Overview

This trial is active, not recruiting.

Condition relapsing-remitting multiple sclerosis
Treatment natalizumab
Sponsor Biogen
Start date February 2012
End date November 2018
Trial size 231 participants
Trial identifier NCT01485003, 101MS407

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])

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective

Primary Outcomes

Measure
Proportion of Participants who are overall disease activity-free at Months 12 and 24
time frame: Baseline and Months 12 and 24
Proportion of participants who are clinical disease activity-free at Months 36 and 48
time frame: Baseline and Months 36 and 48

Secondary Outcomes

Measure
Identification of baseline prognostic factors that predict overall disease-free status
time frame: Baseline and Month 12
Identification of yearly overall disease-free response factors that predict overall disease-free status
time frame: Month 12 and Month 24
Clinical disease-free status
time frame: Months 12, 24, 36, and 48
Identification of baseline prognostic factors that predict clinical disease-free status
time frame: Month 12
Identification of yearly clinical disease-free response factors that predict clinical disease-free status
time frame: Month 48
Annualized Relapse Rate
time frame: Months 12, 24, 36, and 48
Percentage of participants with Sustained EDSS progression
time frame: Baseline and Months 12, 24, 36, and 48
Sustained EDSS improvement
time frame: Baseline and Months 12, 24, 36, and 48
Change form baseline in number of new or newly enlarging T2 hyperintense lesions as assessed by MRI
time frame: Baseline and Months 12, 24, 36, and 48
Change from baseline in number of new T1 hypointense lesions as assessed by MRI
time frame: Baseline and Months 12, 24, 36, and 48
Change form baseline in number of T1 lesions with Gd-enhancing lesions as assessed by MRI
time frame: Baseline and Months 12, 24, 36, and 48
MRI brain atrophy as assessed by MRI
time frame: Baseline and Months 12, 24, 36, and 48
Change from baseline in retinal nerve fiber layer (RNFL) thickness as assessed by OCT
time frame: Baseline and Month 24 and Month 48
Change from baseline in low contrast visual acuity
time frame: Baseline and Month 24 and Month 48
Change from baseline in high contrast visual acuity
time frame: Baseline and Month 24 and Month 48
Cognitive impairment as assessed by change from baseline in SDMT
time frame: Baseline and Months 12, 24, 36 and 48
Capacity for work as assessed by change from baseline in WPAI questionnaire
time frame: Baseline and Months 12, 24, 36 and 48
Quality of Life as measured by MSIS-29
time frame: Baseline and Months 12, 24, 36 and 48

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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.

Additional Information

Official title A Multicenter, Observational, Open-Label, Single-Arm Study of Tysabri in Early Relapsing-Remitting Multiple Sclerosis in Anti-JCV Antibody Negative Patients
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Biogen.