Trial Outcomes & Findings for Phase III Study of BMS-188667 (CTLA4Ig) in Patients With Rheumatoid Arthritis Who Are Currently Failing Anti-TNF Therapy or Who Have Failed Anti-TNF Therapy in the Past. (NCT NCT00048581)

Last Updated: 2011-11-21

Results Overview

ACR 20 response requires a participant to have a 20% reduction in the number of swollen and tender joints, and a reduction of 20% in three of the following five parameters: physician global assessment of disease, participant global assessment of disease, participant assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in Health Assessment Questionnaire (HAQ) score. A participant achieved a sustained ACR 20 response if the participant had ACR 20 observed for at least 2 consecutive study visits.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

738 participants

Primary outcome timeframe

Day 169

Results posted on

2011-11-21

Participant Flow

738 participants were enrolled and 393 participants were randomized. Two participants were randomized in error and were not treated.

Participant milestones

Participant milestones
Measure	Abatacept (ABA) Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing \< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Placebo (PLA) Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.	Open-label ABA All participants who completed the double-blind period were eligible to continue in the open-label period. At the beginning of the open-label period (Day 169), all eligible participants were re-allocated to a 10 mg/kg weight-tiered dose of abatacept at their enrollment visit into the open-label period, based on their entry weight into the study. Participant dose was adjusted based on annual anniversary weight. Participants weighing \> 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing \< 60 kg received 500 mg on a background of DMARDs (at discretion of the investigator). Concomitant biologic RA therapies were later excluded.
Double-Blind Period STARTED	258	133	0
Double-Blind Period COMPLETED	223	99	0
Double-Blind Period NOT COMPLETED	35	34	0
Open-Label Period STARTED	0	0	317
Open-Label Period COMPLETED	0	0	150
Open-Label Period NOT COMPLETED	0	0	167

Reasons for withdrawal

Reasons for withdrawal
Measure	Abatacept (ABA) Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing \< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Placebo (PLA) Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.	Open-label ABA All participants who completed the double-blind period were eligible to continue in the open-label period. At the beginning of the open-label period (Day 169), all eligible participants were re-allocated to a 10 mg/kg weight-tiered dose of abatacept at their enrollment visit into the open-label period, based on their entry weight into the study. Participant dose was adjusted based on annual anniversary weight. Participants weighing \> 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing \< 60 kg received 500 mg on a background of DMARDs (at discretion of the investigator). Concomitant biologic RA therapies were later excluded.
Double-Blind Period Adverse Event	9	5	0
Double-Blind Period Lack of Efficacy	14	27	0
Double-Blind Period Lost to Follow-up	5	0	0
Double-Blind Period Withdrawal by Subject	5	2	0
Double-Blind Period Participant Has History of Lymphopenia	1	0	0
Double-Blind Period Investigator Decision	1	0	0
Open-Label Period Death	0	0	4
Open-Label Period Adverse Event	0	0	37
Open-Label Period Lack of Efficacy	0	0	69
Open-Label Period Lost to Follow-up	0	0	14
Open-Label Period Withdrawal by Subject	0	0	20
Open-Label Period No Longer Meets Study Criteria	0	0	2
Open-Label Period Poor/Non-compliance	0	0	5
Open-Label Period Pregnancy	0	0	7
Open-Label Period Study Site Closure	0	0	2
Open-Label Period Continue ABA With Primary Rheumatologist	0	0	3
Open-Label Period Problem With Transportation To Site	0	0	1
Open-Label Period Primary Investigator Retired	0	0	2
Open-Label Period Study Ended By Sponsor	0	0	1

Baseline Characteristics

Phase III Study of BMS-188667 (CTLA4Ig) in Patients With Rheumatoid Arthritis Who Are Currently Failing Anti-TNF Therapy or Who Have Failed Anti-TNF Therapy in the Past.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Abatacept (ABA) n=258 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing \< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Placebo (PLA) n=133 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.	Total n=391 Participants Total of all reporting groups
Age Continuous	53.4 years STANDARD_DEVIATION 12.4 • n=5 Participants	52.7 years STANDARD_DEVIATION 11.3 • n=7 Participants	53.2 years STANDARD_DEVIATION 12.1 • n=5 Participants
Sex: Female, Male Female	199 Participants n=5 Participants	106 Participants n=7 Participants	305 Participants n=5 Participants
Sex: Female, Male Male	59 Participants n=5 Participants	27 Participants n=7 Participants	86 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	9 Participants n=5 Participants	5 Participants n=7 Participants	14 Participants n=5 Participants
Race (NIH/OMB) White	248 Participants n=5 Participants	124 Participants n=7 Participants	372 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment North America	189 participants n=5 Participants	99 participants n=7 Participants	288 participants n=5 Participants
Region of Enrollment Europe	69 participants n=5 Participants	34 participants n=7 Participants	103 participants n=5 Participants
Weight	78.2 kg STANDARD_DEVIATION 19.0 • n=5 Participants	78.2 kg STANDARD_DEVIATION 21.0 • n=7 Participants	78.2 kg STANDARD_DEVIATION 19.7 • n=5 Participants

PRIMARY outcome

Timeframe: Day 169

Population: Analysis was carried out on the intent-to-treat (ITT) population defined as all randomized participants who received at least one dose of study medication. Two participants were unevaluable for response due to each missing 2 infusions of study drug.

Outcome measures

Outcome measures
Measure	Abatacept (ABA) n=256 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing \< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Placebo (PLA) n=133 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
Double-blind Period (DB); Number of Participants With American College of Rheumatology (ACR) 20 Response at Day 169	129 participants	26 participants

PRIMARY outcome

Timeframe: Day 169

Population: Analysis was carried out on the intent-to-treat (ITT) population defined as all randomized subjects who received at least one dose of study medication. Two participants were unevaluable for response due to each missing 2 infusions of study drug.

The disability section of the full HAQ includes 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. The questions are evaluated on a 4-point scale: 0=without any difficulty, 1= with some difficulty, 2= with much difficulty, and 3= unable to do. Higher scores= greater dysfunction. A disability index was calculated by summing the worst scores in each domain and dividing by the number of domains answered. Clinically meaningful HAQ response=an improvement of at least 0.3 units from baseline in HAQ disability Index.

Outcome measures

Outcome measures
Measure	Abatacept (ABA) n=256 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing \< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Placebo (PLA) n=133 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
DB; Number of Participants Achieving Clinically Meaningful Improvement in Health Assessment Questionnaire (HAQ)	121 participants	31 participants

PRIMARY outcome

Timeframe: From first day of OL to 5.5 years

Population: All treated participants

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

Outcome measures

Outcome measures
Measure	Abatacept (ABA) n=317 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing \< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Placebo (PLA) Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
Open-Label Period (OL); Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuation, AEs, Related AEs, or AEs Leading to Discontinuation Deaths	6 participants	—
Open-Label Period (OL); Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuation, AEs, Related AEs, or AEs Leading to Discontinuation SAEs	136 participants	—
Open-Label Period (OL); Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuation, AEs, Related AEs, or AEs Leading to Discontinuation Related SAEs	24 participants	—
Open-Label Period (OL); Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuation, AEs, Related AEs, or AEs Leading to Discontinuation SAEs Leading to Discontinuation	20 participants	—
Open-Label Period (OL); Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuation, AEs, Related AEs, or AEs Leading to Discontinuation AEs	302 participants	—
Open-Label Period (OL); Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuation, AEs, Related AEs, or AEs Leading to Discontinuation Related AEs	192 participants	—
Open-Label Period (OL); Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuation, AEs, Related AEs, or AEs Leading to Discontinuation AEs Leading to Discontinuation	34 participants	—

PRIMARY outcome

Timeframe: From first day of OL to 5.5 years

Population: All treated participants

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).

Outcome measures

Outcome measures
Measure	Abatacept (ABA) n=317 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing \< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Placebo (PLA) Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
OL; Number of Participants AEs of Special Interest Infections	254 participants	—
OL; Number of Participants AEs of Special Interest Neoplasms (benign, malignant, and unspecified)	42 participants	—
OL; Number of Participants AEs of Special Interest Malignancies	21 participants	—
OL; Number of Participants AEs of Special Interest Pre-specified autoimmune disorders	17 participants	—
OL; Number of Participants AEs of Special Interest Acute infusional AEs	65 participants	—
OL; Number of Participants AEs of Special Interest Peri-infusional AEs	22 participants	—

PRIMARY outcome

Timeframe: From first day of OL to 5.5 years

Population: All treated participants

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.

Outcome measures

Outcome measures
Measure	Abatacept (ABA) n=315 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing \< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Placebo (PLA) Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
OL; Number of Participants With Hematology Laboratories Meeting Marked Abnormality Criteria Low HGB (LLN=11.5 g/dL)	12 participants	—
OL; Number of Participants With Hematology Laboratories Meeting Marked Abnormality Criteria Low hematocrit (LLN=34%)	18 participants	—
OL; Number of Participants With Hematology Laboratories Meeting Marked Abnormality Criteria Low erythrocytes (LLN=3.8 x10*6 cells/μL)	9 participants	—
OL; Number of Participants With Hematology Laboratories Meeting Marked Abnormality Criteria Low PLT (LLN=140*10^9 cells/L)	8 participants	—
OL; Number of Participants With Hematology Laboratories Meeting Marked Abnormality Criteria High PLT (ULN=450*10^9 cells/L)	1 participants	—
OL; Number of Participants With Hematology Laboratories Meeting Marked Abnormality Criteria Low leukocytes (LLN=3.8*10^3 cells/μL)	6 participants	—
OL; Number of Participants With Hematology Laboratories Meeting Marked Abnormality Criteria High leukocytes (ULN=10.6*10^3 c/μL)	49 participants	—
OL; Number of Participants With Hematology Laboratories Meeting Marked Abnormality Criteria Low neutrophils + bands (LLN=1.8*10^3 c/μL))	2 participants	—
OL; Number of Participants With Hematology Laboratories Meeting Marked Abnormality Criteria Low lymphocytes (LLN=0.7*10^3 cells/μL)	61 participants	—
OL; Number of Participants With Hematology Laboratories Meeting Marked Abnormality Criteria High lymphocytes (ULN=4.5*10^3 cells/μL)	0 participants	—
OL; Number of Participants With Hematology Laboratories Meeting Marked Abnormality Criteria High monocytes (ULN=1*10^3 cells/μL)	2 participants	—
OL; Number of Participants With Hematology Laboratories Meeting Marked Abnormality Criteria High basophils (ULN=0.2*10^3 cells/μL)	0 participants	—
OL; Number of Participants With Hematology Laboratories Meeting Marked Abnormality Criteria High eosinophils (ULN=7*10^3 cells/μL)	31 participants	—

PRIMARY outcome

Timeframe: From first day of OL to 5.5 years

Population: All treated participants

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

Outcome measures

Outcome measures
Measure	Abatacept (ABA) n=315 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing \< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Placebo (PLA) Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
OL; Number of Participants With Blood Chemistry Laboratories Meeting Marked Abnormality Criteria High ALP (ULN=400 U/L)	3 participants	—
OL; Number of Participants With Blood Chemistry Laboratories Meeting Marked Abnormality Criteria High AST (ULN=44 U/L)	12 participants	—
OL; Number of Participants With Blood Chemistry Laboratories Meeting Marked Abnormality Criteria High ALT (ULN=55 U/L)	12 participants	—
OL; Number of Participants With Blood Chemistry Laboratories Meeting Marked Abnormality Criteria High GGT (ULN=65 U/L)	30 participants	—
OL; Number of Participants With Blood Chemistry Laboratories Meeting Marked Abnormality Criteria High bilirubin (ULN=1.2 mg/dL)	2 participants	—
OL; Number of Participants With Blood Chemistry Laboratories Meeting Marked Abnormality Criteria High BUN (ULN=26 mg/dL)	20 participants	—
OL; Number of Participants With Blood Chemistry Laboratories Meeting Marked Abnormality Criteria High creatinine (ULN=1.5 mg/dL)	77 participants	—

PRIMARY outcome

Timeframe: Baseline and Days 169, 365, 729, and 1093

Population: All treated participants with available serum samples. N=the total number of participants analyzed, n=the number of participants at that time point with available serum samples. Mean time-matched baseline values reflect changing n-values over time.

Serum samples collected from participants were used to determine serum levels of IgA, IgM, and IgG. Time-matched baseline values were presented by visit and represented the mean baseline value for only that cohort of participants with serum samples available at that visit.

Outcome measures

Outcome measures
Measure	Abatacept (ABA) n=201 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing \< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Placebo (PLA) n=96 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
OL; Mean Time-matched Baseline Immunoglobulin (Ig) Levels Over the OL Day 169 cohort (n=201, n=96): IgA	327.9 mg/dL Standard Deviation 170.8	326.9 mg/dL Standard Deviation 203.3
OL; Mean Time-matched Baseline Immunoglobulin (Ig) Levels Over the OL Day 169 cohort (n=201, n=96): IgG	1346.0 mg/dL Standard Deviation 473.0	1364.0 mg/dL Standard Deviation 532.2
OL; Mean Time-matched Baseline Immunoglobulin (Ig) Levels Over the OL Day 169 cohort (n=201, n=96): IgM	180.1 mg/dL Standard Deviation 128.3	160.1 mg/dL Standard Deviation 86.91
OL; Mean Time-matched Baseline Immunoglobulin (Ig) Levels Over the OL Day 365 cohort (n=182, n=84): IgA	337.6 mg/dL Standard Deviation 173.0	318.6 mg/dL Standard Deviation 204.4
OL; Mean Time-matched Baseline Immunoglobulin (Ig) Levels Over the OL Day 365 cohort (n=182, n=84): IgG	1320.0 mg/dL Standard Deviation 421.2	1341.0 mg/dL Standard Deviation 525.9
OL; Mean Time-matched Baseline Immunoglobulin (Ig) Levels Over the OL Day 365 cohort (n=182, n=84): IgM	175.7 mg/dL Standard Deviation 113.5	159.5 mg/dL Standard Deviation 88.33
OL; Mean Time-matched Baseline Immunoglobulin (Ig) Levels Over the OL Day 729 cohort (n=163, n=75): IgA	322.2 mg/dL Standard Deviation 156.8	327.6 mg/dL Standard Deviation 218.5
OL; Mean Time-matched Baseline Immunoglobulin (Ig) Levels Over the OL Day 729 cohort (n=163, n=75): IgG	1337.0 mg/dL Standard Deviation 421.4	1338.0 mg/dL Standard Deviation 528.7
OL; Mean Time-matched Baseline Immunoglobulin (Ig) Levels Over the OL Day 729 cohort (n=163, n=75): IgM	184.1 mg/dL Standard Deviation 137.0	165.9 mg/dL Standard Deviation 91.12
OL; Mean Time-matched Baseline Immunoglobulin (Ig) Levels Over the OL Day 1093 cohort (n=76, n=42): IgG	1374.0 mg/dL Standard Deviation 537.3	1478.0 mg/dL Standard Deviation 562.9
OL; Mean Time-matched Baseline Immunoglobulin (Ig) Levels Over the OL Day 1093 cohort (n=76, n=42): IgM	175.5 mg/dL Standard Deviation 158.1	174.2 mg/dL Standard Deviation 89.43

PRIMARY outcome

Timeframe: BL, Days 169, 365, 729, and 1093

Serum samples collected from participants were used to determine serum levels of IgA, IgM, and IgG. Time-matched mean change from baseline = Post-baseline value - time-matched baseline value, where the time-matched baseline value represents the mean baseline value for only that cohort of participants with serum samples available at that visit.

Outcome measures

Outcome measures
Measure	Abatacept (ABA) n=201 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing \< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Placebo (PLA) n=96 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
OL; Mean Time-matched Change From Baseline in Immunoglobulin (Ig) Levels Over the OL Day 169 cohort (n=201, n=96): IgA	-35.3 mg/dL Standard Error 3.61	1.10 mg/dL Standard Error 8.12
OL; Mean Time-matched Change From Baseline in Immunoglobulin (Ig) Levels Over the OL Day 169 cohort (n=201, n=96): IgG	-233.0 mg/dL Standard Error 19.54	-72.8 mg/dL Standard Error 35.74
OL; Mean Time-matched Change From Baseline in Immunoglobulin (Ig) Levels Over the OL Day 169 cohort (n=201, n=96): IgM	-17.8 mg/dL Standard Error 3.59	-5.42 mg/dL Standard Error 3.63
OL; Mean Time-matched Change From Baseline in Immunoglobulin (Ig) Levels Over the OL Day 365 cohort (n=182, n=84): IgA	-37.5 mg/dL Standard Error 4.93	-33.0 mg/dL Standard Error 10.12
OL; Mean Time-matched Change From Baseline in Immunoglobulin (Ig) Levels Over the OL Day 365 cohort (n=182, n=84): IgG	-282.0 mg/dL Standard Error 18.60	-251.0 mg/dL Standard Error 39.41
OL; Mean Time-matched Change From Baseline in Immunoglobulin (Ig) Levels Over the OL Day 365 cohort (n=182, n=84): IgM	-23.0 mg/dL Standard Error 4.21	-18.3 mg/dL Standard Error 4.21
OL; Mean Time-matched Change From Baseline in Immunoglobulin (Ig) Levels Over the OL Day 729 cohort (n=163, n=75): IgA	-37.3 mg/dL Standard Error 6.13	-30.0 mg/dL Standard Error 10.42
OL; Mean Time-matched Change From Baseline in Immunoglobulin (Ig) Levels Over the OL Day 729 cohort (n=163, n=75): IgG	-344.0 mg/dL Standard Error 2.81	-257.0 mg/dL Standard Error 38.30
OL; Mean Time-matched Change From Baseline in Immunoglobulin (Ig) Levels Over the OL Day 729 cohort (n=163, n=75): IgM	-19.4 mg/dL Standard Error 6.01	-16.1 mg/dL Standard Error 6.02
OL; Mean Time-matched Change From Baseline in Immunoglobulin (Ig) Levels Over the OL Day 1093 cohort (n=76, n=41): IgA	-35.6 mg/dL Standard Error 7.50	-69.4 mg/dL Standard Error 16.83
OL; Mean Time-matched Change From Baseline in Immunoglobulin (Ig) Levels Over the OL Day 1093 cohort (n=76, n=42): IgG	-396.0 mg/dL Standard Error 46.77	-377.0 mg/dL Standard Error 55.94
OL; Mean Time-matched Change From Baseline in Immunoglobulin (Ig) Levels Over the OL Day 1093 cohort (n=76, n=42): IgM	-29.7 mg/dL Standard Error 9.03	-24.7 mg/dL Standard Error 9.51

SECONDARY outcome

Timeframe: Days 15, 29, 57, 85, 113, 141, and 169

ACR 20/50/70 response requires a participant to have a 20/50/70% reduction in the number of swollen and tender joints, and a reduction of 20/50/70% in three of the following five parameters: physician global assessment of disease, participant global assessment of disease, participant assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in Health Assessment Questionnaire (HAQ) score. A participant achieved a sustained ACR 20/50/70 response if the participant had ACR 20/50/70 observed for at least 2 consecutive study visits.

Outcome measures

Outcome measures
Measure	Abatacept (ABA) n=256 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing \< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Placebo (PLA) n=133 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
DB; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time Day 15 ACR 20	45 participants	7 participants
DB; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time Day 15 ACR 50	6 participants	0 participants
DB; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time Day 15 ACR 70	2 participants	0 participants
DB; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time Day 29 ACR 20	84 participants	25 participants
DB; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time Day 29 ACR 50	22 participants	4 participants
DB; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time Day 29 ACR 70	6 participants	1 participants
DB; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time Day 57 ACR 20	118 participants	32 participants
DB; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time Day 57 ACR 50	34 participants	9 participants
DB; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time Day 57 ACR 70	13 participants	0 participants
DB; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time Day 85 ACR 20	118 participants	24 participants
DB; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time Day 85 ACR 50	46 participants	8 participants
DB; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time Day 85 ACR 70	15 participants	1 participants
DB; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time Day 113 ACR 20	126 participants	31 participants
DB; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time Day 113 ACR 50	46 participants	5 participants
DB; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time Day 113 ACR 70	20 participants	0 participants
DB; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time Day 141 ACR 20	141 participants	26 participants
DB; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time Day 141 ACR 50	65 participants	6 participants
DB; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time Day 141 ACR 70	26 participants	0 participants
DB; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time Day 169 ACR 20	129 participants	26 participants
DB; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time Day 169 ACR 50	52 participants	5 participants
DB; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time Day 169 ACR 70	26 participants	2 participants

SECONDARY outcome

Timeframe: BL

Population: Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with TJCs. Mean time-matched BL values reflect changing n-values over time.

The mean TJC core component of the ACR scoring system was evaluated based on the number of tender joints in a standard 68 joint count, where an increasing number of tender joints indicates increasing level of severity. Time-matched baseline TJC values for each post-baseline TJC in the DB were presented for each visit and represent the mean baseline TJC value for only that cohort of participants with TJCs available at that visit.

Outcome measures

Outcome measures
Measure	Abatacept (ABA) n=256 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing \< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Placebo (PLA) n=133 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
DB; Mean Time-matched Baseline Tender Joint Counts (TJCs) and Post-Baseline TJCs Over Time: ACR Core Component Day 15 cohort (n=251, n=126): baseline	31.33 tender joints Standard Deviation 12.86	32.75 tender joints Standard Deviation 13.13
DB; Mean Time-matched Baseline Tender Joint Counts (TJCs) and Post-Baseline TJCs Over Time: ACR Core Component Day 15 cohort (n=251, n=126): post-baseline	25.58 tender joints Standard Deviation 14.39	30.35 tender joints Standard Deviation 15.37
DB; Mean Time-matched Baseline Tender Joint Counts (TJCs) and Post-Baseline TJCs Over Time: ACR Core Component Day 29 cohort (n=248, n=128): baseline	31.41 tender joints Standard Deviation 13.11	32.72 tender joints Standard Deviation 13.06
DB; Mean Time-matched Baseline Tender Joint Counts (TJCs) and Post-Baseline TJCs Over Time: ACR Core Component Day 29 cohort (n=248, n=128): post-baseline	21.61 tender joints Standard Deviation 14.53	27.52 tender joints Standard Deviation 15.85
DB; Mean Time-matched Baseline Tender Joint Counts (TJCs) and Post-Baseline TJCs Over Time: ACR Core Component Day 57 cohort (n=251, n=129): baseline	31.17 tender joints Standard Deviation 12.90	32.31 tender joints Standard Deviation 13.14
DB; Mean Time-matched Baseline Tender Joint Counts (TJCs) and Post-Baseline TJCs Over Time: ACR Core Component Day 57 cohort (n=251, n=129): post-baseline	18.88 tender joints Standard Deviation 14.41	24.20 tender joints Standard Deviation 16.46
DB; Mean Time-matched Baseline Tender Joint Counts (TJCs) and Post-Baseline TJCs Over Time: ACR Core Component Day 85 cohort (n=249, n=129): baseline	31.42 tender joints Standard Deviation 13.05	32.58 tender joints Standard Deviation 13.10
DB; Mean Time-matched Baseline Tender Joint Counts (TJCs) and Post-Baseline TJCs Over Time: ACR Core Component Day 85 cohort (n=249, n=129): post-baseline	18.51 tender joints Standard Deviation 14.15	25.56 tender joints Standard Deviation 15.80
DB; Mean Time-matched Baseline Tender Joint Counts (TJCs) and Post-Baseline TJCs Over Time: ACR Core Component Day 113 cohort (n=246, n=128): baseline	31.32 tender joints Standard Deviation 13.10	32.65 tender joints Standard Deviation 13.15
DB; Mean Time-matched Baseline Tender Joint Counts (TJCs) and Post-Baseline TJCs Over Time: ACR Core Component Day 113 cohort (n=246, n=128): post-baseline	16.76 tender joints Standard Deviation 14.18	25.21 tender joints Standard Deviation 16.18
DB; Mean Time-matched Baseline Tender Joint Counts (TJCs) and Post-Baseline TJCs Over Time: ACR Core Component Day 141 cohort (n=252, n=128): baseline	31.34 tender joints Standard Deviation 13.10	32.28 tender joints Standard Deviation 13.21
DB; Mean Time-matched Baseline Tender Joint Counts (TJCs) and Post-Baseline TJCs Over Time: ACR Core Component Day 141 cohort (n=252, n=128): post-baseline	16.04 tender joints Standard Deviation 13.89	23.67 tender joints Standard Deviation 15.62
DB; Mean Time-matched Baseline Tender Joint Counts (TJCs) and Post-Baseline TJCs Over Time: ACR Core Component Day 169 cohort (n=254, n=130): baseline	31.33 tender joints Standard Deviation 13.06	32.43 tender joints Standard Deviation 13.16
DB; Mean Time-matched Baseline Tender Joint Counts (TJCs) and Post-Baseline TJCs Over Time: ACR Core Component Day 169 cohort (n=254, n=130): post-baseline	16.21 tender joints Standard Deviation 13.94	25.55 tender joints Standard Deviation 16.30

SECONDARY outcome

Timeframe: BL, Days 15, 29, 57, 85, 113, 141, and 169

The mean TJC core component of the ACR scoring system was evaluated based on the number of tender joints in a standard 68 joint count, where an increasing number of tender joints indicates increasing level of severity. Mean Time-matched percentage of change from baseline = (time-matched baseline value - Post-baseline value)/time-matched baseline value x 100, where the time-matched baseline value represents the mean baseline value for only that cohort of participants with TJCs available at that visit.

Outcome measures

Outcome measures
Measure	Abatacept (ABA) n=256 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing \< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Placebo (PLA) n=133 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
DB; Mean Time-Matched Percentage of Change From Baseline in TJC Over Time: ACR Core Component Day 15 cohort (n=251, n=126)	19.74 percentage of change from BL Standard Error 2.19	6.43 percentage of change from BL Standard Error 3.25
DB; Mean Time-Matched Percentage of Change From Baseline in TJC Over Time: ACR Core Component Day 29 cohort (n=248, n=128)	32.68 percentage of change from BL Standard Error 2.41	14.96 percentage of change from BL Standard Error 3.84
DB; Mean Time-Matched Percentage of Change From Baseline in TJC Over Time: ACR Core Component Day 57 cohort (n=251, n=129)	40.52 percentage of change from BL Standard Error 2.56	24.99 percentage of change from BL Standard Error 3.62
DB; Mean Time-Matched Percentage of Change From Baseline in TJC Over Time: ACR Core Component Day 85 cohort (n=249, n=129)	40.40 percentage of change from BL Standard Error 2.62	20.94 percentage of change from BL Standard Error 3.49
DB; Mean Time-Matched Percentage of Change From Baseline in TJC Over Time: ACR Core Component Day 113 cohort (n=246, n=128)	46.20 percentage of change from BL Standard Error 2.76	21.72 percentage of change from BL Standard Error 3.87
DB; Mean Time-Matched Percentage of Change From Baseline in TJC Over Time: ACR Core Component Day 141 cohort (n=252, n=128)	49.06 percentage of change from BL Standard Error 2.53	24.03 percentage of change from BL Standard Error 4.05
DB; Mean Time-Matched Percentage of Change From Baseline in TJC Over Time: ACR Core Component Day 169 cohort (n=254, n=130)	47.76 percentage of change from BL Standard Error 2.66	20.04 percentage of change from BL Standard Error 3.84

SECONDARY outcome

Timeframe: Days 15, 29, 57, 85, 113, 141, and 169

Population: Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with SJCs. Mean time-matched BL values reflect changing n-values over time.

The mean SJC core component of the ACR scoring system was evaluated based on the number of swollen joints in a standard 66 joint count, where an increasing number of swollen joints indicates increasing level of severity. Time-matched baseline SJC values for each post-baseline SJC in the DB were presented for each visit and represent the mean baseline SJC value for only that cohort of participants with SJCs available at that visit.

Outcome measures

Outcome measures
Measure	Abatacept (ABA) n=256 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing \< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Placebo (PLA) n=133 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
DB; Mean Time-matched Baseline Swollen Joint Count (SJC) and Post-Baseline SJCs Over Time: ACR Core Component Day 15 cohort (n=251, n=126): baseline	22.31 swollen joints Standard Deviation 10.08	22.00 swollen joints Standard Deviation 9.79
DB; Mean Time-matched Baseline Swollen Joint Count (SJC) and Post-Baseline SJCs Over Time: ACR Core Component Day 15 cohort (n=251, n=126): post-line	17.88 swollen joints Standard Deviation 10.42	19.06 swollen joints Standard Deviation 10.97
DB; Mean Time-matched Baseline Swollen Joint Count (SJC) and Post-Baseline SJCs Over Time: ACR Core Component Day 29 cohort (n=248, n=128): baseline	22.49 swollen joints Standard Deviation 10.32	21.86 swollen joints Standard Deviation 9.79
DB; Mean Time-matched Baseline Swollen Joint Count (SJC) and Post-Baseline SJCs Over Time: ACR Core Component Day 29 cohort (n=248, n=128): post-baseline	15.55 swollen joints Standard Deviation 10.62	17.95 swollen joints Standard Deviation 11.83
DB; Mean Time-matched Baseline Swollen Joint Count (SJC) and Post-Baseline SJCs Over Time: ACR Core Component Day 57 cohort (n=251, n=129): baseline	22.15 swollen joints Standard Deviation 10.05	21.80 swollen joints Standard Deviation 9.78
DB; Mean Time-matched Baseline Swollen Joint Count (SJC) and Post-Baseline SJCs Over Time: ACR Core Component Day 57 cohort (n=251, n=129): post-baseline	13.44 swollen joints Standard Deviation 9.81	15.98 swollen joints Standard Deviation 10.17
DB; Mean Time-matched Baseline Swollen Joint Count (SJC) and Post-Baseline SJCs Over Time: ACR Core Component Day 85 cohort (n=249, n=129): baseline	22.42 swollen joints Standard Deviation 10.30	21.81 swollen joints Standard Deviation 9.77
DB; Mean Time-matched Baseline Swollen Joint Count (SJC) and Post-Baseline SJCs Over Time: ACR Core Component Day 85 cohort (n=249, n=129): post-baseline	12.44 swollen joints Standard Deviation 9.41	16.25 swollen joints Standard Deviation 11.92
DB; Mean Time-matched Baseline Swollen Joint Count (SJC) and Post-Baseline SJCs Over Time: ACR Core Component Day 113 cohort (n=246, n=128): baseline	22.48 swollen joints Standard Deviation 10.34	21.82 swollen joints Standard Deviation 9.81
DB; Mean Time-matched Baseline Swollen Joint Count (SJC) and Post-Baseline SJCs Over Time: ACR Core Component Day 113 cohort (n=246, n=128): post-baseline	12.18 swollen joints Standard Deviation 10.18	16.28 swollen joints Standard Deviation 10.78
DB; Mean Time-matched Baseline Swollen Joint Count (SJC) and Post-Baseline SJCs Over Time: ACR Core Component Day 141 cohort (n=252, n=128): baseline	22.38 swollen joints Standard Deviation 10.29	21.63 swollen joints Standard Deviation 9.74
DB; Mean Time-matched Baseline Swollen Joint Count (SJC) and Post-Baseline SJCs Over Time: ACR Core Component Day 141 cohort (n=252, n=128): post-baseline	11.06 swollen joints Standard Deviation 8.91	15.92 swollen joints Standard Deviation 10.49
DB; Mean Time-matched Baseline Swollen Joint Count (SJC) and Post-Baseline SJCs Over Time: ACR Core Component Day 169 cohort (n=254, n=130): baseline	22.35 swollen joints Standard Deviation 10.25	21.77 swollen joints Standard Deviation 9.75
DB; Mean Time-matched Baseline Swollen Joint Count (SJC) and Post-Baseline SJCs Over Time: ACR Core Component Day 169 cohort (n=254, n=130): post-baseline	12.00 swollen joints Standard Deviation 9.78	16.18 swollen joints Standard Deviation 11.10

SECONDARY outcome

Timeframe: Days 15, 29, 57, 85, 113, 141, and 169

Population: Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with SJCs. Mean time-matched BL values reflect changing n-values over time.

The mean SJC core component of the ACR scoring system was evaluated based on the number of swollen joints in a standard 66 joint count, where an increasing number of swollen joints indicate increasing level of severity. Mean Time-matched percentage of change from baseline = (time-matched baseline value - Post-baseline value)/time-matched baseline value x 100, where the time-matched baseline value represents the mean baseline value for only that cohort of participants with TJCs available at that visit.

