Overview

This trial has been completed.

Condition rheumatoid arthritis
Treatments sarilumab sar153191 (regn88), placebo, methotrexate, folic acid
Phase phase 3
Sponsor Sanofi
Collaborator Regeneron Pharmaceuticals
Start date November 2014
End date October 2016
Trial size 243 participants
Trial identifier NCT02293902, EFC14059, U1111-1155-7401

Summary

Primary Objective:

To demonstrate that sarilumab added to MTX reduce signs and symptoms of rheumatoid arthritis (RA) in Japanese RA patients with an inadequate response to MTX.

Secondary Objective:

To assess the safety of sarilumab added to MTX in Japanese RA patients with an inadequate response to MTX.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
sarilumab in a subcutaneously (SC) injection once in 2 weeks (q2w) MTX (stable dose) and folic acid are continued as background therapy
sarilumab sar153191 (regn88)
methotrexate
folic acid
(Experimental)
sarilumab in a SC injection q2w MTX (stable dose) and folic acid are continued as background therapy
sarilumab sar153191 (regn88)
methotrexate
folic acid
(Placebo Comparator)
placebo in a SC injection q2w, switching to sarilumab (SC) q2w at week 24 MTX (stable dose) and folic acid are continued as background therapy
sarilumab sar153191 (regn88)
placebo
methotrexate
folic acid
(Placebo Comparator)
placebo in a SC injection q2w, switching to sarilumab (SC) q2w at week 24 MTX (stable dose) and folic acid are continued as background therapy
sarilumab sar153191 (regn88)
placebo
methotrexate
folic acid

Primary Outcomes

Measure
ACR20 response rate
time frame: 24 weeks

Secondary Outcomes

Measure
Number of treatment-emergent adverse events
time frame: 58 weeks
Clinically significant changes in vital signs
time frame: 58 weeks
Clinically significant changes in electrocardiogram (ECG)
time frame: 58 weeks
Clinically significant changes in laboratory values
time frame: 58 weeks

Eligibility Criteria

Male or female participants from 20 years up to 75 years old.

Inclusion criteria: Diagnosis of RA, according to the American College of Rheumatology/The European League Against Rheumatism (ACR/EULAR) 2010 Rheumatoid Arthritis Classification Criteria with ≥3 months disease duration. Moderately to severely active RA defined as: - At least 8 of 68 tender joints and 6 of 66 swollen joints at screening visit. - High sensitivity C-Reactive Protein (hs-CRP) ≥6mg/L at screening visit. Exclusion criteria: Patients <20 or >75 years of age. Treatment with any Disease-modifying antirheumatic drug (DMARD) other than MTX or biologic agent without the appropriate off-drug period prior to to screening. Prior treatment with anti-interleukin-6 (anti-IL-6) or anti-interleukin-6 receptor (IL-6R) antagonist therapies, including but not limited to tocilizumab or sarilumab. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Additional Information

Official title A Randomized, Double-blind, Multicenter Study With a Placebo-controlled Period Assessing the Efficacy and Safety of Sarilumab Added to Methotrexate (MTX) in Japanese Patients With Moderately to Severely Active Rheumatoid Arthritis Who Are Inadequate Responders to MTX Therapy
Description The total duration of study is expected up to 62 weeks (screening period of 4 weeks, treatment period of 52 weeks, and a 6 week post treatment observation).
Trial information was received from ClinicalTrials.gov and was last updated in December 2016.
Information provided to ClinicalTrials.gov by Sanofi.