Efficacy and Safety of Ivarmacitinib in the Treatment of Patients With Polymyalgia Rheumatica: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 主要终点
- The proportion of patients with CRP PMR-AS ≤10 at Week 12 without oral glucocorticoid use from Week 0 to Week 12;
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age and Weight: 50-75 years old, body weight 40-80 kg.
- •Diagnosis: Confirmed diagnosis of polymyalgia rheumatica (PMR) according to the 2012 ACR/EULAR classification criteria .
- •Disease Activity: CRP-PMR-AS (C-reactive protein polymyalgia rheumatica activity score) ≥17 .
- •Glucocorticoid Use:
- •Newly Diagnosed Patients: No glucocorticoid use within 12 weeks prior to enrollment.
- •Relapsed Patients: No increase in glucocorticoid dosage within 2 weeks prior to enrollment, and willingness to discontinue current glucocorticoids after enrollment.
- •Compliance: Participants must understand and agree to adhere to study procedures and restrictions.
排除标准
- •Allergy: Known hypersensitivity to the investigational drug or excipients (including lactose, cellulose-lactose, low-substituted hydroxypropyl cellulose (L-HPC), colloidal silicon dioxide, stearic acid).
- •Comorbidities:
- •Giant cell arteritis (GCA) .
- •Other diffuse connective tissue diseases (e.g., systemic lupus erythematosus), spondyloarthropathy, or active fibromyalgia .
- •Uncontrolled Chronic Conditions:
- •Diabetes (HbA1c ≥8.0%) or uncontrolled hypertension (resting SBP ≥140 mmHg and/or DBP ≥90 mmHg) .
- •Clinically significant ECG abnormalities (e.g., acute myocardial ischemia, myocardial infarction, severe arrhythmia, QTc >500 ms).
- •Organ Dysfunction:
- •Liver/Kidney Impairment:
- •AST/ALT ≥2× upper limit of normal (ULN).
- •Serum creatinine or total bilirubin ≥1.5× ULN .
- •Malignancy: History of malignancy within the past 5 years.
- •Infections:
- •Active uncontrolled infections (e.g., tuberculosis, hepatitis B surface antigen (HBsAg) positive with elevated HBV-DNA, HCV, HIV, or active syphilis).
- •Severe herpes zoster infection or systemic antimicrobial therapy within 2 weeks prior to randomization.
- •Reproductive Plans: Pregnancy planning within 1 year.
- •Prior Medications: Previous use of JAK inhibitors.
- •Thrombosis: History of thrombotic events.
- •Other: Any condition deemed inappropriate by the investigator for participation in this clinical study.
研究组 & 干预措施
placebo
The placebo group received a matched placebo for Ivarmacitinib treatment up to week 12. At week 12, the trial was unblinded, and the placebo group was switched to receive Ivarmacitinib treatment up to week 48, followed by a 4-week safety follow-up period up to week 52.
干预措施: Ivarmacitinib tablet (Drug)
placebo
The placebo group received a matched placebo for Ivarmacitinib treatment up to week 12. At week 12, the trial was unblinded, and the placebo group was switched to receive Ivarmacitinib treatment up to week 48, followed by a 4-week safety follow-up period up to week 52.
干预措施: placebo for lvarmacitinib (Drug)
Ivarmacitinib tablet
The treated group received Ivarmacitinib at 4 mg/day for 48 weeks, followed by a 4-week safety follow-up period up to week 52.
干预措施: Ivarmacitinib tablet (Drug)
结局指标
主要结局
The proportion of patients with CRP PMR-AS ≤10 at Week 12 without oral glucocorticoid use from Week 0 to Week 12;
时间窗: up to 12 weeks
The proportion of patients with CRP PMR-AS ≤10 at Week 12 without oral glucocorticoid use from Week 0 to Week 12
次要结局
- level of C-reactive protein (CRP)(up to 48 weeks)
- Proportion of Patients Achieving CRP-PMR-AS ≤10 Without Oral Glucocorticoids(up to 48 weeks)
- Erythrocyte sedimentation rate (ESR)(up to 48 weeks)
- level of Interleukin-6 (IL-6).(up to 48 weeks)
- Cumulative Glucocorticoid Dose at Week 48.(up to 48 weeks)
- Relapse Rate at Week 48 in Both Groups(up to 48 weeks)