Baricitinib in the Treatment of New-onset Juvenile Dermatomyositis

Status: Recruiting
Location: See all (13) locations...
Intervention Type: Biological, Behavioral, Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 3
Maximum Age: 18
Healthy Volunteers: f
View:

• Patient aged 3-18 years with new-onset juvenile dermatomyositis, according to the ENMC 2018 dermatomyositis classification criteria

• Muscle weakness at MMT and/or CMAS (MMT \< 74 and/or CMAS \< 45)

• Seropositivity or vaccination for chickenpox

• For patients of childbearing age (following menarche) : Negative βHCG and effective method of contraception (sexual abstinence, hormonal contraception, intrauterine device or hormone-releasing system, cap, diaphragm or sponge with spermicide, condom) until the 7 days after administration of the last dose of Baricitinib

• Informed consent form signed by the patient or child' s parents Patient affiliated to a social security regime

Locations
Other Locations
France
Hôpital Pellegrin
RECRUITING
Bordeaux
Hôpital Femme Mère Enfant
RECRUITING
Bron
Hôpital Jeanne de Flandre
RECRUITING
Lille
Hôpital La Timone
RECRUITING
Marseille
Hôpital Villeneuce
NOT_YET_RECRUITING
Montpellier
Hôpital Brabois
RECRUITING
Nancy
Hôpital du Kremlin-Bicêtre
RECRUITING
Paris
Hôpital Necker - Enfants malades : service de dermatologie
RECRUITING
Paris
Hopital Necker - Enfants malades : unité d'immuno-hématologie et rhumatologie
RECRUITING
Paris
Hôpital Robert Debré
RECRUITING
Paris
Hôpital Trousseau
RECRUITING
Paris
Hôpital de Hautepierre
NOT_YET_RECRUITING
Strasbourg
Hôpital Purpan
RECRUITING
Toulouse
Contact Information
Primary
Brigitte BADER-MEUNIER, Doctor
brigitte.bader-meunier@aphp.fr
+33 1 44 49 43 32
Backup
Laure CHOUPEAUX, MSc
laure.choupeaux@aphp.fr
+33 1 44 38 17 11
Time Frame
Start Date: 2022-11-10
Estimated Completion Date: 2026-09
Participants
Target number of participants: 16
Treatments
Experimental: Baricitinib
Sponsors
Leads: Assistance Publique - Hôpitaux de Paris

This content was sourced from clinicaltrials.gov