mean (Standard Deviation)
Unit of Measure: units on a scale
Change from BL (Day 0) to Day 15 visit (n=429,570) -0.75  (0.04) -0.68  (0.04)
Change from BL (Day 0) to Day 29 visit (n=426,580) -1.18  (0.05) -1.07  (0.05)
Change from BL (Day 0) to Day 57 visit (n=425,563) -1.57  (0.06) -1.44  (0.05)
Change from BL (Day 0) to Day 85 visit (n=403,542) -1.76  (0.06) -1.60  (0.05)
Change from BL (Day 0) to Day 113 visit(n=393,516) -1.96  (0.07) -1.76  (0.06)
Change from BL (Day 0) to Day 141 visit(n=372,493) -2.00  (0.07) -1.90  (0.06)
Change from BL (Day 0) to Day 169 visit(n=369,468) -2.02  (0.07) -2.01  (0.07)
30.Secondary Outcome
Title Short-term Period: Mean Change From Baseline to Day 169 in High Sensitivity C-Reactive Protein (Hs-CRP)
Hide 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.
Time Frame BL, Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants
Arm/Group Title ST Abatacept (ABA)-Previous User ST ABA-Current User
Hide Arm/Group Description:
In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
Overall Number of Participants Analyzed 376 476
Mean (Standard Deviation)
Unit of Measure: mg/dL
-0.88  (0.13) -0.68  (0.13)
31.Secondary Outcome
Title Short-term Period: Mean Change From Baseline to Day 169 in Rheumatoid Factor (RF)
Hide Description RF is an autoantibody (antibody directed against an organism's own tissues) most relevant in rheumatoid arthritis. It is an antibody against the Fc portion of Immunoglobulin (Ig)G, which is itself an antibody. RF and IgG join to form immune complexes which contribute to the disease process.
Time Frame BL, Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants
Arm/Group Title ST Abatacept (ABA)-Previous User ST ABA-Current User
Hide Arm/Group Description:
In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
Overall Number of Participants Analyzed 376 476
Mean (Standard Deviation)
Unit of Measure: IU/mL
-32.2  (11.33) -22.8  (10.19)
32.Secondary Outcome
Title Short-term Period: Mean Change From Baseline to Day 169 in the Health Assessment Questionnaire Disability Index (HAQ-DI)
Hide Description The HAQ-DI includes 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1= with some difficulty, 2= with much difficulty, and 3= unable to do. HAQ-DI= sum of worst scores in each domain divided by the number of domains answered. HAQ-DI ranges from a minimum of 0 (no difficulty) to a maximum overall score of 3(unable to do).
Time Frame BL, Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants
Arm/Group Title ST Abatacept (ABA)-Previous User ST ABA-Current User
Hide Arm/Group Description:
In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
Overall Number of Participants Analyzed 366 475
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.34  (0.03) -0.41  (0.03)
33.Secondary Outcome
Title Short-term Period: Number of Participants Achieving a Clinically Meaningful HAQ Response
Hide Description HAQ-DI includes 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1= with some difficulty, 2= with much difficulty, and 3= unable to do. HAQ-DI= sum of worst scores in each domain divided by the number of domains answered. HAQ-DI ranges from a minimum of 0 (no difficulty) to a maximum overall score of 3(unable to do). Clinically meaningful HAQ response=an improvement of at least 0.3 units from baseline in HAQ disability Index.
Time Frame BL, Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants
Arm/Group Title ST Abatacept (ABA)-Previous User ST ABA-Current User
Hide Arm/Group Description:
In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
Overall Number of Participants Analyzed 449 597
Measure Type: Number
Unit of Measure: participants
208 281
34.Secondary Outcome
Title Short-term Period: Mean Baseline Short Form 36 (SF-36) Quality of Life Physical Component Summary (PCS), Mental Component Summary (MCS), and SF-36 Individual Component Scores
Hide Description The SF-36 is a validated instrument measuring health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores (1) physical component summary=physical functioning, role-physical, bodily pain, and general health; (2) mental component summary=vitality, social functioning, role-emotional, and mental health. There is no total overall score; scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Change from Baseline= post-Baseline - Baseline value.
Time Frame BL
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants. n=number of evaluable participants.
Arm/Group Title ST Abatacept (ABA)-Previous User ST ABA-Current User
Hide Arm/Group Description:
In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
Overall Number of Participants Analyzed 370 475
Mean (Standard Deviation)
Unit of Measure: units on a scale
PCS (n=360, n=466) 28.81  (7.74) 28.75  (7.47)
MCS (n=360, n=466) 42.45  (12.98) 42.43  (12.43)
Physical Function Scale Component (n=367, n=473) 27.72  (9.87) 28.22  (9.54)
Role-Physical Scale Component (n=364, n=473) 32.06  (7.95) 31.38  (7.11)
Bodily Pain Scale Component (n=367, n=472) 31.73  (7.17) 31.13  (7.26)
General Health Scale Component (n=369, n=475) 35.70  (9.40) 35.71  (9.22)
Vitality Scale Component (n=369, n=472) 35.95  (9.21) 36.62  (9.11)
Social Functioning Scale Component (n=370, n=475) 34.76  (11.86) 34.13  (10.99)
Role-Emotional Scale Component (n=365, n=471) 37.21  (13.99) 36.98  (14.03)
Mental Health Scale Component (n=369, n=472) 41.79  (12.79) 41.92  (11.95)
35.Secondary Outcome
Title Short-term Period: Mean Change From Baseline to Day 169 in SF-36 PCS, MCS, and SF-36 Individual Component Scores
Hide Description The SF-36 is a validated instrument measuring health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores (1) physical component summary=physical functioning, role-physical, bodily pain, and general health; (2) mental component summary=vitality, social functioning, role-emotional, and mental health. There is no total overall score; scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Change from Baseline= post-Baseline - Baseline value.
Time Frame BL, Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants. n=number of evaluable participants.
Arm/Group Title ST Abatacept (ABA)-Previous User ST ABA-Current User
Hide Arm/Group Description:
In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
Overall Number of Participants Analyzed 370 475
Mean (Standard Deviation)
Unit of Measure: units on a scale
PCS (n=360, n=466) 5.50  (0.44) 6.08  (0.43)
MCS (n=360, n=466) 4.79  (0.59) 5.43  (0.52)
Physical Function Scale Component (n=367, n=473) 4.31  (0.52) 4.66  (0.49)
Role-Physical Scale Component (n=364, n=473) 5.85  (0.59) 6.82  (0.55)
Bodily Pain Scale Component (n=367, n=472) 8.20  (0.45) 8.72  (0.45)
General Health Scale Component (n=369, n=475) 2.85  (0.38) 3.83  (0.38)
Vitality Scale Component (n=369, n=472) 6.32  (0.51) 6.37  (0.50)
Social Functioning Scale Component (n=370, n=475) 6.44  (0.58) 7.18  (0.54)
Role-Emotional Scale Component (n=365, n=471) 5.30  (0.76) 5.85  (0.71)
Mental Health Scale Component (n=369, n=472) 3.74  (0.52) 4.41  (0.46)
36.Secondary Outcome
Title Short-term Period: Mean Baseline Fatigue Visual Analog Scale (VAS)
Hide Description The VAS for Fatigue (VAS-F) consists of a 100 mm line, with 0 (No Fatigue) on 1 end and 100 (Extreme Fatigue) on the other end, which a participant marks to indicate how much fatigue he or she feels. The marked point in mm is converted into a numeric value from 0 to 100, where 0=no fatigue and 100=maximum fatigue. Increasing numbers=increasing fatigue.
