Status:
COMPLETED
Observational Study of Tysabri in Early Relapsing-Remitting Multiple Sclerosis in Anti-JC Virus Antibody Negative Participants
Lead Sponsor:
Biogen
Conditions:
Relapsing-Remitting Multiple Sclerosis
Eligibility:
All Genders
18-65 years
Brief Summary
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 di...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
February 7 2012
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 26 2018
Estimated Enrollment :
231 Patients enrolled
Trial Details
Trial ID
NCT01485003
Start Date
February 7 2012
End Date
November 26 2018
Last Update
February 12 2019
Active Locations (44)
Enter a location and click search to find clinical trials sorted by distance.
1
Research Site
Homewood, Alabama, United States, 35209
2
Research Site
Sun City, Arizona, United States, 85351
3
Research Site
La Jolla, California, United States, 92037
4
Research Site
Los Angeles, California, United States, 90032