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NCT01526057 · ClinicalTrials.gov registry record · Phase 2
A Pharmacokinetic/Pharmacodynamic Study Comparing PF-05280586 To Rituximab In Subjects With Active Rheumatoid Arthritis With An Inadequate Response To TNF Inhibitors (REFLECTIONS B328-01)
A Phase 2 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 2
- Development phase
- 220
- Enrollment target
NCT01526057: Completed Phase 2 study, sponsored by Pfizer.
NCT01526057 is a Phase 2 study that has completed, run by Pfizer. The registered enrollment target is 220 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (65% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01526057, a Phase 2 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 220 participants
- Enrollment target
Study Summary
In this study, patients with moderate to severe rheumatoid arthritis who are being treated with methotrexate will receive 2 intravenous treatments with either PF-05280586 or Rituxan (Rituximab) or MabThera (Rituximab). During the course of the study, the effects of the drugs will be assessed by sampling the levels of drug in the blood, blood cell counts, and by comparing these levels among the different treatments. Safety, tolerability and immunologic response also will be evaluated throughout.
Primary Outcome
Cmax is the peak serum concentration of study drug (rituximab) after a dose has been administered.
Interventions
- BIOLOGICAL PF-05280586
- BIOLOGICAL Rituxan
- BIOLOGICAL MabThera
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 220 participants |
| Start Date | 2012-03-20 |
| Est. Completion | 2014-05-07 |
| Phase | Phase 2 |
What the finished NCT01526057 record still lists
NCT01526057 is an interventional study that assigns participants to a tested intervention. The registered 220 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (65% higher).
The record links to 0 conditions, and to 3 interventions - of which PF-05280586 is the first listed.
NCT01526057 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01526057 about?
NCT01526057 is a clinical study titled "A Pharmacokinetic/Pharmacodynamic Study Comparing PF-05280586 To Rituximab In Subjects With Active Rheumatoid Arthritis With An Inadequate Response To TNF Inhibitors (REFLECTIONS B328-01)". In this study, patients with moderate to severe rheumatoid arthritis who are being treated with methotrexate will receive 2 intravenous treatments with either PF-05280586 or Rituxan (Rituximab) or MabThera (Rituximab). During the course of the study, the effects of the drugs will be assessed by samp...
What is the current status of trial NCT01526057?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 220 participants. The study started on 2012-03-20. Estimated completion is 2014-05-07.
What interventions are being tested in trial NCT01526057?
The interventions under investigation include: PF-05280586 (BIOLOGICAL), Rituxan (BIOLOGICAL), MabThera (BIOLOGICAL).
Who is sponsoring clinical trial NCT01526057?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01526057's enrollment target sits among peer trials
220 275th of 2000 higher than 1,718 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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