Outcome measures

Outcome measures
Measure	Abatacept (ABA) n=256 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing \< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Placebo (PLA) n=133 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
DB; Mean Time-Matched Percentage of Change From Baseline in SJC Over Time: ACR Core Component Day 15 cohort (n=251, n=126)	18.64 percentage of change from BL Standard Error 2.38	13.13 percentage of change from BL Standard Error 3.03
DB; Mean Time-Matched Percentage of Change From Baseline in SJC Over Time: ACR Core Component Day 29 cohort (n=248, n=128)	32.68 percentage of change from BL Standard Error 2.41	14.96 percentage of change from BL Standard Error 3.84
DB; Mean Time-Matched Percentage of Change From Baseline in SJC Over Time: ACR Core Component Day 57 cohort (n=251, n=129)	38.49 percentage of change from BL Standard Error 2.70	24.98 percentage of change from BL Standard Error 3.45
DB; Mean Time-Matched Percentage of Change From Baseline in SJC Over Time: ACR Core Component Day 85 cohort (n=249, n=129)	44.42 percentage of change from BL Standard Error 2.30	26.22 percentage of change from BL Standard Error 3.72
DB; Mean Time-Matched Percentage of Change From Baseline in SJC Over Time: ACR Core Component Day 113 cohort (n=246, n=128)	45.31 percentage of change from BL Standard Error 2.75	22.87 percentage of change from BL Standard Error 3.72
DB; Mean Time-Matched Percentage of Change From Baseline in SJC Over Time: ACR Core Component Day 141 cohort (n=252, n=128)	49.38 percentage of change from BL Standard Error 2.42	24.33 percentage of change from BL Standard Error 3.77
DB; Mean Time-Matched Percentage of Change From Baseline in SJC Over Time: ACR Core Component Day 169 cohort (n=254, n=130)	44.26 percentage of change from BL Standard Error 2.84	23.78 percentage of change from BL Standard Error 3.87

SECONDARY outcome

Timeframe: BL

Population: Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.

The participant self-reported pain assessment is a core component of the ACR scoring system where increasing score indicates increasing level of severity as indicated on a 100 mm Visual Analog Scale (VAS) with 0 mm representing no pain and 100 mm representing the most pain possible. For each post-baseline visit in the DB, time-matched baseline Participant Pain Assessment values were presented and represent the mean baseline value for only that cohort of participants with assessments available at that visit.

Outcome measures

Outcome measures
Measure	Abatacept (ABA) n=256 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing \< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Placebo (PLA) n=133 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
DB; Mean Time-matched Baseline Participant Pain Assessment Over Time: ACR Core Component Day 15 cohort (n=247, n=126): baseline	71.09 units on a scale Standard Deviation 19.57	69.20 units on a scale Standard Deviation 19.02
DB; Mean Time-matched Baseline Participant Pain Assessment Over Time: ACR Core Component Day 15 cohort (n=247, n=126): post-baseline	61.05 units on a scale Standard Deviation 22.45	67.65 units on a scale Standard Deviation 20.48
DB; Mean Time-matched Baseline Participant Pain Assessment Over Time: ACR Core Component Day 29 cohort (n=240, n=128): baseline	70.45 units on a scale Standard Deviation 19.77	69.80 units on a scale Standard Deviation 18.76
DB; Mean Time-matched Baseline Participant Pain Assessment Over Time: ACR Core Component Day 29 cohort (n=240, n=128): post-baseline	52.88 units on a scale Standard Deviation 23.93	61.07 units on a scale Standard Deviation 24.13
DB; Mean Time-matched Baseline Participant Pain Assessment Over Time: ACR Core Component Day 57 cohort (n=246, n=129): baseline	70.72 units on a scale Standard Deviation 19.70	69.26 units on a scale Standard Deviation 18.79
DB; Mean Time-matched Baseline Participant Pain Assessment Over Time: ACR Core Component Day 57 cohort (n=246, n=129): post-baseline	46.19 units on a scale Standard Deviation 25.26	55.91 units on a scale Standard Deviation 25.85
DB; Mean Time-matched Baseline Participant Pain Assessment Over Time: ACR Core Component Day 85 cohort (n=245, n=129): baseline	70.87 units on a scale Standard Deviation 19.85	69.40 units on a scale Standard Deviation 18.92
DB; Mean Time-matched Baseline Participant Pain Assessment Over Time: ACR Core Component Day 85 cohort (n=245, n=129): post-baseline	44.69 units on a scale Standard Deviation 26.13	60.16 units on a scale Standard Deviation 25.05
DB; Mean Time-matched Baseline Participant Pain Assessment Over Time: ACR Core Component Day 113 cohort (n=239, n=126): baseline	70.93 units on a scale Standard Deviation 19.71	70.27 units on a scale Standard Deviation 18.54
DB; Mean Time-matched Baseline Participant Pain Assessment Over Time: ACR Core Component Day 113 cohort (n=239, n=126): post-baseline	44.60 units on a scale Standard Deviation 26.19	60.17 units on a scale Standard Deviation 25.53
DB; Mean Time-matched Baseline Participant Pain Assessment Over Time: ACR Core Component Day 141 cohort (n=249, n=127): baseline	70.85 units on a scale Standard Deviation 19.73	69.34 units on a scale Standard Deviation 19.02
DB; Mean Time-matched Baseline Participant Pain Assessment Over Time: ACR Core Component Day 141 cohort (n=249, n=127): post-baseline	43.67 units on a scale Standard Deviation 27.20	59.80 units on a scale Standard Deviation 25.08
DB; Mean Time-matched Baseline Participant Pain Assessment Over Time: ACR Core Component Day 169 cohort (n=251, n=130): baseline	70.89 units on a scale Standard Deviation 19.67	69.47 units on a scale Standard Deviation 18.86
DB; Mean Time-matched Baseline Participant Pain Assessment Over Time: ACR Core Component Day 169 cohort (n=251, n=130): post-baseline	43.48 units on a scale Standard Deviation 27.76	62.21 units on a scale Standard Deviation 24.73

SECONDARY outcome

Timeframe: BL, Days 15, 29, 57, 85, 113, 141, and 169

Population: Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.

Participant self-reported pain assessment is a core component of the ACR scoring system where increasing score indicates increasing level of severity as indicated on a 100 mm Visual Analog Scale (VAS) with 0 mm representing no pain and 100 mm representing the most pain possible. Mean Time-matched percentage of change from baseline = (time-matched baseline value - Post-baseline value)/time-matched baseline value x 100, where the time-matched baseline value represents the mean baseline value for only that cohort of participants with assessments available at that visit.

Outcome measures

Outcome measures
Measure	Abatacept (ABA) n=256 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing \< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Placebo (PLA) n=133 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
DB; Mean Time-Matched Percentage of Change From Baseline in Participant Pain Assessment Over Time: ACR Core Component Day 15 cohort (n=247, n=126)	8.48 percentage of change from BL Standard Error 3.82	-3.19 percentage of change from BL Standard Error 3.24
DB; Mean Time-Matched Percentage of Change From Baseline in Participant Pain Assessment Over Time: ACR Core Component Day 29 cohort (n=240, n=128)	18.31 percentage of change from BL Standard Error 3.51	8.36 percentage of change from BL Standard Error 3.26
DB; Mean Time-Matched Percentage of Change From Baseline in Participant Pain Assessment Over Time: ACR Core Component Day 57 cohort (n=246, n=129)	24.58 percentage of change from BL Standard Error 6.39	16.65 percentage of change from BL Standard Error 3.28
DB; Mean Time-Matched Percentage of Change From Baseline in Participant Pain Assessment Over Time: ACR Core Component Day 85 cohort (n=245, n=129)	26.76 percentage of change from BL Standard Error 6.61	8.59 percentage of change from BL Standard Error 3.79
DB; Mean Time-Matched Percentage of Change From Baseline in Participant Pain Assessment Over Time: ACR Core Component Day 113 cohort (n=239, n=126)	28.46 percentage of change from BL Standard Error 4.79	9.87 percentage of change from BL Standard Error 3.98
DB; Mean Time-Matched Percentage of Change From Baseline in Participant Pain Assessment Over Time: ACR Core Component Day 141 cohort (n=249, n=127)	27.29 percentage of change from BL Standard Error 6.72	4.32 percentage of change from BL Standard Error 5.55
DB; Mean Time-Matched Percentage of Change From Baseline in Participant Pain Assessment Over Time: ACR Core Component Day 169 cohort (n=251, n=130)	28.64 percentage of change from BL Standard Error 5.70	4.36 percentage of change from BL Standard Error 4.01

SECONDARY outcome

Timeframe: BL

Population: Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.

HAQ-DI is a self-administered questionnaire composed of 20 questions assessing physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. 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. The HAQ-DI is the weighted sum of the scale scores, with higher scores indicating poorer function. For each post-BL visit, time-matched BL HAQ-DI values were presented and represent the mean BL value for only that cohort of participants with data available at that visit.

Outcome measures

Outcome measures
Measure	Abatacept (ABA) n=256 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing \< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Placebo (PLA) n=133 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
DB; Mean Time-matched Baseline HAQ-DI Over Time: ACR Core Component Day 15 cohort (n=244, n=124): baseline	1.84 units on a scale Standard Deviation 0.56	1.86 units on a scale Standard Deviation 0.56
DB; Mean Time-matched Baseline HAQ-DI Over Time: ACR Core Component Day 15 cohort (n=244, n=124): post-baseline	1.69 units on a scale Standard Deviation 0.60	1.83 units on a scale Standard Deviation 0.56
DB; Mean Time-matched Baseline HAQ-DI Over Time: ACR Core Component Day 29 cohort (n=239, n=127): baseline	1.84 units on a scale Standard Deviation 0.57	1.85 units on a scale Standard Deviation 0.56
DB; Mean Time-matched Baseline HAQ-DI Over Time: ACR Core Component Day 29 cohort (n=239, n=127): post-baseline	1.59 units on a scale Standard Deviation 0.64	1.70 units on a scale Standard Deviation 0.62
DB; Mean Time-matched Baseline HAQ-DI Over Time: ACR Core Component Day 57 cohort (n=245, n=127): baseline	1.83 units on a scale Standard Deviation 0.57	1.84 units on a scale Standard Deviation 0.55
DB; Mean Time-matched Baseline HAQ-DI Over Time: ACR Core Component Day 57 cohort (n=245, n=127): post-baseline	1.49 units on a scale Standard Deviation 0.65	1.65 units on a scale Standard Deviation 0.63
DB; Mean Time-matched Baseline HAQ-DI Over Time: ACR Core Component Day 85 cohort (n=242, n=126): baseline	1.84 units on a scale Standard Deviation 0.57	1.86 units on a scale Standard Deviation 0.56
DB; Mean Time-matched Baseline HAQ-DI Over Time: ACR Core Component Day 85 cohort (n=242, n=126): post-baseline	1.45 units on a scale Standard Deviation 0.64	1.70 units on a scale Standard Deviation 0.63
DB; Mean Time-matched Baseline HAQ-DI Over Time: ACR Core Component Day 113 cohort (n=238, n=126): baseline	1.85 units on a scale Standard Deviation 0.57	1.85 units on a scale Standard Deviation 0.56
DB; Mean Time-matched Baseline HAQ-DI Over Time: ACR Core Component Day 113 cohort (n=238, n=126): post-baseline	1.44 units on a scale Standard Deviation 0.70	1.71 units on a scale Standard Deviation 0.64
DB; Mean Time-matched Baseline HAQ-DI Over Time: ACR Core Component Day 141 cohort (n=247, n=126): baseline	1.84 units on a scale Standard Deviation 0.57	1.86 units on a scale Standard Deviation 0.56
DB; Mean Time-matched Baseline HAQ-DI Over Time: ACR Core Component Day 141 cohort (n=247, n=126): post-baseline	1.41 units on a scale Standard Deviation 0.71	1.72 units on a scale Standard Deviation 0.64
DB; Mean Time-matched Baseline HAQ-DI Over Time: ACR Core Component Day 169 cohort (n=248, n=128): baseline	1.84 units on a scale Standard Deviation 0.57	1.85 units on a scale Standard Deviation 0.56
DB; Mean Time-matched Baseline HAQ-DI Over Time: ACR Core Component Day 169 cohort (n=248, n=128): post-baseline	1.38 units on a scale Standard Deviation 0.72	1.74 units on a scale Standard Deviation 0.63

SECONDARY outcome

Timeframe: BL, Days 15, 29, 57, 85, 113, 141, and 169

Population: Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.

A self-administered questionnaire with 20 questions assessing physical function in 8 domains:dressing,arising,eating,walking,hygiene,reach,grip and common activities.Questions 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=weighted sum of scale scores, with higher scores indicating poorer function. Mean time-matched % change from BL=(time-matched BL value - Post-BL value)/time-matched BL value x100, where time-matched BL value=the mean BL value for only that cohort of participants with data available at that visit.

Outcome measures

Outcome measures
Measure	Abatacept (ABA) n=256 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing \< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Placebo (PLA) n=133 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
DB; Mean Time-Matched Percentage of Change From Baseline in HAQ-DI Over Time: ACR Core Component Day 15 cohort (n=244, n=124)	7.94 percentage of change from BL Standard Error 1.45	-1.10 percentage of change from BL Standard Error 2.99
DB; Mean Time-Matched Percentage of Change From Baseline in HAQ-DI Over Time: ACR Core Component Day 29 cohort (n=239, n=127)	13.75 percentage of change from BL Standard Error 1.81	6.79 percentage of change from BL Standard Error 2.49
DB; Mean Time-Matched Percentage of Change From Baseline in HAQ-DI Over Time: ACR Core Component Day 57 cohort (n=245, n=127)	19.05 percentage of change from BL Standard Error 1.78	9.61 percentage of change from BL Standard Error 2.85
DB; Mean Time-Matched Percentage of Change From Baseline in HAQ-DI Over Time: ACR Core Component Day 85 cohort (n=242, n=126)	21.00 percentage of change from BL Standard Error 1.79	7.10 percentage of change from BL Standard Error 2.68
DB; Mean Time-Matched Percentage of Change From Baseline in HAQ-DI Over Time: ACR Core Component Day 113 cohort (n=238, n=126)	22.77 percentage of change from BL Standard Error 1.98	5.96 percentage of change from BL Standard Error 3.15
DB; Mean Time-Matched Percentage of Change From Baseline in HAQ-DI Over Time: ACR Core Component Day 141 cohort (n=247, n=126)	24.41 percentage of change from BL Standard Error 2.16	6.50 percentage of change from BL Standard Error 2.68
DB; Mean Time-Matched Percentage of Change From Baseline in HAQ-DI Over Time: ACR Core Component Day 169 cohort (n=248, n=128)	25.48 percentage of change from BL Standard Error 2.14	5.08 percentage of change from BL Standard Error 2.84

SECONDARY outcome

Timeframe: BL

Population: Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.

Participant self-reported global RA assessment core component of the ACR scoring system where increasing score indicates increasing level of severity as indicated on a 100 mm Visual Analog Scale (VAS) with 0 mm representing no pain and 100 mm representing the most pain possible. For each post-baseline visit in the DB, time-matched baseline Participant Global Assessment values were presented and represent the mean baseline value for only that cohort of participants with assessments available at that visit.

Outcome measures

Outcome measures
Measure	Abatacept (ABA) n=256 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing \< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Placebo (PLA) n=133 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
DB; Mean Time-matched Baseline Participant Global Assessment Over Time: ACR Core Component Day 15 cohort (n=247, n=126): baseline	69.30 units on a scale Standard Deviation 19.70	68.93 units on a scale Standard Deviation 20.38
DB; Mean Time-matched Baseline Participant Global Assessment Over Time: ACR Core Component Day 15 cohort (n=247, n=126): post-baseline	58.55 units on a scale Standard Deviation 23.50	65.15 units on a scale Standard Deviation 21.38
DB; Mean Time-matched Baseline Participant Global Assessment Over Time: ACR Core Component Day 29 cohort (n=240, n=128): baseline	68.86 units on a scale Standard Deviation 19.88	69.33 units on a scale Standard Deviation 20.03
DB; Mean Time-matched Baseline Participant Global Assessment Over Time: ACR Core Component Day 29 cohort (n=240, n=128): post-baseline	52.48 units on a scale Standard Deviation 22.56	61.13 units on a scale Standard Deviation 24.42
DB; Mean Time-matched Baseline Participant Global Assessment Over Time: ACR Core Component Day 57 cohort (n=246, n=129): baseline	69.02 units on a scale Standard Deviation 19.84	68.97 units on a scale Standard Deviation 20.10
DB; Mean Time-matched Baseline Participant Global Assessment Over Time: ACR Core Component Day 57 cohort (n=246, n=129): post-baseline	45.07 units on a scale Standard Deviation 24.16	56.60 units on a scale Standard Deviation 26.03
DB; Mean Time-matched Baseline Participant Global Assessment Over Time: ACR Core Component Day 85 cohort (n=245, n=129): baseline	69.40 units on a scale Standard Deviation 19.72	69.12 units on a scale Standard Deviation 20.23
DB; Mean Time-matched Baseline Participant Global Assessment Over Time: ACR Core Component Day 85 cohort (n=245, n=129): post-baseline	43.27 units on a scale Standard Deviation 25.65	60.18 units on a scale Standard Deviation 24.88
DB; Mean Time-matched Baseline Participant Global Assessment Over Time: ACR Core Component Day 113 cohort (n=239, n=126): baseline	69.40 units on a scale Standard Deviation 19.68	70.37 units on a scale Standard Deviation 19.15
DB; Mean Time-matched Baseline Participant Global Assessment Over Time: ACR Core Component Day 113 cohort (n=239, n=126): post-baseline	45.05 units on a scale Standard Deviation 25.36	58.46 units on a scale Standard Deviation 25.61
DB; Mean Time-matched Baseline Participant Global Assessment Over Time: ACR Core Component Day 141 cohort (n=249, n=127): baseline	69.09 units on a scale Standard Deviation 19.83	69.15 units on a scale Standard Deviation 20.36
DB; Mean Time-matched Baseline Participant Global Assessment Over Time: ACR Core Component Day 141 cohort (n=249, n=127): post-baseline	43.72 units on a scale Standard Deviation 26.65	59.24 units on a scale Standard Deviation 25.69
DB; Mean Time-matched Baseline Participant Global Assessment Over Time: ACR Core Component Day 169 cohort (n=251, n=130): baseline	69.22 units on a scale Standard Deviation 19.80	69.18 units on a scale Standard Deviation 20.16
DB; Mean Time-matched Baseline Participant Global Assessment Over Time: ACR Core Component Day 169 cohort (n=251, n=130): post-baseline	43.51 units on a scale Standard Deviation 27.19	60.35 units on a scale Standard Deviation 25.69

SECONDARY outcome

Timeframe: BL, Days 15, 29, 57, 85, 113, 141, and 169

Population: Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.

Participant self-reported global RA assessment core component of the ACR scoring system where increasing score indicates increasing level of severity as indicated on a 100mm Visual Analog Scale (VAS) with 0mm representing no pain and 100mm representing the most pain possible. Mean Time-matched percentage of change from baseline = (time-matched baseline value - Post-baseline value)/time-matched baseline value x 100, where the time-matched baseline value represents the mean baseline value for only that cohort of participants with assessments available at that visit.

Outcome measures

Outcome measures
Measure	Abatacept (ABA) n=256 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing \< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Placebo (PLA) n=133 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
DB; Mean Time-Matched Percentage of Change From Baseline in Participant Global Assessment Over Time: ACR Core Component Day 15 cohort (n=247, n=126)	11.54 percentage of change from BL Standard Error 2.88	-3.18 percentage of change from BL Standard Error 4.48
DB; Mean Time-Matched Percentage of Change From Baseline in Participant Global Assessment Over Time: ACR Core Component Day 29 cohort (n=240, n=128)	18.31 percentage of change from BL Standard Error 2.93	2.13 percentage of change from BL Standard Error 5.10
DB; Mean Time-Matched Percentage of Change From Baseline in Participant Global Assessment Over Time: ACR Core Component Day 57 cohort (n=246, n=129)	29.84 percentage of change from BL Standard Error 3.19	10.94 percentage of change from BL Standard Error 4.70
DB; Mean Time-Matched Percentage of Change From Baseline in Participant Global Assessment Over Time: ACR Core Component Day 85 cohort (n=245, n=129)	32.03 percentage of change from BL Standard Error 4.08	2.89 percentage of change from BL Standard Error 5.42
DB; Mean Time-Matched Percentage of Change From Baseline in Participant Global Assessment Over Time: ACR Core Component Day 113 cohort (n=239, n=126)	30.83 percentage of change from BL Standard Error 3.02	8.01 percentage of change from BL Standard Error 5.48
DB; Mean Time-Matched Percentage of Change From Baseline in Participant Global Assessment Over Time: ACR Core Component Day 141cohort (n=249, n=127)	29.46 percentage of change from BL Standard Error 4.72	4.85 percentage of change from BL Standard Error 5.51
DB; Mean Time-Matched Percentage of Change From Baseline in Participant Global Assessment Over Time: ACR Core Component Day 169 cohort (n=251, n=130)	30.87 percentage of change from BL Standard Error 4.10	4.52 percentage of change from BL Standard Error 5.40

SECONDARY outcome

Timeframe: BL

Population: Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.

Physician global rheumatoid arthritis (RA) assessment core component of the ACR scoring system where increasing score indicates increasing level of severity as indicated on a 100mm Visual Analog Scale (VAS) with 0mm representing no pain and 100mm representing the most pain possible. For each post-baseline visit in the DB, time-matched baseline Physician Global Assessment values were presented and represent the mean baseline value for only that cohort of participants with assessments available at that visit.

Outcome measures

Outcome measures
Measure	Abatacept (ABA) n=256 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing \< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Placebo (PLA) n=133 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
DB; Mean Time-matched Baseline Physician Global Assessment Over Time: ACR Core Component Day 15 cohort (n=250, n=126): baseline	68.86 units on a scale Standard Deviation 17.40	66.91 units on a scale Standard Deviation 16.78
DB; Mean Time-matched Baseline Physician Global Assessment Over Time: ACR Core Component Day 15 cohort (n=250, n=126): post-baseline	54.07 units on a scale Standard Deviation 21.93	61.43 units on a scale Standard Deviation 19.03
DB; Mean Time-matched Baseline Physician Global Assessment Over Time: ACR Core Component Day 29 cohort (n=246, n=126): baseline	68.73 units on a scale Standard Deviation 17.41	66.81 units on a scale Standard Deviation 16.91
DB; Mean Time-matched Baseline Physician Global Assessment Over Time: ACR Core Component Day 29 cohort (n=246, n=126): post-baseline	44.96 units on a scale Standard Deviation 21.03	53.71 units on a scale Standard Deviation 23.08
DB; Mean Time-matched Baseline Physician Global Assessment Over Time: ACR Core Component Day 57 cohort (n=252, n=127): baseline	68.74 units on a scale Standard Deviation 17.34	66.92 units on a scale Standard Deviation 16.64
DB; Mean Time-matched Baseline Physician Global Assessment Over Time: ACR Core Component Day 57 cohort (n=252, n=127): post-baseline	41.46 units on a scale Standard Deviation 21.93	49.21 units on a scale Standard Deviation 25.03
DB; Mean Time-matched Baseline Physician Global Assessment Over Time: ACR Core Component Day 85 cohort (n=247, n=124):baseline	69.08 units on a scale Standard Deviation 17.42	66.81 units on a scale Standard Deviation 16.82
DB; Mean Time-matched Baseline Physician Global Assessment Over Time: ACR Core Component Day 85 cohort (n=247, n=124): post-baseline	37.54 units on a scale Standard Deviation 21.29	53.06 units on a scale Standard Deviation 25.63
DB; Mean Time-matched Baseline Physician Global Assessment Over Time: ACR Core Component Day 113 cohort (n=246, n=127): baseline	68.88 units on a scale Standard Deviation 17.26	67.45 units on a scale Standard Deviation 16.66
DB; Mean Time-matched Baseline Physician Global Assessment Over Time: ACR Core Component Day 113 cohort (n=246, n=127): post-baseline	37.15 units on a scale Standard Deviation 21.88	54.49 units on a scale Standard Deviation 24.30
DB; Mean Time-matched Baseline Physician Global Assessment Over Time: ACR Core Component Day 141 cohort (n=252, n=127): baseline	68.82 units on a scale Standard Deviation 17.39	67.03 units on a scale Standard Deviation 16.96
DB; Mean Time-matched Baseline Physician Global Assessment Over Time: ACR Core Component Day 141 cohort (n=252, n=127): post-baseline	34.32 units on a scale Standard Deviation 21.56	51.58 units on a scale Standard Deviation 24.44
DB; Mean Time-matched Baseline Physician Global Assessment Over Time: ACR Core Component Day 169 cohort (n=254, n=129): baseline	68.91 units on a scale Standard Deviation 17.40	67.05 units on a scale Standard Deviation 16.84
DB; Mean Time-matched Baseline Physician Global Assessment Over Time: ACR Core Component Day 169 cohort (n=254, n=129): post-baseline	36.46 units on a scale Standard Deviation 23.65	52.37 units on a scale Standard Deviation 25.10

SECONDARY outcome

Timeframe: BL, Days 15, 29, 57, 85, 113, 141, and 169

Population: Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.

Physician global rheumatoid arthritis (RA) assessment core component of the ACR scoring system where increasing score indicates increasing level of severity as indicated on a 100mm Visual Analog Scale (VAS) with 0mm representing no pain and 100mm representing the most pain possible. Mean Time-matched percentage of change from baseline = (time-matched baseline value - Post-baseline value)/time-matched baseline value x 100, where the time-matched baseline value represents the mean baseline value for only that cohort of participants with assessments available at that visit.

Outcome measures

Outcome measures
Measure	Abatacept (ABA) n=256 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing \< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Placebo (PLA) n=133 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
DB; Mean Time-Matched Percentage of Change From Baseline in Physician Global Assessment Over Time: ACR Core Component Day 15 cohort (n=250, n=126)	19.27 percentage of change from BL Standard Error 2.45	6.26 percentage of change from BL Standard Error 2.47
DB; Mean Time-Matched Percentage of Change From Baseline in Physician Global Assessment Over Time: ACR Core Component Day 29 cohort (n=246, n=126)	32.32 percentage of change from BL Standard Error 2.59	18.00 percentage of change from BL Standard Error 3.08
DB; Mean Time-Matched Percentage of Change From Baseline in Physician Global Assessment Over Time: ACR Core Component Day 57 cohort (n=252, n=127)	38.41 percentage of change from BL Standard Error 2.38	25.51 percentage of change from BL Standard Error 3.28
DB; Mean Time-Matched Percentage of Change From Baseline in Physician Global Assessment Over Time: ACR Core Component Day 85 cohort (n=247, n=124)	43.74 percentage of change from BL Standard Error 2.20	18.05 percentage of change from BL Standard Error 4.04
DB; Mean Time-Matched Percentage of Change From Baseline in Physician Global Assessment Over Time: ACR Core Component Day 113cohort (n=246, n=127)	45.11 percentage of change from BL Standard Error 2.02	17.53 percentage of change from BL Standard Error 3.26
DB; Mean Time-Matched Percentage of Change From Baseline in Physician Global Assessment Over Time: ACR Core Component Day 141 cohort (n=252, n=127)	49.35 percentage of change from BL Standard Error 1.89	21.34 percentage of change from BL Standard Error 3.35
DB; Mean Time-Matched Percentage of Change From Baseline in Physician Global Assessment Over Time: ACR Core Component Day 169 cohort (n=254, n=129)	45.18 percentage of change from BL Standard Error 2.33	21.28 percentage of change from BL Standard Error 3.14

SECONDARY outcome

Timeframe: BL

Population: Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.

CRP is an acute phase reactant protein that is a clinical marker for Rheumatoid Arthritis (RA) and a core component of the ACR scoring system. CRP was evaluated from serum samples. Increasing levels of CRP indicate increasing level of disease. For each post-baseline visit in the DB, time-matched baseline CRP values were presented and represent the mean baseline value for only that cohort of participants with assessments available at that visit.

Outcome measures

Outcome measures
Measure	Abatacept (ABA) n=256 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing \< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Placebo (PLA) n=133 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
DB; Mean Time-matched Baseline C-Reactive Protein (CRP) Levels Over Time: ACR Core Component Day 15 cohort (n=246, n=127): baseline	4.53 mg/dL Standard Deviation 3.92	3.97 mg/dL Standard Deviation 3.57
DB; Mean Time-matched Baseline C-Reactive Protein (CRP) Levels Over Time: ACR Core Component Day 15 cohort (n=246, n=127): post-baseline	3.20 mg/dL Standard Deviation 3.36	4.01 mg/dL Standard Deviation 3.54
DB; Mean Time-matched Baseline C-Reactive Protein (CRP) Levels Over Time: ACR Core Component Day 29 cohort (n=245, n=128): baseline	4.62 mg/dL Standard Deviation 4.03	4.03 mg/dL Standard Deviation 3.62
DB; Mean Time-matched Baseline C-Reactive Protein (CRP) Levels Over Time: ACR Core Component Day 29 cohort (n=245, n=128): post-baseline	2.70 mg/dL Standard Deviation 2.70	4.02 mg/dL Standard Deviation 3.63
DB; Mean Time-matched Baseline C-Reactive Protein (CRP) Levels Over Time: ACR Core Component Day 57 cohort (n=250, n=129): baseline	4.60 mg/dL Standard Deviation 3.99	3.93 mg/dL Standard Deviation 3.58
DB; Mean Time-matched Baseline C-Reactive Protein (CRP) Levels Over Time: ACR Core Component Day 57 cohort (n=250, n=129): post-baseline	2.39 mg/dL Standard Deviation 2.47	3.73 mg/dL Standard Deviation 4.06
DB; Mean Time-matched Baseline C-Reactive Protein (CRP) Levels Over Time: ACR Core Component Day 85 cohort (n=249, n=129): baseline	4.59 mg/dL Standard Deviation 3.95	4.00 mg/dL Standard Deviation 3.61
DB; Mean Time-matched Baseline C-Reactive Protein (CRP) Levels Over Time: ACR Core Component Day 85 cohort (n=249, n=129): post-baseline	2.36 mg/dL Standard Deviation 3.09	4.13 mg/dL Standard Deviation 4.11
DB; Mean Time-matched Baseline C-Reactive Protein (CRP) Levels Over Time: ACR Core Component Day 113 cohort (n=243, n=127): baseline	4.62 mg/dL Standard Deviation 4.00	4.06 mg/dL Standard Deviation 3.62
DB; Mean Time-matched Baseline C-Reactive Protein (CRP) Levels Over Time: ACR Core Component Day 113 cohort (n=243, n=127): post-baseline	2.26 mg/dL Standard Deviation 3.05	4.31 mg/dL Standard Deviation 4.62
DB; Mean Time-matched Baseline C-Reactive Protein (CRP) Levels Over Time: ACR Core Component Day 141 cohort (n=251, n=129): baseline	4.62 mg/dL Standard Deviation 3.98	4.03 mg/dL Standard Deviation 3.60
DB; Mean Time-matched Baseline C-Reactive Protein (CRP) Levels Over Time: ACR Core Component Day 141 cohort (n=251, n=129): post-baseline	2.20 mg/dL Standard Deviation 3.01	3.83 mg/dL Standard Deviation 4.17
DB; Mean Time-matched Baseline C-Reactive Protein (CRP) Levels Over Time: ACR Core Component Day 169 cohort (n=254, n=131): baseline	4.60 mg/dL Standard Deviation 3.97	3.99 mg/dL Standard Deviation 3.59
DB; Mean Time-matched Baseline C-Reactive Protein (CRP) Levels Over Time: ACR Core Component Day 169 cohort (n=254, n=131): post-baseline	2.31 mg/dL Standard Deviation 3.47	3.97 mg/dL Standard Deviation 4.19

SECONDARY outcome

Timeframe: Days 15, 29, 57, 85, 113, 141, and 169

Population: Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.

