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.

A Phase III, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of BMS-188667 in Subjects With Active Rheumatoid Arthritis on Background Disease Modifying Anti-Rheumatic Drugs (DMARDS) Who Have Failed Anti-Tumor Necrosis Factor (TNF) Therapy

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00048581

Enrollment

738

Registered

2002-11-13

Start date

2002-12-31

Completion date

2009-09-30

Last updated

2011-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Brief summary

The purpose of this clinical research study is to determine whether abatacept treatment on a background of Disease Modifying Antirheumatic Drugs (DMARDs) will relieve the symptoms of rheumatoid arthritis (RA) in participants who are currently receiving anti-tumor necrosis factor (TNF) therapy for at least 3 months and are not responding or have taken anti-TNF therapy in the last 3 months and did not respond. The safety of treatment with abatacept will also be evaluated. This study also has a 4.5-year long-term extension beginning 6 months after the start of the study.

Interventions

DRUGAbatacept

Vials, intravenous (IV), \ 10mg/kg abatacept, One every 2 weeks for first month then every 4 weeks thereafter, 6 months.

DRUGPlacebo

Vials, IV, 0mg, One every 2 weeks for first month then every 4 weeks thereafter, 6 months.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Eligibility Criteria: * Active rheumatoid arthritis currently failing anti-TNF therapy or have failed anti-TNF therapy in the past.

Exclusion criteria

* Women who are pregnant or breast feeding * Current symptoms of serious medical disease * History of cancer in last 5 years other than non-melanoma skin cancer * Chronic serious infection * Active TB requiring treatment in last 5 years * Herpes zoster in last 2 months * Any active viral infection including Human Immunodeficiency Virus (HIV) * Serious side effects associated with previous anti-TNF therapy

Design outcomes

Primary

Measure	Time frame	Description
Double-blind Period (DB); Number of Participants With American College of Rheumatology (ACR) 20 Response at Day 169	Day 169	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.
DB; Number of Participants Achieving Clinically Meaningful Improvement in Health Assessment Questionnaire (HAQ)	Day 169	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.
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	From first day of OL to 5.5 years	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
OL; Number of Participants AEs of Special Interest	From first day of OL to 5.5 years	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).
OL; Number of Participants With Hematology Laboratories Meeting Marked Abnormality Criteria	From first day of OL to 5.5 years	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.
OL; Number of Participants With Blood Chemistry Laboratories Meeting Marked Abnormality Criteria	From first day of OL to 5.5 years	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
OL; Mean Time-matched Baseline Immunoglobulin (Ig) Levels Over the OL	Baseline and Days 169, 365, 729, and 1093	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.
OL; Mean Time-matched Change From Baseline in Immunoglobulin (Ig) Levels Over the OL	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.

Secondary

Measure	Time frame	Description
DB; Mean Time-Matched Percentage of Change From Baseline in HAQ-DI Over Time: ACR Core Component	BL, Days 15, 29, 57, 85, 113, 141, and 169	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.
DB; Mean Time-matched Baseline Participant Global Assessment Over Time: ACR Core Component	BL	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.
DB; Mean Time-Matched Percentage of Change From Baseline in Participant Global Assessment Over Time: ACR Core Component	BL, Days 15, 29, 57, 85, 113, 141, and 169	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.
DB; Mean Time-matched Baseline Physician Global Assessment Over Time: ACR Core Component	BL	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.
DB; Mean Time-Matched Percentage of Change From Baseline in Physician Global Assessment Over Time: ACR Core Component	BL, Days 15, 29, 57, 85, 113, 141, and 169	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.
DB; Mean Time-matched Baseline C-Reactive Protein (CRP) Levels Over Time: ACR Core Component	BL	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.
DB; Mean Time-Matched Percentage of Change From Baseline in CRP Levels Over Time: ACR Core Component	Days 15, 29, 57, 85, 113, 141, and 169	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.
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	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.
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	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.
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	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.
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	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.
DB; Mean Change From Baseline to Day 169 in Rheumatoid Factor (RF) Status	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.
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	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.
DB; Adjusted Mean Change From Baseline to Day 85 in Short SF-36 PCS, MCS, and SF-36 Individual Component Scores	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.
DB; Mean Baseline SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participants With Measurements at Day 169	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.
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	BL, Day 169	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 169.
DB; Mean Baseline HAQ-DI and HAQ Component Scores in Participants With Assessments at Day 169	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.
DB; Adjusted Mean Change From Baseline to Day 169 in HAQ-DI and HAQ Component Scores in Participants With Assessments at Day 169	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.
DB; Mean Disease Activity Score (DAS)28 (C-Reactive Protein [CRP]) and Mean Disease Activity Score (Erythrocyte Sedimentation Rate [ESR]) at Day 169	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.
DB; Adjusted Mean Change From Baseline to Day 169 in DAS28 (CRP) and DAS28 (ESR)	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.
DB; Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuation, AEs, Related AEs, or AEs Leading to Discontinuation	From BL up to database lock for DB period (6/2/2004)	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
DB; Number of Participants AEs of Special Interest	From BL up to database lock for DB period (6/2/2004)	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).
DB; Number of Participants With Hematology Laboratories Meeting Marked Abnormality (MA) Criteria	From BL up to database lock for DB period (6/2/2004)	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.
DB; Number of Participants With Blood Chemistry Laboratories Meeting MA Criteria	From BL up to database lock for DB period (6/2/2004)	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
DB; Number of Participants With Positive Anti-Abatacept or Anti-Cytotoxic T-Lymphocyte Antigen 4 (CTLA4) Responses by Enzyme-Linked Immunosorbant Assay (ELISA)	From BL to Day 169	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.
OL; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time For Participants Treated in the OL	Days 15, 29, 57, 85, 113, 141, 169, 253, 365, 449, 533, 617, 729, 813, 897, 981, 1093, 1261, 1457, 1625, and 1821	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.
OL; Number of Participants With Low Disease Activity (LDAS) or Remission For Participants Treated in the OL	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.
OL; Mean Time-matched Baseline DAS28 (CRP) Over Time For Participants Treated in the OL	BL	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.
OL; Mean Time-matched Change From Baseline in DAS28 (CRP) Over Time For Participants Treated in the OL	BL, Days 15, 29, 57, 85, 113, 141, 169, 253, 365, 449, 533, 617, 729, 813, 897, 981, 1093, 1261, 1457, 1625, and 1821	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.
OL; Mean Time-matched Baseline DAS28 (ESR) Over Time For Participants Treated in the OL	BL	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.
OL; Mean Time-matched Change From Baseline in DAS28 (ESR) Over Time For Participants Treated in the OL	BL, Days 169, 253, 365, 449, 533, 617, 729, 813, 897, 981, 1093, 1261, 1457, 1625, and 1821	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.
OL; Number of Participants Achieving HAQ Response Over Time In Participants Treated in the OL	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.
OL; Mean Time-matched Baseline HAQ-DI and HAQ Component Scores Over Time For Participants Treated in the OL	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. 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.
OL; Mean Time-matched Baseline Levels of C-Reactive Protein (CRP) Over Time For Participants Treated in the OL	BL	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.
OL; Mean Time-matched Change From Baseline in HAQ-DI and HAQ Component Scores For Participants Treated in the OL	BL, Days 169, 253, 365, 449, 533, 617, 729, 813, 897, 981, 1093, 1261, 1457, 1625, and 1821	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
OL; Mean Time-matched Baseline Levels of Rheumatoid Factor (RF) Over Time For Participants Treated in the OL	BL	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.
OL; Mean Time-matched Change From Baseline in Levels of RF Over Time For Participants Treated in the OL	BL, Days 169, 365, 729, 1093, 1261, 1457, and 1821	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.
OL; Mean Time-matched Change From Baseline in Levels of CRP Over Time For Participants Treated in the OL	BL, Days 169, 365, 729, 1093, 1261, 1457, and 1821	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.
OL; Mean Time-matched Baseline Erythrocyte Sedimentation Rate (ESR) Over Time For Participants Treated in the OL	BL	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.
OL; Mean Time-matched Baseline Levels of Soluble Interleukin 2 Receptor (sIL-2R) Over Time For Participants Treated in the OL	BL	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
OL; Mean Time-matched Change From Baseline in ESR Over Time For Participants Treated in the OL	BL, Days 169, 365, 729, 1093, 1261, 1457, and 1821	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.
OL; Mean Time-matched Change From Baseline in Levels of sIL-2R Over Time For Participants Treated in the OL	BL, Days 169, 365, 729, 1093, 1261, 1457, and 1821	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.
OL; Mean Time-matched Baseline SF-36 PCS and MCS Over Time For Participants Treated in OL	BL	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.
OL; Mean Time-matched Change From Baseline in SF-36 PCS and MCS Over Time For Participants Treated in OL	BL, Days 169, 365, 729, 1093, 1457, and 1821	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.
OL; Mean Time-matched Baseline Physical Function Score Over Time For Participants Treated in the OL	BL	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.
OL; Mean Time-matched Change From Baseline in Physical Function Score Over Time For Participants Treated in the OL	BL, Days 169, 365, 729, 1093, 1457, and 1821	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.
OL; Mean Time-matched Baseline Role-Physical Score Over Time For Participants Treated in the OL	BL	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.
OL; Mean Time-matched Change From Baseline in Role-Physical Score Over Time For Participants Treated in the OL	BL, Days 169, 365, 729, 1093, 1457, and 1821	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.
OL; Mean Time-matched Baseline Bodily Pain Score Over Time For Participants Treated in the OL	BL	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.
OL; Mean Time-matched Change From Baseline in Bodily Pain Score Over Time For Participants Treated in the OL	BL, Days 169, 365, 729, 1093, 1457, and 1821	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.
OL; Mean Time-matched Baseline General Health Score Over Time For Participants Treated in the OL	BL	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.
OL; Mean Time-matched Change From Baseline in General Health Score Over Time For Participants Treated in the OL	BL, Days 169, 365, 729, 1093, 1457, and 1821	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.
OL; Mean Time-matched Baseline Vitality Score Over Time For Participants Treated in the OL	BL	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.
OL; Mean Time-matched Change From Baseline in Vitality Score Over Time For Participants Treated in the OL	BL, Days 169, 365, 729, 1093, 1457, and 1821	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.
OL; Mean Time-matched Baseline Social Functioning Score Over Time For Participants Treated in the OL	BL	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.
OL; Mean Time-matched Change From Baseline in Social Functioning Score Over Time For Participants Treated in the OL	BL, Days 169, 365, 729, 1093, 1457, and 1821	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.
OL; Mean Time-matched Baseline Role-Emotional Score Over Time For Participants Treated in the OL	BL	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.
OL; Mean Time-matched Change From Baseline in Role-Emotional Score Over Time For Participants Treated in the OL	BL, Days 169, 365, 729, 1093, 1457, and 1821	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.
OL; Mean Time-matched Baseline Mental Health Score Over Time For Participants Treated in the OL	BL	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.
OL; Mean Time-matched Change From Baseline in Mental Health Score Over Time For Participants Treated in the OL	BL, Days 169, 365, 729, 1093, 1457, and 1821	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.
OL; Mean Time-matched Baseline Medical Outcomes Study Sleep Module (MOS-sleep) Score Over Time For Participants Treated in the OL	BL	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.
OL; Mean Time-matched Change From Baseline in MOS-Sleep Score Over Time For Participants Treated in the OL	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.
OL; Mean Time-matched Baseline Fatigue Visual Analog Score (VAS) Over Time For Participants Treated in the OL	BL	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.
OL; Mean Time-matched Change From Baseline in Fatigue VAS Over Time For Participants Treated in the OL	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.
DB; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time	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.
OL; Mean Change From Baseline in Activity Limitation Score Over Time For Participants Treated in the OL	Days 169, 365, 729, 1093, 1457, and 1821	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.
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)	From BL (Day 1) to Day 1821	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.
OL; Mean Time-matched Baseline Activity Limitation Score Over Time For Participants Treated in the OL	BL	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.
DB; Mean Time-matched Baseline Tender Joint Counts (TJCs) and Post-Baseline TJCs Over Time: ACR Core Component	BL	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.
DB; Mean Time-Matched Percentage of Change From Baseline in TJC Over Time: ACR Core Component	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.
DB; Mean Time-matched Baseline Swollen Joint Count (SJC) and Post-Baseline SJCs Over Time: ACR Core Component	Days 15, 29, 57, 85, 113, 141, and 169	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.
DB; Mean Time-Matched Percentage of Change From Baseline in SJC Over Time: ACR Core Component	Days 15, 29, 57, 85, 113, 141, and 169	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.
DB; Mean Time-matched Baseline Participant Pain Assessment Over Time: ACR Core Component	BL	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.
DB; Mean Time-Matched Percentage of Change From Baseline in Participant Pain Assessment Over Time: ACR Core Component	BL, Days 15, 29, 57, 85, 113, 141, and 169	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.
DB; Mean Time-matched Baseline HAQ-DI Over Time: ACR Core Component	BL	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.

Countries

United States

Participant flow

Pre-assignment details

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

Participants by arm

Arm	Count
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.	258
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.	133
Total	391

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002
Double-Blind Period	Adverse Event	9	5	0
Double-Blind Period	Investigator Decision	1	0	0
Double-Blind Period	Lack of Efficacy	14	27	0
Double-Blind Period	Lost to Follow-up	5	0	0
Double-Blind Period	Participant Has History of Lymphopenia	1	0	0
Double-Blind Period	Withdrawal by Subject	5	2	0
Open-Label Period	Adverse Event	0	0	37
Open-Label Period	Continue ABA With Primary Rheumatologist	0	0	3
Open-Label Period	Death	0	0	4
Open-Label Period	Lack of Efficacy	0	0	69
Open-Label Period	Lost to Follow-up	0	0	14
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	Primary Investigator Retired	0	0	2
Open-Label Period	Problem With Transportation To Site	0	0	1
Open-Label Period	Study Ended By Sponsor	0	0	1
Open-Label Period	Study Site Closure	0	0	2
Open-Label Period	Withdrawal by Subject	0	0	20

Baseline characteristics

Characteristic	Placebo (PLA)	Total	Abatacept (ABA)
Age Continuous	52.7 years STANDARD_DEVIATION 11.3	53.2 years STANDARD_DEVIATION 12.1	53.4 years STANDARD_DEVIATION 12.4
Race (NIH/OMB) American Indian or Alaska Native	1 Participants	2 Participants	1 Participants
Race (NIH/OMB) Asian	2 Participants	2 Participants	0 Participants
Race (NIH/OMB) Black or African American	5 Participants	14 Participants	9 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants	1 Participants	0 Participants
Race (NIH/OMB) White	124 Participants	372 Participants	248 Participants
Region of Enrollment Europe	34 participants	103 participants	69 participants
Region of Enrollment North America	99 participants	288 participants	189 participants
Sex: Female, Male Female	106 Participants	305 Participants	199 Participants
Sex: Female, Male Male	27 Participants	86 Participants	59 Participants
Weight	78.2 kg STANDARD_DEVIATION 21	78.2 kg STANDARD_DEVIATION 19.7	78.2 kg STANDARD_DEVIATION 19

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —
other Total, other adverse events	276 / 317	153 / 258	65 / 133
serious Total, serious adverse events	136 / 317	28 / 258	16 / 133

Outcome results

Primary

DB; Number of Participants Achieving Clinically Meaningful Improvement in Health Assessment Questionnaire (HAQ)

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.

Time frame: 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.

Arm	Measure	Value (NUMBER)
Abatacept (ABA)	DB; Number of Participants Achieving Clinically Meaningful Improvement in Health Assessment Questionnaire (HAQ)	121 participants
Placebo (PLA)	DB; Number of Participants Achieving Clinically Meaningful Improvement in Health Assessment Questionnaire (HAQ)	31 participants

Comparison: The two primary efficacy analyses tested first for differences in ACR 20 followed by testing HAQ response rates between the treatment arm receiving ABA plus background DMARDs and the treatment arm receiving PLA plus background DMARDs on Day 169. A 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test was used to compare these two treatment groups at the .05 level of significance, with stratification based on baseline history of anti-TNF status (current or prior use).p-value: <0.00195% CI: [13.8, 34.2]Cochran-Mantel-Haenszel

Primary

Double-blind Period (DB); Number of Participants With American College of Rheumatology (ACR) 20 Response at Day 169

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.

Time frame: 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.

Arm	Measure	Value (NUMBER)
Abatacept (ABA)	Double-blind Period (DB); Number of Participants With American College of Rheumatology (ACR) 20 Response at Day 169	129 participants
Placebo (PLA)	Double-blind Period (DB); Number of Participants With American College of Rheumatology (ACR) 20 Response at Day 169	26 participants

Comparison: The first coprimary endpoint efficacy analysis tested for differences in ACR 20 response rate (RR) between the treatment arm receiving ABA plus background DMARDs and the treatment arm receiving placebo plus background DMARDs on Day 169. A 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test was used to compare these two treatment groups at the .05 level of significance, with stratification based on baseline history of anti-TNF status (current or prior use).p-value: <0.00195% CI: [20.6, 41.1]Cochran-Mantel-Haenszel

Primary

OL; Mean Time-matched Baseline Immunoglobulin (Ig) Levels Over the OL

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.

Time frame: 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.

Arm	Measure	Group	Value (MEAN)	Dispersion
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	OL; Mean Time-matched Baseline Immunoglobulin (Ig) Levels Over the OL	Day 1093 cohort (n=76, n=42): IgG	294.1 mg/dL	Standard Deviation 128.6
Abatacept (ABA)	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
Placebo (PLA)	OL; Mean Time-matched Baseline Immunoglobulin (Ig) Levels Over the OL	Day 729 cohort (n=163, n=75): IgM	165.9 mg/dL	Standard Deviation 91.12
Placebo (PLA)	OL; Mean Time-matched Baseline Immunoglobulin (Ig) Levels Over the OL	Day 169 cohort (n=201, n=96): IgA	326.9 mg/dL	Standard Deviation 203.3
Placebo (PLA)	OL; Mean Time-matched Baseline Immunoglobulin (Ig) Levels Over the OL	Day 1093 cohort (n=76, n=42): IgG	1478.0 mg/dL	Standard Deviation 562.9
Placebo (PLA)	OL; Mean Time-matched Baseline Immunoglobulin (Ig) Levels Over the OL	Day 169 cohort (n=201, n=96): IgG	1364.0 mg/dL	Standard Deviation 532.2
Placebo (PLA)	OL; Mean Time-matched Baseline Immunoglobulin (Ig) Levels Over the OL	Day 729 cohort (n=163, n=75): IgA	327.6 mg/dL	Standard Deviation 218.5
Placebo (PLA)	OL; Mean Time-matched Baseline Immunoglobulin (Ig) Levels Over the OL	Day 169 cohort (n=201, n=96): IgM	160.1 mg/dL	Standard Deviation 86.91
Placebo (PLA)	OL; Mean Time-matched Baseline Immunoglobulin (Ig) Levels Over the OL	Day 1093 cohort (n=76, n=42): IgG	329.6 mg/dL	Standard Deviation 167.8
Placebo (PLA)	OL; Mean Time-matched Baseline Immunoglobulin (Ig) Levels Over the OL	Day 365 cohort (n=182, n=84): IgA	318.6 mg/dL	Standard Deviation 204.4
Placebo (PLA)	OL; Mean Time-matched Baseline Immunoglobulin (Ig) Levels Over the OL	Day 729 cohort (n=163, n=75): IgG	1338.0 mg/dL	Standard Deviation 528.7
Placebo (PLA)	OL; Mean Time-matched Baseline Immunoglobulin (Ig) Levels Over the OL	Day 365 cohort (n=182, n=84): IgG	1341.0 mg/dL	Standard Deviation 525.9
Placebo (PLA)	OL; Mean Time-matched Baseline Immunoglobulin (Ig) Levels Over the OL	Day 1093 cohort (n=76, n=42): IgM	174.2 mg/dL	Standard Deviation 89.43
Placebo (PLA)	OL; Mean Time-matched Baseline Immunoglobulin (Ig) Levels Over the OL	Day 365 cohort (n=182, n=84): IgM	159.5 mg/dL	Standard Deviation 88.33

Primary

OL; Mean Time-matched Change From Baseline in Immunoglobulin (Ig) Levels Over the OL

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.

