Treatment With High Dose Methotrexate in Patients With Eosinophilic Fasciitis

• Status: Completed
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Evaluate the effect of high dose MTX on skin induration in patients with eosinophilic fascia.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Radboud University
• Treatments: Methotrexate

Criteria

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