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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
18
Nemanja Damjanov
Belgrade, Serbia
Difference in incidence rates of adverse events between treament groups
Time frame: 12 months
Joint imaging
Time frame: 12 months
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