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

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.

Study Overview

• Status: Completed
• Conditions: Relapsing-remitting Multiple Sclerosis
• Intervention / Treatment: Drug: Rebif; Drug: Tecfidera

• Study Type: Observational
• Enrollment (Actual): 479

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, H2X 0A9
      • Centre Hospitalier de l'Université de Montréal
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35209
      • Alabama Neurology Associates
  • Colorado
    • Colorado Springs, Colorado, United States, 80907
      • Colorado Springs Neurological Associates
  • Georgia
    • Savannah, Georgia, United States, 31406
      • Savannah Neurology Specialists
  • Illinois
    • Evanston, Illinois, United States, 60201
      • NorthShore University
    • Peoria, Illinois, United States, 61637
      • OSF Multi-specialty Group d/b/a Illinois Neurological Institute
  • Massachusetts
    • Brighton, Massachusetts, United States, 02135
      • St Elizabeths/ Dragonfly Research
    • Burlington, Massachusetts, United States, 01805
      • Lahey Clinic
  • Minnesota
    • Golden Valley, Minnesota, United States, 55422
      • Minneapolis Clinic of Neurology
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University
  • Nebraska
    • Lincoln, Nebraska, United States, 68588
      • University of Nebraska Medical Center
  • New York
    • Buffalo, New York, United States, 14203
      • University of Buffalo Clinical and Translational research Center
    • Lake Success, New York, United States, 11042
      • Neurological Associates of Long Island
  • North Carolina
    • Charlotte, North Carolina, United States, 28277
      • Onsite Clinical Solutions
    • Raleigh, North Carolina, United States, 27607
      • Raleigh Neurology Associates
  • Ohio
    • Centerville, Ohio, United States, 45459
      • Dayton Center for Neurological Disorders
    • Uniontown, Ohio, United States, 44685
      • Oak Clinic-Multiple Sclerosis
  • Oregon
    • Portland, Oregon, United States, 97228
      • Providence St. Vincent Medical Center
  • Texas
    • San Antonio, Texas, United States, 78229
      • The University of Texas Health Science Center at San Antonio
  • Vermont
    • Burlington, Vermont, United States, 05405
      • University of Vermont
  • Virginia
    • Christiansburg, Virginia, United States, 24073
      • Blacksburg Neurology
  • Washington
    • Tacoma, Washington, United States, 98405
      • MultiCare Health System
  • Wisconsin
    • Neenah, Wisconsin, United States, 54956
      • Neuroscience Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Treatment naive patients for Rebif or Tecfidera with at least 1 months follow-up data available from clinical chart review.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

10

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Drug: Rebif
Rebif - 1 year clinical cohort; Treatment naive patients starting with Rebif, 1 year follow-up available, MRI scan available at baseline	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	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	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	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	Drug: Tecfidera
Tecfidera - 1 year clinical cohort; Treatment naive patients starting with Tecfidera, 1 year follow-up available, MRI scan available at baseline	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	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	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	Drug: Tecfidera

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical differences between the two treatment groups	Comparison of number of relapses between the two treatment groups.	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.	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.	12 months

Collaborators and Investigators

• Sponsor: IMS HEALTH GmbH & Co. OHG
• Collaborators: EMD Serono

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (ACTUAL): April 1, 2017
• Study Completion (ACTUAL): February 1, 2018

Study Registration Dates

• First Submitted: March 3, 2016
• First Submitted That Met QC Criteria: June 30, 2016
• First Posted (ESTIMATE): July 6, 2016

Study Record Updates

• Last Update Posted (ACTUAL): March 1, 2018
• Last Update Submitted That Met QC Criteria: February 28, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Physiological Effects of Drugs; Immunosuppressive Agents; Immunologic Factors; Dermatologic Agents; Dimethyl Fumarate
• Other Study ID Numbers: MS200136_0037

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO