Multicenter Study to Evaluate CRx-102 vs. Each of Its Components to Treat Active Rheumatoid Arthritis
Status:
Completed
Trial end date:
2009-01-01
Target enrollment:
Participant gender:
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.