Time frame: BL, Days 169, 365, 729, and 1093

Arm	Measure	Group	Value (MEAN)	Dispersion
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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 18.6
Abatacept (ABA)	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 7.5
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Placebo (PLA)	OL; Mean Time-matched Change From Baseline in Immunoglobulin (Ig) Levels Over the OL	Day 365 cohort (n=182, n=84): IgM	-18.3 mg/dL	Standard Error 4.21
Placebo (PLA)	OL; Mean Time-matched Change From Baseline in Immunoglobulin (Ig) Levels Over the OL	Day 169 cohort (n=201, n=96): IgA	1.10 mg/dL	Standard Error 8.12
Placebo (PLA)	OL; Mean Time-matched Change From Baseline in Immunoglobulin (Ig) Levels Over the OL	Day 169 cohort (n=201, n=96): IgG	-72.8 mg/dL	Standard Error 35.74
Placebo (PLA)	OL; Mean Time-matched Change From Baseline in Immunoglobulin (Ig) Levels Over the OL	Day 169 cohort (n=201, n=96): IgM	-5.42 mg/dL	Standard Error 3.63
Placebo (PLA)	OL; Mean Time-matched Change From Baseline in Immunoglobulin (Ig) Levels Over the OL	Day 365 cohort (n=182, n=84): IgA	-33.0 mg/dL	Standard Error 10.12
Placebo (PLA)	OL; Mean Time-matched Change From Baseline in Immunoglobulin (Ig) Levels Over the OL	Day 365 cohort (n=182, n=84): IgG	-251.0 mg/dL	Standard Error 39.41
Placebo (PLA)	OL; Mean Time-matched Change From Baseline in Immunoglobulin (Ig) Levels Over the OL	Day 1093 cohort (n=76, n=42): IgM	-24.7 mg/dL	Standard Error 9.51
Placebo (PLA)	OL; Mean Time-matched Change From Baseline in Immunoglobulin (Ig) Levels Over the OL	Day 729 cohort (n=163, n=75): IgA	-30.0 mg/dL	Standard Error 10.42
Placebo (PLA)	OL; Mean Time-matched Change From Baseline in Immunoglobulin (Ig) Levels Over the OL	Day 729 cohort (n=163, n=75): IgG	-257.0 mg/dL	Standard Error 38.3
Placebo (PLA)	OL; Mean Time-matched Change From Baseline in Immunoglobulin (Ig) Levels Over the OL	Day 729 cohort (n=163, n=75): IgM	-16.1 mg/dL	Standard Error 6.02
Placebo (PLA)	OL; Mean Time-matched Change From Baseline in Immunoglobulin (Ig) Levels Over the OL	Day 1093 cohort (n=76, n=41): IgA	-69.4 mg/dL	Standard Error 16.83
Placebo (PLA)	OL; Mean Time-matched Change From Baseline in Immunoglobulin (Ig) Levels Over the OL	Day 1093 cohort (n=76, n=42): IgG	-377.0 mg/dL	Standard Error 55.94

Primary

OL; Number of Participants AEs of Special Interest

AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs, including all infections, serious infections, and opportunistic infections; autoimmune disorders; neoplasms; acute infusional AEs (pre-specified AEs occurring within 1 hour of start of infusion) and peri-infusional AEs (pre-specified AEs occurring within 24 hours of the start of infusion).

Time frame: From first day of OL to 5.5 years

Population: All treated participants

Arm	Measure	Group	Value (NUMBER)
Abatacept (ABA)	OL; Number of Participants AEs of Special Interest	Infections	254 participants
Abatacept (ABA)	OL; Number of Participants AEs of Special Interest	Neoplasms (benign, malignant, and unspecified)	42 participants
Abatacept (ABA)	OL; Number of Participants AEs of Special Interest	Malignancies	21 participants
Abatacept (ABA)	OL; Number of Participants AEs of Special Interest	Pre-specified autoimmune disorders	17 participants
Abatacept (ABA)	OL; Number of Participants AEs of Special Interest	Acute infusional AEs	65 participants
Abatacept (ABA)	OL; Number of Participants AEs of Special Interest	Peri-infusional AEs	22 participants

Primary

OL; Number of Participants With Blood Chemistry Laboratories Meeting Marked Abnormality Criteria

Marked abnormality criteria: Alkaline phosphatase (ALP): \>2\* ULN, or if BL\>ULN then use \>3\* BL; aspartate aminotransferase (AST): \>3\* ULN, or if BL\>ULN then use \>4\* BL; alanine aminotransferase (ALT): \>3\* ULN, or if BL\>ULN then use \>4\* BL; G-Glutamyl transferase (GGT): \>2\* ULN, or if BL\>ULN then use \>3\* BL; Bilirubin: \>2\* ULN, or if BL\>ULN then use \>4\* BL; blood urea nitrogen (BUN): \>2\* BL; creatinine: \>1.5\* BL

Time frame: From first day of OL to 5.5 years

Population: All treated participants

Arm	Measure	Group	Value (NUMBER)
Abatacept (ABA)	OL; Number of Participants With Blood Chemistry Laboratories Meeting Marked Abnormality Criteria	High ALT (ULN=55 U/L)	12 participants
Abatacept (ABA)	OL; Number of Participants With Blood Chemistry Laboratories Meeting Marked Abnormality Criteria	High GGT (ULN=65 U/L)	30 participants
Abatacept (ABA)	OL; Number of Participants With Blood Chemistry Laboratories Meeting Marked Abnormality Criteria	High bilirubin (ULN=1.2 mg/dL)	2 participants
Abatacept (ABA)	OL; Number of Participants With Blood Chemistry Laboratories Meeting Marked Abnormality Criteria	High BUN (ULN=26 mg/dL)	20 participants
Abatacept (ABA)	OL; Number of Participants With Blood Chemistry Laboratories Meeting Marked Abnormality Criteria	High creatinine (ULN=1.5 mg/dL)	77 participants
Abatacept (ABA)	OL; Number of Participants With Blood Chemistry Laboratories Meeting Marked Abnormality Criteria	High ALP (ULN=400 U/L)	3 participants
Abatacept (ABA)	OL; Number of Participants With Blood Chemistry Laboratories Meeting Marked Abnormality Criteria	High AST (ULN=44 U/L)	12 participants

Primary

OL; Number of Participants With Hematology Laboratories Meeting Marked Abnormality Criteria

Upper Normal Limit (ULN), Lower Normal Limit (LLN), Baseline (BL). Marked abnormality criteria are: Hemoglobin (HGB): \>3 g/dL decrease from BL; Hematocrit: \<0.75 \* BL; Erythrocytes: \<0.75 \* BL; Platelets (PLT): \<0.67 \* LLN/\>1.5 \* ULN, or if BL \< LLN then use 0.5 \* BL/\<100,000 mm\^3; Leukocytes: \<0.75 \* LLN/ \>1.25 \* ULN, or if BL\<LLN then use \<0.8 \* BL/\>ULN, or if BL\>ULN then use \>1.2 \* BL/\<LLN; neutrophils+bands: \<1.0 \* 10\^3 c/uL; eosinophils: \>0.750 \* 10\^3 c/uL; basophils: \> 400 mm\^3; monocytes: \>2000 mm\^3; lymphocytes: \<0.750 \* 10\^3 c/uL/ \>7.50 \* 10\^3 c/uL.

Time frame: From first day of OL to 5.5 years

Population: All treated participants

Arm	Measure	Group	Value (NUMBER)
Abatacept (ABA)	OL; Number of Participants With Hematology Laboratories Meeting Marked Abnormality Criteria	Low neutrophils + bands (LLN=1.8*10^3 c/μL))	2 participants
Abatacept (ABA)	OL; Number of Participants With Hematology Laboratories Meeting Marked Abnormality Criteria	Low lymphocytes (LLN=0.7*10^3 cells/μL)	61 participants
Abatacept (ABA)	OL; Number of Participants With Hematology Laboratories Meeting Marked Abnormality Criteria	High lymphocytes (ULN=4.5*10^3 cells/μL)	0 participants
Abatacept (ABA)	OL; Number of Participants With Hematology Laboratories Meeting Marked Abnormality Criteria	High monocytes (ULN=1*10^3 cells/μL)	2 participants
Abatacept (ABA)	OL; Number of Participants With Hematology Laboratories Meeting Marked Abnormality Criteria	High basophils (ULN=0.2*10^3 cells/μL)	0 participants
Abatacept (ABA)	OL; Number of Participants With Hematology Laboratories Meeting Marked Abnormality Criteria	High eosinophils (ULN=7*10^3 cells/μL)	31 participants
Abatacept (ABA)	OL; Number of Participants With Hematology Laboratories Meeting Marked Abnormality Criteria	Low HGB (LLN=11.5 g/dL)	12 participants
Abatacept (ABA)	OL; Number of Participants With Hematology Laboratories Meeting Marked Abnormality Criteria	Low hematocrit (LLN=34%)	18 participants
Abatacept (ABA)	OL; Number of Participants With Hematology Laboratories Meeting Marked Abnormality Criteria	Low erythrocytes (LLN=3.8 x10*6 cells/μL)	9 participants
Abatacept (ABA)	OL; Number of Participants With Hematology Laboratories Meeting Marked Abnormality Criteria	Low PLT (LLN=140*10^9 cells/L)	8 participants
Abatacept (ABA)	OL; Number of Participants With Hematology Laboratories Meeting Marked Abnormality Criteria	High PLT (ULN=450*10^9 cells/L)	1 participants
Abatacept (ABA)	OL; Number of Participants With Hematology Laboratories Meeting Marked Abnormality Criteria	Low leukocytes (LLN=3.8*10^3 cells/μL)	6 participants
Abatacept (ABA)	OL; Number of Participants With Hematology Laboratories Meeting Marked Abnormality Criteria	High leukocytes (ULN=10.6*10^3 c/μL)	49 participants

Primary

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

AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.Related AE/SAE=Certain,Probable,Possible,or Missing relationship to Drug

Time frame: From first day of OL to 5.5 years

Population: All treated participants

Arm	Measure	Group	Value (NUMBER)
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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

Secondary

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)

Serum samples from all treated adult participants with active rheumatoid arthritis (RA) were screened for the presence of drug-specific antibodies using ELISA. Immunogenicity was defined as the presence of a positive anti-abatacept or anti-CTLA4 antibody.

Time frame: From BL (Day 1) to Day 1821

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

Arm	Measure	Group	Value (NUMBER)
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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

Secondary

DB; Adjusted Mean Change From Baseline to Day 169 in DAS28 (CRP) and DAS28 (ESR)

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.

Time frame: BL, Day 169

Arm	Measure	Group	Value (MEAN)	Dispersion
Abatacept (ABA)	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
Abatacept (ABA)	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 0.1
Placebo (PLA)	DB; Adjusted Mean Change From Baseline to Day 169 in DAS28 (CRP) and DAS28 (ESR)	DAS28 (CRP); n=251, n=130	-0.74 Units on a Scale	Standard Error 0.11
Placebo (PLA)	DB; Adjusted Mean Change From Baseline to Day 169 in DAS28 (CRP) and DAS28 (ESR)	DAS28 (ESR); n=182, n=98	-0.71 Units on a Scale	Standard Error 0.14

Secondary

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 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.

Time frame: BL, Day 169

Arm	Measure	Group	Value (MEAN)	Dispersion
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Placebo (PLA)	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)	-0.08 units on a scale	Standard Deviation 0.07
Placebo (PLA)	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)	-0.11 units on a scale	Standard Deviation 0.04
Placebo (PLA)	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)	-0.26 units on a scale	Standard Deviation 0.07
Placebo (PLA)	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)	-0.29 units on a scale	Standard Deviation 0.07
Placebo (PLA)	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)	-0.07 units on a scale	Standard Deviation 0.07
Placebo (PLA)	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)	-0.24 units on a scale	Standard Deviation 0.07
Placebo (PLA)	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)	-0.05 units on a scale	Standard Deviation 0.07
Placebo (PLA)	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)	-0.11 units on a scale	Standard Deviation 0.08
Placebo (PLA)	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)	-0.15 units on a scale	Standard Deviation 0.07

Comparison: Mean changes from baseline in HAQ disability index were compared between treatment groups using analysis of covariance (ANCOVA) models and 95% confidence intervals were calculated. This analysis was based on the LOCF data set. Similar analyses were also conducted for each of the 8 individual categories: 1) dressing and grooming; 2) arising; 3) eating; 4) walking; 5) hygiene; 6) reach; 7) grip; and 8) common daily activities. Adjusted Mean Change From Baseline = Adj M Chg From BLp-value: <0.00195% CI: [-0.44, -0.23]ANCOVA

Comparison: Mean changes from baseline in HAQ disability index were compared between treatment groups using analysis of covariance (ANCOVA) models and 95% confidence intervals were calculated. This analysis was based on the LOCF data set. Similar analyses were also conducted for each of the 8 individual categories: 1) dressing and grooming; 2) arising; 3) eating; 4) walking; 5) hygiene; 6) reach; 7) grip; and 8) common daily activities. Adjusted Mean Change From Baseline= Adj M Chg From BLp-value: <0.00195% CI: [-0.49, -0.14]ANCOVA

Comparison: Mean changes from baseline in HAQ disability index were compared between treatment groups using analysis of covariance (ANCOVA) models and 95% confidence intervals were calculated. This analysis was based on the LOCF data set. Similar analyses were also conducted for each of the 8 individual categories: 1) dressing and grooming; 2) arising; 3) eating; 4) walking; 5) hygiene; 6) reach; 7) grip; and 8) common daily activities. Adjusted Mean Change From Baseline= Adj M Chg From BLp-value: <0.00195% CI: [-0.47, -0.16]ANCOVA

Comparison: Mean changes from baseline in HAQ disability index were compared between treatment groups using analysis of covariance (ANCOVA) models and 95% confidence intervals were calculated. This analysis was based on the LOCF data set. Similar analyses were also conducted for each of the 8 individual categories: 1) dressing and grooming; 2) arising; 3) eating; 4) walking; 5) hygiene; 6) reach; 7) grip; and 8) common daily activities. Adjusted Mean Change From Baseline= Adj M Chg from BLp-value: 0.00395% CI: [-0.44, -0.09]ANCOVA

Comparison: Mean changes from baseline in HAQ disability index were compared between treatment groups using analysis of covariance (ANCOVA) models and 95% confidence intervals were calculated. This analysis was based on the LOCF data set. Similar analyses were also conducted for each of the 8 individual categories: 1) dressing and grooming; 2) arising; 3) eating; 4) walking; 5) hygiene; 6) reach; 7) grip; and 8) common daily activities. Adjusted Mean Change From Baseline= Adj M Chg from BLp-value: 0.0195% CI: [-0.39, -0.05]ANCOVA

Comparison: Mean changes from baseline in HAQ disability index were compared between treatment groups using analysis of covariance (ANCOVA) models and 95% confidence intervals were calculated. This analysis was based on the LOCF data set. Similar analyses were also conducted for each of the 8 individual categories: 1) dressing and grooming; 2) arising; 3) eating; 4) walking; 5) hygiene; 6) reach; 7) grip; and 8) common daily activities. Adjusted Mean Change From Baseline= Adj M Chg from BLp-value: <0.00195% CI: [-0.61, -0.25]ANCOVA

Comparison: Mean changes from baseline in HAQ disability index were compared between treatment groups using analysis of covariance (ANCOVA) models and 95% confidence intervals were calculated. This analysis was based on the LOCF data set. Similar analyses were also conducted for each of the 8 individual categories: 1) dressing and grooming; 2) arising; 3) eating; 4) walking; 5) hygiene; 6) reach; 7) grip; and 8) common daily activities. Adjusted Mean Change From Baseline= Adj M Chg from BLp-value: <0.00195% CI: [-0.49, -0.15]ANCOVA

Comparison: Mean changes from baseline in HAQ disability index were compared between treatment groups using analysis of covariance (ANCOVA) models and 95% confidence intervals were calculated. This analysis was based on the LOCF data set. Similar analyses were also conducted for each of the 8 individual categories: 1) dressing and grooming; 2) arising; 3) eating; 4) walking; 5) hygiene; 6) reach; 7) grip; and 8) common daily activities. Adjusted Mean Change From Baseline= Adj M Chg from BLp-value: <0.00195% CI: [-0.58, -0.22]ANCOVA

Secondary

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

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 169.

Time frame: BL, Day 169

Arm	Measure	Group	Value (MEAN)	Dispersion
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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 0.6
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Placebo (PLA)	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)	2.39 Units on a Scale	Standard Deviation 0.91
Placebo (PLA)	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)	1.12 Units on a Scale	Standard Deviation 0.75
Placebo (PLA)	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)	0.74 Units on a Scale	Standard Deviation 0.67
Placebo (PLA)	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)	2.11 Units on a Scale	Standard Deviation 0.87
Placebo (PLA)	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)	1.61 Units on a Scale	Standard Deviation 0.79
Placebo (PLA)	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)	1.27 Units on a Scale	Standard Deviation 0.8
Placebo (PLA)	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)	1.77 Units on a Scale	Standard Deviation 0.83
Placebo (PLA)	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)	1.29 Units on a Scale	Standard Deviation 0.87
Placebo (PLA)	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)	2.46 Units on a Scale	Standard Deviation 1.15
Placebo (PLA)	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)	2.48 Units on a Scale	Standard Deviation 0.77

Comparison: Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group as factor and baseline value as covariate.p-value: <0.00195% CI: [3.64, 7.29]ANCOVA

p-value: <0.00195% CI: [3.1, 7.35]ANCOVA

p-value: <0.00195% CI: [4.37, 8.11]ANCOVA

Secondary

DB; Adjusted Mean Change From Baseline to Day 85 in Short SF-36 PCS, MCS, and SF-36 Individual Component Scores

Time frame: BL, Day 85

Arm	Measure	Group	Value (MEAN)	Dispersion
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Placebo (PLA)	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)	2.13 Units on a Scale	Standard Error 0.87
Placebo (PLA)	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)	2.12 Units on a Scale	Standard Error 0.72
Placebo (PLA)	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)	1.15 Units on a Scale	Standard Error 0.62
Placebo (PLA)	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)	2.08 Units on a Scale	Standard Error 0.86
Placebo (PLA)	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)	1.70 Units on a Scale	Standard Error 0.8
Placebo (PLA)	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)	2.27 Units on a Scale	Standard Error 0.71
Placebo (PLA)	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)	2.32 Units on a Scale	Standard Error 0.8
Placebo (PLA)	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)	2.87 Units on a Scale	Standard Error 0.9
Placebo (PLA)	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)	3.14 Units on a Scale	Standard Error 1.16
Placebo (PLA)	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)	2.81 Units on a Scale	Standard Error 0.76

Secondary

DB; Mean Baseline HAQ-DI and HAQ Component Scores in Participants With Assessments at Day 169

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.

Time frame: BL

Arm	Measure	Group	Value (MEAN)	Dispersion
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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 0.7
Abatacept (ABA)	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
Abatacept (ABA)	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
Placebo (PLA)	DB; Mean Baseline HAQ-DI and HAQ Component Scores in Participants With Assessments at Day 169	HAQ activities (n=213, n=97)	1.95 units on a scale	Standard Deviation 0.86
Placebo (PLA)	DB; Mean Baseline HAQ-DI and HAQ Component Scores in Participants With Assessments at Day 169	HAQ-DI (n=249, n=130)	1.82 units on a scale	Standard Deviation 0.6
Placebo (PLA)	DB; Mean Baseline HAQ-DI and HAQ Component Scores in Participants With Assessments at Day 169	HAQ dressing and grooming (n=214, n=97)	1.54 units on a scale	Standard Deviation 0.69
Placebo (PLA)	DB; Mean Baseline HAQ-DI and HAQ Component Scores in Participants With Assessments at Day 169	HAQ arising (n=214, n=97)	1.43 units on a scale	Standard Deviation 0.73
Placebo (PLA)	DB; Mean Baseline HAQ-DI and HAQ Component Scores in Participants With Assessments at Day 169	HAQ eating (n=214, n=97)	1.78 units on a scale	Standard Deviation 0.87
Placebo (PLA)	DB; Mean Baseline HAQ-DI and HAQ Component Scores in Participants With Assessments at Day 169	HAQ walking (n=213, n=95)	1.51 units on a scale	Standard Deviation 0.76
Placebo (PLA)	DB; Mean Baseline HAQ-DI and HAQ Component Scores in Participants With Assessments at Day 169	HAQ hygiene (n=213, n=97)	2.21 units on a scale	Standard Deviation 0.87
Placebo (PLA)	DB; Mean Baseline HAQ-DI and HAQ Component Scores in Participants With Assessments at Day 169	HAQ reaching (n=213, n=97)	1.97 units on a scale	Standard Deviation 0.87
Placebo (PLA)	DB; Mean Baseline HAQ-DI and HAQ Component Scores in Participants With Assessments at Day 169	HAQ gripping (n=212, n=97)	1.93 units on a scale	Standard Deviation 0.62

Secondary

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

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.

