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Main
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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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3 April 2023 |
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Main ID: |
NCT00323960 |
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Date of registration:
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09/05/2006 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Five-year Actively Controlled Clinical Trial in New Onset Juvenile Dermatomyositis
PRINTOJDMTR |
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Scientific title:
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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 Methotrexate |
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Date of first enrolment:
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May 31, 2006 |
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Target sample size:
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139 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00323960 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 3
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Countries of recruitment
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Italy
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Contacts
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Name:
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Nicolino Ruperto, MD, MPH |
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Address:
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Telephone:
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Email:
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Affiliation:
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Istituto Giannina Gaslini _ PRINTO Senior Scientist |
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Name:
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Alberto Martini, MD, Prof. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Istituto Giannina Gaslini_PRINTO Chairman |
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Key inclusion & exclusion criteria
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Inclusion Criteria. Each patient must meet all the following criteria in order to
participate in this trial:
1. 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.
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.
Exclusion Criteria. Any of the following will exclude a patient from this trial:
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.
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.
1. Non compliance with study medication administration
2. Enrolment in other therapeutic trials.
Age minimum:
1 Year
Age maximum:
18 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Juvenile Dermatomyositis
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Intervention(s)
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Drug: 3 MPDN pulse + PDN + CSA
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Drug: 3 MPDN pulse + PDN
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Drug: 3 MPDN pulse + PDN + MTX
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Primary Outcome(s)
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Responder Status Defined as 20% Improvement in at Least 3 Core Set Variables With no More Than 1 of the Remaining Variables, (Muscle Strength Excluded), Worsened by > 30%.
[Time Frame: 6 months]
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Time to Clinical Remission
[Time Frame: 60 months]
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Secondary Outcome(s)
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Time to Prednisone, or Equivalent, Discontinuation
[Time Frame: 60 months]
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Time to Major Therapeutic Changes
[Time Frame: 60 months]
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Secondary ID(s)
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AIFA
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Myositis Association
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IGG-PRINTO-002
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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