Clinical trial NCT01903291: Effectiveness of DMF and Its Impact on PROs in Suboptimal GA Responders With RMS
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Relapsing Forms of Multiple Sclerosis
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2013-07-19
Enrollment: 333
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


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

Primary outcomes:
measure: Annualized Relapse Rate
timeFrame: 12 months
Secondary outcomes:
measure: Change in 14-item Treatment Satisfaction Questionnaire for Medication (TSQM-14) scores.
timeFrame: Baseline to 12 months
measure: Change in Short-Form 36 (SF-36) scores.
timeFrame: Baseline to 12 months
measure: Change in Modified Fatigue Impact Scale (MFIS-5) scores.
timeFrame: Baseline to 12 months
measure: Change in Beck Depression Inventory (BDI-7) scores.
timeFrame: Baseline to 12 months
measure: Change in Work Productivity and Impairment Questionnaire: Multiple Sclerosis (WPAI-MS) scores.
timeFrame: Baseline to 12 months
measure: Change in Morisky 8-item Medication Adherence Scale (MMAS-8) scores.
timeFrame: Baseline to 12 months
measure: Change in Patient-reported Expanded Disability Status Scale (patient-reported EDSS) scores.
timeFrame: Baseline to 12 months
measure: Proportion of patients experiencing a relapse.
timeFrame: Baseline to 12 months
measure: Proportion of patients with relapses associated with hospitalizations.
timeFrame: Baseline to 12 months
measure: Proportion of patients with relapses associated with steroid use.
timeFrame: Baseline to 12 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Research Site
state: Alabama
city: Tuscon
country: United States
facility: Research Site
state: Arizona
city: Los Angeles
country: United States
facility: Research Site
state: California
city: Sacramento
country: United States
facility: Research Site
state: California
city: San Jose
country: United States
facility: Research Site
state: California
city: Englewood
country: United States
facility: Research Site
state: Colorado
city: Dover
country: United States
facility: Research Site
state: Delaware
city: Jacksonville
country: United States
facility: Research Site
state: Florida
city: Lighthouse Point
country: United States
facility: Research Site
state: Florida
city: Port Charlotte
country: United States
facility: Research Site
state: Florida
city: St. Petersburg
country: United States
facility: Research Site
state: Florida
city: Tampa
country: United States
facility: Research Site
state: Florida
city: Atlanta
country: United States
facility: Research Site
state: Georgia
city: Atlanta
country: United States
facility: Research Site
state: Georgia
city: Savannah
country: United States
facility: Research Site
state: Georgia
city: Chicago
country: United States
facility: Research Site
state: Illinois
city: Evanston
country: United States
facility: Research Site
state: Illinois
city: Franklin
country: United States
facility: Research Site
state: Illinois
city: Indianapolis
country: United States
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state: Indiana
city: Des Moines
country: United States
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state: Iowa
city: Lenexa
country: United States
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state: Kansas
city: Lexington
country: United States
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state: Kentucky
city: Louisville
country: United States
facility: Research Site
state: Kentucky
city: Baton Rouge
country: United States
facility: Research Site
state: Louisiana
city: Annapolis
country: United States
facility: Research Site
state: Maryland
city: Baltimore
country: United States
facility: Research Site
state: Maryland
city: Lexington
country: United States
facility: Research Site
state: Massachusetts
city: Springfield
country: United States
facility: Research Site
state: Massachusetts
city: Worcester
country: United States
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state: Massachusetts
city: Clinton Township
country: United States
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state: Michigan
city: Muskegon
country: United States
facility: Research Site
state: Michigan
city: Golden Valley
country: United States
facility: Research Site
state: Minnesota
city: Columbia
country: United States
facility: Research Site
state: Missouri
city: Great Falls
country: United States
facility: Research Site
state: Montana
city: Lincoln
country: United States
facility: Research Site
state: Nebraska
city: Lincoln
country: United States
facility: Research Site
state: Nebraska
city: Omaha
country: United States
facility: Research Site
state: Nebraska
city: Freehold
country: United States
facility: Research Site
state: New Jersey
city: Bronx
country: United States
facility: Research Site
state: New York
city: New York
country: United States
facility: Research Site
state: New York
city: Patchogue
country: United States
facility: Research Site
state: New York
city: Asheville
country: United States
facility: Research Site
state: North Carolina
city: Hickory
country: United States
facility: Research Site
state: North Carolina
city: Raleigh
country: United States
facility: Research Site
state: North Carolina
city: Akron
country: United States
facility: Research Site
state: Ohio
city: Canton
country: United States
facility: Research Site
state: Ohio
city: Centerville
country: United States
facility: Research Site
state: Ohio
city: Columbus
country: United States
facility: Research Site
state: Ohio
city: Medford
country: United States
facility: Research Site
state: Oregon
city: Portland
country: United States
facility: Research Site
state: Oregon
city: Abington
country: United States
facility: Research Site
state: Pennsylvania
city: Greensburg
country: United States
facility: Research Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Research Site
state: Pennsylvania
city: Knoxville
country: United States
facility: Research Site
state: Tennessee
city: Round Rock
country: United States
facility: Research Site
state: Texas
city: Salt Lake City
country: United States
facility: Research Site
state: Utah
city: Norfolk
country: United States
facility: Research Site
state: Virginia
city: Richmond
country: United States
facility: Research Site
state: Virginia
city: Bellingham
country: United States
facility: Research Site
state: Washington
city: Seattle
country: United States
facility: Research Site
state: Washington
city: Tacoma
country: United States
facility: Research Site
state: Washington
city: Neenah
country: United States
facility: Research Site
state: Wisconsin
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Repovic P, Robertson D, Kresa-Reahl K, Cohan SL, Su R, Avila R, Koulinska I, Mendoza JP. Effectiveness of Dimethyl Fumarate in Patients With Relapsing Multiple Sclerosis Switching After Suboptimal Response to Glatiramer Acetate, Including Patients With Early Multiple Sclerosis: Subgroup Analysis of RESPOND. Neurol Ther. 2021 Jun;10(1):169-182. doi: 10.1007/s40120-020-00223-2. Epub 2020 Nov 23.
citation: Kresa-Reahl K, Repovic P, Robertson D, Okwuokenye M, Meltzer L, Mendoza JP. Effectiveness of Delayed-release Dimethyl Fumarate on Clinical and Patient-reported Outcomes in Patients With Relapsing Multiple Sclerosis Switching From Glatiramer Acetate: RESPOND, a Prospective Observational Study. Clin Ther. 2018 Dec;40(12):2077-2087. doi: 10.1016/j.clinthera.2018.10.011. Epub 2018 Nov 22.