Time frame: BL

Arm	Measure	Group	Value (MEAN)	Dispersion
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Placebo (PLA)	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)	84.53 ng/ml	Standard Deviation 71.64
Placebo (PLA)	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)	443.5 ng/ml	Standard Deviation 327.1
Placebo (PLA)	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)	84.18 ng/ml	Standard Deviation 133.5

Secondary

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

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.

Time frame: BL

Arm	Measure	Group	Value (MEAN)	Dispersion
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Placebo (PLA)	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)	43.18 pg/ml	Standard Deviation 62.9
Placebo (PLA)	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)	1879 pg/ml	Standard Deviation 1001
Placebo (PLA)	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)	30.64 pg/ml	Standard Deviation 54.08

Secondary

DB; Mean Baseline SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participants With Measurements at Day 169

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.

Time frame: BL

Arm	Measure	Group	Value (MEAN)	Dispersion
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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 9.2
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Placebo (PLA)	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)	33.84 Units on a Scale	Standard Deviation 11.52
Placebo (PLA)	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)	27.75 Units on a Scale	Standard Deviation 6.29
Placebo (PLA)	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)	35.05 Units on a Scale	Standard Deviation 8.51
Placebo (PLA)	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)	42.98 Units on a Scale	Standard Deviation 11.9
Placebo (PLA)	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)	42.80 Units on a Scale	Standard Deviation 11.14
Placebo (PLA)	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)	26.24 Units on a Scale	Standard Deviation 8.37
Placebo (PLA)	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)	36.69 Units on a Scale	Standard Deviation 9.06
Placebo (PLA)	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)	31.93 Units on a Scale	Standard Deviation 6.82
Placebo (PLA)	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)	36.97 Units on a Scale	Standard Deviation 13.83
Placebo (PLA)	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)	31.27 Units on a Scale	Standard Deviation 6.62

Secondary

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

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.

Time frame: BL

Arm	Measure	Group	Value (MEAN)	Dispersion
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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 8.9
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Placebo (PLA)	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)	33.95 Units on a Scale	Standard Deviation 11.49
Placebo (PLA)	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)	27.77 Units on a Scale	Standard Deviation 6.31
Placebo (PLA)	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)	34.95 Units on a Scale	Standard Deviation 8.46
Placebo (PLA)	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)	43.00 Units on a Scale	Standard Deviation 11.94
Placebo (PLA)	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)	42.72 Units on a Scale	Standard Deviation 11.15
Placebo (PLA)	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)	26.31 Units on a Scale	Standard Deviation 8.36
Placebo (PLA)	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)	36.70 Units on a Scale	Standard Deviation 9.1
Placebo (PLA)	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)	31.96 Units on a Scale	Standard Deviation 6.84
Placebo (PLA)	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)	37.07 Units on a Scale	Standard Deviation 13.83
Placebo (PLA)	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)	31.28 Units on a Scale	Standard Deviation 6.64

Secondary

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

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.

Time frame: BL, Day 169

Arm	Measure	Group	Value (MEAN)	Dispersion
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Placebo (PLA)	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)	6.54 ng/ml	Standard Error 4.34
Placebo (PLA)	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)	-29.5 ng/ml	Standard Error 20.17
Placebo (PLA)	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)	-9.62 ng/ml	Standard Error 11.51

Secondary

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

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.

Time frame: BL, Day 169

Arm	Measure	Group	Value (MEAN)	Dispersion
Abatacept (ABA)	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
Abatacept (ABA)	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 40.4
Abatacept (ABA)	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
Placebo (PLA)	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)	4.71 pg/ml	Standard Error 8.13
Placebo (PLA)	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)	-36.1 pg/ml	Standard Error 77.37
Placebo (PLA)	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)	5.87 pg/ml	Standard Error 8.27

Secondary

DB; Mean Change From Baseline to Day 169 in Rheumatoid Factor (RF) Status

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.

Time frame: BL, Day 169

Arm	Measure	Group	Value (NUMBER)
Abatacept (ABA)	DB; Mean Change From Baseline to Day 169 in Rheumatoid Factor (RF) Status	Baseline RF negative	46 participants
Abatacept (ABA)	DB; Mean Change From Baseline to Day 169 in Rheumatoid Factor (RF) Status	Baseline RF negative change to RF positive	3 participants
Abatacept (ABA)	DB; Mean Change From Baseline to Day 169 in Rheumatoid Factor (RF) Status	Baseline RF positive	154 participants
Abatacept (ABA)	DB; Mean Change From Baseline to Day 169 in Rheumatoid Factor (RF) Status	Baseline RF positive change to RF negative	13 participants
Placebo (PLA)	DB; Mean Change From Baseline to Day 169 in Rheumatoid Factor (RF) Status	Baseline RF positive change to RF negative	0 participants
Placebo (PLA)	DB; Mean Change From Baseline to Day 169 in Rheumatoid Factor (RF) Status	Baseline RF negative	25 participants
Placebo (PLA)	DB; Mean Change From Baseline to Day 169 in Rheumatoid Factor (RF) Status	Baseline RF positive	73 participants
Placebo (PLA)	DB; Mean Change From Baseline to Day 169 in Rheumatoid Factor (RF) Status	Baseline RF negative change to RF positive	3 participants

Secondary

DB; Mean Disease Activity Score (DAS)28 (C-Reactive Protein [CRP]) and Mean Disease Activity Score (Erythrocyte Sedimentation Rate [ESR]) at 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.

Time frame: BL, Day 169

Arm	Measure	Group	Value (MEAN)	Dispersion
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Placebo (PLA)	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	6.17 Units on a Scale	Standard Deviation 1.34
Placebo (PLA)	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	6.51 Units on a Scale	Standard Deviation 0.78
Placebo (PLA)	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 0.92
Placebo (PLA)	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	5.78 Units on a Scale	Standard Deviation 1.33

Secondary

DB; Mean Time-matched Baseline C-Reactive Protein (CRP) Levels Over Time: ACR Core Component

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.

Time frame: 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.

Arm	Measure	Group	Value (MEAN)	Dispersion
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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 2.7
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Placebo (PLA)	DB; Mean Time-matched Baseline C-Reactive Protein (CRP) Levels Over Time: ACR Core Component	Day 141 cohort (n=251, n=129): baseline	4.03 mg/dL	Standard Deviation 3.6
Placebo (PLA)	DB; Mean Time-matched Baseline C-Reactive Protein (CRP) Levels Over Time: ACR Core Component	Day 15 cohort (n=246, n=127): baseline	3.97 mg/dL	Standard Deviation 3.57
Placebo (PLA)	DB; Mean Time-matched Baseline C-Reactive Protein (CRP) Levels Over Time: ACR Core Component	Day 85 cohort (n=249, n=129): post-baseline	4.13 mg/dL	Standard Deviation 4.11
Placebo (PLA)	DB; Mean Time-matched Baseline C-Reactive Protein (CRP) Levels Over Time: ACR Core Component	Day 15 cohort (n=246, n=127): post-baseline	4.01 mg/dL	Standard Deviation 3.54
Placebo (PLA)	DB; Mean Time-matched Baseline C-Reactive Protein (CRP) Levels Over Time: ACR Core Component	Day 169 cohort (n=254, n=131): baseline	3.99 mg/dL	Standard Deviation 3.59
Placebo (PLA)	DB; Mean Time-matched Baseline C-Reactive Protein (CRP) Levels Over Time: ACR Core Component	Day 29 cohort (n=245, n=128): baseline	4.03 mg/dL	Standard Deviation 3.62
Placebo (PLA)	DB; Mean Time-matched Baseline C-Reactive Protein (CRP) Levels Over Time: ACR Core Component	Day 113 cohort (n=243, n=127): baseline	4.06 mg/dL	Standard Deviation 3.62
Placebo (PLA)	DB; Mean Time-matched Baseline C-Reactive Protein (CRP) Levels Over Time: ACR Core Component	Day 29 cohort (n=245, n=128): post-baseline	4.02 mg/dL	Standard Deviation 3.63
Placebo (PLA)	DB; Mean Time-matched Baseline C-Reactive Protein (CRP) Levels Over Time: ACR Core Component	Day 141 cohort (n=251, n=129): post-baseline	3.83 mg/dL	Standard Deviation 4.17
Placebo (PLA)	DB; Mean Time-matched Baseline C-Reactive Protein (CRP) Levels Over Time: ACR Core Component	Day 57 cohort (n=250, n=129): baseline	3.93 mg/dL	Standard Deviation 3.58
Placebo (PLA)	DB; Mean Time-matched Baseline C-Reactive Protein (CRP) Levels Over Time: ACR Core Component	Day 113 cohort (n=243, n=127): post-baseline	4.31 mg/dL	Standard Deviation 4.62
Placebo (PLA)	DB; Mean Time-matched Baseline C-Reactive Protein (CRP) Levels Over Time: ACR Core Component	Day 57 cohort (n=250, n=129): post-baseline	3.73 mg/dL	Standard Deviation 4.06
Placebo (PLA)	DB; Mean Time-matched Baseline C-Reactive Protein (CRP) Levels Over Time: ACR Core Component	Day 169 cohort (n=254, n=131): post-baseline	3.97 mg/dL	Standard Deviation 4.19
Placebo (PLA)	DB; Mean Time-matched Baseline C-Reactive Protein (CRP) Levels Over Time: ACR Core Component	Day 85 cohort (n=249, n=129): baseline	4.00 mg/dL	Standard Deviation 3.61

Secondary

DB; Mean Time-matched Baseline HAQ-DI Over Time: ACR Core Component

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.

Time frame: BL

Arm	Measure	Group	Value (MEAN)	Dispersion
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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 0.7
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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 0.6
Abatacept (ABA)	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
Placebo (PLA)	DB; Mean Time-matched Baseline HAQ-DI Over Time: ACR Core Component	Day 15 cohort (n=244, n=124): post-baseline	1.83 units on a scale	Standard Deviation 0.56
Placebo (PLA)	DB; Mean Time-matched Baseline HAQ-DI Over Time: ACR Core Component	Day 29 cohort (n=239, n=127): baseline	1.85 units on a scale	Standard Deviation 0.56
Placebo (PLA)	DB; Mean Time-matched Baseline HAQ-DI Over Time: ACR Core Component	Day 57 cohort (n=245, n=127): baseline	1.84 units on a scale	Standard Deviation 0.55
Placebo (PLA)	DB; Mean Time-matched Baseline HAQ-DI Over Time: ACR Core Component	Day 141 cohort (n=247, n=126): post-baseline	1.72 units on a scale	Standard Deviation 0.64
Placebo (PLA)	DB; Mean Time-matched Baseline HAQ-DI Over Time: ACR Core Component	Day 169 cohort (n=248, n=128): baseline	1.85 units on a scale	Standard Deviation 0.56
Placebo (PLA)	DB; Mean Time-matched Baseline HAQ-DI Over Time: ACR Core Component	Day 169 cohort (n=248, n=128): post-baseline	1.74 units on a scale	Standard Deviation 0.63
Placebo (PLA)	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 0.56
Placebo (PLA)	DB; Mean Time-matched Baseline HAQ-DI Over Time: ACR Core Component	Day 15 cohort (n=244, n=124): baseline	1.86 units on a scale	Standard Deviation 0.56
Placebo (PLA)	DB; Mean Time-matched Baseline HAQ-DI Over Time: ACR Core Component	Day 29 cohort (n=239, n=127): post-baseline	1.70 units on a scale	Standard Deviation 0.62
Placebo (PLA)	DB; Mean Time-matched Baseline HAQ-DI Over Time: ACR Core Component	Day 57 cohort (n=245, n=127): post-baseline	1.65 units on a scale	Standard Deviation 0.63
Placebo (PLA)	DB; Mean Time-matched Baseline HAQ-DI Over Time: ACR Core Component	Day 85 cohort (n=242, n=126): baseline	1.86 units on a scale	Standard Deviation 0.56
Placebo (PLA)	DB; Mean Time-matched Baseline HAQ-DI Over Time: ACR Core Component	Day 85 cohort (n=242, n=126): post-baseline	1.70 units on a scale	Standard Deviation 0.63
Placebo (PLA)	DB; Mean Time-matched Baseline HAQ-DI Over Time: ACR Core Component	Day 113 cohort (n=238, n=126): post-baseline	1.71 units on a scale	Standard Deviation 0.64
Placebo (PLA)	DB; Mean Time-matched Baseline HAQ-DI Over Time: ACR Core Component	Day 141 cohort (n=247, n=126): baseline	1.86 units on a scale	Standard Deviation 0.56

Secondary

DB; Mean Time-matched Baseline Participant Global Assessment Over Time: ACR Core Component

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.

Time frame: BL

Arm	Measure	Group	Value (MEAN)	Dispersion
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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 19.7
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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 19.8
Abatacept (ABA)	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 23.5
Abatacept (ABA)	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
Abatacept (ABA)	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
Placebo (PLA)	DB; Mean Time-matched Baseline Participant Global Assessment Over Time: ACR Core Component	Day 169 cohort (n=251, n=130): post-baseline	60.35 units on a scale	Standard Deviation 25.69
Placebo (PLA)	DB; Mean Time-matched Baseline Participant Global Assessment Over Time: ACR Core Component	Day 15 cohort (n=247, n=126): baseline	68.93 units on a scale	Standard Deviation 20.38
Placebo (PLA)	DB; Mean Time-matched Baseline Participant Global Assessment Over Time: ACR Core Component	Day 15 cohort (n=247, n=126): post-baseline	65.15 units on a scale	Standard Deviation 21.38
Placebo (PLA)	DB; Mean Time-matched Baseline Participant Global Assessment Over Time: ACR Core Component	Day 29 cohort (n=240, n=128): baseline	69.33 units on a scale	Standard Deviation 20.03
Placebo (PLA)	DB; Mean Time-matched Baseline Participant Global Assessment Over Time: ACR Core Component	Day 29 cohort (n=240, n=128): post-baseline	61.13 units on a scale	Standard Deviation 24.42
Placebo (PLA)	DB; Mean Time-matched Baseline Participant Global Assessment Over Time: ACR Core Component	Day 57 cohort (n=246, n=129): baseline	68.97 units on a scale	Standard Deviation 20.1
Placebo (PLA)	DB; Mean Time-matched Baseline Participant Global Assessment Over Time: ACR Core Component	Day 57 cohort (n=246, n=129): post-baseline	56.60 units on a scale	Standard Deviation 26.03
Placebo (PLA)	DB; Mean Time-matched Baseline Participant Global Assessment Over Time: ACR Core Component	Day 85 cohort (n=245, n=129): baseline	69.12 units on a scale	Standard Deviation 20.23
Placebo (PLA)	DB; Mean Time-matched Baseline Participant Global Assessment Over Time: ACR Core Component	Day 113 cohort (n=239, n=126): baseline	70.37 units on a scale	Standard Deviation 19.15
Placebo (PLA)	DB; Mean Time-matched Baseline Participant Global Assessment Over Time: ACR Core Component	Day 113 cohort (n=239, n=126): post-baseline	58.46 units on a scale	Standard Deviation 25.61
Placebo (PLA)	DB; Mean Time-matched Baseline Participant Global Assessment Over Time: ACR Core Component	Day 141 cohort (n=249, n=127): baseline	69.15 units on a scale	Standard Deviation 20.36
Placebo (PLA)	DB; Mean Time-matched Baseline Participant Global Assessment Over Time: ACR Core Component	Day 141 cohort (n=249, n=127): post-baseline	59.24 units on a scale	Standard Deviation 25.69
Placebo (PLA)	DB; Mean Time-matched Baseline Participant Global Assessment Over Time: ACR Core Component	Day 169 cohort (n=251, n=130): baseline	69.18 units on a scale	Standard Deviation 20.16
Placebo (PLA)	DB; Mean Time-matched Baseline Participant Global Assessment Over Time: ACR Core Component	Day 85 cohort (n=245, n=129): post-baseline	60.18 units on a scale	Standard Deviation 24.88

Secondary

DB; Mean Time-matched Baseline Participant Pain Assessment Over Time: ACR Core Component

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.

Time frame: BL

Arm	Measure	Group	Value (MEAN)	Dispersion
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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 19.7
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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 27.2
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Placebo (PLA)	DB; Mean Time-matched Baseline Participant Pain Assessment Over Time: ACR Core Component	Day 141 cohort (n=249, n=127): post-baseline	59.80 units on a scale	Standard Deviation 25.08
Placebo (PLA)	DB; Mean Time-matched Baseline Participant Pain Assessment Over Time: ACR Core Component	Day 15 cohort (n=247, n=126): post-baseline	67.65 units on a scale	Standard Deviation 20.48
Placebo (PLA)	DB; Mean Time-matched Baseline Participant Pain Assessment Over Time: ACR Core Component	Day 113 cohort (n=239, n=126): baseline	70.27 units on a scale	Standard Deviation 18.54
Placebo (PLA)	DB; Mean Time-matched Baseline Participant Pain Assessment Over Time: ACR Core Component	Day 29 cohort (n=240, n=128): baseline	69.80 units on a scale	Standard Deviation 18.76
Placebo (PLA)	DB; Mean Time-matched Baseline Participant Pain Assessment Over Time: ACR Core Component	Day 169 cohort (n=251, n=130): post-baseline	62.21 units on a scale	Standard Deviation 24.73
Placebo (PLA)	DB; Mean Time-matched Baseline Participant Pain Assessment Over Time: ACR Core Component	Day 29 cohort (n=240, n=128): post-baseline	61.07 units on a scale	Standard Deviation 24.13
Placebo (PLA)	DB; Mean Time-matched Baseline Participant Pain Assessment Over Time: ACR Core Component	Day 113 cohort (n=239, n=126): post-baseline	60.17 units on a scale	Standard Deviation 25.53
Placebo (PLA)	DB; Mean Time-matched Baseline Participant Pain Assessment Over Time: ACR Core Component	Day 57 cohort (n=246, n=129): baseline	69.26 units on a scale	Standard Deviation 18.79
Placebo (PLA)	DB; Mean Time-matched Baseline Participant Pain Assessment Over Time: ACR Core Component	Day 169 cohort (n=251, n=130): baseline	69.47 units on a scale	Standard Deviation 18.86
Placebo (PLA)	DB; Mean Time-matched Baseline Participant Pain Assessment Over Time: ACR Core Component	Day 57 cohort (n=246, n=129): post-baseline	55.91 units on a scale	Standard Deviation 25.85
Placebo (PLA)	DB; Mean Time-matched Baseline Participant Pain Assessment Over Time: ACR Core Component	Day 141 cohort (n=249, n=127): baseline	69.34 units on a scale	Standard Deviation 19.02
Placebo (PLA)	DB; Mean Time-matched Baseline Participant Pain Assessment Over Time: ACR Core Component	Day 85 cohort (n=245, n=129): baseline	69.40 units on a scale	Standard Deviation 18.92
Placebo (PLA)	DB; Mean Time-matched Baseline Participant Pain Assessment Over Time: ACR Core Component	Day 15 cohort (n=247, n=126): baseline	69.20 units on a scale	Standard Deviation 19.02
Placebo (PLA)	DB; Mean Time-matched Baseline Participant Pain Assessment Over Time: ACR Core Component	Day 85 cohort (n=245, n=129): post-baseline	60.16 units on a scale	Standard Deviation 25.05

Secondary

DB; Mean Time-matched Baseline Physician Global Assessment Over Time: ACR Core Component

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.

