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MYOCIT - Baricitinib in the treatment of new-onset juvenile dermatomyositis: a phase II trial
EU CTIS ID: 2024-513651-32-00
What this study is testing
To assess the efficacy of baricitinib in patients with a new-onset JDM at week 24 according to PRINTO 20 level of improvement
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- Amyopathic dermatomyositis (without muscle weakness)
- 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).
See the full eligibility criteria
- 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
- Amyopathic dermatomyositis (without muscle weakness)
- 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
- 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 is 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.