Comparison of Tofacitinib and Prednisolone in the Treatment of Active Takayasu's Arteritis

Launched by CHINESE SLE TREATMENT AND RESEARCH GROUP · Feb 19, 2023

Keywords

ClinConnect Summary

This clinical trial is comparing two treatments, tofacitinib and prednisolone, for people with active Takayasu's arteritis, a condition that causes inflammation of the blood vessels. The study aims to see which medication is more effective and safe for patients. They are currently looking for participants aged 18 to 65 who meet specific criteria, such as having been diagnosed with active Takayasu's arteritis and being able to provide informed consent. However, individuals with certain health issues, like severe liver disease, uncontrolled diabetes, or recent infections, will not be eligible to participate.

Participants in the trial will receive either tofacitinib or prednisolone and will be monitored closely for their health and response to the treatment. The study is designed to be double-blinded, meaning neither the participants nor the researchers will know which treatment each participant is receiving, which helps ensure the results are unbiased. If you or someone you know has Takayasu's arteritis and meets the criteria, this trial could be a chance to access new treatment options while contributing to medical research.

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. Active TAK: defined by the definition of active disease in the recommendations released by EULAR in 2018 or Kerr's criteria by NIH;
• • 4. Patients who signed the informed consent form.
• Exclusion Criteria:
• • 1. Patients who failed or intolerant to either tofacitinib or its similar drugs;
• • 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. Moderate and severe hyperlipedimia;
• • 5. Patients with history of thrombus;
• • 6. Uncontrolled heart failure od renal dysfunction (eGFR \<30ml/min);
• • 7. Patients with active infection, including tuberculosis, hepatitis B and C, HIV infection, bacterial or fungal infection;
• • 8. Upper GI bleeding happened in 3 months before enrollment;
• • 9. Refractory hypertension;
• • 10. Pregnant or intended to be pregnant recently;
• • 11. Severe coronary artery involvement demonstrated by CTA;
• • 12. Severe cranial or cervical or renal artery diseases that need surgery;
• • 13. Patients that should not be included judged by the investigator.