Conditions: Rheumatoid Arthritis
Keywords: treatment of rheumatoid arthritis treatment of RA patients on methotrexate for rheumatoid arthritis prednisone for rheumatoid arthritis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 323
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None arm 7: None

Interventions: intervention 1: PF-04171327 intervention 2: PF-04171327 intervention 3: PF-04171327 intervention 4: PF-04171327 intervention 5: prednisone intervention 6: prednisone intervention 7: placebo
Intervention descriptions: intervention 1: 1 mg tablet once daily (QD) for 8 weeks intervention 2: 5 mg tablet once daily (QD) for 8 weeks intervention 3: 10 mg tablet once daily (QD) for 8 weeks intervention 4: 15 mg tablet once daily (QD) for 8 weeks intervention 5: 5 mg capsule once daily for 8 weeks intervention 6: 10 mg capsule once daily for 8 weeks intervention 7: placebo (tablet or capsule) once daily (QD) for 8 weeks

Protocol document: