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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for phase_4 rheumatoid-arthritis

Timeline

Completed

Started Mar 2018

Shorter than P25 for phase_4 rheumatoid-arthritis

Geographic Reach

1 country

33 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.4 years study duration

First Submitted

Initial submission to the registry

February 8, 2018

Completed

20 days until next milestone

First Posted

Study publicly available on registry

February 28, 2018

Completed

5 days until next milestone

Study Start

First participant enrolled

March 5, 2018

Completed

1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2019

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2019

Completed

1 year until next milestone

Results Posted

Study results publicly available

August 10, 2020

Completed

Last Updated

April 28, 2022

Status Verified

March 1, 2022

Enrollment Period

1.4 years

First QC Date

February 8, 2018

Results QC Date

July 20, 2020

Last Update Submit

March 30, 2022

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

Change From Baseline in Rheumatoid Arthritis Impact of Disease Total Score at Week 24
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.
Baseline, Week 24

Secondary Outcomes (29)

Rheumatoid Arthritis Impact of Disease Total Score at Baseline, Weeks 4, 12 and 24
Baseline, Weeks 4, 12 and 24
Change From Baseline in Rheumatoid Arthritis Impact of Disease Total Score at Weeks 4 and 12
Baseline, Weeks 4 and 12
Hospital Anxiety and Depression Scale (HADS): Anxiety (HADS-A) and Depression (HADS-D) Subscale Scores at Baseline, Weeks 4, 12, and 24
Baseline, Weeks 4, 12 and 24
Change From Baseline in Hospital Anxiety and Depression Scale: Anxiety (HADS-A) and Depression (HADS-D) Subscale Scores at Weeks 4, 12 and 24
Baseline, Weeks 4, 12 and 24
Multidimensional Assessment of Thymic States (MAThyS) Scale Total Score at Baseline, Weeks 4, 12 and 24
Baseline, Weeks 4, 12 and 24
+24 more secondary outcomes

Study Arms (1)

Sarilumab

EXPERIMENTAL

Sarilumab 200 milligram (mg) subcutaneous (SC) injection every 2 weeks (q2w) from Day 1 of Week 0 up to Week 24 as monotherapy and/or in combination with methotrexate (MTX) or other csDMARD during the randomized 6-month (24 weeks) core treatment period. Participants completing 24 weeks period entered in a long-term extension treatment period and received sarilumab 200 mg q2w from Week 25 until the commercial availability of sarilumab in the country or maximum of up to Week 39.7.

Drug: SARILUMABDrug: AzathioprineDrug: ChloroquineDrug: HydroxychloroquineDrug: LeflunomideDrug: MethotrexateDrug: Sulfasalazine

Interventions

SARILUMABDRUG

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

Also known as: SAR153191 (REGN88), Kevzara®

Sarilumab

AzathioprineDRUG