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Real-world Outcomes on Tecfidera (BG00012, Dimethyl Fumarate) Post-Tysabri (BG00002, Natalizumab)

NCT02159573 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 530

Last updated 2016-06-07

No results posted yet for this study

Summary

The primary objective of the study is to evaluate relapse activity, as measured by the proportion of participants relapsed at 12 months, in participants with relapsing-remitting multiple sclerosis (RRMS) who transition from Tysabri (BG00002) to Tecfidera (BG00012) in the real-world setting. The secondary objective is to further evaluate relapse activity, defined as annualized relapse rate (ARR), hospitalization and intravenous corticosteroid use, during the first year of Tecfidera treatment following transition from Tysabri treatment.

Conditions

  • Relapsing-Remitting Multiple Sclerosis

Interventions

BIOLOGICAL

natalizumab

Administered as per routine clinical practice

DRUG

dimethyl fumarate

Administered as per routine clinical practice

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Biogen

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2015-01-31
Completion
2015-01-31

Countries

  • United States

Study Locations

More Related Trials

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 NCT02159573 on ClinicalTrials.gov