Sarilumab for early polymyalgia rheumatica in adults

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 3, randomized, double-blind trial compares two dosing regimens of sarilumab (150 mg every 2 weeks or 200 mg every 2 weeks) against placebo, each combined with a 52-week prednisone taper, in adults with early PMR. Participants will be adults ≥50 who have recently been diagnosed or have early relapse PMR and have been on corticosteroids within the past year. The study includes a 58-week overall timeline with visits spanning screening, baseline treatment initiation, weekly-to-biweekly dosing, end of treatment at week 52, and end of study at week 58. Primary goals are to determine if sarilumab regimens provide superior outcomes and to assess safety and tolerability. The trial is led by Sanofi with Regeneron as a collaborator at multiple Arizona sites.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Adults ≥50 years with polymyalgia rheumatica according to the EULAR/ACR classification criteria
* Meet criteria for newly diagnosed PMR (newly diagnosed PMR must have met the EULAR/ACR classification criteria for a first-time diagnosis of PMR within 8 weeks prior to randomization) OR for early relapsing PMR (early relapsing PMR must have met the EULAR/ACR classification criteria prior to initiating treatment for PMR) AND
* Have initiated treatment with corticosteroid(s) (CS) for PMR no more than 1 year prior to randomization,
* Be on a prednisone dose of at least 7.5 mg/day (or equivalent) and not exceeding 20 mg/day at screening and during the screening period,
* Have a history of being treated for at least 8 weeks with prednisone (at a dose of ≥10 mg/day prednisone or equivalent),
* Had at least one episode of unequivocal PMR flare while attempting to taper prednisone at a dose that is ≥5 mg/day (or equivalent) within the past 12 weeks prior to screening: (unequivocal symptoms of PMR flare include shoulder and/or hip girdle pain associated with inflammatory stiffness)
* Participants must be willing and able to take prednisone of 15 mg/day at randomization
* 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:

* Diagnosis of Giant Cell Arteritis (GCA)
* Concurrent rheumatoid arthritis, inflammatory arthritis, connective tissue diseases, fibromyalgia
* Inadequately treated hypothyroidism
* Exclusion related to tuberculosis (TB), invasive opportunistic infections, recurrent or persistent infections including hepatitis B, C or HIV, recurrent herpes zoster or active herpes zoster
* Patients with uncontrolled diabetes mellitus (HbA1c ≥9%)
* Immunosuppressive therapies including systemic corticosteroids
* Malignancy
* Organ transplant recipient

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

• Arizona Arthritis & Rheumatology Research - West Beverly Lane- Site Number : 8400055
  Avondale, Arizona, United States Recruiting
• Arizona Arthritis & Rheumatology Associates - East Bell Road- Site Number : 8400010
  Phoenix, Arizona, United States Recruiting
• Arizona Arthritis & Rheumatology Associates - Tucson- Site Number : 8400039
  Tucson, Arizona, United States Recruiting
• Medvin Clinical Research - Covina - West San Bernardino Road- Site Number : 8400028
  Covina, California, United States Recruiting
• Care Access - Huntington Beach- Site Number : 8400087
  Huntington Beach, California, United States Recruiting
• Southland Arthritis- Site Number : 8400047
  Temecula, California, United States Recruiting

+35 more sites. See ClinicalTrials.gov for the full list.

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.