Effectiveness of DMF and Its Impact on PROs in Suboptimal GA Responders With RMS
Public ClinicalTrials.gov record NCT01903291. 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
A Multicenter, Open-Label, 12-Month Observational Study Evaluating the Clinical Effectiveness and Impact on Patient-Reported Outcomes of Oral Tecfidera™ (Dimethyl Fumarate) Delayed-Release Capsules in Patients With Relapsing Forms of Multiple Sclerosis After Suboptimal Response to Glatiramer Acetate
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The primary objective of the study is to estimate the annualized relapse rate (ARR) over a 12-month period in patients with relapsing forms of multiple sclerosis (MS) who are treated with dimethyl fumarate (DMF) after suboptimal response to glatiramer acetate (GA). The secondary objectives of this study in this study population are to assess the impact of DMF over a 12-month period on patient-reported outcomes (PROs) and health economic-related outcomes and to evaluate additional clinical outcomes at Month 12.
Study identification
- NCT ID
- NCT01903291
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 333 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- 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
- Jul 31, 2013
- Primary completion
- Jan 31, 2016
- Completion
- Jan 31, 2016
- Last update posted
- Jul 24, 2016
2013 – 2016
United States locations
- U.S. sites
- 62
- U.S. states
- 32
- U.S. cities
- 60
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Research Site | Birmingham | Alabama | 35209 | — |
| Research Site | Tuscon | Arizona | 85741-1196 | — |
| Research Site | Los Angeles | California | 90015 | — |
| Research Site | Sacramento | California | 95816 | — |
| Research Site | San Jose | California | 95124 | — |
| Research Site | Englewood | Colorado | 80113 | — |
| Research Site | Dover | Delaware | 19901 | — |
| Research Site | Jacksonville | Florida | 32209 | — |
| Research Site | Lighthouse PT | Florida | 33064 | — |
| Research Site | Port Charlotte | Florida | 33952 | — |
| Research Site | St. Petersburg | Florida | 33705 | — |
| Research Site | Tampa | Florida | 33612 | — |
| Research Site | Atlanta | Georgia | 30309 | — |
| Research Site | Atlanta | Georgia | 30327 | — |
| Research Site | Savannah | Georgia | 31405 | — |
| Research Site | Chicago | Illinois | 60637-1463 | — |
| Research Site | Evanston | Illinois | 60201 | — |
| Research Site | Franklin | Illinois | 37064 | — |
| Research Site | Indianapolis | Indiana | 46256 | — |
| Research Site | Des Moines | Iowa | 50314 | — |
| Research Site | Lenexa | Kansas | 66214-9836 | — |
| Research Site | Lexington | Kentucky | 40513 | — |
| Research Site | Louisville | Kentucky | 40207 | — |
| Research Site | Baton Rouge | Louisiana | 70810-1686 | — |
| Research Site | Annapolis | Maryland | 21401 | — |
| Research Site | Baltimore | Maryland | 21201 | — |
| Research Site | Lexington | Massachusetts | 02421 | — |
| Research Site | Springfield | Massachusetts | 01104 | — |
| Research Site | Worcester | Massachusetts | 01655 | — |
| Research Site | Clinton Township | Michigan | 48035 | — |
| Research Site | Muskegon | Michigan | 49444-3719 | — |
| Research Site | Golden Valley | Minnesota | 55422 | — |
| Research Site | Columbia | Missouri | 65201 | — |
| Research Site | Great Falls | Montana | 59405 | — |
| Research Site | Lincoln | Nebraska | 68506-2960 | — |
| Research Site | Lincoln | Nebraska | 68521 | — |
| Research Site | Omaha | Nebraska | 68198 | — |
| Research Site | Freehold | New Jersey | 07728 | — |
| Research Site | New York | New York | 10032 | — |
| Research Site | Patchogue | New York | 11772 | — |
| Research Site | The Bronx | New York | 10467 | — |
| Research Site | Asheville | North Carolina | 28806 | — |
| Research Site | Hickory | North Carolina | 28602 | — |
| Research Site | Raleigh | North Carolina | 27607-6010 | — |
| Research Site | Akron | Ohio | 44302 | — |
| Research Site | Canton | Ohio | 44718 | — |
| Research Site | Centerville | Ohio | 45459 | — |
| Research Site | Columbus | Ohio | 43221 | — |
| Research Site | Medford | Oregon | 97504 | — |
| Research Site | Portland | Oregon | 97225 | — |
| Research Site | Abington | Pennsylvania | 19001 | — |
| Research Site | Greensburg | Pennsylvania | 15601 | — |
| Research Site | Pittsburgh | Pennsylvania | 15212 | — |
| Research Site | Knoxville | Tennessee | 37934 | — |
| Research Site | Round Rock | Texas | 78681 | — |
| Research Site | Salt Lake City | Utah | 84103 | — |
| Research Site | Norfolk | Virginia | 23502 | — |
| Research Site | Richmond | Virginia | 23226 | — |
| Research Site | Bellingham | Washington | 98225 | — |
| Research Site | Seattle | Washington | 98122 | — |
| Research Site | Tacoma | Washington | 98405 | — |
| Research Site | Neenah | Wisconsin | 54946 | — |
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 NCT01903291, 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 Jul 24, 2016 · Synced Sep 4, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01903291 live on ClinicalTrials.gov.