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NCT02047097 · ClinicalTrials.gov registry record
Dimethyl Fumarate (DMF) Observational Study
A clinical trial, sponsored by Biogen.
- Completed
- Registry status
- 5,487
- Enrollment target
NCT02047097 is a clinical trial that has completed, run by Biogen. The registered enrollment target is 5,487 participants.
The verdict
NCT02047097 has completed, sponsored by Biogen.
- COMPLETED
- Registry status
- 5,487 participants
- Enrollment target
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.
Interventions
- DRUG dimethyl fumarate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5,487 participants |
| Start Date | 2013-11-19 |
| Est. Completion | 2022-10-31 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02047097
The ClinicalTrials.gov registry entry for NCT02047097 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 5,487 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Biogen, which has 334 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which dimethyl fumarate is the first listed.
NCT02047097 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02047097 about?
NCT02047097 is a clinical study titled "Dimethyl Fumarate (DMF) Observational Study". 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 discont...
What is the current status of trial NCT02047097?
This trial is currently completed. The enrollment target is 5,487 participants. The study started on 2013-11-19. Estimated completion is 2022-10-31.
What interventions are being tested in trial NCT02047097?
The interventions under investigation include: dimethyl fumarate (DRUG).
Who is sponsoring clinical trial NCT02047097?
This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.
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