Time Frame BL
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants
Arm/Group Title ST Abatacept (ABA)-Previous User ST ABA-Current User
Hide Arm/Group Description:
In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
Overall Number of Participants Analyzed 376 476
Mean (Standard Deviation)
Unit of Measure: units on a scale
73.33  (19.67) 72.70  (20.75)
37.Secondary Outcome
Title Short-term Period: Mean Change From Baseline to Day 169 in Fatigue Visual Analog Scale (VAS)
Hide Description The VAS for Fatigue (VAS-F) consists of a 100 mm line, with 0 (No Fatigue) on 1 end and 100 (Extreme Fatigue) on the other end, which a participant marks to indicate how much fatigue he or she feels. The marked point in mm is converted into a numeric value from 0 to 100, where 0=no fatigue and 100=maximum fatigue. Increasing numbers=increasing fatigue.
Time Frame BL, Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants
Arm/Group Title ST Abatacept (ABA)-Previous User ST ABA-Current User
Hide Arm/Group Description:
In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
Overall Number of Participants Analyzed 376 476
Mean (Standard Deviation)
Unit of Measure: units on a scale
-18.3  (1.35) -20.2  (1.25)
38.Secondary Outcome
Title Long-term Period: Number of Participants With Clinically Meaningful Improvement in DAS 28, Low Disease Activity, or Remission Over Time
Hide Description The DAS28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR or CRP, and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thresholds that define high disease activity (> 5.1), low disease activity (< 3.2) and remission (< 2.6). A clinically significant response= decrease in DAS28 score of >1.2 from baseline.
Time Frame BL, Days 365, 449, 533, 617, 729, 813
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants. n=number of evaluable participants.
Arm/Group Title Long-term ABA
Hide Arm/Group Description:
Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
Overall Number of Participants Analyzed 213
Measure Type: Number
Unit of Measure: participants
Day 365 CMI (n=212) 163
Day 365 LDAS (n=213) 70
Day 365 Remission (n=213) 31
Day 449 CMI (n=119) 105
Day 449 LDAS (n=120) 43
Day 449 Remission (n=120) 25
Day 533 CMI (n=102) 91
Day 533 LDAS (n=102) 38
Day 533 Remission (n=102) 25
Day 617 CMI (n=78) 69
Day 617 LDAS (n=79) 38
Day 617 Remission (79) 17
Day 729 CMI (n=59) 51
Day 729 LDAS (n=60) 23
Day 729 Remission (n=60) 12
Day 813 CMI (n=38) 34
Day 813 LDAS (n=38) 21
Day 813 Remission (n=38) 12
39.Secondary Outcome
Title Long-term Period: Mean Time-matched Baseline (Day 0) DAS 28 and DAS 28 for Post-Baseline Visits Over the Long Term
Hide Description The DAS28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR or CRP, and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thresholds that define high disease activity (> 5.1), low disease activity (< 3.2) and remission (< 2.6). Time-matched baseline (Day 0)values and post-baseline values were presented for each post-baseline visit, and represent only that cohort of participants with measurements available at that post-baseline visit.
Time Frame BL (Day 0), Days 365, 449, 533, 617, 729, 813
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants analyzed in the LT. N=the total number of participants analyzed, n=the number of participants at that time point with available measurements. Mean time-matched baseline values reflect changing n-values over time
Arm/Group Title Long-term ABA
Hide Arm/Group Description:
Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
Overall Number of Participants Analyzed 212
Mean (Standard Deviation)
Unit of Measure: units on a scale
BL (Day 0) for Day 365 cohort (n=212) 6.18  (0.73)
Day 365 visit (n=212) 3.90  (1.32)
BL (Day 0) for Day 449 cohort (n=212) 6.16  (0.70)
Day 449 visit (n=212) 3.55  (1.11)
BL (Day 0) for Day 533 cohort (n=102) 6.16  (0.73)
Day 533 visit (n=102) 3.52  (1.09)
BL (Day 0) for Day 617 cohort (n=78) 6.15  (0.68)
Day 617 visit (n=78) 3.44  (1.12)
BL (Day 0) for Day 729 cohort (n=59) 6.16  (0.69)
Day 729 visit (n=59) 3.49  (1.18)
BL (Day 0) for Day 813 cohort (n=38) 6.26  (0.67)
Day 813 visit (n=38) 3.28  (1.07)
40.Secondary Outcome
Title Long-term Period: Mean Time-matched Change From Baseline (Day 0) in DAS 28 Over The Long Term
Hide Description The DAS28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR or CRP, and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thresholds that define high disease activity (> 5.1), low disease activity (< 3.2) and remission (< 2.6). Time-matched mean change from BL= Post-BL value - time-matched BL value, where the time-matched BL value represents the mean BL(Day 0)value for only that cohort of participants with measurements available at that post-BL visit.
Time Frame BL (Day 0), Days 365, 449, 533, 617, 729, 813
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants analyzed in the LT. N=the total number of participants analyzed, n=the number of participants at that time point with available measurements. Mean time-matched baseline values reflect changing n-values over time
Arm/Group Title Long-term ABA
Hide Arm/Group Description:
Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
Overall Number of Participants Analyzed 212
Mean (Standard Error)
Unit of Measure: units on a scale
Change from BL (Day 0) to Day 365 visit (n=212) -2.28  (0.10)
Change from BL (Day 0) to Day 449 visit (n=212) -2.62  (0.11)
Change from BL (Day 0) to Day 533 visit (n=102) -2.64  (0.13)
Change from BL (Day 0) to Day 617 visit (n=78) -2.72  (0.15)
Change from BL (Day 0) to Day 729 visit (n=59) -2.66  (0.19)
Change from BL (Day 0) to Day 813 visit (n=38) -2.97  (0.22)
41.Secondary Outcome
Title Long-term Period: Mean Time-matched Baseline (Day 0) Number of Tender Joints and Number of Tender Joints for Post-Baseline Visits Over the Long Term
Hide Description The mean number of tender joints was evaluated based on the number of tender joints in a standard 68 joint count. Time-matched baseline (Day 0) values and post-baseline values were presented for each post-baseline visit, and represent only that cohort of participants with measurements available at that post-baseline visit.
Time Frame BL (Day 0), Days 365, 449, 533, 617, 729, 813
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants analyzed in the LT. N=the total number of participants analyzed, n=the number of participants at that time point with available measurements. Mean time-matched baseline values reflect changing n-values over time
Arm/Group Title Long-term ABA
Hide Arm/Group Description:
Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
Overall Number of Participants Analyzed 221
Mean (Standard Deviation)
Unit of Measure: tender joints
BL (Day 0) for Day 365 cohort (n=221) 16.90  (5.82)
Day 365 visit (n=221) 6.04  (6.75)
BL (Day 0) for Day 449 cohort (n=221) 16.57  (5.68)
Day 449 visit (n=221) 4.39  (5.17)
BL (Day 0) for Day 533 cohort (n=107) 16.14  (5.81)
Day 533 visit (n=107) 4.34  (4.83)
BL (Day 0) for Day 617 cohort (n=87) 16.29  (5.75)
Day 617 visit (n=87) 3.75  (4.75)
BL (Day 0) for Day 729 cohort (n=63) 16.40  (5.97)
Day 729 visit (n=63) 4.02  (5.08)
BL (Day 0) for Day 813 cohort (n=43) 17.42  (5.57)
Day 813 visit (n=43) 3.67  (4.04)
42.Secondary Outcome
Title Long-term Period: Mean Time-matched Change From Baseline (Day 0) in Number of Tender Joints Over the Long Term
Hide Description The mean number of tender joints was evaluated based on the number of tender joints in a standard 68 joint count. Time-matched mean change from baseline = Post-baseline value - time-matched baseline value, where the time-matched baseline value represents the mean baseline (Day 0) value for only that cohort of participants with measurements available at that post-baseline visit.
