Trial intelligence / Profile preview

Maraviroc in Rheumatoid Arthritis

NCT00427934Phase 2

Key facts

Status: Terminated
Start: Feb 2007
Primary completion: Oct 2008
Countries: 9
Sponsor: Pfizer
Modality: Small Molecules

Drugs: maraviroc
Conditions: rheumatoid arthritis (RA)

Overview

Phase 2, randomised, double-blind trial in rheumatoid arthritis (RA) comparing Maraviroc + MTX with Placebo + MTX (2 arms). Primary endpoint: American College of Rheumatology 20% Response at 12 weeks. Started Feb 2007; status: terminated.

Design

2 arms

Study design: RandomizedDouble-blind

Maraviroc + MTX
Maraviroc 300 mg BID + Methotrexate
Placebo + MTX
Placebo BID + Methotrexate

Who it enrols

Adult patients with active rheumatoid arthritis receiving stable methotrexate, excluding those with CCR5 delta 32 mutation, active infections (HIV, Hep B/C, TB), or significant heart failure.

Endpoints

Primary

American College of Rheumatology 20% Response12 weeks

Secondary

American College of Rheumatology 20% Response8 weeks
American College of Rheumatology 50% Response12 weeks
American College of Rheumatology 70% Response12 weeks
Disease Activity Score 28-joint count C-reactive protein12 weeks
Health Assessment Questionnaire-Disability Index12 weeks
C-Reactive Protein12 weeks
Tender/Painful Joint Count12 weeks
Swollen Joint Count12 weeks

Results

Not all primary endpoints met

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