Phase 3 Completed N=652 Randomized Double-blind Treatment

A Phase III Study of Abatacept (BMS-188667) in Patients With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate

Rheumatoid Arthritis

Source: ClinicalTrials.gov NCT00048568 ↗

Enrolled (actual)

652

Serious AEs

26.0%

Results posted

Dec 2011

Primary outcomePrimary: Number of American College of Rheumatology 20 (ACR 20) Responders at Day 169 — 288; 85 Participants — p=<0.001

Summary

Short Term: The purpose of this clinical research study is to learn if abatacept (BMS-188667) in combination with methotrexate is better than methotrexate alone in participants that have active rheumatoid arthritis and are not responding to methotrexate. The safety of this treatment will also be studied. Long Term Extension: The purpose of this amendment is to provide participants who have completed the initial 12-month double-blind treatment period the opportunity to receive open label treatment with active drug treatment until abatacept is approved in the local country or until clinical development has been discontinued.

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of American College of Rheumatology 20 (ACR 20) Responders at Day 169	288; 85	<0.001 sig
PRIMARY Number of Participants Achieving Clinically Meaningful Improvement in Health Assessment Questionnaire (HAQ) at Day 365	270; 84	<0.001 sig
PRIMARY Baseline and Mean Change From Baseline (BL) in Radiographic Erosion Score Results at Day 365	21.68; 21.83; 0.63; 1.14	0.029 sig
PRIMARY Participants With Deaths, Adverse Events (AEs) and SAEs in the Open-Label (OL) Period	17; 215; 60; 36; 518; 323	—
PRIMARY Participants With Hematology Values Meeting the Marked Abnormality Criteria in the OL Period	21; 20; 15; 9; 4; 53	—
PRIMARY Participants With Liver and Kidney Function Values Meeting the Marked Abnormality Criteria in the OL Period	3; 14; 20; 36; 6; 40	—
PRIMARY Participants With Electrolyte Values Meeting the Marked Abnormality Criteria in the OL Period	11; 2; 11; 32; 1; 0	—
PRIMARY Participants With Glucose, Protein, Metabolites, and Urinalysis Values Meeting the Marked Abnormality Criteria in the OL Period	120; 36; 25; 22; 11; 6	—
PRIMARY Mean BL Immunoglobulins Over Time in the OL Period	327.0; 319.2; 1278; 1317; 145.1; 154.3	—
PRIMARY Mean Change From BL in Immunoglobulins in the OL Period	-47.8; -8.30; -212; -52.7; -5.05; 6.95	—
PRIMARY Participants With Immunogenicity to Abatacept in the Cumulative DB + OL Period	56	—
PRIMARY Number of Participants Experiencing Clinically Significant Changes in Vital Signs in the OL Period	0; 0; 0	—
PRIMARY Number of Participants Experiencing AEs of Special Interest in the OL Period	452; 71; 52; 30; 86	—
PRIMARY Mean BL Hematocrit in the OL Period	38.79; 39.38; 38.72; 39.39; 38.69; 39.46	—
PRIMARY Mean Change From BL in Participant Hematocrit in the OL Period	1.87; -0.04; 2.16; 1.36; 1.41; 0.56	—
PRIMARY Mean BL Platelet Count in the OL Period	352.7; 339.2; 351.8; 334.2; 351.7; 334.8	—
PRIMARY Mean Change From BL in Participant Platelet Count in the OL Period	-66.9; -29.9; -59.5; -45.4; -53.5; -36.8	—
PRIMARY Mean BL Hemoglobin, Total Protein, and Albumin in the OL Period	12.49; 12.70; 7.23; 7.35; 4.03; 4.13	—
PRIMARY Mean Change From BL in Hemoglobin, Total Protein, and Albumin in the OL Period	0.62; -0.09; -0.26; -0.25; 0.22; 0.02	—
