Phase 1b/2 Study of IV Sarilumab in Adult With RA
Recruiting
Phase 1
Phase 2
Interventional Study
Rheumatoid Arthritis
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 1/2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 140 (estimated)
- Sponsor
- Sanofi · Industry
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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 yea…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 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 Associatio…
Contacts
Trial Transparency email recommended (Toll free for US & Canada)
800-633-1610
CONTACT