Rheumatoid Arthritis Clinical Trial
Official title:
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)
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.
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. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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