ADATOFTAK: Comparison of Adalimumab and Tofacitinib in the Treatment of Active Takayasu Arteritis
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.
|Condition or Disease||Intervention/Treatment||Phase|
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 52.
The efficacy will be evaluated at week 12, 24, 36 and 52. If the patient does not respond to one drug at week 12,then the investigator will shift the treatment to another intervention.Safety is also monitored during the study.
Arms and Interventions
|Experimental: Adalimumab group
Adalimumab 40mg injected subcutaneously every 2 weeks for 52 weeks.
Drug: Adalimumab Injection
Adalimumab Injection injected subcutaneously every other week for 52 weeks
|Active Comparator: Tofacitinib 5MG group
Tofacitinib 5mg BID taken orally for 52 weeks.
Drug: Tofacitinib 5 MG
Tofacitinib 5 MG BID taken orally for 52 weeks
Primary Outcome Measures
- percentage of patients with complete response [week 52]
percentage of patients with complete response at week 52
Secondary Outcome Measures
- percentage of patients with partial response [week 52]
percentage of patients with partial response at week 52
- Percentage of patients with image progression at the end of study [week 52]
percentage of patients with progress disease demonstrated by CTA or Doppler at week 52
- adverse events [52 weeks]
safety profile of both Adalimumab and Tofacitinib treatment group
- intervention procedures [52 weeks]
percentage of patients who require intervention procedures during the study period
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. -
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;
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. -
Contacts and Locations
|1||Beijing Anzhen Hospital||Beijing||China||100000|
|2||The General Hospital of the People's Liberation Army||Beijing||China||100000|
|3||Beijing Shijitan Hospital||Beijing||China||100053|
|4||Beijing Xuanwu Hospital||Beijing||China||100053|
Sponsors and Collaborators
- Chinese SLE Treatment And Research Group
- Principal Investigator: Xiaofeng Zeng, MD, Peking Union Medical College Hospital
Study Documents (Full-Text)None provided.