Time frame: BL

Arm	Measure	Group	Value (MEAN)	Dispersion
Abatacept (ABA)	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 17.4
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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 17.4
Abatacept (ABA)	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
Placebo (PLA)	DB; Mean Time-matched Baseline Physician Global Assessment Over Time: ACR Core Component	Day 141 cohort (n=252, n=127): baseline	67.03 units on a scale	Standard Deviation 16.96
Placebo (PLA)	DB; Mean Time-matched Baseline Physician Global Assessment Over Time: ACR Core Component	Day 15 cohort (n=250, n=126): baseline	66.91 units on a scale	Standard Deviation 16.78
Placebo (PLA)	DB; Mean Time-matched Baseline Physician Global Assessment Over Time: ACR Core Component	Day 85 cohort (n=247, n=124): post-baseline	53.06 units on a scale	Standard Deviation 25.63
Placebo (PLA)	DB; Mean Time-matched Baseline Physician Global Assessment Over Time: ACR Core Component	Day 15 cohort (n=250, n=126): post-baseline	61.43 units on a scale	Standard Deviation 19.03
Placebo (PLA)	DB; Mean Time-matched Baseline Physician Global Assessment Over Time: ACR Core Component	Day 169 cohort (n=254, n=129): baseline	67.05 units on a scale	Standard Deviation 16.84
Placebo (PLA)	DB; Mean Time-matched Baseline Physician Global Assessment Over Time: ACR Core Component	Day 29 cohort (n=246, n=126): baseline	66.81 units on a scale	Standard Deviation 16.91
Placebo (PLA)	DB; Mean Time-matched Baseline Physician Global Assessment Over Time: ACR Core Component	Day 113 cohort (n=246, n=127): baseline	67.45 units on a scale	Standard Deviation 16.66
Placebo (PLA)	DB; Mean Time-matched Baseline Physician Global Assessment Over Time: ACR Core Component	Day 29 cohort (n=246, n=126): post-baseline	53.71 units on a scale	Standard Deviation 23.08
Placebo (PLA)	DB; Mean Time-matched Baseline Physician Global Assessment Over Time: ACR Core Component	Day 141 cohort (n=252, n=127): post-baseline	51.58 units on a scale	Standard Deviation 24.44
Placebo (PLA)	DB; Mean Time-matched Baseline Physician Global Assessment Over Time: ACR Core Component	Day 57 cohort (n=252, n=127): baseline	66.92 units on a scale	Standard Deviation 16.64
Placebo (PLA)	DB; Mean Time-matched Baseline Physician Global Assessment Over Time: ACR Core Component	Day 113 cohort (n=246, n=127): post-baseline	54.49 units on a scale	Standard Deviation 24.3
Placebo (PLA)	DB; Mean Time-matched Baseline Physician Global Assessment Over Time: ACR Core Component	Day 57 cohort (n=252, n=127): post-baseline	49.21 units on a scale	Standard Deviation 25.03
Placebo (PLA)	DB; Mean Time-matched Baseline Physician Global Assessment Over Time: ACR Core Component	Day 169 cohort (n=254, n=129): post-baseline	52.37 units on a scale	Standard Deviation 25.1
Placebo (PLA)	DB; Mean Time-matched Baseline Physician Global Assessment Over Time: ACR Core Component	Day 85 cohort (n=247, n=124):baseline	66.81 units on a scale	Standard Deviation 16.82

Secondary

DB; Mean Time-matched Baseline Swollen Joint Count (SJC) and Post-Baseline SJCs Over Time: ACR Core Component

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.

Time frame: 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.

Arm	Measure	Group	Value (MEAN)	Dispersion
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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 10.3
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Placebo (PLA)	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	21.63 swollen joints	Standard Deviation 9.74
Placebo (PLA)	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	22.00 swollen joints	Standard Deviation 9.79
Placebo (PLA)	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	16.25 swollen joints	Standard Deviation 11.92
Placebo (PLA)	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	19.06 swollen joints	Standard Deviation 10.97
Placebo (PLA)	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	21.77 swollen joints	Standard Deviation 9.75
Placebo (PLA)	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	21.86 swollen joints	Standard Deviation 9.79
Placebo (PLA)	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	21.82 swollen joints	Standard Deviation 9.81
Placebo (PLA)	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	17.95 swollen joints	Standard Deviation 11.83
Placebo (PLA)	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	15.92 swollen joints	Standard Deviation 10.49
Placebo (PLA)	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	21.80 swollen joints	Standard Deviation 9.78
Placebo (PLA)	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	16.28 swollen joints	Standard Deviation 10.78
Placebo (PLA)	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	15.98 swollen joints	Standard Deviation 10.17
Placebo (PLA)	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	16.18 swollen joints	Standard Deviation 11.1
Placebo (PLA)	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	21.81 swollen joints	Standard Deviation 9.77

Secondary

DB; Mean Time-matched Baseline Tender Joint Counts (TJCs) and Post-Baseline TJCs Over Time: ACR Core Component

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.

Time frame: 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.

Arm	Measure	Group	Value (MEAN)	Dispersion
Abatacept (ABA)	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
Abatacept (ABA)	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 13.1
Abatacept (ABA)	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
Abatacept (ABA)	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 13.1
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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 12.9
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Placebo (PLA)	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	24.20 tender joints	Standard Deviation 16.46
Placebo (PLA)	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	25.56 tender joints	Standard Deviation 15.8
Placebo (PLA)	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	32.75 tender joints	Standard Deviation 13.13
Placebo (PLA)	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	32.65 tender joints	Standard Deviation 13.15
Placebo (PLA)	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	32.31 tender joints	Standard Deviation 13.14
Placebo (PLA)	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	25.21 tender joints	Standard Deviation 16.18
Placebo (PLA)	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	30.35 tender joints	Standard Deviation 15.37
Placebo (PLA)	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	32.28 tender joints	Standard Deviation 13.21
Placebo (PLA)	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	32.72 tender joints	Standard Deviation 13.06
Placebo (PLA)	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	23.67 tender joints	Standard Deviation 15.62
Placebo (PLA)	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	32.58 tender joints	Standard Deviation 13.1
Placebo (PLA)	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	32.43 tender joints	Standard Deviation 13.16
Placebo (PLA)	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	27.52 tender joints	Standard Deviation 15.85
Placebo (PLA)	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	25.55 tender joints	Standard Deviation 16.3

Secondary

DB; Mean Time-Matched Percentage of Change From Baseline in CRP Levels Over Time: ACR Core Component

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.

Time frame: Days 15, 29, 57, 85, 113, 141, and 169

Arm	Measure	Group	Value (MEAN)	Dispersion
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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 4.2
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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 6.7
Placebo (PLA)	DB; Mean Time-Matched Percentage of Change From Baseline in CRP Levels Over Time: ACR Core Component	Day 169 cohort (n=254, n=131)	-28.4 percentage of change from BL	Standard Error 11.82
Placebo (PLA)	DB; Mean Time-Matched Percentage of Change From Baseline in CRP Levels Over Time: ACR Core Component	Day 15 cohort (n=246, n=127)	-20.8 percentage of change from BL	Standard Error 8.24
Placebo (PLA)	DB; Mean Time-Matched Percentage of Change From Baseline in CRP Levels Over Time: ACR Core Component	Day 29 cohort (n=245, n=128)	-20.1 percentage of change from BL	Standard Error 6.81
Placebo (PLA)	DB; Mean Time-Matched Percentage of Change From Baseline in CRP Levels Over Time: ACR Core Component	Day 57 cohort (n=250, n=129)	-14.8 percentage of change from BL	Standard Error 8.23
Placebo (PLA)	DB; Mean Time-Matched Percentage of Change From Baseline in CRP Levels Over Time: ACR Core Component	Day 85 cohort (n=249, n=129)	-31.9 percentage of change from BL	Standard Error 9.82
Placebo (PLA)	DB; Mean Time-Matched Percentage of Change From Baseline in CRP Levels Over Time: ACR Core Component	Day 113 cohort (n=243, n=127)	-32.1 percentage of change from BL	Standard Error 10.37
Placebo (PLA)	DB; Mean Time-Matched Percentage of Change From Baseline in CRP Levels Over Time: ACR Core Component	Day 141 cohort (n=251, n=129)	-22.8 percentage of change from BL	Standard Error 9.78

Secondary

DB; Mean Time-Matched Percentage of Change From Baseline in HAQ-DI Over Time: ACR Core Component

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.

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

Arm	Measure	Group	Value (MEAN)	Dispersion
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Placebo (PLA)	DB; Mean Time-Matched Percentage of Change From Baseline in HAQ-DI Over Time: ACR Core Component	Day 169 cohort (n=248, n=128)	5.08 percentage of change from BL	Standard Error 2.84
Placebo (PLA)	DB; Mean Time-Matched Percentage of Change From Baseline in HAQ-DI Over Time: ACR Core Component	Day 15 cohort (n=244, n=124)	-1.10 percentage of change from BL	Standard Error 2.99
Placebo (PLA)	DB; Mean Time-Matched Percentage of Change From Baseline in HAQ-DI Over Time: ACR Core Component	Day 29 cohort (n=239, n=127)	6.79 percentage of change from BL	Standard Error 2.49
Placebo (PLA)	DB; Mean Time-Matched Percentage of Change From Baseline in HAQ-DI Over Time: ACR Core Component	Day 57 cohort (n=245, n=127)	9.61 percentage of change from BL	Standard Error 2.85
Placebo (PLA)	DB; Mean Time-Matched Percentage of Change From Baseline in HAQ-DI Over Time: ACR Core Component	Day 85 cohort (n=242, n=126)	7.10 percentage of change from BL	Standard Error 2.68
Placebo (PLA)	DB; Mean Time-Matched Percentage of Change From Baseline in HAQ-DI Over Time: ACR Core Component	Day 141 cohort (n=247, n=126)	6.50 percentage of change from BL	Standard Error 2.68
Placebo (PLA)	DB; Mean Time-Matched Percentage of Change From Baseline in HAQ-DI Over Time: ACR Core Component	Day 113 cohort (n=238, n=126)	5.96 percentage of change from BL	Standard Error 3.15

Secondary

DB; Mean Time-Matched Percentage of Change From Baseline in Participant Global Assessment Over Time: ACR Core Component

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.

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

Arm	Measure	Group	Value (MEAN)	Dispersion
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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 4.1
Abatacept (ABA)	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
Placebo (PLA)	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)	4.52 percentage of change from BL	Standard Error 5.4
Placebo (PLA)	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)	-3.18 percentage of change from BL	Standard Error 4.48
Placebo (PLA)	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)	2.13 percentage of change from BL	Standard Error 5.1
Placebo (PLA)	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)	10.94 percentage of change from BL	Standard Error 4.7
Placebo (PLA)	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)	2.89 percentage of change from BL	Standard Error 5.42
Placebo (PLA)	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)	8.01 percentage of change from BL	Standard Error 5.48
Placebo (PLA)	DB; Mean Time-Matched Percentage of Change From Baseline in Participant Global Assessment Over Time: ACR Core Component	Day 141cohort (n=249, n=127)	4.85 percentage of change from BL	Standard Error 5.51

Secondary

DB; Mean Time-Matched Percentage of Change From Baseline in Participant Pain Assessment Over Time: ACR Core Component

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.

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

Arm	Measure	Group	Value (MEAN)	Dispersion
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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 5.7
Abatacept (ABA)	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
Placebo (PLA)	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)	4.36 percentage of change from BL	Standard Error 4.01
Placebo (PLA)	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)	-3.19 percentage of change from BL	Standard Error 3.24
Placebo (PLA)	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)	8.36 percentage of change from BL	Standard Error 3.26
Placebo (PLA)	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)	16.65 percentage of change from BL	Standard Error 3.28
Placebo (PLA)	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)	8.59 percentage of change from BL	Standard Error 3.79
Placebo (PLA)	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)	9.87 percentage of change from BL	Standard Error 3.98
Placebo (PLA)	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)	4.32 percentage of change from BL	Standard Error 5.55

Secondary

DB; Mean Time-Matched Percentage of Change From Baseline in Physician Global Assessment Over Time: ACR Core Component

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.

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

Arm	Measure	Group	Value (MEAN)	Dispersion
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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 2.2
Abatacept (ABA)	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
Abatacept (ABA)	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
Placebo (PLA)	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)	21.28 percentage of change from BL	Standard Error 3.14
Placebo (PLA)	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)	6.26 percentage of change from BL	Standard Error 2.47
Placebo (PLA)	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)	18.00 percentage of change from BL	Standard Error 3.08
Placebo (PLA)	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)	25.51 percentage of change from BL	Standard Error 3.28
Placebo (PLA)	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)	18.05 percentage of change from BL	Standard Error 4.04
Placebo (PLA)	DB; Mean Time-Matched Percentage of Change From Baseline in Physician Global Assessment Over Time: ACR Core Component	Day 113cohort (n=246, n=127)	17.53 percentage of change from BL	Standard Error 3.26
Placebo (PLA)	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)	21.34 percentage of change from BL	Standard Error 3.35

Secondary

DB; Mean Time-Matched Percentage of Change From Baseline in SJC Over Time: ACR Core Component

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.

Time frame: 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.

Arm	Measure	Group	Value (MEAN)	Dispersion
Abatacept (ABA)	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 2.7
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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 2.3
Abatacept (ABA)	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
Abatacept (ABA)	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
Placebo (PLA)	DB; Mean Time-Matched Percentage of Change From Baseline in SJC Over Time: ACR Core Component	Day 169 cohort (n=254, n=130)	23.78 percentage of change from BL	Standard Error 3.87
Placebo (PLA)	DB; Mean Time-Matched Percentage of Change From Baseline in SJC Over Time: ACR Core Component	Day 15 cohort (n=251, n=126)	13.13 percentage of change from BL	Standard Error 3.03
Placebo (PLA)	DB; Mean Time-Matched Percentage of Change From Baseline in SJC Over Time: ACR Core Component	Day 29 cohort (n=248, n=128)	14.96 percentage of change from BL	Standard Error 3.84
Placebo (PLA)	DB; Mean Time-Matched Percentage of Change From Baseline in SJC Over Time: ACR Core Component	Day 57 cohort (n=251, n=129)	24.98 percentage of change from BL	Standard Error 3.45
Placebo (PLA)	DB; Mean Time-Matched Percentage of Change From Baseline in SJC Over Time: ACR Core Component	Day 85 cohort (n=249, n=129)	26.22 percentage of change from BL	Standard Error 3.72
Placebo (PLA)	DB; Mean Time-Matched Percentage of Change From Baseline in SJC Over Time: ACR Core Component	Day 113 cohort (n=246, n=128)	22.87 percentage of change from BL	Standard Error 3.72
Placebo (PLA)	DB; Mean Time-Matched Percentage of Change From Baseline in SJC Over Time: ACR Core Component	Day 141 cohort (n=252, n=128)	24.33 percentage of change from BL	Standard Error 3.77

Secondary

DB; Mean Time-Matched Percentage of Change From Baseline in TJC Over Time: ACR Core Component

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.

Time frame: 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 TJCs. Mean time-matched BL values reflect changing n-values over time.

Arm	Measure	Group	Value (MEAN)	Dispersion
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Placebo (PLA)	DB; Mean Time-Matched Percentage of Change From Baseline in TJC Over Time: ACR Core Component	Day 169 cohort (n=254, n=130)	20.04 percentage of change from BL	Standard Error 3.84
Placebo (PLA)	DB; Mean Time-Matched Percentage of Change From Baseline in TJC Over Time: ACR Core Component	Day 15 cohort (n=251, n=126)	6.43 percentage of change from BL	Standard Error 3.25
Placebo (PLA)	DB; Mean Time-Matched Percentage of Change From Baseline in TJC Over Time: ACR Core Component	Day 29 cohort (n=248, n=128)	14.96 percentage of change from BL	Standard Error 3.84
Placebo (PLA)	DB; Mean Time-Matched Percentage of Change From Baseline in TJC Over Time: ACR Core Component	Day 57 cohort (n=251, n=129)	24.99 percentage of change from BL	Standard Error 3.62
Placebo (PLA)	DB; Mean Time-Matched Percentage of Change From Baseline in TJC Over Time: ACR Core Component	Day 85 cohort (n=249, n=129)	20.94 percentage of change from BL	Standard Error 3.49
Placebo (PLA)	DB; Mean Time-Matched Percentage of Change From Baseline in TJC Over Time: ACR Core Component	Day 113 cohort (n=246, n=128)	21.72 percentage of change from BL	Standard Error 3.87
Placebo (PLA)	DB; Mean Time-Matched Percentage of Change From Baseline in TJC Over Time: ACR Core Component	Day 141 cohort (n=252, n=128)	24.03 percentage of change from BL	Standard Error 4.05

Secondary

DB; Number of Participants AEs of Special Interest

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

Population: All treated participants

Arm	Measure	Group	Value (NUMBER)
Abatacept (ABA)	DB; Number of Participants AEs of Special Interest	Neoplasms	7 participants
Abatacept (ABA)	DB; Number of Participants AEs of Special Interest	Acute infusional AEs	13 participants
Abatacept (ABA)	DB; Number of Participants AEs of Special Interest	Pre-specified autoimmune disorders	4 participants
Abatacept (ABA)	DB; Number of Participants AEs of Special Interest	Peri-infusional AEs	40 participants
Abatacept (ABA)	DB; Number of Participants AEs of Special Interest	Infections	97 participants
Placebo (PLA)	DB; Number of Participants AEs of Special Interest	Peri-infusional AEs	17 participants
Placebo (PLA)	DB; Number of Participants AEs of Special Interest	Infections	43 participants
Placebo (PLA)	DB; Number of Participants AEs of Special Interest	Neoplasms	1 participants
Placebo (PLA)	DB; Number of Participants AEs of Special Interest	Pre-specified autoimmune disorders	0 participants
Placebo (PLA)	DB; Number of Participants AEs of Special Interest	Acute infusional AEs	4 participants

Secondary

DB; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time

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.

Time frame: Days 15, 29, 57, 85, 113, 141, and 169

Arm	Measure	Group	Value (NUMBER)
Abatacept (ABA)	DB; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time	Day 29 ACR 20	84 participants
Abatacept (ABA)	DB; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time	Day 85 ACR 50	46 participants
Abatacept (ABA)	DB; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time	Day 169 ACR 70	26 participants
Abatacept (ABA)	DB; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time	Day 85 ACR 70	15 participants
Abatacept (ABA)	DB; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time	Day 29 ACR 50	22 participants
Abatacept (ABA)	DB; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time	Day 113 ACR 20	126 participants
Abatacept (ABA)	DB; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time	Day 57 ACR 20	118 participants
Abatacept (ABA)	DB; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time	Day 113 ACR 50	46 participants
Abatacept (ABA)	DB; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time	Day 15 ACR 50	6 participants
Abatacept (ABA)	DB; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time	Day 113 ACR 70	20 participants
Abatacept (ABA)	DB; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time	Day 15 ACR 70	2 participants
Abatacept (ABA)	DB; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time	Day 141 ACR 20	141 participants
Abatacept (ABA)	DB; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time	Day 57 ACR 50	34 participants
Abatacept (ABA)	DB; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time	Day 141 ACR 50	65 participants
Abatacept (ABA)	DB; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time	Day 29 ACR 70	6 participants
Abatacept (ABA)	DB; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time	Day 141 ACR 70	26 participants
Abatacept (ABA)	DB; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time	Day 169 ACR 20	129 participants
Abatacept (ABA)	DB; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time	Day 57 ACR 70	13 participants
Abatacept (ABA)	DB; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time	Day 169 ACR 50	52 participants
Abatacept (ABA)	DB; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time	Day 85 ACR 20	118 participants
Abatacept (ABA)	DB; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time	Day 15 ACR 20	45 participants
Placebo (PLA)	DB; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time	Day 169 ACR 70	2 participants
Placebo (PLA)	DB; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time	Day 15 ACR 20	7 participants
Placebo (PLA)	DB; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time	Day 57 ACR 70	0 participants
Placebo (PLA)	DB; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time	Day 141 ACR 70	0 participants
Placebo (PLA)	DB; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time	Day 15 ACR 50	0 participants
Placebo (PLA)	DB; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time	Day 15 ACR 70	0 participants
Placebo (PLA)	DB; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time	Day 29 ACR 20	25 participants
Placebo (PLA)	DB; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time	Day 29 ACR 50	4 participants
Placebo (PLA)	DB; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time	Day 29 ACR 70	1 participants
Placebo (PLA)	DB; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time	Day 57 ACR 20	32 participants
Placebo (PLA)	DB; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time	Day 57 ACR 50	9 participants
Placebo (PLA)	DB; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time	Day 85 ACR 20	24 participants
Placebo (PLA)	DB; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time	Day 85 ACR 50	8 participants
Placebo (PLA)	DB; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time	Day 85 ACR 70	1 participants
Placebo (PLA)	DB; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time	Day 113 ACR 20	31 participants
Placebo (PLA)	DB; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time	Day 113 ACR 50	5 participants
Placebo (PLA)	DB; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time	Day 113 ACR 70	0 participants
Placebo (PLA)	DB; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time	Day 141 ACR 20	26 participants
Placebo (PLA)	DB; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time	Day 141 ACR 50	6 participants
Placebo (PLA)	DB; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time	Day 169 ACR 20	26 participants
Placebo (PLA)	DB; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time	Day 169 ACR 50	5 participants

