Multiple SclerosisEFFECTNCT02776072
Observational Study to Characterize Real-world Clinical Outcomes With Relapsing-remitting Multiple Sclerosis (RRMS)
An observational study of Multiple Sclerosis, run by Biogen at 121 sites in 13 countries.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 2,978 participants
- Where
- 121 sitesin 13 countries
- Study dates
- May 2016to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants with a diagnosis of RRMS treated with dimethyl fumarate, fingolimod, teriflunomide, or glatiramer acetate in routine clinical practice.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
121 sites in 13 countries.
121 sites in 13 countries
United States38 sites
Research Site
Amherst, New York, 14226
Research Site
Aurora, Colorado, 80045
Research Site
Avon, Indiana, 46123
Research Site
Boston, Massachusetts, 02135
Research Site
Boston, Massachusetts, 02215
Research Site
Cleveland, Ohio, 44195
Research Site
Columbus, Ohio, 43210
Research Site
Columbus, Ohio, 43221
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Dallas, Texas, 75246
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Danbury, Connecticut, 06810
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Franklin, Indiana, 46131
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Gilbert, Arizona, 85234
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Golden Valley, Minnesota, 55422
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Hanford, California, 93230
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Hartford, Connecticut, 6112
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Homewood, Alabama, 35209
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Houston, Texas, 77018
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Jacksonville, Florida, 32256
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Mansfield, Texas, 76063
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Medford, Oregon, 97504
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Modesto, California, 95355
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Muncie, Indiana, 47304
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New Hyde Park, New York, 11042
Research Site
New York, New York, 10019
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Norfolk, Virginia, 23502
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Overland Park, Kansas, 66212
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Patchogue, New York, 11772
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Philadelphia, Pennsylvania, 19107
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Pittsburgh, Pennsylvania, 15212
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Port Orange, Florida, 32127
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Portland, Oregon, 97225
Research Site
Raleigh, North Carolina, 27607-6010
Research Site
Round Rock, Texas, 78681
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Salt Lake City, Utah, 84103
Research Site
Santa Ana, California, 92704
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Savannah, Georgia, 31406
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Tacoma, Washington, 98405
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Wellesley, Massachusetts, 02481
Germany22 sites
Research Site
Bamberg, Bavaria, 96052
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Berlin, State of Berlin, 10961
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Berlin, State of Berlin, 12099
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Bochum, North Rhine-Westphalia, 44787
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Düsseldorf, North Rhine-Westphalia, 40211
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Freiburg im Breisgau, Baden-Wurttemberg, 79098
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Gelsenkirchen, North Rhine-Westphalia, 45879
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Hagen, North Rhine-Westphalia, 58095
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Hamburg, Free and Hanseatic City of Hamburg, 20249
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Kandel, Rhineland-Palatinate, 76870
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Kassel, Hesse, 34121
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Kiel, Schleswig-Holstein, 24105
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Leipzig, Saxony, 04229
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Oldenburg, Lower Saxony, 26122
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Osnabrück, Lower Saxony, 49076
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Pforzheim, Baden-Wurttemberg, 75172
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Potsdam, Brandenburg, 14471
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Saint Ingbert, Saarland, 66386
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Siegen, North Rhine-Westphalia, 57076
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Sprockhövel, North Rhine-Westphalia, 45549
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Stade, Lower Saxony, 21682
Research Site
Stuttgart, Baden-Wurttemberg, 70182
Czechia9 sites
Research Site
Brno, 656 91
Research Site
Hradec Králové, 500 05
Research Site
Hradec Králové, 50003
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Jihlava, 58633
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Olomouc, 775 20
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Ostrava-Poruba, 70800
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Pardubice, 532 03
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Prague, 150 06
Research Site
Teplice, 41501
Canada8 sites
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Burnaby, British Columbia, V5H 4K7
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Cambridge, Ontario, N1R7L6
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Chicoutimi, Quebec, G7H 5H6
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Gatineau, Quebec, J9J 0A5
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Greenfield Park, Quebec, J4V 2J2
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Guelph, Ontario, N1H 4J4
Research Site
Halifax, Nova Scotia, B3H4K4
Research Site
Saint John, New Brunswick, E2L4L2
Spain8 sites
Research Site
Alicante, Alicante, 03010
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Badalona, Barcelona, 08916
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Córdoba, Cordoba, 14011
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Madrid, Madrid, 28007
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Málaga, Malaga, 29010
