A randomized, double-blind, parallel-group, placebo- and active calibrator-controlled study 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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-021020-94-DE

Enrollment

250

Registered

2010-09-15

Start date

2011-03-10

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

active rheumatoid arthritis MedDRA version: 13.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Interventions

Product Code: SAR153191 Pharmaceutical Form: Solution for injection Current Sponsor code: SAR153191 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 75

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: Age 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

Design outcomes

Primary

Measure	Time frame
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 - To document the pharmacokinetic profile of SAR153191 ;Primary end point(s): 20% improvement response according to the American College of Rheumatology core set disease activity index (ACR20)	—

Measure

Time frame

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 - To document the pharmacokinetic profile of SAR153191 ;Primary end point(s): 20% improvement response according to the American College of Rheumatology core set disease activity index (ACR20)

—

Countries

Czech Republic, Germany, Hungary, Italy, Spain

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026