Comparison: Differences in ACR 20 between the treatment arm receiving ABA plus background DMARDs and the treatment arm receiving PLA plus background DMARDs were compared using a 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test (.05 level of significance), with stratification based on baseline history of anti-TNF status (current or prior use).p-value: 0.00195% CI: [4.6, 20]Cochran-Mantel-Haenszel

Comparison: If ACR20 comparison was significant (5% level), then CMH Chi-square test compared ACR 50 response between groups (5% level). If the ACR20 analysis was not significant (5% level), then the comparison for ACR 50 response was not undertaken. A 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test was used to compare these two treatment groups at the .05 level of significance, with stratification based on baseline history of anti-TNF status (current or prior use).p-value: 0.00195% CI: [-0.8, 5.5]Cochran-Mantel-Haenszel

Comparison: If ACR20 comparison was significant (5% level), then CMH Chi-square test compared ACR 70 response between groups (5% level). If the ACR20 analysis was not significant (5% level), then the comparison for ACR 70 response was not undertaken. A 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test was used to compare these two treatment groups at the .05 level of significance, with stratification based on baseline history of anti-TNF status (current or prior use).p-value: 0.78495% CI: [-1.3, 2.9]Cochran-Mantel-Haenszel

Secondary

DB; Number of Participants With Blood Chemistry Laboratories Meeting MA Criteria

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

Population: All treated participants

Arm	Measure	Group	Value (NUMBER)
Abatacept (ABA)	DB; Number of Participants With Blood Chemistry Laboratories Meeting MA Criteria	High ALT (ULN=55 U/L)	4 participants
Abatacept (ABA)	DB; Number of Participants With Blood Chemistry Laboratories Meeting MA Criteria	High bilirubin (ULN=1.2 mg/dL)	0 participants
Abatacept (ABA)	DB; Number of Participants With Blood Chemistry Laboratories Meeting MA Criteria	High AST (ULN=44 U/L)	2 participants
Abatacept (ABA)	DB; Number of Participants With Blood Chemistry Laboratories Meeting MA Criteria	High BUN (ULN=26 mg/dL)	0 participants
Abatacept (ABA)	DB; Number of Participants With Blood Chemistry Laboratories Meeting MA Criteria	High GGT (ULN=65 U/L)	0 participants
Abatacept (ABA)	DB; Number of Participants With Blood Chemistry Laboratories Meeting MA Criteria	High creatinine (ULN=1.5 mg/dL)	11 participants
Abatacept (ABA)	DB; Number of Participants With Blood Chemistry Laboratories Meeting MA Criteria	High ALP (ULN=400 U/L)	0 participants
Placebo (PLA)	DB; Number of Participants With Blood Chemistry Laboratories Meeting MA Criteria	High creatinine (ULN=1.5 mg/dL)	5 participants
Placebo (PLA)	DB; Number of Participants With Blood Chemistry Laboratories Meeting MA Criteria	High ALP (ULN=400 U/L)	0 participants
Placebo (PLA)	DB; Number of Participants With Blood Chemistry Laboratories Meeting MA Criteria	High AST (ULN=44 U/L)	2 participants
Placebo (PLA)	DB; Number of Participants With Blood Chemistry Laboratories Meeting MA Criteria	High ALT (ULN=55 U/L)	1 participants
Placebo (PLA)	DB; Number of Participants With Blood Chemistry Laboratories Meeting MA Criteria	High GGT (ULN=65 U/L)	0 participants
Placebo (PLA)	DB; Number of Participants With Blood Chemistry Laboratories Meeting MA Criteria	High bilirubin (ULN=1.2 mg/dL)	0 participants
Placebo (PLA)	DB; Number of Participants With Blood Chemistry Laboratories Meeting MA Criteria	High BUN (ULN=26 mg/dL)	0 participants

Secondary

DB; Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuation, AEs, Related AEs, or AEs Leading to Discontinuation

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

Population: All treated participants

Arm	Measure	Group	Value (NUMBER)
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Placebo (PLA)	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	4 participants
Placebo (PLA)	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	0 participants
Placebo (PLA)	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	15 participants
Placebo (PLA)	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	1 participants
Placebo (PLA)	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	2 participants
Placebo (PLA)	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	95 participants
Placebo (PLA)	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	39 participants

Secondary

DB; Number of Participants With Hematology Laboratories Meeting Marked Abnormality (MA) Criteria

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

Population: All treated participants

Arm	Measure	Group	Value (NUMBER)
Abatacept (ABA)	DB; Number of Participants With Hematology Laboratories Meeting Marked Abnormality (MA) Criteria	Low erythrocytes (LLN=3.8 x10*6 cells/μL)	0 participants
Abatacept (ABA)	DB; Number of Participants With Hematology Laboratories Meeting Marked Abnormality (MA) Criteria	Low neutrophils+bands(LLN=1.8*10^3 cells/μL)	0 participants
Abatacept (ABA)	DB; Number of Participants With Hematology Laboratories Meeting Marked Abnormality (MA) Criteria	High PLT (ULN=450*10^9 cells/L)	1 participants
Abatacept (ABA)	DB; Number of Participants With Hematology Laboratories Meeting Marked Abnormality (MA) Criteria	Low lymphocytes (LLN= 0.7*10^3 cells/μL)	0 participants
Abatacept (ABA)	DB; Number of Participants With Hematology Laboratories Meeting Marked Abnormality (MA) Criteria	Low hematocrit (LLN=34%)	0 participants
Abatacept (ABA)	DB; Number of Participants With Hematology Laboratories Meeting Marked Abnormality (MA) Criteria	High lymphocytes(ULN=4.5*10^3 cells/μL)	0 participants
Abatacept (ABA)	DB; Number of Participants With Hematology Laboratories Meeting Marked Abnormality (MA) Criteria	Low leukocytes (LLN= 3.8*10^3 cells/μL)	2 participants
Abatacept (ABA)	DB; Number of Participants With Hematology Laboratories Meeting Marked Abnormality (MA) Criteria	High monocytes (ULN=1*10^3 cells/μL)	0 participants
Abatacept (ABA)	DB; Number of Participants With Hematology Laboratories Meeting Marked Abnormality (MA) Criteria	Low PLT (LLN=140*10^9 cells/μL)	1 participants
Abatacept (ABA)	DB; Number of Participants With Hematology Laboratories Meeting Marked Abnormality (MA) Criteria	High basophils (ULN= 0.2*10^3 cells/μL)	0 participants
Abatacept (ABA)	DB; Number of Participants With Hematology Laboratories Meeting Marked Abnormality (MA) Criteria	High leukocytes (ULN = 10.6*10^3 cells/μL)	18 participants
Abatacept (ABA)	DB; Number of Participants With Hematology Laboratories Meeting Marked Abnormality (MA) Criteria	High eosinophils (ULN= 7*10^3 cells/μL)	0 participants
Abatacept (ABA)	DB; Number of Participants With Hematology Laboratories Meeting Marked Abnormality (MA) Criteria	Low HGB (LLN=11.5 g/dL)	0 participants
Placebo (PLA)	DB; Number of Participants With Hematology Laboratories Meeting Marked Abnormality (MA) Criteria	High eosinophils (ULN= 7*10^3 cells/μL)	0 participants
Placebo (PLA)	DB; Number of Participants With Hematology Laboratories Meeting Marked Abnormality (MA) Criteria	Low HGB (LLN=11.5 g/dL)	1 participants
Placebo (PLA)	DB; Number of Participants With Hematology Laboratories Meeting Marked Abnormality (MA) Criteria	Low hematocrit (LLN=34%)	1 participants
Placebo (PLA)	DB; Number of Participants With Hematology Laboratories Meeting Marked Abnormality (MA) Criteria	Low erythrocytes (LLN=3.8 x10*6 cells/μL)	0 participants
Placebo (PLA)	DB; Number of Participants With Hematology Laboratories Meeting Marked Abnormality (MA) Criteria	Low PLT (LLN=140*10^9 cells/μL)	1 participants
Placebo (PLA)	DB; Number of Participants With Hematology Laboratories Meeting Marked Abnormality (MA) Criteria	High PLT (ULN=450*10^9 cells/L)	0 participants
Placebo (PLA)	DB; Number of Participants With Hematology Laboratories Meeting Marked Abnormality (MA) Criteria	Low leukocytes (LLN= 3.8*10^3 cells/μL)	0 participants
Placebo (PLA)	DB; Number of Participants With Hematology Laboratories Meeting Marked Abnormality (MA) Criteria	High leukocytes (ULN = 10.6*10^3 cells/μL)	14 participants
Placebo (PLA)	DB; Number of Participants With Hematology Laboratories Meeting Marked Abnormality (MA) Criteria	Low neutrophils+bands(LLN=1.8*10^3 cells/μL)	0 participants
Placebo (PLA)	DB; Number of Participants With Hematology Laboratories Meeting Marked Abnormality (MA) Criteria	Low lymphocytes (LLN= 0.7*10^3 cells/μL)	0 participants
Placebo (PLA)	DB; Number of Participants With Hematology Laboratories Meeting Marked Abnormality (MA) Criteria	High lymphocytes(ULN=4.5*10^3 cells/μL)	0 participants
Placebo (PLA)	DB; Number of Participants With Hematology Laboratories Meeting Marked Abnormality (MA) Criteria	High monocytes (ULN=1*10^3 cells/μL)	0 participants
Placebo (PLA)	DB; Number of Participants With Hematology Laboratories Meeting Marked Abnormality (MA) Criteria	High basophils (ULN= 0.2*10^3 cells/μL)	0 participants

Secondary

DB; Number of Participants With Positive Anti-Abatacept or Anti-Cytotoxic T-Lymphocyte Antigen 4 (CTLA4) Responses by Enzyme-Linked Immunosorbant Assay (ELISA)

Time frame: From BL to Day 169

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

Arm	Measure	Group	Value (NUMBER)
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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

OL; Mean Change From Baseline in Activity Limitation Score Over Time For Participants Treated in the OL

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.

Time frame: Days 169, 365, 729, 1093, 1457, and 1821

Arm	Measure	Group	Value (MEAN)	Dispersion
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Placebo (PLA)	OL; Mean Change From Baseline in Activity Limitation Score Over Time For Participants Treated in the OL	Day 1093 cohort (n=128, n=56)	-8.88 units on a scale	Standard Error 1.51
Placebo (PLA)	OL; Mean Change From Baseline in Activity Limitation Score Over Time For Participants Treated in the OL	Day 169 cohort (n=206, n=94)	-1.78 units on a scale	Standard Error 1.01
Placebo (PLA)	OL; Mean Change From Baseline in Activity Limitation Score Over Time For Participants Treated in the OL	Day 729 cohort (n=150, n=72)	-8.32 units on a scale	Standard Error 1.25
Placebo (PLA)	OL; Mean Change From Baseline in Activity Limitation Score Over Time For Participants Treated in the OL	Day 365 cohort (n=196, n=93)	-6.08 units on a scale	Standard Error 0.98

Secondary

OL; Mean Time-matched Baseline Activity Limitation Score Over Time For Participants Treated in the OL

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.

Time frame: BL

Arm	Measure	Group	Value (MEAN)	Dispersion
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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 11.4
Abatacept (ABA)	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
Placebo (PLA)	OL; Mean Time-matched Baseline Activity Limitation Score Over Time For Participants Treated in the OL	Day 1093 cohort (n=128, n=56)	15.38 units on a scale	Standard Deviation 10.94
Placebo (PLA)	OL; Mean Time-matched Baseline Activity Limitation Score Over Time For Participants Treated in the OL	Day 169 cohort (n=206, n=94)	15.01 units on a scale	Standard Deviation 11.34
Placebo (PLA)	OL; Mean Time-matched Baseline Activity Limitation Score Over Time For Participants Treated in the OL	Day 729 cohort (n=150, n=72)	14.56 units on a scale	Standard Deviation 10.87
Placebo (PLA)	OL; Mean Time-matched Baseline Activity Limitation Score Over Time For Participants Treated in the OL	Day 365 cohort (n=196, n=93)	15.70 units on a scale	Standard Deviation 11.29

Secondary

OL; Mean Time-matched Baseline Bodily Pain Score Over Time For Participants Treated in the OL

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.

Time frame: BL

Arm	Measure	Group	Value (MEAN)	Dispersion
Abatacept (ABA)	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
Abatacept (ABA)	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 6.8
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Placebo (PLA)	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	31.38 units on a scale	Standard Deviation 6.31
Placebo (PLA)	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	31.90 units on a scale	Standard Deviation 6.55
Placebo (PLA)	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	31.71 units on a scale	Standard Deviation 6.32
Placebo (PLA)	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	31.84 units on a scale	Standard Deviation 6.56
Placebo (PLA)	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	31.78 units on a scale	Standard Deviation 6.67
Placebo (PLA)	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	31.98 units on a scale	Standard Deviation 6.65

Secondary

OL; Mean Time-matched Baseline DAS28 (CRP) Over Time For Participants Treated in the OL

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.

Time frame: BL

Arm	Measure	Group	Value (MEAN)	Dispersion
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Placebo (PLA)	OL; Mean Time-matched Baseline DAS28 (CRP) Over Time For Participants Treated in the OL	Day 729 cohort (n=151, n=68)	6.52 units on a scale	Standard Deviation 0.76
Placebo (PLA)	OL; Mean Time-matched Baseline DAS28 (CRP) Over Time For Participants Treated in the OL	Day 57 cohort (n=207, n=97)	6.43 units on a scale	Standard Deviation 0.81
Placebo (PLA)	OL; Mean Time-matched Baseline DAS28 (CRP) Over Time For Participants Treated in the OL	Day 1821 cohort (n=101, n=45)	6.54 units on a scale	Standard Deviation 0.78
Placebo (PLA)	OL; Mean Time-matched Baseline DAS28 (CRP) Over Time For Participants Treated in the OL	Day 85 cohort (n=209, n=98)	6.45 units on a scale	Standard Deviation 0.82
Placebo (PLA)	OL; Mean Time-matched Baseline DAS28 (CRP) Over Time For Participants Treated in the OL	Day 15 cohort (n=206, n=95)	6.46 units on a scale	Standard Deviation 0.81
Placebo (PLA)	OL; Mean Time-matched Baseline DAS28 (CRP) Over Time For Participants Treated in the OL	Day 113 cohort (n=199, n=93)	6.49 units on a scale	Standard Deviation 0.8
Placebo (PLA)	OL; Mean Time-matched Baseline DAS28 (CRP) Over Time For Participants Treated in the OL	Day 1261 cohort (n=124, n=51)	6.50 units on a scale	Standard Deviation 0.76
Placebo (PLA)	OL; Mean Time-matched Baseline DAS28 (CRP) Over Time For Participants Treated in the OL	Day 141 cohort (n=210, n=96)	6.43 units on a scale	Standard Deviation 0.82
Placebo (PLA)	OL; Mean Time-matched Baseline DAS28 (CRP) Over Time For Participants Treated in the OL	Day 29 cohort (n=204, n=96)	6.46 units on a scale	Standard Deviation 0.82
Placebo (PLA)	OL; Mean Time-matched Baseline DAS28 (CRP) Over Time For Participants Treated in the OL	Day 169 cohort (n=205, n=96)	6.44 units on a scale	Standard Deviation 0.81
Placebo (PLA)	OL; Mean Time-matched Baseline DAS28 (CRP) Over Time For Participants Treated in the OL	Day 813 cohort (n=137, n=58)	6.56 units on a scale	Standard Deviation 0.78
Placebo (PLA)	OL; Mean Time-matched Baseline DAS28 (CRP) Over Time For Participants Treated in the OL	Day 253 cohort (n=193, n=89)	6.44 units on a scale	Standard Deviation 0.79
Placebo (PLA)	OL; Mean Time-matched Baseline DAS28 (CRP) Over Time For Participants Treated in the OL	Day 533 cohort (n=162, n=73)	6.45 units on a scale	Standard Deviation 0.78
Placebo (PLA)	OL; Mean Time-matched Baseline DAS28 (CRP) Over Time For Participants Treated in the OL	Day 365 cohort (n=192, n=93)	6.43 units on a scale	Standard Deviation 0.83
Placebo (PLA)	OL; Mean Time-matched Baseline DAS28 (CRP) Over Time For Participants Treated in the OL	Day 617 cohort (n=163, n=69)	6.49 units on a scale	Standard Deviation 0.75
Placebo (PLA)	OL; Mean Time-matched Baseline DAS28 (CRP) Over Time For Participants Treated in the OL	Day 1625 cohort (n=105, n=46)	6.50 units on a scale	Standard Deviation 0.79
Placebo (PLA)	OL; Mean Time-matched Baseline DAS28 (CRP) Over Time For Participants Treated in the OL	Day 897 cohort (n=132, n=60)	6.61 units on a scale	Standard Deviation 0.73
Placebo (PLA)	OL; Mean Time-matched Baseline DAS28 (CRP) Over Time For Participants Treated in the OL	Day 981 cohort (n=119, n=49)	6.56 units on a scale	Standard Deviation 0.72
Placebo (PLA)	OL; Mean Time-matched Baseline DAS28 (CRP) Over Time For Participants Treated in the OL	Day 449 cohort (n=168, n=76)	6.42 units on a scale	Standard Deviation 0.83
Placebo (PLA)	OL; Mean Time-matched Baseline DAS28 (CRP) Over Time For Participants Treated in the OL	Day 1457 cohort (n=113, n=50)	6.54 units on a scale	Standard Deviation 0.77
Placebo (PLA)	OL; Mean Time-matched Baseline DAS28 (CRP) Over Time For Participants Treated in the OL	Day 1093 cohort (n=133, n=56)	6.53 units on a scale	Standard Deviation 0.77

Secondary

OL; Mean Time-matched Baseline DAS28 (ESR) Over Time For Participants Treated in the OL

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.

Time frame: BL

Arm	Measure	Group	Value (MEAN)	Dispersion
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Placebo (PLA)	OL; Mean Time-matched Baseline DAS28 (ESR) Over Time For Participants Treated in the OL	Day 1821 cohort (n=87, n=42)	6.91 units on a scale	Standard Deviation 0.91
Placebo (PLA)	OL; Mean Time-matched Baseline DAS28 (ESR) Over Time For Participants Treated in the OL	Day 169 cohort (n=178, n=83)	6.83 units on a scale	Standard Deviation 0.98
Placebo (PLA)	OL; Mean Time-matched Baseline DAS28 (ESR) Over Time For Participants Treated in the OL	Day 253 cohort (n=163, n=75)	6.85 units on a scale	Standard Deviation 1.01
Placebo (PLA)	OL; Mean Time-matched Baseline DAS28 (ESR) Over Time For Participants Treated in the OL	Day 365 cohort (n=176, n=82)	6.80 units on a scale	Standard Deviation 1.03
Placebo (PLA)	OL; Mean Time-matched Baseline DAS28 (ESR) Over Time For Participants Treated in the OL	Day 449 cohort (n=152, n=70)	6.85 units on a scale	Standard Deviation 0.97
Placebo (PLA)	OL; Mean Time-matched Baseline DAS28 (ESR) Over Time For Participants Treated in the OL	Day 533 cohort (n=134, n=66)	6.81 units on a scale	Standard Deviation 0.81
Placebo (PLA)	OL; Mean Time-matched Baseline DAS28 (ESR) Over Time For Participants Treated in the OL	Day 617 cohort (n=143, n=59)	6.88 units on a scale	Standard Deviation 0.82
Placebo (PLA)	OL; Mean Time-matched Baseline DAS28 (ESR) Over Time For Participants Treated in the OL	Day 729 cohort (n=133, n=64)	6.86 units on a scale	Standard Deviation 0.89
Placebo (PLA)	OL; Mean Time-matched Baseline DAS28 (ESR) Over Time For Participants Treated in the OL	Day 813 cohort (n=120, n=52)	6.93 units on a scale	Standard Deviation 0.93
Placebo (PLA)	OL; Mean Time-matched Baseline DAS28 (ESR) Over Time For Participants Treated in the OL	Day 897 cohort (n=118, n=56)	6.93 units on a scale	Standard Deviation 0.85
Placebo (PLA)	OL; Mean Time-matched Baseline DAS28 (ESR) Over Time For Participants Treated in the OL	Day 981 cohort (n=119, n=50)	6.91 units on a scale	Standard Deviation 0.84
Placebo (PLA)	OL; Mean Time-matched Baseline DAS28 (ESR) Over Time For Participants Treated in the OL	Day 1093 cohort (n=111, n=50)	6.92 units on a scale	Standard Deviation 0.88
Placebo (PLA)	OL; Mean Time-matched Baseline DAS28 (ESR) Over Time For Participants Treated in the OL	Day 1261 cohort (n=107, n=50)	6.88 units on a scale	Standard Deviation 0.87
Placebo (PLA)	OL; Mean Time-matched Baseline DAS28 (ESR) Over Time For Participants Treated in the OL	Day 1457 cohort (n=94, n=45)	6.87 units on a scale	Standard Deviation 0.89
Placebo (PLA)	OL; Mean Time-matched Baseline DAS28 (ESR) Over Time For Participants Treated in the OL	Day 1625 cohort (n=89, n=41)	6.89 units on a scale	Standard Deviation 0.9

Secondary

OL; Mean Time-matched Baseline Erythrocyte Sedimentation Rate (ESR) Over Time For Participants Treated in the OL

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.

