Observational Study of Tysabri in Early Relapsing-Remitting Multiple Sclerosis in Anti-JC Virus Antibody Negative Participants

NCT ID: NCT01485003

Last Updated: 2019-02-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 231 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-02-07
• Study Completion Date: 2018-11-26

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 disease-free status in subsequent Months 36 and 48. The secondary objectives are: To identify prognostic factors at Baseline that predict overall disease-free status at Month 12, and to assess if yearly overall disease-free response factors predict overall disease-free status at Month 24; To evaluate clinical disease-free status (relapse, Expanded Disability Status Scale [EDSS]) at each analysis time point of Months 12, 24, 36, and 48; To identify prognostic factors at Baseline that predict clinical disease-free status at Month 12, and to assess yearly clinical disease-free response factors that predict clinical disease-free status (relapse, EDSS) in subsequent years at Months 24, 36, and 48; To evaluate the impact of Tysabri at each analysis time point of Months 12, 24, 36, and 48 on the following: annualized relapse rate (ARR), sustained EDSS progression and improvement (24-week sustained); To evaluate the impact of Tysabri at each analysis time point of Months 12, 24, 36, and 48 on the following: magnetic resonance image (MRI) measures: T2, T1, T1 with Gadolinium (Gd), brain atrophy; To evaluate the impact of Tysabri at Month 24 and Month 48 on the following: optical coherence tomography (OCT), Low and High Contrast Visual Acuity Assessment; To evaluate the impact of Tysabri at each analysis time point of Months 12, 24, 36, and 48 on the following: cognitive impairment (Symbol Digit Modalities Test [SDMT]), capacity for work (Work Productivity and Activity Impairment Questionnaire [WPAI]), quality of life (QoL) (Multiple Sclerosis Impact Scale [MSIS-29])

Conditions

Relapsing-Remitting Multiple Sclerosis

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

natalizumab

Natalizumab will not be provided as a part of this study. Participants will receive natalizumab as prescribed by their treating physician.

Intervention Type: BIOLOGICAL

Other Intervention Names

BG00002; Tysabri

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biogen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Biogen

Locations

Research Site

Homewood, Alabama, United States

Research Site

Sun City, Arizona, United States

Research Site

La Jolla, California, United States

Research Site

Los Angeles, California, United States

Research Site

Aurora, Colorado, United States

Research Site

Fort Collins, Colorado, United States

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Newark, Delaware, United States

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Washington D.C., District of Columbia, United States

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Jacksonville, Florida, United States

Research Site

Atlanta, Georgia, United States

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Chicago, Illinois, United States

Research Site

Lake Barrington, Illinois, United States

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Peoria, Illinois, United States

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Indianapolis, Indiana, United States

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Indianapolis, Indiana, United States

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Overland Park, Kansas, United States

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Louisville, Kentucky, United States

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New Orleans, Louisiana, United States

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Baltimore, Maryland, United States

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Boston, Massachusetts, United States

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Lexington, Massachusetts, United States

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Wellesley Hills, Massachusetts, United States

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Worcester, Massachusetts, United States

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East Lansing, Michigan, United States

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Lincoln, Nebraska, United States

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Freehold, New Jersey, United States

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New York, New York, United States

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New York, New York, United States

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Patchogue, New York, United States

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Plainview, New York, United States

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Staten Island, New York, United States

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Stony Brook, New York, United States

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Cincinnati, Ohio, United States

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Cleveland, Ohio, United States

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Gahanna, Ohio, United States

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Uniontown, Ohio, United States

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Portland, Oregon, United States

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Dallas, Texas, United States

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Round Rock, Texas, United States

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Salt Lake City, Utah, United States

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Newport News, Virginia, United States

Research Site

Norfolk, Virginia, United States

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Seattle, Washington, United States

Research Site

Tacoma, Washington, United States

Countries

United States

References

Perumal J, Balabanov R, Balcer L, Galetta S, Sun Z, Li H, Rutledge D, Avila RL, Fox RJ. Long-Term Effectiveness and Safety of Natalizumab in African American and Hispanic/Latino Patients with Early Relapsing-Remitting Multiple Sclerosis: STRIVE Data Analysis. Neurol Ther. 2023 Jun;12(3):833-848. doi: 10.1007/s40120-023-00461-0. Epub 2023 Mar 26.

Reference Type: DERIVED

PMID: 36966440 (View on PubMed)

Perumal J, Balabanov R, Su R, Chang R, Balcer LJ, Galetta SL, Avila RL, Rutledge D, Fox RJ. Correction to: Improvements in Cognitive Processing Speed, Disability, and Patient-Reported Outcomes in Patients with Early Relapsing-Remitting Multiple Sclerosis Treated with Natalizumab: Results of a 4-year, Real-World, Open-Label Study. CNS Drugs. 2023 Mar;37(3):275-289. doi: 10.1007/s40263-022-00982-6.

Reference Type: DERIVED

PMID: 36780107 (View on PubMed)

Perumal J, Balabanov R, Su R, Chang R, Balcer LJ, Galetta SL, Avila RL, Rutledge D, Fox RJ. Improvements in Cognitive Processing Speed, Disability, and Patient-Reported Outcomes in Patients with Early Relapsing-Remitting Multiple Sclerosis Treated with Natalizumab: Results of a 4-year, Real-World, Open-Label Study. CNS Drugs. 2022 Sep;36(9):977-993. doi: 10.1007/s40263-022-00950-0. Epub 2022 Sep 5.

Reference Type: DERIVED

PMID: 36064841 (View on PubMed)

Perumal J, Balabanov R, Su R, Chang R, Balcer L, Galetta S, Campagnolo DI, Avila R, Lee L, Rutledge D, Fox RJ. Natalizumab in Early Relapsing-Remitting Multiple Sclerosis: A 4-Year, Open-Label Study. Adv Ther. 2021 Jul;38(7):3724-3742. doi: 10.1007/s12325-021-01722-w. Epub 2021 May 20.

Reference Type: DERIVED

PMID: 34014549 (View on PubMed)

Perumal J, Fox RJ, Balabanov R, Balcer LJ, Galetta S, Makh S, Santra S, Hotermans C, Lee L. Outcomes of natalizumab treatment within 3 years of relapsing-remitting multiple sclerosis diagnosis: a prespecified 2-year interim analysis of STRIVE. BMC Neurol. 2019 Jun 8;19(1):116. doi: 10.1186/s12883-019-1337-z.

Reference Type: DERIVED

PMID: 31176355 (View on PubMed)

Other Identifiers

101MS407

Identifier Type: -

Identifier Source: org_study_id