Relapsing-remitting Multiple SclerosisPROTRACTNCT02823951
Patient Real-world Clinical, Neurological, Tolerability, and Safety Outcomes for Tecfidera® and Rebif®
An observational study of Relapsing-remitting Multiple Sclerosis, run by IMS HEALTH GmbH & Co. OHG at 23 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate the proportion of patients who demonstrate no medical need to discontinue therapy among DMT-naïve patients with relapsing forms of multiple sclerosis after 1 year of treatment with Rebif 44 mcg tiw or with Tecfidera 240 mg bid based on real-world data. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Relapsing-remitting Multiple Sclerosis
- What is being tested?
- Rebif and Tecfidera
- How many people
- 479 participants
- Where
- 23 sitesin 2 countries
- Study dates
- Feb 2016to Feb 2018
- 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 to 55 years
- All sexes
- No healthy volunteers
- Adult
Study population: Treatment naive patients for Rebif or Tecfidera with at least 1 months follow-up data available from clinical chart review.
Who may be able to join
- Diagnosis of Clinically Isolated Syndrome (CIS) or a relapse remitting multiple sclerosis (RRMS).
- Age between 18 - 55 years at the time of index.
- No evidence of prior disease modifying therapy for MS.
- Initiated treatment with either Rebif or Tecfidera at the time of index. Patient is considered to have initiated treatment if they took at least one dose. Treatment must have been initiated after the product was approved by the FDA.
- Availability of a high quality baseline MRI brain scan, which must have occurred between 6 months prior to the index date to 2 weeks after the index date.
- Availability of clinical data in the patient's record for the full study observation period, as defined in the primary objective.
Who cannot join
- Pregnant at any time during the study observation period.
- Presence of pre-existing medical conditions known to be associated with brain pathology (cerebrovascular and neurodegenerative diseases, presence of active alcohol or substance abuse).
- Patient discontinued initial therapy prior to completing 1 year of treatment due to a reason other than disease activity, tolerability, or safety (e.g. financial, convenience, preference, etc.).
- Phase III registrational trial patients
Trial locations and contacts
23 sites in 2 countries.
23 sites in 2 countries
United States22 sites
Alabama Neurology Associates
Birmingham, Alabama, 35209
St Elizabeths/ Dragonfly Research
Brighton, Massachusetts, 02135
University of Buffalo Clinical and Translational research Center
Buffalo, New York, 14203
Lahey Clinic
Burlington, Massachusetts, 01805
University of Vermont
Burlington, Vermont, 05405
Dayton Center for Neurological Disorders
Centerville, Ohio, 45459
Onsite Clinical Solutions
Charlotte, North Carolina, 28277
Blacksburg Neurology
Christiansburg, Virginia, 24073
Colorado Springs Neurological Associates
Colorado Springs, Colorado, 80907
Northshore University
Evanston, Illinois, 60201
Minneapolis Clinic of Neurology
Golden Valley, Minnesota, 55422
Neurological Associates of Long Island
Lake Success, New York, 11042
University of Nebraska Medical Center
Lincoln, Nebraska, 68588
Neuroscience Group
Neenah, Wisconsin, 54956
OSF Multi-specialty Group d/b/a Illinois Neurological Institute
Peoria, Illinois, 61637
Providence St. Vincent Medical Center
Portland, Oregon, 97228
Raleigh Neurology Associates
Raleigh, North Carolina, 27607
The university of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
Savannah Neurology Specialists
Savannah, Georgia, 31406
Washington university
St Louis, Missouri, 63110
MultiCare Health System
Tacoma, Washington, 98405
Oak Clinic-Multiple Sclerosis
Uniontown, Ohio, 44685
Canada1 site
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, H2X 0A9
About this study
Official title: Patient Real-world Clinical, Neurological, Tolerability, and Safety Outcomes for Tecfidera® and Rebif®: A Retrospective Study (PROTRACT)
The purpose of this study is to evaluate the proportion of patients who demonstrate no medical need to discontinue therapy among DMT-naïve patients with relapsing forms of multiple sclerosis after 1 year of treatment with Rebif 44 mcg tiw or with Tecfidera 240 mg bid based on real-world data.
- Conditions
- Relapsing-remitting Multiple Sclerosis
- Being tested
- Rebif, Tecfidera
- 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.
