Methotrexate in Fasciitis - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Fasciitis

Intervention / Treatment

Drug: methotrexate

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

6

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Netherlands
- - Nijmegen, Netherlands, 6500 HB
    - Radboud University Nijmegen Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Efficacy is evaluated after 6 months. Time Frame: December 2008	December 2008

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Investigators

Principal Investigator: H. Knaapen, MD, Radboud University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

February 28, 2007

First Submitted That Met QC Criteria