Safety and Tolerability of Oral Two-Doses Estroprogestins Associated With Interferon-Beta 1a in Patients With Relapsing-Remitting Multiple Sclerosis
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Safety assessment at 6, 12, 18 and 24 months, including adverse events, physical examination and laboratory parameters
研究概览
简要总结
Clinical and experimental evidences suggests an immunomodulatory effect of sex hormones in multiple sclerosis.
The role of oral estroprogestins in the pathogenesis and in the clinical course of the disease is actually unknown.
The aim of the study is to investigate safety and tolerability of association of estroprogestins in two different doses with interferon-beta 1a in patients with relapsing-remitting multiple sclerosis.
详细描述
Phase 2, randomised, single blind, three arms study.
Follow-up of 24 months.
The study will include relapsing-remitting multiple sclerosis female patients.
Patients will be equally randomised into three groups: 1) patients treated with IFN-beta 1a (44 mcg for three times a week), 2) patients treated with IFN-beta 1a and lower-dose estroprogestins (desogestrel 150 mcg, etinilestradiol 20 mcg), 3) patients treated with IFN-beta 1a and higher-dose estroprogestins (desogestrel 25 mcg, etinilestradiol 40 mcg).
Safety and tolerability of the treatment will be evaluated using neurological examination and MRI analysis.
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
- Single
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients
- •Clinically definite relapsing-remitting MS according to the McDonald criteria
- •Age between 18-40 y.o.
- •EDSS from 0 to 4.0, inclusive
排除标准
- •History of migraine or thromboembolic events
- •Reproductive system disorders
- •Pregnancy or suspension of pregnancy within 12 months prior to randomisation
- •Prior use of estroprogestins within the last 3 months prior to randomisation
- •Prior use of immunosuppressive drugs within the last 12 months prior to randomisation
- •Prior use of immunomodulating drugs within the last 6 months prior to randomisation
- •Prior use of corticosteroids within the last 3 months prior to randomisation
- •Have clinical relapse 30 days prior to randomisation
结局指标
主要结局
Safety assessment at 6, 12, 18 and 24 months, including adverse events, physical examination and laboratory parameters
Relapse rate at 6, 12, 18 and 24 months,
EDSS progression at 12 and 24 months,
MS functional composite score at 12 and 24 months,
次要结局
- Number and volume of new gad-enhancing lesions at 12 and 24 months
- Number of new T1 and T2 lesions at 12 and 24 months
- Brain volume changes at 12 and 24 months
- Neuropsychological examination at 0, 12, 24 months
- Hamilton scale for depression score at 0, 12, 24 months
- MS Quality of Life scale score(MSQOL54)at 0, 12, 24 months
- Fatigue Severity Scale score at 0, 12, 24 months