Comparison of Rebif Compared to Tecifdera on Six-month Outcomes in Patients With Relapsing-remitting MS
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- T2 lesion load: Rebif v. Tecfidera
研究概览
简要总结
To compare two commonly used MS medications, IFN β-1a subcutaneous three times per week (Rebif) and oral twice daily dimethyl fumarate (Tecfidera), on mean number of new or enlarging T2 lesions at 6 months in adults with relapsing-remitting multiple sclerosis who are prescribed these medications and receive a 6 month MRI scan as standard of care.
详细描述
Primary objective To compare two commonly used MS medications, IFN β-1a subcutaneous three times per week (Rebif) and oral twice daily dimethyl fumarate (Tecfidera), on mean number of new or enlarging T2 lesions at 6 months in adults with relapsing-remitting multiple sclerosis who are prescribed these medications and receive a 6 month MRI scan as standard of care.
Key secondary objective To compare Rebif vs. Tecfidera in reducing the T2 lesion volume, number of T1 black holes, gadolinium-enhancing lesions, brain parenchymal fraction, brain white matter fraction and brain gray matter fraction on the 6 month MRI.
Other secondary objectives
- To compare the two treatments on the following clinical efficacy measures which are routinely obtained as part of our clinical practice: Expanded disability status score (EDSS), ambulation index (AI), disease steps and number of relapses. In addition we will obtain the MSFC-4, which in addition to the AI which is routinely done, will include the symbol digit modalities test (SDMT), low contrast visual acuity, and 9 hole peg test.
- To compare adherence to the two treatments using an adherence question.
Tertiary objectives
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Male and female subjects aged 18-65 years old, inclusive.
- •A diagnosis of MS as defined by the McDonald 2010 criteria for MS.
- •Relapsing form of MS, defined as at least one relapse in the prior 5 years.
- •Expanded Disability Status Scale (EDSS) score of 0 to 5.5, inclusive.
- •English language skills adequate for the completion of questionnaires and cognitive measures.
排除标准
- •Subjects with progressive MS.
- •Subjects with a contraindications for standard treatment with Rebif or Tecfidera including GI disease, needle phobia, liver disease.
- •Subjects treated with:
- •High dose intravenous immunoglobulin within 2 months prior to study entry
- •Natalizumab within 3 months prior to study entry
- •Immunosuppressive/immunomodulatory medications including cyclophosphamide, mitoxantrone, azathioprine, methotrexate, rituximab, ofatumumab, ocrelizumab, or alemtuzumab at any time.
- •Subjects with absolute lymphocyte count < 800 cells (mm3).
- •Subjects with any of the following neurologic/psychiatric disorder:
- •Severe depression during the past 12 months before screening;
- •History of substance abuse (treatment or alcohol) or any other factor (i.e., serious psychiatric condition) that may interfere with the subject's ability to cooperate and comply with the study procedures;
- •Subjects unable to undergo MRI scans, including claustrophobia or history of hypersensitivity to gadolinium-DTPA.
- •Pregnant or nursing females, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive HCG laboratory test.
- •Female subjects of childbearing potential, defined as all females physiologically capable of becoming pregnant, unless they agree to abstinence or, if sexually active, the use of contraception.
- •History of hypersensitivity to any of the study treatments or to treatments of similar chemical classes.
- •Subjects with abnormal Liver Function Test (LFT) levels
研究组 & 干预措施
Randomized Treatment Arm: Rebif
120 patients treated with Rebif (IFN β-1a subcutaneous three times per week)
干预措施: Rebif (IFN β-1a subcutaneous three times per week) (Drug)
Randomized Treatment Arm: Tecfidera
120 patients treated with Tecfidera (dimethyl fumarate)
干预措施: Tecifdera (dimethyl fumarate) (Drug)
结局指标
主要结局
T2 lesion load: Rebif v. Tecfidera
时间窗: 6 months
To compare two commonly used MS medications, IFN β-1a subcutaneous three times per week (Rebif) and oral twice daily dimethyl fumarate (Tecfidera), on mean number of new or enlarging T2 lesions at 6 months in adults with relapsing-remitting multiple sclerosis who are prescribed these medications and receive a 6 month MRI scan as standard of care.
次要结局
- Reducing lesion load and MRI characteristics: Rebif v. Tecfidera(6 months)
研究者
Tanuja Chitnis
Attending Neurologist, Assoc. Professor of Neurology
Brigham and Women's Hospital