IV sarilumab for adults with rheumatoid arthritis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1b/2 trial evaluates pharmacokinetics and safety of intravenous sarilumab in adults with moderately to severely active rheumatoid arthritis. The study uses a 5-arm Part A design and a single-arm Part B to explore dosing with or without concomitant csDMARDs, over up to 64 weeks total and up to 6 months per phase. Participants will undergo regular assessments, with additional visits for those in an open-label extension to receive the approved 200 mg every two weeks. Subcutaneous and intravenous sarilumab comparisons are included, with follow-up after treatment ends. Key eligibility includes adults 18+ with RA per ACR/EULAR criteria, active disease, and prior intolerance or inadequate response to first-line DMARDs.

Why it matters

Who can join: the full rules

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 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.
* Inability to continue treatment with a RA DMARD approved for first line use because of intolerance or inadequate response.
* Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

Exclusion Criteria:

* Any prior (within the defined periods below) or concurrent use of immunosuppressive:

  * 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.
  * Tumor necrosis factor (TNF) inhibitors within 2 to 8 weeks.
  * Alkylating agents including cyclophosphamide (CYC) within 6 months of baseline.
  * Cyclosporine (CsA), azathioprine (AZA) or mycophenolate mofetil (MMF) or leflunomide within 4 weeks of baseline.
* Therapeutic failure, including inadequate response or intolerance, or contraindication, to biological IL-6 antagonist (prior IL-6 antagonist treatment that was terminated for reasons unrelated to therapeutic failure at least 3 months before baseline is not exclusionary).
* Unstable methotrexate (MTX) dose (if participant is on concomitant MTX).
* Concurrent use of systemic corticosteroids (CS) of more than 10 mg/day.
* Pregnant or breastfeeding woman.
* Exclusion related to tuberculosis (TB): active TB or a history of incompletely treated TB regardless of screening Quantiferon® result.
* History of invasive opportunistic infections, including but not limited to histoplasmosis, listeriosis, coccidioidomycosis, candidiasis, pneumocystis jirovecii, aspergillosis despite resolution or John Cunningham virus (progressive multifocal leukoencephalopathy).
* Uncontrolled diabetes mellitus.
* History of prior articular or prosthetic joint infection.
* Prior or current history of malignancy, including lymphoproliferative diseases, other than adequately-treated carcinoma in-situ of the cervix, non-metastatic squamous cell or basal cell carcinoma of the skin, within 5 years prior to the baseline visit.
* History of inflammatory bowel disease or severe diverticulitis or previous gastrointestinal perforation.
* History of juvenile idiopathic arthritis or arthritis onset prior to age 16.
* Severe systemic RA, including but not limited to vasculitis, pulmonary fibrosis, and/or Felty's syndrome.

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Where it's running

• Veros Health- Site Number : 8400017
  Centennial, Colorado, United States Recruiting
• Clinical Research of West Florida - Phase I Unit- Site Number : 8400014
  Clearwater, Florida, United States Recruiting
• Sweet Hope Research Specialty- Site Number : 8400023
  Hialeah, Florida, United States Recruiting
• Encore Medical Research - Hollywood- Site Number : 8400010
  Hollywood, Florida, United States Recruiting
• Rheumwell Comprehensive Rheumatology- Site Number : 8400019
  Miami, Florida, United States Recruiting
• Integral Rheumatology and Immunology Specialists- Site Number : 8400018
  Plantation, Florida, United States Recruiting

Study contacts

• Study coordinator: Trial Transparency email recommended (Toll free for US & Canada)
• Email: Contact-US@sanofi.com
• Phone: 800-633-1610

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.