Prednisone Timed-Release Tablet (TRT) Study: Modified-Release (MR) Formulation of Prednisone Compared to Standard Immediate-Release (IR) Prednisone in Participants With Rheumatoid Arthritis

• Status: Completed
• Trial end date: 2007-01-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck KGaA; Merck KGaA, Darmstadt, Germany
• Treatments: Prednisone

Criteria

Inclusion Criteria:

• Active disease (inflammatory signs, erythrocyte sedimentation rate [ESR], C-reactive protein [CRP])

• Stable condition

• Stable basic treatments

• Morning stiffness on previous treatment with standard prednisone (below or equal to 10 mg per day) greater than or equal to (>/=) 45 minutes

Exclusion Criteria:

• All contra-indications for glucocorticoids

• Pregnancy

• Concomitant treatment with biologics

• Intra-articular injections or synovectomy within the previous 4 months