Clinical trial NCT02776072: Observational Study to Characterize Real-world Clinical Outcomes With Relapsing-remitting Multiple Sclerosis (RRMS)
Official title: A Multicenter, Global, Retrospective, Observational Study to Characterize Real-world Clinical Outcomes in Patients With Relapsing-remitting Multiple Sclerosis Treated With Disease-modifying Therapies (Tecfidera®, Copaxone®, Aubagio®, or Gilenya®)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Keywords: Tecfidera, DMF, dimethyl fumarate, Fingolimod, Glatiramer acetate, Teriflunomide, Gilenya, Copaxone, Aubagio
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2016-05-18
Enrollment: 2978
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with a diagnosis of RRMS treated with dimethyl fumarate, fingolimod, teriflunomide, or glatiramer acetate in routine clinical practice.

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Proportion of participants relapsed at 12 months in participants treated with DMF
timeFrame: One day
Secondary outcomes:
measure: 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
timeFrame: One day
measure: ARR at 12 months in participants treated with index therapy in the overall population as well as in the matched cohorts
timeFrame: One day
measure: 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
timeFrame: One day
measure: 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
timeFrame: One day
Other outcomes:
Locations:
city: Homewood
country: United States
facility: Research Site
state: Alabama
city: Gilbert
country: United States
facility: Research Site
state: Arizona
city: Hanford
country: United States
facility: Research Site
state: California
city: Modesto
country: United States
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state: California
city: Santa Ana
country: United States
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state: California
city: Aurora
country: United States
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state: Colorado
city: Danbury
country: United States
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state: Connecticut
city: Hartford
country: United States
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state: Connecticut
city: Jacksonville
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state: Florida
city: Port Orange
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state: Florida
city: Savannah
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state: Georgia
city: Avon
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state: Indiana
city: Franklin
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state: Indiana
city: Muncie
country: United States
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city: Overland Park
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city: Boston
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state: Massachusetts
city: Boston
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state: Massachusetts
city: Wellesley
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state: Massachusetts
city: Golden Valley
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state: Minnesota
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city: New Hyde park
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city: Patchogue
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city: Columbus
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city: Ciudad Autonoma de Buenos Aires
country: Argentina
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city: Ciudad Autonoma de Buenos Aires
country: Argentina
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state: Buenos Aires
city: Rosario
country: Argentina
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state: Santa Fe
city: Rosario
country: Argentina
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state: Santa Fe
city: Ciudad Autonoma Buenos Aires
country: Argentina
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country: Argentina
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country: Argentina
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country: Australia
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state: New South Wales
city: Box Hill
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state: Victoria
city: Heidelberg
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state: Victoria
city: Melbourne
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state: Victoria
city: Burnaby
country: Canada
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state: British Columbia
city: St. John
country: Canada
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city: Halifax
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city: Cambridge
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city: Guelph
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city: Chicoutimi
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state: Quebec
city: Gatineau
country: Canada
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city: Greenfield Park
country: Canada
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state: Quebec
city: Osijek
country: Croatia
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country: Croatia
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city: Brno
country: Czech Republic
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city: Hradec Kralove
country: Czech Republic
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city: Hradec Kralove
country: Czech Republic
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country: Czech Republic
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country: Czech Republic
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country: Czech Republic
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country: Czech Republic
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city: Prague 5
country: Czech Republic
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country: Czech Republic
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city: Libourne Cedex
country: France
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state: Gironde
city: Toulouse cedex 9
country: France
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state: Haute Garonne
city: Le Mans cedex 9
country: France
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state: Sarthe
city: Le Chesnay Cedex
country: France
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state: Yvelines
city: Freiburg
country: Germany
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state: Baden Wuerttemberg
city: Pforzheim
country: Germany
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state: Baden Wuerttemberg
city: Stuttgart
country: Germany
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state: Baden Wuerttemberg
city: Bamberg
country: Germany
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state: Bayern
city: Potsdam
country: Germany
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state: Brandenburg
city: Kassel
country: Germany
facility: Research Site
state: Hessen
city: Oldenburg
country: Germany
facility: Research Site
state: Niedersachsen
city: Osnabrueck
country: Germany
facility: Research Site
state: Niedersachsen
city: Stade
country: Germany
facility: Research Site
state: Niedersachsen
city: Bochum
country: Germany
facility: Research Site
state: Nordrhein Westfalen
city: Düsseldorf
country: Germany
facility: Research Site
state: Nordrhein Westfalen
city: Gelsenkirchen
country: Germany
facility: Research Site
state: Nordrhein Westfalen
city: Hagen
country: Germany
facility: Research Site
state: Nordrhein Westfalen
city: Siegen
country: Germany
facility: Research Site
state: Nordrhein Westfalen
city: Sprockhoevel
country: Germany
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state: Nordrhein Westfalen
city: Kandel
country: Germany
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state: Rheinland Pfalz
city: St. Ingbert
country: Germany
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state: Saarland
city: Leipzig
country: Germany
facility: Research Site
state: Sachsen
city: Kiel
country: Germany
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state: Schleswig Holstein
city: Berlin
country: Germany
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city: Berlin
country: Germany
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country: Germany
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city: Budapest
country: Hungary
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country: Hungary
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city: Eger
country: Hungary
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city: Esztergom
country: Hungary
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city: Kecskemet
country: Hungary
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city: Nyiregyhaza
country: Hungary
facility: Research Site
city: Cagliari
country: Italy
facility: Research Site
city: Catania
country: Italy
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city: Napoli
country: Italy
facility: Research Site
city: Napoli
country: Italy
facility: Research Site
city: Badalona
country: Spain
facility: Research Site
state: Barcelona
city: Santiago de Compostela
country: Spain
facility: Research Site
state: La Coruña
city: Vigo
country: Spain
facility: Research Site
state: Pontevedra
city: Alicante
country: Spain
facility: Research Site
city: Cordoba
country: Spain
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city: Madrid
country: Spain
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city: Malaga
country: Spain
facility: Research Site
city: Sevilla
country: Spain
facility: Research Site
city: Lausanne
country: Switzerland
facility: Research Site
city: Lugano
country: Switzerland
facility: Research Site
city: Truro
country: United Kingdom
facility: Research Site
state: Cornwall
city: Exeter
country: United Kingdom
facility: Research Site
state: Devon
city: Chelmsford
country: United Kingdom
facility: Research Site
state: Essex
city: Romford
country: United Kingdom
facility: Research Site
state: Essex
city: London
country: United Kingdom
facility: Research Site
state: Greater London
city: Glasgow
country: United Kingdom
facility: Research Site
state: Strathclyde
city: Chertsey
country: United Kingdom
facility: Research Site
state: Surrey
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Min J, Cohan S, Alvarez E, Sloane J, Phillips JT, van der Walt A, Koulinska I, Fang F, Miller C, Chan A. Real-World Characterization of Dimethyl Fumarate-Related Gastrointestinal Events in Multiple Sclerosis: Management Strategies to Improve Persistence on Treatment and Patient Outcomes. Neurol Ther. 2019 Jun;8(1):109-119. doi: 10.1007/s40120-019-0127-2. Epub 2019 Jan 31.