Efficacy and Safety of Ivarmacitinib in the Treatment of Patients With Polymyalgia Rheumatica: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 80
- Primary Endpoint
- The proportion of patients with CRP PMR-AS ≤10 at Week 12 without oral glucocorticoid use from Week 0 to Week 12;
Study Overview
Brief Summary
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.
Detailed Description
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 50 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
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.
Intervention: 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.
Intervention: 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.
Intervention: Ivarmacitinib tablet (Drug)
Outcomes
Primary Outcomes
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
The proportion of patients with CRP PMR-AS ≤10 at Week 12 without oral glucocorticoid use from Week 0 to Week 12
Secondary Outcomes
- 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)