Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis Moderate to severe
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 294
Healthy volunteers: no

Brief summary:
Thus study will test an experimental drug called Z-102 (combination of prednisolone and dipyridamole) to treat patients with moderate to severe rheumatoid arthritis.

Detailed description:
The primary objective of the study was to demonstrate the efficacy of Z102 (2.7 mg prednisolone/360 mg dipyridamole) versus placebo on the Disease Activity Score 28 using C reactive protein (DAS28-CRP) in subjects with rheumatoid arthritis at the study endpoint of 12 weeks

Arms:
arm 1: Prednisolone 2.7 mg daily for 12 weeks arm 2: Dipyridamole 360 mg daily for 12 weeks arm 3: Prednisone 5 mg daily for 12 weeks arm 4: Prednisolone 2.7 mg plus dipyridamole 360 mg daily for 12 weeks arm 5: Placebo daily for 12 weeks

Interventions: intervention 1: Prednisolone intervention 2: dipyridamole intervention 3: Prednisone intervention 4: Z102 intervention 5: placebo
Intervention descriptions: intervention 1: Prednisolone 2.7 mg daily intervention 2: dipyridamole 360 mg daily intervention 3: Prednisone 5 mg daily intervention 4: Prednisolone 2.7 mg plus dipyridamole 360 mg daily intervention 5: None

Protocol document: