To evaluate the efficacy safety and tolerability of 6-week extended interval dosing of Natalizumab (BG00002) switching from treatment with 4-Week Natalizumab standard interval dosing (SID) in relation to continued SID treatment
Are you eligible to participate in this study?
You may be eligible for this study if you meet the following criteria:
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Conditions: Multiple Sclerosis
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Age: Between 18 - 60 Years
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Gender: Male or Female
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Other Inclusion Criteria:
- Subjects have ability of the subject to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use confidential health information in accordance with national and local subject privacy regulations
- Subjects who are between the ages of 18 and 60 years old
- Subjects with the diagnosis of RRMS according to the McDonald criteria
- Subjects with EDSS =5.5 at Screening.
- Subjects with no relapses in the last 12 months prior to randomization, as determined by the enrolling Investigator.
- Female subjects of childbearing potential must practice highly effective contraception during the study and for 3 months after their last dose of study treatment.
You may not be eligible for this study if the following are true:
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- Subjects with primary- and secondary-progressive MS.
- Subjects who are MRI positive for Gd-enhancing lesions at Screening.
- Subjects for whom MRI is contraindicated
- Subjects with a history of any clinically significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, or other major disease that would preclude participation in a clinical study, in the opinion of the Investigator
- Subjects with History of human immunodeficiency virus or positive test result at Screening, or history of other immunodeficient conditions.
- Subjects who have known history of hepatitis C or hepatitis B virus.
- Subjects with history of malignant disease, including solid tumors and hematologic malignancies
- Subjects with history of transplantation or any antirejection therapy.
- Subjects with history of severe allergic or anaphylactic reactions or known hypersensitivity to any antibody drug therapy.
- Subjects with clinically significant infectious illness within 30 days prior to Screening, or PML or other opportunistic infections at any time.
- Subjects with the presence of anti-natalizumab antibodies at Screening.
- Subjects with signs or symptoms suggestive of any serious infection, based on medical history, physical examination, or laboratory testing, as determined by the Investigator.
- Subjects with prior treatment with cladribine, mitoxantrone, T-cell or T-cell receptor vaccination, cyclophosphamide, cyclosporine, azathioprine, methotrexate, or mycophenolate mofetil.
- Subjects with prior treatment with any therapeutic mAb other than natalizumab within 24 months prior to randomization.
- Subjects with prior treatment with total lymphoid irradiation.
- Subjects with prior treatment with IV immunoglobulin, plasmapheresis, or cytapheresis within 12 months prior to randomization.
- Subjects who have treatment with IV or oral corticosteroids or related products within 3 months prior to randomization.
- Subjects with history of drug or alcohol abuse within 2 years prior to entry, per Investigator judgment.
- Subjects who are currently enrolled or a plan to enroll in any interventional clinical study in which an investigational treatment or approved therapy for investigational use is administered within 30 days prior to the Baseline Visit or at any time during this study.
- Subjects who are unable to comply with study requirements.
- Subjects who are pregnant or breastfeeding, and women intending to become pregnant during the study.
- Subjects who are for other unspecified reasons that, in the opinion of the Investigator or Biogen, unsuitable for enrollment.
If you are registered as a volunteer, please log in to contact the study team/express interest in this study.