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NCT01164579 · ClinicalTrials.gov registry record · Phase 2
Effects of Tofacitinib (CP-690,550) on Magnetic Resonance Imaging (MRI)- Assessed Joint Structure In Early Rheumatoid Arthritis (RA)
A Phase 2 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 2
- Development phase
- 109
- Enrollment target
NCT01164579: Completed Phase 2 study, sponsored by Pfizer.
NCT01164579 is a Phase 2 study that has completed, run by Pfizer. The registered enrollment target is 109 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (18% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01164579, a Phase 2 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 109 participants
- Enrollment target
Study Summary
Evaluation of efficacy and safety of tofacitinib (CP-690,550) for the treatment of early rheumatoid arthritis in adult patients with moderate to severe disease who are methotrexate naïve. The efficacy will be evaluated by exploring the effects on joint structure assessed by magnetic resonance imaging, x-rays and by standard clinical assessment.
Primary Outcome
Synovitis is defined as an area in the synovial compartment that shows above normal postgadolinium enhancement of a thickness greater than the width of the normal synovium. T1-weighted images were acquired before and after the administration of intravenous contrast agent containing gadolinium. Intravenous contrast was required to demonstrate enhancing synovitis. Synovitis was scored 0 to 3 in 3 wrist regions and in each of the first through fifth MCP joints. A score of 0 is normal, with no enhan
Interventions
- DRUG Tasocitinib plus Methotrexate
- DRUG Tofacitinib plus placebo methotrexate
- DRUG Placebo tofacitinib plus Methotrexate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 109 participants |
| Start Date | 2010-10 |
| Est. Completion | 2013-11 |
| Phase | Phase 2 |
What the finished NCT01164579 record still lists
NCT01164579 is an interventional study that assigns participants to a tested intervention. The registered 109 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (18% lower).
The record links to 0 conditions, and to 3 interventions - of which Tasocitinib plus Methotrexate is the first listed.
NCT01164579 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01164579 about?
NCT01164579 is a clinical study titled "Effects of Tofacitinib (CP-690,550) on Magnetic Resonance Imaging (MRI)- Assessed Joint Structure In Early Rheumatoid Arthritis (RA)". Evaluation of efficacy and safety of tofacitinib (CP-690,550) for the treatment of early rheumatoid arthritis in adult patients with moderate to severe disease who are methotrexate naïve. The efficacy will be evaluated by exploring the effects on joint structure assessed by magnetic resonance imagin...
What is the current status of trial NCT01164579?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 109 participants. The study started on 2010-10. Estimated completion is 2013-11.
What interventions are being tested in trial NCT01164579?
The interventions under investigation include: Tasocitinib plus Methotrexate (DRUG), Tofacitinib plus placebo methotrexate (DRUG), Placebo tofacitinib plus Methotrexate (DRUG).
Who is sponsoring clinical trial NCT01164579?
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 NCT01164579's enrollment target sits among peer trials
109 640th of 2000 higher than 1,361 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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