Overview

This trial is active, not recruiting.

Condition rheumatoid arthritis
Treatments sarilumab sar153191 (regn88), adalimumab
Phase phase 3
Target TNF-alpha
Sponsor Sanofi
Collaborator Regeneron Pharmaceuticals
Start date February 2015
End date January 2016
Trial size 369 participants
Trial identifier NCT02332590, 2014-002541-22, EFC14092, U1111-1160-6154

Summary

Primary Objective:

To demonstrate that sarilumab monotherapy is superior to adalimumab monotherapy with respect to signs and symptoms as assessed by disease activity score 28 (DAS28)-erythrocyte sedimentation rate (ESR) in patients with active rheumatoid arthritis (RA) who are either intolerant of, or considered inappropriate candidates for continued treatment with methotrexate (MTX), or after at least 12 weeks of continuous treatment with MTX, are determined to be inadequate responders.

Secondary Objectives:

To demonstrate that sarilumab monotherapy is superior to adalimumab monotherapy in patients with active RA who are either intolerant of, or considered inappropriate candidates for continued treatment with methotrexate (MTX), or after at least 12 weeks of continuous treatment with MTX, are determined to be inadequate responders, with respect to:

- Reduction of signs and symptoms of RA.

- Improvement in quality of life assessed by patient reported outcome questionnaires.

Assessment of the safety and tolerability of sarilumab monotherapy (including immunogenicity) throughout the study.

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)
Subcutaneous injection every two weeks
sarilumab sar153191 (regn88)
Pharmaceutical form: solution; Route of administration: subcutaneous
(Active Comparator)
Subcutaneous injection every two weeks
adalimumab Humira
Pharmaceutical form:solution; Route of administration: subcutaneous

Primary Outcomes

Measure
Change from baseline in disease activity score 28 (DAS28) - erythrocyte sedimentation rate (ESR)
time frame: Week 24

Secondary Outcomes

Measure
American College of Rheumatology 20 (ACR2020, ACR50 and ACR70 response
time frame: Week 24
Change from baseline in each individual ACR component
time frame: Week 24
Change from baseline in DAS28-CRP
time frame: Week 24
DAS28-ESR remission (<2.6)
time frame: Week 24
DAS28-CRP remission (<2.6)
time frame: Week 24
Low disease activity (DAS28-ESR <3.2)
time frame: Week 24
Remission based on clinical disease activity index (CDAI) (≤2.8)
time frame: Week 24
Change from baseline in CDAI
time frame: Week 24
Sarilumab exposure assessed by trough serum sarilumab concentrations
time frame: Over time, maximum to Week 306
Change from baseline in: short form 36 (SF-36) scores
time frame: Week 24
Change from baseline in: EQ-5D-3L scores
time frame: Week 24
Change from baseline in: rheumatoid arthritis impact of disease (RAID) scores
time frame: Week 24
Change from baseline in: work productivity survey-rheumatoid arthritis (WPS-RA) scores
time frame: Week 24
Change from baseline in: functional assessment of chronic illness therapy-fatigue (FACIT-F) scores
time frame: Week 24
Change from baseline in: morning stiffness visual analog scale (VAS) scores
time frame: Week 24
Number of patients with adverse events
time frame: Over time, maximum to Week 306
Clinically significant changes in laboratory values: hematology, clinical chemistry, and urinalysis
time frame: Over time, maximum to Week 306
Clinically significant changes in ECG
time frame: Over time, maximum to Week 306
Clinically significant changes in vital signs
time frame: Over time, maximum to Week 306
Measurement of anti-drug antibody (ADA) levels
time frame: Over time, maximum to Week 306

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion criteria: Diagnosis of rheumatoid arthritis ≥3 months duration. American College of Rheumatology (ACR) Class I-III functional status. Active RA was defined as: - At least 6 of 66 swollen joints and 8 of 68 tender joints, - High sensitivity C-reactive protein (hs-CRP) ≥8 mg/L or ESR ≥28 mm/H, and - DAS28ESR >5.1. Patients who per Investigator judgment were either intolerant of, or considered inappropriate candidates for continued treatment with methotrexate (MTX), or after at least 12 weeks of continuous treatment with MTX, or inadequate responders treated with an adequate MTX dose for at least 12 weeks. Exclusion criteria: Age <18 years or the legal age of consent in the country of the study site, whichever is higher. Current treatment with disease-modifying antirheumatic drug (DMARDs)/immunosuppressive agents including MTX, cyclosporine, mycophenolate, tacrolimus, gold, penicillamine, sulfasalazine or hydroxychloroquine within 2 weeks prior to the baseline (Randomization Visit) or azathioprine, cyclophosphamide within 12 weeks prior to baseline (Randomization Visit) or leflunomide within 8 weeks prior to the Randomization Visit, or 4 weeks after cholestyramine washout. Treatment with any prior biologic agent, including anti-interleukin 6 (IL-6), IL-6 receptor (IL-6R) antagonists, and prior treatment with a Janus kinase inhibitor. Use of parenteral corticosteroids or intra-articular corticosteroids within 4 weeks prior to screening. 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, Parallel-group Study Assessing the Efficacy and Safety of Sarilumab Monotherapy Versus Adalimumab Monotherapy in Patients With Rheumatoid Arthritis
Description Total study duration is up to 310 weeks: Up to a 4 week screening period, 24 week randomized treatment phase, 276 week open label extension, and 6 weeks post-treatment final study visit.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Sanofi.