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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: Completed study, sponsored by Biogen.
NCT02047097 is a clinical trial that has completed, run by Biogen. The registered enrollment target is 5,487 participants. According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT02047097 record still lists
NCT02047097 is an observational study that tracks outcomes without assigning an intervention. Its 5,487 participants enrollment target places it among the larger protocols in the corpus.
The record links to 0 conditions, and to 1 intervention - of which dimethyl fumarate is the first listed.
NCT02047097 does not publish any study locations in the registry export this page uses.
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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