Adult active dermatomyositis
Conditions
Interventions
Experimental group:Tetacipumab
Sponsors
Affiliated Hospital of North Sichuan Medical College
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The age at the time of enrollment was 18 to 75 years old. 2. The patients diagnosed with dermatomyositis, who met at least 4 items in the 1975 Bohan /Peter diagnostic criteria table. 3. The patients were using glucocorticoids (>= 0.5mg /kg /day, lasting >=1 month) in combination with at least one other immunosuppressive drug
Exclusion criteria
Exclusion criteria: 1. The patient has severe basic diseases 2. Any of the following information was received within 30 days before screening: non-biological research drugs (30 days window or 5 half-lives, whichever is longer), any new immunosuppressive agents/immunomodulators 3. Other B-cell-targeted biological agents were received within 1 year before screening 4. Hormone shock therapy was received within 3 months before screening (>1.5mg /kg /day 0.5g /d methylprednisolone) 5. Planned pregnancy or lactation patients 6. Planned surgery 7. History of malignant tumor in the past 5 years 8. Acute or chronic infection requiring treatment in the past 60 days 9. Positive test in history or in screening for HIV, hepatitis B or hepatitis C 10. Allergic reaction to X-ray contrast agent or biological agent 11. Suicide behavior or thought 12. Other researchers think it is not appropriate to continue to participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| manual muscle testing; | — |
Countries
China
Contacts
Public ContactQing Yufeng
Affiliated Hospital of North Sichuan Medical College
Outcome results
None listed