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Baricitinib in the Treatment of New-onset Juvenile Dermatomyositis (MYOCIT)
Sponsor: Assistance Publique - Hôpitaux de Paris
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.
Official title: Baricitinib in the Treatment of New-onset Juvenile Dermatomyositis
Key Details
Gender
All
Age Range
3 Years - 18 Years
Study Type
INTERVENTIONAL
Enrollment
16
Start Date
2022-11-10
Completion Date
2026-01-02
Last Updated
2026-04-23
Healthy Volunteers
No
Conditions
Interventions
Baricitinib
Oral tablets (2 mg) will be used For children \> or = 6 years: 4 mg once a day (2 x 2 mg) during the 24 weeks-period study For children \< 6 years: 2 mg once a day during the 24 weeks -period study
pharmacokinetics study
additionnal blood sampling at week 4, 8, 12, and 24
dosage of cytokines
additionnal blood sampling at weeks 0, 4 and 24
transcriptomic analysis
additionnal blood sampling at weeks 0, 4 and 24
Parent version of the Child Health Questionnaire (CHQ)
Evaluate by parents at each visits
Childhood Health Assessment Questionnaire
Evaluate by parents at each visits
Pregnancy test
Urine pregnancy test at V4 A dosage of bHCG with current biological analysis is done at each visit (except V4)
Locations (13)
Hôpital Pellegrin
Bordeaux, France
Hôpital Femme Mère Enfant
Bron, France
Hôpital Jeanne de Flandre
Lille, France
Hôpital La Timone
Marseille, France
Hôpital Villeneuce
Montpellier, France
Hôpital Brabois
Nancy, France
Hopital Necker - Enfants malades : unité d'immuno-hématologie et rhumatologie
Paris, France
Hôpital du Kremlin-Bicêtre
Paris, France
Hôpital Necker - Enfants malades : service de dermatologie
Paris, France
Hôpital Robert Debré
Paris, France
Hôpital Trousseau
Paris, France
Hôpital de Hautepierre
Strasbourg, France
Hôpital Purpan
Toulouse, France