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| Tracking Information | |||||
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| First Received Date ICMJE | August 30, 2007 | ||||
| Last Updated Date | July 9, 2009 | ||||
| Start Date ICMJE | August 2007 | ||||
| Estimated Primary Completion Date | July 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Polymyalgia rheumatica activity score (PMR-AS) [ Time Frame: 14 days ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Polymyalgia rheumatica activity score (PMR-AS) [ Time Frame: 14 days ] | ||||
| Change History | Complete list of historical versions of study NCT00524381 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Descriptive Information | |||||
| Brief Title ICMJE | Etanercept Treatment in the Early Course of Polymyalgia Rheumatica | ||||
| Official Title ICMJE | The Effect of Etanercept on the Early Clinical Course of Polymyalgia Rheumatica (Pilot Study) | ||||
| Brief Summary | 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. |
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| Detailed Description | |||||
| Study Phase | Phase III | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study | ||||
| Condition ICMJE | Polymyalgia Rheumatica | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 40 | ||||
| Estimated Completion Date | September 2009 | ||||
| Estimated Primary Completion Date | July 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
Exclusion Criteria (controls):
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| Gender | Both | ||||
| Ages | 50 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Denmark | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00524381 | ||||
| Responsible Party | Professor Henrik Galbo, Department of Rheumatology, Bispebjerg Hospital | ||||
| Study ID Numbers ICMJE | PMR-ENBREL-1 | ||||
| Study Sponsor ICMJE | Bispebjerg Hospital | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Bispebjerg Hospital | ||||
| Verification Date | July 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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