Characterize Flu-like Symptoms in Relapsing Multiple Sclerosis Patients Transitioning From Non-Pegylated Interferon Beta (IFN-β) Therapies to Peginterferon Beta-1a (BIIB017)
Public ClinicalTrials.gov record NCT01939002. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
An Open-Label, Two-Arm Randomized Study to Characterize Flu-Like Symptoms in Relapsing Multiple Sclerosis Patients Transitioning From Current Interferon Beta Therapies to BIIB017
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01939002
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 251 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 2013 (Type not available)
- Primary completion
- Oct 2015 (Actual)
- Completion
- Nov 2015 (Actual)
- Last update posted
- Jan 25, 2017
2013 – 2015
United States locations
- U.S. sites
- 38
- U.S. states
- 22
- U.S. cities
- 37
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Research Site | Gilbert | Arizona | 85234 | — |
| Research Site | Phoenix | Arizona | 85004 | — |
| Research Site | Phoenix | Arizona | 85018 | — |
| Research Site | Tucson | Arizona | 85704 | — |
| Research Site | Boulder | Colorado | 80301 | — |
| Research Site | Fort Collins | Colorado | 80528 | — |
| Research Site | Dover | Delaware | 19901 | — |
| Research Site | Newark | Delaware | 19713 | — |
| Research Site | Jacksonville | Florida | 32209 | — |
| Research Site | Melbourne | Florida | 32901 | — |
| Research Site | Tampa | Florida | 33609 | — |
| Research Site | Atlanta | Georgia | 30327 | — |
| Research Site | Kansas City | Kansas | 66160 | — |
| Research Site | Lexington | Kentucky | 40513 | — |
| Research Site | Louisville | Kentucky | 40207 | — |
| Research Site | Boston | Massachusetts | 02135 | — |
| Research Site | Lexington | Massachusetts | 02421 | — |
| Research Site | Worcester | Massachusetts | 01655 | — |
| Research Site | Detroit | Michigan | 48202 | — |
| Research Site | Chesterfield | Missouri | 63017 | — |
| Research Site | St Louis | Missouri | 63110 | — |
| Research Site | Great Falls | Montana | 59405 | — |
| Research Site | Lincoln | Nebraska | 68521 | — |
| Research Site | Latham | New York | 12110 | — |
| Research Site | Plainview | New York | 11803 | — |
| Research Site | Asheville | North Carolina | 28806 | — |
| Research Site | Akron | Ohio | 44320 | — |
| Research Site | Dayton | Ohio | 45417 | — |
| Research Site | Uniontown | Ohio | 44685 | — |
| Research Site | Oklahoma City | Oklahoma | 73104 | — |
| Research Site | Portland | Oregon | 97225 | — |
| Research Site | Greenville | South Carolina | 29607 | — |
| Research Site | Franklin | Tennessee | 37064 | — |
| Research Site | Knoxville | Tennessee | 37934 | — |
| Research Site | Salt Lake City | Utah | 84103 | — |
| Research Site | Newport News | Virginia | 23601 | — |
| Research Site | Roanoke | Virginia | 24018 | — |
| Research Site | Spokane | Washington | 99202 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01939002, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 25, 2017 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01939002 live on ClinicalTrials.gov.