NCT03449758

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

Effect of Sarilumab on Patient-reported Outcomes in Patients With Moderately to Severely Active Rheumatoid Arthritis and With Inadequate Response or Intolerance to Current Conventional Synthetic DMARDs or Tumor Necrosis Factor Inhibitors

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study duration per participant was approximately 32 weeks, with up to 4-week screening, 24 weeks treatment period, and 2-4 weeks post-treatment observations.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-03-05
• Primary completion: 2019-07-31
• Completion: 2019-07-31
• First posted: 2018-02-28
• Last updated: 2022-04-28
• Results posted: 2020-08-10

Locations

33 sites across 1 country: France