Phase 1b/2 Study of IV Sarilumab in Adult With RA
Start Date
7/2/2026
Completion Date
10/26/2028
Summary
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
Age Range: 18 years to No maximum
Interventions
Sarilumab, SAR153191 SC
Sarilumab, SAR153191 IV
Conditions
Locations
Veros Health- Site Number : 8400017
Centennial, Colorado 80112
United States
Clinical Research of West Florida - Phase I Unit- Site Number : 8400014
Clearwater, Florida 33765
United States
Sweet Hope Research Specialty- Site Number : 8400023
Hialeah, Florida 33016
United States
Encore Medical Research - Hollywood- Site Number : 8400010
Hollywood, Florida 33024
United States
Rheumwell Comprehensive Rheumatology- Site Number : 8400019
Miami, Florida 33143
United States
Integral Rheumatology and Immunology Specialists- Site Number : 8400018
Plantation, Florida 33324
United States
Encore Medical Research - Weston- Site Number : 8400011
Weston, Florida 33331
United States
Altoona Center for Clinical Research - Duncansville- Site Number : 8400007
Duncansville, Pennsylvania 16635
United States
Texas Arthritis Center- Site Number : 8400021
El Paso, Texas 79902
United States
Prolato Clinical Research Center- Site Number : 8400006
Houston, Texas 77054
United States
Southwest Rheumatology Research- Site Number : 8400004
Mesquite, Texas 75150
United States
ClinRx Research - Plano- Site Number : 8400015
Plano, Texas 75023
United States