Time Frame BL (Day 0), Days 365, 449, 533, 617, 729, 813
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants analyzed in the LT. N=the total number of participants analyzed, n=the number of participants at that time point with available measurements. Mean time-matched baseline values reflect changing n-values over time
Arm/Group Title Long-term ABA
Hide Arm/Group Description:
Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
Overall Number of Participants Analyzed 221
Mean (Standard Error)
Unit of Measure: tender joints
Change from BL (Day 0) to Day 365 visit (n=221) -10.9  (0.51)
Change from BL (Day 0) to Day 449 visit (n=221) -12.2  (0.58)
Change from BL (Day 0) to Day 533 visit (n=107) -11.8  (0.70)
Change from BL (Day 0) to Day 617 visit (n=87) -12.5  (0.75)
Change from BL (Day 0) to Day 729 visit (n=63) -12.4  (0.98)
Change from BL (Day 0) to Day 813 visit (n=43) -13.7  (1.12)
43.Secondary Outcome
Title Long-term Period: Mean Time-matched Baseline (Day 0) Number of Swollen Joints And Post-Baseline Number of Swollen Joints Over the Long Term
Hide Description The mean number of swollen joints was evaluated based on the number of swollen joints in a standard 66 joint count. Time-matched baseline (Day 0) values and post-baseline values were presented for each post-baseline visit, and represent only that cohort of participants with measurements available at that post-baseline visit.
Time Frame BL (Day 0), Days 365, 449, 533, 617, 729, 813
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants analyzed in the LT. N=the total number of participants analyzed, n=the number of participants at that time point with available measurements. Mean time-matched baseline values reflect changing n-values over time
Arm/Group Title Long-term ABA
Hide Arm/Group Description:
Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
Overall Number of Participants Analyzed 221
Mean (Standard Deviation)
Unit of Measure: swollen joints
BL (Day 0) for Day 365 cohort (n=221) 12.72  (5.37)
Day 365 visit (n=221) 4.56  (4.83)
BL (Day 0) for Day 449 cohort (n=221) 12.50  (4.95)
Day 449 visit (n=221) 3.63  (3.99)
BL (Day 0) for Day 533 cohort (n=107) 11.91  (5.01)
Day 533 visit (n=107) 2.81  (2.67)
BL (Day 0) for Day 617 cohort (n=87) 11.98  (4.91)
Day 617 visit (n=87) 2.97  (3.40)
BL (Day 0) for Day 729 cohort (n=63) 11.57  (4.74)
Day 729 visit (n=63) 3.02  (4.05)
BL (Day 0) for Day 813 cohort (n=43) 12.40  (4.14)
Day 813 visit (n=43) 2.14  (3.10)
44.Secondary Outcome
Title Long-term Period: Mean Time-Matched Change From Baseline (Day 0) in Number of Swollen Joints Over the Long Term
Hide Description The mean number of swollen joints was evaluated based on the number of swollen joints in a standard 66 joint count. Time-matched mean change from baseline = Post-baseline value - time-matched baseline value, where the time-matched baseline value represents the mean baseline (Day 0) value for only that cohort of participants with measurements available at that post-baseline visit.
Time Frame BL (Day 0), Days 365, 449, 533, 617, 729, 813
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants analyzed in the LT. N=the total number of participants analyzed, n=the number of participants at that time point with available measurements. Mean time-matched baseline values reflect changing n-values over time
Arm/Group Title Long-term ABA
Hide Arm/Group Description:
Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
Overall Number of Participants Analyzed 221
Mean (Standard Error)
Unit of Measure: swollen joints
Change from BL (Day 0) to Day 365 visit (n=221) -8.16  (0.40)
Change from BL (Day 0) to Day 449 visit (n=221) -8.87  (0.48)
Change from BL (Day 0) to Day 533 visit (n=107) -9.09  (0.50)
Change from BL (Day 0) to Day 617 visit (n=87) -9.01  (0.60)
Change from BL (Day 0) to Day 729 visit (n=63) -8.56  (0.81)
Change from BL (Day 0) to Day 813 visit (n=43) -10.3  (0.76)
45.Secondary Outcome
Title Long-term Period: Mean Time-matched Baseline (Day 0) Hs-CRP Levels and Hs-CRP Levels for Post-Baseline Over the Long Term
Hide 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. Time-matched baseline (Day 0) values and post-baseline values were presented for each post-baseline visit, and represent only that cohort of participants with measurements available at that post-baseline visit.
Time Frame BL (Day 0), Days 365, 449, 533, 617, 729, 813
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants analyzed in the LT. N=the total number of participants analyzed, n=the number of participants at that time point with available measurements. Mean time-matched baseline values reflect changing n-values over time
Arm/Group Title Long-term ABA
Hide Arm/Group Description:
Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
Overall Number of Participants Analyzed 216
Mean (Standard Deviation)
Unit of Measure: mg/dL
BL (Day 0) for Day 365 cohort (n=216) 2.36  (2.90)
Day 365 visit (n=216) 1.24  (1.78)
BL (Day 0) for Day 449 cohort (n=125) 2.48  (2.89)
Day 449 visit (n=125) 0.97  (1.59)
BL (Day 0) for Day 533 cohort (n=106) 2.65  (2.99)
Day 533 visit (n=106) 0.93  (1.39)
BL (Day 0) for Day 617 cohort (n=80) 2.82  (3.22)
Day 617 visit (n=80) 0.81  (1.21)
BL (Day 0) for Day 729 cohort (n=61) 2.47  (3.21)
Day 729 visit (n=61) 0.98  (1.57)
BL (Day 0) for Day 813 cohort (n=43) 2.60  (2.80)
Day 813 visit (n=43) 0.68  (0.96)
46.Secondary Outcome
Title Long-term Period: Mean Time-matched Change From Baseline (Day 0) in Hs-CRP Level Over the Long Term
Hide 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. Time-matched mean change from baseline = Post-baseline value - time-matched baseline value, where the time-matched baseline value represents the mean baseline (Day 0) value for only that cohort of participants with measurements available at that post-baseline visit.
Time Frame BL (Day 0), Days 365, 449, 533, 617, 729, 813
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants analyzed in the LT. N=the total number of participants analyzed, n=the number of participants at that time point with available measurements. Mean time-matched baseline values reflect changing n-values over time
Arm/Group Title Long-term ABA
Hide Arm/Group Description:
Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
Overall Number of Participants Analyzed 216
Mean (Standard Error)
Unit of Measure: mg/dL
Change from BL (Day 0) to Day 365 visit (n=216) -1.12  (0.19)
Change from BL (Day 0) to Day 449 visit (n=125) -1.51  (0.22)
Change from BL (Day 0) to Day 533 visit (n=106) -1.72  (0.26)
Change from BL (Day 0) to Day 617 visit (n=80) -2.02  (0.32)
Change from BL (Day 0) to Day 729 visit (n=61) -1.49  (0.36)
Change from BL (Day 0) to Day 813 visit (n=43) -1.92  (0.43)
47.Secondary Outcome
Title Long-term Period: Mean Time-matched Baseline (Day 0) Visual Analog Scale (VAS) and VAS for Post-Baseline Visits Over the Long Term
Hide Description The VAS for Fatigue (VAS-F) consists of a 100 mm line, with 0 (No Fatigue) on 1 end and 100 (Extreme Fatigue) on the other end, which a participant marks to indicate how much fatigue he or she feels. The marked point in mm is converted into a numeric value from 0 to 100, where 0=no fatigue and 100=maximum fatigue. Increasing numbers=increasing fatigue. Time-matched baseline (Day 0) values and post-baseline values were presented for each post-baseline visit, and represent only that cohort of participants with measurements available at that post-baseline visit.
