Status:
COMPLETED
Five-year Actively Controlled Clinical Trial in New Onset Juvenile Dermatomyositis
Lead Sponsor:
Istituto Giannina Gaslini
Collaborating Sponsors:
Pediatric Rheumatology International Trials Organization
Conditions:
Juvenile Dermatomyositis
Eligibility:
All Genders
1-18 years
Phase:
PHASE3
Brief Summary
This is a 5-year project, involving 185 partners from 46 countries ((110 in 21 European Union (EU) States and 75 in 25 extra-EU States)), with a randomised clinical trials (RCT) in juvenile dermatomyo...
Detailed Description
Scientific objectives: The proposed project is aimed to improve treatment approaches for rare, severe and disabling paediatric rheumatic diseases (PRD). This goal will be achieved by the Paediatric Rh...
Eligibility Criteria
Inclusion
- Inclusion Criteria. Each patient must meet all the following criteria in order to participate in this trial:
- Newly diagnosed and untreated children (only treatment with 1 NSAID is allowed and/or prednisone \>1 mg/kg/day for no more than 1 month from diagnosis) with probable or definite diagnosis of JDM according to published (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 PRINTO.
- Age at enrolment ≤ 18 years.
- 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.
- 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
- Duly executed, written, informed consent obtained from the parents/patient.
- Exclusion Criteria. Any of the following will exclude a patient from this trial:
- Neutrophil count \<1,500/mm3 and/or platelet count \<50,000/mm3
- Demonstration of cutaneous or gastrointestinal ulceration of JDM related pulmonary disease or cardiomyopathy at the time of diagnosis.
- History of poor compliance.
- Evidence of current use of alcohol or illicit drugs abuse.
- Live vaccines not allowed during the entire duration of the trial.
- Dropout Criteria. Patients will be considered "treatment failures", and dropped from the trial but included in efficacy analysis, if any of the following will occur during the active period of the trial.
- Non compliance with study medication administration
- Enrolment in other therapeutic trials.
Exclusion
Key Trial Info
Start Date :
May 31 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 29 2015
Estimated Enrollment :
139 Patients enrolled
Trial Details
Trial ID
NCT00323960
Start Date
May 31 2006
End Date
November 29 2015
Last Update
March 28 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Istituto Giannina Gaslini
Genoa, Italy, 16147