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NCT05749666
Comparison of Tofacitinib and Prednisolone in the Treatment of Active Takayasu's Arteritis
Conditions: Takayasu Arteritis
Sex: All
Ages: 18 Years – 65 Years
Phase: PHASE3
Enrollment: 50
Sponsor: Chinese SLE Treatment And Research Group
Location: China
Summary
This is a prospective, double-blinded, single center, randomized clinical trial.
It compares the clinical efficacy and safety of thees 2 drugs in the treatment of active Takayasu's arteritis patients.
Eligibility Criteria
Inclusion Criteria:Patients aged between 18-65 years old;Fulfilled the classification criteria of Takayasu's arteritis by ACR 1990;Active TAK: defined by the definition of active disease in the recommendations released by EULAR in 2018 or Kerr's criteria by NIH;Patients who signed the informed consent form.Exclusion Criteria:Patients who failed or intolerant to either tofacitinib or its similar drugs;Patients with severe liver disease defined by the serum ALT or AST elevated more than 2 times the upper limits;Not well controlled diabetes;Moderate and severe hyperlipedimia;Patients with history of thrombus;Uncontrolled heart failure od renal dysfunction (eGFR <30ml/min);Patients with active infection, including tuberculosis, hepatitis B and C, HIV infection, bacterial or fungal infection;Upper GI bleeding happened in 3 months before enrollment;Refractory hypertension;Pregnant or intended to be pregnant recently;Severe coronary artery involvement demonstrated by CTA;Severe cranial or cervical or renal artery diseases that need surgery;Patients that should not be included judged by the investigator.
Source: ClinicalTrials.gov (NCT05749666). StuddyBuddy aggregates publicly available trial information.