Time Frame BL (Day 0), Days 365, 449, 533, 617, 729, 813
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants analyzed in the LT. N=the total number of participants analyzed, n=the number of participants at that time point with available measurements. Mean time-matched baseline values reflect changing n-values over time
Arm/Group Title Long-term ABA
Hide Arm/Group Description:
Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
Overall Number of Participants Analyzed 216
Mean (Standard Deviation)
Unit of Measure: units on a scale
BL (Day 0) for Day 365 cohort (n=220) 74.05  (16.28)
Day 365 visit (n=220) 40.61  (24.76)
BL (Day 0) for Day 449 cohort (n=121) 73.20  (15.46)
Day 449 visit (n=121) 38.74  (24.18)
BL (Day 0) for Day 533 cohort (n=104) 73.41  (15.51)
Day 533 visit (n=104) 39.27  (23.23)
BL (Day 0) for Day 617 cohort (n=85) 73.59  (14.75)
Day 617 visit (n=85) 42.16  (22.75)
BL (Day 0) for Day 729 cohort (n=61) 73.48  (16.71)
Day 729 visit (n=61) 42.90  (23.09)
BL (Day 0) for Day 813 cohort (n=38) 74.47  (16.68)
Day 813 visit (n=38) 39.61  (22.13)
48.Secondary Outcome
Title Long-term Period: Mean Time-matched Change From Baseline (Day 0) in VAS Over the Long Term
Hide Description The VAS for Fatigue (VAS-F) consists of a 100 mm line, with 0 (No Fatigue) on 1 end and 100 (Extreme Fatigue) on the other end, which a participant marks to indicate how much fatigue he or she feels. The marked point in mm is converted into a numeric value from 0 to 100, where 0=no fatigue and 100=maximum fatigue. Increasing numbers=increasing fatigue. Time-matched mean change from BL = Post-BL value - time-matched BL value, where the time-matched BL value represents the mean BL (Day 0) value for only that cohort of participants with data available at that post-BL visit.
Time Frame BL (Day 0), Days 365, 449, 533, 617, 729, 813
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants analyzed in the LT. N=the total number of participants analyzed, n=the number of participants at that time point with available measurements. Mean time-matched baseline values reflect changing n-values over time
Arm/Group Title Long-term ABA
Hide Arm/Group Description:
Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
Overall Number of Participants Analyzed 216
Mean (Standard Error)
Unit of Measure: units on a scale
Change from BL (Day 0) to Day 365 visit (n=220) -33.4  (1.88)
Change from BL (Day 0) to Day 449 visit (n=121) -34.5  (2.43)
Change from BL (Day 0) to Day 533 visit (n=104) -34.1  (2.82)
Change from BL (Day 0) to Day 617 visit (n=85) -31.4  (2.91)
Change from BL (Day 0) to Day 729 visit (n=61) -30.6  (3.65)
Change from BL (Day 0) to Day 813 visit (n=38) -34.9  (4.03)
49.Secondary Outcome
Title Long-term Period: Mean Time-matched Baseline (Day 0) HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Hide Description HAQ-DI includes 20 questions to assess physical functions in 8 domains:dressing, arising,eating,walking, hygiene, reach, grip and common activities. Domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do. HAQ-DI= sum of worst scores in each domain divided by number of domains answered. HAQ-DI minimum=0 (no difficulty), max overall score=3(unable to do). Time-matched BL(Day 0)values presented for each post-BL visit represent only that cohort of participants with measurements available at that post-BL visit.
Time Frame BL (Day 0)
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants analyzed in the LT. N=the total number of participants analyzed, n=the number of participants at that time point with available measurements. Mean time-matched baseline values reflect changing n-values over time
Arm/Group Title Long-term ABA
Hide Arm/Group Description:
Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
Overall Number of Participants Analyzed 216
Mean (Standard Deviation)
Unit of Measure: units on a scale
Day 365 HAQ-DI (n=215) 1.80  (0.62)
Day 365 HAQ dressing and grooming (n=215) 1.62  (0.86)
Day 365 HAQ arising (n=215) 1.39  (0.76)
Day 365 HAQ eating (n=215) 1.84  (0.92)
Day 365 HAQ walking (n=215) 1.43  (0.78)
Day 365 HAQ hygiene (n=214) 2.08  (0.77)
Day 365 HAQ reaching (n=215) 2.12  (0.80)
Day 365 HAQ gripping (n=216) 1.94  (0.70)
Day 365 HAQ activities (n=216) 2.00  (0.80)
Day 449 HAQ-DI (n=116) 1.89  (0.60)
Day 449 HAQ dressing and grooming (n=116) 1.77  (0.81)
Day 449 HAQ arising (n=116) 1.45  (0.74)
Day 449 HAQ eating (n=116) 2.01  (0.90)
Day 449 HAQ walking (n=116) 1.53  (0.76)
Day 449 HAQ hygiene (n=117) 2.11  (0.77)
Day 449 HAQ reaching (n=117) 2.23  (0.77)
Day 449 HAQ gripping (n=117) 1.97  (0.68)
Day 449 HAQ activities (n=117) 2.05  (0.76)
Day 533 HAQ-DI (n=101) 1.87  (0.62)
Day 533 HAQ dressing and grooming (n=102) 1.78  (0.83)
Day 533 HAQ arising (n=102) 1.41  (0.76)
Day 533 HAQ eating (n=102) 1.96  (0.92)
Day 533 HAQ walking (n=102) 1.56  (0.74)
Day 533 HAQ hygiene (n=101) 2.07  (0.78)
Day 533 HAQ reaching (n=101) 2.22  (0.78)
Day 533 HAQ gripping (n=101) 1.96  (0.68)
Day 533 HAQ activities (n=101) 2.03  (0.79)
Day 617 HAQ-DI (n=83) 1.86  (0.61)
Day 617 HAQ dressing and grooming (n=83) 1.78  (0.81)
Day 617 HAQ arising (n=83) 1.40  (0.75)
Day 617 HAQ eating (n=83) 1.94  (0.90)
Day 617 HAQ walking (n=83) 1.54  (0.72)
Day 617 HAQ hygiene (n=83) 2.02  (0.76)
Day 617 HAQ reaching (n=83) 2.20  (0.78)
Day 617 HAQ gripping (n=83) 1.94  (0.69)
Day 617 HAQ activities (n=83) 2.04  (0.83)
Day 729 HAQ-DI (n=63) 1.86  (0.61)
Day 729 HAQ dressing and grooming (n=63) 1.75  (0.82)
Day 729 HAQ arising (n=63) 1.40  (0.75)
Day 729 HAQ eating (n=63) 1.95  (0.92)
Day 729 HAQ walking (n=63) 1.57  (0.67)
Day 729 HAQ hygiene (n=63) 2.00  (0.78)
Day 729 HAQ reaching (n=63) 2.24  (0.71)
Day 729 HAQ gripping (n=63) 1.90  (0.73)
Day 729 HAQ activities (n=63) 2.03  (0.80)
Day 813 HAQ-DI (n=39) 2.01  (0.62)
Day 813 HAQ dressing and grooming (n=39) 1.92  (0.84)
Day 813 HAQ arising (n=39) 1.59  (0.75)
Day 813 HAQ eating (n=39) 2.18  (0.94)
Day 813 HAQ walking (n=39) 1.69  (0.66)
Day 813 HAQ hygiene (n=39) 2.10  (0.82)
Day 813 HAQ reaching (n=39) 2.41  (0.64)
Day 813 HAQ gripping (n=39) 2.00  (0.79)
Day 813 HAQ activities (n=39) 2.18  (0.79)
50.Secondary Outcome
Title Long-term Period: Mean HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Post-baseline Visits Over the Long Term
Hide Description HAQ-DI includes 20 questions to assess physical functions in 8 domains:dressing, arising, eating, walking, hygiene, reach, grip and common activities. Domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do. HAQ-DI= sum of worst scores in each domain divided by number of domains answered. HAQ-DI minimum=0(no difficulty), max overall score=3(unable to do). Post-BL values presented for each visit represent only that cohort of participants with measurements available at that post-BL visit.
