Relapsing-Remitting Multiple SclerosisSTRATEGYNCT02159573
Real-world Outcomes on Tecfidera (BG00012, Dimethyl Fumarate) Post-Tysabri (BG00002, Natalizumab)
An observational study of Relapsing-Remitting Multiple Sclerosis, run by Biogen at 43 sites in United States.
Trial summary
The primary objective of the study is to evaluate relapse activity, as measured by the proportion of participants relapsed at 12 months, in participants with relapsing-remitting multiple sclerosis (RRMS) who transition from Tysabri (BG00002) to Tecfidera (BG00012) in the real-world setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsing-Remitting Multiple Sclerosis
- What is being tested?
- natalizumab and dimethyl fumarate
- How many people
- 530 participants
- Where
- 43 sitesUnited States
- Study dates
- Jul 2014to Jan 2015
- 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 receiving at least 12 months of continuous treatment with Tysabri monotherapy prior to initiation of Tecfidera. Additionally, participants must have initiated treatment with Tecfidera at least 12 months prior to enrollment into the study.
Who may be able to join
- Diagnosis of RRMS per McDonald criteria
- Received at least 12 months of continuous treatment with Tysabri monotherapy prior to initiation of Tecfidera. Note: continuous treatment with Tysabri is defined as treatment uninterrupted by other disease-modifying treatment.
- Initiated treatment with Tecfidera at least 12 months prior to enrollment into the study
- Patient has sufficient available medical records for data abstraction to meet the objectives of the study
Who cannot join
- Diagnosed with a progressive form of multiple sclerosis (MS) (progressive-relapsing, primary progressive, secondary progressive)
- Received treatment with any of the following after discontinuation of Tysabri and before initiation of treatment with Tecfidera (i.e., during washout period): interferon-beta, glatiramer acetate, fingolimod, teriflunomide, rituximab, alemtuzumab, ocrelizumab or any investigational compound for the treatment of RRMS
- Received BG00012, or other formulations of dimethyl fumarate, or Fumaderm® or compounded fumarates at any time prior to initiation of treatment with Tecfidera
- History of progressive multifocal leukoencephalopathy (PML) while on Tysabri or within 6 months of discontinuing treatment with Tysabri
- NOTE: Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
43 sites in 1 country.
43 sites in 1 country
United States43 sites
Research Site
Altoona, Pennsylvania
Research Site
Amherst, New York
Research Site
Athens, Georgia
Research Site
Atlanta, Georgia
Research Site
Aurora, Colorado
Research Site
Baton Rouge, Louisiana
Research Site
Birmingham, Alabama
Research Site
Boston, Massachusetts
Research Site
Centennial, Colorado
Research Site
Charlotte, North Carolina
Research Site
Chicago, Illinois
Research Site
Columbus, Ohio
Research Site
Cullman, Alabama
Research Site
Dallas, Texas
Research Site
East Meadow, New York
Research Site
Farmington Hills, Michigan
Research Site
Gahanna, Ohio
Research Site
Gilbert, Arizona
Research Site
Glen Burnie, Maryland
Research Site
Golden Valley, Minnesota
Research Site
Idaho Falls, Idaho
Research Site
Jacksonville Beach, Florida
Research Site
Lincoln, Nebraska
Research Site
Madison, Wisconsin
Research Site
Milwaukee, Wisconsin
Research Site
Nashville, Tennessee
Research Site
New York, New York
Research Site
Newport News, Virginia
Research Site
Norfolk, Virginia
Research Site
Oklahoma City, Oklahoma
Research Site
Palm Bay, Florida
Research Site
Peoria, Illinois
Research Site
Phoenix, Arizona
Research Site
Pittsburgh, Pennsylvania
Research Site
Portland, Oregon
Research Site
Raleigh, North Carolina
Research Site
Salt Lake City, Utah
Research Site
Seattle, Washington
Research Site
Spokane, Washington
Research Site
Tampa, Florida
Research Site
Teaneck, New Jersey
Research Site
Uniontown, Ohio
Research Site
Washington D.C., District of Columbia
About this study
Official title: A Multicenter, Retrospective, Observational Study Evaluating Real-world Clinical Outcomes in Relapsing-remitting Multiple Sclerosis Patients Who Transition From Tysabri® (Natalizumab) to Tecfidera® (Dimethyl Fumarate)
The primary objective of the study is to evaluate relapse activity, as measured by the proportion of participants relapsed at 12 months, in participants with relapsing-remitting multiple sclerosis (RRMS) who transition from Tysabri (BG00002) to Tecfidera (BG00012) in the real-world setting. The secondary objective is to further evaluate relapse activity, defined as annualized relapse rate (ARR), hospitalization and intravenous corticosteroid use, during the first year of Tecfidera treatment following transition from Tysabri treatment.
Read the detailed description
The study period will consist of a single time point retrospective medical chart abstraction with no required study visits or procedures. Data collection for this study is expected to last up to approximately five months.
- Conditions
- Relapsing-Remitting Multiple Sclerosis
- Being tested
- natalizumab, dimethyl fumarate
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
natalizumabBiological
Also called BG00002, Tysabri
Administered as per routine clinical practice
dimethyl fumarateDrug
Also called BG00012, Tecfidera, DMF
Administered as per routine clinical practice
What is being measured
The primary outcome is the main question the study is designed to answer.
