Prednisone Timed-Release Tablet (TRT) Study: TRT Formulation of Prednisone Compared to Standard Prednisone in Patients With Rheumatoid Arthritis
Information source: EMD Pharmaceuticals
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Rheumatoid Arthritis
Intervention: Prednisone (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Merck KGaA Official(s) and/or principal investigator(s):
Frank Buttgereit, Prof. Dr., Principal Investigator, Affiliation: University Medicine Berlin, Charité Campus Mitte, Berlin, Germany
Summary
The objective of this study is to investigate if low doses of prednisone TRT, 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 prednisone given in the morning.
Treatment duration per patient takes 12 months (the double-blind comparative study takes 3
months; 9 months subsequent open treatment on the TRT-medication).
Clinical Details
Official title: 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
Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: duration of morning stiffness after 3 months of double-blind treatment with either formulation of prednisone
Secondary outcome: all other symptoms and routine assessments as usually measured in rheumatoid arthritissafety of long term treatment
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
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
10mg per day) equal to or above 45 minutes
Exclusion Criteria:
- All contra-indications for glucocorticoids
- Pregnancy
- Concomitant treatment with biologics
- Intra-articular injections or synovectomy within the previous 4 months
Locations and Contacts
Research Site, Berlin, Germany
Research Site, Leipzig, Germany
Research Site, Jena, Germany
Research Site, Erlangen, Germany
Research Site, Frankfurt/Main, Germany
Research Site, Köln, Germany
Research Site, München, Germany
Research Site, Rostock, Germany
Research Site, Dresden, Germany
Research Site, Düsseldorf, Germany
Research Site, Ratingen, Germany
Research Site, Hamburg, Germany
Research Site, Hannover, Germany
Research Site, Bad Kreuznach, Germany
Research Site, Aachen, Germany
Research Site, Wroclaw, Poland
Research Site, Warszawa, Poland
Research Site, Poznan, Poland
Research Site, Lublin, Poland
Research Site, Kraków, Poland
Research Site, Torun, Poland
Research Site, Sopot, Poland
Research Site, Bialystok, Poland
Research Site, Katowice, Poland
Additional Information
Starting date: August 2004
Ending date: February 2007
Last updated: April 2, 2007
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