Comparison of Tofacitinib and Methotrexate in Takayasu's Arteritis

Launched by SHANGHAI ZHONGSHAN HOSPITAL · Oct 19, 2021

Keywords

ClinConnect Summary

This clinical trial is studying two medications, tofacitinib and methotrexate, to see which one works better and is safer for people with Takayasu arteritis, a condition that affects the blood vessels. The trial is currently looking for participants who are between 18 and 65 years old and have been diagnosed with Takayasu arteritis based on specific medical guidelines. Eligible individuals must not have certain serious health issues, such as severe organ problems or other autoimmune diseases, and they need to agree to avoid pregnancy during the study.

If you decide to participate, you will receive either tofacitinib or methotrexate while continuing your current treatment with prednisone, a type of steroid used to reduce inflammation. Throughout the trial, you will be monitored closely to ensure your safety and to track how well the medications are working. This study is important as it aims to find the most effective treatment for Takayasu arteritis, which can help improve the quality of life for many patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients met 1990 American College of Rheumatology (ACR) classification criteria or 2018 ACR classification criteria (draft) of TAK
• • 2. Women or men aged 18-65
• • 3. All patients agreed that there is no fertility plan during clinical trials, and the results of female serum or urinary pregnancy tests must be negative
• • 4. Active TAK patients according to NIH disease activity criteria
• • 5. All patients agreed to sign the informed consent
• Exclusion Criteria:
• 1. Patients with organ failure who accord to one or more of the following conditions:
• • I.Heart function New York class 4 II.Glomerular filtration rate ≤ 60ml/min III.Liver function Child grade 2 and above IV.High-frequency melanoma (attacks for 3 consecutive days) V.Acute cerebral infarction or cerebral hemorrhage VI.Blood pressure \> 160/100mmHg
• • 2. Patients who received revascularization surgery related to the treatment of TAK within 3 months (except balloon dilatation); balloon dilatation or surgery unrelated to TAK within 1 month
• • 3. Patients who have other autoimmune diseases (e.g. ANCA-associated vasculitis, systemic lupus erythematosus, Behcet's disease, etc.)
• • 4. Patients with severe, progressive or uncontrolled comorbidities of kidney, liver, blood system, gastrointestinal, lung, heart, etc or other coexisting medical conditions that may exert unexpected risks
• • 5. Patients with concomitant diseases, such as asthma, that may require additional medium to high doses of glucocorticoids (prednisone ≥ 10mg/ days or equivalent dose) during the study period
• • 6. Patients with active infections with HBV, HCV, tuberculosis or other serious acute or chronic infections
• • 7. Patients with malignancies
• • 8. Patients with one or more of the following abnormal laboratory examinations I.Serum ALT or AST ≥ 1.5 times the normal upper limit; II.White blood cell count ≤ 4 × 109/L III.Platelet count ≤ 100x109/L IV.Hemoglobin \< 85g/L V.Other abnormal laboratory tests that may cause unacceptable risks
• • 9. Patients allergic to the experimental drug
• • 10. Patients who have ever failed to tofacitinib or methotrexate after 3 months' treatment in previous medical history