Menu
Peptide Database
Results
No peptides found
Featured

Use search to browse all 100+ peptides

Thymalin

Thymulin, Thymic Factor, Serum Thymic Factor, Facteur Thymique Serique

Quick Stats
Studies 202
Trials 37
Completed PHASE4 INTERVENTIONAL NCT03449758

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

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief 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.

Interventions

Name: SARILUMAB
Type: DRUG
Description: Pharmaceutical form:Solution for injection in pre-filled syringe Route of administration: Subcutaneous
Name: Azathioprine
Type: DRUG
Description: Pharmaceutical form:Tablet Route of administration: Oral
Name: Chloroquine
Type: DRUG
Description: Pharmaceutical form:Tablet Route of administration: Oral
Name: Hydroxychloroquine
Type: DRUG
Description: Pharmaceutical form:Tablet Route of administration: Oral
Name: Leflunomide
Type: DRUG
Description: Pharmaceutical form:Tablet Route of administration: Oral
Name: Methotrexate
Type: DRUG
Description: Pharmaceutical form:Solution for injection Route of administration: Subcutaneous / Intramuscular
Name: Sulfasalazine
Type: DRUG
Description: Pharmaceutical form:Tablet Route of administration: Oral

Primary Outcomes

Measure: Change From Baseline in Rheumatoid Arthritis Impact of Disease Total Score at Week 24
TimeFrame: Baseline, Week 24
Description: RAID was a participant reported outcome measure used to evaluate the impact of RA on participant's quality of life which comprised 7 domains: • pain, • function, • fatigue, • physical and psychological well-being, • sleep disturbance, and • coping. Each domain was a single question scored on a 0 to 10 continuous NRS. The values for each of these domains were weighed by participant assessment of relative importance and combined in a single value. Total RAID score range was 0 (not affected, very good) to 10 (most affected), where higher value indicated worse status.

Trial Information

NCT ID

NCT03449758

Status

Completed

Study Type

INTERVENTIONAL

Phases

PHASE4

Sponsor

Sanofi

Last Updated

December 15, 2025