CRP is an acute phase reactant protein that is a clinical marker for Rheumatoid Arthritis (RA) and a core component of the ACR scoring system. CRP was evaluated from serum samples. Increasing levels indicate increasing level of disease. Mean Time-matched percentage of change from baseline = (time-matched baseline value - Post-baseline value)/time-matched baseline value x 100, where the time-matched baseline value represents the mean baseline value for only that cohort of participants with data available at that visit.

Outcome measures

Outcome measures
Measure	Abatacept (ABA) n=256 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing \< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Placebo (PLA) n=133 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
DB; Mean Time-Matched Percentage of Change From Baseline in CRP Levels Over Time: ACR Core Component Day 15 cohort (n=246, n=127)	14.03 percentage of change from BL Standard Error 6.70	-20.8 percentage of change from BL Standard Error 8.24
DB; Mean Time-Matched Percentage of Change From Baseline in CRP Levels Over Time: ACR Core Component Day 29 cohort (n=245, n=128)	24.05 percentage of change from BL Standard Error 4.20	-20.1 percentage of change from BL Standard Error 6.81
DB; Mean Time-Matched Percentage of Change From Baseline in CRP Levels Over Time: ACR Core Component Day 57 cohort (n=250, n=129)	22.83 percentage of change from BL Standard Error 8.55	-14.8 percentage of change from BL Standard Error 8.23
DB; Mean Time-Matched Percentage of Change From Baseline in CRP Levels Over Time: ACR Core Component Day 85 cohort (n=249, n=129)	25.87 percentage of change from BL Standard Error 9.68	-31.9 percentage of change from BL Standard Error 9.82
DB; Mean Time-Matched Percentage of Change From Baseline in CRP Levels Over Time: ACR Core Component Day 113 cohort (n=243, n=127)	34.52 percentage of change from BL Standard Error 4.33	-32.1 percentage of change from BL Standard Error 10.37
DB; Mean Time-Matched Percentage of Change From Baseline in CRP Levels Over Time: ACR Core Component Day 141 cohort (n=251, n=129)	33.47 percentage of change from BL Standard Error 4.76	-22.8 percentage of change from BL Standard Error 9.78
DB; Mean Time-Matched Percentage of Change From Baseline in CRP Levels Over Time: ACR Core Component Day 169 cohort (n=254, n=131)	25.05 percentage of change from BL Standard Error 8.44	-28.4 percentage of change from BL Standard Error 11.82

SECONDARY outcome

Timeframe: BL

Potential biomarkers of disease (IL-6, SIL-2R, and TNF-Alpha) were determined from serum samples for all participants. The mean baseline value presented represents a time-matched Day 169 baseline value for only that cohort of participants with assessments available at that visit.

Outcome measures

Outcome measures
Measure	Abatacept (ABA) n=256 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing \< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Placebo (PLA) n=133 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
DB; Mean Baseline Levels of Disease Biomarkers (Interleukin-6 (IL-6), Soluble IL-2 Receptor [sIL-2R], and Tumor Necrosing Factor [TNF]-Alpha) in Participants With Measurements at Day 169 IL-6 (n=194, n=103)	46.19 pg/ml Standard Deviation 62.49	43.18 pg/ml Standard Deviation 62.90
DB; Mean Baseline Levels of Disease Biomarkers (Interleukin-6 (IL-6), Soluble IL-2 Receptor [sIL-2R], and Tumor Necrosing Factor [TNF]-Alpha) in Participants With Measurements at Day 169 sIL-2R (n=193, n=88)	1840 pg/ml Standard Deviation 767.0	1879 pg/ml Standard Deviation 1001
DB; Mean Baseline Levels of Disease Biomarkers (Interleukin-6 (IL-6), Soluble IL-2 Receptor [sIL-2R], and Tumor Necrosing Factor [TNF]-Alpha) in Participants With Measurements at Day 169 TNF-alpha (n=250, n=129)	35.24 pg/ml Standard Deviation 73.17	30.64 pg/ml Standard Deviation 54.08

SECONDARY outcome

Timeframe: BL, Day 169

The mean change from baseline in levels of potential biomarkers of disease (IL-6, SIL-2R, and TNF-Alpha) were determined from serum samples for all participants. Change from Baseline = Post-baseline value - time-matched baseline value, where the time-matched baseline value represents the mean baseline value for only that cohort of participants with data available at Day 169.

Outcome measures

Outcome measures
Measure	Abatacept (ABA) n=256 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing \< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Placebo (PLA) n=133 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
DB; Mean Change From Baseline to Day 169 in Levels of Disease Biomarkers (IL-6, sIL-2R, and TNF-alpha) in Participants With Measurements at Day 169 IL-6 (n=194, n=103)	-24.4 pg/ml Standard Error 4.54	4.71 pg/ml Standard Error 8.13
DB; Mean Change From Baseline to Day 169 in Levels of Disease Biomarkers (IL-6, sIL-2R, and TNF-alpha) in Participants With Measurements at Day 169 sIL-2R (n=193, n=88)	-565 pg/ml Standard Error 40.40	-36.1 pg/ml Standard Error 77.37
DB; Mean Change From Baseline to Day 169 in Levels of Disease Biomarkers (IL-6, sIL-2R, and TNF-alpha) in Participants With Measurements at Day 169 TNF-alpha (n=250, n=129)	-13.5 pg/ml Standard Error 4.06	5.87 pg/ml Standard Error 8.27

SECONDARY outcome

Timeframe: BL

Potential biomarkers of disease (E-selectin, sICAM-1, and MMP-3) were determined from serum samples for all participants. The mean baseline value presented represents a time-matched Day 169 baseline value for only that cohort of participants with assessments available at that visit.

Outcome measures

Outcome measures
Measure	Abatacept (ABA) n=256 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing \< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Placebo (PLA) n=133 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
DB; Mean Baseline Levels of Disease Biomarkers (E-Selectin, Soluble Inter-Cellular Adhesion Molecule 1 [sICAM-1], and Matrix Metalloproteinase-3 [MMP-3]) in Participants With Measurements at Day 169 E-selectin (n=190, n=103)	93.03 ng/ml Standard Deviation 101.2	84.53 ng/ml Standard Deviation 71.64
DB; Mean Baseline Levels of Disease Biomarkers (E-Selectin, Soluble Inter-Cellular Adhesion Molecule 1 [sICAM-1], and Matrix Metalloproteinase-3 [MMP-3]) in Participants With Measurements at Day 169 sICAM-1 (n=187, n=103)	426.6 ng/ml Standard Deviation 218.6	443.5 ng/ml Standard Deviation 327.1
DB; Mean Baseline Levels of Disease Biomarkers (E-Selectin, Soluble Inter-Cellular Adhesion Molecule 1 [sICAM-1], and Matrix Metalloproteinase-3 [MMP-3]) in Participants With Measurements at Day 169 MMP3 (n=192, n=133)	86.53 ng/ml Standard Deviation 97.59	84.18 ng/ml Standard Deviation 133.5

SECONDARY outcome

Timeframe: BL, Day 169

Potential biomarkers of disease (E-selectin, sICAM-1, and MMP-3) were determined from serum samples for all participants. Change from Baseline = Post-baseline value - time-matched baseline value, where the time-matched baseline value represents the mean baseline value for only that cohort of participants with data available at Day 169.

Outcome measures

Outcome measures
Measure	Abatacept (ABA) n=256 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing \< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Placebo (PLA) n=133 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
DB; Mean Change From Baseline to Day 169 in Levels of Disease Biomarkers (E-Selectin, sICAM-1, and MMP-3) in Participants With Measurements at Day 169 E-selectin (n=190, n=103)	-10.6 ng/ml Standard Error 4.97	6.54 ng/ml Standard Error 4.34
DB; Mean Change From Baseline to Day 169 in Levels of Disease Biomarkers (E-Selectin, sICAM-1, and MMP-3) in Participants With Measurements at Day 169 sICAM-1 (n=187, n=103)	-22.2 ng/ml Standard Error 16.58	-29.5 ng/ml Standard Error 20.17
DB; Mean Change From Baseline to Day 169 in Levels of Disease Biomarkers (E-Selectin, sICAM-1, and MMP-3) in Participants With Measurements at Day 169 MMP3 (n=192, n=133)	-37.0 ng/ml Standard Error 6.42	-9.62 ng/ml Standard Error 11.51

SECONDARY outcome

Timeframe: BL, Day 169

Rheumatoid factor (RF or RhF) is an autoantibody (antibody directed against an organism's own tissues) most relevant in rheumatoid arthritis. It is an antibody against the Fc portion of Immunoglobulin (Ig)G, which is itself an antibody. RF and IgG join to form immune complexes which contribute to the disease process. A positive value for RF was \>20 IU/mL; a negative value for RF was ≤ 20 IU/mL.

Outcome measures

Outcome measures
Measure	Abatacept (ABA) n=256 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing \< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Placebo (PLA) n=133 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
DB; Mean Change From Baseline to Day 169 in Rheumatoid Factor (RF) Status Baseline RF negative	46 participants	25 participants
DB; Mean Change From Baseline to Day 169 in Rheumatoid Factor (RF) Status Baseline RF negative change to RF positive	3 participants	3 participants
DB; Mean Change From Baseline to Day 169 in Rheumatoid Factor (RF) Status Baseline RF positive	154 participants	73 participants
DB; Mean Change From Baseline to Day 169 in Rheumatoid Factor (RF) Status Baseline RF positive change to RF negative	13 participants	0 participants

SECONDARY outcome

Timeframe: BL

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: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. 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. Mean BL value presented represents a time-matched Day 85 BL value for only that cohort of participants with data available at that visit.

Outcome measures

Outcome measures
Measure	Abatacept (ABA) n=256 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing \< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Placebo (PLA) n=133 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
DB; Mean Baseline Short Form 36 (SF-36) Quality of Life Physical Component Summary (PCS), Mental Component Summary (MCS), and SF-36 Individual Component Scores For Participants With Measurements at Day 85 PCS (n=243, n=128)	27.41 Units on a Scale Standard Deviation 6.94	27.77 Units on a Scale Standard Deviation 6.31
DB; Mean Baseline Short Form 36 (SF-36) Quality of Life Physical Component Summary (PCS), Mental Component Summary (MCS), and SF-36 Individual Component Scores For Participants With Measurements at Day 85 MCS (n=243, n=128)	41.13 Units on a Scale Standard Deviation 12.35	43.00 Units on a Scale Standard Deviation 11.94
DB; Mean Baseline Short Form 36 (SF-36) Quality of Life Physical Component Summary (PCS), Mental Component Summary (MCS), and SF-36 Individual Component Scores For Participants With Measurements at Day 85 Physical Function Scale Component (n=246, n=129)	25.94 Units on a Scale Standard Deviation 8.90	26.31 Units on a Scale Standard Deviation 8.36
DB; Mean Baseline Short Form 36 (SF-36) Quality of Life Physical Component Summary (PCS), Mental Component Summary (MCS), and SF-36 Individual Component Scores For Participants With Measurements at Day 85 Role-Physical Scale Component (n=249, n=129)	30.50 Units on a Scale Standard Deviation 6.25	31.96 Units on a Scale Standard Deviation 6.84
DB; Mean Baseline Short Form 36 (SF-36) Quality of Life Physical Component Summary (PCS), Mental Component Summary (MCS), and SF-36 Individual Component Scores For Participants With Measurements at Day 85 Bodily Pain Scale Component (n=248, n=129)	30.49 Units on a Scale Standard Deviation 6.72	31.28 Units on a Scale Standard Deviation 6.64
DB; Mean Baseline Short Form 36 (SF-36) Quality of Life Physical Component Summary (PCS), Mental Component Summary (MCS), and SF-36 Individual Component Scores For Participants With Measurements at Day 85 General Health Scale Component (n=250, n=129)	34.75 Units on a Scale Standard Deviation 9.18	34.95 Units on a Scale Standard Deviation 8.46
DB; Mean Baseline Short Form 36 (SF-36) Quality of Life Physical Component Summary (PCS), Mental Component Summary (MCS), and SF-36 Individual Component Scores For Participants With Measurements at Day 85 Vitality Scale Component (n=249, n=129)	34.99 Units on a Scale Standard Deviation 8.51	36.70 Units on a Scale Standard Deviation 9.10
DB; Mean Baseline Short Form 36 (SF-36) Quality of Life Physical Component Summary (PCS), Mental Component Summary (MCS), and SF-36 Individual Component Scores For Participants With Measurements at Day 85 Social Functioning Scale Component (n=250, n=129)	33.06 Units on a Scale Standard Deviation 10.78	33.95 Units on a Scale Standard Deviation 11.49
DB; Mean Baseline Short Form 36 (SF-36) Quality of Life Physical Component Summary (PCS), Mental Component Summary (MCS), and SF-36 Individual Component Scores For Participants With Measurements at Day 85 Role-Emotional Scale Component (n=249, n=128)	35.79 Units on a Scale Standard Deviation 13.76	37.07 Units on a Scale Standard Deviation 13.83
DB; Mean Baseline Short Form 36 (SF-36) Quality of Life Physical Component Summary (PCS), Mental Component Summary (MCS), and SF-36 Individual Component Scores For Participants With Measurements at Day 85 Mental Health Scale Component (n=249, n=129)	40.35 Units on a Scale Standard Deviation 12.75	42.72 Units on a Scale Standard Deviation 11.15

SECONDARY outcome

Timeframe: BL, Day 85

SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0=worst score (or quality of life) and 100=best score. Change from Baseline= Post-baseline value - time-matched baseline value, where time-matched BL value = the mean BL value for only that cohort of participants with data available at Day 85.

Outcome measures

Outcome measures
Measure	Abatacept (ABA) n=256 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing \< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Placebo (PLA) n=133 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
DB; Adjusted Mean Change From Baseline to Day 85 in Short SF-36 PCS, MCS, and SF-36 Individual Component Scores PCS (n=243, n=128)	5.76 Units on a Scale Standard Error 0.52	2.12 Units on a Scale Standard Error 0.72
DB; Adjusted Mean Change From Baseline to Day 85 in Short SF-36 PCS, MCS, and SF-36 Individual Component Scores MCS (n=243, n=128)	4.64 Units on a Scale Standard Error 0.63	2.08 Units on a Scale Standard Error 0.86
DB; Adjusted Mean Change From Baseline to Day 85 in Short SF-36 PCS, MCS, and SF-36 Individual Component Scores Physical Function Scale Component (n=246, n=129)	3.97 Units on a Scale Standard Error 0.51	2.27 Units on a Scale Standard Error 0.71
DB; Adjusted Mean Change From Baseline to Day 85 in Short SF-36 PCS, MCS, and SF-36 Individual Component Scores Role-Physical Scale Component (n=249, n=129)	5.88 Units on a Scale Standard Error 0.65	2.87 Units on a Scale Standard Error 0.90
DB; Adjusted Mean Change From Baseline to Day 85 in Short SF-36 PCS, MCS, and SF-36 Individual Component Scores Bodily Pain Scale Component (n=248, n=129)	8.43 Units on a Scale Standard Error 0.55	2.81 Units on a Scale Standard Error 0.76
DB; Adjusted Mean Change From Baseline to Day 85 in Short SF-36 PCS, MCS, and SF-36 Individual Component Scores General Health Scale Component (n=250, n=129)	3.65 Units on a Scale Standard Error 0.45	1.15 Units on a Scale Standard Error 0.62
DB; Adjusted Mean Change From Baseline to Day 85 in Short SF-36 PCS, MCS, and SF-36 Individual Component Scores Vitality Scale Component (n=249, n=129)	5.49 Units on a Scale Standard Error 0.57	2.32 Units on a Scale Standard Error 0.80
DB; Adjusted Mean Change From Baseline to Day 85 in Short SF-36 PCS, MCS, and SF-36 Individual Component Scores Social Functioning Scale Component (n=250, n=129)	6.83 Units on a Scale Standard Error 0.62	2.13 Units on a Scale Standard Error 0.87
DB; Adjusted Mean Change From Baseline to Day 85 in Short SF-36 PCS, MCS, and SF-36 Individual Component Scores Role-Emotional Scale Component (n=249, n=128)	4.12 Units on a Scale Standard Error 0.83	3.14 Units on a Scale Standard Error 1.16
DB; Adjusted Mean Change From Baseline to Day 85 in Short SF-36 PCS, MCS, and SF-36 Individual Component Scores Mental Health Scale Component (n=249, n=129)	4.29 Units on a Scale Standard Error 0.58	1.70 Units on a Scale Standard Error 0.80

SECONDARY outcome

Timeframe: BL

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: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. 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. Mean BL value presented represents a time-matched Day 169 BL value for only that cohort of participants with data available at that visit.

Outcome measures

Outcome measures
Measure	Abatacept (ABA) n=256 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing \< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Placebo (PLA) n=133 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
DB; Mean Baseline SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participants With Measurements at Day 169 PCS (n=242, n=129)	27.36 Units on a Scale Standard Deviation 6.88	27.75 Units on a Scale Standard Deviation 6.29
DB; Mean Baseline SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participants With Measurements at Day 169 MCS (n=242, n=129)	41.56 Units on a Scale Standard Deviation 12.33	42.98 Units on a Scale Standard Deviation 11.90
DB; Mean Baseline SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participants With Measurements at Day 169 Physical Function Scale Component (n=247, n=130)	25.96 Units on a Scale Standard Deviation 8.88	26.24 Units on a Scale Standard Deviation 8.37
DB; Mean Baseline SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participants With Measurements at Day 169 Role-Physical Scale Component (n=249, n=130)	30.56 Units on a Scale Standard Deviation 6.29	31.93 Units on a Scale Standard Deviation 6.82
DB; Mean Baseline SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participants With Measurements at Day 169 Bodily Pain Scale Component (n=248, n=130)	30.54 Units on a Scale Standard Deviation 6.76	31.27 Units on a Scale Standard Deviation 6.62
DB; Mean Baseline SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participants With Measurements at Day 169 General Health Scale Component (n=252, n=130)	34.81 Units on a Scale Standard Deviation 9.20	35.05 Units on a Scale Standard Deviation 8.51
DB; Mean Baseline SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participants With Measurements at Day 169 Vitality Scale Component (n=252, n=130)	35.07 Units on a Scale Standard Deviation 8.52	36.69 Units on a Scale Standard Deviation 9.06
DB; Mean Baseline SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participants With Measurements at Day 169 Social Functioning Scale Component (n=251, n=130)	33.17 Units on a Scale Standard Deviation 10.81	33.84 Units on a Scale Standard Deviation 11.52
DB; Mean Baseline SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participants With Measurements at Day 169 Role-Emotional Scale Component (n=249, n=129)	35.96 Units on a Scale Standard Deviation 13.77	36.97 Units on a Scale Standard Deviation 13.83
DB; Mean Baseline SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participants With Measurements at Day 169 Mental Health Scale Component (n=252, n=130)	40.50 Units on a Scale Standard Deviation 12.81	42.80 Units on a Scale Standard Deviation 11.14

SECONDARY outcome

Timeframe: BL, Day 169

Outcome measures

Outcome measures
Measure	Abatacept (ABA) n=256 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing \< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Placebo (PLA) n=133 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
DB; Adjusted Mean Change From Baseline to Day 169 in SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participants With Measurements at Day 169 PCS (n=242, n=129)	6.58 Units on a Scale Standard Deviation 0.55	1.12 Units on a Scale Standard Deviation 0.75
DB; Adjusted Mean Change From Baseline to Day 169 in SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participants With Measurements at Day 169 MCS (n=242, n=129)	5.15 Units on a Scale Standard Deviation 0.64	2.11 Units on a Scale Standard Deviation 0.87
DB; Adjusted Mean Change From Baseline to Day 169 in SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participants With Measurements at Day 169 Physical Function Scale Component (n=247, n=130)	5.30 Units on a Scale Standard Deviation 0.58	1.27 Units on a Scale Standard Deviation 0.80
DB; Adjusted Mean Change From Baseline to Day 169 in SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participants With Measurements at Day 169 Role-Physical Scale Component (n=249, n=130)	6.52 Units on a Scale Standard Deviation 0.63	1.29 Units on a Scale Standard Deviation 0.87
DB; Adjusted Mean Change From Baseline to Day 169 in SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participants With Measurements at Day 169 Bodily Pain Scale Component (n=248, n=130)	8.72 Units on a Scale Standard Deviation 0.56	2.48 Units on a Scale Standard Deviation 0.77
DB; Adjusted Mean Change From Baseline to Day 169 in SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participants With Measurements at Day 169 General Health Scale Component (n=252, n=130)	4.02 Units on a Scale Standard Deviation 0.48	0.74 Units on a Scale Standard Deviation 0.67
DB; Adjusted Mean Change From Baseline to Day 169 in SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participants With Measurements at Day 169 Vitality Scale Component (n=252, n=130)	6.55 Units on a Scale Standard Deviation 0.60	1.77 Units on a Scale Standard Deviation 0.83
DB; Adjusted Mean Change From Baseline to Day 169 in SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participants With Measurements at Day 169 Social Functioning Scale Component (n=251, n=130)	7.31 Units on a Scale Standard Deviation 0.65	2.39 Units on a Scale Standard Deviation 0.91
DB; Adjusted Mean Change From Baseline to Day 169 in SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participants With Measurements at Day 169 Role-Emotional Scale Component (n=249, n=129)	6.00 Units on a Scale Standard Deviation 0.83	2.46 Units on a Scale Standard Deviation 1.15
DB; Adjusted Mean Change From Baseline to Day 169 in SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participants With Measurements at Day 169 Mental Health Scale Component (n=252, n=130)	4.31 Units on a Scale Standard Deviation 0.56	1.61 Units on a Scale Standard Deviation 0.79

SECONDARY outcome

Timeframe: BL

The HAQ DI is a self-administered questionnaire composed of 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. 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 is a weighted sum of the scale scores, with a higher score indicating poorer function. The mean baseline value presented represents a time-matched Day 169 baseline value for only that cohort of participants with assessments available at that visit.

Outcome measures

Outcome measures
Measure	Abatacept (ABA) n=256 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing \< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Placebo (PLA) n=133 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
DB; Mean Baseline HAQ-DI and HAQ Component Scores in Participants With Assessments at Day 169 HAQ eating (n=214, n=97)	1.76 units on a scale Standard Deviation 0.83	1.78 units on a scale Standard Deviation 0.87
DB; Mean Baseline HAQ-DI and HAQ Component Scores in Participants With Assessments at Day 169 HAQ walking (n=213, n=95)	1.56 units on a scale Standard Deviation 0.70	1.51 units on a scale Standard Deviation 0.76
DB; Mean Baseline HAQ-DI and HAQ Component Scores in Participants With Assessments at Day 169 HAQ-DI (n=249, n=130)	1.83 units on a scale Standard Deviation 0.58	1.82 units on a scale Standard Deviation 0.60
DB; Mean Baseline HAQ-DI and HAQ Component Scores in Participants With Assessments at Day 169 HAQ dressing and grooming (n=214, n=97)	1.64 units on a scale Standard Deviation 0.75	1.54 units on a scale Standard Deviation 0.69
DB; Mean Baseline HAQ-DI and HAQ Component Scores in Participants With Assessments at Day 169 HAQ arising (n=214, n=97)	1.42 units on a scale Standard Deviation 0.72	1.43 units on a scale Standard Deviation 0.73
DB; Mean Baseline HAQ-DI and HAQ Component Scores in Participants With Assessments at Day 169 HAQ hygiene (n=213, n=97)	2.14 units on a scale Standard Deviation 0.88	2.21 units on a scale Standard Deviation 0.87
DB; Mean Baseline HAQ-DI and HAQ Component Scores in Participants With Assessments at Day 169 HAQ reaching (n=213, n=97)	2.04 units on a scale Standard Deviation 0.79	1.97 units on a scale Standard Deviation 0.87
DB; Mean Baseline HAQ-DI and HAQ Component Scores in Participants With Assessments at Day 169 HAQ gripping (n=212, n=97)	1.96 units on a scale Standard Deviation 0.53	1.93 units on a scale Standard Deviation 0.62
DB; Mean Baseline HAQ-DI and HAQ Component Scores in Participants With Assessments at Day 169 HAQ activities (n=213, n=97)	2.00 units on a scale Standard Deviation 0.79	1.95 units on a scale Standard Deviation 0.86

SECONDARY outcome

Timeframe: BL, Day 169

HAQ DI is a self-administered questionnaire composed of 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. Questions 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=weighted sum of the scale scores. Higher score indicates poorer function.Change from BL = Post-BL value - time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at Day 169.

Outcome measures

Outcome measures
Measure	Abatacept (ABA) n=256 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing \< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Placebo (PLA) n=133 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
DB; Adjusted Mean Change From Baseline to Day 169 in HAQ-DI and HAQ Component Scores in Participants With Assessments at Day 169 HAQ-DI (n=249, n=130)	-0.45 units on a scale Standard Deviation 0.03	-0.11 units on a scale Standard Deviation 0.04
DB; Adjusted Mean Change From Baseline to Day 169 in HAQ-DI and HAQ Component Scores in Participants With Assessments at Day 169 HAQ dressing and grooming (n=214, n=97)	-0.58 units on a scale Standard Deviation 0.05	-0.26 units on a scale Standard Deviation 0.07
DB; Adjusted Mean Change From Baseline to Day 169 in HAQ-DI and HAQ Component Scores in Participants With Assessments at Day 169 HAQ arising (n=214, n=97)	-0.61 units on a scale Standard Deviation 0.04	-0.29 units on a scale Standard Deviation 0.07
DB; Adjusted Mean Change From Baseline to Day 169 in HAQ-DI and HAQ Component Scores in Participants With Assessments at Day 169 HAQ eating (n=214, n=97)	-0.54 units on a scale Standard Deviation 0.05	-0.07 units on a scale Standard Deviation 0.07
DB; Adjusted Mean Change From Baseline to Day 169 in HAQ-DI and HAQ Component Scores in Participants With Assessments at Day 169 HAQ walking (n=213, n=95)	-0.50 units on a scale Standard Deviation 0.05	-0.24 units on a scale Standard Deviation 0.07
DB; Adjusted Mean Change From Baseline to Day 169 in HAQ-DI and HAQ Component Scores in Participants With Assessments at Day 169 HAQ hygiene (n=213, n=97)	-0.28 units on a scale Standard Deviation 0.05	-0.05 units on a scale Standard Deviation 0.07
DB; Adjusted Mean Change From Baseline to Day 169 in HAQ-DI and HAQ Component Scores in Participants With Assessments at Day 169 HAQ reaching (n=213, n=97)	-0.54 units on a scale Standard Deviation 0.05	-0.11 units on a scale Standard Deviation 0.08
DB; Adjusted Mean Change From Baseline to Day 169 in HAQ-DI and HAQ Component Scores in Participants With Assessments at Day 169 HAQ gripping (n=212, n=97)	-0.47 units on a scale Standard Deviation 0.05	-0.15 units on a scale Standard Deviation 0.07
DB; Adjusted Mean Change From Baseline to Day 169 in HAQ-DI and HAQ Component Scores in Participants With Assessments at Day 169 HAQ activities (n=213, n=97)	-0.48 units on a scale Standard Deviation 0.05	-0.08 units on a scale Standard Deviation 0.07

SECONDARY outcome

Timeframe: BL, Day 169

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 levels, 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. The mean BL value presented represents a time-matched Day 169 BL value for only that cohort of participants with assessments available at that visit.

Outcome measures

Outcome measures
Measure	Abatacept (ABA) n=256 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing \< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Placebo (PLA) n=133 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
DB; Mean Disease Activity Score (DAS)28 (C-Reactive Protein [CRP]) and Mean Disease Activity Score (Erythrocyte Sedimentation Rate [ESR]) at Day 169 Baseline DAS28 (CRP); n=251, n=130	6.53 Units on a Scale Standard Deviation 0.89	6.51 Units on a Scale Standard Deviation 0.78
DB; Mean Disease Activity Score (DAS)28 (C-Reactive Protein [CRP]) and Mean Disease Activity Score (Erythrocyte Sedimentation Rate [ESR]) at Day 169 Day 169 DAS28 (CRP); n=251, n=130	4.70 Units on a Scale Standard Deviation 1.45	5.78 Units on a Scale Standard Deviation 1.33
DB; Mean Disease Activity Score (DAS)28 (C-Reactive Protein [CRP]) and Mean Disease Activity Score (Erythrocyte Sedimentation Rate [ESR]) at Day 169 Baseline DAS28 (ESR); n=182, n=98	6.88 Units on a Scale Standard Deviation 0.99	6.88 Units on a Scale Standard Deviation 0.92
DB; Mean Disease Activity Score (DAS)28 (C-Reactive Protein [CRP]) and Mean Disease Activity Score (Erythrocyte Sedimentation Rate [ESR]) at Day 169 Day 169 DAS28 (ESR); n=182, n=98	4.90 Units on a Scale Standard Deviation 1.55	6.17 Units on a Scale Standard Deviation 1.34

SECONDARY outcome

Timeframe: BL, Day 169

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). Change from BL = Post-BL value - time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at Day 169.

Outcome measures

Outcome measures
Measure	Abatacept (ABA) n=256 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing \< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Placebo (PLA) n=133 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
DB; Adjusted Mean Change From Baseline to Day 169 in DAS28 (CRP) and DAS28 (ESR) DAS28 (CRP); n=251, n=130	-1.83 Units on a Scale Standard Error 0.08	-0.74 Units on a Scale Standard Error 0.11
DB; Adjusted Mean Change From Baseline to Day 169 in DAS28 (CRP) and DAS28 (ESR) DAS28 (ESR); n=182, n=98	-1.98 Units on a Scale Standard Error 0.10	-0.71 Units on a Scale Standard Error 0.14

SECONDARY outcome

Timeframe: From BL up to database lock for DB period (6/2/2004)

Population: All treated participants

Outcome measures

Outcome measures
Measure	Abatacept (ABA) n=258 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing \< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Placebo (PLA) n=133 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
DB; Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuation, AEs, Related AEs, or AEs Leading to Discontinuation Deaths	1 participants	0 participants
DB; Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuation, AEs, Related AEs, or AEs Leading to Discontinuation SAEs	27 participants	15 participants
DB; Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuation, AEs, Related AEs, or AEs Leading to Discontinuation Related SAEs	7 participants	1 participants
DB; Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuation, AEs, Related AEs, or AEs Leading to Discontinuation SAEs Leading to Discontinuation	7 participants	2 participants
DB; Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuation, AEs, Related AEs, or AEs Leading to Discontinuation AEs	205 participants	95 participants
DB; Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuation, AEs, Related AEs, or AEs Leading to Discontinuation Related AEs	107 participants	39 participants
DB; Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuation, AEs, Related AEs, or AEs Leading to Discontinuation AEs Leading to Discontinuation	9 participants	4 participants

SECONDARY outcome

Timeframe: From BL up to database lock for DB period (6/2/2004)

Population: All treated participants

Outcome measures

Outcome measures
Measure	Abatacept (ABA) n=258 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing \< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Placebo (PLA) n=133 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
DB; Number of Participants AEs of Special Interest Infections	97 participants	43 participants
DB; Number of Participants AEs of Special Interest Neoplasms	7 participants	1 participants
DB; Number of Participants AEs of Special Interest Pre-specified autoimmune disorders	4 participants	0 participants
DB; Number of Participants AEs of Special Interest Acute infusional AEs	13 participants	4 participants
DB; Number of Participants AEs of Special Interest Peri-infusional AEs	40 participants	17 participants

SECONDARY outcome

Timeframe: From BL up to database lock for DB period (6/2/2004)

Population: All treated participants

Outcome measures

Outcome measures
Measure	Abatacept (ABA) n=256 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing \< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Placebo (PLA) n=131 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
DB; Number of Participants With Hematology Laboratories Meeting Marked Abnormality (MA) Criteria Low HGB (LLN=11.5 g/dL)	0 participants	1 participants
DB; Number of Participants With Hematology Laboratories Meeting Marked Abnormality (MA) Criteria Low hematocrit (LLN=34%)	0 participants	1 participants
DB; Number of Participants With Hematology Laboratories Meeting Marked Abnormality (MA) Criteria Low erythrocytes (LLN=3.8 x10*6 cells/μL)	0 participants	0 participants
DB; Number of Participants With Hematology Laboratories Meeting Marked Abnormality (MA) Criteria Low PLT (LLN=140*10^9 cells/μL)	1 participants	1 participants
DB; Number of Participants With Hematology Laboratories Meeting Marked Abnormality (MA) Criteria High PLT (ULN=450*10^9 cells/L)	1 participants	0 participants
DB; Number of Participants With Hematology Laboratories Meeting Marked Abnormality (MA) Criteria Low leukocytes (LLN= 3.8*10^3 cells/μL)	2 participants	0 participants
DB; Number of Participants With Hematology Laboratories Meeting Marked Abnormality (MA) Criteria High leukocytes (ULN = 10.6*10^3 cells/μL)	18 participants	14 participants
DB; Number of Participants With Hematology Laboratories Meeting Marked Abnormality (MA) Criteria Low neutrophils+bands(LLN=1.8*10^3 cells/μL)	0 participants	0 participants
DB; Number of Participants With Hematology Laboratories Meeting Marked Abnormality (MA) Criteria Low lymphocytes (LLN= 0.7*10^3 cells/μL)	0 participants	0 participants
DB; Number of Participants With Hematology Laboratories Meeting Marked Abnormality (MA) Criteria High lymphocytes(ULN=4.5*10^3 cells/μL)	0 participants	0 participants
DB; Number of Participants With Hematology Laboratories Meeting Marked Abnormality (MA) Criteria High monocytes (ULN=1*10^3 cells/μL)	0 participants	0 participants
DB; Number of Participants With Hematology Laboratories Meeting Marked Abnormality (MA) Criteria High basophils (ULN= 0.2*10^3 cells/μL)	0 participants	0 participants
DB; Number of Participants With Hematology Laboratories Meeting Marked Abnormality (MA) Criteria High eosinophils (ULN= 7*10^3 cells/μL)	0 participants	0 participants

SECONDARY outcome

Timeframe: From BL up to database lock for DB period (6/2/2004)

Population: All treated participants

Outcome measures

Outcome measures
Measure	Abatacept (ABA) n=256 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing \< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Placebo (PLA) n=131 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
DB; Number of Participants With Blood Chemistry Laboratories Meeting MA Criteria High ALP (ULN=400 U/L)	0 participants	0 participants
DB; Number of Participants With Blood Chemistry Laboratories Meeting MA Criteria High AST (ULN=44 U/L)	2 participants	2 participants
DB; Number of Participants With Blood Chemistry Laboratories Meeting MA Criteria High ALT (ULN=55 U/L)	4 participants	1 participants
DB; Number of Participants With Blood Chemistry Laboratories Meeting MA Criteria High GGT (ULN=65 U/L)	0 participants	0 participants
DB; Number of Participants With Blood Chemistry Laboratories Meeting MA Criteria High bilirubin (ULN=1.2 mg/dL)	0 participants	0 participants
DB; Number of Participants With Blood Chemistry Laboratories Meeting MA Criteria High BUN (ULN=26 mg/dL)	0 participants	0 participants
DB; Number of Participants With Blood Chemistry Laboratories Meeting MA Criteria High creatinine (ULN=1.5 mg/dL)	11 participants	5 participants

SECONDARY outcome

Timeframe: From BL to Day 169

Population: All treated participants in the double-blind period with at least 1 post-baseline immunogenicity result

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.

