Comparing two medications for treating active Takayasu arteritis

An Open-label，Randomized, Controlled, Multicenter Study of Adalimumab and Tofacitinib in the Treatment of Active Takayasu Arteritis

This study is testing whether two different medications, adalimumab and tofacitinib, can help people with active Takayasu arteritis feel better and stay that way for a longer time.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Chinese SLE Treatment And Research Group (other)
• Drugs / interventions: adalimumab, tofacitinib
• Locations: 4 sites (Beijing and 3 other locations)
• Trial ID: NCT05151848 on ClinicalTrials.gov

What this trial studies

This clinical trial is a prospective, open-label, multi-center, randomized study involving 100 patients with relapse active Takayasu arteritis. Participants will be randomly assigned to receive either adalimumab or tofacitinib, alongside a reduced dose of glucocorticoids. The primary endpoint is to assess the percentage of patients achieving complete response at week 12 and maintaining it until week 78, with efficacy evaluations at multiple intervals. If a patient does not respond to the assigned treatment by week 24, they will be switched to the alternative medication. Safety will also 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 relapse active Takayasu arteritis.

Not a fit: Patients who have previously failed or are intolerant to either adalimumab or tofacitinib will not benefit from this study.

Why it matters

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

How similar studies have performed: While this approach is novel in the context of Takayasu arteritis, similar studies comparing biologics and targeted therapies have shown promising results in other autoimmune conditions.

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. relapse 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 intolerant 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 enrolement;
7. refractory hypertension;
8. Pregnant or intended to be pregnant 3 months after the trial;
9. Severe coronary artery involvement demonstrated by CTA;
10. severe cranial or cervical or renal artery diseases that need surgery;
11. Patients that should not be included by the investigator.

Where this trial is running

Beijing and 3 other locations

• Beijing Anzhen Hospital — Beijing, China (RECRUITING)
• The General Hospital of the People's Liberation Army — Beijing, China (NOT_YET_RECRUITING)
• Beijing Shijitan Hospital — Beijing, China (NOT_YET_RECRUITING)
• Beijing Xuanwu Hospital — Beijing, China (NOT_YET_RECRUITING)

Study contacts

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

Conditions: Takayasu Arteritis