NCT01116141

A Study of CH-4051 in Patients With Rheumatoid Arthritis (RA)

A Phase II, Multi-center, Randomized, Parallel Group, Double-blind, MTX Controlled Study to Assess the Clinical Efficacy, Safety and Tolerability of CH-4051 in Patients With Active RA Who Have Shown an Inadequate Response to MTX Monotherapy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 250 (actual)
• Sponsor: Chelsea Therapeutics · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if CH-4051 is a safe and effective treatment for rheumatoid arthritis.

Detailed description

Multi-center, multi-national, double-blind, randomized, active-controlled (MTX), 3-month study with 4 doses of CH-4051 (0.3 mg, 1.0 mg, 3.0 mg and 3.0 mg with 1mg of folic acid supplementation p.o. daily) compared to a "standard" dose of MTX at 20 mg per week with 1 mg of folic acid supplementation p.o. daily. This study will be conducted in two parts: Part A: Patients will be randomized to 0.3 mg CH-4051, 1.0 mg CH-4051 or MTX. Part B: Patients will not be randomized into Part B until the Data Monitoring Committee has reviewed safety data from the Part A when approximately 25 patients (10 patients in each CH-4051 dose groups and 5 patients in the MTX groups) have completed 3 months of treatment. At this time the DMC will make a recommendation whether or not to commence randomization to 3.0 mg CH-4051, 3.0 mg CH-4051 with 1.0 mg of folic acid.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	CH-4051	Different doses CH-4051 to be compared
DRUG	Methotrexate (MTX)	20 mg MTX weekly
DRUG	Folic Acid	1 mg folic acid daily

Timeline

• Start date: 2010-09-01
• Primary completion: 2012-04-01
• Completion: 2012-05-01
• First posted: 2010-05-04
• Last updated: 2013-04-15