Outcome measures

Outcome measures
Measure	Abatacept (ABA) n=234 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing \< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Placebo (PLA) Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
DB; Number of Participants With Positive Anti-Abatacept or Anti-Cytotoxic T-Lymphocyte Antigen 4 (CTLA4) Responses by Enzyme-Linked Immunosorbant Assay (ELISA) Anti-abatacept antibodies	1 participants	—
DB; Number of Participants With Positive Anti-Abatacept or Anti-Cytotoxic T-Lymphocyte Antigen 4 (CTLA4) Responses by Enzyme-Linked Immunosorbant Assay (ELISA) Anti-CTLA4 antibodies	2 participants	—
DB; Number of Participants With Positive Anti-Abatacept or Anti-Cytotoxic T-Lymphocyte Antigen 4 (CTLA4) Responses by Enzyme-Linked Immunosorbant Assay (ELISA) Total	3 participants	—

SECONDARY outcome

Timeframe: Days 15, 29, 57, 85, 113, 141, 169, 253, 365, 449, 533, 617, 729, 813, 897, 981, 1093, 1261, 1457, 1625, and 1821

Outcome measures

Outcome measures
Measure	Abatacept (ABA) n=214 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing \< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Placebo (PLA) n=98 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
OL; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time For Participants Treated in the OL Day 15 ACR 20 (n=214, n=97)	43 participants	6 participants
OL; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time For Participants Treated in the OL Day 15 ACR 50 (n=213, n=97)	5 participants	0 participants
OL; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time For Participants Treated in the OL Day 15 ACR 70 (n=214, n=97)	1 participants	0 participants
OL; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time For Participants Treated in the OL Day 29 ACR 20 (n=210, n=97)	77 participants	23 participants
OL; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time For Participants Treated in the OL Day 29 ACR 50 (n=213, n=97)	20 participants	4 participants
OL; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time For Participants Treated in the OL Day 29 ACR 70 (n=213, n=97)	4 participants	1 participants
OL; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time For Participants Treated in the OL Day 57 ACR 20 (n=211, n=98)	109 participants	30 participants
OL; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time For Participants Treated in the OL Day 57 ACR 50 (n=213, n=98)	31 participants	9 participants
OL; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time For Participants Treated in the OL Day 57 ACR 70 (n=213, n=98)	11 participants	0 participants
OL; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time For Participants Treated in the OL Day 85 ACR 20 (n=211, n=97)	113 participants	22 participants
OL; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time For Participants Treated in the OL Day 85 ACR 50 (n=211, n=97)	44 participants	8 participants
OL; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time For Participants Treated in the OL Day 85 ACR 70 (n=212, n=98)	15 participants	1 participants
OL; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time For Participants Treated in the OL Day 113 ACR 20 (n=203, n=95)	120 participants	31 participants
OL; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time For Participants Treated in the OL Day 113 ACR 50 (n=206, n=97)	42 participants	5 participants
OL; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time For Participants Treated in the OL Day 113 ACR 70 (n=206, n=97)	20 participants	0 participants
OL; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time For Participants Treated in the OL Day 141 ACR 20 (n=212, n=96)	136 participants	26 participants
OL; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time For Participants Treated in the OL Day 141 ACR 50 (n=214, n=97)	62 participants	6 participants
OL; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time For Participants Treated in the OL Day 141 ACR 70 (n=214, n=97)	25 participants	0 participants
OL; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time For Participants Treated in the OL Day 169 ACR 20 (n=208, n=98)	125 participants	26 participants
OL; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time For Participants Treated in the OL Day 169 ACR 50 (n=209, n=98)	50 participants	5 participants
OL; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time For Participants Treated in the OL Day 169 ACR 70 (n=212, n=98)	25 participants	2 participants
OL; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time For Participants Treated in the OL Day 253 ACR 20 (n=203, n=95)	127 participants	49 participants
OL; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time For Participants Treated in the OL Day 253 ACR 50 (n=199, n=97)	58 participants	28 participants
OL; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time For Participants Treated in the OL Day 253 ACR 70 (n=204, n=98)	25 participants	10 participants
OL; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time For Participants Treated in the OL Day 365 ACR 20 (n=198, n=96)	129 participants	63 participants
OL; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time For Participants Treated in the OL Day 365 ACR 50 (n=201, n=95)	65 participants	37 participants
OL; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time For Participants Treated in the OL Day 365 ACR 70 (n=202, n=96)	37 participants	13 participants
OL; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time For Participants Treated in the OL Day 449 ACR 20 (n=181, n=82)	124 participants	61 participants
OL; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time For Participants Treated in the OL Day 449 ACR 50 (n=181, n=85)	73 participants	37 participants
OL; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time For Participants Treated in the OL Day 449 ACR 70 (n=182, n=85)	32 participants	18 participants
OL; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time For Participants Treated in the OL Day 533 ACR 20 (n=168, n=76)	115 participants	53 participants
OL; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time For Participants Treated in the OL Day 533 ACR 50 (n=169, n=77)	71 participants	30 participants
OL; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time For Participants Treated in the OL Day 533 ACR 70 (n=171, n=78)	36 participants	10 participants
OL; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time For Participants Treated in the OL Day 617 ACR 20 (n=163, n=72)	120 participants	55 participants
OL; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time For Participants Treated in the OL Day 617 ACR 50 (n=161, n=70)	73 participants	32 participants
OL; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time For Participants Treated in the OL Day 617 ACR 70 (n=162, n=71)	33 participants	13 participants
OL; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time For Participants Treated in the OL Day 729 ACR 20 (n=156, n=71)	117 participants	49 participants
OL; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time For Participants Treated in the OL Day 729 ACR 50 (n=153, n=72)	70 participants	30 participants
OL; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time For Participants Treated in the OL Day 729 ACR 70 (n=155, n=74)	35 participants	13 participants
OL; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time For Participants Treated in the OL Day 813 ACR 20 (n=140, n=60)	105 participants	47 participants
OL; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time For Participants Treated in the OL Day 813 ACR 50 (n=141, n=61)	62 participants	23 participants
OL; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time For Participants Treated in the OL Day 813 ACR 70 (n=143, n=62)	28 participants	6 participants
OL; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time For Participants Treated in the OL Day 897 ACR 20 (n=134, n=62)	107 participants	45 participants
OL; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time For Participants Treated in the OL Day 897 ACR 50 (n=137, n=61)	64 participants	29 participants
OL; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time For Participants Treated in the OL Day 897 ACR 70 (n=138, n=62)	27 participants	8 participants
OL; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time For Participants Treated in the OL Day 981 ACR 20 (n=140, n=57)	104 participants	40 participants
OL; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time For Participants Treated in the OL Day 981 ACR 50 (n=143, n=58)	66 participants	25 participants
OL; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time For Participants Treated in the OL Day 981 ACR 70 (n=140, n=60)	31 participants	9 participants
OL; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time For Participants Treated in the OL Day 1093 ACR 20 (n=134, n=55)	109 participants	44 participants
OL; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time For Participants Treated in the OL Day 1093 ACR 50 (n=137, n=57)	70 participants	29 participants
OL; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time For Participants Treated in the OL Day 1093 ACR 70 (n=137, n=58)	32 participants	16 participants
OL; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time For Participants Treated in the OL Day 1261 ACR 20 (n=126, n=52)	99 participants	42 participants
OL; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time For Participants Treated in the OL Day 1261 ACR 50 (n=126, n=53)	60 participants	24 participants
OL; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time For Participants Treated in the OL Day 1261 ACR 70 (n=130, n=55)	27 participants	15 participants
OL; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time For Participants Treated in the OL Day 1457 ACR 20 (n=115, n=50)	87 participants	41 participants
OL; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time For Participants Treated in the OL Day 1457 ACR 50 (n=115, n=50)	53 participants	24 participants
OL; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time For Participants Treated in the OL Day 1457 ACR 70 (n=118, n=50)	22 participants	11 participants
OL; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time For Participants Treated in the OL Day 1625 ACR 20 (n=110, n=49)	89 participants	33 participants
OL; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time For Participants Treated in the OL Day 1625 ACR 50 (n=111, n=48)	50 participants	19 participants
OL; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time For Participants Treated in the OL Day 1625 ACR 70 (n=112, n=49)	26 participants	12 participants
OL; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time For Participants Treated in the OL Day 1821 ACR 20 (n=106, n=46)	81 participants	35 participants
OL; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time For Participants Treated in the OL Day 1821 ACR 50 (n=106, n=47)	55 participants	24 participants
OL; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time For Participants Treated in the OL Day 1821 ACR 70 (n=109, n=47)	24 participants	10 participants

SECONDARY outcome

Timeframe: Days 15, 29, 57, 85, 113, 141, 169, 253, 365, 449, 533, 617, 729, 813, 897, 981, 1093, 1261, 1457, 1625, and 1821

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.

Outcome measures

Outcome measures
Measure	Abatacept (ABA) n=213 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing \< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Placebo (PLA) n=98 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
OL; Number of Participants With Low Disease Activity (LDAS) or Remission For Participants Treated in the OL Day 15 LDAS (n=209, n=95)	5 participants	0 participants
OL; Number of Participants With Low Disease Activity (LDAS) or Remission For Participants Treated in the OL Day 15 Remission (n=209, n=95)	1 participants	0 participants
OL; Number of Participants With Low Disease Activity (LDAS) or Remission For Participants Treated in the OL Day 29 LDAS (n=206, n=96)	10 participants	1 participants
OL; Number of Participants With Low Disease Activity (LDAS) or Remission For Participants Treated in the OL Day 29 Remission (n=206, n=96)	5 participants	1 participants
OL; Number of Participants With Low Disease Activity (LDAS) or Remission For Participants Treated in the OL Day 57 LDAS (n=210, n=97)	19 participants	5 participants
OL; Number of Participants With Low Disease Activity (LDAS) or Remission For Participants Treated in the OL Day 57 Remission (n=210, n=97)	11 participants	1 participants
OL; Number of Participants With Low Disease Activity (LDAS) or Remission For Participants Treated in the OL Day 85 LDAS (n=212, n=98)	22 participants	4 participants
OL; Number of Participants With Low Disease Activity (LDAS) or Remission For Participants Treated in the OL Day 85 Remission (n=212, n=98)	11 participants	3 participants
OL; Number of Participants With Low Disease Activity (LDAS) or Remission For Participants Treated in the OL Day 113 LDAS (n=202, n=93)	28 participants	4 participants
OL; Number of Participants With Low Disease Activity (LDAS) or Remission For Participants Treated in the OL Day 113 Remission (n=202, n=93)	11 participants	0 participants
OL; Number of Participants With Low Disease Activity (LDAS) or Remission For Participants Treated in the OL Day 141 LDAS (n=213, n=96)	41 participants	4 participants
OL; Number of Participants With Low Disease Activity (LDAS) or Remission For Participants Treated in the OL Day 141 Remission (n=213, n=96)	15 participants	2 participants
OL; Number of Participants With Low Disease Activity (LDAS) or Remission For Participants Treated in the OL Day 169 LDAS (n=208, n=96)	38 participants	5 participants
OL; Number of Participants With Low Disease Activity (LDAS) or Remission For Participants Treated in the OL Day 169 Remission (n=208, n=96)	23 participants	1 participants
OL; Number of Participants With Low Disease Activity (LDAS) or Remission For Participants Treated in the OL Day 253 LDAS (n=195, n=89)	33 participants	19 participants
OL; Number of Participants With Low Disease Activity (LDAS) or Remission For Participants Treated in the OL Day 253 Remission (n=195, n=89)	19 participants	12 participants
OL; Number of Participants With Low Disease Activity (LDAS) or Remission For Participants Treated in the OL Day 365 LDAS (n=194, n=93)	47 participants	22 participants
OL; Number of Participants With Low Disease Activity (LDAS) or Remission For Participants Treated in the OL Day 365 Remission (n=194, n=93)	27 participants	17 participants
OL; Number of Participants With Low Disease Activity (LDAS) or Remission For Participants Treated in the OL Day 449 LDAS (n=170, n=76)	48 participants	25 participants
OL; Number of Participants With Low Disease Activity (LDAS) or Remission For Participants Treated in the OL Day 449 Remission (n=170, n=76)	24 participants	15 participants
OL; Number of Participants With Low Disease Activity (LDAS) or Remission For Participants Treated in the OL Day 533 LDAS (n=164, n=73)	46 participants	21 participants
OL; Number of Participants With Low Disease Activity (LDAS) or Remission For Participants Treated in the OL Day 533 Remission (n=164, n=73)	26 participants	13 participants
OL; Number of Participants With Low Disease Activity (LDAS) or Remission For Participants Treated in the OL Day 617 LDAS (n=164, n=69)	51 participants	23 participants
OL; Number of Participants With Low Disease Activity (LDAS) or Remission For Participants Treated in the OL Day 617 Remission (n=164, n=69)	29 participants	13 participants
OL; Number of Participants With Low Disease Activity (LDAS) or Remission For Participants Treated in the OL Day 729 LDAS (n=153, n=68)	49 participants	12 participants
OL; Number of Participants With Low Disease Activity (LDAS) or Remission For Participants Treated in the OL Day 729 Remission (n=153, n=68)	31 participants	7 participants
OL; Number of Participants With Low Disease Activity (LDAS) or Remission For Participants Treated in the OL Day 813 LDAS (n=139, n=58)	43 participants	16 participants
OL; Number of Participants With Low Disease Activity (LDAS) or Remission For Participants Treated in the OL Day 813 Remission (n=139, n=58)	26 participants	6 participants
OL; Number of Participants With Low Disease Activity (LDAS) or Remission For Participants Treated in the OL Day 897 LDAS (n=134, n=60)	50 participants	14 participants
OL; Number of Participants With Low Disease Activity (LDAS) or Remission For Participants Treated in the OL Day 897 Remission (n=134, n=60)	26 participants	8 participants
OL; Number of Participants With Low Disease Activity (LDAS) or Remission For Participants Treated in the OL Day 981 LDAS (n=121, n=49)	47 participants	14 participants
OL; Number of Participants With Low Disease Activity (LDAS) or Remission For Participants Treated in the OL Day 981 Remission (n=121, n=49)	28 participants	7 participants
OL; Number of Participants With Low Disease Activity (LDAS) or Remission For Participants Treated in the OL Day 1093 LDAS (n=134, n=56)	50 participants	15 participants
OL; Number of Participants With Low Disease Activity (LDAS) or Remission For Participants Treated in the OL Day 1093 Remission (n=134, n=56)	31 participants	8 participants
OL; Number of Participants With Low Disease Activity (LDAS) or Remission For Participants Treated in the OL Day 1261 LDAS (n=126, n=51)	50 participants	19 participants
OL; Number of Participants With Low Disease Activity (LDAS) or Remission For Participants Treated in the OL Day 1261 Remission (n=126, n=51)	25 participants	9 participants
OL; Number of Participants With Low Disease Activity (LDAS) or Remission For Participants Treated in the OL Day 1457 LDAS (n=115, n=50)	46 participants	14 participants
OL; Number of Participants With Low Disease Activity (LDAS) or Remission For Participants Treated in the OL Day 1457 Remission (n=115, n=50)	24 participants	9 participants
OL; Number of Participants With Low Disease Activity (LDAS) or Remission For Participants Treated in the OL Day 1625 LDAS (n=107, n=46)	40 participants	14 participants
OL; Number of Participants With Low Disease Activity (LDAS) or Remission For Participants Treated in the OL Day 1625 Remission (n=107, n=46)	28 participants	11 participants
OL; Number of Participants With Low Disease Activity (LDAS) or Remission For Participants Treated in the OL Day 1821 LDAS (n=103, n=45)	38 participants	12 participants
OL; Number of Participants With Low Disease Activity (LDAS) or Remission For Participants Treated in the OL Day 1821 Remission (n=103, n=45)	23 participants	10 participants

SECONDARY outcome

Timeframe: BL

Population: Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.

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 levels, 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 values were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit.

Outcome measures

Outcome measures
Measure	Abatacept (ABA) n=209 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing \< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Placebo (PLA) n=98 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
OL; Mean Time-matched Baseline DAS28 (CRP) Over Time For Participants Treated in the OL Day 15 cohort (n=206, n=95)	6.52 units on a scale Standard Deviation 0.84	6.46 units on a scale Standard Deviation 0.81
OL; Mean Time-matched Baseline DAS28 (CRP) Over Time For Participants Treated in the OL Day 29 cohort (n=204, n=96)	6.53 units on a scale Standard Deviation 0.86	6.46 units on a scale Standard Deviation 0.82
OL; Mean Time-matched Baseline DAS28 (CRP) Over Time For Participants Treated in the OL Day 57 cohort (n=207, n=97)	6.51 units on a scale Standard Deviation 0.84	6.43 units on a scale Standard Deviation 0.81
OL; Mean Time-matched Baseline DAS28 (CRP) Over Time For Participants Treated in the OL Day 85 cohort (n=209, n=98)	6.55 units on a scale Standard Deviation 0.84	6.45 units on a scale Standard Deviation 0.82
OL; Mean Time-matched Baseline DAS28 (CRP) Over Time For Participants Treated in the OL Day 113 cohort (n=199, n=93)	6.55 units on a scale Standard Deviation 0.85	6.49 units on a scale Standard Deviation 0.80
OL; Mean Time-matched Baseline DAS28 (CRP) Over Time For Participants Treated in the OL Day 141 cohort (n=210, n=96)	6.53 units on a scale Standard Deviation 0.85	6.43 units on a scale Standard Deviation 0.82
OL; Mean Time-matched Baseline DAS28 (CRP) Over Time For Participants Treated in the OL Day 169 cohort (n=205, n=96)	6.54 units on a scale Standard Deviation 0.85	6.44 units on a scale Standard Deviation 0.81
OL; Mean Time-matched Baseline DAS28 (CRP) Over Time For Participants Treated in the OL Day 253 cohort (n=193, n=89)	6.53 units on a scale Standard Deviation 0.86	6.44 units on a scale Standard Deviation 0.79
OL; Mean Time-matched Baseline DAS28 (CRP) Over Time For Participants Treated in the OL Day 365 cohort (n=192, n=93)	6.51 units on a scale Standard Deviation 0.85	6.43 units on a scale Standard Deviation 0.83
OL; Mean Time-matched Baseline DAS28 (CRP) Over Time For Participants Treated in the OL Day 449 cohort (n=168, n=76)	6.52 units on a scale Standard Deviation 0.86	6.42 units on a scale Standard Deviation 0.83
OL; Mean Time-matched Baseline DAS28 (CRP) Over Time For Participants Treated in the OL Day 533 cohort (n=162, n=73)	6.52 units on a scale Standard Deviation 0.85	6.45 units on a scale Standard Deviation 0.78
OL; Mean Time-matched Baseline DAS28 (CRP) Over Time For Participants Treated in the OL Day 617 cohort (n=163, n=69)	6.51 units on a scale Standard Deviation 0.82	6.49 units on a scale Standard Deviation 0.75
OL; Mean Time-matched Baseline DAS28 (CRP) Over Time For Participants Treated in the OL Day 729 cohort (n=151, n=68)	6.50 units on a scale Standard Deviation 0.84	6.52 units on a scale Standard Deviation 0.76
OL; Mean Time-matched Baseline DAS28 (CRP) Over Time For Participants Treated in the OL Day 813 cohort (n=137, n=58)	6.47 units on a scale Standard Deviation 0.83	6.56 units on a scale Standard Deviation 0.78
OL; Mean Time-matched Baseline DAS28 (CRP) Over Time For Participants Treated in the OL Day 897 cohort (n=132, n=60)	6.43 units on a scale Standard Deviation 0.82	6.61 units on a scale Standard Deviation 0.73
OL; Mean Time-matched Baseline DAS28 (CRP) Over Time For Participants Treated in the OL Day 981 cohort (n=119, n=49)	6.46 units on a scale Standard Deviation 0.84	6.56 units on a scale Standard Deviation 0.72
OL; Mean Time-matched Baseline DAS28 (CRP) Over Time For Participants Treated in the OL Day 1093 cohort (n=133, n=56)	6.49 units on a scale Standard Deviation 0.81	6.53 units on a scale Standard Deviation 0.77
OL; Mean Time-matched Baseline DAS28 (CRP) Over Time For Participants Treated in the OL Day 1261 cohort (n=124, n=51)	6.42 units on a scale Standard Deviation 0.83	6.50 units on a scale Standard Deviation 0.76
OL; Mean Time-matched Baseline DAS28 (CRP) Over Time For Participants Treated in the OL Day 1457 cohort (n=113, n=50)	6.41 units on a scale Standard Deviation 0.83	6.54 units on a scale Standard Deviation 0.77
OL; Mean Time-matched Baseline DAS28 (CRP) Over Time For Participants Treated in the OL Day 1625 cohort (n=105, n=46)	6.44 units on a scale Standard Deviation 0.85	6.50 units on a scale Standard Deviation 0.79
OL; Mean Time-matched Baseline DAS28 (CRP) Over Time For Participants Treated in the OL Day 1821 cohort (n=101, n=45)	6.47 units on a scale Standard Deviation 0.82	6.54 units on a scale Standard Deviation 0.78

SECONDARY outcome

Timeframe: BL, Days 15, 29, 57, 85, 113, 141, 169, 253, 365, 449, 533, 617, 729, 813, 897, 981, 1093, 1261, 1457, 1625, and 1821

Population: Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.

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 baseline = Post-baseline value - time-matched baseline value, where the time-matched baseline value represents the mean baseline value for only that cohort of participants with data available at that visit.

Outcome measures

Outcome measures
Measure	Abatacept (ABA) n=209 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing \< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Placebo (PLA) n=98 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
OL; Mean Time-matched Change From Baseline in DAS28 (CRP) Over Time For Participants Treated in the OL Day 1093 cohort (n=133, n=56)	-2.84 units on a scale Standard Error 0.12	-2.62 units on a scale Standard Error 0.20
OL; Mean Time-matched Change From Baseline in DAS28 (CRP) Over Time For Participants Treated in the OL Day 1261 cohort (n=124, n=51)	-2.83 units on a scale Standard Error 0.12	-2.85 units on a scale Standard Error 0.18
OL; Mean Time-matched Change From Baseline in DAS28 (CRP) Over Time For Participants Treated in the OL Day 1457 cohort (n=113, n=50)	-2.78 units on a scale Standard Error 0.13	-2.78 units on a scale Standard Error 0.19
OL; Mean Time-matched Change From Baseline in DAS28 (CRP) Over Time For Participants Treated in the OL Day 1625 cohort (n=105, n=46)	-2.88 units on a scale Standard Error 0.13	-2.80 units on a scale Standard Error 0.20
OL; Mean Time-matched Change From Baseline in DAS28 (CRP) Over Time For Participants Treated in the OL Day 1821 cohort (n=101, n=45)	-2.89 units on a scale Standard Error 0.14	-2.98 units on a scale Standard Error 0.18
OL; Mean Time-matched Change From Baseline in DAS28 (CRP) Over Time For Participants Treated in the OL Day 15 cohort (n=206, n=95)	-0.74 units on a scale Standard Error 0.06	-0.40 units on a scale Standard Error 0.08
OL; Mean Time-matched Change From Baseline in DAS28 (CRP) Over Time For Participants Treated in the OL Day 29 cohort (n=204, n=96)	-1.15 units on a scale Standard Error 0.07	-0.72 units on a scale Standard Error 0.11
OL; Mean Time-matched Change From Baseline in DAS28 (CRP) Over Time For Participants Treated in the OL Day 57 cohort (n=207, n=97)	-1.59 units on a scale Standard Error 0.08	-1.05 units on a scale Standard Error 0.12
OL; Mean Time-matched Change From Baseline in DAS28 (CRP) Over Time For Participants Treated in the OL Day 85 cohort (n=209, n=98)	-1.75 units on a scale Standard Error 0.08	-0.88 units on a scale Standard Error 0.12
OL; Mean Time-matched Change From Baseline in DAS28 (CRP) Over Time For Participants Treated in the OL Day 113 cohort (n=199, n=93)	-1.92 units on a scale Standard Error 0.09	-1.00 units on a scale Standard Error 0.13
OL; Mean Time-matched Change From Baseline in DAS28 (CRP) Over Time For Participants Treated in the OL Day 141 cohort (n=210, n=96)	-2.03 units on a scale Standard Error 0.09	-1.05 units on a scale Standard Error 0.13
OL; Mean Time-matched Change From Baseline in DAS28 (CRP) Over Time For Participants Treated in the OL Day 169 cohort (n=205, n=96)	-2.00 units on a scale Standard Error 0.10	-0.93 units on a scale Standard Error 0.12
OL; Mean Time-matched Change From Baseline in DAS28 (CRP) Over Time For Participants Treated in the OL Day 253 cohort (n=193, n=89)	-2.11 units on a scale Standard Error 0.09	-2.03 units on a scale Standard Error 0.15
OL; Mean Time-matched Change From Baseline in DAS28 (CRP) Over Time For Participants Treated in the OL Day 365 cohort (n=192, n=93)	-2.33 units on a scale Standard Error 0.10	-2.13 units on a scale Standard Error 0.15
OL; Mean Time-matched Change From Baseline in DAS28 (CRP) Over Time For Participants Treated in the OL Day 449 cohort (n=168, n=76)	-2.43 units on a scale Standard Error 0.11	-2.49 units on a scale Standard Error 0.15
OL; Mean Time-matched Change From Baseline in DAS28 (CRP) Over Time For Participants Treated in the OL Day 533 cohort (n=162, n=73)	-2.57 units on a scale Standard Error 0.11	-2.50 units on a scale Standard Error 0.16
OL; Mean Time-matched Change From Baseline in DAS28 (CRP) Over Time For Participants Treated in the OL Day 617 cohort (n=163, n=69)	-2.65 units on a scale Standard Error 0.10	-2.58 units on a scale Standard Error 0.14
OL; Mean Time-matched Change From Baseline in DAS28 (CRP) Over Time For Participants Treated in the OL Day 729 cohort (n=151, n=68)	-2.66 units on a scale Standard Error 0.11	-2.23 units on a scale Standard Error 0.17
OL; Mean Time-matched Change From Baseline in DAS28 (CRP) Over Time For Participants Treated in the OL Day 813 cohort (n=137, n=58)	-2.70 units on a scale Standard Error 0.12	-2.40 units on a scale Standard Error 0.15
OL; Mean Time-matched Change From Baseline in DAS28 (CRP) Over Time For Participants Treated in the OL Day 897 cohort (n=132, n=60)	-2.73 units on a scale Standard Error 0.11	-2.61 units on a scale Standard Error 0.16
OL; Mean Time-matched Change From Baseline in DAS28 (CRP) Over Time For Participants Treated in the OL Day 981 cohort (n=119, n=49)	-2.76 units on a scale Standard Error 0.13	-2.66 units on a scale Standard Error 0.17

SECONDARY outcome

Timeframe: BL

Population: Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.

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 levels, 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 values were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit.

Outcome measures

Outcome measures
Measure	Abatacept (ABA) n=178 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing \< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Placebo (PLA) n=83 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
OL; Mean Time-matched Baseline DAS28 (ESR) Over Time For Participants Treated in the OL Day 1821 cohort (n=87, n=42)	6.85 units on a scale Standard Deviation 0.99	6.91 units on a scale Standard Deviation 0.91
OL; Mean Time-matched Baseline DAS28 (ESR) Over Time For Participants Treated in the OL Day 169 cohort (n=178, n=83)	6.89 units on a scale Standard Deviation 1.00	6.83 units on a scale Standard Deviation 0.98
OL; Mean Time-matched Baseline DAS28 (ESR) Over Time For Participants Treated in the OL Day 253 cohort (n=163, n=75)	6.87 units on a scale Standard Deviation 1.00	6.85 units on a scale Standard Deviation 1.01
OL; Mean Time-matched Baseline DAS28 (ESR) Over Time For Participants Treated in the OL Day 365 cohort (n=176, n=82)	6.91 units on a scale Standard Deviation 1.01	6.80 units on a scale Standard Deviation 1.03
OL; Mean Time-matched Baseline DAS28 (ESR) Over Time For Participants Treated in the OL Day 449 cohort (n=152, n=70)	6.94 units on a scale Standard Deviation 0.99	6.85 units on a scale Standard Deviation 0.97
OL; Mean Time-matched Baseline DAS28 (ESR) Over Time For Participants Treated in the OL Day 533 cohort (n=134, n=66)	6.89 units on a scale Standard Deviation 1.02	6.81 units on a scale Standard Deviation 0.81
OL; Mean Time-matched Baseline DAS28 (ESR) Over Time For Participants Treated in the OL Day 617 cohort (n=143, n=59)	6.86 units on a scale Standard Deviation 0.98	6.88 units on a scale Standard Deviation 0.82
OL; Mean Time-matched Baseline DAS28 (ESR) Over Time For Participants Treated in the OL Day 729 cohort (n=133, n=64)	6.85 units on a scale Standard Deviation 1.01	6.86 units on a scale Standard Deviation 0.89
OL; Mean Time-matched Baseline DAS28 (ESR) Over Time For Participants Treated in the OL Day 813 cohort (n=120, n=52)	6.84 units on a scale Standard Deviation 0.94	6.93 units on a scale Standard Deviation 0.93
OL; Mean Time-matched Baseline DAS28 (ESR) Over Time For Participants Treated in the OL Day 897 cohort (n=118, n=56)	6.78 units on a scale Standard Deviation 0.96	6.93 units on a scale Standard Deviation 0.85
OL; Mean Time-matched Baseline DAS28 (ESR) Over Time For Participants Treated in the OL Day 981 cohort (n=119, n=50)	6.85 units on a scale Standard Deviation 0.96	6.91 units on a scale Standard Deviation 0.84
OL; Mean Time-matched Baseline DAS28 (ESR) Over Time For Participants Treated in the OL Day 1093 cohort (n=111, n=50)	6.84 units on a scale Standard Deviation 0.95	6.92 units on a scale Standard Deviation 0.88
OL; Mean Time-matched Baseline DAS28 (ESR) Over Time For Participants Treated in the OL Day 1261 cohort (n=107, n=50)	6.77 units on a scale Standard Deviation 0.97	6.88 units on a scale Standard Deviation 0.87
OL; Mean Time-matched Baseline DAS28 (ESR) Over Time For Participants Treated in the OL Day 1457 cohort (n=94, n=45)	6.80 units on a scale Standard Deviation 0.99	6.87 units on a scale Standard Deviation 0.89
OL; Mean Time-matched Baseline DAS28 (ESR) Over Time For Participants Treated in the OL Day 1625 cohort (n=89, n=41)	6.81 units on a scale Standard Deviation 0.99	6.89 units on a scale Standard Deviation 0.90

SECONDARY outcome

Timeframe: BL, Days 169, 253, 365, 449, 533, 617, 729, 813, 897, 981, 1093, 1261, 1457, 1625, and 1821

Population: Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.

