About this trial
This is a Phase 1/Phase 2 study with:
* 5-arms design for Part A; * and a single arm for Part B.
The purpose of this study is to measure PK parameters and safety with sarilumab intravenous (IV) with or without concomitant oral conventional synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) in male and female participants with moderately to severely active rheumatoid arthritis aged 18 years of age or older.
Study details include:
* The study duration will be up to 64 weeks. * The treatment duration will be up to 6 months for each study phase. * Part A has 10 visits, including a post-treatment end of study (EOS) follow-up visit.
* For participants entering the open label extension to receive the approved 200 mg sarilumab every two weeks (Q2W) dose, there will be 3 additional study visits. * For the intra-study sarilumab 200 mg Q2W subcutaneous (SC) arm, participants will be evaluated over the course of 24 weeks plus post-treatment EOS follow-up visit following the schedule of activities (SoA) of Part A from Day -1 to Day 29 (total of 8 visits) and the SoA of Part B from Week 4 to Week 24 (total of 8 visits) and a post-treatment end of study (EOS) follow-up visit at Week 30 (Part B) for a total of 17 visits, including a post-treatment EOS follow-up visit. * Part B has 13 visits, including a post-treatment EOS follow-up visit.
Eligibility criteria
Qualifiers
Participant must be 18 years old or the legal age of consent in the jurisdiction in which the study is taking place or older, at the time of signing the informed consent.
Diagnosis of RA, according to the American College of Rheumatology (ACR)/European Alliance of Associations for Rheumatology (EULAR) 2010 RA Classification Criteria with ≥3 months disease duration.
ACR Class I to III functional status, based on the 1991 revised criteria
Moderate-to-severely active RA, defined as: DAS28-ESR>3.2.
Disqualifiers
Janus kinase (JAK) inhibitor (eg, tofacitinib) within 4 weeks of baseline.
Cell-depletion agents (eg, anti CD20) without evidence of recovery of B cells to baseline level.
Anakinra within 1 week of baseline.
Abatacept within 8 weeks of baseline.
Trial design
Treatments tested in this trial
- Sarilumab, SAR153191 SC
- Sarilumab, SAR153191 IV
Treatment groups
6
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Sanofi
Lead sponsor
Regeneron Pharmaceuticals
Collaborator