At a glance
ClinicalIndex Comparison Record- ✓Active rheumatoid arthritis with inflammatory signs (elevated ESR and/or CRP)
- ✓Stable overall clinical condition
- ✓Stable background RA treatments during screening
- ✓Morning stiffness ≥45 minutes on previous standard prednisone therapy (≤10 mg/day)
- ✕Any contraindication to glucocorticoid therapy
- ✕Pregnancy
- ✕Concurrent biologic immunosuppressive therapy
- ✕Intra-articular steroid injection or synovectomy within 4 months
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A New Timed-Release Tablet Formulation of Prednisone Compared to Standard Prednisone in Patients With Rheumatoid Arthritis- A Randomized, Multi-Centre, Double-Blind, Active Controlled Study With Open Extension on the New Drug Only
In Brief
A Phase 3 clinical trial evaluating MR Prednisone, IR Prednisone, and 2 other interventions for Rheumatoid Arthritis. Completed, enrolled 288 participants across 24 sites in 2 countries.
Detailed Summary
The objective of this study is to investigate if low doses of prednisone MR formulation, given at night and, with active drug release at 2 am, are more effective in controlling joint stiffness, and other disease symptoms of rheumatoid arthritis than standard IR prednisone given in the morning.
Study Details
Timeline
Interventions
Participants will receive tablets containing MR prednisone (to achieve the appropriate dose of 3-10 milligrams \[mg\] prednisone per day) at bed time.
Participants will receive tablets containing IR prednisone (to achieve the appropriate dose of 3-10 mg prednisone per day) in the morning.
Participants will receive placebo matching to MR prednisone tablet at bed time.
Participants will receive placebo matching to IR prednisone tablet in the morning.