2023-506429-13-00招募中3 期
An Open-Label, Single-Arm 4-Year Study to Evaluate Effectiveness and Safety of Ocrelizumab Treatment in Patients with Progressive Multiple Sclerosis
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 520
- 试验地点
- 46
- 主要终点
- 1. Proportion of patients with no evidence of progression (NEP) sustained for at least 24 weeks
研究概览
简要总结
To evaluate the effectiveness of ocrelizumab treatment in patients with PMS disease course
研究设计
- 分配方式
- Not Applicable
- 主要目的
- An Open-Label, single-arm 4-year study to evaluate Ocrelizumab in patients with progressive MS
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Have a definite diagnosis of PMS (as per the revised McDonald 2010 criteria for PPMS or Lublin et al. 2014 criteria for PMS)
- •EDSS (Expanded Disability Status Scale) </ =6.5 at screening
- •Have a documented evidence of disability progression independent of relapse at any point over the 2 years prior to the screening visit. In case relapse(s) have occurred in the last 2 years, disability progression will have to be considered as independent of relapse activity as per treating physician's judgment
- •Fulfill at least one of the 21 criteria assessing the evidence of disability progression independent of relapse activity in the last 2 years using the pre-baseline disability progression rating system checklist
- •Have experience of having used a smartphone and connecting a smartphone to Wi-Fi network providers
- •For women of childbearing potential: agreement to remain abstinent or use acceptable contraceptive methods during the treatment period and for at least 6 months, or longer if the local label is more stringent after the last dose of study drug
排除标准
- •Relapsing-remitting multiple sclerosis (RRMS) at screening
- •Inability to complete an MRI
- •Gadolinium (Gd) intolerance
- •Known presence of other neurological disorders
- •Positive screening tests for hepatitis B
- •Previous treatment with B-cell targeted therapies (i.e., atacicept, tabalumab, belimumab, ofatumumab, or obinutuzumab). Note: previous treatment with rituximab is allowed as long as the last dose was administered more than 6 months before the ocrelizumab infusion AND if discontinuation was due to adverse events or
结局指标
主要结局
1. Proportion of patients with no evidence of progression (NEP) sustained for at least 24 weeks
1. Proportion of patients with no evidence of progression (NEP) sustained for at least 24 weeks
2. Proportion of patients with NEP and no active disease (NEPAD) sustained for at least 24 weeks
2. Proportion of patients with NEP and no active disease (NEPAD) sustained for at least 24 weeks
次要结局
- 1. Change from baseline in cognitive function as measured by the Symbol Digit Modalities Test (SDMT) and the Brief Visuospatial Memory Test – Revised (BVMT-R)
- 2. Change from baseline in the patient-reported outcomes including Multiple Sclerosis Impact Scale -29, Multiple Sclerosis Walking scale -12 items, ABILHAND-56 Questionnaire, Fatigue Scale for Motor and Cognitive (FSMC) function, SymptoMScreen, 88-item Multiple Sclerosis Spasticity Scale, Numerical Pain Rating Scale, Patient Global Impression of Severity (PGIS) for upper limb, lower limb and cognitive functions
- 3. Mean change from baseline in the EDSS score over the course of the study
- 4. Time to onset of first confirmed disability progression (as measured by EDSS) sustained for at least 24 and 48 weeks
- 5. Time to onset of first >=20% increase in timed 25-foot walk test sustained for at least 24 weeks
- 6. Time to onset of first >=20% increase in 9-hole peg test sustained for at least 24 weeks
- 7. Proportion of patients with NEP
- 8. Proportion of patients with NEPAD
- 9. Proportion of patients with confirmed disability improvement (CDI) sustained for at least 24 weeks
- 10. Change in the following MRI volumetric measures: whole brain volume, cerebral white matter volume change, cortical gray matter volume, deep grey matter volume, thalamic volumes, whole and regional cerebellar volume
- 11. Change in the following lesion and tissue integrity parameters: - Number of new/enlarging T2 lesions and total T2 lesion volume - Number of T1 Gd+ lesions and total volume - Number of T1 lesions and total volume - Gd-enhancing fluid-attenuated inversion-recovery (FLAIR) meningeal lesions
- 12. Rate and nature of adverse events
- 13. Changes in clinical laboratory results
- 14. Rates of study treatment discontinuation due to adverse events
- 15. Change in the number of falls and near-falls
研究者
Trial Information System - TISL
Scientific
F. Hoffmann-La Roche AG
研究点 (46)
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