Comparison of Tofacitinib and Prednisolone in the Treatment of Active Takayasu's Arteritis

• Status: Recruiting
• Trial end date: 2025-07-20
• Target enrollment: 0
• Participant gender: All

Summary

This is a prospective, double-blinded, single center, randomized clinical trial. It compares the clinical efficacy and safety of thees 2 drugs in the treatment of active Takayasu's arteritis patients.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinese SLE Treatment And Research Group
• Treatments: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Tofacitinib

Criteria

Inclusion Criteria:

1. Patients aged between 18-65 years old;

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

3. Active TAK: defined by the definition of active disease in the recommendations released by EULAR in 2018 or Kerr's criteria by NIH;

4. Patients who signed the informed consent form.

Exclusion Criteria:

1. Patients who failed or intolerant to either tofacitinib or its similar drugs;

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. Moderate and severe hyperlipedimia;

5. Patients with history of thrombus;

6. Uncontrolled heart failure od renal dysfunction (eGFR <30ml/min);

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

8. Upper GI bleeding happened in 3 months before enrollment;

9. Refractory hypertension;

10. Pregnant or intended to be pregnant recently;

11. Severe coronary artery involvement demonstrated by CTA;

12. Severe cranial or cervical or renal artery diseases that need surgery;

13. Patients that should not be included judged by the investigator.