inflammatory myopathy
Conditions
Interventions
Control group:Placebo
Sponsors
Peking Union Medical College Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Fulfill the diagnosis of inflammatory myopathy; 2. The age is between 18 and 70; 3. Fulfill the activity criteria for recurrent or refractory IIMs: Recurrence criteria: After 6 months of continuous remission of the disease, evaluate the recurrence of the disease activity; Refractory criteria: intolerance or insufficient response to high-dose corticosteroids and at least one immunosuppressive agent. 4. Signed informed consent statement.
Exclusion criteria
Exclusion criteria: 1. The patient has other immune system diseases; 2. The patient has potentially life-threatening complications; 3. The patient is pregnant or breastfeeding, or planning to become pregnant or breastfeeding; 4. The patient has a history of active hepatitis or tuberculosis; 5. Denied to join this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| International Myositis Assessment and Clinical Studies definition of improvement (IMACS); | — |
Secondary
| Measure | Time frame |
|---|---|
| physician global assessment,PGA;Patient Global Activity,PGA;manual muscle testing,MMT;cutaneous dermatomyositis disease area and severity index, CDASI;Myositis Disease Activity Assessment Visual Analogue Scales, MYOACT;myositis damage index,MDI; | — |
Countries
China
Contacts
Public ContactChanyuan Wu
Peking Union Medical College Hospital
Outcome results
None listed