An Open Label Trial of Safety and Efficacy of Combination Therapy With Interferon-B-1a and Oral Doxycycline in Patients With Relapsing-remitting Multiple Sclerosis (RRMS)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Gadolinium-enhancing (Gd+)Lesion Number Change.
研究概览
简要总结
To evaluate the efficacy, safety, and tolerability of combination therapy with intramuscular interferon beta-1a and oral doxycycline, a potent inhibitor of matrix metalloproteinases, in patients with relapsing remitting multiple sclerosis (RRMS) having breakthrough disease activity.
详细描述
Eligible individuals were evaluated monthly for 3 months while taking intramuscular interferon beta-1a, 30 micrograms weekly, then monthly for 4 months while receiving intramuscular interferon beta-1a, 30 micrograms and oral doxycycline, 100 mg daily.
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
- 是
入选标准
- •age 18-55
- •Relapsing-Remitting Multiple Sclerosis (RRMS)
- •Avonex therapy for 6 months prior continuous
- •annualized relapse rate >2 during Avonex therapy
- •most recent relapse within 60 days of baseline
- •entry Expanded Disability Status Scale (EDSS) 1.5-4.5
- •one or more gadolinium (Gd+) MRI lesions on a baseline MRI
- •no history of immune modulator or immunosuppressant therapy used in combination with Avonex (other then GSC administer for clinical relapses)
- •not participating in any other study of ms therapeutics
- •Serum neutralizing antibodies (NABs) titer to Avonex <20
排除标准
- •Medical or Psychiatric conditions that will affect patients ability to provide informed consent
- •inability to undergo MRI
- •clinically serious medical conditions or significantly abnormal labs
- •no use of these medications or procedures within six months prior to study:
- •*monoclonal antibodies,total lymphoid radiation,systemic steroids,cytotoxic or immunosuppressive medications such as mitoxantrone or cyclophosphamide or any other investigational drugs
- •Interferon neutralizing antibody titers >20
- •no breast feeding or pregnant
- •no patients with any systemic illness,psychiatric condition or other disorder that would concern safety of patient to complete procedures of protocol
- •abnormal blood test
- •clinically significant abnormality on chest x-ray (CXR)
研究组 & 干预措施
Single Arm
Interferon beta 1a, oral doxycycline
干预措施: Interferon beta 1a, oral doxycycline (Drug)
结局指标
主要结局
Gadolinium-enhancing (Gd+)Lesion Number Change.
时间窗: 8 months
Before treatment is the number of lesions per image from months -3, -2, -1, and 0. During treatment is the number of lesions from months 1,2, and 3. The mean number of Gd+ lesions during each treatment period was calculated for each patient as the total number of Gd+ lesions observed across all images divided by the number of images. Hence, the mean number of Gd+ lesions per patient represents the number of lesions per MRI.
次要结局
- Relapse Rates, Serum Matrix Metalloproteinase 9 Levels, Transendothelial Migration of Monocytes(8 months)