Clinical trial NCT05151848: Comparison of Adalimumab and Tofacitinib in the Treatment of Active Takayasu Arteritis
Official title: An Open-label，Randomized, Controlled, Multicenter Study of Adalimumab and Tofacitinib in the Treatment of Active Takayasu Arteritis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Takayasu Arteritis
Lead sponsor: Chinese SLE Treatment And Research Group
Sponsor class: OTHER
First posted: 2021-12-09
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: open-label, multicenter,randomized trial
Primary purpose: TREATMENT

Brief summary: This is a prospective,open-labelled,multi-center,randomized clinical trial.It compares the clinical efficacy and safety of there 2 drugs in the treatment of relapse active Takayasu's arteritis patients.

Detailed description: In this study, 100 relapse Takayasu's arteritis patients will be enrolled. Patients are randomized into the adalimumab treatment group and tofacitinib treatment.Patients will also be treated with reduced dose of glucocorticoid at the same time. The primary end point is the percentage of patients who are in complete response at week 12 and maintain in complete response at week 78.

The efficacy will be evaluated at week 12, 24, 36, 52 and 78. If the patient does not respond to one drug at week 24, then the investigator will shift the treatment to another intervention. Safety is also monitored during the study.

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.

Primary outcomes:
measure: percentage of patients with complete response
timeFrame: week 78
Secondary outcomes:
measure: percentage of patients with partial response
timeFrame: week 78
measure: Percentage of patients with image progression at the end of study
timeFrame: week 78
measure: adverse events
timeFrame: 78 weeks
measure: intervention procedures
timeFrame: 78 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anzhen Hospital
city: Beijing
country: China
facility: The General Hospital of the People's Liberation Army
city: Beijing
country: China
facility: Beijing Shijitan Hospital
city: Beijing
country: China
facility: Beijing Xuanwu Hospital
Study officials:
affiliation: Peking Union Medical College Hospital
name: Xiaofeng Zeng, MD
role: PRINCIPAL_INVESTIGATOR
References: