Mepolizumab As a Steroid Sparing Treatment Option in the Churg Strauss Syndrome
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Number of Participants With Indicated Side Effects
研究概览
简要总结
The purpose of this study is to determine whether Mepolizumab (a monoclonal antibody against interleukin-5) is a safe and well-tolerated therapy that will allow for steroid tapering in patients with steroid-dependent Churg-Strauss Syndrome (CSS).
详细描述
Specific Aims:
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Document the safety of mepolizumab therapy in patients with CSS.
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Demonstrate the steroid sparing effect of mepolizumab therapy by decreasing corticosteroid dosage while using this anti-IL5 therapy.
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Demonstrate the efficacy of anti-IL5 therapy in improving the signs and symptoms of CSS by:
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Measuring serum markers of CSS disease activity, including: peripheral eosinophilia, erythrocyte sedimentation rate, anti- neutrophil cytoplasmic antigen, C-reactive protein and IgE levels.
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Assessing the activity level of vasculitis via the Birmingham Vasculitis Activity Score
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Evaluating asthmatic response via serial peak flow and FEV1 measurements as well as asthma symptom scores using the Juniper scale.
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Assessing changes in novel parameters such as fractional excretion of nitric oxide and IL-5 levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >18 years old
- •Diagnosis of Churg Strauss Syndrome
- •Maintained on stable corticosteroid dose of at least prednisone 10mg daily (or equivalent) prior to enrollment in study
- •If on cyclophosphamide, azathioprine or methotrexate, must be on a stable dose and be able to maintain that dose for the duration of the study
排除标准
- •Hypereosinophilic Syndrome
- •Wegener's Granulomatosis
- •Malignancy
- •Parasitic Disease
- •Pregnant or nursing
- •If female and of child-bearing potential, must have negative pregnancy test prior to each infusion of study medication and must adhere to acceptable method of contraception (with <1% failure rate)
- •Any other medical illness that precludes study involvement
结局指标
主要结局
Number of Participants With Indicated Side Effects
时间窗: Participants were followed for the duration of the study, approximately 44 weeks
Side effects experienced by participants 1 to 2 days after Mepolizumab infusion.
Number of Participants Who Experienced Specific Symptoms
时间窗: 44 weeks
Number of participants who experienced specific symptoms during the trial.
次要结局
- Steroid Dosing During Trial(20 weeks)
- Evaluate Overall Positive Change in Churg-Strauss Syndrome Via the Measures Outlined in Study Aims(20 weeks)
- Efficacy- Exacerbation Rate(Treatment period (12 weeks))
研究者
Michael Wechsler, MD
Assistant Professor of Medicine at Harvard Medical School and Brigham and Women's Hospital
Brigham and Women's Hospital