IV Sarilumab for Active Rheumatoid Arthritis

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.
Ready to participate?

Review the details below, then apply to join this clinical 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
Who this trial is looking for

This trial is looking for adults with rheumatoid arthritis who have not responded well to previous treatments. Participants will receive treatments and be followed for up to 64 weeks.

Are You a Good Fit for This Trial?

You may be able to join if

  • I am at least 18 years old.
  • I have been diagnosed with rheumatoid arthritis for at least 3 months.
  • I have moderate to severe active rheumatoid arthritis.
  • I cannot continue my current rheumatoid arthritis treatment due to intolerance or inadequate response.
  • I have a functional status of ACR Class I to III.
  • I agree to use contraception as required.

You may not be able to join if

  • I have used certain immunosuppressive drugs in the past few weeks.
  • I have been pregnant or breastfeeding.
  • I have active tuberculosis or an incomplete history of tuberculosis treatment.
  • I have had serious infections in the past.
  • I have uncontrolled diabetes.
  • I have a history of cancer in the past 5 years.
  • I have a severe systemic form of rheumatoid arthritis.
  • I have a history of certain bowel diseases.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.

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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-US@sanofi.com

CONTACT