PRIMARY Mean BL White Blood Cells in the OL Period	8.78; 8.81; 6.45; 6.39; 0.18; 0.18	—
PRIMARY Mean Change From BL in White Blood Cells in the OL Period	-.10; -0.44; -1.20; -0.43; -0.02; -0.01	—
PRIMARY Mean BL Liver Function Parameters in the OL Period	99.56; 98.73; 22.35; 23.40; 21.53; 22.87	—
PRIMARY Mean Change From BL in Liver Function Parameters in the OL Period	-7.27; -10.8; 1.10; -2.64; 1.50; -1.42	—
PRIMARY Mean BL Select Laboratory Parameters in the OL Period	0.42; 0.48; 16.05; 15.09; 0.74; 0.74	—
PRIMARY Mean Change From BL in Select Laboratory Parameters in the OL Period	0.06; 0.00; 16.05; 15.09; 0.74; 0.74	—
PRIMARY Mean BL Serum Electrolytes in the OL Period	139.9; 140.7; 4.27; 4.29; 104.1; 105.0	—
PRIMARY Mean Change From BL in Serum Electrolytes in the OL Period	-0.42; -1.37; -0.01; -0.06; 0.43; -0.21	—
SECONDARY Mean Number of Tender Joints and Swollen Joints at DB BL	31.0; 32.3; 21.4; 22.1	—
SECONDARY Mean DB BL Participant Physical Pain Assessment, Participant Global Assessment, and Physician Global Assessment	63.3; 65.9; 62.7; 62.8; 68.0; 67.4	—
SECONDARY BL Rheumatoid Factor (RF) Status for Participants Continuing in the OL Period	42; 18; 312; 130	—
SECONDARY ACR 20 Responders at Day 365	310; 85	<0.001 sig
SECONDARY ACR 20 Responders in the Double-Blind (DB) Period	97; 30; 155; 51; 237; 75	—
SECONDARY ACR 50 Responders at Day 169	169; 36	<0.001 sig
SECONDARY ACR 50 Responders at Day 365	205; 39	<0.001 sig
SECONDARY ACR 50 Responders in the DB Period	12; 2; 36; 9; 87; 16	—
SECONDARY ACR 70 Responders at Day 169	84; 14	<0.001 sig
SECONDARY ACR 70 Responders at Day 365	122; 13	<0.001 sig
SECONDARY ACR 70 Responders in the DB Period	4; 1; 8; 2; 27; 6	—
SECONDARY Number of Participants Achieving Major Clinical Response By Day 365	60; 4	<0.001 sig
SECONDARY Mean BL and Disease Activity Score 28 (DAS-28; Erythrocyte Sedimentation Rate [ESR]) at Day 169 and Day 365	6.82; 6.84; 4.34; 5.50; 6.82; 6.83	<0.001 sig
SECONDARY Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, Discontinuation Due to SAEs, AEs, Related AEs, or Discontinued Due to AEs in the DB Period	1; 1; 65; 26; 15; 1	—
SECONDARY Mean DB BL and Mean Change From BL in Joint Space Narrowing (JSN) and Total Score (TS)	22.79; 23.02; 0.58; 1.18; 44.47; 44.85	—
SECONDARY Mean DB BL Physical Component Summary of Health-Related Quality of Life (SF-36)	30.49; 30.61; 30.51; 30.62	—
SECONDARY Adjusted Mean Change From BL in the Physical Component Summary of Health-Related Quality of Life (SF-36) in the DB Period	8.82; 4.77; 9.12; 4.97	<0.001 sig
SECONDARY Participants in the DB Period Achieving an Extended Major Clinical Response	26; 1	0.002 sig
SECONDARY Mean BL DAS-28 C-Reactive Protein (CRP) and ESR in the DB Period	6.37; 6.36; 6.82; 6.84; 6.38; 6.35	—
SECONDARY Adjusted Mean Change From BL in DAS-28 CRP and ESR in the DB Period	-2.38; -1.29; -2.48; -1.33; -2.71; -1.41	—
SECONDARY Mean BL Soluble Interleukin-2 Receptors (sIL2-r) in the DB Period	1776.0; 1603.0; 1674.0; 1601.0	—
SECONDARY Mean Change From BL in Soluble Interleukin-2 Receptors (sIL2-r) in the DB Period	-519.00; -85.50; -562.00; -290.00	—
SECONDARY ACR Core Component: Mean Number of Tender Joints at All Post-BL Visits in the DB Period	25.19; 27.93; 21.14; 24.11; 16.70; 21.41	—
