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NCT02057250 · ClinicalTrials.gov registry record · Phase 3
To Evaluate Sarilumab - SAR153191 (REGN88) - Auto-injector Device In Patients With Rheumatoid Arthritis
A Phase 3 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 217
- Enrollment target
NCT02057250: Completed Phase 3 study, sponsored by Sanofi.
NCT02057250 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 217 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02057250, a Phase 3 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 217 participants
- Enrollment target
Study Summary
Primary Objective: To collect real-use data of the sarilumab auto-injector device (AID) used by rheumatoid arthritis (RA) participants. Secondary Objective: To compare the pharmacokinetic (PK) exposure of sarilumab administered by AID versus prefilled syringes (PFS).
Primary Outcome
A PTF was defined as any product technical complaint (PTC) related to the use of the AID that had a validated technical cause. Each participant was given a diary having questions related to participant's ability to remove the cap, to start the injection, to complete the injection and regarding confirmation of completing the injection. Participants were asked to answer the questions each time they self-inject the sarilumab. If the response was "no" to any of the first 3 questions, this was consid
Interventions
- DRUG Methotrexate
- DRUG Sarilumab
- DRUG Sulfasalazine
- DEVICE Auto-Injector Device (AID)
- DEVICE Pre-filled Syringe (PFS)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 217 participants |
| Start Date | 2014-03 |
| Est. Completion | 2016-03 |
| Phase | Phase 3 |
What the finished NCT02057250 record still lists
NCT02057250 is an interventional study that assigns participants to a tested intervention. The registered 217 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 (72% lower).
The record links to 0 conditions, and to 5 interventions - of which Methotrexate is the first listed.
NCT02057250 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02057250 about?
NCT02057250 is a clinical study titled "To Evaluate Sarilumab - SAR153191 (REGN88) - Auto-injector Device In Patients With Rheumatoid Arthritis". Primary Objective: To collect real-use data of the sarilumab auto-injector device (AID) used by rheumatoid arthritis (RA) participants. Secondary Objective: To compare the pharmacokinetic (PK) exposure of sarilumab administered by AID versus prefilled syringes (PFS).
What is the current status of trial NCT02057250?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 217 participants. The study started on 2014-03. Estimated completion is 2016-03.
What interventions are being tested in trial NCT02057250?
The interventions under investigation include: Methotrexate (DRUG), Sarilumab (DRUG), Sulfasalazine (DRUG), Auto-Injector Device (AID) (DEVICE), Pre-filled Syringe (PFS) (DEVICE).
Who is sponsoring clinical trial NCT02057250?
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 NCT02057250's enrollment target sits among peer trials
217 1332nd of 2000 higher than 669 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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