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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 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 2,023 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01146652
The ClinicalTrials.gov registry entry for NCT01146652 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 2,023 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which SAR153191 (REGN88) is the first listed.
NCT01146652 reports 0 study locations.
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.
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