2024-511899-32-00招募中3 期
BIRD - Baricitinib in patients with relapsing or naive Dermatomyositis
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 62
- 试验地点
- 15
- 主要终点
- Primary endpoint: moderate improvement (defined as a total improvement score superior or equal to 40 following ACR/EULAR definition) without corticosteroids at week 24 (prednisone-free moderate improvement).
研究概览
简要总结
to evaluate the efficacy of baricitinib (JAK1/2 inhibitor) to obtain prednisone-free DM moderate improvement as compared to placebo, in addition to usual care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Double blind randomized placebo-controlled trial with two parallel arms (1:1)
- 盲法
- Double (Analyst, Investigator, Carer, Monitor, Subject)
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Adult subjects (≥ 18 years old) < 65 years old
- •Dermatomyositis (DM) 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) <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/non naïve DM patients o 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. o Stable dose of immunosuppressive therapy for at least 3 months before
- •Affiliation to a social security regime
- •Written informed consent
排除标准
- •Life-threatening complications o 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 o 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% (pulmonary function test) o Symptomatic myocarditis o Loss of walking ability
- •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)
- •Patient with deep vein thrombosis/pulmonary embolism or antecedent
- •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 active disease and from complications of therapy or other events (e.g.; muscle atrophy, fatty replacement; skin scars, poikiloderma). Severe disease damage is considered when the patient condition has no or minor ability to improve with the treatment.
- •Significant uncontrolled cardiovascular, cerebrovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, or neuropsychiatric disorders, or abnormal laboratory values that developed during a qualifying study that, in the opinion of the investigator, poses an unacceptable risk for the patient’s participation
- •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
- •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
- •Active severe infection including active hepatitis
- •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
- •Participants included in other intervention research involving humans
- •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 follows: • Rituximab treatment within 6 months 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 drugs alone is not an exclusion criterion) • 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
结局指标
主要结局
Primary endpoint: moderate improvement (defined as a total improvement score superior or equal to 40 following ACR/EULAR definition) without corticosteroids at week 24 (prednisone-free moderate improvement).
Primary endpoint: moderate improvement (defined as a total improvement score superior or equal to 40 following ACR/EULAR definition) without corticosteroids at week 24 (prednisone-free moderate improvement).
次要结局
- -DM improvement at 5, 12 and 24 weeks in terms of: • minimal improvement (≥20 points total improvement ACR/EULAR), • moderate improvement (≥40 points total improvement ACR/EULAR) • major improvement (≥60 points total improvement ACR/EULAR)
- -Primary endpoint (prednisone-free moderate improvement at W24) in the following subgroups: • DM naive patients at baseline vs others • DM with a severe muscle weakness (MMT8 baseline <125/150) vs others
- -Cutaneous disease activity and damage evaluated using the CDASI - Activity and CDASI damages at 5, 12 and 24 weeks
- -Cumulative incidence of relapse and the time to first relapse
- -Cumulative dose of corticosteroids
- -Proportions of participants with an average prednisone dose of 0 mg per day, of more than 0 mg to not more than 4.0 mg per day, of more than 4.0 mg to not more than 7.5 mg per day, and of more than 7.5 mg per day during weeks 20 through 24.
- -Safety including the incidence, nature, and severity of adverse events and serious adverse events and laboratory abnormalities.
研究者
Yves ALLENBACH
Scientific
Assistance Publique Hopitaux De Paris
研究点 (15)
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