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NCT01393639 · ClinicalTrials.gov registry record · Phase 2
Study Comparing Doses Of An Experimental Glucocorticoid Compound To Prednisone And Placebo In Rheumatoid Arthritis
A Phase 2 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 2
- Development phase
- 323
- Enrollment target
NCT01393639: Completed Phase 2 study, sponsored by Pfizer.
NCT01393639 is a Phase 2 study that has completed, run by Pfizer. The registered enrollment target is 323 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (143% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01393639, a Phase 2 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 323 participants
- Enrollment target
Study Summary
The purpose of this study is to compare the safety and efficacy of multiple doses of PF-04171327, an experimental glucocorticoid drug, to prednisone at 5 mg or 10 mg and placebo in the treatment of rheumatoid arthritis. All subjects will also be receiving background treatment of methotrexate for their rheumatoid arthritis. Study medication will be given for eight weeks followed by a 4 week period during which the dose of study medication will be gradually reduced. The efficacy of the study medications will be determined by assessing severity of the rheumatoid arthritis during the study and safety will be determined by adverse event reporting, laboratory tests and biomarker analysis.
Primary Outcome
ACR20 response: greater than or equal to (≥) 20 percent (%) improvement in tender joint count; ≥ 20% improvement in swollen joint count; and ≥ 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and C-Reactive Protein (CRP).
Interventions
- DRUG prednisone
- DRUG PF-04171327
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 323 participants |
| Start Date | 2011-09-27 |
| Est. Completion | 2014-06-09 |
| Phase | Phase 2 |
What the finished NCT01393639 record still lists
NCT01393639 is an interventional study that assigns participants to a tested intervention. The registered 323 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 (143% higher).
The record links to 0 conditions, and to 2 interventions - of which prednisone is the first listed.
NCT01393639 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01393639 about?
NCT01393639 is a clinical study titled "Study Comparing Doses Of An Experimental Glucocorticoid Compound To Prednisone And Placebo In Rheumatoid Arthritis". The purpose of this study is to compare the safety and efficacy of multiple doses of PF-04171327, an experimental glucocorticoid drug, to prednisone at 5 mg or 10 mg and placebo in the treatment of rheumatoid arthritis. All subjects will also be receiving background treatment of methotrexate for the...
What is the current status of trial NCT01393639?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 323 participants. The study started on 2011-09-27. Estimated completion is 2014-06-09.
What interventions are being tested in trial NCT01393639?
The interventions under investigation include: prednisone (DRUG), PF-04171327 (DRUG).
Who is sponsoring clinical trial NCT01393639?
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 NCT01393639's enrollment target sits among peer trials
323 150th of 2000 higher than 1,851 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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