Effect of Cyclical Administration of Interferon β-1b in Multiple Sclerosis - Comparison With Normal Dose.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- number of gad-enhancing lesions (CELs) in T1
研究概览
简要总结
The therapy with Interferon-ß-1b reduces the inflammatory component of multiple sclerosis with positive effects on the disease course. The 8 MUI dose at alternate days is kept constant for years. About 1/3 of patients suspend treatment by three years due to side effects or suspected or accepted ineffectiveness. The main objective of the study is to verify the safety and effectiveness of a cyclical administration (a month of suspension after two of treatment) from the beginning of treatment. There is the possibility that a scheme envisaging therapy free intervals can reduce the onset of negative feedbacks (antagonising the drug therapeutic effect) compared to the standard administration protocol. This might also result in an increase of the drug effectiveness and/or in a longer duration of effectiveness itself. Finally, cyclical administration allows patients to spend actual periods of "therapeutic vacation", with positive psychological effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Patients affected by remitting Multiple Sclerosis who had at least a relapse in the last year of the disease.
- •Satisfying general clinical conditions according to the researcher. Adequate hepatic function. Capacity to use adequate contraceptive techniques during the study.
排除标准
- •Any other disease that might better explain signs and symptoms of the patient.
- •Any other disability condition that might interfere with the clinical evolution.
- •History of hypersensitivity to natural or recombinant interferon or to human albumin.
- •Clinically significant heart diseases and not controlled like dysrhythmias, angina pectoris or congestive heart failure.
- •Not adequately controlled epilepsy.
- •Inability, according to the examining commission, to grant a complete compliance with the protocol requirements for the whole study.
- •Previous therapies modifying the disease course in the last six months.
- •Steroid therapies in the last 3 months.
- •Pregnancy, lactation, serological positivity to the pregnancy test during the screening period.
研究组 & 干预措施
interferon beta cyclical administration
Interferon ß-1b Treatment by Cyclical Administration
干预措施: Interferon-ß-1b (Drug)
Interferon ß-1b Treatment
Interferon ß-1b Treatment
干预措施: Interferon ß-1b (Drug)
结局指标
主要结局
number of gad-enhancing lesions (CELs) in T1
时间窗: baseline and after 12 months
Group (cyclic withdrawal vs full regimen) differences in the cumulative number of CELs
次要结局
- number of new and enlarging T2 lesions(baseline and after 12 months)
- volume of T1 lesions (black holes)(baseline and after 12 months)
- relapse rate(baseline and after 12 months)
研究者
Giovanni Ristori
MD
S. Andrea Hospital