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| Sponsored by: |
Radboud University |
|---|---|
| Information provided by: | Radboud University |
| ClinicalTrials.gov Identifier: | NCT00441961 |
Purpose
Evaluate the effect of high dose MTX on skin induration in patients with eosinophilic fascia.
| Condition | Intervention |
|---|---|
|
Fasciitis |
Drug: methotrexate |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Treatment With High Dose Methotrexate in Patients With Eosinophilic Fasciitis |
| Estimated Enrollment: | 6 |
| Study Start Date: | October 2006 |
| Estimated Study Completion Date: | June 2011 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Histologically confirmed with a skin-fascia-muscle biopsy, and in additon:
Exclusion Criteria:
Contacts and Locations| Contact: M. CW Creemers, PhD | 0031-24-3617714 | m.creemers@reuma.umcn.nl |
| Contact: E. MGJ de Jong, PhD | 0031-24-3613644 | e.dejong@derma.umcn.nl |
| Netherlands | |
| Radboud University Nijmegen Medical Centre | Recruiting |
| Nijmegen, Netherlands, 6500 HB | |
| Principal Investigator: M. CW Creemers, PhD | |
| Principal Investigator: | M. CW Creemers, PhD | Radboud University |
More Information
| Responsible Party: | Radboud University ( Dr. M. Creemers ) |
| Study ID Numbers: | mtx in eosinophilic fasciitis |
| Study First Received: | February 28, 2007 |
| Last Updated: | March 5, 2009 |
| ClinicalTrials.gov Identifier: | NCT00441961 History of Changes |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
|
Eosinophilic fasciitis, Shulman's syndrome, methotrexate |
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Antimetabolites Immunologic Factors Folate Folic Acid Antagonists Folinic Acid Immunosuppressive Agents Vitamin B9 |
Folic Acid Eosinophilic Fasciitis Musculoskeletal Diseases Methotrexate Fasciitis Antirheumatic Agents |
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Antimetabolites Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors Reproductive Control Agents Folic Acid Antagonists Abortifacient Agents, Nonsteroidal |
Immunosuppressive Agents Pharmacologic Actions Musculoskeletal Diseases Therapeutic Uses Abortifacient Agents Methotrexate Fasciitis Antirheumatic Agents Dermatologic Agents Nucleic Acid Synthesis Inhibitors |