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

Launched by CHINESE SLE TREATMENT AND RESEARCH GROUP · Nov 26, 2021

Keywords

ClinConnect Summary

This clinical trial is comparing two medications, adalimumab and tofacitinib, to see which one works better for treating active Takayasu arteritis, a condition that affects blood vessels and can lead to serious health issues. The study is open to both men and women aged 18 to 65 who have been diagnosed with Takayasu arteritis and are experiencing a relapse of their symptoms. To participate, individuals must meet specific criteria, such as having confirmed Takayasu arteritis and signing a consent form, while those with certain health issues, like severe liver disease or uncontrolled infections, will not be eligible.

Participants in the trial will receive either adalimumab or tofacitinib and will be monitored for how well the treatment works and any side effects they may experience. The trial is currently recruiting participants, and it aims to gather important information that could help improve treatment options for people with this condition. If you or a loved one is considering participation, it's a great opportunity to contribute to research that may benefit many others facing similar health challenges.

Gender

ALL

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.