Evaluating the Efficacy and Safety of Transitioning Patients From Natalizumab to Ocrelizumab
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 5
- 主要终点
- Relapse Free Survival at Month 12
研究概览
简要总结
The primary objective of this study is to assess the efficacy of Ocrelizumab (OCR) in Relapsing Multiple Sclerosis patients who have been previously treated with natalizumab (NTZ) by evaluating relapse rate, progression on MRI and disability progression.
详细描述
This is a multicenter, prospective, open-label, Phase IV clinical trial. Patients with relapsing forms of Multiple Sclerosis (MS), ages 18 to 65, who have received 12 or more continuous infusions of NTZ, and have been free of relapses, disability worsening or Magnetic Resonance Imaging (MRI) progression 6 months prior to the transition screening visit will be eligible for the study. After informed consent to participate has been obtained, the patient will have physical exam (PE), non-blinded Expanded Disability Status Scale (EDSS), MRI, Multiple Sclerosis Impact Scale (MSIS-29) and labs done for the screening visit to determine eligibility. Brain MRI with and without contrast will be performed with the standard MS protocol. MRIs will be performed with 3mm slice thickness with no gaps between slices. Patients will receive their first dose of OCR 4 to 6 weeks after the last dose of NTZ. Other baseline measures, including physical exam, EDSS, MSIS-29, and labs will be performed within 4 weeks of screening. Physical exam, non-blinded EDSS, and labs will be performed at month 3, month 6, month 9, and month 12. MSIS-29 will be performed at months 6 and 12. In addition, MRIs will be performed at months 3, 6, and 12.
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
- •Able to understand the purpose and risk of the study and provide signed informed consent document.
- •Must have received 12 or more consecutive monthly infusions of NTZ, and have had no evidence of on-NTZ disease activity (clinically or on MRI) for the 6 months prior to the screening visit.
- •Naïve to OCR.
- •No evidence, in the opinion of the investigators of significant cognitive limitation or psychiatric disorder that would interfere with the conduct of the study.
- •EDSS of ≤ 6.0 at screening.
- •Female patients of childbearing potential must practice effective contraception and continue contraception during the study.
排除标准
- •History of primary or secondary progressive multiple sclerosis.
- •Any mental condition of such that patient is unable to understand the nature, scope, and possible consequences of the study.
- •Patients with a known history of hepatitis B, hepatitis C, tuberculosis, PML, or who are HIV positive.
- •Any persistent or severe infection.
- •Any malignancy within 5 years, except for basal or squamous cell skin lesions, which have been surgically excised, with no evidence of metastasis.
- •Pregnancy or lactation.
- •Significant or uncontrolled somatic disease or severe depression in the last year.
- •Inability to complete an MRI.
- •Previous treatment with B-cell targeted therapies.
- •Current use of immunosuppressive medication.
- •Patients who have had evidence of disease activity within the 6 months prior to screening. This includes MS relapse, or new or enlarging T2 lesions or Gd+ enhancing lesions, or disability progression.
- •Patients with any significant comorbidity that in the opinion of the investigator, would interfere with participation in the study.
结局指标
主要结局
Relapse Free Survival at Month 12
时间窗: 12 Months
The proportion of relapse-free patients at month 12 after switching from natalizumab to ocrelizumab.
次要结局
- Relapse Rate at Months 3, 6, and 9(3, 6, and 9 months)
- MRI Evidence of MS Disease Activity at Months 3, 6, and 12(3, 6, and 12 Months)
- New or Enlarging T2 Lesions at 3, 6, and 12 Months(3, 6, and 12 months)
- New Gd+ Lesions Detected at Months 3, 6, and 12(3, 6, and 12 months)
- Change in the EDSS Score From Baseline to Month 12(12 months)
- Change in MSIS-29 From Baseline to Months 6 and 12(6 and 12 months)
- Proportion of Patients That Discontinued OCR(12 months)