NCT00427934

Maraviroc in Rheumatoid Arthritis

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Safety and Efficacy of Maraviroc in the Treatment of Rheumatoid Arthritis in Subjects Receiving Methotrexate

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 128 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate whether maraviroc, an investigational drug given with methotrexate (MTX) is safe and effective in the treatment of rheumatoid arthritis in adult patients.

Detailed description

Following a planned interim analysis in the POC component on 21 August 2008 by the internal DMC (Data Monitoring Committee) of study A4001056, the trial was discontinued due to lack of efficacy. All participating investigators/country offices and monitors were notified on 22 August 2008 to cease patient enrollment. The DMC indicated that maraviroc was well tolerated in the Rheumatoid Arthritis patients and there were no safety concerns in the study. The termination date of this trial was 07 October 2008 when the last patient last visit occurred.

Conditions

• Arthritis, Rheumatoid

Interventions

Type	Name	Description
DRUG	Maraviroc	300 mg (2- 150 mg tablets) are administered by mouth twice a day (BID) for 12 weeks.
DRUG	Maraviroc Placebo	Placebo tablets to match active drug. Two tablets are administered by mouth twice a day (BID) for 12 weeks.

Timeline

• Start date: 2007-02-01
• Primary completion: 2008-10-01
• Completion: 2008-10-01
• First posted: 2007-01-29
• Last updated: 2014-11-05
• Results posted: 2010-02-05

Locations

44 sites across 9 countries: United States, Australia, Germany, India, Italy, Mexico, Portugal, Spain, Ukraine