RebifDrug
TecfideraDrug
| Study group | Role | What they receive |
|---|---|---|
| Rebif - 1 year MRI cohort | Treatment naive patients starting with Rebif, 1 year follow-up available, MRI scan available at baseline and at 12 months Receives: Drug: Rebif | |
| Rebif - 1 year clinical cohort | Treatment naive patients starting with Rebif, 1 year follow-up available, MRI scan available at baseline Receives: Drug: Rebif | |
| Rebif - early discontinuation cohort - tolerability | Treatment naive patients starting with Rebif, MRI scan available at baseline, discontinuation within the first treatment year due to tolerability Receives: Drug: Rebif | |
| Rebif - early discontinuation cohort - adverse events | Treatment naive patients starting with Rebif, MRI scan available at baseline, discontinuation within the first treatment year due to adverse events Receives: Drug: Rebif | |
| Rebif - early discontinuation cohort - disease activity | Treatment naive patients starting with Rebif, MRI scan available at baseline, discontinuation within the first treatment year due to disease activity Receives: Drug: Rebif | |
| Tecfidera - 1 year MRI cohort | Treatment naive patients starting with Tecfidera, 1 year follow-up available, MRI scan available at baseline and at 12 months Receives: Drug: Tecfidera | |
| Tecfidera - 1 year clinical cohort | Treatment naive patients starting with Tecfidera, 1 year follow-up available, MRI scan available at baseline Receives: Drug: Tecfidera | |
| Tecfidera - early discontinuation cohort - tolerability | Treatment naive patients starting with Tecfidera, MRI scan available at baseline, discontinuation within the first treatment year due to tolerability Receives: Drug: Tecfidera | |
| Tecfidera - early discontinuation cohort - adverse events | Treatment naive patients starting with Tecfidera, MRI scan available at baseline, discontinuation within the first treatment year due to adverse events Receives: Drug: Tecfidera | |
| Tecfidera - early discontinuation cohort - disease activity | Treatment naive patients starting with Tecfidera, MRI scan available at baseline, discontinuation within the first treatment year due to disease activity Receives: Drug: Tecfidera |
What is being measured
The primary outcome is the main question the study is designed to answer.
NEDA-2
Number of patients who had no need to discontinue therapy within the first 12months after index date. Unit of measure is number of patients.
No medical need to discontinue therapy is reached if there are no relapses and no new lesions, and no enlarging lesions and the patient did not stop the index medication due to tolerability, adverse events or disease activity. If any of the above occurs, NEDA-2 is not reached.
Measured: 12 months
Secondary outcomes (3)
Clinical differences between the two treatment groups
Comparison of number of relapses between the two treatment groups.
Measured: 12 months
Neurological differences between two treatment groups
Comparison of number of new lesions and number of enlarging lesions between the two treatment groups. Unit of measurement is number of each lesion type.
Measured: 12 months
Proportion of individuals within each treatment group who discontinued, stratified by reason
Proportion of individuals within each treatment group who discontinued treatment due
- to tolerability
- to adverse events
- to disease activity Unit of measurement is the share of patients who discontinued compared to total patients stratified by reason of discontinuation.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2016 (estimated)
- Study startFeb 2016
- Primary completionApr 2017
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsing-remitting Multiple SclerosisStudies of the same condition, open and under way.
