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Canadian Multicenter Observational Study of Tysabri in Early Relapsing Remitting Multiple Sclerosis Participants

NCT01706107 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 73

Last updated 2024-06-03

No results posted yet for this study

Summary

The primary objective of the study is to evaluate the impact of early treatment with Tysabri in Relapsing Remitting Multiple Sclerosis (RRMS) participants on their quality of life (QoL) as measured by Multiple Sclerosis Impact Scale-29 (MSIS-29) over 2 years. The secondary objectives of the study are: to evaluate the impact of early treatment with Tysabri in RRMS participants over 2 years on the following: annualized relapse rate (ARR), Expanded Disability Status Scale (EDSS), work productivity, quality of life (QoL) by EuroQol 5-Dimension questionnaire (EQ-5D), QoL by Subject Global Assessment of Wellbeing visual analog scale (VAS) and to evaluate clinical disease-free status (relapses, EDSS) over 2 years.

Conditions

  • Relapsing-Remitting Multiple Sclerosis

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Biogen

Eligibility

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

Timeline & Regulatory

Start
2012-11-07
Primary Completion
2015-10-02
Completion
2015-10-02

Countries

  • Canada

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 NCT01706107 on ClinicalTrials.gov