Baricitinib in the Treatment of New-onset Juvenile Dermatomyositis (MYOCIT) (NCT05524311) | Clinical Trial Compass
CompletedPhase 2
Baricitinib in the Treatment of New-onset Juvenile Dermatomyositis (MYOCIT)
France16 participantsStarted 2022-11-10
Plain-language summary
The MYOCIT study aims to evaluate the efficacy and safety of baricitinib in association with corticosteroids in new-onset patients with juvenile dermatomyositis (JDM) in a phase II trial with the objective to obtain a better efficacy than the conventional combination methotrexate (MTX) and corticosteroids over the 24 week study period. Thus, the investigators hypothesize that baricitinib could be used as a first line treatment in all forms of DMJ, including the most severe one, with a good safety profile.
Who can participate
Age range3 Years – 18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patient aged 3-18 years with new-onset juvenile dermatomyositis, according to the ENMC 2018 dermatomyositis classification criteria
* Muscle weakness at MMT and/or CMAS (MMT \< 74 and/or CMAS \< 45)
* Seropositivity or vaccination for chickenpox
* For patients of childbearing age (following menarche) : Negative βHCG and effective method of contraception (sexual abstinence, hormonal contraception, intrauterine device or hormone-releasing system, cap, diaphragm or sponge with spermicide, condom) until the 7 days after administration of the last dose of Baricitinib
* Informed consent form signed by the patient or child' s parents Patient affiliated to a social security regime
Exclusion Criteria
* Amyopathic dermatomyositis (without muscle weakness)
* Inability to be treated by oral way or to take pills
* Previous treatment with JAK inhibitor
* Previous treatment of JDM with immunosuppressive drugs or biologics other than corticosteroids. Previous treatment with prednisone was allowed for no more than 1 month.
* Previous history of cancer
* Live vaccine within the 4 weeks before starting baricitinib therapy
* Current, or recent (\< 4 weeks prior to baseline) of active infections according to investigator appreciation, but necessarily, including HBV, HCV, HIV, tuberculosis.
* Positive blood CMV PCR
* Creatinine clearance \< 40 ml/min
* Lymphocytes \< 0,5x109 cell/L and Neutrophils \< 1x109 cell/L
* Hemoglobin \< 8 g/dL
* Symptomatic herpes herpes simplex i…
What they're measuring
1
PRINTO 20 (Paediatric Rheumatology INternational Trials Organisation scale)