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

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ClinicalTrials.gov Identifier: NCT01903291
Recruitment Status : Completed
First Posted : July 19, 2013
Last Update Posted : July 25, 2016
Sponsor:
Information provided by (Responsible Party):
Biogen

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
Relapsing Forms of Multiple Sclerosis Drug: dimethyl fumarate

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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 : August 2013
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine


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:
  • Tecfidera
  • BG00012
  • DMF




Primary Outcome Measures :
  1. Annualized Relapse Rate [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. Proportion of patients experiencing a relapse. [ Time Frame: Baseline to 12 months ]
  9. Proportion of patients with relapses associated with hospitalizations. [ Time Frame: Baseline to 12 months ]
  10. Proportion of patients with relapses associated with steroid use. [ Time Frame: Baseline to 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01903291


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Sponsors and Collaborators
Biogen
Investigators
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Study Director: Medical Director Biogen

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT01903291     History of Changes
Other Study ID Numbers: 109MS404
First Posted: July 19, 2013    Key Record Dates
Last Update Posted: July 25, 2016
Last Verified: July 2016

Additional relevant MeSH terms:
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Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Dimethyl Fumarate
Dermatologic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs