Status:
COMPLETED
Prednisone Timed-Release Tablet (TRT) Study: Modified-Release (MR) Formulation of Prednisone Compared to Standard Immediate-Release (IR) Prednisone in Participants With Rheumatoid Arthritis
Lead Sponsor:
Merck KGaA, Darmstadt, Germany
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief 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 ot...
Eligibility Criteria
Inclusion
- 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
- All contra-indications for glucocorticoids
- Pregnancy
- Concomitant treatment with biologics
- Intra-articular injections or synovectomy within the previous 4 months
Key Trial Info
Start Date :
August 31 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2007
Estimated Enrollment :
288 Patients enrolled
Trial Details
Trial ID
NCT00146640
Start Date
August 31 2004
End Date
January 31 2007
Last Update
July 3 2018
Active Locations (24)
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1
Research Site
Aachen, Germany
2
Research Site
Bad Kreuznach, Germany
3
Research Site
Berlin, Germany
4
Research Site
Cologne, Germany