An Open-label，Randomized, Controlled, Multicenter Study of Adalimumab and Tofacitinib in the Treatment of Active Takayasu Arteritis
Overview
- Phase
- Phase 4
- Intervention
- Adalimumab Injection
- Conditions
- Takayasu Arteritis
- Sponsor
- Chinese SLE Treatment And Research Group
- Enrollment
- 100
- Locations
- 4
- Primary Endpoint
- percentage of patients with complete response
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Xinping Tian
Professor of Medicine
Chinese SLE Treatment And Research Group
Eligibility Criteria
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;
Arms & Interventions
Adalimumab group
Adalimumab 40mg injected subcutaneously every 2 weeks for 78 weeks.
Intervention: Adalimumab Injection
Tofacitinib 5MG group
Tofacitinib 5mg BID taken orally for 78 weeks.
Intervention: Tofacitinib 5 MG
Outcomes
Primary Outcomes
percentage of patients with complete response
Time Frame: week 78
percentage of patients with complete response at week 78
Secondary Outcomes
- Percentage of patients with image progression at the end of study(week 78)
- intervention procedures(78 weeks)
- adverse events(78 weeks)
- percentage of patients with partial response(week 78)