SECONDARY ACR Core Component: Mean Number of Swollen Joints at All Post-BL Visits in the DB Period	16.40; 18.49; 14.04; 16.03; 11.02; 14.77	—
SECONDARY ACR Core Component: Mean Participant Pain Assessment at All Post-BL Visits in the DB Period	52.39; 60.08; 47.03; 54.69; 40.34; 50.11	—
SECONDARY ACR Core Component: Mean Participant Physical Function Assessment at All Post-BL Visits in the DB Period	1.51; 1.58; 1.41; 1.47; 1.29; 1.42	—
SECONDARY ACR Core Component: Mean Participant Global Assessment at All Post-BL Visits in the DB Period	50.90; 56.66; 45.26; 53.11; 39.78; 49.34	—
SECONDARY ACR Core Component: Mean Physician Global Assessment at All Post-BL Visits in the DB Period	52.79; 56.68; 45.24; 51.83; 35.89; 45.21	—
SECONDARY ACR Core Component: Mean CRP at All Post-BL Visits in the DB Period	3.27; 2.65; 1.94; 2.65; 1.70; 2.36	—
SECONDARY Number of Participants Discontinuing in the DB Period	32; 45; 11; 33; 16; 12	—
SECONDARY Change From BL in Joint Narrowing Score (JSN), Erosion Score (ES), and Total Score (TS) by Category in the DB Period	—	—
SECONDARY Participants Experiencing Clinically Significant Changes in Vital Signs in the DB Period	0; 0	—
SECONDARY Participants Experiencing AEs of Special Interest in the DB Period	50; 12; 14; 9; 13; 2	—
SECONDARY Mean BL Individual Components of the HAQ DI at Day 169 and Day 365	1.68; 1.70; 1.68; 1.70; 1.48; 1.48	—
SECONDARY Adjusted Mean Change From BL in Individual Components of the HAQ DI at Day 169	-0.62; -0.52; -0.73; -0.55; -0.69; -0.65	—
SECONDARY Adjusted Mean Change From BL in Individual Components of the HAQ DI at Day 365	-0.68; -0.51; -0.78; -0.61; -0.75; -0.58	—
SECONDARY Number of Participants With Immunogenicity to Abatacept in the DB Period	6	—
SECONDARY Number of New Tender Joints and Number of New Swollen Joints in the DB Period	—	—
SECONDARY Number of Participants Experiencing a 100% Reduction in Tender Joints or 100% Reduction in Swollen Joints in the DB Period	43; 9; 59; 14; 67; 8	—
SECONDARY Number of Participants With Hematology Laboratories Meeting Marked Abnormality Criteria in the DB Period	7; 4; 4; 3; 4; 1	—
SECONDARY Number of Participants With Liver and Kidney Function Tests Meeting Marked Abnormality Criteria in the DB Period	4; 2; 7; 5; 23; 15	—
SECONDARY Mean BL ESR and CRP Levels in the OL Period	43.56; 43.61; 32.48; 24.72; 43.74; 41.37	—
SECONDARY Mean Change From BL in ESR in the OL Period	-17.9; -6.85; -19.3; -16.3; -17.2; -16.6	—
SECONDARY Participant RF Seroconversion in the OL Period	2; 3; 31; 2; 8; 1	—
SECONDARY Number of ACR 20 Responders in the DB and OL Periods	95; 26; 145; 44; 218; 66	—
SECONDARY Number of ACR 50 Responders in the DB and OL Periods	12; 2; 35; 8; 82; 15	—
SECONDARY Number of ACR 70 Responders in the DB and OL Periods	4; 1; 8; 2; 27; 6	—
SECONDARY Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time	1; 0; 5; 1; 8; 0	—
SECONDARY Mean BL DAS-28 CRP Over Time for Participants Continuing in the OL Period	6.36; 6.32; 6.36; 6.35; 6.36; 6.35	—
SECONDARY Mean Change From BL in DAS-28 CRP Over Time for Participants Continuing in the OL Period	-0.83; -0.47; -1.27; -0.87; -1.80; -1.17	—
SECONDARY Mean BL DAS-28 ESR Over Time in the OL Period	6.82; 6.88; 6.82; 6.89; 6.83; 6.88	—
SECONDARY Mean Change From BL in DAS-28 ESR Over Time in the OL Period	-2.96; -1.76; -3.04; -2.87; -3.14; -2.95	—