Time Frame Days 365, 449, 533, 617, 729, 813
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants analyzed in the LT. N=the total number of participants analyzed, n=the number of participants at that time point with available measurements. Mean post-baseline values reflect changing n-values over time
Arm/Group Title Long-term ABA
Hide Arm/Group Description:
Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
Overall Number of Participants Analyzed 216
Mean (Standard Deviation)
Unit of Measure: units on a scale
Day 365 HAQ-DI (n=215) 1.34  (0.75)
Day 365 HAQ dressing and grooming (n=215) 1.15  (0.93)
Day 365 HAQ arising (n=215) 0.85  (0.80)
Day 365 HAQ eating (n=215) 1.26  (1.00)
Day 365 HAQ walking (n=215) 1.03  (0.86)
Day 365 HAQ hygiene (n=214) 1.70  (1.06)
Day 365 HAQ reaching (n=215) 1.73  (1.01)
Day 365 HAQ gripping (n=216) 1.45  (0.90)
Day 365 HAQ activities (n=216) 1.52  (1.01)
Day 449 HAQ-DI (n=116) 1.37  (0.75)
Day 449 HAQ dressing and grooming (n=116) 1.17  (0.94)
Day 449 HAQ arising (n=116) 0.84  (0.80)
Day 449 HAQ eating (n=116) 1.35  (1.03)
Day 449 HAQ walking (n=116) 1.02  (0.85)
Day 449 HAQ hygiene (n=117) 1.67  (1.02)
Day 449 HAQ reaching (n=117) 1.79  (0.96)
Day 449 HAQ gripping (n=117) 1.50  (0.91)
Day 449 HAQ activities (n=117) 1.61  (1.01)
Day 533 HAQ-DI (n=101) 1.33  (0.74)
Day 533 HAQ dressing and grooming (n=102) 1.15  (0.95)
Day 533 HAQ arising (n=102) 0.82  (0.80)
Day 533 HAQ eating (n=102) 1.30  (0.97)
Day 533 HAQ walking (n=102) 0.98  (0.87)
Day 533 HAQ hygiene (n=101) 1.57  (1.04)
Day 533 HAQ reaching (n=101) 1.81  (0.94)
Day 533 HAQ gripping (n=101) 1.48  (0.97)
Day 533 HAQ activities (n=101) 1.58  (0.94)
Day 617 HAQ-DI (n=83) 1.27  (0.68)
Day 617 HAQ dressing and grooming (n=83) 0.98  (0.88)
Day 617 HAQ arising (n=83) 0.73  (0.81)
Day 617 HAQ eating (n=83) 1.33  (0.88)
Day 617 HAQ walking (n=83) 0.96  (0.76)
Day 617 HAQ hygiene (n=83) 1.48  (0.95)
Day 617 HAQ reaching (n=83) 1.70  (0.85)
Day 617 HAQ gripping (n=83) 1.43  (0.84)
Day 617 HAQ activities (n=83) 1.57  (0.93)
Day 729 HAQ-DI (n=63) 1.34  (0.74)
Day 729 HAQ dressing and grooming (n=63) 1.03  (0.95)
Day 729 HAQ arising (n=63) 0.81  (0.82)
Day 729 HAQ eating (n=63) 1.33  (0.97)
Day 729 HAQ walking (n=63) 1.11  (0.94)
Day 729 HAQ hygiene (n=63) 1.48  (1.03)
Day 729 HAQ reaching (n=63) 1.73  (0.81)
Day 729 HAQ gripping (n=63) 1.57  (0.91)
Day 729 HAQ activities (n=63) 1.68  (0.96)
Day 813 HAQ-DI (n=39) 1.38  (0.69)
Day 813 HAQ dressing and grooming (n=39) 1.18  (0.97)
Day 813 HAQ arising (n=39) 0.82  (0.79)
Day 813 HAQ eating (n=39) 1.46  (0.94)
Day 813 HAQ walking (n=39) 1.10  (0.79)
Day 813 HAQ hygiene (n=39) 1.59  (0.88)
Day 813 HAQ reaching (n=39) 1.72  (0.76)
Day 813 HAQ gripping (n=39) 1.36  (0.96)
Day 813 HAQ activities (n=39) 1.77  (0.93)
51.Secondary Outcome
Title Long-term Period: Mean Time-matched Change From Baseline (Day 0) in HAQ-DI and HAQ-DI Components For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Hide Description HAQ-DI includes 20 questions assessing physical functions in 8 domains:dressing,arising,eating,walking,hygiene,reach,grip and common activities.Domain questions evaluated on 4-point scale: 0=without any difficulty,1=with some difficulty,2=with much difficulty,and 3=unable to do. HAQ-DI=sum of worst scores in each domain ÷ number of domains answered. HAQ-DI minimum=0 (no difficulty), max overall score=3(unable to do). Time-matched mean change from BL= Post-BL value - time-matched BL value. Time-matched BL value=mean BL (Day 0)value for only that cohort with data available at that post-BL visit.
Time Frame BL (Day 0), Days 365, 449, 533, 617, 729, 813
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants analyzed in the LT. N=the total number of participants analyzed, n=the number of participants at that time point with available measurements. Mean time-matched baseline values reflect changing n-values over time
Arm/Group Title Long-term ABA
Hide Arm/Group Description:
Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
Overall Number of Participants Analyzed 216
Mean (Standard Error)
Unit of Measure: units on a scale
Day 365 HAQ-DI (n=215) -0.46  (0.04)
Day 365 HAQ dressing and grooming (n=215) -0.47  (0.06)
Day 365 HAQ arising (n=215) -0.54  (0.06)
Day 365 HAQ eating (n=215) -0.58  (0.06)
Day 365 HAQ walking (n=215) -0.39  (0.05)
Day 365 HAQ hygiene (n=214) -0.38  (0.06)
Day 365 HAQ reaching (n=215) -0.38  (0.05)
Day 365 HAQ gripping (n=216) -0.49  (0.06)
Day 365 HAQ activities (n=216) -0.47  (0.06)
Day 449 HAQ-DI (n=116) -0.52  (0.05)
Day 449 HAQ dressing and grooming (n=116) -0.59  (0.08)
Day 449 HAQ arising (n=116) -0.60  (0.07)
Day 449 HAQ eating (n=116) -0.66  (0.08)
Day 449 HAQ walking (n=116) -0.52  (0.07)
Day 449 HAQ hygiene (n=117) -0.44  (0.08)
Day 449 HAQ reaching (n=117) -0.44  (0.07)
Day 449 HAQ gripping (n=117) -0.47  (0.08)
Day 449 HAQ activities (n=117) -0.44  (0.08)
Day 533 HAQ-DI (n=101) -0.54  (0.06)
Day 533 HAQ dressing and grooming (n=102) -0.64  (0.10)
Day 533 HAQ arising (n=102) -0.59  (0.08)
Day 533 HAQ eating (n=102) -0.66  (0.10)
Day 533 HAQ walking (n=102) -0.58  (0.07)
Day 533 HAQ hygiene (n=101) -0.50  (0.09)
Day 533 HAQ reaching (n=101) -0.41  (0.09)
Day 533 HAQ gripping (n=101) -0.49  (0.10)
Day 533 HAQ activities (n=101) -0.45  (0.09)
Day 617 HAQ-DI (n=83) -0.59  (0.07)
Day 617 HAQ dressing and grooming (n=83) -0.81  (0.10)
Day 617 HAQ arising (n=83) -0.66  (0.10)
Day 617 HAQ eating (n=83) -0.61  (0.11)
Day 617 HAQ walking (n=83) -0.58  (0.09)
Day 617 HAQ hygiene (n=83) -0.54  (0.10)
Day 617 HAQ reaching (n=83) -0.51  (0.09)
Day 617 HAQ gripping (n=83) -0.51  (0.10)
Day 617 HAQ activities (n=83) -0.47  (0.10)
Day 729 HAQ-DI (n=63) -0.51  (0.09)
Day 729 HAQ dressing and grooming (n=63) -0.71  (0.13)
Day 729 HAQ arising (n=63) -0.59  (0.12)
Day 729 HAQ eating (n=63) -0.62  (0.13)
Day 729 HAQ walking (n=63) -0.46  (0.11)
Day 729 HAQ hygiene (n=63) -0.52  (0.13)
Day 729 HAQ reaching (n=63) -0.51  (0.10)
Day 729 HAQ gripping (n=63) -0.33  (0.10)
Day 729 HAQ activities (n=63) -0.35  (0.11)
Day 813 HAQ-DI (n=39) -0.63  (0.11)
Day 813 HAQ dressing and grooming (n=39) -0.74  (0.18)
Day 813 HAQ arising (n=39) -0.77  (0.16)
Day 813 HAQ eating (n=39) -0.72  (0.18)
Day 813 HAQ walking (n=39) -0.59  (0.12)
Day 813 HAQ hygiene (n=39) -0.51  (0.17)
Day 813 HAQ reaching (n=39) -0.69  (0.13)
Day 813 HAQ gripping (n=39) -0.64  (0.14)
Day 813 HAQ activities (n=39) -0.41  (0.13)
52.Secondary Outcome
Title Long-term Period: Number of Participants Achieving Clinically Meaningful HAQ Response Over Time
Hide Description HAQ-DI includes 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1= with some difficulty, 2= with much difficulty, and 3= unable to do. HAQ-DI= sum of worst scores in each domain divided by the number of domains answered. HAQ-DI ranges from a minimum of 0 (no difficulty) to a maximum overall score of 3(unable to do). Clinically meaningful HAQ response=an improvement of at least 0.3 units from baseline in HAQ disability Index.
