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NCT01274182 · ClinicalTrials.gov registry record · Phase 1
GP2013 in the Treatment of RA Patients Refractory to or Intolerant of Standard Therapy
A Phase 1 study, sponsored by Sandoz.
- Completed
- Registry status
- Phase 1
- Development phase
- 312
- Enrollment target
NCT01274182: Completed Phase 1 study, sponsored by Sandoz.
NCT01274182 is a Phase 1 study that has completed, run by Sandoz. The registered enrollment target is 312 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (420% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01274182, a Phase 1 study, has completed, sponsored by Sandoz.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 312 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the PK/PD, efficacy and safety of GP2013 in patients with severe rheumatoid arthritis.
Primary Outcome
Area under the curve AUC(0-inf) calculated based on serum samples, collected from baseline up to 24 weeks: Day 1, 4, 8, 15, 18, 29, 57, 85,113 and 169
Interventions
- BIOLOGICAL Rituxan
- BIOLOGICAL GP2013
- BIOLOGICAL MabThera
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 312 participants |
| Start Date | 2011-01 |
| Est. Completion | 2016-11 |
| Phase | Phase 1 |
What the finished NCT01274182 record still lists
NCT01274182 is an interventional study that assigns participants to a tested intervention. The registered 312 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (420% higher).
The record links to 0 conditions, and to 3 interventions - of which Rituxan is the first listed.
NCT01274182 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01274182 about?
NCT01274182 is a clinical study titled "GP2013 in the Treatment of RA Patients Refractory to or Intolerant of Standard Therapy". The purpose of this study is to determine the PK/PD, efficacy and safety of GP2013 in patients with severe rheumatoid arthritis.
What is the current status of trial NCT01274182?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 312 participants. The study started on 2011-01. Estimated completion is 2016-11.
What interventions are being tested in trial NCT01274182?
The interventions under investigation include: Rituxan (BIOLOGICAL), GP2013 (BIOLOGICAL), MabThera (BIOLOGICAL).
Who is sponsoring clinical trial NCT01274182?
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 NCT01274182's enrollment target sits among peer trials
312 119th of 2000 higher than 1,881 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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