CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 323 enrolled
Drug / intervention
PF-04171327 +6 moredrug
Likely dose
PF-04171327 1 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01393639
NCT01393639Phase 2Completed
CompareCT.gov

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.

Pfizer·interventional·Posted Jul 13, 2011·Updated Sep 4, 2024

In Brief

A Phase 2 clinical trial evaluating PF-04171327, prednisone, and 1 other intervention for Rheumatoid Arthritis. Completed, enrolled 323 participants across 93 sites in 18 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesBulgaria, Colombia, Czechia, Germany, Hungary, India, Malaysia, Mexico, Poland, Romania, Russia, Serbia, Slovakia, South Africa, South Korea, Spain, Ukraine, United States
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJul 13, 2011
Enrollment StartSep 27, 2011
Primary CompletionJun 3, 2014
Study CompletionJun 9, 2014
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 15.0 years ago

Interventions

PF-04171327drug

1 mg tablet once daily (QD) for 8 weeks

PF-04171327drug

5 mg tablet once daily (QD) for 8 weeks

PF-04171327drug

10 mg tablet once daily (QD) for 8 weeks

PF-04171327drug

15 mg tablet once daily (QD) for 8 weeks

prednisonedrug

5 mg capsule once daily for 8 weeks

prednisoneother

10 mg capsule once daily for 8 weeks

placeboother

placebo (tablet or capsule) once daily (QD) for 8 weeks