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.
Brief Title
Effectiveness of DMF and Its Impact on PROs in Suboptimal GA Responders With RMS
Categories
Completion Date
Completion Date Type
Actual
Conditions
Relapsing Forms of Multiple Sclerosis
Eligibility 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
* 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
Inclusion Criteria
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).
Inclusion/
* 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).
Inclusion/
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Estimated
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT01903291
Org Class
Industry
Org Full Name
Biogen
Org Study Id
109MS404
Overall Status
Completed
Primary Completion Date
Primary Completion Date Type
Actual
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
Primary Outcomes
Outcome Measure
Annualized Relapse Rate
Outcome Time Frame
12 months
Secondary Outcomes
Outcome Description
TSQM-14 is an instrument to assess patient's satisfaction with medication, providing scores on four scales: Side effects, effectiveness, convenience and global satisfaction.
Outcome Time Frame
Baseline to 12 months
Outcome Measure
Change in 14-item Treatment Satisfaction Questionnaire for Medication (TSQM-14) scores.
Outcome Description
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.
Outcome Time Frame
Baseline to 12 months
Outcome Measure
Change in Short-Form 36 (SF-36) scores.
Outcome Description
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.
Outcome Time Frame
Baseline to 12 months
Outcome Measure
Change in Modified Fatigue Impact Scale (MFIS-5) scores.
Outcome Description
BDI-7 is a self-report inventory for measuring the severity of depression on a 7-item scale.
Outcome Time Frame
Baseline to 12 months
Outcome Measure
Change in Beck Depression Inventory (BDI-7) scores.
Outcome Description
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.
Outcome Time Frame
Baseline to 12 months
Outcome Measure
Change in Work Productivity and Impairment Questionnaire: Multiple Sclerosis (WPAI-MS) scores.
Outcome Description
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.
Outcome Time Frame
Baseline to 12 months
Outcome Measure
Change in Morisky 8-item Medication Adherence Scale (MMAS-8) scores.
Outcome Description
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.
Outcome Time Frame
Baseline to 12 months
Outcome Measure
Change in Patient-reported Expanded Disability Status Scale (patient-reported EDSS) scores.
Outcome Time Frame
Baseline to 12 months
Outcome Measure
Proportion of patients experiencing a relapse.
Outcome Time Frame
Baseline to 12 months
Outcome Measure
Proportion of patients with relapses associated with hospitalizations.
Outcome Time Frame
Baseline to 12 months
Outcome Measure
Proportion of patients with relapses associated with steroid use.
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
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.
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Jerome Graber
Investigator Email
jgraber@montefiore.org
Investigator Phone
718-920-5505