Effect of Interferon Beta-1a (Avonex®) on Changes of Non-conventional MRI Measures in Patients With Relapsing-remitting and Secondary-progressive Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
研究概览
简要总结
Phase IV open label, single-blind study, post-marketing, 1-year MRI observational study evaluating effect of Avonex® monotherapy (6.0 MIU administered i.m. each week) on the year-to-year changes in two annual measures-magnetization transfer imaging and diffusion-weighted imaging in patients with either relapsing-remitting (RR) or secondary-progressive (SP) multiple sclerosis (MS). One hundred fifty (150) patients with RR and SP MS-followed at the Jacobs Neurological Institute, University at Buffalo, Buffalo NY-who satisfy both inclusion and exclusion criteria will be included. They will be assessed at baseline and at 12 months with MRI and clinical examinations.
详细描述
1.1. Protocol Title: Effect of Interferon beta-1a (Avonex®) on changes of non-conventional MRI measures in patients with relapsing-remitting and secondary-progressive multiple sclerosis.
1.2. Study rationale: Only a few longitudinal studies have investigated the effect of disease-modifying (DMT) on annual changes of non-conventional magnetic resonance imaging (MRI) measures, such as magnetization transfer imaging (MTI) in patients with multiple sclerosis (MS). In a previous study, the effect of interferon beta-1a (Avonex®) administered IM each week was investigated on the evolution of monthly magnetization transfer ratio (MTR) within new gadolinium (Gd)-enhancing lesions in patients with very early relapsing-remitting (RR) MS. Eight untreated patients with RRMS who completed up to 14 monthly brain MRI sessions elected to initiate treatment with Avonex®. The difference between MTR at appearance of 47 new Gd+ lesions before treatment versus 23 new Gd+ lesions during treatment with Avonex® was not significant. However, after appearance of new Gd+ lesions, the rate of increase in MTR (index of remyelination) was faster during therapy (p = 0.037). This study indicated that MTR abnormalities within new Gd+ lesions may evolve at a slower rate during treatment with Avonex® than before initiating therapy and that Avonex® may promote resolution of new Gd+ lesions. However, although this study yielded some positive results, it was not empowered to establish whether Avonex® may have a real treatment effect on lesion recovery. Moreover, in that study, the effect of Avonex® was not investigated on changes in normal appearing brain tissue (NABT) over time.
1.3. Study Aims: Aim 1. To define the effect of interferon beta-1 (Avonex®) monotherapy (6.0 MIU administered i.m. each week) on the year-to-year changes in two annual measures-MTI and diffusion-weighted imaging (DWI)-in patients with either RR or secondary-progressive (SP) MS.
Aim 2. To explore differences in the progression of these two non-conventional MRI measures between patients who do and do not develop significant brain atrophy, hyperintense T2- and hypointense T1 (black holes) lesion volume (LV) progression during the same 12 months.
Aim 3. To investigate differences in the progression of non-conventional MRI measures between patients who respond or not respond to Avonex® monotherapy during the same 12 months.
研究设计
- 研究类型
- Observational
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient diagnosed with clinical definite MS according to the McDonald criteria
- •Age 18-65
- •Have a RR or SP disease course
- •Have EDSS scores less than or equal to 6.5
- •Have disease duration 6 months to 20 years
- •Be on intramuscular 6 MIU of Avonex® for a minimum of 3-6 months before the study entry
- •Signed informed consent
- •None of the exclusion criteria
排除标准
- •Previous treatment 3 months prior to study entry with immunosuppressant agents, e.g., mitoxantrone, cyclophosphamide, cladribine, fludarabine, cyclosporine or total body irradiation or any other concomitant immunomodulatory therapies besides Avonex® (e.g., Azathioprine, methotrexate, IVIG, cellcept, natalizumab, etc).
- •Patients who received steroid therapy during the 3 months prior to study entry or patients who received steroid treatment 30-60 days prior to the follow-up MRI scan date.
研究者
Bianca Weinstock-Guttman
Principal Investigator
State University of New York at Buffalo