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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00441961 |
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Date of registration:
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28/02/2007 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Treatment With High Dose Methotrexate in Patients With Eosinophilic Fasciitis
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Scientific title:
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Treatment With High Dose Methotrexate in Patients With Eosinophilic Fasciitis |
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Date of first enrolment:
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October 2006 |
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Target sample size:
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6 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00441961 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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Netherlands
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Contacts
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Name:
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H. Knaapen, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Radboud University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Eosinophilic fasciitis as defined by clinical judgement of an expert,
- Histologically confirmed with a skin-fascia-muscle biopsy, and in additon:
- Either the presence of a modified skin score according to Zachariae of 8 or
higher (0-18), regarded as a generalised eosinophilic fasciitis or the presence
of severe contractures due to eosinophilic fasciitis lesions.
Exclusion Criteria:
- Age < 18 yrs
- Contraindications to MTX: AST/ALT level > 2 times upper limit of normal, WBC count <
3.5 x 109/l or platelet count < 150 x 109/l, serum creatinine > 130 micromol/l or
clearance < 50 ml/min, confirmed by two repeated tests within one month.
- Chronic liver disease, insulin dependant diabetes mellitus, alcohol abuse
- Restrictive pulmonary disease (total lung capacity or vital capacity < 40% of
predicted) or interstitial lung disease (KCO < 60% of predicted)
- Pregnancy or child bearing potential without adequate contraception
- The presence of any serious co-morbidity or malignancy
- Use of other anti-folate drugs than MTX
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Fasciitis
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Intervention(s)
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Drug: methotrexate
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Primary Outcome(s)
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Efficacy is evaluated after 6 months.
[Time Frame: December 2008]
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Secondary ID(s)
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mtx in eosinophilic fasciitis
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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