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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 is a Phase 2 study that has completed, run by Pfizer. The registered enrollment target is 323 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01393639
The ClinicalTrials.gov registry entry for NCT01393639 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 323 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which prednisone is the first listed.
NCT01393639 reports 0 study locations.
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.
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