Evaluation of the Efficacy and Safety of Sarilumab in Patients With Polymyalgia Rheumatica
Public ClinicalTrials.gov record NCT03600818. 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 Sarilumab in Patients With Polymyalgia Rheumatica
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Primary Objective: To evaluate the efficacy of KEVZARA (sarilumab) in participants with polymyalgia rheumatica (PMR) as assessed by the proportion of participants with sustained remission for sarilumab with a shorter corticosteroid (CS) tapering regimen as compared to placebo with a longer CS tapering regimen. Secondary Objectives: * To demonstrate the efficacy of sarilumab in participants with PMR compared to placebo, in combination with a CS taper with regards to: * Clinical responses (such as components of sustained remission, disease remission rates, time to first disease flare) over time. * Cumulative CS (including prednisone) exposure. * To assess the safety (including immunogenicity) and tolerability of sarilumab in participants with PMR. * To measure sarilumab serum concentrations in participants with PMR. * To assess the effect of sarilumab in reducing glucocorticoid toxicity as measured by the composite glucocorticoid toxicity index (GTI) questionnaire.
Study identification
- NCT ID
- NCT03600818
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 118 participants
Conditions and interventions
Conditions
Interventions
- Sarilumab SAR153191 (REGN88) Drug
- Sarilumab-matching placebo Drug
- Prednisone Drug
- Prednisone-matching placebo Drug
Drug
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
- Oct 8, 2018
- Primary completion
- May 18, 2021
- Completion
- May 18, 2021
- Last update posted
- Jun 9, 2022
2018 – 2021
United States locations
- U.S. sites
- 10
- U.S. states
- 9
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Investigational Site Number 8400003 | Upland | California | 91786 | — |
| Investigational Site Number 8400005 | Denver | Colorado | 80230 | — |
| Investigational Site Number 8400009 | Stamford | Connecticut | 06905 | — |
| Investigational Site Number 8400002 | Boca Raton | Florida | 33486 | — |
| Investigational Site Number 8400014 | Iowa City | Iowa | 52242 | — |
| Investigational Site Number 8400006 | Boston | Massachusetts | 02114 | — |
| Investigational Site Number 8400022 | New York | New York | 11201 | — |
| Investigational Site Number 8400011 | Dallas | Texas | 75231 | — |
| Investigational Site Number 8400025 | Lufkin | Texas | 75904 | — |
| Investigational Site Number 8400015 | Spokane | Washington | 99024 | — |
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 74 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03600818, 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 9, 2022 · Synced Sep 10, 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 protocol, eligibility criteria, and contact information for NCT03600818 live on ClinicalTrials.gov.