Study Evaluating CCI-779 in Active Rheumatoid Arthritis on Concomitant Methotrexate Therapy
The primary objective of this study is to compare the therapeutic response and safety of 3 oral dose levels of CCI-779, with placebo in subjects with active rheumatoid arthritis (RA) who have been receiving stable doses of methotrexate (MTX) for at least 8 weeks.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||A Double-Blind, Parallel, Placebo-Controlled, Randomized Study to Evaluate the Efficacy and Safety of 3 Different Oral Dose Levels (1, 2, And 4 Mg) of CCI-779 in Subjects With Active Rheumatoid Arthritis on Concomitant Methotrexate Therapy|
|Study Start Date:||December 2003|
|Study Completion Date:||August 2005|
|Primary Completion Date:||August 2005 (Final data collection date for primary outcome measure)|
CCI-779 1 mg dose to be taken orally daily up to 12 weeks.
CCI-779 2 mg dose to be taken orally daily up to 12 weeks.
CCI-779 4 mg dose to be taken orally daily up to 12 weeks.
Placebo Comparator: D
Placebo dose to be taken orally daily up to 12 weeks.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00076206
|Study Director:||Medical Monitor, MD||Wyeth is now a wholly owned subsidiary of Pfizer|