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Santiago de Compostela, La Coruña, 15706
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Seville, Sevilla, 41071
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Vigo, Pontevedra, 36312
Argentina7 sites
Research Site
Ciudad Autonoma Buenos Aires, Ciudad Autonoma Buenos Aires, C1428AQK
Research Site
Ciudad Autonoma de Buenos Aires, Buenos Aires, C1061ABD
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Ciudad Autonoma de Buenos Aires, Buenos Aires, C1425DKT
Research Site
Córdoba, Córdoba Province, X5000JHQ
Research Site
Rosario, Santa Fe Province, 2000
Research Site
Rosario, Santa Fe Province, S20000
Research Site
Salta, Salta Province, 4400
United Kingdom7 sites
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Chelmsford, Essex, CM1 7ET
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Chertsey, Surrey, KT16 0PZ
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Exeter, Devon, EX2 5DW
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Glasgow, Strathclyde, G51 4TF
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London, Greater London, SW17 0QT
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Romford, Essex, RM7 0AG
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Truro, Cornwall, TR1 3LJ
Hungary6 sites
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Budapest, 1083
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Debrecen, 4032
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Eger, 3300
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Esztergom, 2500
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Kecskemét, 6000
Research Site
Nyíregyháza, 4400
Australia4 sites
Research Site
Box Hill, Victoria, 3128
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Heidelberg, Victoria, 3084
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Melbourne, Victoria, 3050
Research Site
New Lambton Heights, New South Wales, 2305
France4 sites
Research Site
Le Chesnay, Yvelines, 78157
Research Site
Le Mans, Sarthe, 72037
Research Site
Libourne, Gironde, 33505
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Toulouse, Haute Garonne, 31059
Italy4 sites
Research Site
Cagliari, Cagliari, 09126
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Catania, Catania, 95123
Research Site
Naples, Napoli, 80131
Research Site
Naples, Napoli, 80138
Switzerland2 sites
Research Site
Lausanne, CH-1011
Research Site
Lugano, 6903
About this study
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®)
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.
- Conditions
- Multiple Sclerosis
- Keywords
- Tecfidera, DMF, dimethyl fumarate, Fingolimod, Glatiramer acetate, Teriflunomide, Gilenya, Copaxone, Aubagio
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| dimethyl fumarate (DMF) | Participants who initiated DMF during the specified time period | |
| glatiramer acetate (GA) | Participants who initiated GA during the specified time period | |
| teriflunomide | Participants who initiated teriflunomide during the specified time period | |
| fingolimod | Participants who initiated fingolimod during the specified time period |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: One day
Secondary outcomes (4)
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
Measured: One day
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
Measured: One day
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
Measured: One day
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
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2016 (estimated)
- Study startMay 2016
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by BiogenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 2,978 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Biogen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02776072
- Sponsor's protocol ID
- 109MS421
- Acronym
- EFFECT
- Status last verified
- Mar 2017
- First submitted
- 16 May 2016
- Last updated
- 23 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 30706431
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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®)
- ClinicalTrials.gov ID
- NCT02776072
- Acronym / sponsor ID
- EFFECT / 109MS421
- Conditions
- Multiple Sclerosis
- Keywords
- Tecfidera, DMF, dimethyl fumarate, Fingolimod, Glatiramer acetate, Teriflunomide, Gilenya, Copaxone, Aubagio
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,978 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- May 2016
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 18 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| dimethyl fumarate (DMF) | – | –Participants who initiated DMF during the specified time period |
| glatiramer acetate (GA) | – | –Participants who initiated GA during the specified time period |
| teriflunomide | – | –Participants who initiated teriflunomide during the specified time period |
| fingolimod | – | –Participants who initiated fingolimod during the specified time period |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with a diagnosis of RRMS treated with dimethyl fumarate, fingolimod, teriflunomide, or glatiramer acetate in routine clinical practice.
Key inclusion criteria (3 listed)
- 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 (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of participants relapsed at 12 months in participants treated with DMF
Time frame: One day
Single time point per participant retrospective medical record abstraction with no required study visits or procedures
4 secondary outcomes
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
Time frame: One day
ARR at 12 months in participants treated with index therapy in the overall population as well as in the matched cohorts
Time frame: One day
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
Time frame: One day
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
Time frame: One day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2017.
- Derived from this study: PubMed 30706431Min 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Biogen
121 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Biogen at 121 sites in 13 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 121 sites in United States, Germany, Czechia, Canada, Spain and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants relapsed at 12 months in participants treated with DMF (time frame: One day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02776072, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2017.