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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: Completed Phase 3 study, sponsored by Sandoz.
NCT02514772 is a Phase 3 study that has completed, run by Sandoz. The registered enrollment target is 107 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
2006 NIAID/FAAN\* criteria were used for identification of anaphylactic reactions within 24h of each study drug infusion. For patients with no history of infusion-related reactions during their previous treatments with rituximab, symptoms/signs in at least 2 out of 4 organ systems: * Skin/mucosal tissue * Respiratory organs * Drop of systolic blood pressure (\<90 mmHg or variance from baseline \>30%) or associated symptoms * Gastrointestinal organs were defined as an anaphylactic reaction. Th
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 |
What the finished NCT02514772 record still lists
NCT02514772 is an interventional study that assigns participants to a tested intervention. The registered 107 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 (86% lower).
The record links to 0 conditions, and to 2 interventions - of which GP2013 - A Proposed biosimilar rituximab is the first listed.
NCT02514772 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02514772's enrollment target sits among peer trials
107 1666th of 2000 higher than 335 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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