EUCTR2020-001205-23-SE进行中（未招募）1 期
Ocrelizumab VErsus Rituximab off-Label at the Onset of RelapsingMS Disease (OVERLORD-MS) - OVERLORD-MS
Helse Bergen HF, Haukeland University Hospital0 个研究点目标入组 208 人开始时间: 2021年12月6日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 208
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Male and female patients, treatment naïve, and aged between 18 and 60 years included
- •2.Women of childbearing potential1 (WOCBP) able and willing to use highly effective methods of birth control2 per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly for the duration of 12 months after last dose administered to comply with CTFG Contraception guidance version 1.1 (CTFG 21/09/2020).
- •3.A diagnosis of RRMS according to the 2017 revised diagnostic criteria of McDonald (Thompson, Banwell et al. 2018) within the last 12 months.
- •4.Disease activity defined as = 1 relapse3 or = 1 new MRI lesion4 during the last 12 months
- •5.EDSS score = 4.0
- •6.Absence of comorbidity or drug abuse that preclude study participation
- •7.Able to complete treatment or follow-up visits in the study (e.g. no contraindications for MRI or plans of moving)
- •8. Able to understand written and spoken Norwegian or Swedish.
- •9. 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.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 208
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Known hypersensitivity or other known side effects for any of the study medications, including co-medications such as high glucocorticosteroids
- •2.A diagnosis of primary progressive MS according to the revised diagnostic criteria of McDonald (Thompson, Banwell et al. 2018)
- •3.A disease course of secondary progressive MS (Lublin, Reingold et al. 2014)
- •4.Any ongoing infection, including tuberculosis, hepatitis virus or HIV, as well as hepatitis B surface antigen positivity and/or hepatitis C seropositivity.
- •5.Prior or current psychiatric illness, mental deficiency or cognitive dysfunction influencing the patient ability to make an informed consent or comply with the treatment and follow-up phases of this protocol.
- •6.Cardiac insufficiency, cardiomyopathy, significant cardiac dysrhythmia, unstable or advanced ischemic heart disease (NYHA III or IV)
- •7.Active malignancy or prior history of malignancy except localized basal cell, squamous skin cancer or carcinoma in situ of the cervix.
- •8.WBC < 1.5 x 109/L if not caused by a reversible effect of documented ongoing medication. If WBC < 1.5 x 109/L is caused by a reversible effect of documented ongoing medication the WBC count must be > 1,5 x 109/L before start of study treatment.
- •9.Platelet (thrombocyte) count < 100 x 109/L
- •10.ALAT more than 2 times the upper normal reference limit (ULN)
- •11.Serum creatinine > 200 µmol/L
- •12.Serum bilirubin > ULN
- •13.Pregnancy or lactating female patients
- •14.Any disease that can influence the patient safety and compliance, or the evaluation of disability
- •15.History of serious or life-threatening infusion reaction to ocrelizumab or rituximab, if previously treated with these medications for other diseases than MS
- •16. Previous use of MS-therapies such as natalizumab, fingolimod, interferons, glatiramer acetate, dimethyl fumarate, teriflunomide, cladribine, rituximab, alemtuzumab, ocrelizumab, hematopoietic stem cell therapy (HSCT) or other immunosuppression therapies with long lasting effects, or any other disease modifying therapy (DMT) for MS. If any of these medications have been used against other diseases than MS, patients can be included if the medications have not been used the previous year before enrollment.
- •17. Currently enrolled in another investigational device or drug study, or less than 30 days since ending another investigational device or drug study (s), or receiving other investigational treatment(s). Patients participating in a purely observational trial will not be excluded.
- •18.Presence of metallic objects implanted in the body, or allergy to MRI contrast that would preclude the ability of the patient to safely have MRI exams.
- •19.Current alcohol or drug dependencies.
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