A randomized, double-blind, parallel-group, placebo- and active calibrator-controlledstudy assessing the clinical benefit of SAR153191 subcutaneous (SC) on top of methotrexate (MTX) in patients with active rheumatoid arthritis (RA) who have failed previous tumor necrosis factor-alpha (TNF-a) antagonists. - Effect of SAR153191with Methotrexate in patients with active rheumatoid arthritis who failed TNF-a

• Conditions: active rheumatoid arthritis; MedDRA version: 13.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

• Registration Number: EUCTR2010-021020-94-CZ
• Lead Sponsor: Sanofi-aventis Recherche & Développement

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10-05
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

Diagnosis of rheumatoid arthritis = 6 months duration and American College of Rheumatology (ACR) Class I-III functional status at screening and baseline visits
Active disease, defined as:
- At least 6 of 68 tender joints and 6 of 66 swollen joints at screening and baseline visits
- hs-C-Reactive Protein (hs-CRP) >10 g/L or Erythrocyte Sedimentation Rate (ESR) >28 mm/hr at screening visit
Continuous treatment with Methotrexate for at least 12 weeks and on stable dose (minimum 10 mg/week) for at least 6 weeks prior to the screening visit
Patient considered as Primary TNF-a blocker nonresponder. i.e.:
- Appropriate for previous TNF-a blocker therapy
- Lack of adequate clinical response after at least 3 months TNF-a blocker therapy (up to 2 agents) with Methotrexate or other synthetic disease modifiying anti-rheumatic drug (DMARD) co-therapy

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Age <18 years or >75 years
Pregnant or breastfeeding women or women of childbearing potential, unwilling to utilize adequate contraception or not to become pregnant during the entire study.
fever (>38°C), or chronic, persistent, or recurring infection(s)
History of demyelinating disease
Current underlying hepatobiliary disease

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Demonstrate that SAR153191 on top of Methotrexate is superior in efficacy to Placebo for the relief of signs and symptoms of Rheumatoid Arthritis (RA), in patients with active RA who have failed up to 2 TNF-a antagonists;Secondary Objective: - To assess the safety of SAR153191<br>- To document the pharmacokinetic profile of SAR153191<br>;Primary end point(s): 20% improvement response according to the American College of Rheumatology core set disease activity index (ACR20)