Time frame: BL

Arm	Measure	Group	Value (MEAN)	Dispersion
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Placebo (PLA)	OL; Mean Time-matched Baseline Erythrocyte Sedimentation Rate (ESR) Over Time For Participants Treated in the OL	Day 1457 cohort (n=99, n=45)	42.64 mm/hr	Standard Deviation 25.76
Placebo (PLA)	OL; Mean Time-matched Baseline Erythrocyte Sedimentation Rate (ESR) Over Time For Participants Treated in the OL	Day 169 cohort (n=174, n=81)	44.40 mm/hr	Standard Deviation 26.64
Placebo (PLA)	OL; Mean Time-matched Baseline Erythrocyte Sedimentation Rate (ESR) Over Time For Participants Treated in the OL	Day 1093 cohort (n=113, n=53)	43.36 mm/hr	Standard Deviation 24.42
Placebo (PLA)	OL; Mean Time-matched Baseline Erythrocyte Sedimentation Rate (ESR) Over Time For Participants Treated in the OL	Day 365 cohort (n=171, n=81)	44.10 mm/hr	Standard Deviation 26.41
Placebo (PLA)	OL; Mean Time-matched Baseline Erythrocyte Sedimentation Rate (ESR) Over Time For Participants Treated in the OL	Day 1821 cohort (n=90, n=43)	43.02 mm/hr	Standard Deviation 24.96
Placebo (PLA)	OL; Mean Time-matched Baseline Erythrocyte Sedimentation Rate (ESR) Over Time For Participants Treated in the OL	Day 729 cohort (n=135, n=67)	42.06 mm/hr	Standard Deviation 23.77

Secondary

OL; Mean Time-matched Baseline Fatigue Visual Analog Score (VAS) Over Time For Participants Treated in the OL

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.

Time frame: BL

Arm	Measure	Group	Value (MEAN)	Dispersion
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Placebo (PLA)	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)	71.14 units on a scale	Standard Deviation 19.57
Placebo (PLA)	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)	71.24 units on a scale	Standard Deviation 20.27
Placebo (PLA)	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)	70.00 units on a scale	Standard Deviation 21
Placebo (PLA)	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)	70.78 units on a scale	Standard Deviation 20.13
Placebo (PLA)	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)	69.68 units on a scale	Standard Deviation 20.08
Placebo (PLA)	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)	69.59 units on a scale	Standard Deviation 20.74

Secondary

OL; Mean Time-matched Baseline General Health Score Over Time For Participants Treated in the OL

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.

Time frame: BL

Arm	Measure	Group	Value (MEAN)	Dispersion
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Placebo (PLA)	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	35.92 units on a scale	Standard Deviation 8.92
Placebo (PLA)	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	35.52 units on a scale	Standard Deviation 8.76
Placebo (PLA)	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	35.78 units on a scale	Standard Deviation 8.79
Placebo (PLA)	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	35.48 units on a scale	Standard Deviation 8.76
Placebo (PLA)	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	36.14 units on a scale	Standard Deviation 9.02
Placebo (PLA)	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	35.48 units on a scale	Standard Deviation 8.98

Secondary

OL; Mean Time-matched Baseline HAQ-DI and HAQ Component Scores Over Time For Participants Treated in the OL

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.

Time frame: BL

Arm	Measure	Group	Value (MEAN)	Dispersion
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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 0.8
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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 0.9
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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 0.8
Abatacept (ABA)	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 0.6
Abatacept (ABA)	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
Abatacept (ABA)	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 0.8
Abatacept (ABA)	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
Placebo (PLA)	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)	2.00 units on a scale	Standard Error 0.86
Placebo (PLA)	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)	1.79 units on a scale	Standard Error 0.6
Placebo (PLA)	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)	1.54 units on a scale	Standard Error 0.69
Placebo (PLA)	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)	1.44 units on a scale	Standard Error 0.73
Placebo (PLA)	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)	1.80 units on a scale	Standard Error 0.87
Placebo (PLA)	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)	1.51 units on a scale	Standard Error 0.75
Placebo (PLA)	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)	2.21 units on a scale	Standard Error 0.86
Placebo (PLA)	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)	1.97 units on a scale	Standard Error 0.87
Placebo (PLA)	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)	1.92 units on a scale	Standard Error 0.62
Placebo (PLA)	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)	1.96 units on a scale	Standard Error 0.86
Placebo (PLA)	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 0.6
Placebo (PLA)	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)	1.55 units on a scale	Standard Error 0.69
Placebo (PLA)	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)	1.45 units on a scale	Standard Error 0.74
Placebo (PLA)	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)	1.80 units on a scale	Standard Error 0.87
Placebo (PLA)	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)	1.51 units on a scale	Standard Error 0.76
Placebo (PLA)	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)	2.22 units on a scale	Standard Error 0.87
Placebo (PLA)	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)	1.98 units on a scale	Standard Error 0.97
Placebo (PLA)	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)	1.92 units on a scale	Standard Error 0.62
Placebo (PLA)	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)	1.96 units on a scale	Standard Error 0.85
Placebo (PLA)	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)	1.79 units on a scale	Standard Error 0.59
Placebo (PLA)	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)	1.54 units on a scale	Standard Error 0.67
Placebo (PLA)	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)	1.43 units on a scale	Standard Error 0.7
Placebo (PLA)	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)	1.81 units on a scale	Standard Error 0.84
Placebo (PLA)	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)	1.47 units on a scale	Standard Error 0.73
Placebo (PLA)	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)	2.23 units on a scale	Standard Error 0.88
Placebo (PLA)	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)	2.03 units on a scale	Standard Error 0.83
Placebo (PLA)	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)	1.88 units on a scale	Standard Error 0.57
Placebo (PLA)	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)	1.93 units on a scale	Standard Error 0.85
Placebo (PLA)	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)	1.81 units on a scale	Standard Error 0.54
Placebo (PLA)	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)	1.59 units on a scale	Standard Error 0.57
Placebo (PLA)	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)	1.44 units on a scale	Standard Error 0.72
Placebo (PLA)	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)	1.81 units on a scale	Standard Error 0.8
Placebo (PLA)	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)	1.43 units on a scale	Standard Error 0.69
Placebo (PLA)	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)	2.25 units on a scale	Standard Error 0.86
Placebo (PLA)	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)	2.14 units on a scale	Standard Error 0.78
Placebo (PLA)	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)	1.93 units on a scale	Standard Error 0.49
Placebo (PLA)	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)	1.98 units on a scale	Standard Error 0.8
Placebo (PLA)	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)	1.87 units on a scale	Standard Error 0.54
Placebo (PLA)	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 0.56
Placebo (PLA)	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)	1.44 units on a scale	Standard Error 0.73
Placebo (PLA)	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)	1.92 units on a scale	Standard Error 0.85
Placebo (PLA)	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)	1.48 units on a scale	Standard Error 0.71
Placebo (PLA)	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)	2.32 units on a scale	Standard Error 0.82
Placebo (PLA)	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)	2.12 units on a scale	Standard Error 0.8
Placebo (PLA)	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)	1.98 units on a scale	Standard Error 0.43
Placebo (PLA)	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)	2.02 units on a scale	Standard Error 0.82
Placebo (PLA)	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)	1.84 units on a scale	Standard Error 0.57
Placebo (PLA)	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)	1.62 units on a scale	Standard Error 0.57
Placebo (PLA)	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)	1.43 units on a scale	Standard Error 0.74
Placebo (PLA)	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)	1.89 units on a scale	Standard Error 0.89
Placebo (PLA)	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)	1.45 units on a scale	Standard Error 0.72
Placebo (PLA)	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)	2.26 units on a scale	Standard Error 0.85
Placebo (PLA)	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)	2.11 units on a scale	Standard Error 0.81
Placebo (PLA)	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)	1.94 units on a scale	Standard Error 0.53

Secondary

OL; Mean Time-matched Baseline Levels of C-Reactive Protein (CRP) Over Time For Participants Treated in the OL

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.

Time frame: BL

Arm	Measure	Group	Value (MEAN)	Dispersion
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Placebo (PLA)	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)	35.30 mg/dL	Standard Deviation 30.87
Placebo (PLA)	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)	33.34 mg/dL	Standard Deviation 31.13
Placebo (PLA)	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)	35.07 mg/dL	Standard Deviation 29.95
Placebo (PLA)	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)	34.05 mg/dL	Standard Deviation 31.55
Placebo (PLA)	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)	34.83 mg/dL	Standard Deviation 28.26
Placebo (PLA)	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)	34.60 mg/dL	Standard Deviation 30.69

Secondary

OL; Mean Time-matched Baseline Levels of Rheumatoid Factor (RF) Over Time For Participants Treated in the OL

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.

Time frame: BL

Arm	Measure	Group	Value (MEAN)	Dispersion
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Placebo (PLA)	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)	331.3 IU/ml	Standard Deviation 552.9
Placebo (PLA)	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)	264.8 IU/ml	Standard Deviation 430.4
Placebo (PLA)	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)	328.9 IU/ml	Standard Deviation 509.8
Placebo (PLA)	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)	270.4 IU/ml	Standard Deviation 435.9
Placebo (PLA)	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)	318.4 IU/ml	Standard Deviation 552.3
Placebo (PLA)	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)	301.5 IU/ml	Standard Deviation 476.4

Secondary

OL; Mean Time-matched Baseline Levels of Soluble Interleukin 2 Receptor (sIL-2R) Over Time For Participants Treated in the OL

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

Time frame: BL

Arm	Measure	Group	Value (MEAN)	Dispersion
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Placebo (PLA)	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)	1827.0 pg/ml	Standard Deviation 974.2
Placebo (PLA)	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)	1805.0 pg/ml	Standard Deviation 922.9
Placebo (PLA)	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)	1708.0 pg/ml	Standard Deviation 864.9
Placebo (PLA)	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)	1800.0 pg/ml	Standard Deviation 941.5

Secondary

OL; Mean Time-matched Baseline Medical Outcomes Study Sleep Module (MOS-sleep) Score Over Time For Participants Treated in the OL

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.

Time frame: BL

Arm	Measure	Group	Value (MEAN)	Dispersion
Abatacept (ABA)	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 18.1
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Placebo (PLA)	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)	47.14 units on a scale	Standard Deviation 18.47
Placebo (PLA)	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)	45.49 units on a scale	Standard Deviation 17.72
Placebo (PLA)	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)	46.44 units on a scale	Standard Deviation 17.28
Placebo (PLA)	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)	45.54 units on a scale	Standard Deviation 17.86
Placebo (PLA)	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)	45.09 units on a scale	Standard Deviation 17.9
Placebo (PLA)	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)	45.36 units on a scale	Standard Deviation 17.26

Secondary

OL; Mean Time-matched Baseline Mental Health Score Over Time For Participants Treated in the OL

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.

Time frame: BL

Arm	Measure	Group	Value (MEAN)	Dispersion
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Placebo (PLA)	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	41.44 units on a scale	Standard Deviation 10.62
Placebo (PLA)	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	43.47 units on a scale	Standard Deviation 11.34
Placebo (PLA)	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	41.85 units on a scale	Standard Deviation 10.54
Placebo (PLA)	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	43.53 units on a scale	Standard Deviation 11.37
Placebo (PLA)	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	42.50 units on a scale	Standard Deviation 10.36
Placebo (PLA)	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	42.69 units on a scale	Standard Deviation 10.81

Secondary

OL; Mean Time-matched Baseline Physical Function Score Over Time For Participants Treated in the OL

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.

Time frame: BL

Arm	Measure	Group	Value (MEAN)	Dispersion
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Placebo (PLA)	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	25.41 units on a scale	Standard Deviation 8.08
Placebo (PLA)	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	26.60 units on a scale	Standard Deviation 8.65
Placebo (PLA)	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	25.66 units on a scale	Standard Deviation 7.99
Placebo (PLA)	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	26.49 units on a scale	Standard Deviation 8.62
Placebo (PLA)	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	25.61 units on a scale	Standard Deviation 8.45
Placebo (PLA)	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	26.66 units on a scale	Standard Deviation 8.37

Secondary

OL; Mean Time-matched Baseline Role-Emotional Score Over Time For Participants Treated in the OL

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.

Time frame: BL

Arm	Measure	Group	Value (MEAN)	Dispersion
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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 13.8
Placebo (PLA)	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	36.17 units on a scale	Standard Deviation 13.74
Placebo (PLA)	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	37.60 units on a scale	Standard Deviation 14
Placebo (PLA)	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	35.54 units on a scale	Standard Deviation 13.54
Placebo (PLA)	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	37.75 units on a scale	Standard Deviation 14
Placebo (PLA)	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	36.29 units on a scale	Standard Deviation 13.65
Placebo (PLA)	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	35.86 units on a scale	Standard Deviation 13.45

Secondary

OL; Mean Time-matched Baseline Role-Physical Score Over Time For Participants Treated in the OL

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.

Time frame: BL

Arm	Measure	Group	Value (MEAN)	Dispersion
Abatacept (ABA)	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 6.2
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Placebo (PLA)	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	31.91 units on a scale	Standard Deviation 7.02
Placebo (PLA)	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	32.36 units on a scale	Standard Deviation 7.36
Placebo (PLA)	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	31.91 units on a scale	Standard Deviation 6.98
Placebo (PLA)	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	32.40 units on a scale	Standard Deviation 7.38
Placebo (PLA)	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	32.47 units on a scale	Standard Deviation 7.58
Placebo (PLA)	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	32.45 units on a scale	Standard Deviation 7.08

Secondary

OL; Mean Time-matched Baseline SF-36 PCS and MCS Over Time For Participants Treated in OL

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.

Time frame: BL

Arm	Measure	Group	Value (MEAN)	Dispersion
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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 12.2
Abatacept (ABA)	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
Placebo (PLA)	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	41.95 units on a scale	Standard Deviation 11.67
Placebo (PLA)	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	28.07 units on a scale	Standard Deviation 6.86
Placebo (PLA)	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	43.62 units on a scale	Standard Deviation 12.12
Placebo (PLA)	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	27.92 units on a scale	Standard Deviation 6.83
Placebo (PLA)	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	42.13 units on a scale	Standard Deviation 11.75
Placebo (PLA)	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	28.65 units on a scale	Standard Deviation 6.8
Placebo (PLA)	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	43.96 units on a scale	Standard Deviation 11.98
Placebo (PLA)	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	28.25 units on a scale	Standard Deviation 6.72
Placebo (PLA)	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	42.70 units on a scale	Standard Deviation 11.64
Placebo (PLA)	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	28.06 units on a scale	Standard Deviation 6.85
Placebo (PLA)	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	42.42 units on a scale	Standard Deviation 11.89
Placebo (PLA)	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	28.27 units on a scale	Standard Deviation 6.97

Secondary

OL; Mean Time-matched Baseline Social Functioning Score Over Time For Participants Treated in the OL

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.

Time frame: BL

Arm	Measure	Group	Value (MEAN)	Dispersion
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Placebo (PLA)	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	33.36 units on a scale	Standard Deviation 11.6
Placebo (PLA)	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	34.37 units on a scale	Standard Deviation 11.42
Placebo (PLA)	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	34.14 units on a scale	Standard Deviation 11.46
Placebo (PLA)	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	34.30 units on a scale	Standard Deviation 11.46
Placebo (PLA)	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	34.15 units on a scale	Standard Deviation 11.88
Placebo (PLA)	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	34.32 units on a scale	Standard Deviation 11.29

Secondary

OL; Mean Time-matched Baseline Vitality Score Over Time For Participants Treated in the OL

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.

Time frame: BL

Arm	Measure	Group	Value (MEAN)	Dispersion
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Placebo (PLA)	OL; Mean Time-matched Baseline Vitality Score Over Time For Participants Treated in the OL	Day 1457 cohort (n=118, n=50): Vitality	35.83 units on a scale	Standard Deviation 8.18
Placebo (PLA)	OL; Mean Time-matched Baseline Vitality Score Over Time For Participants Treated in the OL	Day 169 cohort (n=212, n=98): Vitality	36.51 units on a scale	Standard Deviation 9.15
Placebo (PLA)	OL; Mean Time-matched Baseline Vitality Score Over Time For Participants Treated in the OL	Day 1093 cohort (n=136, n=59): Vitality	36.53 units on a scale	Standard Deviation 8.23
Placebo (PLA)	OL; Mean Time-matched Baseline Vitality Score Over Time For Participants Treated in the OL	Day 365 cohort (n=204, n=97): Vitality	36.65 units on a scale	Standard Deviation 9.09
Placebo (PLA)	OL; Mean Time-matched Baseline Vitality Score Over Time For Participants Treated in the OL	Day 1821 cohort (n=105, n=47): Vitality	36.35 units on a scale	Standard Deviation 8.47
Placebo (PLA)	OL; Mean Time-matched Baseline Vitality Score Over Time For Participants Treated in the OL	Day 729 cohort (n=157, n=74): Vitality	36.50 units on a scale	Standard Deviation 8.95

Secondary

OL; Mean Time-matched Change From Baseline in Bodily Pain Score Over Time For Participants Treated in the OL

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.

Time frame: BL, Days 169, 365, 729, 1093, 1457, and 1821

Arm	Measure	Group	Value (MEAN)	Dispersion
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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 0.8
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Placebo (PLA)	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	11.52 units on a scale	Standard Error 1.6
Placebo (PLA)	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	3.32 units on a scale	Standard Error 0.78
Placebo (PLA)	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	11.34 units on a scale	Standard Error 1.45
Placebo (PLA)	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	9.55 units on a scale	Standard Error 0.98
Placebo (PLA)	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	14.33 units on a scale	Standard Error 1.43
Placebo (PLA)	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	10.29 units on a scale	Standard Error 1.23

Secondary

OL; Mean Time-matched Change From Baseline in DAS28 (CRP) Over Time For Participants Treated in the OL

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.

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

Arm	Measure	Group	Value (MEAN)	Dispersion
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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 0.1
Abatacept (ABA)	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
Abatacept (ABA)	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 0.1
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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 0.1
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Placebo (PLA)	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)	-2.50 units on a scale	Standard Error 0.16
Placebo (PLA)	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)	-0.40 units on a scale	Standard Error 0.08
Placebo (PLA)	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 0.19
Placebo (PLA)	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)	-0.72 units on a scale	Standard Error 0.11
Placebo (PLA)	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)	-2.58 units on a scale	Standard Error 0.14
Placebo (PLA)	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)	-1.05 units on a scale	Standard Error 0.12
Placebo (PLA)	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)	-2.62 units on a scale	Standard Error 0.2
Placebo (PLA)	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)	-0.88 units on a scale	Standard Error 0.12
Placebo (PLA)	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)	-2.23 units on a scale	Standard Error 0.17
Placebo (PLA)	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)	-1.00 units on a scale	Standard Error 0.13
Placebo (PLA)	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)	-2.98 units on a scale	Standard Error 0.18
Placebo (PLA)	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)	-1.05 units on a scale	Standard Error 0.13
Placebo (PLA)	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)	-2.40 units on a scale	Standard Error 0.15
Placebo (PLA)	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)	-0.93 units on a scale	Standard Error 0.12
Placebo (PLA)	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)	-2.85 units on a scale	Standard Error 0.18
Placebo (PLA)	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)	-2.03 units on a scale	Standard Error 0.15
Placebo (PLA)	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)	-2.61 units on a scale	Standard Error 0.16
Placebo (PLA)	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)	-2.13 units on a scale	Standard Error 0.15
Placebo (PLA)	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)	-2.80 units on a scale	Standard Error 0.2
Placebo (PLA)	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)	-2.49 units on a scale	Standard Error 0.15
Placebo (PLA)	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)	-2.66 units on a scale	Standard Error 0.17

Secondary

OL; Mean Time-matched Change From Baseline in DAS28 (ESR) Over Time For Participants Treated in the OL

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

Arm	Measure	Group	Value (MEAN)	Dispersion
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Placebo (PLA)	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)	-2.73 units on a scale	Standard Error 0.22
Placebo (PLA)	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)	-0.83 units on a scale	Standard Error 0.14
Placebo (PLA)	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)	-2.00 units on a scale	Standard Error 0.16
Placebo (PLA)	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)	-2.05 units on a scale	Standard Error 0.17
Placebo (PLA)	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)	-2.53 units on a scale	Standard Error 0.16
Placebo (PLA)	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)	-2.59 units on a scale	Standard Error 0.16
Placebo (PLA)	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)	-2.60 units on a scale	Standard Error 0.15
Placebo (PLA)	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)	-2.25 units on a scale	Standard Error 0.16
Placebo (PLA)	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)	-2.43 units on a scale	Standard Error 0.16
Placebo (PLA)	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)	-2.70 units on a scale	Standard Error 0.17
Placebo (PLA)	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)	-2.59 units on a scale	Standard Error 0.2
Placebo (PLA)	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)	-2.56 units on a scale	Standard Error 0.23
Placebo (PLA)	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)	-2.56 units on a scale	Standard Error 0.21
Placebo (PLA)	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)	-2.58 units on a scale	Standard Error 0.22
Placebo (PLA)	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)	-2.64 units on a scale	Standard Error 0.24

Secondary

OL; Mean Time-matched Change From Baseline in ESR Over Time For Participants Treated in the OL

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.

