2024-510716-71-00招募中3 期
Ocrelizumab VErsus Rituximab off-Label at the Onset of Relapsing MS Disease (OVERLORD-MS)
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 214
- 试验地点
- 13
- 主要终点
- Proportion of patients with no new or enlarging T2-weighted brain MRI lesions from month 6 (re-baseline) to month 24
研究概览
简要总结
This is a multicenter non-inferiority study, designed to establish non-inferiority of the study treatment rituximab compared with the comparator ocrelizumab for consecutively included patients (male or female) with active relapsing-remitting multiple sclerosis aged 18-60 years.
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •A diagnosis of RRMS according to the revised diagnostic criteria of McDonald (Thompson, Banwell et al. 2018) within the last 12 months.
- •REDUCE: Stable disease, defined as no relapse3 or new MRI lesion4 during the last 24 months before enrollment
- •REDUCE: Women of childbearing potential1 (WOCBP) able and willing to use highly effective methods of birth control2 that result in a low failure rate of less than 1% per year when used consistently and correctly for the duration ofmonths after last dose administered to comply with CTFG Contraception guidance Version 1.1 (CTFG 21/09/2020).
- •REDUCE: Absence of comorbidity or drug abuse that preclude study participation
- •REDUCE: Able to complete treatment or follow-up visits in the study (e.g. no contraindications for MRI or plans of moving)
- •REDUCE: . Able to understand written and spoken Norwegian or Swedish
- •REDUCE: Capable of giving signed informed consent as described in Appendix 1.2 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol
- •Treatment naïve patients aged between 18 and 60 years included
- •Disease activity defined as ≥ 1 relapse1 or ≥ 1 new MRI lesion2 during the last 12 months
- •EDSS score ≤ 4.0
- •Absence of comorbidity that preclude study participation
- •Written informed consent for study participation
- •Able to understand written and spoken Norwegian or Swedish
- •Able to complete treatment or follow-ups in the study (e.g. no contraindications for MRI, plans of moving)
- •REDUCE: Previously enrolled in and completed the OVERLORD-MS trial and OVERLORD-SWITCH study
排除标准
- •A diagnosis of progressive MS according to the revised diagnostic criteria of McDonald (Thompson, Banwell et al. 2018)
- •Previous MS therapy
- •Comorbidity that is not compatible with B cell depletion therapy
- •Blood screening results (i.e. hematology, chemistry, infection) that is not compatible with B cell depletion therapy
- •Comorbidity that otherwise preclude study participation
- •Pregnancy or lactating female patients
- •REDUCE: Any disease that is a contraindication to treatment with rituximab (as described in the SMPC)
- •REDUCE: Not longer treated with rituximab (e.g. switched to another treatment for MS or stopped MStreatme
结局指标
主要结局
Proportion of patients with no new or enlarging T2-weighted brain MRI lesions from month 6 (re-baseline) to month 24
Proportion of patients with no new or enlarging T2-weighted brain MRI lesions from month 6 (re-baseline) to month 24
SWITCH: Proportion of patients with no new or enlarging T2-weighted brain MRI lesions from month 24 to month 36
SWITCH: Proportion of patients with no new or enlarging T2-weighted brain MRI lesions from month 24 to month 36
REDUCE: Proportion of patients with no new or enlarging T2-weighted brain MRI lesions from month 36 to month 60 compared to the period before (month 0-36
REDUCE: Proportion of patients with no new or enlarging T2-weighted brain MRI lesions from month 36 to month 60 compared to the period before (month 0-36
次要结局
- The annual relapse rate from baseline to month 24
- Proportion of patients without relapses from baseline to month 24
- Proportion of patients with progression in SDMT from baseline to month 24. Progression in SDMT is defined as patients experiencing a reduction of 15% or more from baseline (Strober, DeLuca et al. 2019, Marstrand, Osterberg et al. 2020)
- Frequency of SAE/SAR and AESI during 24 months of treatment
- The frequency of immediate and delayed infusion reactions during 24 months of treatment
- The frequency of infections during 24 months of treatment
- The frequency any malignancies during 24 months of treatment
