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)

Summary

Primary Objective:

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

* reduction of signs and symptoms at Week 24 and
* improvement of physical function at Week 12

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

Secondary Objectives:

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

* Reduction of signs and symptoms at Week 12;
* Improvement in physical function at Week 24;
* Improvement in disease activity score as measured by other American College of Rheumatology (ACR) derived components at Weeks 12 and 24;
* Improvement in quality of life as measured by participant reported outcomes (PROs) at intermediate visits and Week 24.

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

To assess the safety of sarilumab in this population.

Conditions

• Rheumatoid Arthritis

Interventions

DRUG

Sarilumab

Pharmaceutical form:solution Route of administration: subcutaneous

DRUG

placebo

Pharmaceutical form:solution Route of administration: subcutaneous

DRUG

hydroxychloroquine

Dispensed according to the local practice.

DRUG

methotrexate

Dispensed according to the local practice.

DRUG

sulfasalazine

Dispensed according to the local practice.

DRUG

leflunomide

Dispensed according to the local practice.

Sponsors & Collaborators

• Regeneron Pharmaceuticals

  collaborator INDUSTRY

• Sanofi

  lead INDUSTRY

Principal Investigators

• Clinical Sciences & Operations · Sanofi

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-10-31

Primary Completion

2015-03-31

Completion

2015-03-31

Countries

• United States
• Argentina
• Australia
• Austria
• Brazil
• Canada
• Chile
• Colombia
• Czechia
• Ecuador
• Germany
• Greece
• Guatemala
• Hungary
• Israel
• Italy
• Lithuania
• Mexico
• New Zealand
• Peru
• Poland
• Portugal
• Romania
• Russia
• Slovakia
• South Korea
• Spain
• Taiwan
• Turkey (Türkiye)
• Ukraine

Study Locations