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Sponsored by: |
Bispebjerg Hospital |
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Information provided by: | Bispebjerg Hospital |
ClinicalTrials.gov Identifier: | NCT00524381 |
The purpose of this study is to evaluate the effect of the tumor necrosis factor alpha (TNF) antagonist, etanercept, on the early clinical course of polymyalgia rheumatica (PMR).
PMR is a common inflammatory disease with an unknown etiology that is characterized by aching, tender, and stiff proximal muscle. Some evidence suggests that TNF plays a central role in the pathophysiology of PMR.
The preferred treatment with glucocorticoids (GCs) is adequate for most patients, but a subset of patients have a more prolonged, relapsing disease course. These patients require treatment with GCs for 1 to 2 years. GC related adverse events are frequent during treatment.
Condition | Intervention | Phase |
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Polymyalgia Rheumatica |
Drug: Etanercept (Enbrel) Drug: Sodium chloride (placebo) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | The Effect of Etanercept on the Early Clinical Course of Polymyalgia Rheumatica (Pilot Study) |
Estimated Enrollment: | 40 |
Study Start Date: | August 2007 |
Estimated Study Completion Date: | July 2009 |
Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Exclusion Criteria (controls):
Contact: Henrik Galbo, Professor | 004540466267 | hgalbo@mfi.ku.dk |
Contact: Frederik Kreiner, MSc | 004527292993 | frederik.kreiner@gmail.com |
Denmark | |
Bispebjerg Hospital, Department of Rheumatology | Recruiting |
Copenhagen NV, Denmark, DK-2400 | |
Contact: Henrik Galbo, Professor 0045-40466267 hgalbo@mfi.ku.dk | |
Contact: Frederik Kreiner, MSc 004527292993 frederik.kreiner@gmail.com | |
Principal Investigator: Henrik Galbo, Professor | |
Sub-Investigator: Frederik Kreiner, MSc | |
Sub-Investigator: Malene Jull, MD |
Study Director: | Henrik Galbo, Professor | Bispebjerg Hospital, Department of Rheumatology |
Responsible Party: | Department of Rheumatology, Bispebjerg Hospital ( Professor Henrik Galbo ) |
Study ID Numbers: | PMR-ENBREL-1 |
Study First Received: | August 30, 2007 |
Last Updated: | December 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00524381 |
Health Authority: | Denmark: Danish Dataprotection Agency; Denmark: Danish Medicines Agency; Denmark: The Danish National Committee on Biomedical Research Ethics |
Temporal arteritis Vasculitis Autoimmune Diseases Skin Diseases Vascular Diseases Central Nervous System Diseases Rheumatic Diseases TNFR-Fc fusion protein Brain Diseases |
Cerebrovascular Disorders Horton’s disease Muscular Diseases Musculoskeletal Diseases Polymyalgia Rheumatica Giant Cell Arteritis Connective Tissue Diseases Arteritis Autoimmune Diseases of the Nervous System |
Anti-Inflammatory Agents Skin Diseases, Vascular Immunologic Factors Immune System Diseases Nervous System Diseases Physiological Effects of Drugs Gastrointestinal Agents Vasculitis, Central Nervous System Immunosuppressive Agents Pharmacologic Actions |
Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Cardiovascular Diseases Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |