Comparison of the Efficacy and Safety of Tofacitinib and Methotrexate Based on Prednisone Therapy in Patients with Active Phase of Takayasu's Arteritis: a Randomized Controlled Trial
Who is this study for? Patients with Takayasu Arteritis
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
The aim of this study is to evaluate and compare the efficacy and safety of tofacitinib and methotrexate based on prednisone therapy in patients with Takayasu arteritis
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
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• Patients met 1990 American College of Rheumatology (ACR) classification criteria or 2018 ACR classification criteria (draft) of TAK
• Women or men aged 18-65
• 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
• Active TAK patients according to NIH disease activity criteria
• All patients agreed to sign the informed consent
Locations
Other Locations
China
Lindi Jiang
RECRUITING
Shanghai
Contact Information
Primary
Lindi Jiang, Ph.D., M.D.
zsh-rheum@hotmail.com
021-64041990
Backup
Xiufang Kong, Ph.D., M.D.
kongxiufang2007@163.com
021-64041990
Time Frame
Start Date: 2021-11-01
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 76
Treatments
Experimental: Tofacitinib
Partcipants would be given one tablet of tofacitinib (5mg per tablet), twice per day, the treatment duration will last 12 months during the whole follow-up period.
Active_comparator: Methotrexate
Participates would be given tablets of methotrexate (2.5mg per tablet) 15mg each week, the treatment duration will last 12 months during the whole follow-up period.
Related Therapeutic Areas
Sponsors
Leads: Shanghai Zhongshan Hospital