NCT00551707

Multicenter Study to Evaluate CRx-102 vs. Each of Its Components to Treat Active Rheumatoid Arthritis

A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Superiority of CRx-102 Over Each of Its Components When Given to Subjects With Active Rheumatoid Arthritis (RA)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Zalicus · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

CRx-102 is a synergistic combination drug candidate containing the cardiovascular drug dipyridamole and a very low dose of the glucocorticoid prednisolone. CRx-102 is believed to work through a novel mechanism of action in which dipyridamole selectively amplifies the anti-inflammatory and immunomodulatory activities of the glucocorticoid without replicating the dose-dependent adverse effects. CRx-102 has been associated with clinical benefit in proof of concept studies in subjects with hand Osteoarthritis (OA) and Rheumatoid Arthritis (RA). In this trial, CRx-102 will be given to subjects with active RA as an add-on therapy to existing stable doses of Disease Modifying Anti-Rheumatic Drugs (DMARDs) including methotrexate (MTX), sulfasalazine, hydroxychloroquine, leflunomide or azathioprine. MTX in combination with other DMARDs (e.g., sulfasalazine or hydroxychloroquine) will be permitted to reflect the current standard of care practices within rheumatology.

Detailed description

The study was discontinued before the enrollment objective was met. Preliminary review of the efficacy dataset revealed that the efficacy dataset was not robust enough to support an extensive formal efficacy analysis as described in the SAP. Therefore, only the CRP values over time and the percent change in C-reactive protein (CRP) values in the As-Treated population were calculated.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	CRx-102 (2.7/180)	prednisolone 2.7 mg plus dipyridamole 180 mg
DRUG	prednisolone	prednisolone (2.7 mg)
DRUG	dipyridamole	dipyridamole 360 mg
DRUG	placebo	placebo
DRUG	CRx-102 (2.7/360)	Prednisolone 2.7 mg plus Dipyridamole 360 mg

Timeline

• Start date: 2007-10-01
• Primary completion: 2008-11-01
• Completion: 2009-01-01
• First posted: 2007-10-31
• Last updated: 2014-04-29
• Results posted: 2014-04-29

Locations

48 sites across 12 countries: United States, Argentina, Canada, Estonia, Hungary, Lithuania, Mexico, Poland, Romania, Russia, Serbia, South Africa