Sarilumab Efficacy and Safety in Adults With Early Polymyalgia Rheumatica
Public ClinicalTrials.gov record NCT07286214. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Each of Two Dose Levels of Sarilumab in Adults With Early Polymyalgia Rheumatica
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a randomized, double-blind, placebo-controlled, parallel-group, Phase 4, 3-group study to assess whether treatment with sarilumab at either 150 mg q2w (once every two weeks) or at 200 mg q2w, each given with a 52-week prednisone taper, is superior to placebo given with a 52-week prednisone taper in participants with early polymyalgia rheumatica (PMR) and to determine the safety and tolerability of the sarilumab regimens. The study will consist of the following visits: Visit 1 (D-42 to D-1): Screening, Visit 2 (D1): Baseline, randomization, first study drug administration, Visit 3 to 12 (Week 2 to Week 52): Treatment period, Visit 13 (Week 52): End of Treatment (EOT) visit, Visit 14 (Week 58): End of Study (EOS) visit.
Study identification
- NCT ID
- NCT07286214
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 300 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 50 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 11, 2026
- Primary completion
- Jun 3, 2029
- Completion
- Jul 15, 2029
- Last update posted
- Jun 22, 2026
2026 – 2029
United States locations
- U.S. sites
- 13
- U.S. states
- 7
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Denver Arthritis Clinic - Lowry- Site Number : 8400001 | Denver | Colorado | 80230 | Recruiting |
| Clinical Research of West Florida - Phase I Unit- Site Number : 8400024 | Clearwater | Florida | 33765 | Recruiting |
| Vitalia Medical Research - Margate- Site Number : 8400021 | Margate | Florida | 33063 | Recruiting |
| Florida Research Center- Site Number : 8400084 | Miami | Florida | 33174 | Recruiting |
| Innovia Research Center- Site Number : 8400029 | Miramar | Florida | 33027 | Recruiting |
| Discovery Clinical Research - Plantation- Site Number : 8400091 | Plantation | Florida | 33324 | Recruiting |
| Vantage Clinical Trials - Tampa- Site Number : 8400064 | Tampa | Florida | 33614 | Recruiting |
| Willow Rheumatology and Wellness- Site Number : 8400012 | Willowbrook | Illinois | 60527 | Recruiting |
| Inspire Santa Fe Medical Group- Site Number : 8400077 | Santa Fe | New Mexico | 87505 | Recruiting |
| Altoona Center for Clinical Research - Duncansville- Site Number : 8400018 | Duncansville | Pennsylvania | 16635 | Recruiting |
| Pennsylvania Regional Center for Arthritis and Osteoporosis Research- Site Number : 8400013 | Wyomissing | Pennsylvania | 19610 | Recruiting |
| West Tennessee Research Institute- Site Number : 8400009 | Jackson | Tennessee | 38305 | Recruiting |
| TAD Clinical Research - Lufkin- Site Number : 8400069 | Lufkin | Texas | 75904 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07286214, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 22, 2026 · Synced Sep 7, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07286214 live on ClinicalTrials.gov.