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

Arm	Measure	Group	Value (MEAN)	Dispersion
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Placebo (PLA)	OL; Mean Time-matched Change From Baseline in ESR Over Time For Participants Treated in the OL	Day 1457 cohort (n=99, n=45)	-9.80 mm/hr	Standard Error 4.44
Placebo (PLA)	OL; Mean Time-matched Change From Baseline in ESR Over Time For Participants Treated in the OL	Day 169 cohort (n=174, n=81)	-0.44 mm/hr	Standard Error 2.6
Placebo (PLA)	OL; Mean Time-matched Change From Baseline in ESR Over Time For Participants Treated in the OL	Day 1093 cohort (n=113, n=53)	-10.6 mm/hr	Standard Error 3.6
Placebo (PLA)	OL; Mean Time-matched Change From Baseline in ESR Over Time For Participants Treated in the OL	Day 365 cohort (n=171, n=81)	-10.1 mm/hr	Standard Error 2.5
Placebo (PLA)	OL; Mean Time-matched Change From Baseline in ESR Over Time For Participants Treated in the OL	Day 1821 cohort (n=90, n=43)	-9.49 mm/hr	Standard Error 4.45
Placebo (PLA)	OL; Mean Time-matched Change From Baseline in ESR Over Time For Participants Treated in the OL	Day 729 cohort (n=135, n=67)	-6.25 mm/hr	Standard Error 3.15

Secondary

OL; Mean Time-matched Change From Baseline in Fatigue VAS Over Time For Participants Treated in the OL

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.

Time frame: BL, Days 169, 365, 729, 1093, 1457, and 1821

Arm	Measure	Group	Value (MEAN)	Dispersion
Abatacept (ABA)	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
Abatacept (ABA)	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 2.1
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Placebo (PLA)	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)	-25.8 units on a scale	Standard Error 4.6
Placebo (PLA)	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)	-7.28 units on a scale	Standard Error 2.86
Placebo (PLA)	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)	-24.6 units on a scale	Standard Error 4.58
Placebo (PLA)	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)	-21.8 units on a scale	Standard Error 2.77
Placebo (PLA)	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)	-28.5 units on a scale	Standard Error 4.71
Placebo (PLA)	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)	-22.2 units on a scale	Standard Error 3.71

Secondary

OL; Mean Time-matched Change From Baseline in General Health Score Over Time For Participants Treated in the OL

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.

Time frame: BL, Days 169, 365, 729, 1093, 1457, and 1821

Arm	Measure	Group	Value (MEAN)	Dispersion
Abatacept (ABA)	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 0.6
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Placebo (PLA)	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	6.92 units on a scale	Standard Error 1.46
Placebo (PLA)	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	1.09 units on a scale	Standard Error 0.82
Placebo (PLA)	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	4.04 units on a scale	Standard Error 0.84
Placebo (PLA)	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	5.85 units on a scale	Standard Error 0.98
Placebo (PLA)	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	5.60 units on a scale	Standard Error 1.41
Placebo (PLA)	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	5.92 units on a scale	Standard Error 1.35

Secondary

OL; Mean Time-matched Change From Baseline in HAQ-DI and HAQ Component Scores For Participants Treated in the OL

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

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

Arm	Measure	Group	Value (MEAN)	Dispersion
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Placebo (PLA)	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)	-0.60 units on a scale	Standard Error 0.13
Placebo (PLA)	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)	-0.38 units on a scale	Standard Error 0.11
Placebo (PLA)	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)	-0.56 units on a scale	Standard Error 0.11
Placebo (PLA)	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)	-0.66 units on a scale	Standard Error 0.09
Placebo (PLA)	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)	-0.83 units on a scale	Standard Error 0.12
Placebo (PLA)	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)	-0.79 units on a scale	Standard Error 0.12
Placebo (PLA)	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)	-0.87 units on a scale	Standard Error 0.12
Placebo (PLA)	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)	-0.57 units on a scale	Standard Error 0.12
Placebo (PLA)	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)	-0.57 units on a scale	Standard Error 0.16
Placebo (PLA)	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)	-0.62 units on a scale	Standard Error 0.1
Placebo (PLA)	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)	-0.40 units on a scale	Standard Error 0.11
Placebo (PLA)	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)	-0.64 units on a scale	Standard Error 0.12
Placebo (PLA)	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)	-0.16 units on a scale	Standard Error 0.04
Placebo (PLA)	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)	-0.26 units on a scale	Standard Error 0.07
Placebo (PLA)	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)	-0.31 units on a scale	Standard Error 0.07
Placebo (PLA)	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)	-0.09 units on a scale	Standard Error 0.06
Placebo (PLA)	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)	-0.23 units on a scale	Standard Error 0.07
Placebo (PLA)	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)	-0.08 units on a scale	Standard Error 0.07
Placebo (PLA)	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)	-0.11 units on a scale	Standard Error 0.06
Placebo (PLA)	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)	-0.14 units on a scale	Standard Error 0.06
Placebo (PLA)	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)	-0.09 units on a scale	Standard Error 0.06
Placebo (PLA)	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)	-0.40 units on a scale	Standard Error 0.05
Placebo (PLA)	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)	-0.44 units on a scale	Standard Error 0.08
Placebo (PLA)	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)	-0.55 units on a scale	Standard Error 0.07
Placebo (PLA)	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)	-0.47 units on a scale	Standard Error 0.08
Placebo (PLA)	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)	-0.55 units on a scale	Standard Error 0.08
Placebo (PLA)	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)	-0.28 units on a scale	Standard Error 0.08
Placebo (PLA)	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)	-0.33 units on a scale	Standard Error 0.09
Placebo (PLA)	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)	-0.28 units on a scale	Standard Error 0.07
Placebo (PLA)	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)	-0.34 units on a scale	Standard Error 0.08
Placebo (PLA)	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)	-0.50 units on a scale	Standard Error 0.07
Placebo (PLA)	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)	-0.59 units on a scale	Standard Error 0.1
Placebo (PLA)	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)	-0.64 units on a scale	Standard Error 0.08
Placebo (PLA)	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)	-0.54 units on a scale	Standard Error 0.09
Placebo (PLA)	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)	-0.49 units on a scale	Standard Error 0.1
Placebo (PLA)	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)	-0.36 units on a scale	Standard Error 0.11
Placebo (PLA)	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)	-0.51 units on a scale	Standard Error 0.1
Placebo (PLA)	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)	-0.43 units on a scale	Standard Error 0.09
Placebo (PLA)	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)	-0.46 units on a scale	Standard Error 0.11
Placebo (PLA)	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)	-0.51 units on a scale	Standard Error 0.07
Placebo (PLA)	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)	-0.65 units on a scale	Standard Error 0.11
Placebo (PLA)	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)	-0.72 units on a scale	Standard Error 0.1
Placebo (PLA)	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)	-0.57 units on a scale	Standard Error 0.1
Placebo (PLA)	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)	-0.52 units on a scale	Standard Error 0.11
Placebo (PLA)	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)	-0.37 units on a scale	Standard Error 0.13
Placebo (PLA)	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)	-0.59 units on a scale	Standard Error 0.1
Placebo (PLA)	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)	-0.31 units on a scale	Standard Error 0.08
Placebo (PLA)	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)	-0.54 units on a scale	Standard Error 0.1
Placebo (PLA)	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)	-0.62 units on a scale	Standard Error 0.09
Placebo (PLA)	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)	-0.76 units on a scale	Standard Error 0.12
Placebo (PLA)	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)	-0.74 units on a scale	Standard Error 0.13
Placebo (PLA)	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)	-0.70 units on a scale	Standard Error 0.14
Placebo (PLA)	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)	-0.64 units on a scale	Standard Error 0.13
Placebo (PLA)	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)	-0.54 units on a scale	Standard Error 0.14

Secondary

OL; Mean Time-matched Change From Baseline in Levels of CRP Over Time For Participants Treated in the OL

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.

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

Arm	Measure	Group	Value (MEAN)	Dispersion
Abatacept (ABA)	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 2.7
Abatacept (ABA)	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
Abatacept (ABA)	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 3.3
Abatacept (ABA)	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
Abatacept (ABA)	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 3.3
Abatacept (ABA)	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
Placebo (PLA)	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)	-22.8 mg/dL	Standard Error 4.86
Placebo (PLA)	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)	-0.36 mg/dL	Standard Error 3.24
Placebo (PLA)	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)	-18.8 mg/dL	Standard Error 3.23
Placebo (PLA)	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)	-16.8 mg/dL	Standard Error 3.07
Placebo (PLA)	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)	-23.2 mg/dL	Standard Error 4.33
Placebo (PLA)	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)	-10.8 mg/dL	Standard Error 4.68

Secondary

OL; Mean Time-matched Change From Baseline in Levels of RF Over Time For Participants Treated in the OL

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.

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

Arm	Measure	Group	Value (MEAN)	Dispersion
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Placebo (PLA)	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)	-68.1 IU/ml	Standard Error 86.8
Placebo (PLA)	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)	-25.1 IU/ml	Standard Error 18.54
Placebo (PLA)	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)	-86.5 IU/ml	Standard Error 65.61
Placebo (PLA)	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)	-69.6 IU/ml	Standard Error 24.58
Placebo (PLA)	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)	-103.0 IU/ml	Standard Error 83.56
Placebo (PLA)	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)	-82.8 IU/ml	Standard Error 41.86

Secondary

OL; Mean Time-matched Change From Baseline in Levels of sIL-2R Over Time For Participants Treated in the OL

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.

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

Arm	Measure	Group	Value (MEAN)	Dispersion
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Placebo (PLA)	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)	-794.0 pg/ml	Standard Error 136.1
Placebo (PLA)	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)	-19.6 pg/ml	Standard Error 73.21
Placebo (PLA)	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)	-424.0 pg/ml	Standard Error 71.42
Placebo (PLA)	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)	-483.0 pg/ml	Standard Error 101.6

Secondary

OL; Mean Time-matched Change From Baseline in Mental Health Score Over Time For Participants Treated in the OL

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.

Time frame: BL, Days 169, 365, 729, 1093, 1457, and 1821

Arm	Measure	Group	Value (MEAN)	Dispersion
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Placebo (PLA)	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	8.91 units on a scale	Standard Error 1.41
Placebo (PLA)	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	1.65 units on a scale	Standard Error 0.83
Placebo (PLA)	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	7.69 units on a scale	Standard Error 1.45
Placebo (PLA)	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	4.29 units on a scale	Standard Error 0.93
Placebo (PLA)	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	8.66 units on a scale	Standard Error 1.53
Placebo (PLA)	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 .	7.19 units on a scale	Standard Error 1.29

Secondary

OL; Mean Time-matched Change From Baseline in MOS-Sleep Score Over Time For Participants Treated in the OL

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.

Time frame: BL, Days 169, 365, 729, 1093, 1457, and 1821

Arm	Measure	Group	Value (MEAN)	Dispersion
Abatacept (ABA)	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 1.1
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Placebo (PLA)	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)	-11.9 units on a scale	Standard Error 2.92
Placebo (PLA)	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)	-4.31 units on a scale	Standard Error 1.59
Placebo (PLA)	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)	-16.1 units on a scale	Standard Error 2.53
Placebo (PLA)	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)	-10.4 units on a scale	Standard Error 1.82
Placebo (PLA)	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)	-15.9 units on a scale	Standard Error 2.84
Placebo (PLA)	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)	-11.9 units on a scale	Standard Error 2.06

Secondary

OL; Mean Time-matched Change From Baseline in Physical Function Score Over Time For Participants Treated in the OL

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.

Time frame: BL, Days 169, 365, 729, 1093, 1457, and 1821

Arm	Measure	Group	Value (MEAN)	Dispersion
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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 0.9
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Placebo (PLA)	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	8.98 units on a scale	Standard Error 1.32
Placebo (PLA)	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	1.82 units on a scale	Standard Error 0.84
Placebo (PLA)	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	9.68 units on a scale	Standard Error 1.26
Placebo (PLA)	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	4.80 units on a scale	Standard Error 0.97
Placebo (PLA)	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	8.57 units on a scale	Standard Error 1.63
Placebo (PLA)	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	7.38 units on a scale	Standard Error 1.09

Secondary

OL; Mean Time-matched Change From Baseline in Role-Emotional Score Over Time For Participants Treated in the OL

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.

Time frame: BL, Days 169, 365, 729, 1093, 1457, and 1821

Arm	Measure	Group	Value (MEAN)	Dispersion
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Placebo (PLA)	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	6.32 units on a scale	Standard Error 2.39
Placebo (PLA)	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	1.83 units on a scale	Standard Error 1.4
Placebo (PLA)	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	11.62 units on a scale	Standard Error 2.28
Placebo (PLA)	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	6.52 units on a scale	Standard Error 1.58
Placebo (PLA)	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	12.10 units on a scale	Standard Error 2.35
Placebo (PLA)	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	10.39 units on a scale	Standard Error 1.94

Secondary

OL; Mean Time-matched Change From Baseline in Role-Physical Score Over Time For Participants Treated in the OL

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.

Time frame: BL, Days 169, 365, 729, 1093, 1457, and 1821

Arm	Measure	Group	Value (MEAN)	Dispersion
Abatacept (ABA)	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 0.8
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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 1.1
Abatacept (ABA)	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
Abatacept (ABA)	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
Placebo (PLA)	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	7.64 units on a scale	Standard Error 1.75
Placebo (PLA)	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	1.30 units on a scale	Standard Error 0.99
Placebo (PLA)	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	8.91 units on a scale	Standard Error 1.58
Placebo (PLA)	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	6.49 units on a scale	Standard Error 1.25
Placebo (PLA)	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	9.93 units on a scale	Standard Error 1.87
Placebo (PLA)	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	6.59 units on a scale	Standard Error 1.42

Secondary

OL; Mean Time-matched Change From Baseline in SF-36 PCS and MCS Over Time For Participants Treated in OL

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.

Time frame: BL, Days 169, 365, 729, 1093, 1457, and 1821

Arm	Measure	Group	Value (MEAN)	Dispersion
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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 0.9
Abatacept (ABA)	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
Abatacept (ABA)	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
Placebo (PLA)	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	10.37 units on a scale	Standard Error 1.75
Placebo (PLA)	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	8.61 units on a scale	Standard Error 1.42
Placebo (PLA)	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	1.90 units on a scale	Standard Error 0.77
Placebo (PLA)	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	6.21 units on a scale	Standard Error 0.94
Placebo (PLA)	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	6.79 units on a scale	Standard Error 1.16
Placebo (PLA)	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	8.61 units on a scale	Standard Error 1.34
Placebo (PLA)	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	8.51 units on a scale	Standard Error 1.39
Placebo (PLA)	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	9.35 units on a scale	Standard Error 1.52
Placebo (PLA)	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	2.16 units on a scale	Standard Error 0.91
Placebo (PLA)	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	9.14 units on a scale	Standard Error 1.72
Placebo (PLA)	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	7.93 units on a scale	Standard Error 1.77
Placebo (PLA)	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	5.32 units on a scale	Standard Error 1.07

Secondary

OL; Mean Time-matched Change From Baseline in Social Functioning Score Over Time For Participants Treated in the OL

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.

Time frame: BL, Days 169, 365, 729, 1093, 1457, and 1821

Arm	Measure	Group	Value (MEAN)	Dispersion
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Placebo (PLA)	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	11.83 units on a scale	Standard Error 1.92
Placebo (PLA)	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	2.99 units on a scale	Standard Error 1.12
Placebo (PLA)	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	10.49 units on a scale	Standard Error 1.54
Placebo (PLA)	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	7.22 units on a scale	Standard Error 1.28
Placebo (PLA)	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	12.24 units on a scale	Standard Error 1.79
Placebo (PLA)	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	9.10 units on a scale	Standard Error 1.48

Secondary

OL; Mean Time-matched Change From Baseline in Vitality Score Over Time For Participants Treated in the OL

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.

Time frame: BL, Days 169, 365, 729, 1093, 1457, and 1821

Arm	Measure	Group	Value (MEAN)	Dispersion
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Placebo (PLA)	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	8.08 units on a scale	Standard Error 1.76
Placebo (PLA)	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	2.89 units on a scale	Standard Error 0.87
Placebo (PLA)	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	8.61 units on a scale	Standard Error 1.63
Placebo (PLA)	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	6.69 units on a scale	Standard Error 0.98
Placebo (PLA)	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	9.82 units on a scale	Standard Error 1.69
Placebo (PLA)	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	7.52 units on a scale	Standard Error 1.2

Secondary

OL; Number of Participants Achieving HAQ Response Over Time In Participants Treated in the OL

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.

