The study intends to explore the efficacy and safety of Ivarmacitinib in therapy for polymyalgia rheumatica through a multicenter, randomized, double-blind, placebo-controlled study, and to explore the effectiveness of Ivarmacitinib as an oral glucocorticoid-sparing alternative in the treatment of polymyalgia rheumatica.
This study plans to enroll 80 patients with clinically confirmed severe active polymyalgia rheumatica. After enrollment, participants will be randomly assigned in a 1:1 ratio to either the experimental group or the placebo group. All patients will receive a single dose of long-acting glucocorticoid in Week 1. Both groups will continue their assigned treatment until Week 12, when unblinding will occur. Thereafter, the placebo group will switch to ivarmacitinib, and both groups will continue treatment until Week 48, followed by a 4-week safety follow-up period until Week 52.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
80
Targets JAK kinases to block signal transduction of the JAK-STAT pathway
Treatment using blank placebo
The proportion of patients with CRP PMR-AS ≤10 at Week 12 without oral glucocorticoid use from Week 0 to Week 12;
The proportion of patients with CRP PMR-AS ≤10 at Week 12 without oral glucocorticoid use from Week 0 to Week 12
Time frame: up to 12 weeks
Proportion of Patients Achieving CRP-PMR-AS ≤10 Without Oral Glucocorticoids
Measured at Weeks 16, 20, 28, 36, and 48.
Time frame: up to 48 weeks
Erythrocyte sedimentation rate (ESR)
Changes in Inflammatory Markers
Time frame: up to 48 weeks
level of C-reactive protein (CRP)
Markers: C-reactive protein (CRP).
Time frame: up to 48 weeks
level of Interleukin-6 (IL-6).
Cytokine: Interleukin-6 (IL-6).
Time frame: up to 48 weeks
Cumulative Glucocorticoid Dose at Week 48.
Long-Term Follow-Up Outcome
Time frame: up to 48 weeks
Relapse Rate at Week 48 in Both Groups
Relapse Definition: PMR-AS ≥10 AND requiring escalation of glucocorticoid therapy based on the original regimen.
Time frame: up to 48 weeks
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