2024-513653-75-00招募中3 期
E-merge - Evaluation of MEpolizumab-based regimen Compared to Conventional Therapeutic Strategy For Remission Induction In Patients With Eosinophilic Granulomatosis With Polyangiitis. Prospective, randomized, controlled, double-blind study
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 35
- 主要终点
- The percentage of patients who achieved a prednisone dose of 4.0 mg or less per day at day 168, without experiencing a relapse
研究概览
简要总结
To determine the glucocorticoid-sparing effect of mepolizumab-based regimen, defined as a prednisone dose of 4.0 mg or less per day at day 168, in patients with newly-diagnosed or relapsing EGPA
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Patients with a diagnosis of EGPA independently of ANCA status
- •Patient aged of 18 years or older
- •Patients with newly-diagnosed disease or relapsing disease at the time of screening, with an active disease defined as a Birmingham Vasculitis Activity Score (BVAS) ≥3
- •Patients within the first 21 days following initiation/increase of corticosteroids at a dose ≤ 1 mg/kg/day (pulses of methylprednisolone before oral corticosteroid therapy are authorized)
- •Written informed consent prior to participation in the study
- •Affiliation to social security or CMU (beneficiary or assignee)
排除标准
- •Patients with GPA, MPA, or other vasculitis, defined by the ACR criteria and/or the Chapel Hill Consensus Conference
- •Patients with contraindication to use mepolizumab, cyclophosphamide, mesna, azathioprine or maintenance therapy used for vasculitis
- •Patients with other uncontrolled diseases, including drug or alcohol abuse, severe psychiatric diseases, that could interfere with participation in the trial according to the protocol
- •Patients included in other investigational therapeutic study within the previous 3 months
- •Patients suspected not to be observant to the proposed treatments
- •Patients who have white blood cell count ≤4,000/mm3
- •Patients who have platelet count ≤100,000/mm3
- •Patients who have ALT or AST level greater that 3 times the upper limit of normal that cannot be attributed to underlying EGPA disease
- •Patients unable to give written informed consent prior to participation in the study
- •Patients under tutorship or curatorship and protected adults
- •Patients with vasculitis in remission of the disease defined as a BVAS <3
- •Patients with severe cardiac failure defined as class IV in New York Heart Association
- •Patients with acute infections or chronic active infections (including HIV, HBV or HCV and checked in the last 12 months)
- •Patients with active cancer or recent cancer (<5 years), except basocellular carcinoma and prostatic cancer of low activity controlled by hormonal treatment
- •Pregnant women and lactation. All women of childbearing potential (WOCBP) are required to have a negative serum pregnancy test before treatment and must agree to maintain highly effective contraception by practicing abstinence or by using an effective method of birth control from the date of consent through the end of the study and for WOCPB with FFS≥1 at least 12 months after stopping cyclophosphamide: Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (Oral, Intravaginal, Transdermal); Progestogen-only hormonal contraception associated with inhibition of ovulation (Oral, Injectable, Implantable); Intrauterine device (IUD); Intrauterine hormone-releasing system (IUS); Bilateral tubal occlusion; Vasectomised Partner
- •Men with FFS≥1 who refuse to use effective method of contraception (condom) from the date of consent through the end of the study and at least 6 months after stopping cyclophosphamide (unless permanently sterile by bilateral orchidectomy)
- •Patients with EGPA who have already been treated with mepolizumab or benraluzimab within the previous 6 months
- •Patients with hypersensitivity to a monoclonal antibody or biologic agent
结局指标
主要结局
The percentage of patients who achieved a prednisone dose of 4.0 mg or less per day at day 168, without experiencing a relapse
The percentage of patients who achieved a prednisone dose of 4.0 mg or less per day at day 168, without experiencing a relapse
次要结局
- Prednisone dosage at days 168 and 364
- The area under the curve for corticosteroids at days 168 and 364 in the two treatment groups
- Proportion of participants with a prednisone dose of 4.0 mg or less per day for 0 weeks, for more than 0 weeks but less than 4 weeks, for more than 4 weeks but less than 12 weeks, and for at least 12 weeks (categorical quantification)
- Proportion of participants with a prednisone dose of 4.0 mg or less per day at both days 168 and 364
- Proportion of participants experiencing a relapse
- Number of relapse during the study period
- Number of asthma and sinonasal exacerbations during the study period
- Time from inclusion to first relapse
- The ACQ and SNOT-22 during the study period
- The number of adverse events, expressed as adverse events according to the CTCAE toxicity grading system per patient-year at days 168 and 364 for the following adverse events combined: death (all causes), grade 2 or higher leukopenia or thrombocytopenia, grade 3 or higher infections, hemorraghic cystitis, malignancies, venous thromboembolic events, hospitalization resulting either from the disease or from a complication due to the study treatment, infusion reactions that result in the cessation
- The Vasculitis Damage Index at days 168 and 364 in the two treatment groups
- The HAQ and SF-36 at days 168 and 364 in the two treatment groups
- Evolution of ANCA titers and eosinophils in the two treatment groups, and correlation with clinical events during follow-up
研究者
Benjamin TERRIER
Scientific
Assistance Publique Hopitaux De Paris
研究点 (35)
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