- 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
- 479 participants (actual)
Sponsor and investigators
- Lead sponsor
- IMS HEALTH GmbH & Co. OHG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- EMD Serono
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02823951
- Sponsor's protocol ID
- MS200136_0037
- Acronym
- PROTRACT
- Status last verified
- Feb 2018
- First submitted
- 3 Mar 2016
- Last updated
- 1 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Real-world Clinical, Neurological, Tolerability, and Safety Outcomes for Tecfidera® and Rebif®: A Retrospective Study (PROTRACT)
- ClinicalTrials.gov ID
- NCT02823951
- Acronym / sponsor ID
- PROTRACT / MS200136_0037
- Conditions
- Relapsing-remitting Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 479 participants (actual)
- Lead sponsor
- IMS HEALTH GmbH & Co. OHGIndustry (pharma, biotech, devices)
- Collaborators
- EMD Serono
- Study start
- Feb 2016
- Primary completion
- Apr 2017 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 6 Jul 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 purpose of this study is to evaluate the proportion of patients who demonstrate no medical need to discontinue therapy among DMT-naïve patients with relapsing forms of multiple sclerosis after 1 year of treatment with Rebif 44 mcg tiw or with Tecfidera 240 mg bid based on real-world data.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Rebif - 1 year MRI cohort | – | Drug: RebifTreatment naive patients starting with Rebif, 1 year follow-up available, MRI scan available at baseline and at 12 months |
| Rebif - 1 year clinical cohort | – | Drug: RebifTreatment naive patients starting with Rebif, 1 year follow-up available, MRI scan available at baseline |
| Rebif - early discontinuation cohort - tolerability | – | Drug: RebifTreatment naive patients starting with Rebif, MRI scan available at baseline, discontinuation within the first treatment year due to tolerability |
| Rebif - early discontinuation cohort - adverse events | – | Drug: RebifTreatment naive patients starting with Rebif, MRI scan available at baseline, discontinuation within the first treatment year due to adverse events |
| Rebif - early discontinuation cohort - disease activity | – | Drug: RebifTreatment naive patients starting with Rebif, MRI scan available at baseline, discontinuation within the first treatment year due to disease activity |
| Tecfidera - 1 year MRI cohort | – | Drug: TecfideraTreatment naive patients starting with Tecfidera, 1 year follow-up available, MRI scan available at baseline and at 12 months |
| Tecfidera - 1 year clinical cohort | – | Drug: TecfideraTreatment naive patients starting with Tecfidera, 1 year follow-up available, MRI scan available at baseline |
| Tecfidera - early discontinuation cohort - tolerability | – | Drug: TecfideraTreatment naive patients starting with Tecfidera, MRI scan available at baseline, discontinuation within the first treatment year due to tolerability |
| Tecfidera - early discontinuation cohort - adverse events | – | Drug: TecfideraTreatment naive patients starting with Tecfidera, MRI scan available at baseline, discontinuation within the first treatment year due to adverse events |
| Tecfidera - early discontinuation cohort - disease activity | – | Drug: TecfideraTreatment naive patients starting with Tecfidera, MRI scan available at baseline, discontinuation within the first treatment year due to disease activity |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Treatment naive patients for Rebif or Tecfidera with at least 1 months follow-up data available from clinical chart review.
Key inclusion criteria (6 listed)
- Diagnosis of Clinically Isolated Syndrome (CIS) or a relapse remitting multiple sclerosis (RRMS).
- Age between 18 - 55 years at the time of index.
- No evidence of prior disease modifying therapy for MS.
- Initiated treatment with either Rebif or Tecfidera at the time of index. Patient is considered to have initiated treatment if they took at least one dose. Treatment must have been initiated after the product was approved by the FDA.
- Availability of a high quality baseline MRI brain scan, which must have occurred between 6 months prior to the index date to 2 weeks after the index date.
Key exclusion criteria (4 listed)
- Pregnant at any time during the study observation period.
- Presence of pre-existing medical conditions known to be associated with brain pathology (cerebrovascular and neurodegenerative diseases, presence of active alcohol or substance abuse).
- Patient discontinued initial therapy prior to completing 1 year of treatment due to a reason other than disease activity, tolerability, or safety (e.g. financial, convenience, preference, etc.).
- Phase III registrational trial patients
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 |
|---|---|---|
| Rebif | Drug | Rebif - 1 year MRI cohort, Rebif - 1 year clinical cohort, Rebif - early discontinuation cohort - adverse events, Rebif - early discontinuation cohort - disease activity, Rebif - early discontinuation cohort - tolerability |
| Tecfidera | Drug | Tecfidera - 1 year MRI cohort, Tecfidera - 1 year clinical cohort, Tecfidera - early discontinuation cohort - adverse events, Tecfidera - early discontinuation cohort - disease activity, Tecfidera - early discontinuation cohort - tolerability |
Primary outcome
NEDA-2
Time frame: 12 months
Number of patients who had no need to discontinue therapy within the first 12months after index date. Unit of measure is number of patients. No medical need to discontinue therapy is reached if there are no relapses and no new lesions, and no enlarging lesions and the patient did not stop the index medication due to tolerability, adverse events or disease activity. If any of the above occurs, NEDA-2 is not reached.
3 secondary outcomes
Clinical differences between the two treatment groups
Time frame: 12 months
Neurological differences between two treatment groups
Time frame: 12 months
Proportion of individuals within each treatment group who discontinued, stratified by reason
Time frame: 12 months
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 1 Mar 2018.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
23 sites in 2 countries: 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 IMS HEALTH GmbH & Co. OHG at 23 sites in 2 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 6 inclusion and 4 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 1 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States, Canada. 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?
NEDA-2 (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Mar 2018.