None listed
Conditions
Interventions
THE FIRST PART (PART A) OF THE STUDY IS A 12-WEEK, 6 ARM DOSE-RANGING PART INTENDED TO SELECT THE 2 BEST DOSE REGIMENS BASED ON EFFICACY (REDUCTION IN SIGNS AND SYMPTOMS) AND SAFETY.
THE SECOND PA
Sponsors
sanofi-aventis Recherche & Development,
Eligibility
Age
18 Years to 75 Years
Inclusion criteria
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
Exclusion criteria: E01. MALE OR FEMALE 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).
Countries
Argentina, Australia, Austria, Belarus, Belgium, Brazil, Canada, Chile, Colombia, Czech Republic, Egypt, Estonia, Finland, Germany, Greece, Hungary, India, Korea North, Lithuania, Malasya, Mexico, Netherlands, New Zealand, Norway, Philippines, Poland, Portugal, Romania, Russian Federation, South Africa, Spain, Taiwan, Thailand, Turkey, Ukraine, United States
Contacts
Public ContactGratte Carolina Valladares
SANOFI AVENTIS DEL PERU S.A.
Outcome results
None listed