EUCTR2015-005597-38-FI进行中（未招募）1 期
An open-label study to evaluate the efficacy and safety of ocrelizumab in patients with relapsing remitting multiple sclerosis who have a suboptimal response to an adequate course of disease-modifying treatment - CASTING
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 680
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
- •- Age 18-55 years
- •- Have a definite diagnosis of RRMS, confirmed as per the revised McDonald 2010 criteria
- •- Have a length of disease duration, from first symptom, of < 10 years. If the date of first symptom is unknown, then the diagnosis of RRMS should be of = 5 years
- •- Have received no more than two prior disease modifying treatments (DMTs), and the discontinuation of the most recent DMT was due to lack of efficacy
- •- Suboptimal disease control while on a DMT
- •- EDSS of 0.0 to 4.0, inclusive, at screening
- •- For women of childbearing potential: agreement to use an acceptable birth control method during the treatment period and for at least 6 months after the last dose of study drug
- •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 750
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Secondary progressive multiple sclerosis (SPMS) or history of primary progressive or progressive relapsing MS
- •- Inability to complete an MRI
- •- Known presence of other neurological disorders
- •Exclusions Related to General Health
- •- Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study
- •- History or currently active primary or secondary immunodeficiency
- •- History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
- •- History of opportunistic infections
- •- History or known presence of recurrent or chronic infection
- •- History of malignancy
- •- Congestive heart failure
- •- Known active bacterial, viral, fungal, mycobacterial infection or other infection, excluding fungal infection of nail beds
- •Exclusions Related to Medications
- •- Receipt of a live vaccine or attenuated live vaccine within 6 weeks prior to the baseline visit
- •- Treatment with any investigational agent within 24 weeks of screening (Visit 1) or five half-lives of the investigational drug (whichever is longer) or treatment with any experimental procedures for MS
- •- Treatment with fampridine/dalfamipridine (Fampyra®)/Ampyra®) unless on stable dose for >= 30 days prior to screening. Wherever possible, patients should remain on stable doses throughout the 96-week treatment period.
- •- Contraindications to or intolerance of oral or IV corticosteroids, according to the country label, including a) Psychosis not yet controlled by a treatment; b) Hypersensitivity to any of the constituents
- •- Previous treatment with B-cell targeted therapies (i.e., rituximab, ocrelizumab, atacicept, belimumab, or ofatumumab)
- •- Systemic corticosteroid therapy within 4 weeks prior to screening
- •- Any previous treatment with alemtuzumab (Campath/Mabcampath/Lemtrada), cladribine, mitoxantrone, daclizumab, laquinimod, total body irradiation, or bone marrow transplantation
- •- Treatment with cyclophosphamide, azathioprine, mycophenolate mofetil, cyclosporine or methotrexate
- •- Treatment with fampridine/dalfamipridine (Fampyra®)/Ampyra®) unless on stable dose for >= 30 days prior to screening. Wherever possible, patients should remain on stable doses throughout the 96-week treatment period.
- •- Previous treatment with natalizumab unless natalizumab was discontinued because of persistent anti-natalizumab antibodies
- •- Treatment with IV immunoglobulin (Ig) within 12 weeks prior to baseline
- •- Any previous treatment with investigational MS DMT not yet approved at time of screening
- •Exclusions Related to Laboratory Findings
- •- Positive serum ß human chorionic gonadotropin (hCG) measured at screening
- •- Positive screening tests for hepatitis B (hepatitis B surface antigen [HBsAg] positive, or positive hepatitis B core antibody [total HBcAb] confirmed by a positive viral DNA polymerase chain reaction [PCR]) or hepatitis C (HepCAb)
- •- Lymphocyte count below lower limit of normal (LLN)
- •- CD4 count<250/mcL
- •- Aspartate aminotransferase (AST)/ serum glutamic oxaloacetic transaminase (SGOT) or alanine aminotransferase (ALT) /serum glutamic pyruvic transaminase (SGPT)=> 3.0 × the upper limit of normal (ULN)
- •- Platelet count <100,000/µL (<100 × 109/L)
- •- Absolute neutrophil count <1.0 × 103/mcL
研究者
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