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| Tracking Information | |||||||||
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| First Received Date ICMJE | February 28, 2007 | ||||||||
| Last Updated Date | March 5, 2009 | ||||||||
| Start Date ICMJE | October 2006 | ||||||||
| Estimated Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Efficacy is evaluated after 6 months. [ Time Frame: December 2008 ] [ Designated as safety issue: Yes ] | ||||||||
| Original Primary Outcome Measures ICMJE |
Efficacy is evaluated after 6 months. | ||||||||
| Change History | Complete list of historical versions of study NCT00441961 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Treatment With High Dose Methotrexate in Patients With Eosinophilic Fasciitis | ||||||||
| Official Title ICMJE | Treatment With High Dose Methotrexate in Patients With Eosinophilic Fasciitis | ||||||||
| Brief Summary | Evaluate the effect of high dose MTX on skin induration in patients with eosinophilic fascia. |
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| Detailed Description | Eosinophilic fasciitis (EF)is a fibrosing skin disorder extensively involving the deep fascia. The aim of this pilot study is to evaluate the effect of high dose MTX on skin induration in patients with EF. In addition, we study the effect of this treatment on joint mobility, peripheral blood eosinophilia, functional ability, and pulmonary function. By administering high dose MTX intravenously every four weeks with a Leukovorin rescue, we hope to induce a more pronounced and sustained effect on the involved skin with less (long-lasting) side effects. |
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| Study Phase | |||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study | ||||||||
| Condition ICMJE | Fasciitis | ||||||||
| Intervention ICMJE | Drug: methotrexate | ||||||||
| 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 | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 6 | ||||||||
| Estimated Completion Date | June 2011 | ||||||||
| Estimated Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Netherlands | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00441961 | ||||||||
| Responsible Party | Dr. M. Creemers, Radboud University | ||||||||
| Study ID Numbers ICMJE | mtx in eosinophilic fasciitis | ||||||||
| Study Sponsor ICMJE | Radboud University | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
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| Information Provided By | Radboud University | ||||||||
| Verification Date | March 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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