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NCT02514772 · ClinicalTrials.gov registry record · Phase 3
GP2013 Treatment in Patients With Active Rheumatoid Arthritis, Previously Treated With Rituxan® or MabThera®
A Phase 3 study, sponsored by Sandoz.
- Completed
- Registry status
- Phase 3
- Development phase
- 107
- Enrollment target
NCT02514772 is a Phase 3 study that has completed, run by Sandoz. The registered enrollment target is 107 participants.
The verdict
NCT02514772, a Phase 3 study, has completed, sponsored by Sandoz.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 107 participants
- Enrollment target
Study Summary
The study objective is to identify potential safety risks of the transition from US-licensed Rituxan® or EU-approved MabThera® to GP2013 (proposed biosimilar product) as compared to continuous treatment with the originator product in terms of general safety and immunogenicity.
Interventions
- BIOLOGICAL GP2013 - A Proposed biosimilar rituximab
- BIOLOGICAL Originator rituximab - Rituxan ® or MabThera ®
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 107 participants |
| Start Date | 2015-07 |
| Est. Completion | 2016-10 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02514772
The ClinicalTrials.gov registry entry for NCT02514772 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 107 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sandoz, which has 29 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which GP2013 - A Proposed biosimilar rituximab is the first listed.
NCT02514772 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02514772 about?
NCT02514772 is a clinical study titled "GP2013 Treatment in Patients With Active Rheumatoid Arthritis, Previously Treated With Rituxan® or MabThera®". The study objective is to identify potential safety risks of the transition from US-licensed Rituxan® or EU-approved MabThera® to GP2013 (proposed biosimilar product) as compared to continuous treatment with the originator product in terms of general safety and immunogenicity.
What is the current status of trial NCT02514772?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 107 participants. The study started on 2015-07. Estimated completion is 2016-10.
What interventions are being tested in trial NCT02514772?
The interventions under investigation include: GP2013 - A Proposed biosimilar rituximab (BIOLOGICAL), Originator rituximab - Rituxan ® or MabThera ® (BIOLOGICAL).
Who is sponsoring clinical trial NCT02514772?
This trial is sponsored by Sandoz, which has 29 total clinical trials registered on ClinicalTrials.gov.
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