Dermatomyositis
Conditions
Interventions
Barretinib group:Barretinib+Regular treatment
Conrol group:Regular treatment
Sponsors
No. 37, Guoxue lane, Chengdu
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: 1.Meet Bohan and Peter diagnostic criteria; 2.18 – 65 years old patients with dermatomyositis; 3.Using hormone therapy (= 0.5mg/kg/ day, treatment for 1 month) or combined with at least one immunosuppressant treatment for more than 3 months, there is still disease activity; 4.If the patient has been treated with other biological agents recently, the drug cleaning period of more than 4 weeks is required; 5.The patient is in a state of disease activity; 6.The subjects must be able and willing to give written informed consent and comply with the requirements of the study agreement; 7.Bilateral mmt-8 score < 150; At least two core evaluation indicators (CSMs) are abnormal; Doctors' overall evaluation = 2cm; Health Assessment Scale (HAQ) = 0.25; The increase of muscle enzyme is more than 1.3 times the upper limit.
Exclusion criteria
Exclusion criteria: Exclusion criteria 1.Dermatomyositis within 2 years after diagnosis of malignant tumor; 2.Overlap syndrome, inclusion body myositis, juvenile dermatomyositis or drug-induced myopathy; 3.Suffering from other serious skin, musculoskeletal diseases or serious medical diseases, unable to score the severity of the disease; 4.Received immunoglobulin and plasma exchange treatment within 6 months; 5.Patients with severe liver and renal dysfunction; 6.Patients with low leukocyte and hemoglobin < 8g/dl; 7.Lactation patients, pregnancy or allergy to this drug and any excipients; 8.Patients with high risk of infection such as viral hepatitis, active tuberculosis infection and immunodeficiency disease; 9.Mental illness is not yet in a stable stage; 10.The patient did not agree to use barretinib for treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| creatine kinase; | — |
Countries
China
Contacts
Public ContactLuo Xiongyan
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Outcome results
None listed