Time Frame BL, Days 365, 449, 533, 617, 729, 813
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants. N=the total number of participants analyzed, n=the number of participants at that time point with available measurements.
Arm/Group Title Long-term ABA
Hide Arm/Group Description:
Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
Overall Number of Participants Analyzed 215
Measure Type: Number
Unit of Measure: participants
Day 365 (n=215) 124
Day 449 (n=116) 69
Day 533 (n=101) 62
Day 617 (n=83) 53
Day 729 (n=63) 38
Day 813 (n=39) 26
53.Secondary Outcome
Title Long-term Period: Mean Time-matched Baseline (Day 0) SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Hide Description SF-36 has 36 questions with 8 subscale scores and 2 summary scores (1) physical component summary=physical functioning, role-physical, bodily pain, and general health;(2) mental component summary=vitality,social functioning,role-emotional, and mental health. There is no total overall score; scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score and 100=best score. Time-matched BL (Day 0) values presented for each post-BL visit represent only that cohort of participants with measurements available at that post-BL visit
Time Frame BL (Day 0)
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants analyzed in the LT. N=the total number of participants analyzed, n=the number of participants at that time point with available measurements. Mean time-matched baseline values reflect changing n-values over time
Arm/Group Title Open-label Abatacept (ABA)-Previous User
Hide Arm/Group Description:
In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
Overall Number of Participants Analyzed 306
Mean (Standard Deviation)
Unit of Measure: units on a scale
Day 365 PCS (n=297) 28.96  (7.22)
Day 365 MCS (n=297) 41.09  (12.90)
Day 365 Physical Function Scale Component (n=306) 28.04  (9.88)
Day 365 Role-Physical Scale Component (n=300) 31.17  (7.16)
Day 365 Bodily Pain Scale Component (n=305) 31.07  (7.39)
Day 365 General Health Scale Component (n=308) 35.04  (9.59)
Day 365 Vitality Scale Component (n=308) 35.96  (9.11)
Day 365 Social Functioning Scale Component (n=308) 34.31  (11.53)
Day 365 Role-Emotional Scale Component (n=300) 35.80  (13.80)
Day 365 Mental Health Scale Component (n=308) 39.89  (12.86)
Day 729 PCS (n=83) 29.76  (6.50)
Day 729 MCS (n=83) 36.06  (13.36)
Day 729 Physical Function Scale Component (n=89) 26.66  (9.46)
Day 729 Role-Physical Scale Component (n=85) 30.87  (6.75)
Day 729 Bodily Pain Scale Component (n=86) 29.35  (7.09)
Day 729 General Health Scale Component (n=90) 33.23  (9.30)
Day 729 Vitality Scale Component (n=90) 36.77  (9.38)
Day 729 Social Functioning Scale Component (n=90) 32.59  (12.27)
Day 729 Role-Emotional Scale Component (n=85) 30.30  (11.61)
Day 729 Mental Health Scale Component (n=89) 33.67  (13.17)
54.Secondary Outcome
Title Long-term Period: Mean SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participant Cohorts at Each Post-baseline Visits Over the Long Term
Hide Description SF-36 measures health-related quality of life and has 36 questions with 8 subscale scores and 2 summary scores (1)physical component summary=physical functioning,role-physical,bodily pain,and general health; (2)mental component summary=vitality,social functioning,role-emotional,and mental health. There is no total overall score; scoring is done for both subscores and summary scores. For subscores and summary scores, 0=worst score and 100=best score. Post-BL values presented for each post-BL visit represent only that cohort of participants with measurements available at that post-BL visit.
Time Frame Days 365 and 729
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants analyzed in the LT. N=the total number of participants analyzed, n=the number of participants at that time point with available measurements. Mean post-baseline values reflect changing n-values over time
Arm/Group Title Open-label Abatacept (ABA)-Previous User
Hide Arm/Group Description:
In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
Overall Number of Participants Analyzed 306
Mean (Standard Deviation)
Unit of Measure: units on a scale
Day 365 PCS (n=297) 35.00  (10.09)
Day 365 MCS (n=297) 47.15  (12.80)
Day 365 Physical Function Scale Component (n=306) 33.33  (11.45)
Day 365 Role-Physical Scale Component (n=300) 37.85  (11.68)
Day 365 Bodily Pain Scale Component (n=305) 39.78  (9.87)
Day 365 General Health Scale Component (n=308) 38.58  (10.20)
Day 365 Vitality Scale Component (n=308) 42.82  (11.27)
Day 365 Social Functioning Scale Component (n=308) 41.24  (11.81)
Day 365 Role-Emotional Scale Component (n=300) 42.63  (14.32)
Day 365 Mental Health Scale Component (n=308) 45.00  (12.82)
Day 729 PCS (n=83) 36.92  (9.30)
Day 729 MCS (n=83) 42.06  (12.46)
Day 729 Physical Function Scale Component (n=89) 33.91  (11.15)
Day 729 Role-Physical Scale Component (n=85) 37.61  (11.59)
Day 729 Bodily Pain Scale Component (n=86) 38.89  (10.26)
Day 729 General Health Scale Component (n=90) 36.99  (9.79)
Day 729 Vitality Scale Component (n=90) 42.94  (10.45)
Day 729 Social Functioning Scale Component (n=90) 39.28  (11.66)
Day 729 Role-Emotional Scale Component (n=85) 37.37  (14.61)
Day 729 Mental Health Scale Component (n=89) 40.02  (11.80)
55.Secondary Outcome
Title Long-term Period: Mean Time-matched Change From Baseline (Day 0) in SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term
Hide Description SF-36 has 36 questions with 8 subscale scores and 2 summary scores (1)physical component summary=physical functioning,role-physical,bodily pain,and general health; (2)mental component summary=vitality,social functioning,role-emotional,and mental health. There is no total overall score; scoring is done for both subscores and summary scores. For subscores and summary scores, 0=worst score and 100=best score. Time-matched mean change from BL= Post-BL value - time-matched BL value. Time-matched BL value=mean BL (Day 0)value for only that cohort with data available at that post-baseline visit.
