Conditions: Rheumatoid Arthritis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 45
Healthy volunteers: no

Brief summary:
The study will compare the effects of prednisone vs placebo on synovial blood flow and overall DAS (disease activity score) in patients with rheumatoid arthritis.

Detailed description:

Arms:
arm 1: Prednisone 15 mg tablets once daily for 15 days arm 2: Prednisone 15 mg placebo tablets once daily for 15 days arm 3: Prednisone 7.5 mg over-encapsulated tablets once daily for 15 days

As per adaptive dose-ranging design, this arm was added to the study because a difference between prednisone 15 mg and placebo was demonstrated during interim analysis. arm 4: Prednisone 7.5 mg placebo over-encapsulated tablets once daily for 15 days

As per adaptive dose-ranging design, this arm was added to the study because a difference between prednisone 15 mg and placebo was demonstrated during interim analysis.

Interventions: intervention 1: Prednisone 15 mg intervention 2: Placebo Tablets intervention 3: Prednisone 7.5 mg intervention 4: Placebo Over-Encapsulated Tablets
Intervention descriptions: intervention 1: Prednisone 15 mg tablets once daily for 15 days. intervention 2: Prednisone placebo tablets once daily for 15 days. intervention 3: Prednisone 7.5 mg over-encapsulated tablets once daily for 15 days intervention 4: Prednisone 7.5 mg placebo over-encapsulated tablets once daily for 15 days

Protocol document: