Effect of Sarilumab on Patient-reported Outcomes in Patients With Active Rheumatoid Arthritis

Summary

Primary Objective:

To assess the effect of sarilumab in combination with conventional synthetic Disease-Modifying Anti-Rheumatic Drug (csDMARD) and/or monotherapy on participant-reported impact of disease, using the rheumatoid arthritis impact of disease (RAID) questionnaire, in participants with moderately to severely active rheumatoid arthritis (RA) and inadequate response or intolerance to current csDMARD or tumor necrosis factor (TNF) inhibitors.

Secondary Objectives:

* To assess the change of the RAID score from baseline (to Week 4, Week 12, and Week 24) in participants with moderately to severely active RA and inadequate response or intolerance to current csDMARD or TNF inhibitors, treated with sarilumab in combination with csDMARD and/or monotherapy.
* To assess the effect of sarilumab in combination with csDMARD and/or monotherapy on other participant-reported outcomes (global assessment of disease activity, disability, morning stiffness, fatigue, anxiety/depression, mood disorders, and physical activities) in participants with moderately to severely active RA and inadequate response or intolerance to current csDMARD or TNF inhibitors.
* To assess the efficacy of sarilumab in combination with csDMARD and/or monotherapy using disease activity score-28 for RA with erythrocyte sedimentation rate (DAS28-ESR) and clinical disease activity index in participants with moderately to severely active RA and inadequate response or intolerance to current csDMARD or TNF inhibitors.
* To assess the safety of sarilumab in combination with csDMARD and/or monotherapy in participants with moderately to severely active RA and inadequate response or intolerance to current csDMARD or TNF inhibitors.

Conditions

• Rheumatoid Arthritis

Interventions

DRUG

SARILUMAB

Pharmaceutical form:Solution for injection in pre-filled syringe Route of administration: Subcutaneous

DRUG

Azathioprine

Pharmaceutical form:Tablet Route of administration: Oral

DRUG

Chloroquine

Pharmaceutical form:Tablet Route of administration: Oral

DRUG

Hydroxychloroquine

Pharmaceutical form:Tablet Route of administration: Oral

DRUG

Leflunomide

Pharmaceutical form:Tablet Route of administration: Oral

DRUG

Methotrexate

Pharmaceutical form:Solution for injection Route of administration: Subcutaneous / Intramuscular

DRUG

Sulfasalazine

Pharmaceutical form:Tablet Route of administration: Oral

Sponsors & Collaborators

• Regeneron Pharmaceuticals

  collaborator INDUSTRY

• Sanofi

  lead INDUSTRY

Principal Investigators

• Clinical Sciences & Operations · Sanofi

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-03-05

Primary Completion

2019-07-31

Completion

2019-07-31

Countries

• France

Study Locations