Comparison of Tofacitinib and Methotrexate in Takayasu's Arteritis

PHASE4RecruitingINTERVENTIONAL
Enrollment

76

Participants

Timeline

Start Date

November 1, 2021

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
Takayasu Arteritis
Interventions
DRUG

Tofacitinib

"1. Tofacitinib 5mg twice a day for 12 months;~2. Basic treatment with prednisone: (1) the initial dose of prednisone (or equivalent): 0.8mg/kg/day (maximum 60mg/day). (2) Glucocorticoids tapering: glucocorticoids is tapered after two weeks treatment and is tapered 5mg each 2 weeks to 10mg qd in the first 6 months if patients were in inactive status based on the NIH disease activity criteria. During the 6th to 12th month, glucocorticoids is tapered 2.5mg each 4 weeks until 7.5mg qd if patients were in inactive status based on the NIH disease activity criteria."

DRUG

Methotrexate

"1. Methotrexate (15mg each week) for 12 months~2. Basic treatment with prednisone: (1) the initial dose of prednisone (or equivalent): 0.8mg/kg/day (maximum 60mg/day). (2) Glucocorticoids tapering: glucocorticoids is tapered after two weeks treatment and is tapered 5mg each 2 weeks to 10mg qd in the first 6 months if patients were in inactive status based on the NIH disease activity criteria. During the 6th to 12th month, glucocorticoids is tapered 2.5mg each 4 weeks until 7.5mg qd if patients were in inactive status based on the NIH disease activity criteria."

Trial Locations (1)

200032

RECRUITING

Lindi Jiang, Shanghai

All Listed Sponsors
lead

Shanghai Zhongshan Hospital

OTHER

NCT05102448 - Comparison of Tofacitinib and Methotrexate in Takayasu's Arteritis | Biotech Hunter | Biotech Hunter