SECONDARY Number of Participants Achieving HAQ Response Over Time for Participants Continuing in the OL Period	115; 46; 148; 57; 199; 73	—
SECONDARY BL and Mean Change From BL in Radiographic Erosion, Joint Space Narrowing (JSN), and Total Scores (TS) in the OL Period	17.65; 18.69; 0.42; 0.84; 10.83; 12.02	—
SECONDARY Mean BL Physical Component Summary of the SF-36 by Visit in the OL Period	30.69; 30.94; 30.55; 30.95; 30.64; 30.86	—
SECONDARY Mean Change From BL by Visit in the Physical Component Summary of the SF-36 in the OL Period	9.70; 6.61; 10.51; 9.91; 10.27; 10.53	—
SECONDARY Mean BL Mental Component Summary of the SF-36 by Visit in the OL Period	41.40; 40.56; 41.20; 40.47; 41.28; 40.53	—
SECONDARY Mean Change From BL by Visit in the Mental Component Summary of the SF-36 in the OL Period	7.29; 6.41; 6.84; 7.73; 7.30; 7.20	—
SECONDARY Mean BL Physical Function Component of the SF-36 by Visit in the OL Period	28.79; 28.09; 28.62; 28.07; 28.63; 28.05	—
SECONDARY Mean Change From BL by Visit in the Physical Function Component of the SF-36 in the OL Period	8.61; 6.44; 9.44; 9.13; 9.43; 9.46	—
SECONDARY Mean BL Role-Physical Component of the SF-36 by Visit in the OL Period	32.06; 32.08; 31.88; 32.02; 32.02; 32.11	—
SECONDARY Mean Change From BL by Visit in the Role-Physical Component of the SF-36 in the OL Period	10.10; 7.59; 10.66; 10.89; 11.18; 10.98	—
SECONDARY Mean BL Bodily Pain Component of the SF-36 by Visit in the OL Period	33.13; 33.43; 32.95; 33.47; 33.05; 33.27	—
SECONDARY Mean Change From BL by Visit in the Bodily Pain Component of the SF-36 in the OL Period	12.08; 7.98; 12.38; 11.78; 11.94; 12.53	—
SECONDARY Mean BL General Health Component of the SF-36 by Visit in the OL Period	35.43; 35.27; 35.33; 35.28; 35.34; 35.17	—
SECONDARY Mean Change From BL by Visit in the General Health Component of the SF-36 in the OL Period	6.88; 5.43; 6.94; 7.32; 6.82; 7.88	—
SECONDARY Mean BL Social Functioning Component of the SF-36 by Visit in the OL Period	35.58; 34.98; 35.42; 34.91; 35.52; 34.94	—
SECONDARY Mean Change From BL by Visit in the Social Functioning Component of the SF-36 in the OL Period	9.01; 7.12; 9.74; 9.47; 9.88; 9.44	—
SECONDARY Mean BL Role-Emotional Component of the SF-36 by Visit in the OL Period	35.78; 33.40; 35.71; 33.26; 35.61; 33.39	—
SECONDARY Mean Change From BL by Visit in the Role-Emotional Component of the SF-36 in the OL Period	8.97; 8.60; 8.02; 10.80; 8.44; 10.13	—
SECONDARY Mean BL Vitality Component of the SF-36 by Visit in the OL Period	40.93; 41.29; 40.77; 41.21; 40.68; 41.21	—
SECONDARY Mean Change From BL by Visit in the Vitality Component of the SF-36 in the OL Period	8.58; 6.04; 8.29; 8.70; 8.68; 8.09	—
SECONDARY Mean BL Mental Health Component of the SF-36 by Visit in the OL Period	39.08; 39.43; 38.87; 39.33; 38.89; 39.40	—
SECONDARY Mean Change From BL by Visit in the Mental Health Component of the SF-36 in the OL Period	7.02; 5.31; 7.27; 6.45; 7.72; 6.49	—
SECONDARY Mean BL Fatigue in the OL Period	63.52; 65.37; 63.59; 65.28; 63.25; 65.78	—
SECONDARY Mean Change From BL in Fatigue in the OL Period	-28.0; -22.6; -28.5; -31.1; -29.4; -31.1	—
SECONDARY Mean BL Sleep Quality in the OL Period	42.42; 43.53; 42.77; 43.22; 42.62; 43.24	—
