EUCTR2015-004616-37-SE进行中（未招募）1 期
An open-label, multicenter, biomarker study to explore the mechanism of action of ocrelizumab and B-cell biology in patients with relapsing multiple sclerosis or primary progressive 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
- 96
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
- •- Age 18 - 55 years, inclusive
- •- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 24 weeks after the last dose of study treatment or until their B cells have repleted, whichever is longer
- •Inclusion Criteria Specific to RMS Patients
- •- Diagnosis of RMS in accordance with the 2010 revised McDonald criteria
- •- Expanded Disability Status Scale (EDSS) score of 0 - 5.5 points, inclusive, at screening
- •- Disease duration less than 15 years in participants with an EDSS > 5.0 at screening
- •- Either treatment-naive or receiving treatment with disease-modifying therapies, including prior use of IFN-beta-1a (Avonex®, Rebif®), IFN-beta-1b (Betaseron®/Betaferon), or glatiramer acetate (Copaxone®)
- •- At least one clinically documented relapse in the past year and/or at least one T1-weighted Gd-enhancing lesion in the past year and/or at least one new T2 lesion in the past year at the time of enrollment
- •Inclusion Criteria Specific to RMS Cohort Arm 4
- •- Must meet inclusion criteria for the RMS cohort
- •- Separate signed Informed Consent Form for the RMS Delayed Time to Start Control Arm (Arm 4)
- •- Must be willing to remain on the same dose and regimen of current standard of care, or no treatment if treatment-naïve, for 12 weeks after study enrollment
- •Inclusion Criteria Specific to primary progressive multiple sclerosis (PPMS) Patients
- •- Diagnosis of PPMS in accordance with the 2010 revised McDonald criteria
- •- EDSS score of 3.0 - 6.5 points, inclusive, at screening
- •- Disease duration from the onset of MS symptoms: Less than 10 years in patients with an EDSS at screening = 5.0
- •- Documented history of at least one of the following laboratory findings in CSF:
- •Elevated IgG Index
- •One or more IgG OCBs detected by isoelectric focusing
- •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 96
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •General Exclusion Criteria
- •- Diagnosis of primary progressive MS
- •- Diagnosis of secondary progressive MS (without relapses for at least 1 year)
- •- History or known presence of recurrent or chronic infection
- •- History of recurrent aspiration pneumonia requiring antibiotic therapy
- •- History of cancer
- •- History of or currently active primary or secondary immunodeficiency
- •- History of coagulation disorders
- •- History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
- •- History of alcohol or other drug abuse within 24 weeks prior to enrollment
- •- Known presence or history of other neurologic disorders
- •- Significant, uncontrolled disease, such as cardiovascular, pulmonary, renal, hepatic, endocrine, gastrointestinal, or any other significant disease
- •- Congestive heart failure
- •- Known active bacterial, viral, fungal, mycobacterial infection, or other infection or any major episode of infection
- •- Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants
- •- Contraindications for, or intolerance to, oral or intravenous (IV) corticosteroids,
- •- Contraindication for lumbar puncture (LP)
- •- Previous treatment with B cell-targeted therapies
- •- Previous treatment with natalizumab (Tysabri®), alemtuzumab, anti-CD4 agents, cladribine, teriflunomide, cyclophosphamide, mitoxantrone, azathioprine, mycophenolate mofetil, cyclosporine, methotrexate, total body irradiation, or bone marrow transplantation
- •- Treatment with fingolimod/Gilenya®, dimethyl fumarate/Tecfidera®, or similar treatment within 6 months prior to enrollment
- •- Receipt of live vaccine
- •- Systemic corticosteroid therapy within 4 weeks prior to baseline
- •- Previous or concurrent treatment with any investigational agent or treatment with any experimental procedure for MS
- •- Laboratory abnormalities or findings at screening
- •- Inability to complete Magnetic Resonance Image (MRI)
- •- Lack of peripheral venous access
- •Exclusion Criteria Specific to RMS Patients
- •- Diagnosis of PPMS or SPMS without relapses
研究者
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