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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: Completed Phase 3 study, sponsored by Coherus Oncology.
NCT02115750 is a Phase 3 study that has completed, run by Coherus Oncology. The registered enrollment target is 647 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (16% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The primary efficacy endpoint in Part 1 was the percentage of subjects who achieved ACR20 (20% improvement according to American College of Rheumatology criteria) at week 24 compared to baseline (last non-missing value prior to first dose). Subjects were considered an ACR20 responder if when compared to baseline (last non-missing value prior to first dose), they achieved a 20% decrease in SJC (Swollen joint count), 20% decrease in TJC (Tender joint count), and 20% improvement in 3 of the followi
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 |
What the finished NCT02115750 record still lists
NCT02115750 is an interventional study that assigns participants to a tested intervention. The registered 647 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 (16% lower).
The record links to 0 conditions, and to 2 interventions - of which Etanercept is the first listed.
NCT02115750 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02115750's enrollment target sits among peer trials
647 572nd of 2000 higher than 1,429 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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