Comparison of Adalimumab and Tofacitinib in the Treatment of Active Takayasu Arteritis

• Status: Not yet recruiting
• Trial end date: 2024-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This is a prospective,open-labelled,multi-center,randomized clincial trial.It comapres the clincal efficiacy and safety of there 2 drugs in the treatment of relapse active Takayasu's arteritis patients.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinese SLE Treatment And Research Group
• Treatments: Adalimumab

Criteria

Inclusion Criteria:

1. Patients aged between 18-65 years old;

2. Fulfilled the classification criteria of Takayasu's arteritis by ACR 1990;

3. relapsed active TAK: defined by the definition of active disease in the recommendations released by EULAR in 2018;

4. Patients who signed the informed consent form. -

Exclusion Criteria:

1. Patients who failed or intolerate to either adalimumab or tofacitinib;

2. patients with severe liver disease defined by the serum ALT or AST elevated more than 2 times the upper limits;

3. not well controlled diabetes;

4. uncontrolled heart failure od renal dysfunction(eGFR<30ml/min);

5. Patients with active infection,including tuberculosis, hepatitis B and C,HIV infection, bacteria or fungal infection;

6. upper GI bleeding 3 months before enrollement;

7. refractory hypertension;

8. Pregnant or intented to be pregnant 3 months after the trial;

9. Severe coronary artery involvement demonstrated by CTA;

10. severe cranial or cervial or renal artery diseases that need surgery;

11. Patients that should not be included by the investigator. -