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NCT01939002 · ClinicalTrials.gov registry record · Phase 3
Characterize Flu-like Symptoms in Relapsing Multiple Sclerosis Patients Transitioning From Non-Pegylated Interferon Beta (IFN-β) Therapies to Peginterferon Beta-1a (BIIB017)
A Phase 3 study, sponsored by Biogen.
- Completed
- Registry status
- Phase 3
- Development phase
- 251
- Enrollment target
NCT01939002 is a Phase 3 study that has completed, run by Biogen. The registered enrollment target is 251 participants.
The verdict
NCT01939002, a Phase 3 study, has completed, sponsored by Biogen.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 251 participants
- Enrollment target
Study Summary
The primary objective of this study is to determine the proportion of participants with relapsing multiple sclerosis who experience new and/or increased flu-like symptoms (FLS) after transitioning from nonpegylated IFN-β therapies to peginterferon beta-1a (BIIB017). Secondary objectives are: to determine the severity and frequency (measured by flu-like symptom score \[FLS-S\]) of FLS in these participants; to determine the duration (measured in number of hours) of FLS in these participants; to determine the effect of BIIB017 on other participant-reported outcomes, including treatment satisfaction (measured with the Treatment Satisfaction Questionnaire for Medication \[TSQM\]) and disability status (measured with the Patient Determined Disease Steps \[PDDS\]) over a 56-week period; to determine whether interferon-related FLS result in missed days of work/daily activities (e.g., absenteeism); to assess the use of additional medications (in addition to current medications used to treat FLS) to relieve BIIB017-related FLS; to determine the incidence of adverse events throughout the study period; to characterize the immunogenicity profiles of participants switching from prior IFN-β therapy to BIIB017.
Interventions
- DRUG naproxen
- DRUG BIIB017
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 251 participants |
| Start Date | 2013-11 |
| Est. Completion | 2015-11 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01939002
The ClinicalTrials.gov registry entry for NCT01939002 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 251 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 2 interventions - of which naproxen is the first listed.
NCT01939002 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01939002 about?
NCT01939002 is a clinical study titled "Characterize Flu-like Symptoms in Relapsing Multiple Sclerosis Patients Transitioning From Non-Pegylated Interferon Beta (IFN-β) Therapies to Peginterferon Beta-1a (BIIB017)". The primary objective of this study is to determine the proportion of participants with relapsing multiple sclerosis who experience new and/or increased flu-like symptoms (FLS) after transitioning from nonpegylated IFN-β therapies to peginterferon beta-1a (BIIB017). Secondary objectives are: to det...
What is the current status of trial NCT01939002?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 251 participants. The study started on 2013-11. Estimated completion is 2015-11.
What interventions are being tested in trial NCT01939002?
The interventions under investigation include: naproxen (DRUG), BIIB017 (DRUG).
Who is sponsoring clinical trial NCT01939002?
This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.
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