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

Status:	Completed
Conditions:	Neurology
Therapuetic Areas:	Neurology
Healthy:	No
Age Range:	18 - 65
Updated:	2/14/2019
Start Date:	February 7, 2012
End Date:	November 26, 2018

A Multicenter, Observational, Open-Label, Single-Arm Study of Tysabri in Early Relapsing-Remitting Multiple Sclerosis in Anti-JCV Antibody Negative Patients

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])

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.

We found this trial at

sites

Clinical Trial Facility in Worcester Massachusetts

Worcester, Massachusetts 01655

from

Worcester, MA