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Completed

NCT Number: NCT02823951

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

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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier de l'Universite de Montreal, Montreal, Quebec, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Rebif

Drug

Tecfidera

Drug

Primary outcomes

  1. 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.

Secondary outcomes

  1. Clinical differences between the two treatment groups

    Time frame: 12 months

    Comparison of number of relapses between the two treatment groups.

  2. Neurological differences between two treatment groups

    Time frame: 12 months

    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.

  3. Proportion of individuals within each treatment group who discontinued, stratified by reason

    Time frame: 12 months

    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.

Sponsors and collaborators

Lead sponsor

IMS HEALTH GmbH & Co. OHG

Industry

Collaborators

  • EMD Serono

Registry information

Official study title

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

Acronym: PROTRACT

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Jul 6, 2016
Registry last updated
Mar 1, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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