Safety/Effectiveness of Adding Monthly Dexamethasone to Weekly Avonex for MS
Steroid Adjunctive Treatment at Initiation of Avonex Therapy for Patients With Mono-Symptomatic or Relapsing-Remitting Multiple Sclerosis
研究概览
地位
详细说明
Beta Interferon-1a (Avonex)was approved by the FDA in 1996 to treat relapsing-remitting multiple sclerosis. Clinical trials have shown evidence in the reduction of relapses and progression of neurological and cognitive disability with the use of Avonex, as well as reduction in brain atrophy and new MS lesions on MRI were observed. Despite this, Avonex does not abolish disease activity, therefore, there is frequent need for adjunctive therapy, such as short courses of corticosteroids.
This study will research the value of adding monthly pulsed corticosteroids as adjunctive therapy during the first year of Avonex use to determine: a)safety and tolerability b)if this therapy will reduce the progression of functional impairment, and c)if this therapy will reduce the progression of whole brain atrophy over a 13 month observation period.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Oregon
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Portland、Oregon、美国、97225
- Providence MS Center
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- male and female patients between the ages of 18-55 years inclusive
- have provided informed consent to be screened for the study
- have been diagnoses as having MS
- meet the McDonald diagnostic criteria for RRMS or CHAMPS criteria for CIS
- have an EDSS score of 0.0-3.5
- have had no immunomodulator or cytoxic agents and have had no steroids or other immunosuppressants within 30 days prior to Baseline Visit
- must have had a brain MRI scan demonstrating lesions consistent with MS on T2-weighted or FLAIR images
- subjects must be willing and able to participate in all aspects of the study, including use of study medications as prescribed, and screening and follow-up clinical and MRI assessments
Exclusion Criteria:
- type I of type II diabetes
- uncontrolled hypertension (systolic >160 or diastolic >100 despite medication therapy)
- history of suicidal ideation
- history of psychosis
- history of alcoholism or other substance abuse
- clinically significant coronary artery disease
- history of hepatic failure and chronic renal failure
- history of cancer other than basal or squamous cell carcinoma of the skin
- pregnancy or unwillingness to use adequate precautions to prevent pregnancy during the duration of this study
- nursing mothers
- history of stroke, dementia, seizure disorder, peripheral neuropathy, Parkinsonism, myasthenia, myelopathy or other primary degenerative disease of the central or peripheral nervous system
- history of peptic ulcer disease
- history of intolerance to corticosteroids or allergy to albumin
- history of osteoporosis
- history of Lupus, Sjogrens syndrome, Lyme disease or syphilis
- abnormal laboratory results indicative of significant hepatic, renal, hematopoetic, or coagulation dysfunction
- the entity of any disease entity, which in the opinion of the investigators would potentially prevent the patient from successfully completing 2 years participation in this trial or confound the observations made during this trial
- prior use of Avonex, Betaseron, Rebif, mitoxantrone, cyclophosphamide, azothioprine, methotrexate, cladribine, cyclosporin, CellCept, IVIG, natalizumab, anti T-cell or anti B-cell antibodies, plasmapheresis or other systemic immunosuppressant or cancer chemotherapeutic agents
- unwillingness or inability to comply with all the requirements of the protocol
- known diagnosis of osteoporosis
学习计划
研究是如何设计的?
设计细节
- 观测模型:病例对照
- 时间观点:预期
队列和干预
团体/队列 |
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IFNβ+DS group
IFNβ+DS group received lyophilized Avonex 30mcg IM weekly plus dexamethasone 160 mg IV every 4 weeks for 52 weeks and was treated with Avonex 30mcg IM weekly from week 53 to 104
|
IFNβ group
IFNβ group received lyophilized Avonex 30mcg IM weekly for 104 weeks
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合作者和调查者
合作者
调查人员
- 首席研究员:Stanley L. Cohan, M.D., Ph.D.、Providence Multiple Sclerosis Center
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 011-03-AVX
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
临床孤立综合征的临床试验
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