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 3, 3-arm 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 44): Receiving study drug (prednisone taper ends at the end of Week 50), 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 3
- 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 12, 2026 (Actual)
- Primary completion
- Jun 4, 2029 (Estimated)
- Completion
- Jul 16, 2029 (Estimated)
- Last update posted
- Oct 21, 2026
2026 – 2029
United States locations
- U.S. sites
- 47
- U.S. states
- 17
- U.S. cities
- 45
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Arizona Arthritis & Rheumatology Research - West Beverly Lane- Site Number : 8400055 | Avondale | Arizona | 85392 | Recruiting |
| Arizona Arthritis & Rheumatology Associates - East Bell Road- Site Number : 8400010 | Phoenix | Arizona | 85032 | Recruiting |
| Arizona Arthritis & Rheumatology Associates - Tucson- Site Number : 8400039 | Tucson | Arizona | 85704 | Recruiting |
| Medvin Clinical Research - Covina - West San Bernardino Road- Site Number : 8400028 | Covina | California | 91722 | Recruiting |
| Care Access - Huntington Beach- Site Number : 8400087 | Huntington Beach | California | 92648 | Recruiting |
| Southland Arthritis- Site Number : 8400047 | Temecula | California | 92592 | Recruiting |
| Cohen Medical Centers- Site Number : 8400023 | Thousand Oaks | California | 91360 | Recruiting |
| Solace Clinical Research - Tustin- Site Number : 8400101 | Tustin | California | 92780 | Recruiting |
| Comprehensive Rheumatology Center- Site Number : 8400060 | West Hills | California | 91307 | Recruiting |
| Denver Arthritis Clinic - Lowry- Site Number : 8400001 | Denver | Colorado | 80230 | Recruiting |
| Arthritis and Rheumatic Disease Specialties- Site Number : 8400014 | Aventura | Florida | 33180 | Recruiting |
| Clinical Research of West Florida - Phase I Unit- Site Number : 8400024 | Clearwater | Florida | 33765 | Recruiting |
| Omega Research Consultants - Debary - North Charles Richard Beall Boulevard- Site Number : 8400092 | DeBary | Florida | 32713 | Recruiting |
| University of Florida Health - Gainesville- Site Number : 8400035 | Gainesville | Florida | 32606 | Recruiting |
| Life Clinical Trials - Margate - Colonial Drive- Site Number : 8400034 | Margate | Florida | 33063 | Recruiting |
| Vitalia Medical Research - Margate- Site Number : 8400021 | Margate | Florida | 33063 | Recruiting |
| Rheumwell Comprehensive Rheumatology- Site Number : 8400004 | Miami | Florida | 33143 | 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 |
| Sarasota Arthritis Center- Site Number : 8400073 | Sarasota | Florida | 34239 | Recruiting |
| Vantage Clinical Trials - Tampa- Site Number : 8400064 | Tampa | Florida | 33614 | Recruiting |
| Arthritis & Rheumatology Center Pc- Site Number : 8400038 | Cumming | Georgia | 30040 | Recruiting |
| Arthritis Center of North Georgia - Gainesville- Site Number : 8400102 | Gainesville | Georgia | 30501 | Recruiting |
| Willow Rheumatology and Wellness- Site Number : 8400012 | Willowbrook | Illinois | 60527 | Recruiting |
| Klein and Associates- Site Number : 8400003 | Hagerstown | Maryland | 21740 | Recruiting |
| Arthritis And Rheumatism Associates- Site Number : 8400083 | Rockville | Maryland | 20850 | Recruiting |
| HealthPartners Specialty Center- Site Number : 8400094 | Saint Paul | Minnesota | 55130 | Recruiting |
| Arthritis Consultants - St. Louis- Site Number : 8400063 | St Louis | Missouri | 63141 | Recruiting |
| Logan Health Research - Glacier View Research Institute - Oncology- Site Number : 8400056 | Kalispell | Montana | 59901 | Recruiting |
| Inspire Santa Fe Medical Group- Site Number : 8400077 | Santa Fe | New Mexico | 87505 | Recruiting |
| Arthritis and Osteoporosis Consultants of the Carolinas- Site Number : 8400005 | Charlotte | North Carolina | 28207 | Recruiting |
| Digestive Health Associates - Rowan Diagnostic Clinic- Site Number : 8400019 | Salisbury | North Carolina | 28144 | Recruiting |
| Altoona Center for Clinical Research - Duncansville- Site Number : 8400018 | Duncansville | Pennsylvania | 16635 | Recruiting |
| Rheumatology Specialty Center - Willow Grove- Site Number : 8400042 | Willow Grove | Pennsylvania | 19090 | 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 |
| Murfreesboro Medical Clinic - Shores Road- Site Number : 8400040 | Murfreesboro | Tennessee | 37128 | Recruiting |
| Accurate Clinical Management - Baytown- Site Number : 8400109 | Baytown | Texas | 77521 | Recruiting |
| Lone Star Arthritis & Rheumatology - Denton- Site Number : 8400044 | Denton | Texas | 76205 | Recruiting |
| Stryde Consulting- Site Number : 8400070 | Frisco | Texas | 75033 | Recruiting |
| Prolato Clinical Research Center- Site Number : 8400045 | Houston | Texas | 77054 | Recruiting |
| TAD Clinical Research - Lufkin- Site Number : 8400069 | Lufkin | Texas | 75904 | Recruiting |
| Rheumatology Associates Of South Texas- Site Number : 8400050 | San Antonio | Texas | 78258 | Recruiting |
| Accurate Clinical Management - Sugar Land- Site Number : 8400061 | Sugar Land | Texas | 77479 | Recruiting |
| Overlake Arthritis and Osteoporosis Center- Site Number : 8400002 | Bellevue | Washington | 98004 | Recruiting |
| Rheumatic Disease Center - Glendale- Site Number : 8400006 | Glendale | Wisconsin | 53217 | 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 38 non-U.S. sites.
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 Oct 21, 2026 · Synced Oct 25, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT07286214 live on ClinicalTrials.gov.