Study Comparing Doses Of An Experimental Glucocorticoid Compound To Prednisone And Placebo In Rheumatoid Arthritis
Public ClinicalTrials.gov record NCT01393639. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A PHASE 2, RANDOMIZED, DOUBLE BLIND ASSESSMENT OF EFFICACY AND SAFETY OF PF 04171327(1, 5, 10, 15 MG DOSE, DAILY) COMPARED TO 5 MG AND 10 MG PREDNISONE DAILY AND PLACEBO DAILY IN SUBJECTS WITH RHEUMATOID ARTHRITIS OVER AN 8 WEEK PERIOD FOLLOWED BY A 4 WEEK PERIOD OF TAPERING OF STUDY DRUG.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01393639
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 323 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 27, 2011 (Actual)
- Primary completion
- Jun 3, 2014 (Actual)
- Completion
- Jun 9, 2014 (Actual)
- Last update posted
- Sep 4, 2024
2011 – 2014
United States locations
- U.S. sites
- 14
- U.S. states
- 10
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Catalina Pointe Clinical Research, Inc. | Tucson | Arizona | 85704 | — |
| C. Michael Neuwelt, MD, Inc. | San Leandro | California | 94578 | — |
| Javed Rheumatology Associates, Inc. | Newark | Delaware | 19713 | — |
| Allergy, Asthma, Arthritis, and Lung Center | Daytona Beach | Florida | 32114 | — |
| Millennium Research | Ormond Beach | Florida | 32174 | — |
| Alastair C. Kennedy, MD | Vero Beach | Florida | 32960 | — |
| The Center for Arthritis and Rheumatism | Vero Beach | Florida | 32960 | — |
| Arthritis and Osteoporosis Medical Associates, PLLC | Brooklyn | New York | 11201 | — |
| Cincinnati Rheumatic Disease Study Group, Inc. | Cincinnati | Ohio | 45219 | — |
| Altoona Center for Clinical Research | Duncansville | Pennsylvania | 16635 | — |
| Low Country Rheumatology, PA | Charleston | South Carolina | 29406 | — |
| Tricounty Radiology | Charleston | South Carolina | 29406 | — |
| Accurate Clinical Research, Inc. | Houston | Texas | 77034 | — |
| Arthritis Northwest, PLLC | Spokane | Washington | 99204 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 79 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01393639, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 4, 2024 · Synced Oct 23, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01393639 live on ClinicalTrials.gov.