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Dimethyl Fumarate (DMF) Observational Study

NCT02047097 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 5487

Last updated 2023-05-24

No results posted yet for this study

Summary

The primary objective of the study is to determine the incidence, type, and pattern of serious adverse events (SAEs), including but not limited to infections (including opportunistic infections), hepatic events, malignancies, and renal events, and of adverse events (AEs) leading to treatment discontinuation in patients with MS treated with dimethyl fumarate (DMF). Secondary objectives of this study in this population are as follows: To determine dimethyl fumarate (DMF) prescription and utilization patterns in routine clinical practice in patients with multiple sclerosis (MS); To assess the effectiveness of dimethyl fumarate (DMF) on multiple sclerosis (MS) disease activity and disability progression in routine clinical practice as determined by the Expanded Disability Status Scale (EDSS) score and multiple sclerosis (MS) relapse information; and To assess the effect of dimethyl fumarate (DMF) on health-related quality of life, healthcare resource consumption, and work productivity.

Conditions

Interventions

DRUG

dimethyl fumarate

Provided under routine clinical care

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Biogen

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-19
Primary Completion
2022-10-31
Completion
2022-10-31

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Canada
  • Czechia
  • Denmark
  • France
  • Germany
  • Hungary
  • Ireland
  • Italy
  • Netherlands
  • New Zealand
  • Norway
  • Poland
  • Portugal
  • Puerto Rico
  • Slovakia
  • Spain
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
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 NCT02047097 on ClinicalTrials.gov