Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:35 PM
Ignite Modification Date:
2025-12-24 @ 12:35 PM
NCT ID:
NCT00441961
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00441961
Study Brief:
Protocol Section:
NCT00441961