Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Biogen
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Ability to understand the purpose and risks of the study and provide signed and dated informed consent.
Documented diagnosis of Relapsing Multiple Sclerosis (McDonald 2010 Criteria).
Must have an Expanded Disability Status Scale (EDSS) score from 0 to 4.0, inclusive.
Must satisfy the approved therapeutic indications for Tysabri as per Product Monograph.
Must either be treatment naïve or have been treated with disease modifying therapy DMT(s) (such as, but not limited to, Avonex, Betaseron, Rebif, Copaxone, Extavia, Tecfidera and/or Gilenya) for ≤5 years total prior to date of informed consent.
Decision to treat with Tysabri must precede enrollment.
You may not be if
Any prior treatment with Tysabri.
Contraindications to treatment with Tysabri as described in the Product Monograph.
History of progressive multifocal leukoencephalopathy (PML) or other opportunistic infections, or an increased risk for such infections.
History of diagnosis of Primary Progressive Multiple Sclerosis \[PPMS\] and/or Secondary Progressive Multiple Sclerosis \[SPMS\].
Receiving immunomodulatory or immunosuppressive therapy.
Prior history of immunosuppressive use (mitoxantrone, azathioprine, methotrexate, cyclophosphamide, mycophenolate, cladribine, rituximab).
Immunocompromised at the time of enrollment.
Known active malignancies (subjects with cutaneous basal cell carcinoma that has been completely excised prior to study entry remain eligible).
Women breastfeeding, pregnant, or planning to become pregnant; women who are not post-menopausal or surgically sterile who are unwilling to practice contraception.
