Baricitinib in patients with relapsing or naïve dermatomyositis
- Conditions
- Baricitinib in patients with relapsing or naïve dermatomyositis.Multicenter trial, double blind randomized controlled trial with 2 parallel groups. This is an add-on trial with intention to treat analysis.MedDRA version: 20.0Level: LLTClassification code 10001403Term: Adult dermatomyositisSystem Organ Class: 100000004858Therapeutic area: Body processes [G] - Immune system processes [G12]
- Registration Number
- EUCTR2020-004987-24-FR
- Lead Sponsor
- Assistance Publique-Hopitaux de Paris
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 62
Adult subjects (= 18 years old) < 75 years old
- Dermatomyositis defined according to the 239th ENMC criteria
- Active disease (ACR/EULAR criteria) defined as:
•Manual Muscle Testing (MMT-8) <145/150 and at least two additional abnormal corset measurements (CSM): >3/10 cm on Visual Analogue Scale (VAS) of patient global, physician global and extra-muscular disease activity, Health Assessment Questionnaire Disability Index >0.25, or elevated muscle enzymes.
•Or cutaneous CDASI > 20 and at least two additional abnormal corset measurements (CSM): >3/10 cm on Visual Analogue Scale (VAS) of patient global, physician global and extra-muscular disease activity, Health Assessment Questionnaire Disability Index >0.25, or elevated muscle enzymes
-for relapsing DM patients
oin case of corticosteroid exposure patient must receive a stable dose < 30 mg/d prednisone with or without additional immunosuppressive therapy for at least 4 weeks before the baseline visit.
oStable dose of immunosuppressive therapy for at least 3 months before
- Affiliation to a social security regime
- Written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Life-threatening complications
oSevere swallowing troubles defined as: food swallowed the wrong way and/or time to drink a glass of 200 ml water above 30 seconds
oInterstitial lung disease related to the DM with one among the following complications (complications must be related to the ILD): dyspnea NYHA III, hypoxemia with PaO2=65 mmHg, and/or DLCOc/Alveolar Volume =70% (pulmonary function test)
oSymptomatic myocarditis
oLoss of walking ability
- Deep vein thrombosis/pulmonary embolism in past medical history in absence of anticoagulant
- Ongoing or planned pregnancy
- No effective contraception during the study and one week after for women of childbearing age
- Renal impairment defined as clearance < 60 ml
- Strong Organic Anion Transporter 3 (OAT3) inhibitors
- Synchronous malignancy
- Active severe infection including active tuberculosis and active hepatitis
- Absolute Neutrophil Count < 1x109 cells/L
- Haemoglobin (Hb) < 8 g/dL
- Liver insufficiency (Prothrombin time <60%)
- Previous treatment exposure relating to the treatment/procedures:
•Rituximab treatment within 6months before inclusion
•IVIg, or cyclophosphamide infusion within the month before inclusion
•both methotrexate (0.3 mg/kg/w) and azathioprine exposure for at least 3 months each and at the 0.3 mg/kg/w and 2-3 mg/kg/d dosages respectively. (but exposure to either of these two drugs alone is not an exclusionary criterion)
•more than 2 weeks treatment duration with corticosteroids at the dose of 1 mg/kg/d before the inclusion.
- Hypersensitivity to the active substance (baricitinib) or to any of the excipients
- Conditions affecting the outcomes (Expected poor compliance
- Severe disease damages: eg. muscle weakness mainly related to muscle damage such as fat replacement of muscle) defined as persistent changes in anatomy, physiology, pathology or function which result from previously active disease and from complications of therapy or other events (e.g; muscle atrophy, fatty replacement; skin skars, poilkilodermy). Severe disease damage is considered when the patient condition has no or minor ability to improve with the treatment.
-Participants included in other intervention research involving humans
- Patient under tutorship or guardianship, and incapable to give informed consent
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method