Outcome measures

Outcome measures
Measure	Abatacept (ABA) n=178 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing \< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Placebo (PLA) n=83 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
OL; Mean Time-matched Change From Baseline in DAS28 (ESR) Over Time For Participants Treated in the OL Day 449 cohort (n=152, n=70)	-2.48 units on a scale Standard Error 0.12	-2.53 units on a scale Standard Error 0.16
OL; Mean Time-matched Change From Baseline in DAS28 (ESR) Over Time For Participants Treated in the OL Day 533 cohort (n=134, n=66)	-2.48 units on a scale Standard Error 0.13	-2.59 units on a scale Standard Error 0.16
OL; Mean Time-matched Change From Baseline in DAS28 (ESR) Over Time For Participants Treated in the OL Day 617 cohort (n=143, n=59)	-2.65 units on a scale Standard Error 0.12	-2.60 units on a scale Standard Error 0.15
OL; Mean Time-matched Change From Baseline in DAS28 (ESR) Over Time For Participants Treated in the OL Day 729 cohort (n=133, n=64)	-2.65 units on a scale Standard Error 0.12	-2.25 units on a scale Standard Error 0.16
OL; Mean Time-matched Change From Baseline in DAS28 (ESR) Over Time For Participants Treated in the OL Day 813 cohort (n=120, n=52)	-2.77 units on a scale Standard Error 0.13	-2.43 units on a scale Standard Error 0.16
OL; Mean Time-matched Change From Baseline in DAS28 (ESR) Over Time For Participants Treated in the OL Day 897 cohort (n=118, n=56)	-2.65 units on a scale Standard Error 0.12	-2.70 units on a scale Standard Error 0.17
OL; Mean Time-matched Change From Baseline in DAS28 (ESR) Over Time For Participants Treated in the OL Day 981 cohort (n=119, n=50)	-2.77 units on a scale Standard Error 0.13	-2.59 units on a scale Standard Error 0.20
OL; Mean Time-matched Change From Baseline in DAS28 (ESR) Over Time For Participants Treated in the OL Day 1093 cohort (n=111, n=50)	-2.78 units on a scale Standard Error 0.14	-2.56 units on a scale Standard Error 0.23
OL; Mean Time-matched Change From Baseline in DAS28 (ESR) Over Time For Participants Treated in the OL Day 1261 cohort (n=107, n=50)	-2.70 units on a scale Standard Error 0.15	-2.56 units on a scale Standard Error 0.21
OL; Mean Time-matched Change From Baseline in DAS28 (ESR) Over Time For Participants Treated in the OL Day 1457 cohort (n=94, n=45)	-2.68 units on a scale Standard Error 0.15	-2.58 units on a scale Standard Error 0.22
OL; Mean Time-matched Change From Baseline in DAS28 (ESR) Over Time For Participants Treated in the OL Day 1625 cohort (n=89, n=41)	-2.69 units on a scale Standard Error 0.15	-2.64 units on a scale Standard Error 0.24
OL; Mean Time-matched Change From Baseline in DAS28 (ESR) Over Time For Participants Treated in the OL Day 1821 cohort (n=87, n=42)	-2.77 units on a scale Standard Error 0.15	-2.73 units on a scale Standard Error 0.22
OL; Mean Time-matched Change From Baseline in DAS28 (ESR) Over Time For Participants Treated in the OL Day 169 cohort (n=178, n=83)	-2.05 units on a scale Standard Error 0.12	-0.83 units on a scale Standard Error 0.14
OL; Mean Time-matched Change From Baseline in DAS28 (ESR) Over Time For Participants Treated in the OL Day 253 cohort (n=163, n=75)	-2.09 units on a scale Standard Error 0.11	-2.00 units on a scale Standard Error 0.16
OL; Mean Time-matched Change From Baseline in DAS28 (ESR) Over Time For Participants Treated in the OL Day 365 cohort (n=176, n=82)	-2.31 units on a scale Standard Error 0.11	-2.05 units on a scale Standard Error 0.17

SECONDARY outcome

Timeframe: Days 15, 29, 57, 85, 113, 141, 169, 253, 365, 449, 533, 617, 729, 813, 897, 981, 1093, 1261, 1457, 1625, and 1821

The HAQ disability index (HAQ DI) is a self-administered questionnaire composed of 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. The questions are evaluated on a 4-point scale: 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do. The HAQ disease index is a weighted sum of the scale scores, with a higher score indicating poorer function. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.

Outcome measures

Outcome measures
Measure	Abatacept (ABA) n=209 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing \< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Placebo (PLA) n=98 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
OL; Number of Participants Achieving HAQ Response Over Time In Participants Treated in the OL Day 15 (n=209, n=96)	59 participants	16 participants
OL; Number of Participants Achieving HAQ Response Over Time In Participants Treated in the OL Day 29 (n=207, n=97)	82 participants	30 participants
OL; Number of Participants Achieving HAQ Response Over Time In Participants Treated in the OL Day 57 (n=209, n=98)	101 participants	34 participants
OL; Number of Participants Achieving HAQ Response Over Time In Participants Treated in the OL Day 85 (n=207, n=97)	119 participants	28 participants
OL; Number of Participants Achieving HAQ Response Over Time In Participants Treated in the OL Day 113 (n=202, n=96)	113 participants	30 participants
OL; Number of Participants Achieving HAQ Response Over Time In Participants Treated in the OL Day 141 (n=209, n=97)	115 participants	29 participants
OL; Number of Participants Achieving HAQ Response Over Time In Participants Treated in the OL Day 169 (n=207, n=98)	115 participants	31 participants
OL; Number of Participants Achieving HAQ Response Over Time In Participants Treated in the OL Day 253 (n=199, n=93)	111 participants	47 participants
OL; Number of Participants Achieving HAQ Response Over Time In Participants Treated in the OL Day 365 (n=182, n=87)	128 participants	49 participants
OL; Number of Participants Achieving HAQ Response Over Time In Participants Treated in the OL Day 449 (n=182, n=87)	108 participants	47 participants
OL; Number of Participants Achieving HAQ Response Over Time In Participants Treated in the OL Day 533 (n=165, n=78)	99 participants	44 participants
OL; Number of Participants Achieving HAQ Response Over Time In Participants Treated in the OL Day 617 (n=161, n=71)	101 participants	40 participants
OL; Number of Participants Achieving HAQ Response Over Time In Participants Treated in the OL Day 729 (n=154, n=74)	101 participants	46 participants
OL; Number of Participants Achieving HAQ Response Over Time In Participants Treated in the OL Day 813 (n=139, n=61)	88 participants	34 participants
OL; Number of Participants Achieving HAQ Response Over Time In Participants Treated in the OL Day 897 (n=132, n=62)	87 participants	37 participants
OL; Number of Participants Achieving HAQ Response Over Time In Participants Treated in the OL Day 981 (n=141, n=59)	92 participants	37 participants
OL; Number of Participants Achieving HAQ Response Over Time In Participants Treated in the OL Day 1093 (n=128, n=54)	88 participants	34 participants
OL; Number of Participants Achieving HAQ Response Over Time In Participants Treated in the OL Day 1261 (n=126, n=56)	80 participants	41 participants
OL; Number of Participants Achieving HAQ Response Over Time In Participants Treated in the OL Day 1457 (n=117, n=50)	81 participants	34 participants
OL; Number of Participants Achieving HAQ Response Over Time In Participants Treated in the OL Day 1625 (n=109, n=49)	69 participants	31 participants
OL; Number of Participants Achieving HAQ Response Over Time In Participants Treated in the OL Day 1821 (n=104, n=47)	65 participants	31 participants

SECONDARY outcome

Timeframe: BL

Population: Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.

The HAQ DI is a self-administered questionnaire composed of 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. 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 is a weighted sum of the scale scores, with a higher score indicating poorer function. Time-matched baseline values were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit.

Outcome measures

Outcome measures
Measure	Abatacept (ABA) n=209 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing \< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Placebo (PLA) n=98 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
OL; Mean Time-matched Baseline HAQ-DI and HAQ Component Scores Over Time For Participants Treated in the OL Day 1821 Walking (n=103, n=47)	1.51 units on a scale Standard Error 0.68	1.45 units on a scale Standard Error 0.72
OL; Mean Time-matched Baseline HAQ-DI and HAQ Component Scores Over Time For Participants Treated in the OL Day 1821 Hygiene (n=104, n=47)	2.02 units on a scale Standard Error 0.90	2.26 units on a scale Standard Error 0.85
OL; Mean Time-matched Baseline HAQ-DI and HAQ Component Scores Over Time For Participants Treated in the OL Day 169 HAQ-DI (n=207, n=98)	1.82 units on a scale Standard Error 0.54	1.79 units on a scale Standard Error 0.60
OL; Mean Time-matched Baseline HAQ-DI and HAQ Component Scores Over Time For Participants Treated in the OL Day 169 Dressing and Grooming (n=209, n=98)	1.65 units on a scale Standard Error 0.73	1.54 units on a scale Standard Error 0.69
OL; Mean Time-matched Baseline HAQ-DI and HAQ Component Scores Over Time For Participants Treated in the OL Day 169 Arising (n=209, n=98)	1.41 units on a scale Standard Error 0.72	1.44 units on a scale Standard Error 0.73
OL; Mean Time-matched Baseline HAQ-DI and HAQ Component Scores Over Time For Participants Treated in the OL Day 169 Eating (n=209, n=98)	1.75 units on a scale Standard Error 0.84	1.80 units on a scale Standard Error 0.87
OL; Mean Time-matched Baseline HAQ-DI and HAQ Component Scores Over Time For Participants Treated in the OL Day 169 Walking (n=208, n=96)	1.57 units on a scale Standard Error 0.71	1.51 units on a scale Standard Error 0.75
OL; Mean Time-matched Baseline HAQ-DI and HAQ Component Scores Over Time For Participants Treated in the OL Day 169 Hygiene (n=208, n=98)	2.14 units on a scale Standard Error 0.88	2.21 units on a scale Standard Error 0.86
OL; Mean Time-matched Baseline HAQ-DI and HAQ Component Scores Over Time For Participants Treated in the OL Day 169 Reaching (n=208, n=98)	2.04 units on a scale Standard Error 0.79	1.97 units on a scale Standard Error 0.87
OL; Mean Time-matched Baseline HAQ-DI and HAQ Component Scores Over Time For Participants Treated in the OL Day 169 Gripping (n=207, n=98)	1.95 units on a scale Standard Error 0.53	1.92 units on a scale Standard Error 0.62
OL; Mean Time-matched Baseline HAQ-DI and HAQ Component Scores Over Time For Participants Treated in the OL Day 169 Activities (n=208, n=98)	2.01 units on a scale Standard Error 0.77	1.96 units on a scale Standard Error 0.86
OL; Mean Time-matched Baseline HAQ-DI and HAQ Component Scores Over Time For Participants Treated in the OL Day 365 HAQ-DI (n=199, n=97)	1.80 units on a scale Standard Error 0.56	1.80 units on a scale Standard Error 0.60
OL; Mean Time-matched Baseline HAQ-DI and HAQ Component Scores Over Time For Participants Treated in the OL Day 365 Dressing and Grooming (n=201, n=97)	1.62 units on a scale Standard Error 0.74	1.55 units on a scale Standard Error 0.69
OL; Mean Time-matched Baseline HAQ-DI and HAQ Component Scores Over Time For Participants Treated in the OL Day 365 Arising (n=201, n=97)	1.39 units on a scale Standard Error 0.71	1.45 units on a scale Standard Error 0.74
OL; Mean Time-matched Baseline HAQ-DI and HAQ Component Scores Over Time For Participants Treated in the OL Day 365 Eating (n=201, n=97)	1.73 units on a scale Standard Error 0.84	1.80 units on a scale Standard Error 0.87
OL; Mean Time-matched Baseline HAQ-DI and HAQ Component Scores Over Time For Participants Treated in the OL Day 365 Walking (n=199, n=95)	1.55 units on a scale Standard Error 0.73	1.51 units on a scale Standard Error 0.76
OL; Mean Time-matched Baseline HAQ-DI and HAQ Component Scores Over Time For Participants Treated in the OL Day 365 Hygiene (n=201, n=97)	2.14 units on a scale Standard Error 0.89	2.22 units on a scale Standard Error 0.87
OL; Mean Time-matched Baseline HAQ-DI and HAQ Component Scores Over Time For Participants Treated in the OL Day 365 Reaching (n=201, n=97)	2.03 units on a scale Standard Error 0.81	1.98 units on a scale Standard Error 0.97
OL; Mean Time-matched Baseline HAQ-DI and HAQ Component Scores Over Time For Participants Treated in the OL Day 365 Gripping (n=200, n=97)	1.94 units on a scale Standard Error 0.55	1.92 units on a scale Standard Error 0.62
OL; Mean Time-matched Baseline HAQ-DI and HAQ Component Scores Over Time For Participants Treated in the OL Day 365 Activities (n=200, n=97)	2.02 units on a scale Standard Error 0.80	1.96 units on a scale Standard Error 0.85
OL; Mean Time-matched Baseline HAQ-DI and HAQ Component Scores Over Time For Participants Treated in the OL Day 729 HAQ-DI (n=154, n=74)	1.77 units on a scale Standard Error 0.57	1.79 units on a scale Standard Error 0.59
OL; Mean Time-matched Baseline HAQ-DI and HAQ Component Scores Over Time For Participants Treated in the OL Day 729 Dressing and Grooming (n=156, n=74)	1.62 units on a scale Standard Error 0.74	1.54 units on a scale Standard Error 0.67
OL; Mean Time-matched Baseline HAQ-DI and HAQ Component Scores Over Time For Participants Treated in the OL Day 729 Arising (n=156, n=74)	1.37 units on a scale Standard Error 0.72	1.43 units on a scale Standard Error 0.70
OL; Mean Time-matched Baseline HAQ-DI and HAQ Component Scores Over Time For Participants Treated in the OL Day 729 Eating (n=156, n=74)	1.69 units on a scale Standard Error 0.86	1.81 units on a scale Standard Error 0.84
OL; Mean Time-matched Baseline HAQ-DI and HAQ Component Scores Over Time For Participants Treated in the OL Day 729 Walking (n=156, n=72)	1.53 units on a scale Standard Error 0.74	1.47 units on a scale Standard Error 0.73
OL; Mean Time-matched Baseline HAQ-DI and HAQ Component Scores Over Time For Participants Treated in the OL Day 729 Hygiene (n=154, n=74)	2.07 units on a scale Standard Error 0.91	2.23 units on a scale Standard Error 0.88
OL; Mean Time-matched Baseline HAQ-DI and HAQ Component Scores Over Time For Participants Treated in the OL Day 729 Reaching (n=154, n=74)	1.98 units on a scale Standard Error 0.83	2.03 units on a scale Standard Error 0.83
OL; Mean Time-matched Baseline HAQ-DI and HAQ Component Scores Over Time For Participants Treated in the OL Day 729 Gripping (n=154, n=74)	1.94 units on a scale Standard Error 0.55	1.88 units on a scale Standard Error 0.57
OL; Mean Time-matched Baseline HAQ-DI and HAQ Component Scores Over Time For Participants Treated in the OL Day 729 Activities (n=154, n=74)	2.01 units on a scale Standard Error 0.80	1.93 units on a scale Standard Error 0.85
OL; Mean Time-matched Baseline HAQ-DI and HAQ Component Scores Over Time For Participants Treated in the OL Day 1093 HAQ-DI (n=128, n=54)	1.78 units on a scale Standard Error 0.57	1.81 units on a scale Standard Error 0.54
OL; Mean Time-matched Baseline HAQ-DI and HAQ Component Scores Over Time For Participants Treated in the OL Day 1093 Dressing and Grooming (n=129, n=54)	1.62 units on a scale Standard Error 0.75	1.59 units on a scale Standard Error 0.57
OL; Mean Time-matched Baseline HAQ-DI and HAQ Component Scores Over Time For Participants Treated in the OL Day 1093 Arising (n=129, n=54)	1.38 units on a scale Standard Error 0.72	1.44 units on a scale Standard Error 0.72
OL; Mean Time-matched Baseline HAQ-DI and HAQ Component Scores Over Time For Participants Treated in the OL Day 1093 Eating (n=129, n=54)	1.68 units on a scale Standard Error 0.84	1.81 units on a scale Standard Error 0.80
OL; Mean Time-matched Baseline HAQ-DI and HAQ Component Scores Over Time For Participants Treated in the OL Day 1093 Walking (n=129, n=54)	1.55 units on a scale Standard Error 0.73	1.43 units on a scale Standard Error 0.69
OL; Mean Time-matched Baseline HAQ-DI and HAQ Component Scores Over Time For Participants Treated in the OL Day 1093 Hygiene (n=135, n=59)	2.04 units on a scale Standard Error 0.91	2.25 units on a scale Standard Error 0.86
OL; Mean Time-matched Baseline HAQ-DI and HAQ Component Scores Over Time For Participants Treated in the OL Day 1093 Reaching (n=135, n=59)	1.95 units on a scale Standard Error 0.83	2.14 units on a scale Standard Error 0.78
OL; Mean Time-matched Baseline HAQ-DI and HAQ Component Scores Over Time For Participants Treated in the OL Day 1093 Gripping (n=135, n=59)	1.95 units on a scale Standard Error 0.52	1.93 units on a scale Standard Error 0.49
OL; Mean Time-matched Baseline HAQ-DI and HAQ Component Scores Over Time For Participants Treated in the OL Day 1093 Activities (n=135, n=59)	1.96 units on a scale Standard Error 0.78	1.98 units on a scale Standard Error 0.80
OL; Mean Time-matched Baseline HAQ-DI and HAQ Component Scores Over Time For Participants Treated in the OL Day 1457 HAQ-DI (n=117, n=50)	1.75 units on a scale Standard Error 0.58	1.87 units on a scale Standard Error 0.54
OL; Mean Time-matched Baseline HAQ-DI and HAQ Component Scores Over Time For Participants Treated in the OL Day 1457 Dressing and Grooming (n=117, n=50)	1.64 units on a scale Standard Error 0.74	1.64 units on a scale Standard Error 0.56
OL; Mean Time-matched Baseline HAQ-DI and HAQ Component Scores Over Time For Participants Treated in the OL Day 1457 Arising (n=117, n=50)	1.35 units on a scale Standard Error 0.71	1.44 units on a scale Standard Error 0.73
OL; Mean Time-matched Baseline HAQ-DI and HAQ Component Scores Over Time For Participants Treated in the OL Day 1457 Eating (n=117, n=50)	1.67 units on a scale Standard Error 0.85	1.92 units on a scale Standard Error 0.85
OL; Mean Time-matched Baseline HAQ-DI and HAQ Component Scores Over Time For Participants Treated in the OL Day 1457 Walking (n=117, n=50)	1.50 units on a scale Standard Error 0.71	1.48 units on a scale Standard Error 0.71
OL; Mean Time-matched Baseline HAQ-DI and HAQ Component Scores Over Time For Participants Treated in the OL Day 1457 Hygiene (n=118, n=50)	2.06 units on a scale Standard Error 0.89	2.32 units on a scale Standard Error 0.82
OL; Mean Time-matched Baseline HAQ-DI and HAQ Component Scores Over Time For Participants Treated in the OL Day 1457 Reaching (n=118, n=50)	1.97 units on a scale Standard Error 0.83	2.12 units on a scale Standard Error 0.80
OL; Mean Time-matched Baseline HAQ-DI and HAQ Component Scores Over Time For Participants Treated in the OL Day 1457 Gripping (n=118, n=50)	1.93 units on a scale Standard Error 0.55	1.98 units on a scale Standard Error 0.43
OL; Mean Time-matched Baseline HAQ-DI and HAQ Component Scores Over Time For Participants Treated in the OL Day 1457 Activities (n=118, n=50)	1.92 units on a scale Standard Error 0.81	2.02 units on a scale Standard Error 0.82
OL; Mean Time-matched Baseline HAQ-DI and HAQ Component Scores Over Time For Participants Treated in the OL Day 1821 HAQ-DI (n=104, n=47)	1.75 units on a scale Standard Error 0.61	1.84 units on a scale Standard Error 0.57
OL; Mean Time-matched Baseline HAQ-DI and HAQ Component Scores Over Time For Participants Treated in the OL Day 1821 Dressing and Grooming (n=105, n=47)	1.65 units on a scale Standard Error 0.77	1.62 units on a scale Standard Error 0.57
OL; Mean Time-matched Baseline HAQ-DI and HAQ Component Scores Over Time For Participants Treated in the OL Day 1821 Arising (n=105, n=47)	1.38 units on a scale Standard Error 0.73	1.43 units on a scale Standard Error 0.74
OL; Mean Time-matched Baseline HAQ-DI and HAQ Component Scores Over Time For Participants Treated in the OL Day 1821 Eating (n=105, n=47)	1.62 units on a scale Standard Error 0.86	1.89 units on a scale Standard Error 0.89
OL; Mean Time-matched Baseline HAQ-DI and HAQ Component Scores Over Time For Participants Treated in the OL Day 1821 Reaching (n=104, n=47)	1.94 units on a scale Standard Error 0.85	2.11 units on a scale Standard Error 0.81
OL; Mean Time-matched Baseline HAQ-DI and HAQ Component Scores Over Time For Participants Treated in the OL Day 1821 Gripping (n=104, n=47)	1.93 units on a scale Standard Error 0.60	1.94 units on a scale Standard Error 0.53
OL; Mean Time-matched Baseline HAQ-DI and HAQ Component Scores Over Time For Participants Treated in the OL Day 1821 Activities (n=104, n=47)	1.93 units on a scale Standard Error 0.80	2.00 units on a scale Standard Error 0.86

SECONDARY outcome

Timeframe: BL, Days 169, 253, 365, 449, 533, 617, 729, 813, 897, 981, 1093, 1261, 1457, 1625, and 1821

Population: Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.

HAQ-DI is a self-administered questionnaire composed of 20 questions to assess physical functions in 8 domains:dressing, arising, eating, walking, hygiene, reach, grip and common activities. Questions 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=weighted sum of the scale scores. Higher score indicates poorer function.Change from BL = Post-BL value - time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at that visit

Outcome measures

Outcome measures
Measure	Abatacept (ABA) n=209 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing \< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Placebo (PLA) n=98 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
OL; Mean Time-matched Change From Baseline in HAQ-DI and HAQ Component Scores For Participants Treated in the OL Day 169 HAQ-DI (n=207, n=98)	-0.51 units on a scale Standard Error 0.04	-0.16 units on a scale Standard Error 0.04
OL; Mean Time-matched Change From Baseline in HAQ-DI and HAQ Component Scores For Participants Treated in the OL Day 169 Dressing and Grooming (n=209, n=98)	-0.60 units on a scale Standard Error 0.06	-0.26 units on a scale Standard Error 0.07
OL; Mean Time-matched Change From Baseline in HAQ-DI and HAQ Component Scores For Participants Treated in the OL Day 169 Arising (n=209, n=98)	-0.61 units on a scale Standard Error 0.05	-0.31 units on a scale Standard Error 0.07
OL; Mean Time-matched Change From Baseline in HAQ-DI and HAQ Component Scores For Participants Treated in the OL Day 169 Eating (n=209, n=98)	-0.53 units on a scale Standard Error 0.06	-0.09 units on a scale Standard Error 0.06
OL; Mean Time-matched Change From Baseline in HAQ-DI and HAQ Component Scores For Participants Treated in the OL Day 169 Walking (n=208, n=96)	-0.52 units on a scale Standard Error 0.05	-0.23 units on a scale Standard Error 0.07
OL; Mean Time-matched Change From Baseline in HAQ-DI and HAQ Component Scores For Participants Treated in the OL Day 169 Hygiene (n=208, n=98)	-0.28 units on a scale Standard Error 0.05	-0.08 units on a scale Standard Error 0.07
OL; Mean Time-matched Change From Baseline in HAQ-DI and HAQ Component Scores For Participants Treated in the OL Day 169 Reaching (n=208, n=98)	-0.55 units on a scale Standard Error 0.06	-0.11 units on a scale Standard Error 0.06
OL; Mean Time-matched Change From Baseline in HAQ-DI and HAQ Component Scores For Participants Treated in the OL Day 169 Gripping (n=207, n=98)	-0.46 units on a scale Standard Error 0.06	-0.14 units on a scale Standard Error 0.06
OL; Mean Time-matched Change From Baseline in HAQ-DI and HAQ Component Scores For Participants Treated in the OL Day 169 Activities (n=208, n=98)	-0.50 units on a scale Standard Error 0.06	-0.09 units on a scale Standard Error 0.06
OL; Mean Time-matched Change From Baseline in HAQ-DI and HAQ Component Scores For Participants Treated in the OL Day 365 HAQ-DI (n=199, n=97)	-0.52 units on a scale Standard Error 0.04	-0.40 units on a scale Standard Error 0.05
OL; Mean Time-matched Change From Baseline in HAQ-DI and HAQ Component Scores For Participants Treated in the OL Day 365 Dressing and Grooming (n=201, n=97)	-0.58 units on a scale Standard Error 0.06	-0.44 units on a scale Standard Error 0.08
OL; Mean Time-matched Change From Baseline in HAQ-DI and HAQ Component Scores For Participants Treated in the OL Day 365 Arising (n=201, n=97)	-0.50 units on a scale Standard Error 0.06	-0.55 units on a scale Standard Error 0.07
OL; Mean Time-matched Change From Baseline in HAQ-DI and HAQ Component Scores For Participants Treated in the OL Day 365 Eating (n=201, n=97)	-0.57 units on a scale Standard Error 0.06	-0.47 units on a scale Standard Error 0.08
OL; Mean Time-matched Change From Baseline in HAQ-DI and HAQ Component Scores For Participants Treated in the OL Day 365 Walking (n=199, n=95)	-0.50 units on a scale Standard Error 0.06	-0.55 units on a scale Standard Error 0.08
OL; Mean Time-matched Change From Baseline in HAQ-DI and HAQ Component Scores For Participants Treated in the OL Day 365 Hygiene (n=201, n=97)	-0.36 units on a scale Standard Error 0.06	-0.28 units on a scale Standard Error 0.08
OL; Mean Time-matched Change From Baseline in HAQ-DI and HAQ Component Scores For Participants Treated in the OL Day 365 Reaching (n=201, n=97)	-0.59 units on a scale Standard Error 0.06	-0.33 units on a scale Standard Error 0.09
OL; Mean Time-matched Change From Baseline in HAQ-DI and HAQ Component Scores For Participants Treated in the OL Day 365 Gripping (n=200, n=97)	-0.55 units on a scale Standard Error 0.06	-0.28 units on a scale Standard Error 0.07
OL; Mean Time-matched Change From Baseline in HAQ-DI and HAQ Component Scores For Participants Treated in the OL Day 365 Activities (n=200, n=97)	-0.51 units on a scale Standard Error 0.06	-0.34 units on a scale Standard Error 0.08
OL; Mean Time-matched Change From Baseline in HAQ-DI and HAQ Component Scores For Participants Treated in the OL Day 729 HAQ-DI (n=154, n=74)	-0.62 units on a scale Standard Error 0.05	-0.50 units on a scale Standard Error 0.07
OL; Mean Time-matched Change From Baseline in HAQ-DI and HAQ Component Scores For Participants Treated in the OL Day 729 Dressing and Grooming (n=156, n=74)	-0.74 units on a scale Standard Error 0.07	-0.59 units on a scale Standard Error 0.10
OL; Mean Time-matched Change From Baseline in HAQ-DI and HAQ Component Scores For Participants Treated in the OL Day 729 Arising (n=156, n=74)	-0.62 units on a scale Standard Error 0.06	-0.64 units on a scale Standard Error 0.08
OL; Mean Time-matched Change From Baseline in HAQ-DI and HAQ Component Scores For Participants Treated in the OL Day 729 Eating (n=156, n=74)	-0.69 units on a scale Standard Error 0.07	-0.54 units on a scale Standard Error 0.09
OL; Mean Time-matched Change From Baseline in HAQ-DI and HAQ Component Scores For Participants Treated in the OL Day 729 Walking (n=156, n=72)	-0.59 units on a scale Standard Error 0.07	-0.49 units on a scale Standard Error 0.10
OL; Mean Time-matched Change From Baseline in HAQ-DI and HAQ Component Scores For Participants Treated in the OL Day 729 Hygiene (n=154, n=74)	-0.35 units on a scale Standard Error 0.07	-0.36 units on a scale Standard Error 0.11
OL; Mean Time-matched Change From Baseline in HAQ-DI and HAQ Component Scores For Participants Treated in the OL Day 729 Reaching (n=154, n=74)	-0.64 units on a scale Standard Error 0.07	-0.51 units on a scale Standard Error 0.10
OL; Mean Time-matched Change From Baseline in HAQ-DI and HAQ Component Scores For Participants Treated in the OL Day 729 Gripping (n=154, n=74)	-0.62 units on a scale Standard Error 0.08	-0.43 units on a scale Standard Error 0.09
OL; Mean Time-matched Change From Baseline in HAQ-DI and HAQ Component Scores For Participants Treated in the OL Day 729 Activities (n=154, n=74)	-0.62 units on a scale Standard Error 0.06	-0.46 units on a scale Standard Error 0.11
OL; Mean Time-matched Change From Baseline in HAQ-DI and HAQ Component Scores For Participants Treated in the OL Day 1093 HAQ-DI (n=128, n=54)	-0.65 units on a scale Standard Error 0.05	-0.51 units on a scale Standard Error 0.07
OL; Mean Time-matched Change From Baseline in HAQ-DI and HAQ Component Scores For Participants Treated in the OL Day 1093 Dressing and Grooming (n=129, n=54)	-0.74 units on a scale Standard Error 0.07	-0.65 units on a scale Standard Error 0.11
OL; Mean Time-matched Change From Baseline in HAQ-DI and HAQ Component Scores For Participants Treated in the OL Day 1093 Arising (n=129, n=54)	-0.67 units on a scale Standard Error 0.07	-0.72 units on a scale Standard Error 0.10
OL; Mean Time-matched Change From Baseline in HAQ-DI and HAQ Component Scores For Participants Treated in the OL Day 1093 Eating (n=129, n=54)	-0.71 units on a scale Standard Error 0.07	-0.57 units on a scale Standard Error 0.10
OL; Mean Time-matched Change From Baseline in HAQ-DI and HAQ Component Scores For Participants Treated in the OL Day 1093 Walking (n=129, n=54)	-0.64 units on a scale Standard Error 0.08	-0.52 units on a scale Standard Error 0.11
OL; Mean Time-matched Change From Baseline in HAQ-DI and HAQ Component Scores For Participants Treated in the OL Day 1093 Hygiene (n=135, n=59)	-0.36 units on a scale Standard Error 0.07	-0.37 units on a scale Standard Error 0.13
OL; Mean Time-matched Change From Baseline in HAQ-DI and HAQ Component Scores For Participants Treated in the OL Day 1093 Reaching (n=135, n=59)	-0.63 units on a scale Standard Error 0.07	-0.59 units on a scale Standard Error 0.10
OL; Mean Time-matched Change From Baseline in HAQ-DI and HAQ Component Scores For Participants Treated in the OL Day 1093 Gripping (n=135, n=59)	-0.69 units on a scale Standard Error 0.08	-0.31 units on a scale Standard Error 0.08
OL; Mean Time-matched Change From Baseline in HAQ-DI and HAQ Component Scores For Participants Treated in the OL Day 1093 Activities (n=135, n=59)	-0.64 units on a scale Standard Error 0.07	-0.54 units on a scale Standard Error 0.10
OL; Mean Time-matched Change From Baseline in HAQ-DI and HAQ Component Scores For Participants Treated in the OL Day 1457 HAQ-DI (n=117, n=50)	-0.58 units on a scale Standard Error 0.05	-0.62 units on a scale Standard Error 0.09
OL; Mean Time-matched Change From Baseline in HAQ-DI and HAQ Component Scores For Participants Treated in the OL Day 1457 Dressing and Grooming (n=117, n=50)	-0.74 units on a scale Standard Error 0.08	-0.76 units on a scale Standard Error 0.12
OL; Mean Time-matched Change From Baseline in HAQ-DI and HAQ Component Scores For Participants Treated in the OL Day 1457 Arising (n=117, n=50)	-0.60 units on a scale Standard Error 0.07	-0.74 units on a scale Standard Error 0.13
OL; Mean Time-matched Change From Baseline in HAQ-DI and HAQ Component Scores For Participants Treated in the OL Day 1457 Eating (n=117, n=50)	-0.64 units on a scale Standard Error 0.08	-0.70 units on a scale Standard Error 0.14
OL; Mean Time-matched Change From Baseline in HAQ-DI and HAQ Component Scores For Participants Treated in the OL Day 1457 Walking (n=117, n=50)	-0.50 units on a scale Standard Error 0.08	-0.64 units on a scale Standard Error 0.13
OL; Mean Time-matched Change From Baseline in HAQ-DI and HAQ Component Scores For Participants Treated in the OL Day 1457 Hygiene (n=118, n=50)	-0.29 units on a scale Standard Error 0.08	-0.54 units on a scale Standard Error 0.14
OL; Mean Time-matched Change From Baseline in HAQ-DI and HAQ Component Scores For Participants Treated in the OL Day 1457 Reaching (n=118, n=50)	-0.68 units on a scale Standard Error 0.07	-0.60 units on a scale Standard Error 0.13
OL; Mean Time-matched Change From Baseline in HAQ-DI and HAQ Component Scores For Participants Treated in the OL Day 1457 Gripping (n=118, n=50)	-0.55 units on a scale Standard Error 0.08	-0.38 units on a scale Standard Error 0.11
OL; Mean Time-matched Change From Baseline in HAQ-DI and HAQ Component Scores For Participants Treated in the OL Day 1457 Activities (n=118, n=50)	-0.59 units on a scale Standard Error 0.08	-0.56 units on a scale Standard Error 0.11
OL; Mean Time-matched Change From Baseline in HAQ-DI and HAQ Component Scores For Participants Treated in the OL Day 1821 HAQ-DI (n=104, n=47)	-0.57 units on a scale Standard Error 0.06	-0.66 units on a scale Standard Error 0.09
OL; Mean Time-matched Change From Baseline in HAQ-DI and HAQ Component Scores For Participants Treated in the OL Day 1821 Dressing and Grooming (n=105, n=47)	-0.75 units on a scale Standard Error 0.08	-0.83 units on a scale Standard Error 0.12
OL; Mean Time-matched Change From Baseline in HAQ-DI and HAQ Component Scores For Participants Treated in the OL Day 1821 Arising (n=105, n=47)	-0.59 units on a scale Standard Error 0.08	-0.79 units on a scale Standard Error 0.12
OL; Mean Time-matched Change From Baseline in HAQ-DI and HAQ Component Scores For Participants Treated in the OL Day 1821 Eating (n=105, n=47)	-0.54 units on a scale Standard Error 0.08	-0.87 units on a scale Standard Error 0.12
OL; Mean Time-matched Change From Baseline in HAQ-DI and HAQ Component Scores For Participants Treated in the OL Day 1821 Walking (n=103, n=47)	-0.54 units on a scale Standard Error 0.09	-0.57 units on a scale Standard Error 0.12
OL; Mean Time-matched Change From Baseline in HAQ-DI and HAQ Component Scores For Participants Treated in the OL Day 1821 Hygiene (n=104, n=47)	-0.27 units on a scale Standard Error 0.09	-0.57 units on a scale Standard Error 0.16
OL; Mean Time-matched Change From Baseline in HAQ-DI and HAQ Component Scores For Participants Treated in the OL Day 1821 Reaching (n=104, n=47)	-0.68 units on a scale Standard Error 0.09	-0.62 units on a scale Standard Error 0.10
OL; Mean Time-matched Change From Baseline in HAQ-DI and HAQ Component Scores For Participants Treated in the OL Day 1821 Gripping (n=104, n=47)	-0.58 units on a scale Standard Error 0.09	-0.40 units on a scale Standard Error 0.11
OL; Mean Time-matched Change From Baseline in HAQ-DI and HAQ Component Scores For Participants Treated in the OL Day 1821 Activities (n=104, n=47)	-0.59 units on a scale Standard Error 0.08	-0.64 units on a scale Standard Error 0.12

