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

Sponsor
Assistance Publique - Hôpitaux de Paris
Study ID
NCT05524311
Phase
PHASE2
Status
Completed

Conditions

  • Juvenile Dermatomyositis

Eligibility Criteria

Sex
ALL
Age
3 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • Baricitinib — DRUG
    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 — BIOLOGICAL
    additionnal blood sampling at week 4, 8, 12, and 24
  • dosage of cytokines — BIOLOGICAL
    additionnal blood sampling at weeks 0, 4 and 24
  • transcriptomic analysis — BIOLOGICAL
    additionnal blood sampling at weeks 0, 4 and 24
  • Parent version of the Child Health Questionnaire (CHQ) — BEHAVIORAL
    Evaluate by parents at each visits
  • Childhood Health Assessment Questionnaire — BEHAVIORAL
    Evaluate by parents at each visits
  • Pregnancy test — BIOLOGICAL
    Urine pregnancy test at V4 A dosage of bHCG with current biological analysis is done at each visit (except V4)

Study Details

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.

Key Dates

Start date
Nov 10, 2022
Status verified
Mar 2026
Primary completion
May 13, 2025
Completion
Jan 2, 2026

Study Design

Enrollment
16 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Baricitinib

Primary Outcome Measure

PRINTO 20 (Paediatric Rheumatology INternational Trials Organisation scale) [ Time Frame: At week 24 ]

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