- Trial ID:
- Charles Smith
Key Inclusion Criteria:
- Documented diagnosis of Relapsing Multiple Sclerosis (McDonald 2010 Criteria ).
- <3 year disease duration.
- Must have an Expanded Disability Status Scale (EDSS) score from 0 to 4.0, inclusive.
- Anti-JCV antibody negative test within 6 months of Screening Visit.
- Must satisfy the approved therapeutic indications for Tysabri.
- Must be treatment-naïve to disease-modifying therapy (DMT) or have been treated with DMT (including but not limited to Avonex, Betaseron, Rebif, Copaxone, Extavia, or Gilenya) for ≤36 months total prior to date of informed consent.
- Decision to treat with Tysabri must precede enrollment.
Key Exclusion Criteria:
- Any prior treatment with Tysabri.
- Anti-JCV antibody positive at any timepoint prior to the Screening Visit.
- Contraindications to treatment with Tysabri as described in the US Prescribing Information.
- 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 (PPM) 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.
- Inability to comply with study requirements.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Why isn't this trial accepting new patients?
The trial may have a limited enrollment number, reached its maximum, or come to the end of its enrollment period. View trials that are recruiting
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How can I find trials that are accepting new participants?
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