SECONDARY outcome

Timeframe: BL

Population: Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.

RF is an autoantibody 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-matched baseline levels of RF were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit.

Outcome measures

Outcome measures
Measure	Abatacept (ABA) n=191 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing \< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Placebo (PLA) n=95 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
OL; Mean Time-matched Baseline Levels of Rheumatoid Factor (RF) Over Time For Participants Treated in the OL Day 169 cohort (n=191, n=95)	262.4 IU/ml Standard Deviation 487.9	264.8 IU/ml Standard Deviation 430.4
OL; Mean Time-matched Baseline Levels of Rheumatoid Factor (RF) Over Time For Participants Treated in the OL Day 365 cohort (n=189, n=92)	275.5 IU/ml Standard Deviation 505.4	270.4 IU/ml Standard Deviation 435.9
OL; Mean Time-matched Baseline Levels of Rheumatoid Factor (RF) Over Time For Participants Treated in the OL Day 729 cohort (n=150, n=71)	276.8 IU/ml Standard Deviation 513.1	301.5 IU/ml Standard Deviation 476.4
OL; Mean Time-matched Baseline Levels of Rheumatoid Factor (RF) Over Time For Participants Treated in the OL Day 1093 cohort (n=123, n=57)	234.6 IU/ml Standard Deviation 404.4	328.9 IU/ml Standard Deviation 509.8
OL; Mean Time-matched Baseline Levels of Rheumatoid Factor (RF) Over Time For Participants Treated in the OL Day 1457 cohort (n=106, n=46)	247.8 IU/ml Standard Deviation 368.0	331.3 IU/ml Standard Deviation 552.9
OL; Mean Time-matched Baseline Levels of Rheumatoid Factor (RF) Over Time For Participants Treated in the OL Day 1821 cohort (n=97, n=45)	214.8 IU/ml Standard Deviation 348.4	318.4 IU/ml Standard Deviation 552.3

SECONDARY outcome

Timeframe: BL, Days 169, 365, 729, 1093, 1261, 1457, and 1821

Population: Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.

RF is an autoantibody 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. Change from BL = Post-BL value - time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at that visit.

Outcome measures

Outcome measures
Measure	Abatacept (ABA) n=191 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing \< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Placebo (PLA) n=95 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
OL; Mean Time-matched Change From Baseline in Levels of RF Over Time For Participants Treated in the OL Day 169 cohort (n=191, n=95)	-80.4 IU/ml Standard Error 20.17	-25.1 IU/ml Standard Error 18.54
OL; Mean Time-matched Change From Baseline in Levels of RF Over Time For Participants Treated in the OL Day 365 cohort (n=189, n=92)	-50.0 IU/ml Standard Error 28.64	-69.6 IU/ml Standard Error 24.58
OL; Mean Time-matched Change From Baseline in Levels of RF Over Time For Participants Treated in the OL Day 729 cohort (n=150, n=71)	-30.2 IU/ml Standard Error 40.77	-82.8 IU/ml Standard Error 41.86
OL; Mean Time-matched Change From Baseline in Levels of RF Over Time For Participants Treated in the OL Day 1093 cohort (n=123, n=57)	-6.70 IU/ml Standard Error 46.76	-86.5 IU/ml Standard Error 65.61
OL; Mean Time-matched Change From Baseline in Levels of RF Over Time For Participants Treated in the OL Day 1457 cohort (n=106, n=46)	6.79 IU/ml Standard Error 42.12	-68.1 IU/ml Standard Error 86.80
OL; Mean Time-matched Change From Baseline in Levels of RF Over Time For Participants Treated in the OL Day 1821 cohort (n=97, n=45)	-10.7 IU/ml Standard Error 32.57	-103.0 IU/ml Standard Error 83.56

SECONDARY outcome

Timeframe: BL

Population: Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.

CRP is an acute phase reactant protein that is a clinical marker for Rheumatoid Arthritis (RA). Time-matched baseline levels of CRP were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit.

Outcome measures

Outcome measures
Measure	Abatacept (ABA) n=210 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing \< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Placebo (PLA) n=99 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
OL; Mean Time-matched Baseline Levels of C-Reactive Protein (CRP) Over Time For Participants Treated in the OL Day 169 cohort (n=210, n=99)	46.00 mg/dL Standard Deviation 38.77	33.34 mg/dL Standard Deviation 31.13
OL; Mean Time-matched Baseline Levels of C-Reactive Protein (CRP) Over Time For Participants Treated in the OL Day 365 cohort (n=196, n=95)	45.62 mg/dL Standard Deviation 39.31	34.05 mg/dL Standard Deviation 31.55
OL; Mean Time-matched Baseline Levels of C-Reactive Protein (CRP) Over Time For Participants Treated in the OL Day 729 cohort (n=158, n=71)	45.61 mg/dL Standard Deviation 39.11	34.60 mg/dL Standard Deviation 30.69
OL; Mean Time-matched Baseline Levels of C-Reactive Protein (CRP) Over Time For Participants Treated in the OL Day 1093 cohort (n=139, n=59)	43.20 mg/dL Standard Deviation 37.17	35.07 mg/dL Standard Deviation 29.95
OL; Mean Time-matched Baseline Levels of C-Reactive Protein (CRP) Over Time For Participants Treated in the OL Day 1457 cohort (n=125, n=52)	41.98 mg/dL Standard Deviation 36.52	35.30 mg/dL Standard Deviation 30.87
OL; Mean Time-matched Baseline Levels of C-Reactive Protein (CRP) Over Time For Participants Treated in the OL Day 1821 cohort (n=108, n=46)	41.23 mg/dL Standard Deviation 35.71	34.83 mg/dL Standard Deviation 28.26

SECONDARY outcome

Timeframe: BL, Days 169, 365, 729, 1093, 1261, 1457, and 1821

Population: Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.

CRP is an acute phase reactant protein that is a clinical marker for RA. Change from BL = Post-BL value - time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at that visit.

Outcome measures

Outcome measures
Measure	Abatacept (ABA) n=210 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing \< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Placebo (PLA) n=99 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
OL; Mean Time-matched Change From Baseline in Levels of CRP Over Time For Participants Treated in the OL Day 169 cohort (n=210, n=99)	-25.3 mg/dL Standard Error 2.70	-0.36 mg/dL Standard Error 3.24
OL; Mean Time-matched Change From Baseline in Levels of CRP Over Time For Participants Treated in the OL Day 365 cohort (n=196, n=95)	-29.1 mg/dL Standard Error 2.72	-16.8 mg/dL Standard Error 3.07
OL; Mean Time-matched Change From Baseline in Levels of CRP Over Time For Participants Treated in the OL Day 729 cohort (n=158, n=71)	-29.4 mg/dL Standard Error 3.30	-10.8 mg/dL Standard Error 4.68
OL; Mean Time-matched Change From Baseline in Levels of CRP Over Time For Participants Treated in the OL Day 1093 cohort (n=139, n=59)	-31.8 mg/dL Standard Error 3.08	-18.8 mg/dL Standard Error 3.23
OL; Mean Time-matched Change From Baseline in Levels of CRP Over Time For Participants Treated in the OL Day 1457 cohort (n=125, n=52)	-30.1 mg/dL Standard Error 3.30	-22.8 mg/dL Standard Error 4.86
OL; Mean Time-matched Change From Baseline in Levels of CRP Over Time For Participants Treated in the OL Day 1821 cohort (n=108, n=46)	-30.1 mg/dL Standard Error 3.47	-23.2 mg/dL Standard Error 4.33

SECONDARY outcome

Timeframe: BL

Population: Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.

ESR, also called a sedimentation rate or Biernacki Reaction, is the rate at which red blood cells sediment in a period of 1 hour. It is a common hematology test that is a non-specific measure of inflammation. Time-matched baseline levels of ESR were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit.

Outcome measures

Outcome measures
Measure	Abatacept (ABA) n=174 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing \< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Placebo (PLA) n=81 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
OL; Mean Time-matched Baseline Erythrocyte Sedimentation Rate (ESR) Over Time For Participants Treated in the OL Day 169 cohort (n=174, n=81)	50.60 mm/hr Standard Deviation 28.06	44.40 mm/hr Standard Deviation 26.64
OL; Mean Time-matched Baseline Erythrocyte Sedimentation Rate (ESR) Over Time For Participants Treated in the OL Day 365 cohort (n=171, n=81)	50.51 mm/hr Standard Deviation 28.61	44.10 mm/hr Standard Deviation 26.41
OL; Mean Time-matched Baseline Erythrocyte Sedimentation Rate (ESR) Over Time For Participants Treated in the OL Day 729 cohort (n=135, n=67)	50.53 mm/hr Standard Deviation 28.52	42.06 mm/hr Standard Deviation 23.77
OL; Mean Time-matched Baseline Erythrocyte Sedimentation Rate (ESR) Over Time For Participants Treated in the OL Day 1093 cohort (n=113, n=53)	49.03 mm/hr Standard Deviation 26.11	43.36 mm/hr Standard Deviation 24.42
OL; Mean Time-matched Baseline Erythrocyte Sedimentation Rate (ESR) Over Time For Participants Treated in the OL Day 1457 cohort (n=99, n=45)	50.04 mm/hr Standard Deviation 26.91	42.64 mm/hr Standard Deviation 25.76
OL; Mean Time-matched Baseline Erythrocyte Sedimentation Rate (ESR) Over Time For Participants Treated in the OL Day 1821 cohort (n=90, n=43)	50.32 mm/hr Standard Deviation 26.41	43.02 mm/hr Standard Deviation 24.96

SECONDARY outcome

Timeframe: BL, Days 169, 365, 729, 1093, 1261, 1457, and 1821

Population: Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.

ESR, also called a sedimentation rate or Biernacki Reaction, is the rate at which red blood cells sediment in a period of 1 hour. It is a common hematology test that is a non-specific measure of inflammation. Change from BL = Post-BL value - time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at that visit.

Outcome measures

Outcome measures
Measure	Abatacept (ABA) n=174 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing \< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Placebo (PLA) n=81 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
OL; Mean Time-matched Change From Baseline in ESR Over Time For Participants Treated in the OL Day 169 cohort (n=174, n=81)	-18.0 mm/hr Standard Error 1.89	-0.44 mm/hr Standard Error 2.60
OL; Mean Time-matched Change From Baseline in ESR Over Time For Participants Treated in the OL Day 365 cohort (n=171, n=81)	-18.8 mm/hr Standard Error 1.97	-10.1 mm/hr Standard Error 2.50
OL; Mean Time-matched Change From Baseline in ESR Over Time For Participants Treated in the OL Day 729 cohort (n=135, n=67)	-20.2 mm/hr Standard Error 2.48	-6.25 mm/hr Standard Error 3.15
OL; Mean Time-matched Change From Baseline in ESR Over Time For Participants Treated in the OL Day 1093 cohort (n=113, n=53)	-19.9 mm/hr Standard Error 2.54	-10.6 mm/hr Standard Error 3.60
OL; Mean Time-matched Change From Baseline in ESR Over Time For Participants Treated in the OL Day 1457 cohort (n=99, n=45)	-20.5 mm/hr Standard Error 2.56	-9.80 mm/hr Standard Error 4.44
OL; Mean Time-matched Change From Baseline in ESR Over Time For Participants Treated in the OL Day 1821 cohort (n=90, n=43)	-19.5 mm/hr Standard Error 2.79	-9.49 mm/hr Standard Error 4.45

SECONDARY outcome

Timeframe: BL

Population: Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.

IL-2 is a proinflammatory cytokine, and the soluble form of its receptor (IL-2R) is a marker for inflammation. Time-matched baseline levels of IL-2R were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit

Outcome measures

Outcome measures
Measure	Abatacept (ABA) n=198 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing \< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Placebo (PLA) n=91 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
OL; Mean Time-matched Baseline Levels of Soluble Interleukin 2 Receptor (sIL-2R) Over Time For Participants Treated in the OL Day 169 cohort (n=198, n=91)	1879.0 pg/ml Standard Deviation 909.3	1805.0 pg/ml Standard Deviation 922.9
OL; Mean Time-matched Baseline Levels of Soluble Interleukin 2 Receptor (sIL-2R) Over Time For Participants Treated in the OL Day 365 cohort (n=183, n=88)	1851.0 pg/ml Standard Deviation 762.5	1800.0 pg/ml Standard Deviation 941.5
OL; Mean Time-matched Baseline Levels of Soluble Interleukin 2 Receptor (sIL-2R) Over Time For Participants Treated in the OL Day 729 cohort (n=135, n=66)	1942.0 pg/ml Standard Deviation 971.5	1708.0 pg/ml Standard Deviation 864.9
OL; Mean Time-matched Baseline Levels of Soluble Interleukin 2 Receptor (sIL-2R) Over Time For Participants Treated in the OL Day 1093 cohort (n=72, n=36)	1813.0 pg/ml Standard Deviation 781.8	1827.0 pg/ml Standard Deviation 974.2

SECONDARY outcome

Timeframe: BL, Days 169, 365, 729, 1093, 1261, 1457, and 1821

Population: Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.

IL-2 is a proinflammatory cytokine, and the soluble form of its receptor (IL-2R) is a marker for inflammation. Change from BL = Post-BL value - time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at that visit.

Outcome measures

Outcome measures
Measure	Abatacept (ABA) n=198 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing \< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Placebo (PLA) n=91 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
OL; Mean Time-matched Change From Baseline in Levels of sIL-2R Over Time For Participants Treated in the OL Day 169 cohort (n=198, n=91)	-590.0 pg/ml Standard Error 41.75	-19.6 pg/ml Standard Error 73.21
OL; Mean Time-matched Change From Baseline in Levels of sIL-2R Over Time For Participants Treated in the OL Day 365 cohort (n=183, n=88)	-522.0 pg/ml Standard Error 50.84	-424.0 pg/ml Standard Error 71.42
OL; Mean Time-matched Change From Baseline in Levels of sIL-2R Over Time For Participants Treated in the OL Day 729 cohort (n=135, n=66)	-836.0 pg/ml Standard Error 58.94	-483.0 pg/ml Standard Error 101.6
OL; Mean Time-matched Change From Baseline in Levels of sIL-2R Over Time For Participants Treated in the OL Day 1093 cohort (n=72, n=36)	-761.0 pg/ml Standard Error 92.88	-794.0 pg/ml Standard Error 136.1

SECONDARY outcome

Timeframe: BL

Population: Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.

SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores:PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. 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. Time-matched baseline values were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit.

Outcome measures

Outcome measures
Measure	Abatacept (ABA) n=204 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing \< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Placebo (PLA) n=98 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
OL; Mean Time-matched Baseline SF-36 PCS and MCS Over Time For Participants Treated in OL Day 169 cohort (n=204, n=98): PCS	27.52 units on a scale Standard Deviation 6.65	28.07 units on a scale Standard Deviation 6.86
OL; Mean Time-matched Baseline SF-36 PCS and MCS Over Time For Participants Treated in OL Day 365 cohort (n=198, n=96): PCS	27.70 units on a scale Standard Deviation 6.76	27.92 units on a scale Standard Deviation 6.83
OL; Mean Time-matched Baseline SF-36 PCS and MCS Over Time For Participants Treated in OL Day 729 cohort (n=155, n=73): PCS	27.81 units on a scale Standard Deviation 6.69	28.65 units on a scale Standard Deviation 6.80
OL; Mean Time-matched Baseline SF-36 PCS and MCS Over Time For Participants Treated in OL Day 1093 cohort (n=130, n=58): PCS	27.92 units on a scale Standard Deviation 6.86	28.25 units on a scale Standard Deviation 6.72
OL; Mean Time-matched Baseline SF-36 PCS and MCS Over Time For Participants Treated in OL Day 1457 cohort (n=114, n=50): PCS	28.31 units on a scale Standard Deviation 6.85	28.06 units on a scale Standard Deviation 6.85
OL; Mean Time-matched Baseline SF-36 PCS and MCS Over Time For Participants Treated in OL Day 1821 cohort (n=103, n=47): PCS	28.48 units on a scale Standard Deviation 6.72	28.27 units on a scale Standard Deviation 6.97
OL; Mean Time-matched Baseline SF-36 PCS and MCS Over Time For Participants Treated in OL Day 169 cohort (n=204, n=98): MCS	41.75 units on a scale Standard Deviation 12.53	43.62 units on a scale Standard Deviation 12.12
OL; Mean Time-matched Baseline SF-36 PCS and MCS Over Time For Participants Treated in OL Day 365 cohort (n=198, n=96): MCS	41.54 units on a scale Standard Deviation 12.69	43.96 units on a scale Standard Deviation 11.98
OL; Mean Time-matched Baseline SF-36 PCS and MCS Over Time For Participants Treated in OL Day 729 cohort (n=155, n=73): MCS	42.23 units on a scale Standard Deviation 12.86	42.42 units on a scale Standard Deviation 11.89
OL; Mean Time-matched Baseline SF-36 PCS and MCS Over Time For Participants Treated in OL Day 1093 cohort (n=130, n=58): MCS	43.29 units on a scale Standard Deviation 12.25	42.13 units on a scale Standard Deviation 11.75
OL; Mean Time-matched Baseline SF-36 PCS and MCS Over Time For Participants Treated in OL Day 1457 cohort (n=114, n=50): MCS	43.38 units on a scale Standard Deviation 12.20	41.95 units on a scale Standard Deviation 11.67
OL; Mean Time-matched Baseline SF-36 PCS and MCS Over Time For Participants Treated in OL Day 1821 cohort (n=103, n=47): MCS	41.74 units on a scale Standard Deviation 12.82	42.70 units on a scale Standard Deviation 11.64

SECONDARY outcome

Timeframe: BL, Days 169, 365, 729, 1093, 1457, and 1821

Population: Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.

SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0=worst score (or quality of life) and 100=best score. Change from BL = Post-BL value - time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at that visit.

Outcome measures

Outcome measures
Measure	Abatacept (ABA) n=204 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing \< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Placebo (PLA) n=98 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
OL; Mean Time-matched Change From Baseline in SF-36 PCS and MCS Over Time For Participants Treated in OL Day 169 cohort (n=204, n=98): PCS	7.46 units on a scale Standard Error 0.69	1.90 units on a scale Standard Error 0.77
OL; Mean Time-matched Change From Baseline in SF-36 PCS and MCS Over Time For Participants Treated in OL Day 365 cohort (n=198, n=96): PCS	8.30 units on a scale Standard Error 0.74	6.21 units on a scale Standard Error 0.94
OL; Mean Time-matched Change From Baseline in SF-36 PCS and MCS Over Time For Participants Treated in OL Day 729 cohort (n=155, n=73): PCS	10.28 units on a scale Standard Error 0.78	6.79 units on a scale Standard Error 1.16
OL; Mean Time-matched Change From Baseline in SF-36 PCS and MCS Over Time For Participants Treated in OL Day 1093 cohort (n=130, n=58): PCS	10.30 units on a scale Standard Error 0.90	8.61 units on a scale Standard Error 1.34
OL; Mean Time-matched Change From Baseline in SF-36 PCS and MCS Over Time For Participants Treated in OL Day 1457 cohort (n=114, n=50): PCS	8.71 units on a scale Standard Error 0.93	8.51 units on a scale Standard Error 1.39
OL; Mean Time-matched Change From Baseline in SF-36 PCS and MCS Over Time For Participants Treated in OL Day 1821 cohort (n=103, n=47): PCS	9.32 units on a scale Standard Error 1.06	9.35 units on a scale Standard Error 1.52
OL; Mean Time-matched Change From Baseline in SF-36 PCS and MCS Over Time For Participants Treated in OL Day 169 cohort (n=204, n=98): MCS	5.83 units on a scale Standard Error 0.83	2.16 units on a scale Standard Error 0.91
OL; Mean Time-matched Change From Baseline in SF-36 PCS and MCS Over Time For Participants Treated in OL Day 365 cohort (n=198, n=96): MCS	5.18 units on a scale Standard Error 0.79	5.32 units on a scale Standard Error 1.07
OL; Mean Time-matched Change From Baseline in SF-36 PCS and MCS Over Time For Participants Treated in OL Day 729 cohort (n=155, n=73): MCS	6.08 units on a scale Standard Error 0.92	8.61 units on a scale Standard Error 1.42
OL; Mean Time-matched Change From Baseline in SF-36 PCS and MCS Over Time For Participants Treated in OL Day 1093 cohort (n=130, n=58): MCS	5.68 units on a scale Standard Error 1.05	9.14 units on a scale Standard Error 1.72
OL; Mean Time-matched Change From Baseline in SF-36 PCS and MCS Over Time For Participants Treated in OL Day 1457 cohort (n=114, n=50): MCS	5.41 units on a scale Standard Error 1.12	7.93 units on a scale Standard Error 1.77
OL; Mean Time-matched Change From Baseline in SF-36 PCS and MCS Over Time For Participants Treated in OL Day 1821 cohort (n=103, n=47): MCS	6.42 units on a scale Standard Error 1.24	10.37 units on a scale Standard Error 1.75

SECONDARY outcome

Timeframe: BL

Population: Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.

SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores:PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. 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. Time-matched baseline values were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit.

Outcome measures

Outcome measures
Measure	Abatacept (ABA) n=208 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing \< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Placebo (PLA) n=98 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
OL; Mean Time-matched Baseline Physical Function Score Over Time For Participants Treated in the OL Day 169 cohort (n=208, n=98): Physical Function	26.22 units on a scale Standard Deviation 8.75	26.60 units on a scale Standard Deviation 8.65
OL; Mean Time-matched Baseline Physical Function Score Over Time For Participants Treated in the OL Day 365 cohort (n=200, n=96): Physical Function	26.37 units on a scale Standard Deviation 8.88	26.49 units on a scale Standard Deviation 8.62
OL; Mean Time-matched Baseline Physical Function Score Over Time For Participants Treated in the OL Day 729 cohort (n=156, n=74): Physical Function	27.03 units on a scale Standard Deviation 9.03	26.66 units on a scale Standard Deviation 8.37
OL; Mean Time-matched Baseline Physical Function Score Over Time For Participants Treated in the OL Day 1093 cohort (n=133, n=59): Physical Function	27.06 units on a scale Standard Deviation 9.03	25.66 units on a scale Standard Deviation 7.99
OL; Mean Time-matched Baseline Physical Function Score Over Time For Participants Treated in the OL Day 1457 cohort (n=118, n=50): Physical Function	27.54 units on a scale Standard Deviation 9.15	25.41 units on a scale Standard Deviation 8.08
OL; Mean Time-matched Baseline Physical Function Score Over Time For Participants Treated in the OL Day 1821 cohort (n=104, n=47): Physical Function	27.86 units on a scale Standard Deviation 9.65	25.61 units on a scale Standard Deviation 8.45

SECONDARY outcome

Timeframe: BL, Days 169, 365, 729, 1093, 1457, and 1821

Population: Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.

SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0=worst score (or quality of life) and 100=best score. Change from BL = Post-BL value - time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at that visit.

Outcome measures

Outcome measures
Measure	Abatacept (ABA) n=208 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing \< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Placebo (PLA) n=98 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
OL; Mean Time-matched Change From Baseline in Physical Function Score Over Time For Participants Treated in the OL Day 169 cohort (n=208, n=98): Physical Function	5.75 units on a scale Standard Error 0.74	1.82 units on a scale Standard Error 0.84
OL; Mean Time-matched Change From Baseline in Physical Function Score Over Time For Participants Treated in the OL Day 365 cohort (n=200, n=96): Physical Function	7.14 units on a scale Standard Error 0.79	4.80 units on a scale Standard Error 0.97
OL; Mean Time-matched Change From Baseline in Physical Function Score Over Time For Participants Treated in the OL Day 729 cohort (n=156, n=74): Physical Function	7.61 units on a scale Standard Error 0.90	7.38 units on a scale Standard Error 1.09
OL; Mean Time-matched Change From Baseline in Physical Function Score Over Time For Participants Treated in the OL Day 1093 cohort (n=133, n=59): Physical Function	8.24 units on a scale Standard Error 1.00	9.68 units on a scale Standard Error 1.26
OL; Mean Time-matched Change From Baseline in Physical Function Score Over Time For Participants Treated in the OL Day 1457 cohort (n=118, n=50): Physical Function	6.36 units on a scale Standard Error 1.06	8.98 units on a scale Standard Error 1.32
OL; Mean Time-matched Change From Baseline in Physical Function Score Over Time For Participants Treated in the OL Day 1821 cohort (n=104, n=47): Physical Function	7.34 units on a scale Standard Error 1.21	8.57 units on a scale Standard Error 1.63

SECONDARY outcome

Timeframe: BL

Population: Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.

SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores:PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. 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. Time-matched baseline values were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit.

Outcome measures

Outcome measures
Measure	Abatacept (ABA) n=208 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing \< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Placebo (PLA) n=98 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
OL; Mean Time-matched Baseline Role-Physical Score Over Time For Participants Treated in the OL Day 169 cohort (n=210, n=98): Role-Physical	30.50 units on a scale Standard Deviation 6.20	32.36 units on a scale Standard Deviation 7.36
OL; Mean Time-matched Baseline Role-Physical Score Over Time For Participants Treated in the OL Day 365 cohort (n=203, n=97): Role-Physical	30.49 units on a scale Standard Deviation 6.24	32.40 units on a scale Standard Deviation 7.38
OL; Mean Time-matched Baseline Role-Physical Score Over Time For Participants Treated in the OL Day 729 cohort (n=156, n=74): Role-Physical	30.48 units on a scale Standard Deviation 6.02	32.45 units on a scale Standard Deviation 7.08
OL; Mean Time-matched Baseline Role-Physical Score Over Time For Participants Treated in the OL Day 1093 cohort (n=135, n=59): Role-Physical	30.71 units on a scale Standard Deviation 6.42	31.91 units on a scale Standard Deviation 6.98
OL; Mean Time-matched Baseline Role-Physical Score Over Time For Participants Treated in the OL Day 1457 cohort (n=117, n=50): Role-Physical	31.20 units on a scale Standard Deviation 6.81	31.91 units on a scale Standard Deviation 7.02
OL; Mean Time-matched Baseline Role-Physical Score Over Time For Participants Treated in the OL Day 1821 cohort (n=106, n=47): Role-Physical	30.93 units on a scale Standard Deviation 6.63	32.47 units on a scale Standard Deviation 7.58

SECONDARY outcome

Timeframe: BL, Days 169, 365, 729, 1093, 1457, and 1821

Population: Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.

SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0=worst score (or quality of life) and 100=best score. Change from BL = Post-BL value - time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at that visit.

