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NCT01146652 · ClinicalTrials.gov registry record · Phase 3
Long Term Evaluation of Sarilumab in Rheumatoid Arthritis Patients (SARIL-RA-EXTEND)
A Phase 3 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 2,023
- Enrollment target
NCT01146652: Completed Phase 3 study, sponsored by Sanofi.
NCT01146652 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 2,023 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (162% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01146652, a Phase 3 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 2,023 participants
- Enrollment target
Study Summary
Main Study: Primary Objective: Assess the long term safety of sarilumab in participants with rheumatoid arthritis (RA). Secondary Objective: Assess the long term efficacy of sarilumab in participants with RA. Sub-Study: This phase 3, open label sub-study was aimed to assess the usability of PFS-S when used by participants with moderate or severe RA, or their professional or non-professional healthcare providers in an unsupervised real-world situation. To mimic the real-world practice, the sub-study was incorporated into the LTS11210 study without additional visits compared to the scheduled visits in the main study. The duration of this sub-study was 12 weeks.
Primary Outcome
An adverse event (AE) was any untoward medical occurrence in a clinical study participant administered a medicinal product and which did not necessarily have to have a causal relationship with the treatment. An SAE was any untoward medical occurrence at any dose that: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medi
Interventions
- DRUG SAR153191 (REGN88)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,023 participants |
| Start Date | 2010-06-21 |
| Est. Completion | 2020-12-31 |
| Phase | Phase 3 |
What the finished NCT01146652 record still lists
NCT01146652 is an interventional study that assigns participants to a tested intervention. Its 2,023 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (162% higher).
The record links to 0 conditions, and to 1 intervention - of which SAR153191 (REGN88) is the first listed.
NCT01146652 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01146652 about?
NCT01146652 is a clinical study titled "Long Term Evaluation of Sarilumab in Rheumatoid Arthritis Patients (SARIL-RA-EXTEND)". Main Study: Primary Objective: Assess the long term safety of sarilumab in participants with rheumatoid arthritis (RA). Secondary Objective: Assess the long term efficacy of sarilumab in participants with RA. Sub-Study: This phase 3, open label sub-study was aimed to assess the usability of PF...
What is the current status of trial NCT01146652?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,023 participants. The study started on 2010-06-21. Estimated completion is 2020-12-31.
What interventions are being tested in trial NCT01146652?
The interventions under investigation include: SAR153191 (REGN88) (DRUG).
Who is sponsoring clinical trial NCT01146652?
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 NCT01146652's enrollment target sits among peer trials
2,023 100th of 2000 higher than 1,901 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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