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NCT02638259 · ClinicalTrials.gov registry record · Phase 3
Comparative Efficacy and Safety Study of GP2015 and Enbrel® in Patients With Rheumatoid Arthritis
A Phase 3 study, sponsored by Sandoz.
- Completed
- Registry status
- Phase 3
- Development phase
- 376
- Enrollment target
NCT02638259: Completed Phase 3 study, sponsored by Sandoz.
NCT02638259 is a Phase 3 study that has completed, run by Sandoz. The registered enrollment target is 376 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (51% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02638259, a Phase 3 study, has completed, sponsored by Sandoz.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 376 participants
- Enrollment target
Study Summary
Demonstrate equivalent efficacy of GP2015 and EU-authorized Enbrel in patients with moderate to severe, active (RA) who had an inadequate response to disease modifying anti-rheumatic drugs (DMARD) including methotrexate (MTX).
Primary Outcome
Disease activity score (DAS) 28-CRP is based on 28-joint count (tender and swollen joints), C-reactive protein and patient's assessment of global disease activity, values range from 0.96 to 10.0 while higher values mean a higher disease activity. • A DAS28-CRP value \>5.1 corresponds to a high disease activity • A DAS28-CRP value between 3.2 and 5.1 corresponds to a moderate disease activity • A DAS28-CRP value between 2.6 and 3.2 corresponds to a low disease activity • A DAS28-CRP value \< 2.6
Interventions
- DRUG GP2015
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 376 participants |
| Start Date | 2015-02-21 |
| Est. Completion | 2017-06-12 |
| Phase | Phase 3 |
What the finished NCT02638259 record still lists
NCT02638259 is an interventional study that assigns participants to a tested intervention. The registered 376 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 (51% lower).
The record links to 0 conditions, and to 1 intervention - of which GP2015 is the first listed.
NCT02638259 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02638259 about?
NCT02638259 is a clinical study titled "Comparative Efficacy and Safety Study of GP2015 and Enbrel® in Patients With Rheumatoid Arthritis". Demonstrate equivalent efficacy of GP2015 and EU-authorized Enbrel in patients with moderate to severe, active (RA) who had an inadequate response to disease modifying anti-rheumatic drugs (DMARD) including methotrexate (MTX).
What is the current status of trial NCT02638259?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 376 participants. The study started on 2015-02-21. Estimated completion is 2017-06-12.
What interventions are being tested in trial NCT02638259?
The interventions under investigation include: GP2015 (DRUG).
Who is sponsoring clinical trial NCT02638259?
This trial is sponsored by Sandoz, which has 29 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02638259's enrollment target sits among peer trials
376 988th of 2000 higher than 1,013 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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