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

Arm	Measure	Group	Value (NUMBER)
Abatacept (ABA)	OL; Number of Participants Achieving HAQ Response Over Time In Participants Treated in the OL	Day 15 (n=209, n=96)	59 participants
Abatacept (ABA)	OL; Number of Participants Achieving HAQ Response Over Time In Participants Treated in the OL	Day 29 (n=207, n=97)	82 participants
Abatacept (ABA)	OL; Number of Participants Achieving HAQ Response Over Time In Participants Treated in the OL	Day 57 (n=209, n=98)	101 participants
Abatacept (ABA)	OL; Number of Participants Achieving HAQ Response Over Time In Participants Treated in the OL	Day 85 (n=207, n=97)	119 participants
Abatacept (ABA)	OL; Number of Participants Achieving HAQ Response Over Time In Participants Treated in the OL	Day 113 (n=202, n=96)	113 participants
Abatacept (ABA)	OL; Number of Participants Achieving HAQ Response Over Time In Participants Treated in the OL	Day 141 (n=209, n=97)	115 participants
Abatacept (ABA)	OL; Number of Participants Achieving HAQ Response Over Time In Participants Treated in the OL	Day 169 (n=207, n=98)	115 participants
Abatacept (ABA)	OL; Number of Participants Achieving HAQ Response Over Time In Participants Treated in the OL	Day 253 (n=199, n=93)	111 participants
Abatacept (ABA)	OL; Number of Participants Achieving HAQ Response Over Time In Participants Treated in the OL	Day 365 (n=182, n=87)	128 participants
Abatacept (ABA)	OL; Number of Participants Achieving HAQ Response Over Time In Participants Treated in the OL	Day 449 (n=182, n=87)	108 participants
Abatacept (ABA)	OL; Number of Participants Achieving HAQ Response Over Time In Participants Treated in the OL	Day 533 (n=165, n=78)	99 participants
Abatacept (ABA)	OL; Number of Participants Achieving HAQ Response Over Time In Participants Treated in the OL	Day 617 (n=161, n=71)	101 participants
Abatacept (ABA)	OL; Number of Participants Achieving HAQ Response Over Time In Participants Treated in the OL	Day 729 (n=154, n=74)	101 participants
Abatacept (ABA)	OL; Number of Participants Achieving HAQ Response Over Time In Participants Treated in the OL	Day 813 (n=139, n=61)	88 participants
Abatacept (ABA)	OL; Number of Participants Achieving HAQ Response Over Time In Participants Treated in the OL	Day 897 (n=132, n=62)	87 participants
Abatacept (ABA)	OL; Number of Participants Achieving HAQ Response Over Time In Participants Treated in the OL	Day 981 (n=141, n=59)	92 participants
Abatacept (ABA)	OL; Number of Participants Achieving HAQ Response Over Time In Participants Treated in the OL	Day 1093 (n=128, n=54)	88 participants
Abatacept (ABA)	OL; Number of Participants Achieving HAQ Response Over Time In Participants Treated in the OL	Day 1261 (n=126, n=56)	80 participants
Abatacept (ABA)	OL; Number of Participants Achieving HAQ Response Over Time In Participants Treated in the OL	Day 1457 (n=117, n=50)	81 participants
Abatacept (ABA)	OL; Number of Participants Achieving HAQ Response Over Time In Participants Treated in the OL	Day 1625 (n=109, n=49)	69 participants
Abatacept (ABA)	OL; Number of Participants Achieving HAQ Response Over Time In Participants Treated in the OL	Day 1821 (n=104, n=47)	65 participants
Placebo (PLA)	OL; Number of Participants Achieving HAQ Response Over Time In Participants Treated in the OL	Day 533 (n=165, n=78)	44 participants
Placebo (PLA)	OL; Number of Participants Achieving HAQ Response Over Time In Participants Treated in the OL	Day 15 (n=209, n=96)	16 participants
Placebo (PLA)	OL; Number of Participants Achieving HAQ Response Over Time In Participants Treated in the OL	Day 1457 (n=117, n=50)	34 participants
Placebo (PLA)	OL; Number of Participants Achieving HAQ Response Over Time In Participants Treated in the OL	Day 29 (n=207, n=97)	30 participants
Placebo (PLA)	OL; Number of Participants Achieving HAQ Response Over Time In Participants Treated in the OL	Day 617 (n=161, n=71)	40 participants
Placebo (PLA)	OL; Number of Participants Achieving HAQ Response Over Time In Participants Treated in the OL	Day 57 (n=209, n=98)	34 participants
Placebo (PLA)	OL; Number of Participants Achieving HAQ Response Over Time In Participants Treated in the OL	Day 1093 (n=128, n=54)	34 participants
Placebo (PLA)	OL; Number of Participants Achieving HAQ Response Over Time In Participants Treated in the OL	Day 85 (n=207, n=97)	28 participants
Placebo (PLA)	OL; Number of Participants Achieving HAQ Response Over Time In Participants Treated in the OL	Day 729 (n=154, n=74)	46 participants
Placebo (PLA)	OL; Number of Participants Achieving HAQ Response Over Time In Participants Treated in the OL	Day 113 (n=202, n=96)	30 participants
Placebo (PLA)	OL; Number of Participants Achieving HAQ Response Over Time In Participants Treated in the OL	Day 1821 (n=104, n=47)	31 participants
Placebo (PLA)	OL; Number of Participants Achieving HAQ Response Over Time In Participants Treated in the OL	Day 141 (n=209, n=97)	29 participants
Placebo (PLA)	OL; Number of Participants Achieving HAQ Response Over Time In Participants Treated in the OL	Day 813 (n=139, n=61)	34 participants
Placebo (PLA)	OL; Number of Participants Achieving HAQ Response Over Time In Participants Treated in the OL	Day 169 (n=207, n=98)	31 participants
Placebo (PLA)	OL; Number of Participants Achieving HAQ Response Over Time In Participants Treated in the OL	Day 1261 (n=126, n=56)	41 participants
Placebo (PLA)	OL; Number of Participants Achieving HAQ Response Over Time In Participants Treated in the OL	Day 253 (n=199, n=93)	47 participants
Placebo (PLA)	OL; Number of Participants Achieving HAQ Response Over Time In Participants Treated in the OL	Day 897 (n=132, n=62)	37 participants
Placebo (PLA)	OL; Number of Participants Achieving HAQ Response Over Time In Participants Treated in the OL	Day 365 (n=182, n=87)	49 participants
Placebo (PLA)	OL; Number of Participants Achieving HAQ Response Over Time In Participants Treated in the OL	Day 1625 (n=109, n=49)	31 participants
Placebo (PLA)	OL; Number of Participants Achieving HAQ Response Over Time In Participants Treated in the OL	Day 449 (n=182, n=87)	47 participants
Placebo (PLA)	OL; Number of Participants Achieving HAQ Response Over Time In Participants Treated in the OL	Day 981 (n=141, n=59)	37 participants

Secondary

OL; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time For Participants Treated in the OL

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

Arm	Measure	Group	Value (NUMBER)
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Placebo (PLA)	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)	53 participants
Placebo (PLA)	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)	9 participants
Placebo (PLA)	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)	8 participants
Placebo (PLA)	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)	1 participants
Placebo (PLA)	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)	31 participants
Placebo (PLA)	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)	26 participants
Placebo (PLA)	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)	6 participants
Placebo (PLA)	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)	26 participants
Placebo (PLA)	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)	15 participants
Placebo (PLA)	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)	11 participants
Placebo (PLA)	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)	19 participants
Placebo (PLA)	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)	12 participants
Placebo (PLA)	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)	35 participants
Placebo (PLA)	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)	10 participants
Placebo (PLA)	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)	0 participants
Placebo (PLA)	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)	6 participants
Placebo (PLA)	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)	0 participants
Placebo (PLA)	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)	4 participants
Placebo (PLA)	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)	1 participants
Placebo (PLA)	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)	30 participants
Placebo (PLA)	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)	0 participants
Placebo (PLA)	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)	22 participants
Placebo (PLA)	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)	5 participants
Placebo (PLA)	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)	63 participants
Placebo (PLA)	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)	37 participants
Placebo (PLA)	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)	13 participants
Placebo (PLA)	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)	61 participants
Placebo (PLA)	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)	37 participants
Placebo (PLA)	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)	0 participants
Placebo (PLA)	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)	0 participants
Placebo (PLA)	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)	18 participants
Placebo (PLA)	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)	5 participants
Placebo (PLA)	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)	23 participants
Placebo (PLA)	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)	30 participants
Placebo (PLA)	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)	2 participants
Placebo (PLA)	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)	49 participants
Placebo (PLA)	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)	28 participants
Placebo (PLA)	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)	10 participants
Placebo (PLA)	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)	30 participants
Placebo (PLA)	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)	13 participants
Placebo (PLA)	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)	47 participants
Placebo (PLA)	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)	23 participants
Placebo (PLA)	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)	6 participants
Placebo (PLA)	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)	45 participants
Placebo (PLA)	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)	10 participants
Placebo (PLA)	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)	29 participants
Placebo (PLA)	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)	8 participants
Placebo (PLA)	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)	40 participants
Placebo (PLA)	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)	25 participants
Placebo (PLA)	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)	9 participants
Placebo (PLA)	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)	44 participants
Placebo (PLA)	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)	29 participants
Placebo (PLA)	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)	16 participants
Placebo (PLA)	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)	32 participants
Placebo (PLA)	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)	42 participants
Placebo (PLA)	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)	24 participants
Placebo (PLA)	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)	41 participants
Placebo (PLA)	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)	24 participants
Placebo (PLA)	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)	33 participants
Placebo (PLA)	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)	24 participants
Placebo (PLA)	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)	13 participants
Placebo (PLA)	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)	49 participants
Placebo (PLA)	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)	55 participants

Secondary

OL; Number of Participants With Low Disease Activity (LDAS) or Remission For Participants Treated in the OL

The DAS28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR or CRP, and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thresholds that define high disease activity (\> 5.1), low disease activity (\< 3.2) and remission (\< 2.6). A clinically significant response= decrease in DAS28 score of \>1.2 from baseline.

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

Arm	Measure	Group	Value (NUMBER)
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Abatacept (ABA)	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
Placebo (PLA)	OL; Number of Participants With Low Disease Activity (LDAS) or Remission For Participants Treated in the OL	Day 1821 Remission (n=103, n=45)	10 participants
Placebo (PLA)	OL; Number of Participants With Low Disease Activity (LDAS) or Remission For Participants Treated in the OL	Day 15 LDAS (n=209, n=95)	0 participants
Placebo (PLA)	OL; Number of Participants With Low Disease Activity (LDAS) or Remission For Participants Treated in the OL	Day 15 Remission (n=209, n=95)	0 participants
Placebo (PLA)	OL; Number of Participants With Low Disease Activity (LDAS) or Remission For Participants Treated in the OL	Day 29 LDAS (n=206, n=96)	1 participants
Placebo (PLA)	OL; Number of Participants With Low Disease Activity (LDAS) or Remission For Participants Treated in the OL	Day 29 Remission (n=206, n=96)	1 participants
Placebo (PLA)	OL; Number of Participants With Low Disease Activity (LDAS) or Remission For Participants Treated in the OL	Day 57 LDAS (n=210, n=97)	5 participants
Placebo (PLA)	OL; Number of Participants With Low Disease Activity (LDAS) or Remission For Participants Treated in the OL	Day 141 LDAS (n=213, n=96)	4 participants
Placebo (PLA)	OL; Number of Participants With Low Disease Activity (LDAS) or Remission For Participants Treated in the OL	Day 141 Remission (n=213, n=96)	2 participants
Placebo (PLA)	OL; Number of Participants With Low Disease Activity (LDAS) or Remission For Participants Treated in the OL	Day 169 LDAS (n=208, n=96)	5 participants
Placebo (PLA)	OL; Number of Participants With Low Disease Activity (LDAS) or Remission For Participants Treated in the OL	Day 169 Remission (n=208, n=96)	1 participants
Placebo (PLA)	OL; Number of Participants With Low Disease Activity (LDAS) or Remission For Participants Treated in the OL	Day 449 LDAS (n=170, n=76)	25 participants
Placebo (PLA)	OL; Number of Participants With Low Disease Activity (LDAS) or Remission For Participants Treated in the OL	Day 449 Remission (n=170, n=76)	15 participants
Placebo (PLA)	OL; Number of Participants With Low Disease Activity (LDAS) or Remission For Participants Treated in the OL	Day 533 LDAS (n=164, n=73)	21 participants
Placebo (PLA)	OL; Number of Participants With Low Disease Activity (LDAS) or Remission For Participants Treated in the OL	Day 533 Remission (n=164, n=73)	13 participants
Placebo (PLA)	OL; Number of Participants With Low Disease Activity (LDAS) or Remission For Participants Treated in the OL	Day 617 LDAS (n=164, n=69)	23 participants
Placebo (PLA)	OL; Number of Participants With Low Disease Activity (LDAS) or Remission For Participants Treated in the OL	Day 1261 Remission (n=126, n=51)	9 participants
Placebo (PLA)	OL; Number of Participants With Low Disease Activity (LDAS) or Remission For Participants Treated in the OL	Day 1457 LDAS (n=115, n=50)	14 participants
Placebo (PLA)	OL; Number of Participants With Low Disease Activity (LDAS) or Remission For Participants Treated in the OL	Day 1457 Remission (n=115, n=50)	9 participants
Placebo (PLA)	OL; Number of Participants With Low Disease Activity (LDAS) or Remission For Participants Treated in the OL	Day 1625 LDAS (n=107, n=46)	14 participants
Placebo (PLA)	OL; Number of Participants With Low Disease Activity (LDAS) or Remission For Participants Treated in the OL	Day 617 Remission (n=164, n=69)	13 participants
Placebo (PLA)	OL; Number of Participants With Low Disease Activity (LDAS) or Remission For Participants Treated in the OL	Day 729 LDAS (n=153, n=68)	12 participants
Placebo (PLA)	OL; Number of Participants With Low Disease Activity (LDAS) or Remission For Participants Treated in the OL	Day 729 Remission (n=153, n=68)	7 participants
Placebo (PLA)	OL; Number of Participants With Low Disease Activity (LDAS) or Remission For Participants Treated in the OL	Day 813 LDAS (n=139, n=58)	16 participants
Placebo (PLA)	OL; Number of Participants With Low Disease Activity (LDAS) or Remission For Participants Treated in the OL	Day 813 Remission (n=139, n=58)	6 participants
Placebo (PLA)	OL; Number of Participants With Low Disease Activity (LDAS) or Remission For Participants Treated in the OL	Day 897 LDAS (n=134, n=60)	14 participants
Placebo (PLA)	OL; Number of Participants With Low Disease Activity (LDAS) or Remission For Participants Treated in the OL	Day 897 Remission (n=134, n=60)	8 participants
Placebo (PLA)	OL; Number of Participants With Low Disease Activity (LDAS) or Remission For Participants Treated in the OL	Day 981 LDAS (n=121, n=49)	14 participants
Placebo (PLA)	OL; Number of Participants With Low Disease Activity (LDAS) or Remission For Participants Treated in the OL	Day 981 Remission (n=121, n=49)	7 participants
Placebo (PLA)	OL; Number of Participants With Low Disease Activity (LDAS) or Remission For Participants Treated in the OL	Day 1093 LDAS (n=134, n=56)	15 participants
Placebo (PLA)	OL; Number of Participants With Low Disease Activity (LDAS) or Remission For Participants Treated in the OL	Day 1093 Remission (n=134, n=56)	8 participants
Placebo (PLA)	OL; Number of Participants With Low Disease Activity (LDAS) or Remission For Participants Treated in the OL	Day 1261 LDAS (n=126, n=51)	19 participants
Placebo (PLA)	OL; Number of Participants With Low Disease Activity (LDAS) or Remission For Participants Treated in the OL	Day 57 Remission (n=210, n=97)	1 participants
Placebo (PLA)	OL; Number of Participants With Low Disease Activity (LDAS) or Remission For Participants Treated in the OL	Day 85 LDAS (n=212, n=98)	4 participants
Placebo (PLA)	OL; Number of Participants With Low Disease Activity (LDAS) or Remission For Participants Treated in the OL	Day 85 Remission (n=212, n=98)	3 participants
Placebo (PLA)	OL; Number of Participants With Low Disease Activity (LDAS) or Remission For Participants Treated in the OL	Day 113 LDAS (n=202, n=93)	4 participants
Placebo (PLA)	OL; Number of Participants With Low Disease Activity (LDAS) or Remission For Participants Treated in the OL	Day 113 Remission (n=202, n=93)	0 participants
Placebo (PLA)	OL; Number of Participants With Low Disease Activity (LDAS) or Remission For Participants Treated in the OL	Day 253 LDAS (n=195, n=89)	19 participants
Placebo (PLA)	OL; Number of Participants With Low Disease Activity (LDAS) or Remission For Participants Treated in the OL	Day 253 Remission (n=195, n=89)	12 participants
Placebo (PLA)	OL; Number of Participants With Low Disease Activity (LDAS) or Remission For Participants Treated in the OL	Day 365 LDAS (n=194, n=93)	22 participants
Placebo (PLA)	OL; Number of Participants With Low Disease Activity (LDAS) or Remission For Participants Treated in the OL	Day 365 Remission (n=194, n=93)	17 participants
Placebo (PLA)	OL; Number of Participants With Low Disease Activity (LDAS) or Remission For Participants Treated in the OL	Day 1625 Remission (n=107, n=46)	11 participants
Placebo (PLA)	OL; Number of Participants With Low Disease Activity (LDAS) or Remission For Participants Treated in the OL	Day 1821 LDAS (n=103, n=45)	12 participants

Source: ClinicalTrials.gov · Data processed: Mar 20, 2026

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.

Conditions

Brief summary

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Pre-assignment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

DB; Number of Participants Achieving Clinically Meaningful Improvement in Health Assessment Questionnaire (HAQ)

Double-blind Period (DB); Number of Participants With American College of Rheumatology (ACR) 20 Response at Day 169

OL; Mean Time-matched Baseline Immunoglobulin (Ig) Levels Over the OL

OL; Mean Time-matched Change From Baseline in Immunoglobulin (Ig) Levels Over the OL

OL; Number of Participants AEs of Special Interest

OL; Number of Participants With Blood Chemistry Laboratories Meeting Marked Abnormality Criteria

OL; Number of Participants With Hematology Laboratories Meeting Marked Abnormality Criteria

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

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)

DB; Adjusted Mean Change From Baseline to Day 169 in DAS28 (CRP) and DAS28 (ESR)

DB; Adjusted Mean Change From Baseline to Day 169 in HAQ-DI and HAQ Component Scores in Participants With Assessments at Day 169

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

DB; Adjusted Mean Change From Baseline to Day 85 in Short SF-36 PCS, MCS, and SF-36 Individual Component Scores

DB; Mean Baseline HAQ-DI and HAQ Component Scores in Participants With Assessments at Day 169

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

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

DB; Mean Baseline SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participants With Measurements at Day 169

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

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

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

DB; Mean Change From Baseline to Day 169 in Rheumatoid Factor (RF) Status

DB; Mean Disease Activity Score (DAS)28 (C-Reactive Protein [CRP]) and Mean Disease Activity Score (Erythrocyte Sedimentation Rate [ESR]) at Day 169

DB; Mean Time-matched Baseline C-Reactive Protein (CRP) Levels Over Time: ACR Core Component

DB; Mean Time-matched Baseline HAQ-DI Over Time: ACR Core Component

DB; Mean Time-matched Baseline Participant Global Assessment Over Time: ACR Core Component

DB; Mean Time-matched Baseline Participant Pain Assessment Over Time: ACR Core Component

DB; Mean Time-matched Baseline Physician Global Assessment Over Time: ACR Core Component

DB; Mean Time-matched Baseline Swollen Joint Count (SJC) and Post-Baseline SJCs Over Time: ACR Core Component

DB; Mean Time-matched Baseline Tender Joint Counts (TJCs) and Post-Baseline TJCs Over Time: ACR Core Component

DB; Mean Time-Matched Percentage of Change From Baseline in CRP Levels Over Time: ACR Core Component

DB; Mean Time-Matched Percentage of Change From Baseline in HAQ-DI Over Time: ACR Core Component

DB; Mean Time-Matched Percentage of Change From Baseline in Participant Global Assessment Over Time: ACR Core Component

DB; Mean Time-Matched Percentage of Change From Baseline in Participant Pain Assessment Over Time: ACR Core Component

DB; Mean Time-Matched Percentage of Change From Baseline in Physician Global Assessment Over Time: ACR Core Component

DB; Mean Time-Matched Percentage of Change From Baseline in SJC Over Time: ACR Core Component

DB; Mean Time-Matched Percentage of Change From Baseline in TJC Over Time: ACR Core Component

DB; Number of Participants AEs of Special Interest

DB; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time

DB; Number of Participants With Blood Chemistry Laboratories Meeting MA Criteria

DB; Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuation, AEs, Related AEs, or AEs Leading to Discontinuation

DB; Number of Participants With Hematology Laboratories Meeting Marked Abnormality (MA) Criteria

DB; Number of Participants With Positive Anti-Abatacept or Anti-Cytotoxic T-Lymphocyte Antigen 4 (CTLA4) Responses by Enzyme-Linked Immunosorbant Assay (ELISA)

OL; Mean Change From Baseline in Activity Limitation Score Over Time For Participants Treated in the OL

OL; Mean Time-matched Baseline Activity Limitation Score Over Time For Participants Treated in the OL

OL; Mean Time-matched Baseline Bodily Pain Score Over Time For Participants Treated in the OL

OL; Mean Time-matched Baseline DAS28 (CRP) Over Time For Participants Treated in the OL

OL; Mean Time-matched Baseline DAS28 (ESR) Over Time For Participants Treated in the OL

OL; Mean Time-matched Baseline Erythrocyte Sedimentation Rate (ESR) Over Time For Participants Treated in the OL

OL; Mean Time-matched Baseline Fatigue Visual Analog Score (VAS) Over Time For Participants Treated in the OL

OL; Mean Time-matched Baseline General Health Score Over Time For Participants Treated in the OL

OL; Mean Time-matched Baseline HAQ-DI and HAQ Component Scores Over Time For Participants Treated in the OL

OL; Mean Time-matched Baseline Levels of C-Reactive Protein (CRP) Over Time For Participants Treated in the OL

OL; Mean Time-matched Baseline Levels of Rheumatoid Factor (RF) Over Time For Participants Treated in the OL

OL; Mean Time-matched Baseline Levels of Soluble Interleukin 2 Receptor (sIL-2R) Over Time For Participants Treated in the OL

OL; Mean Time-matched Baseline Medical Outcomes Study Sleep Module (MOS-sleep) Score Over Time For Participants Treated in the OL

OL; Mean Time-matched Baseline Mental Health Score Over Time For Participants Treated in the OL

OL; Mean Time-matched Baseline Physical Function Score Over Time For Participants Treated in the OL

OL; Mean Time-matched Baseline Role-Emotional Score Over Time For Participants Treated in the OL

OL; Mean Time-matched Baseline Role-Physical Score Over Time For Participants Treated in the OL