Induction and Tapering Therapy With Tofacitinib and Glucocorticoid in Patients With Polymyalgia Rheumatica

PHASE3RecruitingINTERVENTIONAL
Enrollment

98

Participants

Timeline

Start Date

January 20, 2024

Primary Completion Date

September 30, 2025

Study Completion Date

January 30, 2026

Conditions
Polymyalgia Rheumatica
Interventions
DRUG

Prednisone+Tofacitinib

"Withdrawal of prednisone (or equivalent dose of methylprednisolone) within 4 weeks: 5mg tid for 2 weeks, 5mg bid for 1 week, 5mg qd for 1 week, then discontinue.~Take Tofacitinib 10mg/d for 3 months, then 7.5mg/d for 2 months, followed by 5mg qd for 2 months, then 5mg qod for 2 months, and finally 5mg every 3 days for 2 months, discontinue the Tofacitinib for 1 month. If there is a relapse during the dose reduction process, resume Tofacitinib at the original dosage."

DRUG

Prednisone

Prednisone 15mg (or equivalent dose of methylprednisolone) was set as the initial treatment of PMR. When improvement was achieved, the dose of Prednisone was reduced to 10mg daily within 4-10 weeks; When remission was achieved, then taper Prednisone gradually by 2.5mg every 6-8 weeks. Once relapse occurred, the dose increased to the pre-relapse dose. If reducing pred dosage is difficult, Methotrexate (MTX) 10mg qw can be added after 24 weeks.

Trial Locations (1)

313000

RECRUITING

Division of Rheumatology, the First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou

All Listed Sponsors
lead

Zhejiang University

OTHER