Time Frame BL (Day 0), Days 365, 729
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants analyzed in the LT. N=the total number of participants analyzed, n=the number of participants at that time point with available measurements. Mean time-matched baseline values reflect changing n-values over time
Arm/Group Title Open-label Abatacept (ABA)-Previous User
Hide Arm/Group Description:
In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
Overall Number of Participants Analyzed 306
Mean (Standard Error)
Unit of Measure: units on a scale
Day 365 PCS (n=297) 6.04  (0.55)
Day 365 MCS (n=297) 6.06  (0.63)
Day 365 Physical Function Scale Component (n=306) 5.29  (0.64)
Day 365 Role-Physical Scale Component (n=300) 6.69  (0.68)
Day 365 Bodily Pain Scale Component (n=305) 8.70  (0.56)
Day 365 General Health Scale Component (n=308) 3.54  (0.46)
Day 365 Vitality Scale Component (n=308) 6.86  (0.61)
Day 365 Social Functioning Scale Component (n=308) 6.93  (0.67)
Day 365 Role-Emotional Scale Component (n=300) 6.83  (0.84)
Day 365 Mental Health Scale Component (n=308) 5.11  (0.55)
Day 729 PCS (n=83) 7.17  (1.07)
Day 729 MCS (n=83) 5.99  (1.27)
Day 729 Physical Function Scale Component (n=89) 7.25  (1.31)
Day 729 Role-Physical Scale Component (n=85) 6.74  (1.25)
Day 729 Bodily Pain Scale Component (n=86) 9.54  (1.12)
Day 729 General Health Scale Component (n=90) 3.76  (0.99)
Day 729 Vitality Scale Component (n=90) 6.16  (1.09)
Day 729 Social Functioning Scale Component (n=90) 6.69  (1.47)
Day 729 Role-Emotional Scale Component (n=85) 7.06  (1.50)
Day 729 Mental Health Scale Component (n=89) 6.35  (1.16)
56.Secondary Outcome
Title LT; Number of Participants With Positive Anti-Abatacept or Anti-Cytotoxic T-Lymphocyte Antigen 4 (CTLA4) Responses by ELISA
Hide Description Serum samples from all treated adult participants with active rheumatoid arthritis (RA) were screened for the presence of drug-specific antibodies using ELISA. Immunogenicity was defined as the presence of a positive anti-abatacept or anti-CTLA4 antibody.
Time Frame Days 1-813
Hide Outcome Measure Data
Hide Analysis Population Description
Treated participants with available serum samples for assay
Arm/Group Title Long-term ABA
Hide Arm/Group Description:
Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
Overall Number of Participants Analyzed 25
Measure Type: Number
Unit of Measure: participants
Anti-abatacept antibodies 0
Anti-CTLA4 antibodies 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Abatacept (LT) Abatacept (ST)
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
Abatacept (LT) Abatacept (ST)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Abatacept (LT) Abatacept (ST)
Affected / at Risk (%) Affected / at Risk (%)
Total   61/530 (11.51%)   110/1046 (10.52%) 
Blood and lymphatic system disorders     
ANAEMIA  1  1/530 (0.19%)  2/1046 (0.19%) 
COAGULOPATHY  1  0/530 (0.00%)  1/1046 (0.10%) 
MICROCYTIC ANAEMIA  1  1/530 (0.19%)  0/1046 (0.00%) 
Cardiac disorders     
ARRHYTHMIA  1  0/530 (0.00%)  1/1046 (0.10%) 
CARDIOMEGALY  1  0/530 (0.00%)  1/1046 (0.10%) 
CARDIAC ARREST  1  0/530 (0.00%)  1/1046 (0.10%) 
ANGINA UNSTABLE  1  0/530 (0.00%)  1/1046 (0.10%) 
SINOATRIAL BLOCK  1  1/530 (0.19%)  0/1046 (0.00%) 
ATRIAL FIBRILLATION  1  0/530 (0.00%)  2/1046 (0.19%) 
MYOCARDIAL INFARCTION  1  1/530 (0.19%)  3/1046 (0.29%) 
ACUTE CORONARY SYNDROME  1  1/530 (0.19%)  0/1046 (0.00%) 
CORONARY ARTERY DISEASE  1  0/530 (0.00%)  1/1046 (0.10%) 
CORONARY ARTERY STENOSIS  1  1/530 (0.19%)  0/1046 (0.00%) 
AORTIC VALVE INCOMPETENCE  1  0/530 (0.00%)  1/1046 (0.10%) 
CORONARY ARTERY OCCLUSION  1  0/530 (0.00%)  1/1046 (0.10%) 
CARDIAC FAILURE CONGESTIVE  1  0/530 (0.00%)  1/1046 (0.10%) 
ACUTE MYOCARDIAL INFARCTION  1  1/530 (0.19%)  0/1046 (0.00%) 
Ear and labyrinth disorders     
DEAFNESS  1  0/530 (0.00%)  1/1046 (0.10%) 
Gastrointestinal disorders     
NAUSEA  1  0/530 (0.00%)  2/1046 (0.19%) 
COLITIS  1  0/530 (0.00%)  1/1046 (0.10%) 
MELAENA  1  1/530 (0.19%)  0/1046 (0.00%) 
RETCHING  1  0/530 (0.00%)  1/1046 (0.10%) 
VOMITING  1  1/530 (0.19%)  2/1046 (0.19%) 
DIARRHOEA  1  1/530 (0.19%)  0/1046 (0.00%) 
GASTRITIS  1  1/530 (0.19%)  1/1046 (0.10%) 
STOMATITIS  1  1/530 (0.19%)  0/1046 (0.00%) 
PANCREATITIS  1  1/530 (0.19%)  0/1046 (0.00%) 
GASTRIC ULCER  1  0/530 (0.00%)  1/1046 (0.10%) 
ABDOMINAL PAIN  1  1/530 (0.19%)  1/1046 (0.10%) 
MOUTH ULCERATION  1  0/530 (0.00%)  1/1046 (0.10%) 
UMBILICAL HERNIA  1  1/530 (0.19%)  0/1046 (0.00%) 
COLITIS ISCHAEMIC  1  0/530 (0.00%)  2/1046 (0.19%) 
RECTAL HAEMORRHAGE  1  0/530 (0.00%)  1/1046 (0.10%) 
ABDOMINAL PAIN UPPER  1  0/530 (0.00%)  1/1046 (0.10%) 
PROCTITIS ULCERATIVE  1  1/530 (0.19%)  0/1046 (0.00%) 
OESOPHAGEAL OBSTRUCTION  1  0/530 (0.00%)  1/1046 (0.10%) 
GASTROINTESTINAL HAEMORRHAGE  1  0/530 (0.00%)  1/1046 (0.10%) 
General disorders     
ULCER  1  1/530 (0.19%)  0/1046 (0.00%) 
PYREXIA  1  1/530 (0.19%)  0/1046 (0.00%) 
