Treatment With High Dose Methotrexate in Patients With Eosinophilic Fasciitis
1 other identifier
interventional
6
1 country
1
Brief Summary
Evaluate the effect of high dose MTX on skin induration in patients with eosinophilic fascia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2006
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2006
CompletedFirst Submitted
Initial submission to the registry
February 28, 2007
CompletedFirst Posted
Study publicly available on registry
March 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedAugust 11, 2011
July 1, 2010
4.2 years
February 28, 2007
August 10, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Efficacy is evaluated after 6 months.
December 2008
Interventions
methotrexate
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Radboud University Nijmegen Medical Centre
Nijmegen, 6500 HB, Netherlands
Related Publications (1)
Mertens JS, Zweers MC, Kievit W, Knaapen HK, Gerritsen M, Radstake TR, van den Hoogen FH, Creemers MC, de Jong EM. High-Dose Intravenous Pulse Methotrexate in Patients With Eosinophilic Fasciitis. JAMA Dermatol. 2016 Nov 1;152(11):1262-1265. doi: 10.1001/jamadermatol.2016.2873.
PMID: 27541801DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
H. Knaapen, MD
Radboud University Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 28, 2007
First Posted
March 1, 2007
Study Start
October 1, 2006
Primary Completion
December 1, 2010
Study Completion
June 1, 2011
Last Updated
August 11, 2011
Record last verified: 2010-07