SECONDARY Mean Change From BL in Sleep Quality in the OL Period	-10.8; -7.97; -11.0; -11.4; -11.4; -10.9	—
SECONDARY Mean BL Limitations on Activities of Daily Living in the OL Period	13.80; 13.21; 13.82; 13.19; 13.91; 13.55	—
SECONDARY Mean Change From BL in Limitations on Activities of Daily Living in the OL Period	-9.04; -6.39; -8.75; -8.60; -9.21; -9.00	—
SECONDARY Mean BL Interleukin-6 (IL-6), SIL-2R, and Tumor Necrosis Alpha (TNF-Alpha) in the DB Period	36.35; 39.90; 1776; 1603; 5.94; 7.86	—
SECONDARY Mean Change From BL in Interleukin-6 (IL-6), SIL-2R, and Tumor Necrosis Alpha (TNF-Alpha) in the DB Period	-21.0; -5.81; -519.0; -85.5; -0.82; 2.27	—
SECONDARY Mean Change From BL in RF in the DB Period	-49.8; -18.6; -46.5; -5.83	—
SECONDARY Mean BL E-Selectin, SICAM-1, and MMP3 in the DB Period	85.89; 85.53; 444.0; 426.8; 83.37; 77.22	—
SECONDARY Mean Change From BL in E-Selectin, SICAM-1, and MMP3 in the DB Period	-13.8; -6.52; -65.0; -42.0; -37.2; -8.03	—
SECONDARY Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) for the Day 365 Cohort of Participants Continuing in the OL Period	1.68; 1.70; 1.47; 1.49; 1.42; 1.46	—
SECONDARY Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 365 for Participants Continuing in the OL Period	-0.68; -0.51; -0.77; -0.62; -0.75; -0.59	—
SECONDARY Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) for the Day 449 Cohort of Participants Continuing in the OL Period	1.69; 1.71; 1.48; 1.49; 1.42; 1.46	—
SECONDARY Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 449 for Participants Continuing in the OL Period	-0.70; -0.71; -0.78; -0.85; -0.72; -0.86	—
SECONDARY Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) for the Day 533 Cohort of Participants Continuing in the OL Period	1.69; 1.71; 1.47; 1.49; 1.42; 1.45	—
SECONDARY Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 533 for Participants Continuing in the OL Period	-0.73; -0.73; -0.81; -0.85; -0.76; -0.86	—
SECONDARY Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 617 Cohort of Participants Continuing in the OL Period	1.69; 1.71; 1.47; 1.50; 1.42; 1.46	—
SECONDARY Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 617 for Participants Continuing in the OL Period	-0.73; -0.74; -0.76; -0.82; -0.84; -0.81	—
SECONDARY Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 729 Cohort of Participants Continuing in the OL Period	1.69; 1.72; 1.48; 1.51; 1.41; 1.45	—
SECONDARY Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 729 for Participants Continuing in the OL Period	-0.74; -0.72; -0.82; -0.91; -0.80; -0.82	—
SECONDARY Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 813 Cohort of Participants Continuing in the OL Period	1.70; 1.72; 1.48; 1.51; 1.42; 1.46	—
SECONDARY Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 813 for Participants Continuing in the OL Period	-0.77; -0.71; -0.82; -0.87; -0.80; -0.78	—
SECONDARY Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 897 Cohort of Participants Continuing in the OL Period	1.69; 1.72; 1.47; 1.52; 1.43; 1.46	—
SECONDARY Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 897 for Participants Continuing in the OL Period	-0.76; -0.74; -0.86; -0.90; -0.81; -0.87	—
SECONDARY Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 981 Cohort of Participants Continuing in the OL Period	1.69; 1.72; 1.47; 1.52; 1.42; 1.45	—
