Effectiveness of DMF and Its Impact on PROs in Suboptimal GA Responders With RMS (RESPOND)

July 22, 2016 updated by: Biogen

A Multicenter, Open-Label, 12-Month Observational Study Evaluating the Clinical Effectiveness and Impact on Patient-Reported Outcomes of Oral Tecfidera™ (Dimethyl Fumarate) Delayed-Release Capsules in Patients With Relapsing Forms of Multiple Sclerosis After Suboptimal Response to Glatiramer Acetate

The primary objective of the study is to estimate the annualized relapse rate (ARR) over a 12-month period in patients with relapsing forms of multiple sclerosis (MS) who are treated with dimethyl fumarate (DMF) after suboptimal response to glatiramer acetate (GA). The secondary objectives of this study in this study population are to assess the impact of DMF over a 12-month period on patient-reported outcomes (PROs) and health economic-related outcomes and to evaluate additional clinical outcomes at Month 12.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

333

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • Research Site
    • Arizona
      • Tuscon, Arizona, United States, 85741-1196
        • Research Site
    • California
      • Los Angeles, California, United States, 90015
        • Research Site
      • Sacramento, California, United States, 95816
        • Research Site
      • San Jose, California, United States, 95124
        • Research Site
    • Colorado
      • Englewood, Colorado, United States, 80113
        • Research Site
    • Delaware
      • Dover, Delaware, United States, 19901
        • Research Site
    • Florida
      • Jacksonville, Florida, United States, 32209
        • Research Site
      • Lighthouse Point, Florida, United States, 33064
        • Research Site
      • Port Charlotte, Florida, United States, 33952
        • Research Site
      • St. Petersburg, Florida, United States, 33705
        • Research Site
      • Tampa, Florida, United States, 33612
        • Research Site
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Research Site
      • Atlanta, Georgia, United States, 30327
        • Research Site
      • Savannah, Georgia, United States, 31405
        • Research Site
    • Illinois
      • Chicago, Illinois, United States, 60637-1463
        • Research Site
      • Evanston, Illinois, United States, 60201
        • Research Site
      • Franklin, Illinois, United States, 37064
        • Research Site
    • Indiana
      • Indianapolis, Indiana, United States, 46256
        • Research Site
    • Iowa
      • Des Moines, Iowa, United States, 50314
        • Research Site
    • Kansas
      • Lenexa, Kansas, United States, 66214-9836
        • Research Site
    • Kentucky
      • Lexington, Kentucky, United States, 40513
        • Research Site
      • Louisville, Kentucky, United States, 40207
        • Research Site
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70810-1686
        • Research Site
    • Maryland
      • Annapolis, Maryland, United States, 21401
        • Research Site
      • Baltimore, Maryland, United States, 21201
        • Research Site
    • Massachusetts
      • Lexington, Massachusetts, United States, 02421
        • Research Site
      • Springfield, Massachusetts, United States, 01104
        • Research Site
      • Worcester, Massachusetts, United States, 01655
        • Research Site
    • Michigan
      • Clinton Township, Michigan, United States, 48035
        • Research Site
      • Muskegon, Michigan, United States, 49444-3719
        • Research Site
    • Minnesota
      • Golden Valley, Minnesota, United States, 55422
        • Research Site
    • Missouri
      • Columbia, Missouri, United States, 65201
        • Research Site
    • Montana
      • Great Falls, Montana, United States, 59405
        • Research Site
    • Nebraska
      • Lincoln, Nebraska, United States, 68506-2960
        • Research Site
      • Lincoln, Nebraska, United States, 68521
        • Research Site
      • Omaha, Nebraska, United States, 68198
        • Research Site
    • New Jersey
      • Freehold, New Jersey, United States, 07728
        • Research Site
    • New York
      • Bronx, New York, United States, 10467
        • Research Site
      • New York, New York, United States, 10032
        • Research Site
      • Patchogue, New York, United States, 11772
        • Research Site
    • North Carolina
      • Asheville, North Carolina, United States, 28806
        • Research Site
      • Hickory, North Carolina, United States, 28602
        • Research Site
      • Raleigh, North Carolina, United States, 27607-6010
        • Research Site
    • Ohio
      • Akron, Ohio, United States, 44302
        • Research Site
      • Canton, Ohio, United States, 44718
        • Research Site
      • Centerville, Ohio, United States, 45459
        • Research Site
      • Columbus, Ohio, United States, 43221
        • Research Site
    • Oregon
      • Medford, Oregon, United States, 97504
        • Research Site
      • Portland, Oregon, United States, 97225
        • Research Site
    • Pennsylvania
      • Abington, Pennsylvania, United States, 19001
        • Research Site
      • Greensburg, Pennsylvania, United States, 15601
        • Research Site
      • Pittsburgh, Pennsylvania, United States, 15212
        • Research Site
    • Tennessee
      • Knoxville, Tennessee, United States, 37934
        • Research Site
    • Texas
      • Round Rock, Texas, United States, 78681
        • Research Site
    • Utah
      • Salt Lake City, Utah, United States, 84103
        • Research Site
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Research Site
      • Richmond, Virginia, United States, 23226
        • Research Site
    • Washington
      • Bellingham, Washington, United States, 98225
        • Research Site
      • Seattle, Washington, United States, 98122
        • Research Site
      • Tacoma, Washington, United States, 98405
        • Research Site
    • Wisconsin
      • Neenah, Wisconsin, United States, 54946
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

This study will be conducted in male and female patients with relapsing forms of MS who satisfy the therapeutic indication for dimethyl fumarate (DMF) per the United States Prescribing Information, and who are suboptimal responders to glatiramer acetate (GA), as determined by the Prescribing Physician.

