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

PHASE2RecruitingINTERVENTIONAL
Enrollment

16

Participants

Timeline

Start Date

November 10, 2022

Primary Completion Date

May 31, 2026

Study Completion Date

September 30, 2026

Conditions
Juvenile Dermatomyositis
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)

Trial Locations (13)

Unknown

RECRUITING

Hôpital Pellegrin, Bordeaux

RECRUITING

Hôpital Femme Mère Enfant, Bron

RECRUITING

Hôpital Jeanne de Flandre, Lille

RECRUITING

Hôpital La Timone, Marseille

NOT_YET_RECRUITING

Hôpital Villeneuce, Montpellier

RECRUITING

Hôpital Brabois, Nancy

RECRUITING

Hopital Necker - Enfants malades : unité d'immuno-hématologie et rhumatologie, Paris

RECRUITING

Hôpital du Kremlin-Bicêtre, Paris

RECRUITING

Hôpital Necker - Enfants malades : service de dermatologie, Paris

RECRUITING

Hôpital Robert Debré, Paris

RECRUITING

Hôpital Trousseau, Paris

NOT_YET_RECRUITING

Hôpital de Hautepierre, Strasbourg

RECRUITING

Hôpital Purpan, Toulouse

All Listed Sponsors
lead

Assistance Publique - Hôpitaux de Paris

OTHER