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

Biogen

Status: Completed

Conditions: Relapsing-Remitting Multiple Sclerosis

Treatments: Biological: natalizumab

Study type: Observational

Funder types: Industry

Identifiers

NCT01485003

101MS407

Details and patient eligibility

About

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])

Enrollment: 231 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.