Baricitinib in the Treatment of New-onset Juvenile Dermatomyositis (MYOCIT)
NCT ID: NCT05524311
Last Updated: 2025-11-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE2
16 participants
INTERVENTIONAL
2022-11-10
2026-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Baricitinib in Patients With Relapsing or naïve Dermatomyositis
NCT04972760
Baricitinib for Cutaneous Dermatomyositis
NCT05361109
JAK Inhibitor Treatment in AGS
NCT03921554
Safety, Tolerability, and Efficacy of JBT-101 in Subjects With Dermatomyositis
NCT02466243
Baricitinib in the Treatment of Kohlmeier-Degos Disease in Patients With Neurological Involvement
NCT06923072
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Baricitinib
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
pharmacokinetics study
additionnal blood sampling at week 4, 8, 12, and 24
dosage of cytokines
additionnal blood sampling at weeks 0, 4 and 24
transcriptomic analysis
additionnal blood sampling at weeks 0, 4 and 24
Parent version of the Child Health Questionnaire (CHQ)
Evaluate by parents at each visits
Childhood Health Assessment Questionnaire
Evaluate by parents at each visits
Pregnancy test
Urine pregnancy test at V4 A dosage of bHCG with current biological analysis is done at each visit (except V4)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
pharmacokinetics study
additionnal blood sampling at week 4, 8, 12, and 24
dosage of cytokines
additionnal blood sampling at weeks 0, 4 and 24
transcriptomic analysis
additionnal blood sampling at weeks 0, 4 and 24
Parent version of the Child Health Questionnaire (CHQ)
Evaluate by parents at each visits
Childhood Health Assessment Questionnaire
Evaluate by parents at each visits
Pregnancy test
Urine pregnancy test at V4 A dosage of bHCG with current biological analysis is done at each visit (except V4)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion 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
Exclusion Criteria
* Inability to be treated by oral way or to take pills
* Previous treatment with JAK inhibitor
* Previous treatment of JDM with immunosuppressive drugs or biologics other than corticosteroids. Previous treatment with prednisone was allowed for no more than 1 month.
* Previous history of cancer
* Live vaccine within the 4 weeks before starting baricitinib therapy
* Current, or recent (\< 4 weeks prior to baseline) of active infections according to investigator appreciation, but necessarily, including HBV, HCV, HIV, tuberculosis.
* Positive blood CMV PCR
* Creatinine clearance \< 40 ml/min
* Lymphocytes \< 0,5x109 cell/L and Neutrophils \< 1x109 cell/L
* Hemoglobin \< 8 g/dL
* Symptomatic herpes herpes simplex infection within 12 weeks prior to inclusion
* History of thrombosis or considered at high risk of venous thrombosis by the investigator
* Presence of severe JDM-related involvements: cardiovascular (requiring vasopressive drug and/or intensive care unit), respiratory (requiring oxygen and/or intensive care unit), gastrointestinal (requiring abdominal surgery).
* History of severe non-related JDM involvement: cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological or neuropsychiatric disorders or any other serious and/or instable illness that, in the opinion of the investigator, could constitute an unacceptable risk, when taking baricitinib.
* Actual or in project of pregrancy and breast-feeding until the 7 days after administration of the last dose of Baricitinib
* Patient on AME (state medical aid)
* Participation in another interventional study involving human participants or being in the exclusion period at the end of a previous study involving human participants
3 Years
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
URC-CIC Paris Descartes Necker Cochin
OTHER
Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Cyril GITIAUX, Doctor
Role: STUDY_DIRECTOR
Assistance Publique - Hôpitaux de Paris
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Ruperto N, Ravelli A, Pistorio A, Ferriani V, Calvo I, Ganser G, Brunner J, Dannecker G, Silva CA, Stanevicha V, Cate RT, van Suijlekom-Smit LW, Voygioyka O, Fischbach M, Foeldvari I, Hilario O, Modesto C, Saurenmann RK, Sauvain MJ, Scheibel I, Sommelet D, Tambic-Bukovac L, Barcellona R, Brik R, Ehl S, Jovanovic M, Rovensky J, Bagnasco F, Lovell DJ, Martini A; Paediatric Rheumatology International Trials Organisation (PRINTO); Pediatric Rheumatology Collaborative Study Group (PRCSG). The provisional Paediatric Rheumatology International Trials Organisation/American College of Rheumatology/European League Against Rheumatism Disease activity core set for the evaluation of response to therapy in juvenile dermatomyositis: a prospective validation study. Arthritis Rheum. 2008 Jan 15;59(1):4-13. doi: 10.1002/art.23248.
Lazarevic D, Pistorio A, Palmisani E, Miettunen P, Ravelli A, Pilkington C, Wulffraat NM, Malattia C, Garay SM, Hofer M, Quartier P, Dolezalova P, Penades IC, Ferriani VP, Ganser G, Kasapcopur O, Melo-Gomes JA, Reed AM, Wierzbowska M, Rider LG, Martini A, Ruperto N; Paediatric Rheumatology International Trials Organisation (PRINTO). The PRINTO criteria for clinically inactive disease in juvenile dermatomyositis. Ann Rheum Dis. 2013 May;72(5):686-93. doi: 10.1136/annrheumdis-2012-201483. Epub 2012 Jun 26.
Bode RK, Klein-Gitelman MS, Miller ML, Lechman TS, Pachman LM. Disease activity score for children with juvenile dermatomyositis: reliability and validity evidence. Arthritis Rheum. 2003 Feb 15;49(1):7-15. doi: 10.1002/art.10924.
Giancane G, Lavarello C, Pistorio A, Oliveira SK, Zulian F, Cuttica R, Fischbach M, Magnusson B, Pastore S, Marini R, Martino S, Pagnier A, Soler C, Stanevicha V, Ten Cate R, Uziel Y, Vojinovic J, Fueri E, Ravelli A, Martini A, Ruperto N; Paediatric Rheumatology International Trials Organisation (PRINTO). The PRINTO evidence-based proposal for glucocorticoids tapering/discontinuation in new onset juvenile dermatomyositis patients. Pediatr Rheumatol Online J. 2019 May 22;17(1):24. doi: 10.1186/s12969-019-0326-5.
Mammen AL, Allenbach Y, Stenzel W, Benveniste O; ENMC 239th Workshop Study Group. 239th ENMC International Workshop: Classification of dermatomyositis, Amsterdam, the Netherlands, 14-16 December 2018. Neuromuscul Disord. 2020 Jan;30(1):70-92. doi: 10.1016/j.nmd.2019.10.005. Epub 2019 Oct 25. No abstract available.
Singh G, Athreya BH, Fries JF, Goldsmith DP. Measurement of health status in children with juvenile rheumatoid arthritis. Arthritis Rheum. 1994 Dec;37(12):1761-9. doi: 10.1002/art.1780371209.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2022-000506-10
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
APHP211036
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.