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NCT02230969 · ClinicalTrials.gov registry record
Plegridy Observational Program
A clinical trial, sponsored by Biogen.
- Completed
- Registry status
- 1,208
- Enrollment target
NCT02230969 is a clinical trial that has completed, run by Biogen. The registered enrollment target is 1,208 participants.
The verdict
NCT02230969 has completed, sponsored by Biogen.
- COMPLETED
- Registry status
- 1,208 participants
- Enrollment target
Study Summary
The primary objectives of the study are to determine the incidence of serious adverse events (SAEs) in participants with relapsing forms of multiple sclerosis (MS) in routine clinical practice and to assess the overall long-term clinical effectiveness of Plegridy in participants with relapsing forms of MS in routine clinical practice. The secondary objectives of this study in this study population are to describe Plegridy prescription and utilization adherence patterns in routine clinical practice; to assess the specific long-term clinical effectiveness of Plegridy in participants with relapsing forms of MS in routine clinical practice; to monitor the safety and tolerability of Plegridy in routine clinical practice by assessing the incidence of adverse events (AEs) of flu-like symptoms (FLS), injection site reactions (ISRs), and AEs (including laboratory abnormalities) leading to treatment discontinuation; to assess the effect of FLS on participant-reported effectiveness of, and satisfaction with, prophylactic management using a FLS-Visual Analog Scale (FLS-VAS); to evaluate the change in health-related quality of life (HRQoL), FLS, FLS-VAS, healthcare resource consumption, and treatment adherence over time.
Interventions
- DRUG peginterferon beta-1a
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,208 participants |
| Start Date | 2014-11-12 |
| Est. Completion | 2022-01-20 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02230969
The ClinicalTrials.gov registry entry for NCT02230969 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 1,208 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 peginterferon beta-1a is the first listed.
NCT02230969 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02230969 about?
NCT02230969 is a clinical study titled "Plegridy Observational Program". The primary objectives of the study are to determine the incidence of serious adverse events (SAEs) in participants with relapsing forms of multiple sclerosis (MS) in routine clinical practice and to assess the overall long-term clinical effectiveness of Plegridy in participants with relapsing forms...
What is the current status of trial NCT02230969?
This trial is currently completed. The enrollment target is 1,208 participants. The study started on 2014-11-12. Estimated completion is 2022-01-20.
What interventions are being tested in trial NCT02230969?
The interventions under investigation include: peginterferon beta-1a (DRUG).
Who is sponsoring clinical trial NCT02230969?
This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.
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