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-DE
• Lead Sponsor: Sanofi-aventis Recherche & Développement

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09-15
• 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