None listed
Conditions
Interventions
Group 1 Type of group
SAR153191 100mg qw SC+MTX
Group name:Group 6 Type of group
Placebo SC+MTX
Sponsors
sanofi-aventis Recherche & Development,
Eligibility
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: • Diagnosis of Rheumatoid Arthritis (RA) as defined by the revised criteria of the American College of Rheumatology (ACR) 1987 with a duration of the disease of not less than 3 months and ACR class I-III (see Appendix A). • Patients should be on a stable dose of MTX (10 to 25 mg / week) for a minimum of 6 weeks before the Selection Visit and intend to continue for the duration of the study. • Patients must have been treated, and tolerated, a minimum of 12 weeks of treatment with methotrexate (MTX) before the inclusion visit. • Patient with moderate to severe active disease
Exclusion criteria
Exclusion criteria: • Man or woman 75 years • Weight 110kg • Autoimmune disease other than RA or significant systemic association (vasculitis, pulmonary fibrosis, Felty´s syndrome). • History of or current acute inflammatory joint disease other than RA, or RA diagnosed before 16 years of age. • Treatment with oral prednisone or equivalent> 10mg per day within 4 weeks prior to the Inclusion Visit or use of parenteral or intra-articular glucocortiesteroids within 4 weeks prior to the Selection Visit. • Start treatment or change the dose of the current treatment with C0X2 / NSAIDs inhibitors or oral corticosteroids for 4 weeks before baseline. • Current treatment with immunosuppressive agents / DMARDS other than MTX: cyclosporine, mycophenolate, tacrolimus, gold, penicillamine, sulfasalazine or hydroxychloroquine within 4 weeks prior to the Selection Visit or azathioprine, cyclophosphamide within 12 weeks prior to the Visit of Selection or leflunomide within 12 weeks prior to the Selection Visit (or 4 weeks after 11 days of standard cholestyramine wash). • History of lack of response to a previous therapy with TNF antagonist or biological treatment. • Prior therapy with TNF antagonist or any other biological agent within 3 months prior to inclusion. • Participation in any clinical research study that evaluates another investigational drug or therapy within 60 days or at least 5 half-lives, whichever is longer, of the investigational medication, prior to the Selection Visit. • History of malignancy other than in-situ carcinoma of the cervix, or basal or squamous cell carcinoma of the skin, properly treated, within five years prior to the Selection Visit. History of lymphoproliferative disease or possible current lymphoproliferative disease. • History of alcohol or drug abuse within 5 years prior to the Selection Visit. • Have a history or the presence of other significant concomitant diseases according to the Investigator´s judgment, such as, but not limited to cardiovascular disease (including stage III or IV heart failure according to the classification of the New York Cardiology Association ( NYHA)), renal, neurological, endocrinological, gastrointestinal, hepatic, metabolic, pulmonary or lymphatic that could adversely affect the subject´s participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:ACR20 response was defined, based on guidelines set forth by the American College of Rheumatology (ACR), as ≥20 % improvement in tender joint count and swollen joint count as well as ≥20% improvement in at least 3 of 5 following measures: C-Reactive Protein (CRP), Participant assessment of pain; Participants global assessment of disease activity; Physician global assessment of disease activity; and Health Assessment Question-Disability Index (HAQ-DI). Missing data imputed by Last Observation Carried Forward (LOCF). Measure:Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12 Timepoints:Baseline to Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:ACR20 improvement responses were determined without imputation of missing post-baseline values. In addition data collected after treatment discontinuation or rescue was set to missing. Responder status was determined if possible. With these rules, participants automatically became non-responders for all time points beyond the time point they started rescue treatment or discontinued study treatment. Measure:Percentage of Participants Achieving ACR20 Response at Week 24 Timepoints:Baseline to Week 24 ; Outcome name:HAQ-DI was a participant-reported questionnaire that assesses the difficulty of performing daily activities: dress/groom, arise, eat, walk, reach, grip, hygiene and common activities. Overall score range from 0=least difficulty to 3=extreme difficulty. An increase in the score indicates a worsening of physical function while a decrease in the score represents improvement. Data collected after treatment discontinuation was set to missing. Measure:Change From Baseline in Health Assessment Question Disability Index (HAQ-DI) at Week 16 Timepoints:baseline, Week 16 ; Outcome name:The Sharp method modified by D. van der Heijde involves separate scores for erosions and joint space narrowing based on radiographs to assess the degree of structural damage. Total score range from 0 (normal) to 448 (worst possible total score). An increase in total score represents progression of structural damage. Missing data were imputed by the linear extrapolation method. Measure:Change From Baseline in Van Der Heijde Modified Total Sharp Score (mTSS) at Week 52 Timepoints:Baseline, Week 52 ; Outcome name:Major clinical response was defined as an ACR70 response maintained for at least 24 consecutive weeks. ACR70 response uses the same criteria as for ACR20 but requires 70% improvement. In the primary approach, data collected after treatment discontinuation or rescue was set to missing. No imputation of missing post-baseli | — |
Countries
Austria, Estonia, Finland, Germany, Greece, Hungaria, Lithuania, Netherlands, Peru, Portugal, Spain
Contacts
Public ContactYeny Geronimo
SANOFI AVENTIS DEL PERU S.A.
Outcome results
None listed