Effect of SAR153191 (REGN88) With Methotrexate in Patients With Active Rheumatoid Arthritis Who Failed TNF-α Blockers

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Rheumatoid Arthritis

In brief

Primary Objective: \- To demonstrate that sarilumab (SAR153191/REGN88) on top of methotrexate (MTX) was superior in efficacy to placebo for the relief of signs and symptoms of rheumatoid arthritis (RA), in participants with active RA who had failed up to 2 tumor necrosis factor-alpha (TNF-α) antagonists. Secondary Objectives: * To assess the safety of sarilumab; * To document the pharmacokinetic profile of sarilumab.

Key facts

Study ID

NCT01217814

Run by

Sanofi

People needed

16

Starts

2010-11-01

Expected to finish

2011-09-01

Last updated by the study team

2017-09-01

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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, and
• 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;
• Participant considered as Primary TNF-α blocker nonresponder. i.e.:
• Appropriate for previous TNF-α blocker therapy
• Lack of adequate clinical response after at least 3 months TNF-α blocker therapy with MTX or other synthetic disease modifying anti-rheumatic drug (DMARD) co-therapy.

You may not qualify if…

• Age <18 years or >75 years;
• Pregnant or breastfeeding woman or woman 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.
• The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Where it is running

• Investigational Site Number 840026 — Freehold, New Jersey, United States
• Investigational Site Number 840043 — New York, New York, United States
• Investigational Site Number 840025 — Jackson, Tennessee, United States
• Investigational Site Number 840038 — Austin, Texas, United States
• Investigational Site Number 170004 — Barranquilla, Colombia
• Investigational Site Number 170005 — Barranquilla, Colombia
• Investigational Site Number 170007 — Bucaramanga, Colombia
• Investigational Site Number 203002 — Uherské Hradiště, Czechia
• Investigational Site Number 380002 — Florence, Italy
• Investigational Site Number 380005 — Genova, Italy
• Investigational Site Number 484008 — Durango, Mexico
• Investigational Site Number 484002 — Guadalajara, Mexico
• Investigational Site Number 724004 — Oviedo, Spain
• Investigational Site Number 724002 — Valencia, Spain

Full record on ClinicalTrials.gov

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