Health Condition 1: null- Rheumatoid Arthritis Health Condition 2: M069- Rheumatoid arthritis, unspecified
Conditions
Interventions
Intervention1: SAR153191 + Methotrexate: SAR153191 dose 200mg every other week
Duration - 52 weeks
Route of administration - Subcutaneous injection
Intervention2: SAR153191 + Methotrexate: SAR153191 d
Sponsors
Sanofi
Eligibility
Inclusion criteria
Inclusion criteria: I 01. 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 and ACR class I-III (see Appendix A). I 02. 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 I 03. Patients must have been treated with, and tolerated, a minimum of 12 weeks treatment with methotrexate (MTX) prior to the randomization visit. I 04. Patient 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. I 05 - At least 1 locally documented bone erosion (on X-ray) prior to first IMP administration, or - Anti CCP antibody positive according to screening laboratory tests, or - Positive rheumatoid factor according to screening laboratory tests. I 06. Having signed a written informed consent prior to any procedure related to the study.
Exclusion criteria
Exclusion criteria: E 01. Male or female 18 years of age or 75 years of age. E 02. Autoimmune disease other than RA or significant systemic involvement (vasculitis, pulmonary fibrosis, Feltyâ??s syndrome). E 03. History of chronic, or recurrent, and current acute inflammatory joint disease other than RA, or RA diagnosed before the age of 16. E 04. Treatment with oral prednisone or equivalent 10 mg per day within 4 weeks prior to the randomization visit or use of parenteral or intra-articular glucocorticosteroids within 4 weeks prior to the Screening Visit. E 05. Start treatment or change dose of current treatment with NSAIDs/COX2 inhibitors or oral corticosteroids for 4 weeks prior to baseline. E 06. 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). E 07. Past history of nonresponse to prior therapy with TNF antagonist or a biologic treatment. E 08. Prior therapy with a TNF antagonist or any other biologic agents within 3 months prior to randomization. E 09. Administration of an investigational drug or therapy within 60 days or at least 5 half-lives, whichever is longer, of the investigational drug, prior to the Screening Visit. E 10. History of malignancy other than carcinoma in-situ of the cervix, or adequately treated, nonmetastatic squamous or basal cell carcinoma of the skin within five years prior to Screening Visit. History of lymphoproliferative disease or possible current lymphoproliferative disease. E 11. History of alcohol or drug abuse within the 5 years prior to the Screening Visit. E 12. Have a history or presence of significant other concomitant illness according to the Investigator judgment such as, but not limited to cardiovascular (including stage III or IV cardiac failure according to New York Heart Association (NYHA) classification), renal, neurological, endocrinological, gastrointestinal, hepatic disease, metabolic, pulmonary or lymphatic disease that would adversely affect the subjectâ??s participation in this study. E 13. Conditions/situations such as: Patients with short life expectancy - Patients with conditions/concomitant diseases making them nonevaluable for the primary efficacy endpoint - Requirement for concomitant treatment that could bias primary evaluation - Impossibility to meet specific protocol requirements (eg, need for hospitalization, etc) - Patient is the Investigator or any subinvestigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol - Uncooperative or any condition that could make the patient potentially noncompliant with the study procedures Exclusion criteria related to the active comparator and/or mandatory background therapies E 14. Patients not willing to take folic acid with the MTX dose, to minimize toxicity. Exclusion criteria related to the current knowledge o
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients who achieved ACR20 at Week 24Timepoint: Wk 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ Change in modified Van der Heijde Sharp score at Week 52 (composite index on X-ray assessed through central reading). â?¢ Change in physical function as measured by the change from baseline in the Health Assessment Question-Disability (HAQ-DI) at Week 52. â?¢ Percentage of patients who achieved and maintained (for at least 6 months) an ACR70 response. Timepoint: Wk 52 | — |
Countries
Argentina, Australia, Austria, Belarus, Belgium, Brazil, Canada, Chile, Colombia, Czech Republic, Egypt, Estonia, Finland, Germany, Greece, Hungary, India, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Peru, Philippines, Poland, Portugal, Republic of Korea, Romania, Russian Federation, South Africa, Spain, Taiwan, Thailand, Turkey
Contacts
Public ContactDr Mohit Trivedi
Sanofi
Outcome results
None listed