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
- 1
- 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
研究组 & 干预措施
Mepolizumab
Subjects will receive open-label mepolizumab
干预措施: Mepolizumab (Biological)
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
- Efficacy- Exacerbation Rate(Treatment period (12 weeks))
- Steroid Dosing During Trial(20 weeks)
- Evaluate Overall Positive Change in Churg-Strauss Syndrome Via the Measures Outlined in Study Aims(20 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