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NCT02115750 · ClinicalTrials.gov registry record · Phase 3
Comparison of CHS-0214 to Enbrel (Etanercept) in Patients With Rheumatoid Arthritis (RA)
A Phase 3 study, sponsored by Coherus Oncology.
- Completed
- Registry status
- Phase 3
- Development phase
- 647
- Enrollment target
NCT02115750 is a Phase 3 study that has completed, run by Coherus Oncology. The registered enrollment target is 647 participants.
The verdict
NCT02115750, a Phase 3 study, has completed, sponsored by Coherus Oncology.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 647 participants
- Enrollment target
Study Summary
This is a two part study comparing CHS-0214 to Enbrel in patients with active rheumatoid arthritis and an inadequate response with Methotrexate (MTX) who are naive to biologic therapies. Pt.1 is a 24-week randomized, double-blind, active-control, parallel-group, multi-center global study. The primary end point is 20% improvement in American College of Rheumatology criteria (ACR-20) at week 24. Comparing CHS-0214 to Enbrel for efficacy and safety. Pt. 2 is an open-label single arm study in which patients with at least an ACR-20 response receive CHS-0214. Continued response and safety will be evaluated.
Interventions
- DRUG Etanercept
- DRUG CHS-0214
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 647 participants |
| Start Date | 2014-05 |
| Est. Completion | 2016-05 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02115750
The ClinicalTrials.gov registry entry for NCT02115750 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 647 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Coherus Oncology, which has 15 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Etanercept is the first listed.
NCT02115750 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02115750 about?
NCT02115750 is a clinical study titled "Comparison of CHS-0214 to Enbrel (Etanercept) in Patients With Rheumatoid Arthritis (RA)". This is a two part study comparing CHS-0214 to Enbrel in patients with active rheumatoid arthritis and an inadequate response with Methotrexate (MTX) who are naive to biologic therapies. Pt.1 is a 24-week randomized, double-blind, active-control, parallel-group, multi-center global study. The prima...
What is the current status of trial NCT02115750?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 647 participants. The study started on 2014-05. Estimated completion is 2016-05.
What interventions are being tested in trial NCT02115750?
The interventions under investigation include: Etanercept (DRUG), CHS-0214 (DRUG).
Who is sponsoring clinical trial NCT02115750?
This trial is sponsored by Coherus Oncology, which has 15 total clinical trials registered on ClinicalTrials.gov.
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