Prednisone Timed-Release Tablet (TRT) Study: Modified-Release (MR) Formulation of Prednisone Compared to Standard Immediate-Release (IR) Prednisone in Participants With Rheumatoid Arthritis
Rheumatoid Arthritis
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring active disease, morning stiffness of joints, nighttime application of prednisone, modified release prednisone
Eligibility 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
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
MR Prednisone
IR Prednisone
Participants will receive MR prednisone at bed time and placebo matching to IR prednisone in the morning. Total duration of double blind treatment will be 12 weeks.
Participants will receive IR prednisone in the morning and placebo matching to MR prednisone at bed time. Total duration of double blind treatment will be 12 weeks.