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

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.

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)

Sponsors & Collaborators

• URC-CIC Paris Descartes Necker Cochin

  collaborator OTHER

• Assistance Publique - Hôpitaux de Paris

  lead OTHER

Principal Investigators

• Cyril GITIAUX, Doctor · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

3 Years

Max Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-11-10

Primary Completion

2025-05-13

Completion

2026-01-02

Countries

• France

Study Locations