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

Completed · Phase 2 · Has a placebo group

Conditions studied: Rheumatoid Arthritis

In brief

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.

Key facts

Study ID

NCT00551707

Run by

Zalicus

People needed

51

Starts

2007-10-01

Expected to finish

2009-01-01

Last updated by the study team

2014-04-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject must voluntarily give written informed consent
• Subject must be ≥ 18 years of age
• Subject must have RA (ACR criteria)
• Subject must have at least 4 swollen joints and at least 6 tender joints at screening and baseline (28 joint count)
• Subject must have a CRP > Upper Limit of Normal at screening
• Subject must have been on DMARD or DMARD combination (e.g. MTX + hydroxychloroquine) for at least 3 months and be on a stable dose of DMARD(s) for at least 6 weeks prior to screening.
• For MTX subjects: MTX ≥ 7.5 mg weekly (po/sc/im) and willing to take folic acid or folinic acid supplementation
• Subject willing to take concomitant multivitamin or the equivalent of 400 I.U. vitamin D and the equivalent of 1000 mg of elemental calcium daily

You may not qualify if…

• History of clinically significant (as determined by the Investigator) cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease
• Wheelchair or bed bound
• History of osteoporotic fracture
• History of malignancy within the past 10 years. However, subjects with a history of treated or excised basal cell carcinoma or fewer than 3 squamous cell carcinomas are eligible to participate
• History of lymphoma or chronic leukemia
• Moles or lesions that are currently undiagnosed, but are suspicious for malignancy
• Surgery within the previous 3 months (except for minor dental and cosmetic)
• History of drug or alcohol abuse (as defined by the Investigator)
• History of bleeding disorder
• History of gastrointestinal bleeding within 5 years of screening
• History of severe migraines or headaches
• History of glaucoma
• Active diabetic retinopathy
• Visually compromising cataract
• History of opportunistic infection within the previous 12 months
• Active Tuberculosis (TB)
• Serious local infection (e.g., cellulitis, abscess) or systemic infection (e.g., septicemia) within 3 months prior to screening
• Fever or symptomatic viral or bacterial infection within 2 weeks prior to screening
• Positive for Hepatitis C virus (HCV) antibody
• Positive for HBsAg
• Known positive HIV antibody
• Has a history of hypersensitivity to glucocorticoids and/or dipyridamole
• Treatment with oral, intra-articular, intramuscular, or intravenous glucocorticoids within 6 weeks prior to screening; inhaled glucocorticoid is permitted
• Treatment with any tumor necrosis factor-alpha (TNFα) biologic, anakinra or abatacept within 2 months prior to screening
• Treatment with rituximab

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — Huntsville, Alabama, United States
• Study site — Phoenix, Arizona, United States
• Study site — Little Rock, Arkansas, United States
• Study site — Anaheim, California, United States
• Study site — La Jolla, California, United States
• Study site — Westlake Village, California, United States
• Study site — Palm Harbor, Florida, United States
• Study site — Elizabethtown, Kentucky, United States
• Study site — Haddon Heights, New Jersey, United States
• Study site — Mayfield Village, Ohio, United States
• Study site — Oklahoma City, Oklahoma, United States
• Study site — Dallas, Texas, United States
• Study site — Buenos Aires, Buenos Aires, Argentina
• Study site — Rosario, Santa Fe Province, Argentina
• Study site — San Jan, Argentina
• Study site — San Miguel de Tucumán, Argentina
• Study site — Winnipeg, Manitoba, Canada
• Study site — St. John's, Newfoundland and Labrador, Canada
• Study site — Hamilton, Ontario, Canada
• Study site — Windsor, Ontario, Canada
• Study site — Tallinn, Estonia
• Study site — Tartu, Estonia
• Study site — Békéscsaba, Hungary
• Study site — Esztergom, Hungary

Full record on ClinicalTrials.gov

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