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
Rheumatic polymyalgia (PMR) is more commonly observed in individuals over the age of 50, who may have a higher prevalence of osteoporosis, diabetes, cardiovascular diseases, and other chronic conditions. Currently, glucocorticoids are the primary treatment for PMR, but they can lead to various side effects, and recurrence is common during steroid tapering. Our previous 24-week study confirmed the effective treatment of PMR patients with tofacitinib. Given the relatively slow efficacy of tofacitinib, early adjunctive therapy with NSAIDs is needed. To address this, we are planning an open-label 52-week randomized controlled trial. This study aims to assess the use of tofacitinib in combination with glucocorticoids to induce rapid improvement, followed by rapid tapering of steroids and slow tapering of tofacitinib. The objective is to observe the efficacy and safety of this regimen for PMR, providing a new treatment option for clinical use.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
98
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 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.
Division of Rheumatology, the First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
RECRUITINGProportion of patients with PMR-AS score <10 score at weeks 52
PMR-AS score: CRP (mg/dL)+Patient self-evaluation (0-10 visual scale)+ Physician global assessment (0-10 Visual Scale)+\[morning stiffness (min) x0.1\]+ EUL (0-3)
Time frame: at 52 weeks
PMR-AS score at weeks 24
PMR-AS score: CRP (mg/dL)+Patient self-evaluation (0-10 visual scale)+ Physician global assessment (0-10 Visual Scale)+\[morning stiffness (min) x0.1\]+ ability to elevate the upper limbs(EUL 0-3)
Time frame: at 24 weeks
PMR-AS score at weeks 52
PMR-AS score: CRP (mg/dL)+Patient self-evaluation (0-10 visual scale)+ Physician global assessment (0-10 Visual Scale)+\[morning stiffness (min) x0.1\]+EUL (0-3)
Time frame: at 52 weeks
CRP at weeks 24
CRP (mg/dL)
Time frame: at 24 weeks
CRP at weeks 52
CRP (mg/dL)
Time frame: at 52 weeks
ESR at weeks 24
ESR (mm/h)
Time frame: at 24 weeks
ESR at weeks 52
ESR (mm/h)
Time frame: at 52 weeks
Proportion of patients who discontinue drugs at weeks 52
Proportion of patients who discontinue Tof in the treatment group, prednisone in the control group at weeks 52
Time frame: at 52 weeks
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