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

Sponsor
Zhejiang University
Study ID
NCT06172361
Phase
PHASE3
Status
Recruiting
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Conditions

  • Polymyalgia Rheumatica

Eligibility Criteria

Sex
ALL
Age
50 Years - 88 Years
Healthy Volunteers
Not accepted

Interventions

  • Prednisone+Tofacitinib — DRUG
    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.
  • Prednisone — DRUG
    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.

Study Details

This will be efficacy and safety of Induction and Tapering Therapy with Tofacitinib and Glucocorticoid in patients with Polymyalgia Rheumatica (ITTG PMR): An open-label 52-week randomized controlled trial

Key Dates

Start date
Jan 20, 2024
Status verified
Aug 2025
Primary completion
Sep 30, 2025
Completion
Jan 30, 2026

Study Design

Enrollment
98 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment group
    Prednisone (or equivalent dose of methylprednisolone) + Tofacitinib
  • Active Comparator: Positive control group
    prednisone (or equivalent dose of methylprednisolone)

Primary Outcome Measure

Proportion of patients with PMR-AS score <10 score at weeks 52 [ Time Frame: at 52 weeks ]

Central Contacts

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