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New treatment option for Dermatomyositis
Official title Baricitinib in Patients With Relapsing or naïve Dermatomyositis
ClinicalTrials.gov ID: NCT04972760
What this study is testing
What is Baricitinib?
Baricitinib is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for dermatomyositis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Dermatomyositis (DM) is a rare and disabling condition with an important impairment of quality of life and possible life-threatening complications. Treatment is based on high doses of corticosteroids but this exposes patients to adverse events (cardiovascular mortality, glucocorticoids-induced muscle and skin damages).
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 64
You may be able to join if
- Adult people (≥ 18 years old) \< 65 years old
- Dermatomyositis defined according to the 239th ENMC criteria either naïve or non-naïve DM
- Active disease (ACR/EULAR criteria) defined as :
- Manual Muscle Testing (MMT-8) \ 3/10 cm on Visual Analogue Scale (VAS) of patient global, physician global and extra-muscular disease activity...
- Or cutaneous CDASI \> 20 and at least two additional abnormal corset measurements (CSM): \>3/10 cm on Visual Analogue Scale (VAS) of patient global...
You likely can't join if
- Life-threatening complications :
- Severe swallowing troubles defined as: food swallowed the wrong way and/or time to drink a glass of 200 ml water above 30 seconds related to DM.
- Interstitial lung disease related to the DM with one among the following complications (complications must be related to the ILD): dyspnea NYHA III...
- Symptomatic myocarditis o Loss of walking ability
- Patient with deep vein thrombosis/pulmonary embolism or antecedent
- Patient with antecedent of cardiovascular event (myocardial infarction or ischemic stroke)
See the full eligibility criteria
- Adult people (≥ 18 years old) \< 65 years old
- Dermatomyositis defined according to the 239th ENMC criteria either naïve or non-naïve DM
- Active disease (ACR/EULAR criteria) defined as :
- Manual Muscle Testing (MMT-8) \ 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...
- 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...
- for relapsing/non naïve DM patients :
- in 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.
- Stable dose of immunosuppressive therapy for at least 3 months before
- Affiliation to a social security regime
- Written informed consent
- Life-threatening complications :
- Severe swallowing troubles defined as: food swallowed the wrong way and/or time to drink a glass of 200 ml water above 30 seconds related to DM.
- Interstitial 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%...
- Symptomatic myocarditis o Loss of walking ability
- Patient with deep vein thrombosis/pulmonary embolism or antecedent
- Patient with antecedent of cardiovascular event (myocardial infarction or ischemic stroke)
- Patient who is current or past long-time smoker
- Pregnant or lactating, or women planning to become pregnant or initiating breastfeeding
- 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
- Active cancer or history of malignancy
- Active severe infection including active hepatitis
- Evidence of latent tuberculosis (as documented by a positive QuantiFERON-TB Gold plus test)
- Absolute Neutrophil Count \< 1x109 cells/L
- Haemoglobin (Hb) \< 8 g/dL
- Severe hepatic impairment attested by FV (coagulation factor)\<30%
- Liver insufficiency (Prothrombin time \<60%)
- Previous treatment exposure defined as follow : 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 with failure of both (but exposure and/or failure to either of these two...
- for naïve DM patients only, 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
- Contraindication to Methotrexate and/or Azathioprine including hypersensitivity to the active substances or to any of the excipients
- Conditions affecting the outcomes (Expected poor compliance)
- Severe disease damages: e.g. 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...
- Significant uncontrolled cardiovascular, cerebrovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, or neuropsychiatric disorders, or abnormal laboratory values that developed during a...
- Chest imaging (CT scan or radiograph) showing abnormalities not related with the DM in the last 12 weeks judged by the investigator as clinically significant.
- Participants included in other intervention research involving humans
- Patient under tutorship or guardianship, and incapable to give informed consent
The study team makes the final eligibility decision.
Where it's taking place
- Paris, France
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 years to 64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Paris, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.