Observational Study to Characterize Real-world Clinical Outcomes With Relapsing-remitting Multiple Sclerosis (RRMS)

Multiple Sclerosis Clinical Trial

— EFFECT  

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®)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02776072
• Other study ID #: 109MS421
• 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
• 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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Sclerosis

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