Kaplan-Meier Estimates for the Proportion of Participants relapsed at 12 months after initiation of treatment with Tecfidera
Measured: 12 months post initiation of treatment with Tecfidera
Secondary outcomes (3)
ARR at 12 months post-initiation of treatment with Tecfidera
Measured: 12 months post initiation of treatment with Tecfidera
The percent of participants with MS-related hospitalization at 12 months post-initiation of treatment with Tecfidera
Measured: 12 months post initiation of treatment with Tecfidera
The percent of participants with relapses requiring treatment with intravenous steroids
Measured: 12 months post initiation of treatment with Tecfidera
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2014 (estimated)
- Study startJul 2014
- Primary completionJan 2015
- Study completionJan 2015
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 Relapsing-Remitting 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 530 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
- NCT02159573
- Sponsor's protocol ID
- 109MS412
- Other IDs
- US-BGT-13-10564
- Acronym
- STRATEGY
- Status last verified
- Jun 2016
- First submitted
- 19 May 2014
- Last updated
- 7 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Cohan SL, Moses H, Calkwood J, Tornatore C, LaGanke C, Smoot KE, Meka V, Okwuokenye M, Hotermans C, Mendoza JP, Mann MK, Meltzer LA. Clinical outcomes in patients with relapsing-remitting multiple sclerosis who switch from natalizumab to delayed-release dimethyl fumarate: A multicenter retrospective observational study (STRATEGY). Mult Scler Relat Disord. 2018 May;22:27-34. doi: 10.1016/j.msard.2018.02.028. Epub 2018 Feb 26.
PubMed 29524759
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Retrospective, Observational Study Evaluating Real-world Clinical Outcomes in Relapsing-remitting Multiple Sclerosis Patients Who Transition From Tysabri® (Natalizumab) to Tecfidera® (Dimethyl Fumarate)
- ClinicalTrials.gov ID
- NCT02159573
- Acronym / sponsor ID
- STRATEGY / 109MS412
- Conditions
- Relapsing-Remitting Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 530 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- Jul 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 10 Jun 2014 (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 relapse activity, as measured by the proportion of participants relapsed at 12 months, in participants with relapsing-remitting multiple sclerosis (RRMS) who transition from Tysabri (BG00002) to Tecfidera (BG00012) in the real-world setting. The secondary objective is to further evaluate relapse activity, defined as annualized relapse rate (ARR), hospitalization and intravenous corticosteroid use, during the first year of Tecfidera treatment following transition from Tysabri treatment.
Detailed description
The study period will consist of a single time point retrospective medical chart abstraction with no required study visits or procedures. Data collection for this study is expected to last up to approximately five months.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
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 receiving at least 12 months of continuous treatment with Tysabri monotherapy prior to initiation of Tecfidera. Additionally, participants must have initiated treatment with Tecfidera at least 12 months prior to enrollment into the study.
Key inclusion criteria (4 listed)
- Diagnosis of RRMS per McDonald criteria
- Received at least 12 months of continuous treatment with Tysabri monotherapy prior to initiation of Tecfidera. Note: continuous treatment with Tysabri is defined as treatment uninterrupted by other disease-modifying treatment.
- Initiated treatment with Tecfidera at least 12 months prior to enrollment into the study
- Patient has sufficient available medical records for data abstraction to meet the objectives of the study
Key exclusion criteria (5 listed)
- Diagnosed with a progressive form of multiple sclerosis (MS) (progressive-relapsing, primary progressive, secondary progressive)
- Received treatment with any of the following after discontinuation of Tysabri and before initiation of treatment with Tecfidera (i.e., during washout period): interferon-beta, glatiramer acetate, fingolimod, teriflunomide, rituximab, alemtuzumab, ocrelizumab or any investigational compound for the treatment of RRMS
- Received BG00012, or other formulations of dimethyl fumarate, or Fumaderm® or compounded fumarates at any time prior to initiation of treatment with Tecfidera
- History of progressive multifocal leukoencephalopathy (PML) while on Tysabri or within 6 months of discontinuing treatment with Tysabri
- 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| natalizumabAlso: BG00002, TysabriAdministered as per routine clinical practice | Biological | – |
| dimethyl fumarateAlso: BG00012, Tecfidera, DMFAdministered as per routine clinical practice | Drug | – |
Primary outcome
Kaplan-Meier Estimates for the Proportion of Participants relapsed at 12 months after initiation of treatment with Tecfidera
Time frame: 12 months post initiation of treatment with Tecfidera
3 secondary outcomes
ARR at 12 months post-initiation of treatment with Tecfidera
Time frame: 12 months post initiation of treatment with Tecfidera
The percent of participants with MS-related hospitalization at 12 months post-initiation of treatment with Tecfidera
Time frame: 12 months post initiation of treatment with Tecfidera
The percent of participants with relapses requiring treatment with intravenous steroids
Time frame: 12 months post initiation of treatment with Tecfidera
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 7 Jun 2016.
- Derived from this study: PubMed 29524759Cohan SL, Moses H, Calkwood J, Tornatore C, LaGanke C, Smoot KE, Meka V, Okwuokenye M, Hotermans C, Mendoza JP, Mann MK, Meltzer LA. Clinical outcomes in patients with relapsing-remitting multiple sclerosis who switch from natalizumab to delayed-release dimethyl fumarate: A multicenter retrospective observational study (STRATEGY). Mult Scler Relat Disord. 2018 May;22:27-34. doi: 10.1016/j.msard.2018.02.028. Epub 2018 Feb 26.
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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
43 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Relapsing-Remitting Multiple Sclerosis, run by Biogen at 43 sites in United States.
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 4 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 7 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 43 sites in United States. 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?
Kaplan-Meier Estimates for the Proportion of Participants relapsed at 12 months after initiation of treatment with Tecfidera (time frame: 12 months post initiation of treatment with Tecfidera). 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 NCT02159573, 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 7 Jun 2016.