A Multicentre, Open Label, Non-Comparative Trial Investigating the Recovering of INF-Beta Efficacy in Breakthrough Relapsing-Remitting Multiple Sclerosis Patients With Neutralizing Interferon-Beta Antibodies
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Biogen
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Reduction in the proportion of patients being neutralizing antibody (NAb) positive (titre>20)
研究概览
简要总结
This study is to find out if Interferon-beta can recover its effectiveness in patients with Multiple Sclerosis who have previously developed neutralizing antibodies to Interferon-Beta.
详细描述
This is a multi-center, open Label, non-comparative Phase IV trial. Eligible Patients will receive treatment with Interferon-beta-1a (AVONEX) 30mcg I.M. once weekly for up to 12 months.
In the wash-out period prior to commencing treatment with AVONEX, patients will receive treatment with intermittent Methylprednisolone 500 mg PO Daily for three consecutive days at monthly intervals.
The patients will be examined clinically and laboratory tests will be performed at screening (month -1) and after 3, 9, and 15 months.
Neutralizing antibody(NAb)titres and Binding antibody(BAb)titres as well as MxA protein levels will be evaluated at screening/baseline (month -1/0) and after 3, 6, 9, 12, and 15 months.
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
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Relapsing remitting Multiple Sclerosis according to Poser criteria (CDMS or LDMS) or Multiple Sclerosis according to McDonald criteria
- •Disability equivalent to EDSS of 6.0 or less
- •Clinical activity defined as at least one relapse rate within the last 12 months
- •NAb titre >20 (measured at least 48 hours after last interferon-beta injection
- •has been treated with subcutaneously administered interferon-beta-1b or interferon-beta-1a (Rebif) for at least 24 hours before enrollment
排除标准
- •Any condition that might give rise to similar symptoms as MS
- •Immunomodulatory therapy other than interferon-beta-1a or interferon-beta-1b or any immunosuppressive treatment six months prior to inclusion into the trial
- •Treatment with glucocorticoids or ACTH less than one month prior to inclusion into the trial
- •History of major depression
- •Alcohol or drug dependency
- •Cardiac insufficiency, cardiomyopathy, significant cardiac dysrhythmia, unstable or advanced ischemic heart disease (NYHA III or IV)
- •hypertension (BP > 180/110 mmHg)
- •Renal insufficiency defined as serum creatinine > 1.5 times the upper normal reference limit
- •Any systemic disease that can influence the patient's safety and compliance, or the evaluation of the disability
- •Gastro-intestinal ulcers, gastritis, or dyspepsia
- •Women who are pregnant, breast-feeding or have the possibility for pregnancy during the trial. To avoid pregnancy, women have to be postmenopausal, surgical sterile, sexually inactive or practice reliable contraceptives
研究组 & 干预措施
1
干预措施: Interferon-beta-1a (Drug)
1
干预措施: methylprednisolone (Drug)
结局指标
主要结局
Reduction in the proportion of patients being neutralizing antibody (NAb) positive (titre>20)
时间窗: Month -1 and after 3, 6, 9, 12, and 15 months
次要结局
- Change in MxA protein values(Month -1 and after 3, 6, 9, 12, and 15 months)
- Change in binding antibody (Bab) tires(Month -1 and after 3, 6, 9, 12, and 15 months)
- Proportion of patients with NAb positive titre <5(Month -1 and after 3, 6, 9, 12, and 15 months)
- Change in annualised relapse rate(at 3, 6, 9, 12, and 15 months)
- The number of relapse-free patients(at 3, 6, 9, 12, and 15 months)