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NCT01764997 · ClinicalTrials.gov registry record · Phase 3
An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus Methotrexate
A Phase 3 study, sponsored by Sanofi.
- Terminated
- Registry status
- Phase 3
- Development phase
- 776
- Enrollment target
NCT01764997 is a Phase 3 study that was terminated before completion, run by Sanofi. The registered enrollment target is 776 participants.
The verdict
NCT01764997, a Phase 3 study, was terminated before completion, sponsored by Sanofi.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 776 participants
- Enrollment target
Study Summary
Primary Objective: To demonstrate the treatment effect of sarilumab and methotrexate (MTX) compared to etanercept and MTX in participants with rheumatoid arthritis (RA) and an inadequate response to adalimumab and MTX by evaluation of the Disease Activity Score for 28 joints (DAS28). Secondary Objectives: To assess the signs and symptoms of RA in participants taking sarilumab in combination with MTX. To assess the quality of life of participants with RA taking sarilumab in combination with MTX. To assess the safety and tolerability of sarilumab in combination with MTX in participants with RA.
Interventions
- DRUG Sarilumab
- DRUG Etanercept
- DRUG Methotrexate
- DRUG Placebo (for sarilumab)
- DRUG Placebo (for etanercept)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 776 participants |
| Start Date | 2013-04 |
| Est. Completion | 2015-01 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01764997
The ClinicalTrials.gov registry entry for NCT01764997 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 776 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 5 interventions - of which Sarilumab is the first listed.
NCT01764997 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01764997 about?
NCT01764997 is a clinical study titled "An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus Methotrexate". Primary Objective: To demonstrate the treatment effect of sarilumab and methotrexate (MTX) compared to etanercept and MTX in participants with rheumatoid arthritis (RA) and an inadequate response to adalimumab and MTX by evaluation of the Disease Activity Score for 28 joints (DAS28). Secondary Obj...
What is the current status of trial NCT01764997?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 776 participants. The study started on 2013-04. Estimated completion is 2015-01.
What interventions are being tested in trial NCT01764997?
The interventions under investigation include: Sarilumab (DRUG), Etanercept (DRUG), Methotrexate (DRUG), Placebo (for sarilumab) (DRUG), Placebo (for etanercept) (DRUG).
Who is sponsoring clinical trial NCT01764997?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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