Outcome measures

Outcome measures
Measure	Abatacept (ABA) n=208 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing \< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Placebo (PLA) n=98 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
OL; Mean Time-matched Change From Baseline in Role-Physical Score Over Time For Participants Treated in the OL Day 169 cohort (n=210, n=98): Role-Physical	7.82 units on a scale Standard Error 0.80	1.30 units on a scale Standard Error 0.99
OL; Mean Time-matched Change From Baseline in Role-Physical Score Over Time For Participants Treated in the OL Day 365 cohort (n=203, n=97): Role-Physical	7.78 units on a scale Standard Error 0.85	6.49 units on a scale Standard Error 1.25
OL; Mean Time-matched Change From Baseline in Role-Physical Score Over Time For Participants Treated in the OL Day 729 cohort (n=156, n=74): Role-Physical	10.76 units on a scale Standard Error 0.97	6.59 units on a scale Standard Error 1.42
OL; Mean Time-matched Change From Baseline in Role-Physical Score Over Time For Participants Treated in the OL Day 1093 cohort (n=135, n=59): Role-Physical	10.27 units on a scale Standard Error 1.10	8.91 units on a scale Standard Error 1.58
OL; Mean Time-matched Change From Baseline in Role-Physical Score Over Time For Participants Treated in the OL Day 1457 cohort (n=117, n=50): Role-Physical	9.09 units on a scale Standard Error 1.11	7.64 units on a scale Standard Error 1.75
OL; Mean Time-matched Change From Baseline in Role-Physical Score Over Time For Participants Treated in the OL Day 1821 cohort (n=106, n=47): Role-Physical	9.05 units on a scale Standard Error 1.28	9.93 units on a scale Standard Error 1.87

SECONDARY outcome

Timeframe: BL

Population: Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.

SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores:PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. 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. Time-matched baseline values were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit.

Outcome measures

Outcome measures
Measure	Abatacept (ABA) n=208 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing \< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Placebo (PLA) n=98 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
OL; Mean Time-matched Baseline Bodily Pain Score Over Time For Participants Treated in the OL Day 169 cohort (n=209, n=98): Bodily Pain	30.76 units on a scale Standard Deviation 6.77	31.90 units on a scale Standard Deviation 6.55
OL; Mean Time-matched Baseline Bodily Pain Score Over Time For Participants Treated in the OL Day 365 cohort (n=202, n=97): Bodily Pain	30.75 units on a scale Standard Deviation 6.80	31.84 units on a scale Standard Deviation 6.56
OL; Mean Time-matched Baseline Bodily Pain Score Over Time For Participants Treated in the OL Day 729 cohort (n=156, n=74): Bodily Pain	31.00 units on a scale Standard Deviation 6.77	31.98 units on a scale Standard Deviation 6.65
OL; Mean Time-matched Baseline Bodily Pain Score Over Time For Participants Treated in the OL Day 1093 cohort (n=135, n=59): Bodily Pain	31.41 units on a scale Standard Deviation 6.86	31.71 units on a scale Standard Deviation 6.32
OL; Mean Time-matched Baseline Bodily Pain Score Over Time For Participants Treated in the OL Day 1457 cohort (n=117, n=50): Bodily Pain	31.73 units on a scale Standard Deviation 6.85	31.38 units on a scale Standard Deviation 6.31
OL; Mean Time-matched Baseline Bodily Pain Score Over Time For Participants Treated in the OL Day 1821 cohort (n=106, n=47): Bodily Pain	31.60 units on a scale Standard Deviation 7.07	31.78 units on a scale Standard Deviation 6.67

SECONDARY outcome

Timeframe: BL, Days 169, 365, 729, 1093, 1457, and 1821

Population: Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.

SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0=worst score (or quality of life) and 100=best score. Change from BL = Post-BL value - time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at that visit.

Outcome measures

Outcome measures
Measure	Abatacept (ABA) n=208 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing \< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Placebo (PLA) n=98 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
OL; Mean Time-matched Change From Baseline in Bodily Pain Score Over Time For Participants Treated in the OL Day 169 cohort (n=209, n=98): Bodily Pain	9.59 units on a scale Standard Error 0.72	3.32 units on a scale Standard Error 0.78
OL; Mean Time-matched Change From Baseline in Bodily Pain Score Over Time For Participants Treated in the OL Day 365 cohort (n=202, n=97): Bodily Pain	10.25 units on a scale Standard Error 0.73	9.55 units on a scale Standard Error 0.98
OL; Mean Time-matched Change From Baseline in Bodily Pain Score Over Time For Participants Treated in the OL Day 729 cohort (n=156, n=74): Bodily Pain	12.36 units on a scale Standard Error 0.80	10.29 units on a scale Standard Error 1.23
OL; Mean Time-matched Change From Baseline in Bodily Pain Score Over Time For Participants Treated in the OL Day 1093 cohort (n=135, n=59): Bodily Pain	12.33 units on a scale Standard Error 0.95	11.34 units on a scale Standard Error 1.45
OL; Mean Time-matched Change From Baseline in Bodily Pain Score Over Time For Participants Treated in the OL Day 1457 cohort (n=117, n=50): Bodily Pain	10.79 units on a scale Standard Error 0.91	11.52 units on a scale Standard Error 1.60
OL; Mean Time-matched Change From Baseline in Bodily Pain Score Over Time For Participants Treated in the OL Day 1821 cohort (n=106, n=47): Bodily Pain	11.83 units on a scale Standard Error 1.13	14.33 units on a scale Standard Error 1.43

SECONDARY outcome

Timeframe: BL

Population: Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.

SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores:PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. 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. Time-matched baseline values were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit.

Outcome measures

Outcome measures
Measure	Abatacept (ABA) n=208 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing \< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Placebo (PLA) n=98 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
OL; Mean Time-matched Baseline General Health Score Over Time For Participants Treated in the OL Day 169 cohort (n=212, n=98): General Health	35.28 units on a scale Standard Deviation 9.49	35.52 units on a scale Standard Deviation 8.76
OL; Mean Time-matched Baseline General Health Score Over Time For Participants Treated in the OL Day 365 cohort (n=204, n=97): General Health	35.50 units on a scale Standard Deviation 9.55	35.48 units on a scale Standard Deviation 8.76
OL; Mean Time-matched Baseline General Health Score Over Time For Participants Treated in the OL Day 729 cohort (n=157, n=74): General Health	35.49 units on a scale Standard Deviation 9.79	35.48 units on a scale Standard Deviation 8.98
OL; Mean Time-matched Baseline General Health Score Over Time For Participants Treated in the OL Day 1093 cohort (n=136, n=59): General Health	36.21 units on a scale Standard Deviation 9.79	35.78 units on a scale Standard Deviation 8.79
OL; Mean Time-matched Baseline General Health Score Over Time For Participants Treated in the OL Day 1457 cohort (n=119, n=50): General Health	36.21 units on a scale Standard Deviation 9.99	35.92 units on a scale Standard Deviation 8.92
OL; Mean Time-matched Baseline General Health Score Over Time For Participants Treated in the OL Day 1821 cohort (n=106, n=47): General Health	35.50 units on a scale Standard Deviation 10.1	36.14 units on a scale Standard Deviation 9.02

SECONDARY outcome

Timeframe: BL, Days 169, 365, 729, 1093, 1457, and 1821

Population: Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.

SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0=worst score (or quality of life) and 100=best score. Change from BL = Post-BL value - time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at that visit.

Outcome measures

Outcome measures
Measure	Abatacept (ABA) n=208 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing \< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Placebo (PLA) n=98 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
OL; Mean Time-matched Change From Baseline in General Health Score Over Time For Participants Treated in the OL Day 169 cohort (n=212, n=98): General Health	4.48 units on a scale Standard Error 0.59	1.09 units on a scale Standard Error 0.82
OL; Mean Time-matched Change From Baseline in General Health Score Over Time For Participants Treated in the OL Day 365 cohort (n=204, n=97): General Health	4.36 units on a scale Standard Error 0.60	4.04 units on a scale Standard Error 0.84
OL; Mean Time-matched Change From Baseline in General Health Score Over Time For Participants Treated in the OL Day 729 cohort (n=157, n=74): General Health	6.43 units on a scale Standard Error 0.67	5.85 units on a scale Standard Error 0.98
OL; Mean Time-matched Change From Baseline in General Health Score Over Time For Participants Treated in the OL Day 1093 cohort (n=136, n=59): General Health	6.05 units on a scale Standard Error 0.71	5.92 units on a scale Standard Error 1.35
OL; Mean Time-matched Change From Baseline in General Health Score Over Time For Participants Treated in the OL Day 1457 cohort (n=119, n=50): General Health	5.29 units on a scale Standard Error 0.82	5.60 units on a scale Standard Error 1.41
OL; Mean Time-matched Change From Baseline in General Health Score Over Time For Participants Treated in the OL Day 1821 cohort (n=106, n=47): General Health	5.75 units on a scale Standard Error 0.81	6.92 units on a scale Standard Error 1.46

SECONDARY outcome

Timeframe: BL

Population: Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.

SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores:PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. 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. Time-matched baseline values were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit.

Outcome measures

Outcome measures
Measure	Abatacept (ABA) n=208 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing \< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Placebo (PLA) n=98 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
OL; Mean Time-matched Baseline Vitality Score Over Time For Participants Treated in the OL Day 169 cohort (n=212, n=98): Vitality	35.06 units on a scale Standard Deviation 8.82	36.51 units on a scale Standard Deviation 9.15
OL; Mean Time-matched Baseline Vitality Score Over Time For Participants Treated in the OL Day 365 cohort (n=204, n=97): Vitality	35.09 units on a scale Standard Deviation 8.73	36.65 units on a scale Standard Deviation 9.09
OL; Mean Time-matched Baseline Vitality Score Over Time For Participants Treated in the OL Day 729 cohort (n=157, n=74): Vitality	35.45 units on a scale Standard Deviation 9.00	36.50 units on a scale Standard Deviation 8.95
OL; Mean Time-matched Baseline Vitality Score Over Time For Participants Treated in the OL Day 1093 cohort (n=136, n=59): Vitality	35.74 units on a scale Standard Deviation 9.06	36.53 units on a scale Standard Deviation 8.23
OL; Mean Time-matched Baseline Vitality Score Over Time For Participants Treated in the OL Day 1457 cohort (n=118, n=50): Vitality	35.94 units on a scale Standard Deviation 8.99	35.83 units on a scale Standard Deviation 8.18
OL; Mean Time-matched Baseline Vitality Score Over Time For Participants Treated in the OL Day 1821 cohort (n=105, n=47): Vitality	35.01 units on a scale Standard Deviation 8.54	36.35 units on a scale Standard Deviation 8.47

SECONDARY outcome

Timeframe: BL, Days 169, 365, 729, 1093, 1457, and 1821

Population: Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.

SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0=worst score (or quality of life) and 100=best score. Change from BL = Post-BL value - time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at that visit.

Outcome measures

Outcome measures
Measure	Abatacept (ABA) n=208 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing \< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Placebo (PLA) n=98 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
OL; Mean Time-matched Change From Baseline in Vitality Score Over Time For Participants Treated in the OL Day 169 cohort (n=212, n=98): Vitality	7.80 units on a scale Standard Error 0.75	2.89 units on a scale Standard Error 0.87
OL; Mean Time-matched Change From Baseline in Vitality Score Over Time For Participants Treated in the OL Day 365 cohort (n=204, n=97): Vitality	8.00 units on a scale Standard Error 0.76	6.69 units on a scale Standard Error 0.98
OL; Mean Time-matched Change From Baseline in Vitality Score Over Time For Participants Treated in the OL Day 729 cohort (n=157, n=74): Vitality	8.49 units on a scale Standard Error 0.83	7.52 units on a scale Standard Error 1.20
OL; Mean Time-matched Change From Baseline in Vitality Score Over Time For Participants Treated in the OL Day 1093 cohort (n=136, n=59): Vitality	8.23 units on a scale Standard Error 0.96	8.61 units on a scale Standard Error 1.63
OL; Mean Time-matched Change From Baseline in Vitality Score Over Time For Participants Treated in the OL Day 1457 cohort (n=118, n=50): Vitality	7.62 units on a scale Standard Error 0.96	8.08 units on a scale Standard Error 1.76
OL; Mean Time-matched Change From Baseline in Vitality Score Over Time For Participants Treated in the OL Day 1821 cohort (n=105, n=47): Vitality	8.51 units on a scale Standard Error 1.05	9.82 units on a scale Standard Error 1.69

SECONDARY outcome

Timeframe: BL

Population: Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.

SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores:PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. 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. Time-matched baseline values were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit.

Outcome measures

Outcome measures
Measure	Abatacept (ABA) n=208 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing \< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Placebo (PLA) n=98 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
OL; Mean Time-matched Baseline Social Functioning Score Over Time For Participants Treated in the OL Day 169 cohort (n=211, n=98): Social Functioning	33.31 units on a scale Standard Deviation 11.01	34.37 units on a scale Standard Deviation 11.42
OL; Mean Time-matched Baseline Social Functioning Score Over Time For Participants Treated in the OL Day 365 cohort (n=204, n=97): Social Functioning	33.59 units on a scale Standard Deviation 11.01	34.30 units on a scale Standard Deviation 11.46
OL; Mean Time-matched Baseline Social Functioning Score Over Time For Participants Treated in the OL Day 729 cohort (n=157, n=74): Social Functioning	33.87 units on a scale Standard Deviation 11.22	34.32 units on a scale Standard Deviation 11.29
OL; Mean Time-matched Baseline Social Functioning Score Over Time For Participants Treated in the OL Day 1093 cohort (n=136, n=59): Social Functioning	34.43 units on a scale Standard Deviation 10.86	34.14 units on a scale Standard Deviation 11.46
OL; Mean Time-matched Baseline Social Functioning Score Over Time For Participants Treated in the OL Day 1457 cohort (n=119, n=50): Social Functioning	35.20 units on a scale Standard Deviation 11.12	33.36 units on a scale Standard Deviation 11.60
OL; Mean Time-matched Baseline Social Functioning Score Over Time For Participants Treated in the OL Day 1821 cohort (n=106, n=47): Social Functioning	34.91 units on a scale Standard Deviation 11.62	34.15 units on a scale Standard Deviation 11.88

SECONDARY outcome

Timeframe: BL, Days 169, 365, 729, 1093, 1457, and 1821

Population: Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.

SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0=worst score (or quality of life) and 100=best score. Change from BL = Post-BL value - time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at that visit.

Outcome measures

Outcome measures
Measure	Abatacept (ABA) n=208 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing \< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Placebo (PLA) n=98 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
OL; Mean Time-matched Change From Baseline in Social Functioning Score Over Time For Participants Treated in the OL Day 169 cohort (n=211, n=98): Social Functioning	8.36 units on a scale Standard Error 0.85	2.99 units on a scale Standard Error 1.12
OL; Mean Time-matched Change From Baseline in Social Functioning Score Over Time For Participants Treated in the OL Day 365 cohort (n=204, n=97): Social Functioning	8.17 units on a scale Standard Error 0.85	7.22 units on a scale Standard Error 1.28
OL; Mean Time-matched Change From Baseline in Social Functioning Score Over Time For Participants Treated in the OL Day 729 cohort (n=157, n=74): Social Functioning	9.89 units on a scale Standard Error 0.96	9.10 units on a scale Standard Error 1.48
OL; Mean Time-matched Change From Baseline in Social Functioning Score Over Time For Participants Treated in the OL Day 1093 cohort (n=136, n=59): Social Functioning	10.46 units on a scale Standard Error 1.05	10.49 units on a scale Standard Error 1.54
OL; Mean Time-matched Change From Baseline in Social Functioning Score Over Time For Participants Treated in the OL Day 1457 cohort (n=119, n=50): Social Functioning	8.62 units on a scale Standard Error 1.08	11.83 units on a scale Standard Error 1.92
OL; Mean Time-matched Change From Baseline in Social Functioning Score Over Time For Participants Treated in the OL Day 1821 cohort (n=106, n=47): Social Functioning	9.17 units on a scale Standard Error 1.16	12.24 units on a scale Standard Error 1.79

SECONDARY outcome

Timeframe: BL

Population: Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.

SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores:PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. 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. Time-matched baseline values were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit.

Outcome measures

Outcome measures
Measure	Abatacept (ABA) n=208 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing \< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Placebo (PLA) n=98 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
OL; Mean Time-matched Baseline Role-Emotional Score Over Time For Participants Treated in the OL Day 169 cohort (n=210, n=98): Role-Emotional	35.73 units on a scale Standard Deviation 13.69	37.60 units on a scale Standard Deviation 14.00
OL; Mean Time-matched Baseline Role-Emotional Score Over Time For Participants Treated in the OL Day 365 cohort (n=203, n=97): Role-Emotional	35.93 units on a scale Standard Deviation 13.73	37.75 units on a scale Standard Deviation 14.00
OL; Mean Time-matched Baseline Role-Emotional Score Over Time For Participants Treated in the OL Day 729 cohort (n=156, n=73): Role-Emotional	36.09 units on a scale Standard Deviation 13.65	35.86 units on a scale Standard Deviation 13.45
OL; Mean Time-matched Baseline Role-Emotional Score Over Time For Participants Treated in the OL Day 1093 cohort (n=134, n=58): Role-Emotional	36.87 units on a scale Standard Deviation 13.82	35.54 units on a scale Standard Deviation 13.54
OL; Mean Time-matched Baseline Role-Emotional Score Over Time For Participants Treated in the OL Day 1457 cohort (n=117, n=50): Role-Emotional	37.06 units on a scale Standard Deviation 13.58	36.17 units on a scale Standard Deviation 13.74
OL; Mean Time-matched Baseline Role-Emotional Score Over Time For Participants Treated in the OL Day 1821 cohort (n=106, n=47): Role-Emotional	36.26 units on a scale Standard Deviation 13.80	36.29 units on a scale Standard Deviation 13.65

SECONDARY outcome

Timeframe: BL, Days 169, 365, 729, 1093, 1457, and 1821

Population: Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.

SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0=worst score (or quality of life) and 100=best score. Change from BL = Post-BL value - time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at that visit.

Outcome measures

Outcome measures
Measure	Abatacept (ABA) n=208 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing \< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Placebo (PLA) n=98 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
OL; Mean Time-matched Change From Baseline in Role-Emotional Score Over Time For Participants Treated in the OL Day 169 cohort (n=210, n=98): Role-Emotional	7.17 units on a scale Standard Error 1.11	1.83 units on a scale Standard Error 1.40
OL; Mean Time-matched Change From Baseline in Role-Emotional Score Over Time For Participants Treated in the OL Day 365 cohort (n=203, n=97): Role-Emotional	5.47 units on a scale Standard Error 1.04	6.52 units on a scale Standard Error 1.58
OL; Mean Time-matched Change From Baseline in Role-Emotional Score Over Time For Participants Treated in the OL Day 729 cohort (n=156, n=73): Role-Emotional	7.29 units on a scale Standard Error 1.18	10.39 units on a scale Standard Error 1.94
OL; Mean Time-matched Change From Baseline in Role-Emotional Score Over Time For Participants Treated in the OL Day 1093 cohort (n=134, n=58): Role-Emotional	6.88 units on a scale Standard Error 1.36	11.62 units on a scale Standard Error 2.28
OL; Mean Time-matched Change From Baseline in Role-Emotional Score Over Time For Participants Treated in the OL Day 1457 cohort (n=117, n=50): Role-Emotional	6.66 units on a scale Standard Error 1.49	6.32 units on a scale Standard Error 2.39
OL; Mean Time-matched Change From Baseline in Role-Emotional Score Over Time For Participants Treated in the OL Day 1821 cohort (n=106, n=47): Role-Emotional	7.26 units on a scale Standard Error 1.55	12.10 units on a scale Standard Error 2.35

SECONDARY outcome

Timeframe: BL

Population: Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.

SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores:PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. 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. Time-matched baseline values were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit.

Outcome measures

Outcome measures
Measure	Abatacept (ABA) n=208 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing \< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Placebo (PLA) n=98 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
OL; Mean Time-matched Baseline Mental Health Score Over Time For Participants Treated in the OL Day 169 cohort (n=212, n=98): Mental Health	40.96 units on a scale Standard Deviation 13.07	43.47 units on a scale Standard Deviation 11.34
OL; Mean Time-matched Baseline Mental Health Score Over Time For Participants Treated in the OL Day 365 cohort (n=204, n=97): Mental Health	41.11 units on a scale Standard Deviation 13.06	43.53 units on a scale Standard Deviation 11.37
OL; Mean Time-matched Baseline Mental Health Score Over Time For Participants Treated in the OL Day 729 cohort (n=157, n=73): Mental Health	41.85 units on a scale Standard Deviation 13.38	42.69 units on a scale Standard Deviation 10.81
OL; Mean Time-matched Baseline Mental Health Score Over Time For Participants Treated in the OL Day 1093 cohort (n=136, n=59): Mental Health	42.68 units on a scale Standard Deviation 12.58	41.85 units on a scale Standard Deviation 10.54
OL; Mean Time-matched Baseline Mental Health Score Over Time For Participants Treated in the OL Day 1457 cohort (n=118, n=50): Mental Health	42.52 units on a scale Standard Deviation 12.74	41.44 units on a scale Standard Deviation 10.62
OL; Mean Time-matched Baseline Mental Health Score Over Time For Participants Treated in the OL Day 1821 cohort (n=105, n=47): Mental Health	41.36 units on a scale Standard Deviation 13.05	42.50 units on a scale Standard Deviation 10.36

SECONDARY outcome

Timeframe: BL, Days 169, 365, 729, 1093, 1457, and 1821

Population: Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.

SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0=worst score (or quality of life) and 100=best score. Change from BL = Post-BL value - time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at that visit.

Outcome measures

Outcome measures
Measure	Abatacept (ABA) n=208 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing \< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Placebo (PLA) n=98 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
OL; Mean Time-matched Change From Baseline in Mental Health Score Over Time For Participants Treated in the OL Day 169 cohort (n=212, n=98): Mental Health	4.42 units on a scale Standard Error 0.71	1.65 units on a scale Standard Error 0.83
OL; Mean Time-matched Change From Baseline in Mental Health Score Over Time For Participants Treated in the OL Day 365 cohort (n=204, n=97): Mental Health	4.53 units on a scale Standard Error 0.73	4.29 units on a scale Standard Error 0.93
OL; Mean Time-matched Change From Baseline in Mental Health Score Over Time For Participants Treated in the OL Day 729 cohort (n=157, n=73): Mental Health .	5.54 units on a scale Standard Error 0.84	7.19 units on a scale Standard Error 1.29
OL; Mean Time-matched Change From Baseline in Mental Health Score Over Time For Participants Treated in the OL Day 1093 cohort (n=136, n=59): Mental Health	5.24 units on a scale Standard Error 0.95	7.69 units on a scale Standard Error 1.45
OL; Mean Time-matched Change From Baseline in Mental Health Score Over Time For Participants Treated in the OL Day 1457 cohort (n=118, n=50): Mental Health	4.60 units on a scale Standard Error 0.89	8.91 units on a scale Standard Error 1.41
OL; Mean Time-matched Change From Baseline in Mental Health Score Over Time For Participants Treated in the OL Day 1821 cohort (n=105, n=47): Mental Health	5.31 units on a scale Standard Error 1.08	8.66 units on a scale Standard Error 1.53

SECONDARY outcome

Timeframe: BL

Population: Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.

The validated 12-it3em Medical Outcomes Study sleep questionnaire (MOS-sleep) was used to measure sleep quality. An overall Sleep Problem Index (SPI) was generated as a summary measure of different types of sleep problems (sleep disturbance, sleep quantity, sleep adequacy, etc.). The score ranges from 0 to 100 with a higher score reflecting more severe problems with sleep. The mean score of the SPI in a population with chronic problems is 29.

Outcome measures

Outcome measures
Measure	Abatacept (ABA) n=208 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing \< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Placebo (PLA) n=98 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
OL; Mean Time-matched Baseline Medical Outcomes Study Sleep Module (MOS-sleep) Score Over Time For Participants Treated in the OL Day 169 cohort (n=212, n=98)	49.18 units on a scale Standard Deviation 18.10	45.49 units on a scale Standard Deviation 17.72
OL; Mean Time-matched Baseline Medical Outcomes Study Sleep Module (MOS-sleep) Score Over Time For Participants Treated in the OL Day 365 cohort (n=204, n=97)	48.87 units on a scale Standard Deviation 19.09	45.54 units on a scale Standard Deviation 17.86
OL; Mean Time-matched Baseline Medical Outcomes Study Sleep Module (MOS-sleep) Score Over Time For Participants Treated in the OL Day 729 cohort (n=157, n=74)	48.62 units on a scale Standard Deviation 18.12	45.36 units on a scale Standard Deviation 17.26
OL; Mean Time-matched Baseline Medical Outcomes Study Sleep Module (MOS-sleep) Score Over Time For Participants Treated in the OL Day 1093 cohort (n=136, n=59)	48.01 units on a scale Standard Deviation 17.86	46.44 units on a scale Standard Deviation 17.28
OL; Mean Time-matched Baseline Medical Outcomes Study Sleep Module (MOS-sleep) Score Over Time For Participants Treated in the OL Day 1457 cohort (n=119, n=50)	46.71 units on a scale Standard Deviation 17.97	47.14 units on a scale Standard Deviation 18.47
OL; Mean Time-matched Baseline Medical Outcomes Study Sleep Module (MOS-sleep) Score Over Time For Participants Treated in the OL Day 1821 cohort (n=106, n=47)	47.49 units on a scale Standard Deviation 17.27	45.09 units on a scale Standard Deviation 17.90

SECONDARY outcome

Timeframe: BL, Days 169, 365, 729, 1093, 1457, and 1821

The validated 12-it3em Medical Outcomes Study sleep questionnaire (MOS-sleep) was used to measure sleep quality. An overall Sleep Problem Index (SPI) was generated as a summary measure of different types of sleep problems (sleep disturbance, sleep quantity, sleep adequacy, etc.). The score ranges from 0 to 100 with a higher score reflecting more severe problems with sleep. Change from BL = Post-BL value - time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at that visit.

Outcome measures

Outcome measures
Measure	Abatacept (ABA) n=208 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing \< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Placebo (PLA) n=98 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
OL; Mean Time-matched Change From Baseline in MOS-Sleep Score Over Time For Participants Treated in the OL Day 169 cohort (n=212, n=98)	-11.1 units on a scale Standard Error 1.10	-4.31 units on a scale Standard Error 1.59
OL; Mean Time-matched Change From Baseline in MOS-Sleep Score Over Time For Participants Treated in the OL Day 365 cohort (n=204, n=97)	-11.2 units on a scale Standard Error 1.33	-10.4 units on a scale Standard Error 1.82
OL; Mean Time-matched Change From Baseline in MOS-Sleep Score Over Time For Participants Treated in the OL Day 729 cohort (n=157, n=74)	-12.5 units on a scale Standard Error 1.38	-11.9 units on a scale Standard Error 2.06
OL; Mean Time-matched Change From Baseline in MOS-Sleep Score Over Time For Participants Treated in the OL Day 1093 cohort (n=136, n=59)	-12.9 units on a scale Standard Error 1.47	-16.1 units on a scale Standard Error 2.53
OL; Mean Time-matched Change From Baseline in MOS-Sleep Score Over Time For Participants Treated in the OL Day 1457 cohort (n=119, n=50)	-9.86 units on a scale Standard Error 1.56	-11.9 units on a scale Standard Error 2.92
OL; Mean Time-matched Change From Baseline in MOS-Sleep Score Over Time For Participants Treated in the OL Day 1821 cohort (n=106, n=47)	-11.7 units on a scale Standard Error 1.55	-15.9 units on a scale Standard Error 2.84

SECONDARY outcome

Timeframe: BL

Population: Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.

Fatigue severity was assessed on the VAS 100 mm where 0= no fatigue to 100 = the worst fatigue imaginable. Time-matched baseline values were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit.

Outcome measures

Outcome measures
Measure	Abatacept (ABA) n=212 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing \< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Placebo (PLA) n=98 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
OL; Mean Time-matched Baseline Fatigue Visual Analog Score (VAS) Over Time For Participants Treated in the OL Day 169 cohort (n=212, n=98)	73.73 units on a scale Standard Deviation 19.84	71.24 units on a scale Standard Deviation 20.27
OL; Mean Time-matched Baseline Fatigue Visual Analog Score (VAS) Over Time For Participants Treated in the OL Day 365 cohort (n=204, n=97)	73.54 units on a scale Standard Deviation 20.00	70.78 units on a scale Standard Deviation 20.13
OL; Mean Time-matched Baseline Fatigue Visual Analog Score (VAS) Over Time For Participants Treated in the OL Day 729 cohort (n=157, n=74)	73.75 units on a scale Standard Deviation 19.18	69.59 units on a scale Standard Deviation 20.74
OL; Mean Time-matched Baseline Fatigue Visual Analog Score (VAS) Over Time For Participants Treated in the OL Day 1093 cohort (n=135, n=59)	73.21 units on a scale Standard Deviation 19.93	70.00 units on a scale Standard Deviation 21.00
OL; Mean Time-matched Baseline Fatigue Visual Analog Score (VAS) Over Time For Participants Treated in the OL Day 1457 cohort (n=119, n=50)	72.15 units on a scale Standard Deviation 19.73	71.14 units on a scale Standard Deviation 19.57
OL; Mean Time-matched Baseline Fatigue Visual Analog Score (VAS) Over Time For Participants Treated in the OL Day 1821 cohort (n=106, n=47)	72.36 units on a scale Standard Deviation 20.51	69.68 units on a scale Standard Deviation 20.08

SECONDARY outcome

Timeframe: BL, Days 169, 365, 729, 1093, 1457, and 1821

Fatigue severity was assessed on the VAS 100 mm where 0= no fatigue to 100 = the worst fatigue imaginable. Change from BL = Post-BL value - time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at that visit.

Outcome measures

Outcome measures
Measure	Abatacept (ABA) n=212 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing \< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Placebo (PLA) n=98 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
OL; Mean Time-matched Change From Baseline in Fatigue VAS Over Time For Participants Treated in the OL Day 1093 cohort (n=135, n=59)	-28.4 units on a scale Standard Error 2.53	-24.6 units on a scale Standard Error 4.58
OL; Mean Time-matched Change From Baseline in Fatigue VAS Over Time For Participants Treated in the OL Day 169 cohort (n=212, n=98)	-25.0 units on a scale Standard Error 1.95	-7.28 units on a scale Standard Error 2.86
OL; Mean Time-matched Change From Baseline in Fatigue VAS Over Time For Participants Treated in the OL Day 365 cohort (n=204, n=97)	-26.1 units on a scale Standard Error 2.10	-21.8 units on a scale Standard Error 2.77
OL; Mean Time-matched Change From Baseline in Fatigue VAS Over Time For Participants Treated in the OL Day 729 cohort (n=157, n=74)	-28.2 units on a scale Standard Error 2.08	-22.2 units on a scale Standard Error 3.71
OL; Mean Time-matched Change From Baseline in Fatigue VAS Over Time For Participants Treated in the OL Day 1457 cohort (n=119, n=50)	-26.9 units on a scale Standard Error 2.52	-25.8 units on a scale Standard Error 4.60
OL; Mean Time-matched Change From Baseline in Fatigue VAS Over Time For Participants Treated in the OL Day 1821 cohort (n=106, n=47)	-26.8 units on a scale Standard Error 3.03	-28.5 units on a scale Standard Error 4.71

SECONDARY outcome

Timeframe: BL

Population: Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.

Limitations on activities of daily living in the OL period at each study visit were measured by a 2-item questionnaire that was developed to collect data on the amount of time that a participant is unable to perform their usual activities because of their rheumatoid arthritis. Time-matched baseline values were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit. The scale ranges from 0 to 100 with increasing score indicating increasing restrictions on levels of activity.

Outcome measures

Outcome measures
Measure	Abatacept (ABA) n=206 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing \< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Placebo (PLA) n=94 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
OL; Mean Time-matched Baseline Activity Limitation Score Over Time For Participants Treated in the OL Day 169 cohort (n=206, n=94)	17.18 units on a scale Standard Deviation 11.09	15.01 units on a scale Standard Deviation 11.34
OL; Mean Time-matched Baseline Activity Limitation Score Over Time For Participants Treated in the OL Day 365 cohort (n=196, n=93)	16.97 units on a scale Standard Deviation 11.17	15.70 units on a scale Standard Deviation 11.29
OL; Mean Time-matched Baseline Activity Limitation Score Over Time For Participants Treated in the OL Day 729 cohort (n=150, n=72)	16.59 units on a scale Standard Deviation 11.40	14.56 units on a scale Standard Deviation 10.87
OL; Mean Time-matched Baseline Activity Limitation Score Over Time For Participants Treated in the OL Day 1093 cohort (n=128, n=56)	15.66 units on a scale Standard Deviation 11.26	15.38 units on a scale Standard Deviation 10.94

SECONDARY outcome

Timeframe: Days 169, 365, 729, 1093, 1457, and 1821

Population: Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.

