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Sponsored by: |
Merck KGaA |
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Information provided by: | Merck KGaA |
ClinicalTrials.gov Identifier: | NCT00146640 |
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).
Condition | Intervention | Phase |
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Rheumatoid Arthritis |
Drug: Prednisone |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 240 |
Study Start Date: | August 2004 |
Estimated Study Completion Date: | February 2007 |
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Germany | |
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Berlin, Germany | |
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Leipzig, Germany | |
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Jena, Germany | |
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Erlangen, Germany | |
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Frankfurt/Main, Germany | |
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Köln, Germany | |
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Hamburg, Germany | |
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Rostock, Germany | |
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Dresden, Germany | |
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Düsseldorf, Germany | |
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Ratingen, Germany | |
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München, Germany | |
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Hannover, Germany | |
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Bad Kreuznach, Germany | |
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Aachen, Germany | |
Poland | |
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Wroclaw, Poland | |
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Warszawa, Poland | |
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Poznan, Poland | |
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Katowice, Poland | |
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Kraków, Poland | |
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Torun, Poland | |
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Sopot, Poland | |
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Bialystok, Poland | |
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Lublin, Poland |
Principal Investigator: | Frank Buttgereit, Prof. Dr. | University Medicine Berlin, Charité Campus Mitte, Berlin, Germany |
Study ID Numbers: | EMR 62215-003 |
Study First Received: | September 6, 2005 |
Last Updated: | March 21, 2009 |
ClinicalTrials.gov Identifier: | NCT00146640 History of Changes |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
active disease morning stiffness of joints nighttime application of prednisone modified releae prednisone |
Anti-Inflammatory Agents Prednisone Autoimmune Diseases Antineoplastic Agents, Hormonal Joint Diseases Hormone Antagonists Arthritis, Rheumatoid |
Hormones, Hormone Substitutes, and Hormone Antagonists Rheumatic Diseases Glucocorticoids Hormones Musculoskeletal Diseases Arthritis Connective Tissue Diseases |
Anti-Inflammatory Agents Prednisone Autoimmune Diseases Antineoplastic Agents, Hormonal Immune System Diseases Antineoplastic Agents Joint Diseases Physiological Effects of Drugs Arthritis, Rheumatoid |
Hormones, Hormone Substitutes, and Hormone Antagonists Rheumatic Diseases Glucocorticoids Hormones Pharmacologic Actions Musculoskeletal Diseases Therapeutic Uses Arthritis Connective Tissue Diseases |