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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02776072
Other study ID # 109MS421
Secondary ID
Status Completed
Phase N/A
First received May 16, 2016
Last updated March 21, 2017
Start date May 2016
Est. completion date December 2016

Study information

Verified date March 2017
Source Biogen
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The primary objective of the study is to evaluate the real-world clinical effectiveness, as measured by the proportion of participants relapsed at 12 months, in participants treated with dimethyl fumarate (DMF).

Secondary objectives of the study are: To evaluate the real-world clinical effectiveness, as measured by the proportion of participants relapsed at 12 months, in participants treated with DMF, glatiramer acetate (GA), teriflunomide, or fingolimod both in the overall participant cohort and in a subset of participants who were naïve to disease-modifying therapy (DMT) and were diagnosed with multiple sclerosis (MS) within 3 years of starting the index therapy; To compare relapse activity, defined as annualized relapse rate (ARR), among participants treated with DMF, GA, teriflunomide, or fingolimod; To compare MS-related hospitalizations among participants treated with DMF, GA, teriflunomide, or fingolimod; To compare intravenous corticosteroid use among participants treated with DMF, GA, teriflunomide, or fingolimod.


Recruitment information / eligibility

Status Completed
Enrollment 2978
Est. completion date December 2016
Est. primary completion date December 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Key Inclusion Criteria:

- Diagnosis of RRMS per McDonald criteria

- Initiated treatment with DMF, GA, teriflunomide, or fingolimod (defined as index therapy) no earlier than January 2011 and no later than 12 months prior to the date of medical record abstraction (i.e., patient has at least 12 months of data available in the medical record following initiation of index treatment). Note: Patients who have initiated the index therapy but subsequently discontinued or switched to other therapies are allowed in this study as long as there is at least 12 months of follow-up following the initiation of the index therapy.

- Have sufficient available medical records for data abstraction to meet the objectives of the study, i.e., the patient was either under the medical care of the investigating site during the entire period of the index treatment or the patient's complete MS disease and treatment history is otherwise available at the investigating site

Key Exclusion Criteria:

- Diagnosis of a progressive form of MS (progressive relapsing, primary progressive, secondary progressive) at any time before or during the period for which data will be collected

- Have received disease-modifying therapies other than one platform therapy (IFN or GA) prior to initiation of index therapy. In patients for whom GA is index therapy, only one prior IFN therapy is allowed.

- Have received any formulations of DMF, Fumaderm®, or compounded fumarates (e.g., Psorinovo) at any time prior to initiation of treatment with Tecfidera®

- Concurrent enrollment in any interventional clinical trial of an investigational product during time evaluated for medical record abstraction

