Clinical Disease Activity With Long Term Natalizumab Treatment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

277 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-12-31

Study Completion Date

2016-08-18

Brief Summary

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The primary objective of the study is to retrospectively investigate the proportion of participants free of new or enlarging fluid-attenuated inversion recovery (FLAIR) lesions over time in approximately 300 Relapsing-Remitting Multiple Sclerosis (RRMS) participants with regular MRI follow-up, who have received natalizumab ≥24 month from two different observational cohorts: 1) approximately 230 participants from the Czech Republic; and 2) approximately 70 participants from Belgium. The secondary objectives of this study are as follows: Brain volume change by various measures; Changes in the number and volume of magnetic resonance imaging (MRI) lesions; No evidence of disease activity (NEDA) with and without brain volume change.

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Detailed Description

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Natalizumab will not be provided to participants by Biogen as a part of this study. Participants will remain on natalizumab therapy as prescribed by their physician.

Conditions

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Relapsing-Remitting Multiple Sclerosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Czech Republic

Approximately 230 participants with RRMS receiving commercial natalizumab in Czech Republic

natalizumab

Intervention Type DRUG

Participants with RRMS receiving commercial natalizumab in Belgium and Czech Republic

Belgium

Approximately 70 participants with RRMS receiving commercial natalizumab in Belgium

natalizumab

Intervention Type DRUG

Participants with RRMS receiving commercial natalizumab in Belgium and Czech Republic

Interventions

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natalizumab

Participants with RRMS receiving commercial natalizumab in Belgium and Czech Republic

Intervention Type DRUG

Other Intervention Names

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BG00002 Tysabri

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of RRMS.
* Continuous treatment with natalizumab of ≥24 months. In case of a treatment interruption from natalizumab ≥60 days after a total treatment period of ≥24 months, only the treatment prior to the interruption will be analyzed. Any data after this treatment interruption (even if the patient restarts natalizumab) will not be analyzed/collected.
* ≥1 MRI scan of sufficient quality for reliable measurement.
* Baseline MRI scan ≤6 month prior to natalizumab treatment acquired.
* ≥1 MRI scan of sufficient quality for reliable measurement taken while on natalizumab treatment for ≥6 months.
* EDSS ≤ 6.5.

Exclusion Criteria

* Anti-natalizumab antibody detection.
* Prior treatment with alemtuzumab.
* Prior treatment with mitoxantrone within 12 months of the first infusion of natalizumab.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No