Comparing Tofacitinib and Prednisolone for Active Takayasu's Arteritis

A Prospective Randomized Double-blinded Controlled Single Center Clinical Study of the Efficacy and Safety for Tofacitinib Compared With Glucocorticoid in the Remission-reduction Treatment of Active Takayasu's Arteritis

This study is testing whether tofacitinib works better than prednisolone for treating people with active Takayasu's arteritis.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Chinese SLE Treatment And Research Group (Academic / other)
• Drugs / interventions: tofacitinib
• Locations: 1 site (Beijing)
• Trial ID: NCT05749666 on ClinicalTrials.gov

What this trial studies

This clinical trial is a prospective, double-blinded, single-center, randomized study that aims to compare the efficacy and safety of tofacitinib and prednisolone in treating patients with active Takayasu's arteritis. A total of 40 patients will be enrolled and randomly assigned to receive either tofacitinib or prednisolone, with a placebo group for each treatment. The primary endpoint is the percentage of patients achieving a complete response at week 24, with efficacy evaluated at weeks 4, 12, and 24, while safety will be monitored throughout the study.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18-65 who have been diagnosed with active Takayasu's arteritis.

Not a fit: Patients who have previously failed or are intolerant to tofacitinib or similar drugs may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for patients suffering from active Takayasu's arteritis.

How similar studies have performed: While there have been studies on the use of tofacitinib for other conditions, this specific comparison in Takayasu's arteritis is novel and has not been extensively tested.

Eligibility 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.

Where this trial is running

Beijing

• Peking Union Medical College Hospital — Beijing, China (Recruiting)

Study contacts

• Principal investigator: Xinping Tian, MD — Peking Union Medical College Hospital
• Study coordinator: Xinping Tian, MD

Conditions Takayasu Arteritis; Tofacitinib; prednisolone