EUCTR2016-002667-34-PL进行中（未招募）1 期
AN OPEN-LABEL, PARALLEL-GROUP STUDY TO EVALUATE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMIC EFFECTS OF OCRELIZUMAB IN CHILDREN AND ADOLESCENTS WITH RELAPSING-REMITTING MULTIPLE SCLEROSIS
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 36
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
- •General Inclusion Criteria:
- •- Able to comply with the study protocol, in the investigator's judgment
- •- Age at screening between >= 10 and < 18 years
- •- Body weight >= 25 kg Note: enrollment of patients with a body weight >= 40 kg is closed.
- •- Children and adolescents must have received all childhood required vaccinations as per local/national recommendations for childhood vaccination against infectious diseases calendar of immunization
- •- For female patients of childbearing potential must agree to either remain completely abstinent or use two methods of contraception including at least one method with a failure rate of < 1% per year, during the treatment period and for at least 24 weeks after the final dose of ocrelizumab. Adherence to local requirements, if more stringent, is required
- •Inclusion Criteria Related to Pediatric MS:
- •- Diagnosis of relapsing-remitting multiple sclerosis (RRMS) in
- •accordance with the International Pediatric Multiple Sclerosis Study
- •Group (IPMSSG) criteria for pediatric MS, Version 2012, and McDonald
- •criteria 2017
- •- Expanded Disability Status Scale (EDSS) at screening: 0-5.5, inclusive
- •- Patients naïve to prior disease-modifying therapy (DMT) or patients
- •who have had less than a total of 6 months of DMT within the past 1 year
- •must have one of the following:
- •o At least two relapses in the last 2 years, with at least one relapse
- •experienced in the previous year
- •o At least two relapses in the last 2 years and >= 1 Gd-enhancing
- •lesion(s) (silent or not) on T1-weighted brain MRI at any time within the
- •previous year
- •o At least one relapse in the previous year and >= 1 Gd-enhancing
- •lesion(s) on T1-weighted brain MRI at any time within the last year
- •- Patients who have had at least 6 contiguous months of DMT within the
- •past 1 year must have evidence of disease activity occurring after the
- •full 6-month course of treatment, that is, at least one relapse or >= 1
- •Gd-enhancing lesion(s) on a T1-weighted brain MRI
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 36
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Exclusions Related to General Health:
- •- Pregnancy or lactation
- •-Known presence or suspicion of other neurologic disorders that may mimic MS, including, but not limited to, acute disseminated encephalomyelitis, and neuromyelitis optica or neuromyelitis optica spectrum disorders and any neurologic, somatic, or metabolic condition that could interfere with brain function or normal cognitive or neurological development
- •- Patients that are aquaporin 4 positive and myelin oligodendrocyte glycoprotein (MOG) antibody positive are not eligible to participate in the study
- •- In case of an ADEM-like appearance of the first MS attack, a second attack with clear MS-like features is required.
- •- Significant or uncontrolled somatic diseases or any other significant condition that may preclude patient from participating in the study
- •- Known active bacterial, viral, fungal, mycobacterial infection, or other infection, excluding fungal infection of nail beds
- •- Infection requiring hospitalization or treatment with IV anti-infective agents within 4 weeks prior to baseline visit or oral anti-infective agents within 2 weeks prior to baseline visit
- •- History or known presence of recurrent or chronic infection (e.g., HIV, syphilis, tuberculosis)
- •- Receipt of a live or live-attenuated vaccine within 6 weeks prior to treatment allocation. The patient's vaccination record and a need for immunization should be carefully reviewed
- •- History or laboratory evidence of coagulation disorders
- •- Peripheral venous access that precludes IV administration and venous blood sampling as required per study protocol
- •- Inability to complete a magnetic resonance imaging (MRI) scan
- •- Teeth braces interfering with MRI acquisition
- •- History of cancer, including solid tumors, hematologic malignancies, and carcinoma in situ (except basal cell and squamous cell carcinoma of the skin that have been excised and cured)
- •- Currently active alcohol or drug abuse or history of alcohol or drug abuse
- •Exclusions Related to Medications:
- •- History of a severe allergic or anaphylactic reaction to humanized or murine monoclonal antibody (mAbs) or known hypersensitivity to any component of ocrelizumab solution
- •- Contraindications to or intolerance of oral or IV corticosteroids, antihistaminics, or antipyretics according to the country label
- •- Treatment with any investigational agent within 24 weeks of screening or 5 half-lives, whichever is longer
- •- Previous treatment with B-cell-targeted therapies
- •- Any previous treatment with alemtuzumab, anti-CD4, cladribine, mitoxantrone, daclizumab, laquinimod, total body irradiation, or bone marrow transplantation
- •- Treatment with cyclophosphamide, azathioprine, mycophenolate mofetil, cyclosporine or methotrexate within 24 months prior to treatment allocation
- •- Treatment with natalizumab within 12 months prior to treatment allocation
- •- Treatment with teriflunomide within 24 weeks prior to treatment allocation
- •- Treatment with fingolimod within 6 weeks prior to treatment allocation and lymphocyte count < lower limit of normal (LLN) for age- and sexspecific reference range treatment with any other S1P receptor modulator (e.g., BAF312/siponimod) within 24 weeks prior to treatment allocation
- •- Treatment with dimethyl fumarate within 4 weeks prior to treatment allocation and lymphocyte count < LLN for age- and sex-specific reference range
- •- Treatment with IVIg within 12 weeks prior to treatment allocation
- •- Treatment with plasmapheresis within 4 weeks prior to treatme
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