EUCTR2010-024000-10-ES进行中（未招募）不适用
A Randomized, Blinded, Parallel-Group, Phase 2 Study Exploring the Safety, Tolerability, and Efficacy of Multiple Regimens of Natalizumab in Adult Subjects With Relapsing Multiple Sclerosis - REFINE
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 300
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. Ability to understand the purpose and risks of the study and provide
- •signed and dated informed consent and authorization to use protected
- •health information (PHI) in accordance with national and local subject
- •privacy regulations.
- •2. Aged 18 to 55 years old, inclusive, at the time of informed consent.
- •3. Subjects of childbearing potential must practice effective
- •contraception during the study.
- •4. A documented diagnosis of RRMS.
- •5. Free of MS relapse, as determined by the enrolling Investigator, for 12
- •months prior to randomization.
- •6. Treatment with natalizumab according to locally approved pescribing
- •information for a minimum of the 12 months immediately prior to
- •randomization. The subject must have received at least 11 doses of
- •natalizumab in the 12 months prior to randomization with no missed doses in the 3 months prior to randomization.
- •7. In the 12 months prior to the initiation of natalizumab, subject must
- •have experienced a minimal level of disease activity as defined by:
- •2 or more documented clinical relapses
- •1 relapse and documented MRI activity, defined by the presence of at
- •least one Gd enhancing lesion on MRI, unrelated to the relapse
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 300
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •1. Known history of Human Immunodeficiency Virus (HIV).
- •2. Known history of hepatitis C (test for hepatitis C virus antibody [HCV
- •Ab]) or hepatitis B virus (test for Hepatitis B Surface Antigen [HBsAg]
- •and/or Hepatitis B Core Antibody [HBcAb]).
- •3. Positive for anti-natalizumab antibodies at Screening.
- •4. MRI positive for Gd-enhancing lesions at study entry.
- •5. Subjects for whom MRI is contraindicated, e.g., have a pacemaker or
- •other contraindicated implanted metal devices, have suffered, or are at
- •risk for, side effects from Gd, or have claustrophobia that cannot be
- •medically managed.
- •6. History of any clinically significant (as determined by the
- •Investigator) cardiac, endocrinologic, hematologic, hepatic,
- •immunologic, metabolic (including diabetes), urologic, pulmonary,
- •neurologic (except for RRMS), dermatologic, psychiatric, renal, or
- •other major disease that would preclude participation in a clinical study.
- •7. History of malignant disease, including solid tumors and hematologic
- •malignancies (with the exception of basal cell and squamous cell
- •carcinomas of the skin that have been completely excised and are
- •considered cured).
- •8. History of transplantation or any anti-rejection therapy.
- •9. History of severe allergic or anaphylactic reactions or known
- •hypersensitivity to any drug.
- •10. A clinically significant infectious illness (e.g., cellulitis, abscess,
- •pneumonia, septicemia) within 30 days prior to Screening, or PML or
- •other opportunistic infections at any time.
- •11. Signs or symptoms suggestive of any serious infection, based on
- •medical history, physical examination, or laboratory testing, as
- •determined by the Investigator.
- •MS Treatment History
- •12. Prior treatment with total lymphoid irradiation.
- •13. Prior treatment with cladribine, mitoxantrone, fingolimod, T-cell or
- •T-cell receptor vaccination, cyclophosphamide, cyclosporine,
- •azathioprine, methotrexate, mycophenolate mofetil, or any therapeutic
- •monoclonal antibody other than natalizumab within 24 months
- •prior to randomization.
- •14. Prior treatment with intravenous immunoglobulin (IVIg),
- •plasmapheresis, or cytapheresis within 12 months prior to
- •randomization.
- •15. Treatment with IV or oral corticosteroids (topical corticosteroids are
- •acceptable) or related products within 3 months prior to randomization.
- •Miscellaneous
- •16. Female subjects considering becoming pregnant while in the study.
- •17. Female subjects who are pregnant or currently breastfeeding.
- •18. History of drug or alcohol abuse within 2 years prior to entry per
- •Investigator judgment.
- •19. Unwillingness or inability to comply with the requirements of this
- •protocol including the presence of any condition (physical, mental, or
- •social) that is likely to affect the subject's ability to comply with the study protocol.
- •20. Receiving any other investigational treatment within the 12 months
- •prior to Screening or concurrent with this study.
- 另有 6 项未显示
研究者
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