Takayasu's arteritis
Conditions
Interventions
Secukinumab:Secukinumab
Tumor necrosis factor inhibitor:Tumor necrosis factor inhibitor
Sponsors
Peking Union Medical College Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients have to fulfill the classification criteria of modified 1990 American College of Rheumatology (ACR) criteria; 2. Patients must be in active disease based on the National Institutes of Health (NIH) criteria or 2018 EULAR recommendation or physicians general assessment. Refractory cases were defined as patients who failed to achieve partial response or relapsed (recurrence of active disease) on 2 or more conventional ISs or at least one conventional IS and one biologic agent combined with low dose GC (<=10mg/d prednisone or equivalent dose); 3. Patients aged older than 18 years old but below 45 years old; 4. Either male or female could be included; 5. Patients with signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients with active or uncontrolled hepatitis B or C infection; 2. Patients with latent tuberculosis infection without prophylaxis therapy; 3. Patients who had ever been treated with the study drugs; 4. Patients with uncontrolled diabetes, and hypertension before entry; 5. Patients with active digestive tract bleeding 3 months before entry; 6. Patients with severe liver and kidney dysfunction, and damage defined as the alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level were above 3 upper limits of the normal range and the serum creatinine level was 1.5 times above the upper limits; 7. Patients with active infection, including bacteria, viruses, fungi, and mycobacteria; 8. Patient who is pregnant or who is planning for pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion pf patients with overall response at 12 and 24 weeks; | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion pf patients with complete response at 12 and 24 weeks;The proportion pf patients with partial response at 12 and 24 weeks;The change of inflammatory markers after treatment for 12 and 24 weeks;The change of mural thickness and lumen diameter, and newly onset, deteriorated, stable, of improved lesions of bilateral common carotid arteries, subclavian arteries, abdominal artery and their major branches; | — |
Countries
China
Contacts
Public ContactXinping Tian
Peking Union Medical College Hospital
Outcome results
None listed