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

NCT01903291 | Completed

• 1 other identifier: 109MS404
• Study Type: observational
• Target: 333
• Locations: 1 country
• Sites: 62

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.

Conditions

Relapsing Forms of Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• Annualized Relapse Rate

  12 months

Secondary Outcomes (10)

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

  Baseline to 12 months

• Change in Short-Form 36 (SF-36) scores.

  Baseline to 12 months

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

  Baseline to 12 months

• Change in Beck Depression Inventory (BDI-7) scores.

  Baseline to 12 months

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

  Baseline to 12 months

Study Arms (1)

dimethyl fumarate

To be taken according to the United States Prescribing Information (USPI)

Drug: dimethyl fumarate

Interventions

dimethyl fumarate DRUG

As described in the treatment arm

Also known as: Tecfidera, BG00012, DMF

dimethyl fumarate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Biogen: lead

Study Sites (62)

Research Site

Birmingham, Alabama, 35209, United States

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Tuscon, Arizona, 85741-1196, United States

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Los Angeles, California, 90015, United States

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Sacramento, California, 95816, United States

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San Jose, California, 95124, United States

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Englewood, Colorado, 80113, United States

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Dover, Delaware, 19901, United States

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Jacksonville, Florida, 32209, United States

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Lighthouse PT, Florida, 33064, United States

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Port Charlotte, Florida, 33952, United States

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St. Petersburg, Florida, 33705, United States

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Tampa, Florida, 33612, United States

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Atlanta, Georgia, 30309, United States

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Atlanta, Georgia, 30327, United States

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Savannah, Georgia, 31405, United States

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Chicago, Illinois, 60637-1463, United States

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Evanston, Illinois, 60201, United States

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Franklin, Illinois, 37064, United States

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Indianapolis, Indiana, 46256, United States

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Des Moines, Iowa, 50314, United States

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Lenexa, Kansas, 66214-9836, United States

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Lexington, Kentucky, 40513, United States

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Louisville, Kentucky, 40207, United States

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Baton Rouge, Louisiana, 70810-1686, United States

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Annapolis, Maryland, 21401, United States

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Baltimore, Maryland, 21201, United States

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Lexington, Massachusetts, 02421, United States

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Springfield, Massachusetts, 01104, United States

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Worcester, Massachusetts, 01655, United States

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Clinton Township, Michigan, 48035, United States

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Muskegon, Michigan, 49444-3719, United States

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Golden Valley, Minnesota, 55422, United States

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Columbia, Missouri, 65201, United States

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Great Falls, Montana, 59405, United States

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Lincoln, Nebraska, 68506-2960, United States

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Lincoln, Nebraska, 68521, United States

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Omaha, Nebraska, 68198, United States

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Freehold, New Jersey, 07728, United States

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New York, New York, 10032, United States

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Patchogue, New York, 11772, United States

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The Bronx, New York, 10467, United States

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Asheville, North Carolina, 28806, United States

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Hickory, North Carolina, 28602, United States

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Raleigh, North Carolina, 27607-6010, United States

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Akron, Ohio, 44302, United States

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Canton, Ohio, 44718, United States

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Centerville, Ohio, 45459, United States

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Columbus, Ohio, 43221, United States

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Medford, Oregon, 97504, United States

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Portland, Oregon, 97225, United States

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Abington, Pennsylvania, 19001, United States

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Greensburg, Pennsylvania, 15601, United States

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Pittsburgh, Pennsylvania, 15212, United States

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Knoxville, Tennessee, 37934, United States

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Round Rock, Texas, 78681, United States

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Salt Lake City, Utah, 84103, United States

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Norfolk, Virginia, 23502, United States

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Richmond, Virginia, 23226, United States

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Bellingham, Washington, 98225, United States

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Seattle, Washington, 98122, United States

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Tacoma, Washington, 98405, United States

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Neenah, Wisconsin, 54946, United States

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Related Publications (2)

• 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.

  PMID: 33225410 DERIVED

• 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.

  PMID: 30470580 DERIVED

MeSH Terms

Interventions

Dimethyl Fumarate

Intervention Hierarchy (Ancestors)

Fumarates; Dicarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Medical Director

  Biogen

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2013
• First Posted: July 19, 2013
• Study Start: August 1, 2013
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: July 25, 2016

Record last verified: 2016-07

Locations

US (62)