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Clinical Disease Activity With Long Term Natalizumab Treatment

NCT02677077 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 277

Last updated 2019-01-04

No results posted yet for this study

Summary

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.

Conditions

  • Relapsing-Remitting Multiple Sclerosis

Interventions

DRUG

natalizumab

Participants with RRMS receiving commercial natalizumab in Belgium and Czech Republic

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Biogen

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2016-08-18
Completion
2016-08-18

Countries

  • Belgium
  • Czechia

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02677077 on ClinicalTrials.gov