To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET)

Rheumatoid Arthritis Clinical Trial

Official title: A Randomized, Double-blind, Parallel, Placebo-controlled Study Assessing the Efficacy and Safety of Sarilumab Added to Non-biologic DMARD Therapy in Patients With Rheumatoid Arthritis Who Are Inadequate Responders to or Intolerant of TNF-α Antagonists

Status Completed

Clinical Trial Summary

Primary Objective:

To demonstrate that sarilumab added to disease modifying anti-rheumatic drugs (DMARDs) is effective for:

• reduction of signs and symptoms at Week 24 and

• improvement of physical function at Week 12

in patients with active rheumatoid arthritis (RA) who are inadequate responders or intolerant to tumor necrosis factor alpha (TNF-α) antagonists.

Secondary Objectives:

The secondary objectives are to investigate the effects of SAR153191 (REGN88) when added to DMARD therapy, in patients with active RA who are inadequate responders or intolerant to TNF-α antagonists, for:

• Reduction of signs and symptoms at 12 weeks.

• Improvement in physical function at Week 24.

• Improvement in disease activity score as measured by other American College of Rheumatology derived components at Weeks 12 and 24.

• Improvement in quality of life as measured by patient reported outcomes (PROs) at intermediate visits and Week 24.

To assess the safety of sarilumab in this population.

To assess the exposure of sarilumab added to DMARD therapy in this population.

Clinical Trial Description

Total study duration is up to 34 weeks: Screening up to 28 days, Treatment phase of 24 weeks, and post-treatment follow-up of 6 weeks.

After completion of the treatment phase of this study, patients are eligible to enter a long term safety study (LTS11210) for active treatment wit SAR153191 (REGN88). ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

• NCT number: NCT01709578
• Study type: Interventional
• Source: Sanofi
• Status: Completed
• Phase: Phase 3
• Start date: October 2012
• Completion date: March 2015