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

Sponsor
Biogen (Industry)
Overall Status
Completed
CT.gov ID
NCT01903291
Collaborator
(none)
333
Enrollment
62
Locations
30
Duration (Months)
5.4
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: dimethyl fumarate

Study Design

Study Type:
Observational
Actual Enrollment :
333 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
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
Study Start Date :
Aug 1, 2013
Actual Primary Completion Date :
Feb 1, 2016
Actual Study Completion Date :
Feb 1, 2016

Arms and Interventions

Arm 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:
  • Tecfidera
  • BG00012
  • DMF

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Annualized Relapse Rate [12 months]

    Secondary Outcome Measures

    1. Change in 14-item Treatment Satisfaction Questionnaire for Medication (TSQM-14) scores. [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.

    2. Change in Short-Form 36 (SF-36) scores. [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.

    3. Change in Modified Fatigue Impact Scale (MFIS-5) scores. [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.

    4. Change in Beck Depression Inventory (BDI-7) scores. [Baseline to 12 months]

      BDI-7 is a self-report inventory for measuring the severity of depression on a 7-item scale.

    5. Change in Work Productivity and Impairment Questionnaire: Multiple Sclerosis (WPAI-MS) scores. [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.

    6. Change in Morisky 8-item Medication Adherence Scale (MMAS-8) scores. [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.

    7. Change in Patient-reported Expanded Disability Status Scale (patient-reported EDSS) scores. [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.

    8. Proportion of patients experiencing a relapse. [Baseline to 12 months]

    9. Proportion of patients with relapses associated with hospitalizations. [Baseline to 12 months]

    10. Proportion of patients with relapses associated with steroid use. [Baseline to 12 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Research Site Birmingham Alabama United States 35209
    2 Research Site Tuscon Arizona United States 85741-1196
    3 Research Site Los Angeles California United States 90015
    4 Research Site Sacramento California United States 95816
    5 Research Site San Jose California United States 95124
    6 Research Site Englewood Colorado United States 80113
    7 Research Site Dover Delaware United States 19901
    8 Research Site Jacksonville Florida United States 32209
    9 Research Site Lighthouse Point Florida United States 33064
    10 Research Site Port Charlotte Florida United States 33952
    11 Research Site St. Petersburg Florida United States 33705
    12 Research Site Tampa Florida United States 33612
    13 Research Site Atlanta Georgia United States 30309
    14 Research Site Atlanta Georgia United States 30327
    15 Research Site Savannah Georgia United States 31405
    16 Research Site Chicago Illinois United States 60637-1463
    17 Research Site Evanston Illinois United States 60201
    18 Research Site Franklin Illinois United States 37064
    19 Research Site Indianapolis Indiana United States 46256
    20 Research Site Des Moines Iowa United States 50314
    21 Research Site Lenexa Kansas United States 66214-9836
    22 Research Site Lexington Kentucky United States 40513
    23 Research Site Louisville Kentucky United States 40207
    24 Research Site Baton Rouge Louisiana United States 70810-1686
    25 Research Site Annapolis Maryland United States 21401
    26 Research Site Baltimore Maryland United States 21201
    27 Research Site Lexington Massachusetts United States 02421
    28 Research Site Springfield Massachusetts United States 01104
    29 Research Site Worcester Massachusetts United States 01655
    30 Research Site Clinton Township Michigan United States 48035
    31 Research Site Muskegon Michigan United States 49444-3719
    32 Research Site Golden Valley Minnesota United States 55422
    33 Research Site Columbia Missouri United States 65201
    34 Research Site Great Falls Montana United States 59405
    35 Research Site Lincoln Nebraska United States 68506-2960
    36 Research Site Lincoln Nebraska United States 68521
    37 Research Site Omaha Nebraska United States 68198
    38 Research Site Freehold New Jersey United States 07728
    39 Research Site Bronx New York United States 10467
    40 Research Site New York New York United States 10032
    41 Research Site Patchogue New York United States 11772
    42 Research Site Asheville North Carolina United States 28806
    43 Research Site Hickory North Carolina United States 28602
    44 Research Site Raleigh North Carolina United States 27607-6010
    45 Research Site Akron Ohio United States 44302
    46 Research Site Canton Ohio United States 44718
    47 Research Site Centerville Ohio United States 45459
    48 Research Site Columbus Ohio United States 43221
    49 Research Site Medford Oregon United States 97504
    50 Research Site Portland Oregon United States 97225
    51 Research Site Abington Pennsylvania United States 19001
    52 Research Site Greensburg Pennsylvania United States 15601
    53 Research Site Pittsburgh Pennsylvania United States 15212
    54 Research Site Knoxville Tennessee United States 37934
    55 Research Site Round Rock Texas United States 78681
    56 Research Site Salt Lake City Utah United States 84103
    57 Research Site Norfolk Virginia United States 23502
    58 Research Site Richmond Virginia United States 23226
    59 Research Site Bellingham Washington United States 98225
    60 Research Site Seattle Washington United States 98122
    61 Research Site Tacoma Washington United States 98405
    62 Research Site Neenah Wisconsin United States 54946

    Sponsors and Collaborators

    • Biogen

    Investigators

    • Study Director: Medical Director, Biogen

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Biogen
    ClinicalTrials.gov Identifier:
    NCT01903291
    Other Study ID Numbers:
    • 109MS404
    First Posted:
    Jul 19, 2013
    Last Update Posted:
    Jul 25, 2016
    Last Verified:
    Jul 1, 2016
    Additional relevant MeSH terms:
    Multiple Sclerosis
    Sclerosis
    Dimethyl Fumarate

    Study Results

    No Results Posted as of Jul 25, 2016