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NCT03600818 · ClinicalTrials.gov registry record · Phase 3
Evaluation of the Efficacy and Safety of Sarilumab in Patients With Polymyalgia Rheumatica
A Phase 3 study, sponsored by Sanofi.
- Terminated
- Registry status
- Phase 3
- Development phase
- 118
- Enrollment target
NCT03600818: Clinical Trial Phase 3 study, sponsored by Sanofi.
NCT03600818 is a Phase 3 study that was terminated before completion, run by Sanofi. The registered enrollment target is 118 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03600818, a Phase 3 study, was terminated before completion, sponsored by Sanofi.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 118 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Sustained remission was defined as meeting all of the following parameters: achievement of disease remission (defined as resolution of signs and symptoms of polymyalgia rheumatica \[PMR\], and normalization of C-reactive protein \[CRP\] {less than \[\<\]10 milligrams per liter \[mg/L\]}) not later than Week 12, absence of disease flare (defined as recurrence of signs and symptoms attributable to active PMR plus an increase in corticosteroid \[CS\] dose due to PMR or elevation of erythrocyte sedi
Interventions
- DRUG Prednisone
- DRUG Sarilumab SAR153191 (REGN88)
- DRUG Sarilumab-matching placebo
- DRUG Prednisone-matching placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 118 participants |
| Start Date | 2018-10-09 |
| Est. Completion | 2021-05-19 |
| Phase | Phase 3 |
Why NCT03600818 stopped before completion
NCT03600818 is an interventional study that assigns participants to a tested intervention. The registered 118 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 4 interventions - of which Prednisone is the first listed.
NCT03600818 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03600818 about?
NCT03600818 is a clinical study titled "Evaluation of the Efficacy and Safety of Sarilumab in Patients With Polymyalgia Rheumatica". 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 taper...
What is the current status of trial NCT03600818?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 118 participants. The study started on 2018-10-09. Estimated completion is 2021-05-19.
What interventions are being tested in trial NCT03600818?
The interventions under investigation include: Prednisone (DRUG), Sarilumab SAR153191 (REGN88) (DRUG), Sarilumab-matching placebo (DRUG), Prednisone-matching placebo (DRUG).
Who is sponsoring clinical trial NCT03600818?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03600818's enrollment target sits among peer trials
118 1641st of 2000 higher than 359 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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