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Patient Real-world Clinical, Neurological, Tolerability, and Safety Outcomes for Tecfidera® and Rebif® | Clinical Trials | Clareo Health

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Patient Real-world Clinical, Neurological, Tolerability, and Safety Outcomes for Tecfidera® and Rebif®

Patient Real-world Clinical, Neurological, Tolerability, and Safety Outcomes for Tecfidera® and Rebif®: A Retrospective Study (PROTRACT)

NCT02823951•IMS HEALTH GmbH & Co. OHG

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Diagnosis of Clinically Isolated Syndrome (CIS) or a relapse remitting multiple sclerosis (RRMS).
•2. Age between 18 - 55 years at the time of index.
•3. No evidence of prior disease modifying therapy for MS.
•4. 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.
•5. 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.
•6. Availability of clinical data in the patient's record for the full study observation period, as defined in the primary objective.

Exclusion Criteria

•1. Pregnant at any time during the study observation period.
•2. Presence of pre-existing medical conditions known to be associated with brain pathology (cerebrovascular and neurodegenerative diseases, presence of active alcohol or substance abuse).
•3. 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.).
•4. Phase III registrational trial patients

Locations (23)

Alabama Neurology Associates

Birmingham, Alabama, United States

Colorado Springs Neurological Associates

Colorado Springs, Colorado, United States

Savannah Neurology Specialists

Savannah, Georgia, United States

Northshore University

Evanston, Illinois, United States

OSF Multi-specialty Group d/b/a Illinois Neurological Institute

Peoria, Illinois, United States

St Elizabeths/ Dragonfly Research

Brighton, Massachusetts, United States

Lahey Clinic

Burlington, Massachusetts, United States

Minneapolis Clinic of Neurology

Golden Valley, Minnesota, United States

Washington university

St Louis, Missouri, United States

University of Nebraska Medical Center

Lincoln, Nebraska, United States

Key Dates

Start Date

February 1, 2016

Primary Completion Date

April 1, 2017

Completion Date

February 1, 2018

Last Updated

March 1, 2018

Enrollment

479

ACTUAL participants

Conditions

Relapsing-remitting Multiple Sclerosis

Interventions

Rebif

DRUG

Tecfidera

DRUG

RItuximab Versus Ocrelizumab in Relapsing-remitting Multiple Sclerosis.

NCT05758831

Multiple SclerosisRelapsing-remitting Multiple Sclerosis

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RECRUITING

Understanding the 'Durable Effect' Concept of B-cell Modulating Therapies

NCT06586177

Relapsing-remitting Multiple Sclerosis

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RECRUITINGPHASE3

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 1, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Patient Real-world Clinical, Neurological, Tolerability, and Safety Outcomes for Tecfidera® and Rebif®

Inclusion Criteria

Exclusion Criteria

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