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COMPLETED
NCT05524311
PHASE2

Baricitinib in the Treatment of New-onset Juvenile Dermatomyositis (MYOCIT)

Sponsor: Assistance Publique - Hôpitaux de Paris

View on ClinicalTrials.gov

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

Interventions

DRUG

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

BIOLOGICAL

pharmacokinetics study

additionnal blood sampling at week 4, 8, 12, and 24

BIOLOGICAL

dosage of cytokines

additionnal blood sampling at weeks 0, 4 and 24

BIOLOGICAL

transcriptomic analysis

additionnal blood sampling at weeks 0, 4 and 24

BEHAVIORAL

Parent version of the Child Health Questionnaire (CHQ)

Evaluate by parents at each visits

BEHAVIORAL

Childhood Health Assessment Questionnaire

Evaluate by parents at each visits

BIOLOGICAL

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