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Argentina Research Site Ciudad Autonoma Buenos Aires
Argentina Research Site Ciudad Autonoma de Buenos Aires Buenos Aires
Argentina Research Site Ciudad Autonoma de Buenos Aires Buenos Aires
Argentina Research Site Cordoba
Argentina Research Site Rosario Santa Fe
Argentina Research Site Rosario Santa Fe
Argentina Research Site Salta
Australia Research Site Box Hill Victoria
Australia Research Site Heidelberg Victoria
Australia Research Site Melbourne Victoria
Australia Research Site New Lambton Heights New South Wales
Canada Research Site Burnaby British Columbia
Canada Research Site Cambridge Ontario
Canada Research Site Chicoutimi Quebec
Canada Research Site Gatineau Quebec
Canada Research Site Greenfield Park Quebec
Canada Research Site Guelph Ontario
Canada Research Site Halifax Nova Scotia
Canada Research Site St. John New Brunswick
Croatia Research Site Osijek
Croatia Research Site Varazdin
Czech Republic Research Site Brno
Czech Republic Research Site Hradec Kralove
Czech Republic Research Site Hradec Kralove
Czech Republic Research Site Jihlava
Czech Republic Research Site Olomouc
Czech Republic Research Site Ostrava-Poruba
Czech Republic Research Site Pardubice
Czech Republic Research Site Prague 5
Czech Republic Research Site Teplice
France Research Site Le Chesnay Cedex Yvelines
France Research Site Le Mans cedex 9 Sarthe
France Research Site Libourne Cedex Gironde
France Research Site Toulouse cedex 9 Haute Garonne
Germany Research Site Bamberg Bayern
Germany Research Site Berlin
Germany Research Site Berlin
Germany Research Site Bochum Nordrhein Westfalen
Germany Research Site Düsseldorf Nordrhein Westfalen
Germany Research Site Freiburg Baden Wuerttemberg
Germany Research Site Gelsenkirchen Nordrhein Westfalen
Germany Research Site Hagen Nordrhein Westfalen
Germany Research Site Hamburg
Germany Research Site Kandel Rheinland Pfalz
Germany Research Site Kassel Hessen
Germany Research Site Kiel Schleswig Holstein
Germany Research Site Leipzig Sachsen
Germany Research Site Oldenburg Niedersachsen
Germany Research Site Osnabrueck Niedersachsen
Germany Research Site Pforzheim Baden Wuerttemberg
Germany Research Site Potsdam Brandenburg
Germany Research Site Siegen Nordrhein Westfalen
Germany Research Site Sprockhoevel Nordrhein Westfalen
Germany Research Site St. Ingbert Saarland
Germany Research Site Stade Niedersachsen
Germany Research Site Stuttgart Baden Wuerttemberg
Hungary Research Site Budapest
Hungary Research Site Debrecen
Hungary Research Site Eger
Hungary Research Site Esztergom
Hungary Research Site Kecskemet
Hungary Research Site Nyiregyhaza
Italy Research Site Cagliari
Italy Research Site Catania
Italy Research Site Napoli
Italy Research Site Napoli
Spain Research Site Alicante
Spain Research Site Badalona Barcelona
Spain Research Site Cordoba
Spain Research Site Madrid
Spain Research Site Malaga
Spain Research Site Santiago de Compostela La Coruña
Spain Research Site Sevilla
Spain Research Site Vigo Pontevedra
Switzerland Research Site Lausanne
Switzerland Research Site Lugano
United Kingdom Research Site Chelmsford Essex
United Kingdom Research Site Chertsey Surrey
United Kingdom Research Site Exeter Devon
United Kingdom Research Site Glasgow Strathclyde
United Kingdom Research Site London Greater London
United Kingdom Research Site Romford Essex
United Kingdom Research Site Truro Cornwall
United States Research Site Amherst New York
United States Research Site Aurora Colorado
United States Research Site Avon Indiana
United States Research Site Boston Massachusetts
United States Research Site Boston Massachusetts
United States Research Site Cleveland Ohio
United States Research Site Columbus Ohio
United States Research Site Columbus Ohio
United States Research Site Dallas Texas
United States Research Site Danbury Connecticut
United States Research Site Franklin Indiana
United States Research Site Gilbert Arizona
United States Research Site Golden Valley Minnesota
United States Research Site Hanford California
United States Research Site Hartford Connecticut
United States Research Site Homewood Alabama
United States Research Site Houston Texas
United States Research Site Jacksonville Florida
United States Research Site Mansfield Texas
United States Research Site Medford Oregon
United States Research Site Modesto California
United States Research Site Muncie Indiana
United States Research Site New Hyde park New York
United States Research Site New York New York
United States Research Site Norfolk Virginia
United States Research Site Overland Park Kansas
United States Research Site Patchogue New York
United States Research Site Philadelphia Pennsylvania
United States Research Site Pittsburgh Pennsylvania
United States Research Site Port Orange Florida
United States Research Site Portland Oregon
United States Research Site Raleigh North Carolina
United States Research Site Round Rock Texas
United States Research Site Salt Lake City Utah
United States Research Site Santa Ana California
United States Research Site Savannah Georgia
United States Research Site Tacoma Washington
United States Research Site Wellesley Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Biogen

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Canada,  Croatia,  Czech Republic,  France,  Germany,  Hungary,  Italy,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of participants relapsed at 12 months in participants treated with DMF Single time point per participant retrospective medical record abstraction with no required study visits or procedures One day
Secondary Proportion of participants relapsed at 12 months treated with index therapy in the overall population as well as the subgroup of MS participants who were naïve to DMTs and were diagnosed with MS within 3 years of starting the index therapy Single time point per participant retrospective medical record abstraction with no required study visits or procedures One day
Secondary ARR at 12 months in participants treated with index therapy in the overall population as well as in the matched cohorts Single time point per participant retrospective medical record abstraction with no required study visits or procedures One day
Secondary Proportion of relapsed participants with one or more MS-related hospitalizations during the 12 months following treatment initiation in participants treated with index therapy in the overall population and the matched cohorts Single time point per participant retrospective medical record abstraction with no required study visits or procedures One day
Secondary Proportion of relapsed participants requiring treatment with intravenous corticosteroids during the 12 months following treatment initiation in participants treated with index therapy in the overall participant population and the matched cohorts Single time point per participant retrospective medical record abstraction with no required study visits or procedures One day
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