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NCT03600805 · ClinicalTrials.gov registry record · Phase 3
Evaluation of Efficacy and Safety of Sarilumab in Patients With GCA
A Phase 3 study, sponsored by Sanofi.
- Terminated
- Registry status
- Phase 3
- Development phase
- 83
- Enrollment target
NCT03600805: Clinical Trial Phase 3 study, sponsored by Sanofi.
NCT03600805 is a Phase 3 study that was terminated before completion, run by Sanofi. The registered enrollment target is 83 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03600805, a Phase 3 study, was terminated before completion, sponsored by Sanofi.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 83 participants
- Enrollment target
Study Summary
Primary Objective: To evaluate the efficacy of sarilumab in participants with giant cell arteritis (GCA) as assessed by the proportion of participants with sustained remission for sarilumab compared to placebo, in combination with a corticosteroid (CS) tapering course. Secondary Objective: * To demonstrate the efficacy of sarilumab in participants with GCA compared to placebo, in combination with CS taper with regards to: * Clinical responses (such as responses based on 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 GCA. * To measure sarilumab serum concentrations in participants with GCA. * To assess the effect of sarilumab on sparing glucocorticoid toxicity as measured by glucocorticoid toxicity index (GTI).
Primary Outcome
Disease remission was defined as resolution of signs and symptoms of giant cell arteries (GCA), and normalization of C-reactive protein (CRP) (\<10 mg/L). Sustained remission was defined as meeting all of the following parameters: achievement of disease remission not later than Week 12, absence of disease flare (defined as recurrence of signs and symptoms attributable to active GCA plus an increase in corticosteroid \[CS\] dose due to GCA or elevation of erythrocyte sedimentation rate \[ESR\] at
Interventions
- DRUG Prednisone
- DRUG Sarilumab SAR153191
- DRUG Sarilumab matching placebo
- DRUG Prednisone matching placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 83 participants |
| Start Date | 2018-11-20 |
| Est. Completion | 2020-11-24 |
| Phase | Phase 3 |
Why NCT03600805 stopped before completion
NCT03600805 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 83 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 4 interventions - of which Prednisone is the first listed.
NCT03600805 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03600805 about?
NCT03600805 is a clinical study titled "Evaluation of Efficacy and Safety of Sarilumab in Patients With GCA". Primary Objective: To evaluate the efficacy of sarilumab in participants with giant cell arteritis (GCA) as assessed by the proportion of participants with sustained remission for sarilumab compared to placebo, in combination with a corticosteroid (CS) tapering course. Secondary Objective: * To d...
What is the current status of trial NCT03600805?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 83 participants. The study started on 2018-11-20. Estimated completion is 2020-11-24.
What interventions are being tested in trial NCT03600805?
The interventions under investigation include: Prednisone (DRUG), Sarilumab SAR153191 (DRUG), Sarilumab matching placebo (DRUG), Prednisone matching placebo (DRUG).
Who is sponsoring clinical trial NCT03600805?
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 NCT03600805's enrollment target sits among peer trials
83 1751st of 2000 higher than 249 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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