- Proportion of patients with no new or enlarging T2-weighted brain MRI lesions from baseline to month 6, and from baseline to month 24
- Proportion of patients without new gadolinium enhancing T1-weighted brain MRI lesions at month 6, month 12 and month 24
- Change in brain volumes from baseline to month 24 and from month 6 to month 24
- SWITCH: The annual relapse rate from month 30 to month 36
- SWITCH: Proportion of patients without relapses from month 30 to month 36
- SWITCH: Proportion of patients without new gadolinium enhancing T1-weighted brain MRI lesions from month 24 to month 36
- SWITCH: Change in brain volumes from month 24 to month 36
- SWITCH: Proportion of patients with 6-months confirmed disability progression (6M-CDP) as measured by the Expanded disability status scale (EDSS) from month 30 to month 36
- SWITCH: Proportion of patients with 6-months confirmed disability improvement (6M-CDI) as measured by the Expanded disability status scale (EDSS) from month 30 to month 36
- SWITCH: Proportion of patients with 6M-CDP in SDMT from month 30 to month 36
- SWITCH: Frequency of SAE/SAR and AESI from month 30 to month 36
- SWITCH: The frequency of immediate and delayed infusion reactions from month 30 to month 36
- SWITCH: The frequency of infections from month 30 to month 36
- SWITCH: The frequency any malignancies from month 30 to month 36
- REDUCE: The annual relapse rate from month 36 to month 60
- REDUCE: Proportion of patients without relapses from month 36 to month 60
- REDUCE: Proportion of patients with no new or enlarging T2-weighted brain MRI lesions from month 36 to month 60
- REDUCE: Change in brain volumes from month 36 to month 60
- REDUCE: Proportion of patients with 6-months confirmed disability progression (6M-CDP) as measured by the Expanded disability status scale (EDSS) (Kurtzke 1983) from month 36 to month 60
- REDUCE: Proportion of patients with 6-months confirmed disability improvement (6M-CDI) as measured by the Expanded disability status scale (EDSS) (Kurtzke 1983) from month 36 to month 60
- REDUCE: Proportion of patients with 6M-CDP in SDMT from month 36 to month 60
- REDUCE: Frequency of SAE/SAR and AESI from month 36 to month 60
- REDUCE: The frequency of grade 2 or above immediate and delayed infusion reactions from month 36 to month 60
- REDUCE: The frequency of grade 2 or above infections from month 36 to month 60
- REDUCE: The frequency any malignancies from month 36 to month 60
- Proportion of patients with 6-months confirmed disability progression (6M-CDP) as measured by the Expanded disability status scale (EDSS) (Kurtzke 1983) from baseline to month 24.EDSS at month 24 is confirmed at month 30 (6M-CDP is defined in section 8.2.3).
- Proportion of patients with 6-months confirmed disability improvement (6M-CDI) as measured by the Expanded disability status scale (EDSS) (Kurtzke 1983) from baseline to month 24. EDSS at month 24 is confirmed at month 30 (6M-CDI is defined in section 8.2.3)
- SWITCH: Proportion of patients with no new or enlarging T2-weighted brain MRI lesions from month 24 to month 36
研究者
Øivind Torkildsen
Scientific
Helse Bergen HF
研究点 (13)
Loading locations...
相似试验
招募中
3 期
A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults with Primary Progressive Multiple Sclerosis2023-505980-36-00F. Hoffmann-La Roche AG363
招募中
3 期
Efficacy and Safety of Obinutuzumab versus Rituximab in childhood Steroid Dependant and Frequent Relapsing Nephrotic Syndrome : à double-blind multicenter randomized controlled study2024-514240-93-00Assistance Publique Hopitaux De Paris88
招募中
4 期
A Phase 4 Multicenter, Randomized, Open-label, Efficacy Assessor-blinded Study of Risankizumab Compared to Deucravacitinib for the Treatment of Adult Subjects with Moderate Plaque Psoriasis who are Candidates for Systemic TherapyPlaque Psoriasis2023-509738-20-00AbbVie Deutschland GmbH & Co. KG150
招募中
3 期
A Global Study to Assess the Effects of Durvalumab with Oleclumab or Durvalumab with Monalizumab Following Concurrent Chemoradiation in Patients With Stage III Unresectable Non-Small Cell Lung Cancer (PACIFIC-9)2023-503999-24-00AstraZeneca AB437
招募中
2 期
Orelabrutinib Plus Lisaftoclax and Rituximab in Untreated Mantle Cell Lymphoma With High-Risk DiseaseNCT07272499Ruijin Hospital25