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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.

Register:	EUCTR
Last refreshed on:	15 September 2020
Main ID:	EUCTR2006-006812-31-DE
Date of registration:	25/06/2008
Prospective Registration:	Yes
Primary sponsor:	University of Munster
Public title:	Multicenter randomized clinical trial in Patients with Juvenile Idiopathic Arthritis and Methotrexate related side effects: Psychological Behavioural therapy versus switch to MTX parenteral versus standard of care - MTX tolerance study
Scientific title:	Multicenter randomized clinical trial in Patients with Juvenile Idiopathic Arthritis and Methotrexate related side effects: Psychological Behavioural therapy versus switch to MTX parenteral versus standard of care - MTX tolerance study
Date of first enrolment:	03/12/2008
Target sample size:	120
Recruitment status:	Not Recruiting
URL:	https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-006812-31
Study type:	Interventional clinical trial of medicinal product
Study design:	Controlled: yes Randomised: yes Open: yes Single blind: Double blind: Parallel group: Cross over: Other: If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: yes Other specify the comparator: standard of care
Phase:	Human pharmacology (Phase I): Therapeutic exploratory (Phase II): Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment
Germany	Netherlands

Contacts

Name:
Address:
Telephone:
Email:
Affiliation:

Name:
Address:
Telephone:
Email:
Affiliation:

Key inclusion & exclusion criteria

Inclusion criteria:
Inclusion criteria:
1. diagnosis: all subtypes JIA according to ILAR classification (15).
2. MTX oral (dosing 10-20mg/m2/week)
3. other medication: NSAID, biologicals (etanercept, infliximab, anakinra) allowed

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years)
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1. MTX parenteral
2. Other diagnosis
3. Steroid usage (more than 0.2mg/kg/day)
4. Other MTX related side effects:
4a. Abnormal Liver function tests (definitie (1) waarsch verdubbeling uitgangswaarde
4b. Abnormal renal function tests (serum creatinin increasing to twice baseline values)
4c. Cytopenias (see above(1))
5. History of non-compliance to earlier treatments not related to MTX
6. Patients currently included in other studies

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Patients with Juvenile Idiopathic Arthritis and Methotrexate related side effects

Intervention(s)

Pharmaceutical Form:
CAS Number: 7413345
Other descriptive name: METHOTREXATE DISODIUM
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2,5-

Trade Name: metoject
Pharmaceutical Form: Injection*

Primary Outcome(s)

Primary end point(s): • The incidence of MTX intolerance. Side effects are defined as
o Gastroenterological side effects leading to intolerance: nausea, nausea occurring prior to dosing (anticipatory nausea), abdominal dysconfort before/after MTX or oral ulcers. For these self reported MTX side effects, a patient log (“diary”) will be used weekly to report observed effects.
• Primary clinical outcome measures of JIA after 3 and 6 months of treatment. These variables are(13;14):
o Functional ability assessment by CHAQ (laatse versie)
o Number of active joints (pain/swelling)
o Limitation of movement (defined by EPM-ROM scale)
o Physician’s global assessment of disease activity on a 10cm VAS
o Parent/patient global assessment of disease activity on a 10cm VAS
o Parent/patient global assessment of pain on a 10 cm VAS
o ESR and CRP
• Number of MTX treatment failures, switching to TNF blockade
• The incidence of other MTX related side effects

Secondary Objective:

Main Objective: The goal of the current protocol is to describe the follow-up of JIA patients during MTX therapy using validated response criteria for JIA disease activity (PRINTO core set criteria) and validated psychological response criteria for psychological behavioural therapy. In addition, we aim to explore the incidence, mechanisms and treatment options of MTX intolerance.

To assess effectiveness of the 3 treatment options of management of MTX related side effects in children with JIA

Secondary Outcome(s)

Secondary ID(s)

umcu mtx 1

2006-006812-31-NL

Source(s) of Monetary Support

Secondary Sponsor(s)

Ethics review

Status: Approved
Approval date: 26/08/2008
Contact:

Results

Results available:
Date Posted:
Date Completed:
URL:

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