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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:	14 August 2012
Main ID:	EUCTR2005-003956-37-NL
Date of registration:	01/06/2006
Prospective Registration:	Yes
Primary sponsor:	Istituto Giannina Gaslini
Public title:	Five year single-blind, phase III effectiveness randomised actively controlled clinical trial in new onset juvenile dermatomyositis:prednisone versus prednisone plus cyclosporine A versus prednisone plus mehotrexate
Scientific title:	Five year single-blind, phase III effectiveness randomised actively controlled clinical trial in new onset juvenile dermatomyositis:prednisone versus prednisone plus cyclosporine A versus prednisone plus mehotrexate
Date of first enrolment:	26/09/2006
Target sample size:	160
Recruitment status:	Authorised-recruitment may be ongoing or finished
URL:	https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-003956-37
Study type:	Interventional clinical trial of medicinal product
Study design:	Controlled: yes Randomised: yes Open: no Single blind: yes Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no
Phase:

Countries of recruitment
Belgium	Italy	Netherlands	Sweden	United Kingdom

Contacts

Name:
Address:
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Email:
Affiliation:

Name:
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Key inclusion & exclusion criteria

Inclusion criteria:
10
Newly diagnosed and untreated children with probable or definite diagnosis of JDM
according to the Bohan and Peter criteria (12;13). If a muscle biopsy will be performed
(optional) it will be read by the pathologists of the participating centres (light and
immunofluorescence). Slides of paraffin-embedded sections from all patients will be
re-viewed by a blinded myopathologist at the PRINTO coordinating centre.
2) Age at enrolment = 18 years.
3) Female of child-bearing potential must have a negative pregnancy test at the beginning
of the trial, and then every 3 months. If sexually active, they must agree to use adequate
contraception, throughout study participation, and must have no intention of conceiving
during the course of the study. Post-pubertal males must have no plans to father a child
during the study and agree to use adequate birth control methods if sexually active.
4) Ability to comply with the entire study procedures, ability to communicate
meaningfully with the investigational staff, competence to give written informed
consent; to be applied to the parents and/or patients, as appropriate
5) Duly executed, written, informed consent obtained from the parents/patient.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1) Neutrophil count <1,500/mm3 and/or platelet count <50,000/mm3
2) Demonstration of cutaneous or gastrointestinal ulceration of JDM related
pulmonary disease or cardiomyopathy at the time of diagnosis.
3) History of poor compliance.
4) Evidence of current use of alcohol or illicit drugs abuse.
5) Live vaccines not allowed during the entire duration of the trial.

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

Health Condition(s) or Problem(s) studied

Juvenile Dermatomyositis at onset

Intervention(s)

Pharmaceutical Form: Tablet
INN or Proposed INN: Prednisone
CAS Number: 53-03-2
Concentration unit: mg milligram(s)
Concentration number: 5-

Pharmaceutical Form: Powder and solvent for solution for infusion
INN or Proposed INN: Methylprednisolone
CAS Number: 2921-57-5
Concentration unit: mg milligram(s)
Concentration number: 8-

Pharmaceutical Form: Capsule, soft
INN or Proposed INN: Ciclosporin
CAS Number: 59865-59-5
Concentration unit: mg milligram(s)
Concentration number: 10-

Pharmaceutical Form: Oral solution
INN or Proposed INN: Ciclosporin
CAS Number: 59865-59-5
Concentration unit: mg milligram(s)
Concentration number: 100-

Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Ciclosporin
CAS Number: 59865-59-5
Concentration unit: mg milligram(s)
Concentration number: 50-

Pharmaceutical Form: Solution for injection
INN or Proposed INN: Methotrexate
Concentration unit: mg milligram(s)
Concentration number: 5-

Pharmaceutical Form: Solution for injection
INN or Proposed INN: Methotrexate
Concentration unit: mg milligram(s)
Concentration number: 5-

Primary Outcome(s)

Primary end point(s): To assess the effectiveness (efficacy, safety, tolerability and compliance to
treatment) of the 3 treatment approaches for the treatment of children with JDM

Main Objective: To assess the effectiveness (efficacy, safety, tolerability and compliance to
treatment) of the 3 treatment approaches for the treatment of children with JDM.

Secondary Objective: THE OVERALL HYPOTHESIS TO BE TESTED IN THIS TRIAL is that the early
introduction of combination therapy of corticosteroids and either MTX or CsA will prove more
effective and safe than corticosteroids alone in the treatment of JDM.

Secondary Outcome(s)

Secondary ID(s)

IGG-PRINTO-002

Source(s) of Monetary Support

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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