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NCT02121210 · ClinicalTrials.gov registry record · Phase 3
To Evaluate the Immunogenicity and Safety of Sarilumab Administered as Monotherapy in Patients With Rheumatoid Arthritis (RA)
A Phase 3 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 132
- Enrollment target
NCT02121210: Completed Phase 3 study, sponsored by Sanofi.
NCT02121210 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 132 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02121210, a Phase 3 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 132 participants
- Enrollment target
Study Summary
Primary Objective: To evaluate the immunogenicity of sarilumab administered as monotherapy. Secondary Objectives: * To evaluate the other safety aspects of sarilumab administered as monotherapy. * To assess the exposure of sarilumab administered as monotherapy.
Primary Outcome
ADA to sarilumab and anti-sarilumab neutralizing antibodies in serum samples were determined using a validated electrochemiluminescence immunoassay method. Percentage of participants with positive ADA during treatment emergent adverse event (TEAE) period (time from first dose of investigational medicinal product \[IMP\] to last dose of IMP + 60 days) was determined. Persistent ADA Response: treatment-emergent ADA detected at 2 or more consecutive sampling time points during the TEAE period, wher
Interventions
- DRUG sarilumab SAR153191 (REGN88)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 132 participants |
| Start Date | 2014-06 |
| Est. Completion | 2015-05 |
| Phase | Phase 3 |
What the finished NCT02121210 record still lists
NCT02121210 is an interventional study that assigns participants to a tested intervention. The registered 132 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 (83% lower).
The record links to 0 conditions, and to 1 intervention - of which sarilumab SAR153191 (REGN88) is the first listed.
NCT02121210 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02121210 about?
NCT02121210 is a clinical study titled "To Evaluate the Immunogenicity and Safety of Sarilumab Administered as Monotherapy in Patients With Rheumatoid Arthritis (RA)". Primary Objective: To evaluate the immunogenicity of sarilumab administered as monotherapy. Secondary Objectives: * To evaluate the other safety aspects of sarilumab administered as monotherapy. * To assess the exposure of sarilumab administered as monotherapy.
What is the current status of trial NCT02121210?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 132 participants. The study started on 2014-06. Estimated completion is 2015-05.
What interventions are being tested in trial NCT02121210?
The interventions under investigation include: sarilumab SAR153191 (REGN88) (DRUG).
Who is sponsoring clinical trial NCT02121210?
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 NCT02121210's enrollment target sits among peer trials
132 1588th of 2000 higher than 408 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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