A Multicenter, Observational, Open-Label, Single-Arm Study of Tysabri in Early Relapsing-Remitting Multiple Sclerosis in Anti-JCV Antibody Negative Patients [Protocol:101MS407]

Trial ID:
IRB-12-5904
Charles Smith
The primary objective of the study is to determine which baseline and yearly response factors (clinical and para clinical) predict overall disease-free status at Month 12 and Month 24, and clinical disease-free status in subsequent Months 36 and 48. The response factors include clinical assessments of sustained Expanded Disability Status Scale (EDSS) progression, relapse status, and magnetic resonance image (MRI) measures, and participant reported outcomes (PROs) of cognition, capacity to work, quality of life (QoL), and visual function assessments.

Key Inclusion Criteria:

  • 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 patient privacy regulations.
  • 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 at Screening Visit
  • Must satisfy the approved therapeutic indications for Tysabri®.
  • Must be treatment-naïve to disease-modifying therapy (DMT) or have been treated with a single DMT (including Avonex, Betaseron, Rebif, Copaxone, Extavia, or Gilenya) for ≤12 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.

Contact Info:

  • Biogen Idec
  • clinicaltrials@biogenidec.com