A Study to Assess CH1504 in Patients With Active Rheumatoid Arthritis

Phase 2 Completed 201 enrolled Chelsea Therapeutics

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this trial is to assess the clinical effect of CH-1504 at doses of 0.25, 0.5 and 1.0 mg per day in patients with active rheumatoid arthritis by determining the proportion of patients achieving an American College of Rheumatology (ACR) 20% improvement response.

Timeline

Start: 2008-04
Primary completion: 2009-02
Completion: 2009-06

Publications

Keystone EC, Shirinsky VS, Simon LS, Pedder S, Hewitt LA; CH-1504 Study Group. Efficacy and safety of CH-1504, a metabolically stable antifolate, in patients with active rheumatoid arthritis: results of a phase II multicenter randomized study. J Rheumatol. 2011 Sep;38(9):1875-83. doi: 10.3899/jrheum.101038. Epub 2011 Jul 1.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	CH-1504	Other / unclassified	0.25 mg	Oral
Subject	CH-1504	Other / unclassified	0.5 mg	Oral
Subject	CH-1504	Other / unclassified	1 mg	Oral
Comparator	Methotrexate	Small molecule	20 mg	Oral

A Study to Assess CH1504 in Patients With Active Rheumatoid Arthritis

Summary

Timeline

Publications

Drugs

Indications