long term safety trial of z102 and prednisone in patients with moderate to severe rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: this study will compare an experimental drug called z102 (combination of prednisolone and dipyridamole, against prednisone 5mg and prednisone 7.5mg in patients with moderate to severe rheumatoid arthritis for a period of 52 weeks.

this is a long-term phase ii safety study of approximately 52 weeks in duration. eligible patients will have completed at least 6 weeks of protocol z102-008 and will have met all inclusion and exclusion criteria for this study. all patients will be up-titrated on z102 over 3 weeks or will receive prednisone 5.0 mg or 7.5 mg: primary objectives: * adverse events (aes) * vital signs * clinical laboratory and clinical chemistry evaluations secondary objectives: * joint imaging and bone density * das28-crp and individual components * patient global assessment of disease activity * american college of rheumatology criteria (acr 20, acr 50, acr 70) * multidimensional assessment of fatigue (maf) * time to failure

Eligibility criteria:
inclusion criteria: * have completed all 12 weeks of protocol z102-008 or discontinued after participating in at least 6 weeks of the randomized withdrawal portion of z102-008 for acceptable reasons * have met all inclusion/exclusion criteria for enrollment into protocol z102-008 * have been on dmard therapy for at least 90 days and have been on a stable dmard dose without dosage adjustment or modification for 6 weeks prior to enrollment into protocol z102-008, and be able to maintain the same dose of conventional dmard therapy during protocol z102-009 participation exclusion criteria: * did not complete 6 weeks of the double-blind section of protocol z102-008, or was discontinued from protocol z102-008 for reasons of an ae, protocol violation, or non-compliance * active cardiovascular disease, unless well controlled by appropriate treatment, for a minimum of 3 months prior to screening for enrollment into protocol z102-008 * currently taking aspirin for reasons other than for cardiovascular prophylaxis or their total daily dose is greater than 325 mg * taking oral steroids at a daily prednisone dose, or the equivalent, of \>10 mg/day within the past 2 weeks * intraarticular, intramuscular, or intravenous glucocorticoids must not have been given at least 6 weeks prior to entering study protocol z102-008 or protocol z102-009, at any time during the study, or be anticipated to be given at any time during the study * the need to continue the use of one or multiple nsaids at the same time, or use acetaminophen on a chronic basis * all opiate use is prohibited. * use of any other medications or herbs or non-pharmacological treatments (e.g., acupuncture) used for the treatment of pain is prohibited * has, or has had, any active severe infections or recent invasive surgical procedures within 30 days of protocol z102-008 or protocol z102-009 initiation * hiv, hepatitis b, or hepatitis c infection * has undergone administration of any investigational drug within 30 days of study * all biologic agents are excluded for 90 days prior to screening and during the conduct of protocol z102-008, and protocol z102-009 * has undergone administration of rituximab or any b-cell depleting investigational drugs within 6 months of protocol z102-008 screening or protocol z102-009 initiation, or at any time during participation in study protocol z102-008 * has a history of hypersensitivity reaction to glucocorticoids and/or dipyridamole * known or suspected history of alcohol or drug abuse within 2 years prior to screening for protocol z102-008 * has any other medical condition which may interfere with the conduct of this study in the opinion of the investigator

Keywords: moderate to severe