A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER, TWO-PART, DOSE RANGING AND CONFIRMATORY STUDY WITH AN OPERATIONALLY SEAMLESS DESIGN, EVALUATING EFFICACY AND SAFETY OF SAR153191 IN ADDITION TO METHOTREXATE (MTX) IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO ARE INADEQUATE RESPONDERS TO MTX THERAPY

Not Applicable

• Registration Number: PER-072-11
• Lead Sponsor: sanofi-aventis Recherche & Development,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-10-14
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

101. DIAGNOSIS OF RHEUMATOID ARTHRITIS (RA) AS DEFINED BY THE 1987 REVISED AMERICAN COLLEGE OF RHEUMATOLOGY (ACR) CRITERIA WITH DISEASE DURATION OF NO LESS THAN 3 MONTHS AN ACR CLASS I-III (SEE APPENDIX A).
102. PATIENTS MUST BE ON A STABLE DOSE OF MTX (10 TO 25 mg/week) FOR A MINIMUM OF 6 WEEKS PRIOR TO THE SCREENING VISIT, EXCEPT PATIENTS WITHIN OF THE ASIA-PACIFIC REGION (TAIWAN, SOUTH KOREA, MALAYSIA, PHILIPPINES, THAILAND, AND INDIA) ARE ALLOWED TO USE A STABLE DOSE OF MTX BETWEEN 6 TO 25 mg/week FOR A MINIMUM OF 6 WEEKS PRIOR TO THE SCREENING VISIT. PATIENTS MUST INTEND TO CONTINUE THE STABLE DOSE OF MTX FOR THE DURATION OF THE STUDY.
J03. PATIENTS MUST HAVE BEEN TREATED WITH, AND TOLERATED, A MINIMUM OF 12 WEEKS TREATMENT WITH METHOTREXATE (MTX) PRIOR TO THE RANDOMIZATION VISIT.
J04. PATIENTS WITH MODERATE TO SEVERE ACTIVE DISEASE DEFINED AS:
.AT LEAST 8 OUT OF 68 JOINTS ASSESSED AS PAINFUL OR TENDER ON MOTION AT BOTH SCREENING AND BASELINE VISITS, AND
.AT LEAST 6 OUT OF 66 JOINTS ASSESSED AS SWOLLEN AT BOTH SCREENING AND BASELINE VISITS, AND,
.HS C-REACTIVE PROTEIN > 6 mg/L (> 0.6 mg/dL) AT SCREENING VISIT. 

Exclusion Criteria

E01. MALE OR FEMALE < 18 YEARS OF AGE OR > 75 YEARS OF AGE.
E02. DELETED
E03. AUTOIMMUNE DISEASE OTHER THAN RA OR SIGNIFICANT SYSTEMIC INVOLVEMENT (VASCULITIS, PULMONARY FIBROSIS, FELTY´S SYNDROME).
E04. HISTORY OF CHRONIC, OR RECURRENT AND CURRENT ACUTE INFLAMMATORY JOINT DISEASE OTHER THAN RA, OR RA DIAGNOSED BEFORE THE AGE OF 16.
E05. TREATMENT WITH ORAL PREDNISONE OR EQUIVALENT > 10 mg PER DAY WITHIN 4 WEEKS PRIOR TO THE RAMDOMIZATION VISIT OR USE OF PARENTERAL OR INTRA-ARTICULAR GLUCOCORTIESTEROIDS WITHIN 4 WEEKS PRIOR TO THE SCREENING VISIT.
E06. START TREATMENT OR CHANGE DOSE OF CURRENT TREATMENT WITH NSAIDs/COX2 INHIBITORS OR ORAL CORTICOSTEROIDS FOR 4 WEEKS PRIOR TO BASELINE.
E07. CURRENT TREATMENT WITH DMARDS/ IMMUNOSUPPRESSIVE AGENTS OTHER THAN MTX: CYCLOSPORINE, MYCOPHENOLATE, TACROLIMUS, GOLD, PENICILLAMINE, SULFASALAZINE OR HYDROXYCHLOROQUINE WITHIN 4 WEEKS PRIOR TO THE SCREENING VISIT OR AZATHIOPRINE, CYCLOPHOSPHAMIDE WITHIN 12 WEEKS PRIOR TO THE SCREENING VISIT OR LEFLUNOMIDE WITHIN 12 WEEKS PRIOR TO THE SCREENING VISIT (OR 4 WEEKS AFTER 11 DAYS OF STANDARD CHOLESTYRAMINE WASHOUT).

Study & Design

• Study Type: Interventional
• Study Design: Not specified