EUCTR2018-000780-91-FR进行中（未招募）1 期
AN OPEN-LABEL, SINGLE-ARM PHASE IV STUDY TO ASSESS OCRELIZUMAB EFFICACY, SAFETY AND IMPACT ON PATIENT REPORTED OUTCOMES (PROS) IN PATIENTS WITH ACTIVE RELAPSING MULTIPLE SCLEROSIS(PRO-MSACTIVE) - PRO-MSActive
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- ROCHE
- 入组人数
- 570
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
- •o Signed informed consent form
- •o Age =18 years at screening
- •o Patients with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features:
- •- At least one clinical relapse over a 6-month period prior to screening
- •- AND/OR at least one T1 gadolinium-enhancing lesion or new and/or enlarging T2 lesion as detected by brain MRI performed over a 3 months period prior to screening with no change of DMT compared to a previous MRI performed within 24 months before screening
- •o For women of childbearing potential: agreement to use an acceptable birth control method during the treatment period and for at least 12 months after the last dose of ocrelizumab.
- •o Patients should be beneficiary of healthcare coverage under the social security system
- •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 570
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •o Diagnosis of primary progressive MS
- •o Inability to complete an MRI
- •o Gadolinium intolerance
- •o Known presence of other neurological disorders,
- •o Patients not able to comply with the study protocol, in the investigator’s judgment
- •o Vulnerable patients
- •o Pregnancy or lactation
- •o Current active infection
- •o Severely immunocompromised state
- •o Known active malignancies
- •o Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study
- •o Lack of peripheral venous access
- •o Significant or uncontrolled somatic disease or any other significant disease that may preclude patient from participating in the study
- •o History or known presence of progressive multifocal leukoencephalopathy
- •o Hypersensitivity to ocrelizumab or to any of the excipients
- •o Receipt of any vaccine within 6 weeks prior to the baseline visit.
- •o Treatment with any investigational agent within 24 weeks of screening or five half-lives of the investigational drug (whichever is longer) or treatment with any experimental procedures for MS within 24 weeks prior to screening
- •o Previous treatment with CD20 B-cell targeted therapies (i.e., rituximab, ocrelizumab, or ofatumumab) in the last 12 months
- •o Any previous treatment with alemtuzumab Campath®/Mabcampath®/Lemtrada®), total body irradiation, or bone marrow transplantation
- •o Previous treatment with natalizumab or fingolimod in the last 8 weeks
- •o Previous treatment with daclizumab in the last 12 weeks
- •o Previous treatment with natalizumab where PML has not been excluded according to specific algorithm in Appendix 5
- •o Previous treatment with azathioprine, cyclophosphamide, mycophenolate mofetil or methotrexate in the last 12 weeks
- •o Previous treatment with mitoxantrone, cyclosporine or cladribine in the last 2 years
- •o Treatment with dimethyl fumarate within five half-lives of dimethyl fumarate prior to screening
- •o Treatment with biotin within five half-lives of biotin prior to screening
- •o Patients previously treated with teriflunomide, unless an accelerated elimination procedure is implemented before screening visit
- •o Contraindications to or intolerance of antihistamine drugs, oral or IV corticosteroids, including methylprednisolone administered IV, according to the country label, including psychosis not yet controlled by a treatment and hypersensitivity to any of the constituents
- •o Treatment with IV Ig within 12 weeks prior to baseline
- •o Systemic corticosteroid therapy within 4 weeks prior to screening
- •o Treatment with fampridine/dalfampridine (Fampyra®)/Ampyra®) or other symptomatic MS treatment unless on stable dose for =30 days prior to screening. Wherever possible, patients should remain on stable doses throughout the treatment period
- •o Positive serum ? human chorionic gonadotropin (hCG) measured at screening
- •o Positive hepatitis B surface antigen [HBsAg] at screening.
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