SECONDARY Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 981 for Participants Continuing in the OL Period	-0.74; -0.69; -0.80; -0.86; -0.82; -0.77	—
SECONDARY Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,093 Cohort of Participants Continuing in the OL Period	1.69; 1.72; 1.47; 1.51; 1.41; 1.45	—
SECONDARY Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,093 for Participants Continuing in the OL Period	-0.74; -0.76; -0.80; -0.91; -0.82; -0.87	—
SECONDARY Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,177 Cohort of Participants Continuing in the OL Period	1.69; 1.71; 1.47; 1.53; 1.39; 1.45	—
SECONDARY Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,177 for Participants Continuing in the OL Period	-0.76; -0.74; -0.82; -0.86; -0.74; -0.79	—
SECONDARY Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,261 Cohort of Participants Continuing in the OL Period	1.69; 1.70; 1.47; 1.51; 1.42; 1.44	—
SECONDARY Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,261 for Participants Continuing in the OL Period	-0.74; -0.73; -0.81; -0.91; -0.82; -0.82	—
SECONDARY Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,345 Cohort of Participants Continuing in the OL Period	1.65; 1.73; 1.45; 1.50; 1.34; 1.44	—
SECONDARY Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,345 for Participants Continuing in the OL Period	-0.69; -0.73; -0.74; -0.81; -0.68; -0.84	—
SECONDARY Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,457 Cohort of Participants Continuing in the OL Period	1.70; 1.71; 1.48; 1.51; 1.43; 1.44	—
SECONDARY Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,457 for Participants Continuing in the OL Period	-0.77; -0.74; -0.85; -0.91; -0.80; -0.82	—
SECONDARY Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,625 Cohort of Participants Continuing in the OL Period	1.69; 1.72; 1.46; 1.52; 1.42; 1.45	—
SECONDARY Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,625 for Participants Continuing in the OL Period	-0.76; -0.78; -0.84; -0.98; -0.79; -0.84	—
SECONDARY Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,821 Cohort of Participants Continuing in the OL Period	1.69; 1.69; 1.47; 1.49; 1.41; 1.42	—
SECONDARY Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,821 for Participants Continuing in the OL Period	-0.77; -0.72; -0.82; -0.86; -0.83; -0.90	—
SECONDARY Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,989 Cohort of Participants Continuing in the OL Period	1.72; 1.67; 1.51; 1.49; 1.36; 1.38	—
SECONDARY Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,989 for Participants Continuing in the OL Period	-0.81; -0.70; -0.84; -0.76; -0.86; -0.84	—
SECONDARY Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 2,185 Cohort of Participants Continuing in the OL Period	1.73; 1.69; 1.54; 1.54; 1.36; 1.37	—
SECONDARY Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 2,185 for Participants Continuing in the OL Period	-0.70; -0.68; -0.68; -0.78; -0.66; -0.82	—

Eligibility Criteria

Rheumatoid Arthritis (RA) for greater than 1 year from the time of initial diagnosis of RA.
Participants must have been taking methotrexate for at least 3 months with at least a weekly dose of 15 mg.

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Data sourced from ClinicalTrials.gov (NCT00048568). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.