Limitations on activities of daily living in the OL period at each study visit was measured by a 2-item questionnaire that was developed to collect data on the amount of time that a participant is unable to perform their usual activities because of their rheumatoid arthritis. The scale ranges from 0 to 100 with increasing score indicating increasing restrictions on levels of activity.

Outcome measures

Outcome measures
Measure	Abatacept (ABA) n=206 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing \< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Placebo (PLA) n=94 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
OL; Mean Change From Baseline in Activity Limitation Score Over Time For Participants Treated in the OL Day 169 cohort (n=206, n=94)	-7.80 units on a scale Standard Error 0.83	-1.78 units on a scale Standard Error 1.01
OL; Mean Change From Baseline in Activity Limitation Score Over Time For Participants Treated in the OL Day 365 cohort (n=196, n=93)	-8.04 units on a scale Standard Error 0.91	-6.08 units on a scale Standard Error 0.98
OL; Mean Change From Baseline in Activity Limitation Score Over Time For Participants Treated in the OL Day 729 cohort (n=150, n=72)	-8.29 units on a scale Standard Error 1.00	-8.32 units on a scale Standard Error 1.25
OL; Mean Change From Baseline in Activity Limitation Score Over Time For Participants Treated in the OL Day 1093 cohort (n=128, n=56)	-8.98 units on a scale Standard Error 1.09	-8.88 units on a scale Standard Error 1.51

SECONDARY outcome

Timeframe: From BL (Day 1) to Day 1821

Population: All participants treated on study with at least one post-baseline immunogenicity measurement.

Outcome measures

Outcome measures
Measure	Abatacept (ABA) n=329 Participants Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing \< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Placebo (PLA) Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
Cumulative Analysis (DB + OL); Number of Participants With Positive Anti-Abatacept or Anti-Cytotoxic T-Lymphocyte Antigen 4 (CTLA4) Responses by Enzyme-Linked Immunosorbent Assay (ELISA) Anti-abatacept antibodies	22 participants	—
Cumulative Analysis (DB + OL); Number of Participants With Positive Anti-Abatacept or Anti-Cytotoxic T-Lymphocyte Antigen 4 (CTLA4) Responses by Enzyme-Linked Immunosorbent Assay (ELISA) Anti-CTLA4 antibodies	5 participants	—
Cumulative Analysis (DB + OL); Number of Participants With Positive Anti-Abatacept or Anti-Cytotoxic T-Lymphocyte Antigen 4 (CTLA4) Responses by Enzyme-Linked Immunosorbent Assay (ELISA) Total	26 participants	—

Adverse Events

Open-label ABA

Serious events: 136 serious events

Other events: 276 other events

Deaths: 0 deaths

Abatacept (ABA)

Serious events: 28 serious events

Other events: 153 other events

Deaths: 0 deaths

Placebo (PLA)

Serious events: 16 serious events

Other events: 65 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Open-label ABA n=317 participants at risk All participants who completed the double-blind period were eligible to continue in the open-label period. At the beginning of the open-label period (Day 169), all eligible participants were re-allocated to a 10 mg/kg weight-tiered dose of abatacept at their enrollment visit into the open-label period. Participants weighing \> 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing \< 60 kg received 500 mg on a background of DMARDs (at discretion of the investigator). Concomitant biologic RA therapies were later excluded.	Abatacept (ABA) n=258 participants at risk Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing \< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Placebo (PLA) n=133 participants at risk Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
Investigations WEIGHT DECREASED	0.32% 1/317	0.00% 0/258	0.00% 0/133
Investigations BLOOD GLUCOSE DECREASED	0.32% 1/317	0.00% 0/258	0.00% 0/133
Investigations ELECTROCARDIOGRAM CHANGE	0.32% 1/317	0.00% 0/258	0.00% 0/133
Investigations RED BLOOD CELL SEDIMENTATION RATE INCREASED	0.32% 1/317	0.00% 0/258	0.00% 0/133
Cardiac disorders PERICARDITIS	0.32% 1/317	0.00% 0/258	0.00% 0/133
Cardiac disorders ANGINA PECTORIS	0.00% 0/317	0.39% 1/258	0.00% 0/133
Cardiac disorders CARDIAC TAMPONADE	0.00% 0/317	0.39% 1/258	0.00% 0/133
Cardiac disorders ATRIAL FIBRILLATION	0.00% 0/317	0.39% 1/258	0.75% 1/133
Cardiac disorders SICK SINUS SYNDROME	0.00% 0/317	0.39% 1/258	0.00% 0/133
Cardiac disorders MYOCARDIAL INFARCTION	0.95% 3/317	0.39% 1/258	0.00% 0/133
Cardiac disorders PERICARDIAL HAEMORRHAGE	0.32% 1/317	0.00% 0/258	0.00% 0/133
Cardiac disorders CARDIAC FAILURE CONGESTIVE	0.63% 2/317	0.78% 2/258	0.75% 1/133
Cardiac disorders ACUTE MYOCARDIAL INFARCTION	0.32% 1/317	0.00% 0/258	0.00% 0/133
Cardiac disorders SUPRAVENTRICULAR TACHYCARDIA	0.32% 1/317	0.00% 0/258	0.00% 0/133
Cardiac disorders ATRIOVENTRICULAR BLOCK COMPLETE	0.32% 1/317	0.00% 0/258	0.00% 0/133
Vascular disorders HAEMATOMA	0.32% 1/317	0.00% 0/258	0.00% 0/133
Vascular disorders ISCHAEMIA	0.32% 1/317	0.00% 0/258	0.00% 0/133
Vascular disorders HAEMORRHAGE	0.32% 1/317	0.00% 0/258	0.00% 0/133
Vascular disorders HYPERTENSION	0.95% 3/317	0.39% 1/258	0.00% 0/133
Vascular disorders PERIPHERAL EMBOLISM	0.32% 1/317	0.00% 0/258	0.00% 0/133
Vascular disorders DEEP VEIN THROMBOSIS	0.95% 3/317	0.00% 0/258	0.00% 0/133
Vascular disorders PERIPHERAL ISCHAEMIA	0.32% 1/317	0.00% 0/258	0.00% 0/133
Hepatobiliary disorders LIVER INJURY	0.32% 1/317	0.00% 0/258	0.00% 0/133
Hepatobiliary disorders CHOLECYSTITIS	0.00% 0/317	0.39% 1/258	0.00% 0/133
Hepatobiliary disorders CHOLELITHIASIS	1.6% 5/317	0.39% 1/258	0.00% 0/133
Hepatobiliary disorders CYTOLYTIC HEPATITIS	0.32% 1/317	0.00% 0/258	0.00% 0/133
Hepatobiliary disorders AUTOIMMUNE HEPATITIS	0.63% 2/317	0.00% 0/258	0.00% 0/133
Immune system disorders AMYLOIDOSIS	0.00% 0/317	0.00% 0/258	0.75% 1/133
Nervous system disorders SYNCOPE	0.63% 2/317	0.00% 0/258	0.00% 0/133
Nervous system disorders DEMENTIA	0.32% 1/317	0.00% 0/258	0.00% 0/133
Nervous system disorders HEADACHE	0.63% 2/317	0.00% 0/258	0.00% 0/133
Nervous system disorders SCIATICA	0.32% 1/317	0.00% 0/258	0.00% 0/133
Nervous system disorders CONVULSION	0.32% 1/317	0.00% 0/258	0.00% 0/133
Nervous system disorders HYPOAESTHESIA	0.32% 1/317	0.00% 0/258	0.00% 0/133
Nervous system disorders RADICULOPATHY	0.32% 1/317	0.00% 0/258	0.00% 0/133
Nervous system disorders ISCHAEMIC STROKE	0.32% 1/317	0.00% 0/258	0.00% 0/133
Nervous system disorders NERVE COMPRESSION	0.00% 0/317	0.00% 0/258	0.75% 1/133
Nervous system disorders CEREBRAL ISCHAEMIA	0.00% 0/317	0.39% 1/258	0.00% 0/133
Nervous system disorders CEREBRAL INFARCTION	0.32% 1/317	0.00% 0/258	0.00% 0/133
Nervous system disorders CERVICAL MYELOPATHY	0.32% 1/317	0.00% 0/258	0.00% 0/133
Nervous system disorders LOSS OF CONSCIOUSNESS	0.32% 1/317	0.00% 0/258	0.00% 0/133
Nervous system disorders CEREBROVASCULAR ACCIDENT	0.32% 1/317	0.39% 1/258	0.00% 0/133
Gastrointestinal disorders NAUSEA	0.00% 0/317	0.00% 0/258	0.75% 1/133
Gastrointestinal disorders VOMITING	0.00% 0/317	0.00% 0/258	0.75% 1/133
Gastrointestinal disorders DIARRHOEA	0.32% 1/317	0.00% 0/258	0.00% 0/133
Gastrointestinal disorders DYSPHAGIA	0.00% 0/317	0.00% 0/258	0.75% 1/133
Gastrointestinal disorders JEJUNITIS	0.32% 1/317	0.00% 0/258	0.00% 0/133
Gastrointestinal disorders PERITONITIS	0.32% 1/317	0.00% 0/258	0.00% 0/133
Gastrointestinal disorders DIVERTICULUM	0.00% 0/317	0.39% 1/258	0.00% 0/133
Gastrointestinal disorders PANCREATITIS	0.32% 1/317	0.00% 0/258	0.00% 0/133
Gastrointestinal disorders GASTRIC ULCER	0.00% 0/317	0.39% 1/258	0.00% 0/133
Gastrointestinal disorders ABDOMINAL PAIN	0.32% 1/317	0.39% 1/258	0.00% 0/133
Gastrointestinal disorders UMBILICAL HERNIA	0.32% 1/317	0.00% 0/258	0.00% 0/133
Gastrointestinal disorders COLITIS ISCHAEMIC	0.00% 0/317	0.00% 0/258	0.75% 1/133
Gastrointestinal disorders HERNIAL EVENTRATION	0.63% 2/317	0.00% 0/258	0.00% 0/133
Gastrointestinal disorders OBSTRUCTION GASTRIC	0.32% 1/317	0.00% 0/258	0.00% 0/133
Gastrointestinal disorders ABDOMINAL DISCOMFORT	0.32% 1/317	0.00% 0/258	0.00% 0/133
Gastrointestinal disorders ABDOMINAL PAIN UPPER	0.00% 0/317	0.39% 1/258	0.00% 0/133
Gastrointestinal disorders DIARRHOEA HAEMORRHAGIC	0.32% 1/317	0.00% 0/258	0.00% 0/133
Gastrointestinal disorders INTESTINAL OBSTRUCTION	0.32% 1/317	0.00% 0/258	0.00% 0/133
Gastrointestinal disorders INTESTINAL PERFORATION	0.32% 1/317	0.00% 0/258	0.00% 0/133
Gastrointestinal disorders RETROPERITONEAL HAEMORRHAGE	0.32% 1/317	0.00% 0/258	0.75% 1/133
Gastrointestinal disorders SMALL INTESTINAL OBSTRUCTION	0.32% 1/317	0.00% 0/258	0.00% 0/133
Infections and infestations SEPSIS	0.63% 2/317	0.00% 0/258	0.75% 1/133
Infections and infestations PNEUMONIA	3.2% 10/317	0.39% 1/258	0.00% 0/133
Infections and infestations PYOTHORAX	0.32% 1/317	0.00% 0/258	0.00% 0/133
Infections and infestations CELLULITIS	0.63% 2/317	0.00% 0/258	0.00% 0/133
Infections and infestations BACTERAEMIA	0.32% 1/317	0.00% 0/258	0.00% 0/133
Infections and infestations PHARYNGITIS	0.00% 0/317	0.00% 0/258	0.75% 1/133
Infections and infestations OSTEOMYELITIS	0.32% 1/317	0.00% 0/258	0.75% 1/133
Infections and infestations DIVERTICULITIS	0.32% 1/317	0.39% 1/258	0.00% 0/133
Infections and infestations PYELONEPHRITIS	0.32% 1/317	0.00% 0/258	0.00% 0/133
Infections and infestations RECTAL ABSCESS	0.32% 1/317	0.00% 0/258	0.00% 0/133
Infections and infestations ACUTE SINUSITIS	0.00% 0/317	0.00% 0/258	0.75% 1/133
Infections and infestations GASTROENTERITIS	0.32% 1/317	0.00% 0/258	0.00% 0/133
Infections and infestations GRAFT INFECTION	0.32% 1/317	0.00% 0/258	0.00% 0/133
Infections and infestations LOBAR PNEUMONIA	1.6% 5/317	0.00% 0/258	0.00% 0/133
Infections and infestations BRONCHOPNEUMONIA	0.32% 1/317	0.00% 0/258	0.00% 0/133
Infections and infestations ORAL CANDIDIASIS	0.32% 1/317	0.00% 0/258	0.00% 0/133
Infections and infestations BURSITIS INFECTIVE	0.32% 1/317	0.00% 0/258	0.00% 0/133
Infections and infestations KERATITIS HERPETIC	0.32% 1/317	0.00% 0/258	0.00% 0/133
Infections and infestations INFECTED SKIN ULCER	0.32% 1/317	0.39% 1/258	0.00% 0/133
Infections and infestations PNEUMONIA BACTERIAL	0.00% 0/317	0.39% 1/258	0.00% 0/133
Infections and infestations PNEUMONIA INFLUENZAL	0.00% 0/317	0.39% 1/258	0.00% 0/133
Infections and infestations PYELONEPHRITIS ACUTE	0.32% 1/317	0.00% 0/258	0.00% 0/133
Infections and infestations STREPTOCOCCAL SEPSIS	0.00% 0/317	0.39% 1/258	0.00% 0/133
Infections and infestations GASTROENTERITIS VIRAL	0.32% 1/317	0.00% 0/258	0.00% 0/133
Infections and infestations SUBACUTE ENDOCARDITIS	0.32% 1/317	0.00% 0/258	0.00% 0/133
Infections and infestations ENDOCARDITIS BACTERIAL	0.32% 1/317	0.00% 0/258	0.00% 0/133
Infections and infestations ENTEROBACTER PNEUMONIA	0.32% 1/317	0.00% 0/258	0.00% 0/133
Infections and infestations PERIORBITAL CELLULITIS	0.32% 1/317	0.00% 0/258	0.00% 0/133
Infections and infestations STAPHYLOCOCCAL ABSCESS	0.00% 0/317	0.00% 0/258	0.75% 1/133
Infections and infestations URINARY TRACT INFECTION	0.32% 1/317	0.00% 0/258	0.00% 0/133
Infections and infestations DEVICE RELATED INFECTION	0.32% 1/317	0.00% 0/258	0.00% 0/133
Infections and infestations PERIDIVERTICULAR ABSCESS	0.00% 0/317	0.39% 1/258	0.00% 0/133
Infections and infestations WOUND INFECTION STAPHYLOCOCCAL	0.32% 1/317	0.00% 0/258	0.00% 0/133
Infections and infestations LOWER RESPIRATORY TRACT INFECTION	0.32% 1/317	0.00% 0/258	0.00% 0/133
Renal and urinary disorders RENAL COLIC	0.32% 1/317	0.00% 0/258	0.00% 0/133
Renal and urinary disorders RENAL FAILURE	0.32% 1/317	0.00% 0/258	0.75% 1/133
Renal and urinary disorders NEPHROLITHIASIS	0.95% 3/317	0.00% 0/258	0.00% 0/133
Renal and urinary disorders RENAL IMPAIRMENT	0.00% 0/317	0.00% 0/258	0.75% 1/133
Renal and urinary disorders CALCULUS URETHRAL	0.32% 1/317	0.00% 0/258	0.00% 0/133
Renal and urinary disorders RENAL FAILURE ACUTE	0.32% 1/317	0.39% 1/258	0.00% 0/133
Metabolism and nutrition disorders OBESITY	0.95% 3/317	0.00% 0/258	0.00% 0/133
Metabolism and nutrition disorders DEHYDRATION	0.32% 1/317	0.00% 0/258	0.00% 0/133
Metabolism and nutrition disorders HYPOKALAEMIA	0.00% 0/317	0.00% 0/258	0.75% 1/133
Metabolism and nutrition disorders HYPERKALAEMIA	0.32% 1/317	0.00% 0/258	0.00% 0/133
Metabolism and nutrition disorders ELECTROLYTE IMBALANCE	0.32% 1/317	0.00% 0/258	0.00% 0/133
Blood and lymphatic system disorders ANAEMIA	0.63% 2/317	0.00% 0/258	0.00% 0/133
Blood and lymphatic system disorders LEUKOCYTOSIS	0.32% 1/317	0.00% 0/258	0.00% 0/133
Skin and subcutaneous tissue disorders DECUBITUS ULCER	0.32% 1/317	0.00% 0/258	0.00% 0/133
Reproductive system and breast disorders CYSTOCELE	0.32% 1/317	0.00% 0/258	0.00% 0/133
Reproductive system and breast disorders MENORRHAGIA	0.32% 1/317	0.39% 1/258	0.00% 0/133
Reproductive system and breast disorders METRORRHAGIA	0.00% 0/317	0.39% 1/258	0.00% 0/133
Reproductive system and breast disorders OVARIAN CYST	0.63% 2/317	0.00% 0/258	0.75% 1/133
Reproductive system and breast disorders ENDOMETRIOSIS	0.32% 1/317	0.00% 0/258	0.75% 1/133
Reproductive system and breast disorders UTERINE POLYP	0.32% 1/317	0.00% 0/258	0.00% 0/133
Reproductive system and breast disorders BREAST ATROPHY	0.32% 1/317	0.00% 0/258	0.00% 0/133
Reproductive system and breast disorders MENOMETRORRHAGIA	0.32% 1/317	0.00% 0/258	0.00% 0/133
Reproductive system and breast disorders ADNEXA UTERI MASS	0.00% 0/317	0.00% 0/258	0.75% 1/133
Reproductive system and breast disorders FEMALE GENITAL TRACT FISTULA	0.32% 1/317	0.00% 0/258	0.00% 0/133
Congenital, familial and genetic disorders URETHRAL INTRINSIC SPHINCTER DEFICIENCY	0.32% 1/317	0.00% 0/258	0.00% 0/133
Injury, poisoning and procedural complications FALL	0.32% 1/317	0.00% 0/258	0.00% 0/133
Injury, poisoning and procedural complications WOUND	0.00% 0/317	0.39% 1/258	0.00% 0/133
Injury, poisoning and procedural complications CORNEAL SCAR	0.32% 1/317	0.00% 0/258	0.00% 0/133
Injury, poisoning and procedural complications HIP FRACTURE	1.9% 6/317	0.00% 0/258	0.75% 1/133
Injury, poisoning and procedural complications JOINT INJURY	0.63% 2/317	0.00% 0/258	0.00% 0/133
Injury, poisoning and procedural complications ANKLE FRACTURE	0.32% 1/317	0.00% 0/258	0.00% 0/133
Injury, poisoning and procedural complications FEMUR FRACTURE	0.63% 2/317	0.00% 0/258	0.00% 0/133
Injury, poisoning and procedural complications MENISCUS LESION	0.32% 1/317	0.00% 0/258	0.00% 0/133
Injury, poisoning and procedural complications HUMERUS FRACTURE	0.95% 3/317	0.00% 0/258	0.00% 0/133
Injury, poisoning and procedural complications JOINT DISLOCATION	0.00% 0/317	0.39% 1/258	0.00% 0/133
Injury, poisoning and procedural complications DEVICE DISLOCATION	0.32% 1/317	0.00% 0/258	0.00% 0/133
Injury, poisoning and procedural complications FAILURE OF IMPLANT	0.32% 1/317	0.00% 0/258	0.00% 0/133
Injury, poisoning and procedural complications UPPER LIMB FRACTURE	0.32% 1/317	0.00% 0/258	0.00% 0/133
Injury, poisoning and procedural complications FEMORAL NECK FRACTURE	0.32% 1/317	0.00% 0/258	0.00% 0/133
Injury, poisoning and procedural complications DISLOCATION OF VERTEBRA	0.00% 0/317	0.39% 1/258	0.00% 0/133
Injury, poisoning and procedural complications CERVICAL VERTEBRAL FRACTURE	0.32% 1/317	0.00% 0/258	0.00% 0/133
Injury, poisoning and procedural complications MEDICAL DEVICE COMPLICATION	0.32% 1/317	0.00% 0/258	0.00% 0/133
Musculoskeletal and connective tissue disorders BURSITIS	0.32% 1/317	0.00% 0/258	0.00% 0/133
Musculoskeletal and connective tissue disorders ARTHRITIS	1.3% 4/317	0.00% 0/258	0.00% 0/133
Musculoskeletal and connective tissue disorders BACK PAIN	1.3% 4/317	0.00% 0/258	0.75% 1/133
Musculoskeletal and connective tissue disorders SYNOVITIS	0.32% 1/317	0.00% 0/258	0.00% 0/133
Musculoskeletal and connective tissue disorders ARTHRALGIA	0.63% 2/317	0.00% 0/258	0.00% 0/133
Musculoskeletal and connective tissue disorders OSTEONECROSIS	0.63% 2/317	0.00% 0/258	0.00% 0/133
Musculoskeletal and connective tissue disorders OSTEOARTHRITIS	4.1% 13/317	0.78% 2/258	0.75% 1/133
Musculoskeletal and connective tissue disorders FRACTURE NONUNION	0.32% 1/317	0.00% 0/258	0.00% 0/133
Musculoskeletal and connective tissue disorders MUSCULAR WEAKNESS	0.32% 1/317	0.00% 0/258	0.00% 0/133
Musculoskeletal and connective tissue disorders RHEUMATOID NODULE	0.32% 1/317	0.00% 0/258	0.00% 0/133
Musculoskeletal and connective tissue disorders RHEUMATOID ARTHRITIS	13.2% 42/317	1.9% 5/258	2.3% 3/133
Musculoskeletal and connective tissue disorders ROTATOR CUFF SYNDROME	0.32% 1/317	0.00% 0/258	0.00% 0/133
Musculoskeletal and connective tissue disorders LUMBAR SPINAL STENOSIS	0.32% 1/317	0.00% 0/258	0.00% 0/133
Musculoskeletal and connective tissue disorders SPINAL COLUMN STENOSIS	0.32% 1/317	0.00% 0/258	0.00% 0/133
Musculoskeletal and connective tissue disorders INTERVERTEBRAL DISC DISORDER	0.00% 0/317	0.00% 0/258	0.75% 1/133
Musculoskeletal and connective tissue disorders INTERVERTEBRAL DISC PROTRUSION	0.32% 1/317	0.00% 0/258	0.75% 1/133
Respiratory, thoracic and mediastinal disorders ASTHMA	0.32% 1/317	0.00% 0/258	0.00% 0/133
Respiratory, thoracic and mediastinal disorders ASPHYXIA	0.32% 1/317	0.00% 0/258	0.00% 0/133
Respiratory, thoracic and mediastinal disorders DYSPNOEA	0.32% 1/317	0.00% 0/258	0.75% 1/133
Respiratory, thoracic and mediastinal disorders PLEURISY	0.63% 2/317	0.00% 0/258	0.00% 0/133
Respiratory, thoracic and mediastinal disorders EMPHYSEMA	0.32% 1/317	0.00% 0/258	0.00% 0/133
Respiratory, thoracic and mediastinal disorders SINUS POLYP	0.32% 1/317	0.00% 0/258	0.00% 0/133
Respiratory, thoracic and mediastinal disorders PULMONARY EMBOLISM	0.32% 1/317	0.39% 1/258	0.00% 0/133
Respiratory, thoracic and mediastinal disorders RESPIRATORY FAILURE	0.32% 1/317	0.00% 0/258	0.00% 0/133
Respiratory, thoracic and mediastinal disorders PULMONARY CAVITATION	0.32% 1/317	0.00% 0/258	0.00% 0/133
Respiratory, thoracic and mediastinal disorders RESPIRATORY DISTRESS	0.32% 1/317	0.00% 0/258	0.00% 0/133
Respiratory, thoracic and mediastinal disorders INTERSTITIAL LUNG DISEASE	0.32% 1/317	0.00% 0/258	0.00% 0/133
General disorders PAIN	0.00% 0/317	0.00% 0/258	1.5% 2/133
General disorders DEATH	0.32% 1/317	0.00% 0/258	0.00% 0/133
General disorders PYREXIA	0.32% 1/317	0.00% 0/258	0.00% 0/133
General disorders ASTHENIA	0.32% 1/317	0.00% 0/258	0.00% 0/133
General disorders CHEST PAIN	1.9% 6/317	0.00% 0/258	0.75% 1/133
General disorders IMPAIRED HEALING	0.00% 0/317	0.39% 1/258	0.00% 0/133
General disorders OEDEMA PERIPHERAL	0.63% 2/317	0.00% 0/258	0.00% 0/133
General disorders ADVERSE DRUG REACTION	0.32% 1/317	0.00% 0/258	0.00% 0/133
General disorders CATHETER SITE HAEMORRHAGE	0.32% 1/317	0.00% 0/258	0.00% 0/133
General disorders MECHANICAL COMPLICATION OF IMPLANT	0.32% 1/317	0.00% 0/258	0.00% 0/133
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LYMPHOMA	0.32% 1/317	0.00% 0/258	0.00% 0/133
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LEIOMYOMA	0.00% 0/317	0.00% 0/258	0.75% 1/133
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SKIN CANCER	0.32% 1/317	0.00% 0/258	0.00% 0/133
Neoplasms benign, malignant and unspecified (incl cysts and polyps) COLON CANCER	0.32% 1/317	0.00% 0/258	0.00% 0/133
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BREAST CANCER	0.32% 1/317	0.00% 0/258	0.00% 0/133
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LUNG NEOPLASM	0.63% 2/317	0.00% 0/258	0.00% 0/133
Neoplasms benign, malignant and unspecified (incl cysts and polyps) GASTRIC CANCER	0.32% 1/317	0.00% 0/258	0.00% 0/133
Neoplasms benign, malignant and unspecified (incl cysts and polyps) UTERINE CANCER	0.32% 1/317	0.00% 0/258	0.00% 0/133
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PROSTATE CANCER	0.00% 0/317	0.39% 1/258	0.00% 0/133
Neoplasms benign, malignant and unspecified (incl cysts and polyps) T-CELL LYMPHOMA	0.32% 1/317	0.00% 0/258	0.00% 0/133
Neoplasms benign, malignant and unspecified (incl cysts and polyps) ACOUSTIC NEUROMA	0.00% 0/317	0.39% 1/258	0.00% 0/133
Neoplasms benign, malignant and unspecified (incl cysts and polyps) THYROID NEOPLASM	0.00% 0/317	0.39% 1/258	0.00% 0/133
Neoplasms benign, malignant and unspecified (incl cysts and polyps) METASTATIC NEOPLASM	0.32% 1/317	0.00% 0/258	0.00% 0/133
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BASAL CELL CARCINOMA	1.3% 4/317	0.39% 1/258	0.00% 0/133
Neoplasms benign, malignant and unspecified (incl cysts and polyps) HEAD AND NECK CANCER	0.32% 1/317	0.00% 0/258	0.00% 0/133
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SQUAMOUS CELL CARCINOMA	0.95% 3/317	0.00% 0/258	0.00% 0/133
Neoplasms benign, malignant and unspecified (incl cysts and polyps) OVARIAN EPITHELIAL CANCER	0.32% 1/317	0.00% 0/258	0.00% 0/133
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PARATHYROID TUMOUR BENIGN	0.32% 1/317	0.00% 0/258	0.00% 0/133
Neoplasms benign, malignant and unspecified (incl cysts and polyps) THYROID CANCER METASTATIC	0.00% 0/317	0.39% 1/258	0.00% 0/133
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SQUAMOUS CELL CARCINOMA OF SKIN	0.95% 3/317	0.00% 0/258	0.00% 0/133

Other adverse events

Other adverse events
Measure	Open-label ABA n=317 participants at risk All participants who completed the double-blind period were eligible to continue in the open-label period. At the beginning of the open-label period (Day 169), all eligible participants were re-allocated to a 10 mg/kg weight-tiered dose of abatacept at their enrollment visit into the open-label period. Participants weighing \> 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing \< 60 kg received 500 mg on a background of DMARDs (at discretion of the investigator). Concomitant biologic RA therapies were later excluded.	Abatacept (ABA) n=258 participants at risk Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing \< 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.	Placebo (PLA) n=133 participants at risk Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
Vascular disorders HYPERTENSION	13.6% 43/317	3.9% 10/258	3.0% 4/133
Psychiatric disorders INSOMNIA	6.6% 21/317	2.7% 7/258	2.3% 3/133
Psychiatric disorders DEPRESSION	7.6% 24/317	2.3% 6/258	2.3% 3/133
Immune system disorders SEASONAL ALLERGY	5.7% 18/317	0.39% 1/258	0.00% 0/133
Nervous system disorders HEADACHE	16.1% 51/317	12.4% 32/258	5.3% 7/133
Nervous system disorders DIZZINESS	10.4% 33/317	4.3% 11/258	3.8% 5/133
Gastrointestinal disorders NAUSEA	14.8% 47/317	6.6% 17/258	6.0% 8/133
Gastrointestinal disorders VOMITING	7.3% 23/317	2.3% 6/258	2.3% 3/133
Gastrointestinal disorders DIARRHOEA	15.5% 49/317	5.4% 14/258	6.0% 8/133
Gastrointestinal disorders ABDOMINAL PAIN	5.4% 17/317	2.3% 6/258	0.75% 1/133
Gastrointestinal disorders ABDOMINAL PAIN UPPER	6.3% 20/317	1.6% 4/258	1.5% 2/133
Infections and infestations INFLUENZA	10.1% 32/317	2.3% 6/258	2.3% 3/133
Infections and infestations SINUSITIS	18.6% 59/317	5.8% 15/258	3.8% 5/133
Infections and infestations BRONCHITIS	20.8% 66/317	5.8% 15/258	4.5% 6/133
Infections and infestations HERPES ZOSTER	5.7% 18/317	1.6% 4/258	2.3% 3/133
Infections and infestations TOOTH ABSCESS	5.7% 18/317	0.39% 1/258	0.75% 1/133
Infections and infestations GASTROENTERITIS	6.9% 22/317	0.78% 2/258	0.75% 1/133
Infections and infestations NASOPHARYNGITIS	19.2% 61/317	7.8% 20/258	6.0% 8/133
Infections and infestations URINARY TRACT INFECTION	17.7% 56/317	2.7% 7/258	5.3% 7/133
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	33.1% 105/317	5.8% 15/258	7.5% 10/133
Blood and lymphatic system disorders ANAEMIA	5.0% 16/317	1.2% 3/258	2.3% 3/133
Skin and subcutaneous tissue disorders RASH	9.8% 31/317	2.3% 6/258	2.3% 3/133
Injury, poisoning and procedural complications FALL	7.3% 23/317	3.5% 9/258	5.3% 7/133
Injury, poisoning and procedural complications CONTUSION	5.4% 17/317	3.1% 8/258	0.75% 1/133
Musculoskeletal and connective tissue disorders BURSITIS	6.0% 19/317	0.39% 1/258	0.00% 0/133
Musculoskeletal and connective tissue disorders BACK PAIN	17.0% 54/317	5.8% 15/258	4.5% 6/133
Respiratory, thoracic and mediastinal disorders COUGH	13.6% 43/317	4.7% 12/258	3.0% 4/133
Respiratory, thoracic and mediastinal disorders DYSPNOEA	5.0% 16/317	2.7% 7/258	0.75% 1/133
General disorders FATIGUE	9.5% 30/317	3.1% 8/258	4.5% 6/133
General disorders PYREXIA	6.3% 20/317	2.3% 6/258	1.5% 2/133
General disorders CHEST PAIN	7.3% 23/317	0.78% 2/258	0.75% 1/133
General disorders OEDEMA PERIPHERAL	6.3% 20/317	1.9% 5/258	2.3% 3/133

Additional Information

BMS Study Director

Bristol-Myers Squibb

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
Publication restrictions are in place

Restriction type: OTHER