Description

Key Inclusion Criteria:

  • Have the ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use Protected Health Information in accordance with national and local patient privacy regulations.
  • Have the ability to read and understand written English.
  • Have access to the internet and are able to complete online assessments on a computer
  • Have a relapsing form of Multiple Sclerosis and satisfy the approved therapeutic indication for dimethyl fumarate (DMF) per the United States Prescribing Information (USPI).
  • Are being treated for relapsing forms of multiple sclerosis (MS) with glatiramer acetate (GA) but, per the Prescribing Physician, have a suboptimal response (e.g., suboptimal efficacy, intolerance, or poor adherence) to GA or have stopped treatment with GA for relapsing forms of MS as a result of suboptimal response within 30 days of enrollment.
  • Have decided to initiate treatment with dimethyl fumarate (DMF) under routine clinical care. The decision to initiate treatment with DMF must precede enrollment.
  • Have a complete blood count (CBC) available within 6 months of initiation of treatment with dimethyl fumarate (DMF).

Key Exclusion Criteria:

  • Are unwilling or unable to comply with study requirements, or, are deemed unsuitable for study participation at the discretion of the Prescribing Physician.
  • Have major comorbid conditions that would preclude their participation in the study as determined by the Prescribing Physician.
  • Have a history of malignancy. (Patients with basal cell carcinoma that has been completely excised prior to study entry remain eligible.)
  • Have a history of and/or current serious infections.
  • Are pregnant or breastfeeding, or are planning to become pregnant or breastfeed.
  • Are receiving concomitant disease modifying therapies other than glatiramer acetate (GA) or have initiated treatment with a new disease-modifying therapy since discontinuation of glatiramer acetate (GA).
  • Are currently enrolled in any other clinical studies, with the exception of the dimethyl fumarate (DMF) Pregnancy Registry.
  • Have received prior treatment with dimethyl fumarate (DMF).

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
dimethyl fumarate
To be taken according to the United States Prescribing Information (USPI)
Drug: dimethyl fumarate
As described in the treatment arm
Other Names:
  • BG00012
  • DMF
  • Tecfidera

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Annualized Relapse Rate
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in 14-item Treatment Satisfaction Questionnaire for Medication (TSQM-14) scores.
Time Frame: Baseline to 12 months
TSQM-14 is an instrument to assess patient's satisfaction with medication, providing scores on four scales: Side effects, effectiveness, convenience and global satisfaction.
Baseline to 12 months
Change in Short-Form 36 (SF-36) scores.
Time Frame: Baseline to 12 months
SF-36 is a self-administered, generic health status questionnaire consisting of 36 questions that measure 8 health concepts: physical functioning, role limitations due to physical problems, bodily pain, general health perception, vitality, social functioning, role limitations due to emotional problems and mental health.
Baseline to 12 months
Change in Modified Fatigue Impact Scale (MFIS-5) scores.
Time Frame: Baseline to 12 months
MFIS-5 is a modified form of the Fatigue Impact Scale that consists of five questions that assess the impact of fatigue on physical, cognitive, and psychosocial functioning, with five response levels ranging from 0 ("Never") to 4 ("Almost always"). Total scores range from 0 to 20, with higher scores representing a greater impact of fatigue.
Baseline to 12 months
Change in Beck Depression Inventory (BDI-7) scores.
Time Frame: Baseline to 12 months
BDI-7 is a self-report inventory for measuring the severity of depression on a 7-item scale.
Baseline to 12 months
Change in Work Productivity and Impairment Questionnaire: Multiple Sclerosis (WPAI-MS) scores.
Time Frame: Baseline to 12 months
The Work Productivity and Activity Impairment (WPAI) questionnaire is a validated instrument to measure impairments in work and activities. The WPAI yields four types of scores: 1. Absenteeism (work time missed) 2. Presenteesism (impairment at work / reduced on-the-job effectiveness) 3. Work productivity loss (overall work impairment / absenteeism plus presenteeism) 4. Activity Impairment. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.
Baseline to 12 months
Change in Morisky 8-item Medication Adherence Scale (MMAS-8) scores.
Time Frame: Baseline to 12 months
MMAS-8 is a self-reporting tool to facilitate the identification of barriers to and behaviors associated with adherence to chronic medications. Scores on the MMAS-8 range from 0-8, with scores of less than 6 reflecting low adherence.
Baseline to 12 months
Change in Patient-reported Expanded Disability Status Scale (patient-reported EDSS) scores.
Time Frame: Baseline to 12 months
The patient-reported EDSS measures disability status based on patient report of degree of difficulty in eight different functional areas (on a 4-point scale), and overall function, taking into account the eight areas and descriptions of gait.
Baseline to 12 months
Proportion of patients experiencing a relapse.
Time Frame: Baseline to 12 months
Baseline to 12 months
Proportion of patients with relapses associated with hospitalizations.
Time Frame: Baseline to 12 months
Baseline to 12 months
Proportion of patients with relapses associated with steroid use.
Time Frame: Baseline to 12 months
Baseline to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biogen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

July 17, 2013

First Submitted That Met QC Criteria

July 17, 2013

First Posted (Estimate)

July 19, 2013

Study Record Updates

Last Update Posted (Estimate)

July 25, 2016

Last Update Submitted That Met QC Criteria

July 22, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 109MS404

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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