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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Takayasu Arteritis

Intervention / Treatment
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* Drug: Adalimumab Injection
* Drug: Tofacitinib 5 MG


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged between 18-65 years old; Fulfilled the classification criteria of Takayasu's arteritis by ACR 1990; relapse active TAK: defined by the definition of active disease in the recommendations released by EULAR in 2018; Patients who signed the informed consent form. Exclusion Criteria: Patients who failed or intolerant to either adalimumab or tofacitinib; patients with severe liver disease defined by the serum ALT or AST elevated more than 2 times the upper limits; not well controlled diabetes; uncontrolled heart failure od renal dysfunction(eGFR<30ml/min); Patients with active infection,including tuberculosis, hepatitis B and C,HIV infection, bacteria or fungal infection; upper GI bleeding 3 months before enrolement; refractory hypertension; Pregnant or intended to be pregnant 3 months after the trial; Severe coronary artery involvement demonstrated by CTA; severe cranial or cervical or renal artery diseases that need surgery; Patients that should not be included by the investigator.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: open-label, multicenter,randomized trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adalimumab group<br>Adalimumab 40mg injected subcutaneously every 2 weeks for 78 weeks. | Drug: Adalimumab Injection<br>* Adalimumab Injection injected subcutaneously every other week for 78 weeks<br>* Other names: An-jian-ning;|
| Active Comparator: Tofacitinib 5MG group<br>Tofacitinib 5mg BID taken orally for 78 weeks. | Drug: Tofacitinib 5 MG<br>* Tofacitinib 5 MG BID taken orally for 78 weeks<br>* Other names: An-shu-zheng;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percentage of patients with complete response | percentage of patients with complete response at week 78 | week 78 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percentage of patients with partial response | percentage of patients with partial response at week 78 | week 78 | 
| Percentage of patients with image progression at the end of study | percentage of patients with progress disease demonstrated by CTA or Doppler at week 78 | week 78 | 
| adverse events | safety profile of both Adalimumab and Tofacitinib treatment group | 78 weeks | 
| intervention procedures | percentage of patients who require intervention procedures during the study period | 78 weeks |