ASTHENIA  1  1/530 (0.19%)  0/1046 (0.00%) 
CHEST PAIN  1  3/530 (0.57%)  4/1046 (0.38%) 
CHEST DISCOMFORT  1  0/530 (0.00%)  2/1046 (0.19%) 
IMPAIRED HEALING  1  0/530 (0.00%)  1/1046 (0.10%) 
Hepatobiliary disorders     
CHOLANGITIS  1  0/530 (0.00%)  1/1046 (0.10%) 
CHOLELITHIASIS  1  0/530 (0.00%)  1/1046 (0.10%) 
HEPATOTOXICITY  1  0/530 (0.00%)  1/1046 (0.10%) 
CHOLECYSTITIS ACUTE  1  0/530 (0.00%)  1/1046 (0.10%) 
CHOLECYSTITIS CHRONIC  1  0/530 (0.00%)  1/1046 (0.10%) 
GALLBLADDER ENLARGEMENT  1  0/530 (0.00%)  1/1046 (0.10%) 
Immune system disorders     
ANAPHYLACTIC REACTION  1  0/530 (0.00%)  1/1046 (0.10%) 
Infections and infestations     
PNEUMONIA  1  2/530 (0.38%)  4/1046 (0.38%) 
UROSEPSIS  1  0/530 (0.00%)  1/1046 (0.10%) 
BRONCHITIS  1  0/530 (0.00%)  3/1046 (0.29%) 
BACTERAEMIA  1  1/530 (0.19%)  0/1046 (0.00%) 
PHARYNGITIS  1  1/530 (0.19%)  0/1046 (0.00%) 
APPENDICITIS  1  1/530 (0.19%)  0/1046 (0.00%) 
SEPTIC SHOCK  1  0/530 (0.00%)  1/1046 (0.10%) 
HERPES ZOSTER  1  1/530 (0.19%)  0/1046 (0.00%) 
DIVERTICULITIS  1  0/530 (0.00%)  1/1046 (0.10%) 
PYELONEPHRITIS  1  1/530 (0.19%)  1/1046 (0.10%) 
ACUTE SINUSITIS  1  0/530 (0.00%)  1/1046 (0.10%) 
GASTROENTERITIS  1  3/530 (0.57%)  1/1046 (0.10%) 
LOBAR PNEUMONIA  1  0/530 (0.00%)  2/1046 (0.19%) 
TOOTH INFECTION  1  0/530 (0.00%)  1/1046 (0.10%) 
VIRAL INFECTION  1  1/530 (0.19%)  0/1046 (0.00%) 
TRACHEOBRONCHITIS  1  0/530 (0.00%)  1/1046 (0.10%) 
ABSCESS INTESTINAL  1  0/530 (0.00%)  1/1046 (0.10%) 
ESCHERICHIA SEPSIS  1  0/530 (0.00%)  1/1046 (0.10%) 
ARTHRITIS BACTERIAL  1  0/530 (0.00%)  1/1046 (0.10%) 
ARTHRITIS INFECTIVE  1  0/530 (0.00%)  1/1046 (0.10%) 
HAEMOPHILUS INFECTION  1  0/530 (0.00%)  1/1046 (0.10%) 
PNEUMONIA PNEUMOCOCCAL  1  0/530 (0.00%)  1/1046 (0.10%) 
URINARY TRACT INFECTION  1  1/530 (0.19%)  1/1046 (0.10%) 
STAPHYLOCOCCAL INFECTION  1  1/530 (0.19%)  0/1046 (0.00%) 
GASTROENTERITIS NOROVIRUS  1  0/530 (0.00%)  1/1046 (0.10%) 
GASTROENTERITIS SALMONELLA  1  0/530 (0.00%)  1/1046 (0.10%) 
POSTOPERATIVE WOUND INFECTION  1  0/530 (0.00%)  1/1046 (0.10%) 
UPPER RESPIRATORY TRACT INFECTION  1  1/530 (0.19%)  1/1046 (0.10%) 
Injury, poisoning and procedural complications     
FALL  1  1/530 (0.19%)  0/1046 (0.00%) 
WOUND  1  1/530 (0.19%)  0/1046 (0.00%) 
OVERDOSE  1  0/530 (0.00%)  1/1046 (0.10%) 
ANKLE FRACTURE  1  0/530 (0.00%)  1/1046 (0.10%) 
FEMUR FRACTURE  1  0/530 (0.00%)  1/1046 (0.10%) 
FIBULA FRACTURE  1  1/530 (0.19%)  0/1046 (0.00%) 
RADIUS FRACTURE  1  1/530 (0.19%)  0/1046 (0.00%) 
UPPER LIMB FRACTURE  1  1/530 (0.19%)  0/1046 (0.00%) 
FEMORAL NECK FRACTURE  1  0/530 (0.00%)  1/1046 (0.10%) 
ROAD TRAFFIC ACCIDENT  1  1/530 (0.19%)  0/1046 (0.00%) 
MEDICAL DEVICE COMPLICATION  1  1/530 (0.19%)  1/1046 (0.10%) 
Investigations     
MEDICAL OBSERVATION  1  0/530 (0.00%)  2/1046 (0.19%) 
BLOOD SODIUM DECREASED  1  1/530 (0.19%)  0/1046 (0.00%) 
WHITE BLOOD CELL COUNT DECREASED  1  0/530 (0.00%)  1/1046 (0.10%) 
Metabolism and nutrition disorders     
OBESITY  1  1/530 (0.19%)  0/1046 (0.00%) 
DEHYDRATION  1  1/530 (0.19%)  0/1046 (0.00%) 
HYPOKALAEMIA  1  0/530 (0.00%)  2/1046 (0.19%) 
DIABETIC KETOACIDOSIS  1  0/530 (0.00%)  1/1046 (0.10%) 
Musculoskeletal and connective tissue disorders     
BURSITIS  1  1/530 (0.19%)  0/1046 (0.00%) 
ARTHRITIS  1  0/530 (0.00%)  2/1046 (0.19%) 
BACK PAIN  1  1/530 (0.19%)  2/1046 (0.19%) 
ARTHRALGIA  1  2/530 (0.38%)  2/1046 (0.19%) 
METATARSALGIA  1  1/530 (0.19%)  0/1046 (0.00%) 
OSTEONECROSIS  1  1/530 (0.19%)  0/1046 (0.00%) 
OSTEOARTHRITIS  1  5/530 (0.94%)  5/1046 (0.48%) 
COSTOCHONDRITIS  1  0/530 (0.00%)  1/1046 (0.10%) 
TENDON DISORDER  1  1/530 (0.19%)  0/1046 (0.00%) 
MUSCULOSKELETAL PAIN  1  0/530 (0.00%)  1/1046 (0.10%) 
RHEUMATOID ARTHRITIS  1  15/530 (2.83%)  17/1046 (1.63%) 
ROTATOR CUFF SYNDROME  1  0/530 (0.00%)  1/1046 (0.10%) 
SPINAL OSTEOARTHRITIS  1  0/530 (0.00%)  1/1046 (0.10%) 
SPINAL COLUMN STENOSIS  1  1/530 (0.19%)  1/1046 (0.10%) 
INTERVERTEBRAL DISC PROTRUSION  1  1/530 (0.19%)  3/1046 (0.29%) 
INTERVERTEBRAL DISC DEGENERATION  1  0/530 (0.00%)  1/1046 (0.10%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
LYMPHOMA  1  1/530 (0.19%)  0/1046 (0.00%) 
HAEMANGIOMA  1  0/530 (0.00%)  1/1046 (0.10%) 
BREAST CANCER  1  0/530 (0.00%)  2/1046 (0.19%) 
UTERINE CANCER  1  0/530 (0.00%)  1/1046 (0.10%) 
LUNG ADENOCARCINOMA  1  0/530 (0.00%)  1/1046 (0.10%) 
BASAL CELL CARCINOMA  1  1/530 (0.19%)  3/1046 (0.29%) 
BLADDER CANCER RECURRENT  1  1/530 (0.19%)  0/1046 (0.00%) 
Nervous system disorders     
SYNCOPE  1  0/530 (0.00%)  1/1046 (0.10%) 
HEADACHE  1  0/530 (0.00%)  1/1046 (0.10%) 
MIGRAINE  1  0/530 (0.00%)  1/1046 (0.10%) 
SCIATICA  1  1/530 (0.19%)  0/1046 (0.00%) 
DIZZINESS  1  0/530 (0.00%)  1/1046 (0.10%) 
CERVICAL ROOT PAIN  1  1/530 (0.19%)  0/1046 (0.00%) 
LUMBAR RADICULOPATHY  1  0/530 (0.00%)  1/1046 (0.10%) 
CEREBELLAR INFARCTION  1  0/530 (0.00%)  1/1046 (0.10%) 
CARPAL TUNNEL SYNDROME  1  0/530 (0.00%)  2/1046 (0.