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

Relapsing Forms of Multiple Sclerosis Clinical Trial

— RESPOND  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01903291
• Other study ID #: 109MS404
• Status: Completed
• Phase: N/A
• First received: July 17, 2013
• Last updated: July 22, 2016
• Start date: August 2013
• Est. completion date: February 2016

Study information

• Verified date: July 2016
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 333
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Multiple Sclerosis
• Relapsing Forms of Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• dimethyl fumarate
As described in the treatment arm

Locations

Country	Name	City	State
United States	Research Site	Abington	Pennsylvania
United States	Research Site	Akron	Ohio
United States	Research Site	Annapolis	Maryland
United States	Research Site	Asheville	North Carolina
United States	Research Site	Atlanta	Georgia
United States	Research Site	Atlanta	Georgia
United States	Research Site	Baltimore	Maryland
United States	Research Site	Baton Rouge	Louisiana
United States	Research Site	Bellingham	Washington
United States	Research Site	Birmingham	Alabama
United States	Research Site	Bronx	New York
United States	Research Site	Canton	Ohio
United States	Research Site	Centerville	Ohio
United States	Research Site	Chicago	Illinois
United States	Research Site	Clinton Township	Michigan
United States	Research Site	Columbia	Missouri
United States	Research Site	Columbus	Ohio
United States	Research Site	Des Moines	Iowa
United States	Research Site	Dover	Delaware
United States	Research Site	Englewood	Colorado
United States	Research Site	Evanston	Illinois
United States	Research Site	Franklin	Illinois
United States	Research Site	Freehold	New Jersey
United States	Research Site	Golden Valley	Minnesota
United States	Research Site	Great Falls	Montana
United States	Research Site	Greensburg	Pennsylvania
United States	Research Site	Hickory	North Carolina
United States	Research Site	Indianapolis	Indiana
United States	Research Site	Jacksonville	Florida
United States	Research Site	Knoxville	Tennessee
United States	Research Site	Lenexa	Kansas
United States	Research Site	Lexington	Kentucky
United States	Research Site	Lexington	Massachusetts
United States	Research Site	Lighthouse Point	Florida
United States	Research Site	Lincoln	Nebraska
United States	Research Site	Lincoln	Nebraska
United States	Research Site	Los Angeles	California
United States	Research Site	Louisville	Kentucky
United States	Research Site	Medford	Oregon
United States	Research Site	Muskegon	Michigan
United States	Research Site	Neenah	Wisconsin
United States	Research Site	New York	New York
United States	Research Site	Norfolk	Virginia
United States	Research Site	Omaha	Nebraska
United States	Research Site	Patchogue	New York
United States	Research Site	Pittsburgh	Pennsylvania
United States	Research Site	Port Charlotte	Florida
United States	Research Site	Portland	Oregon
United States	Research Site	Raleigh	North Carolina
United States	Research Site	Richmond	Virginia
United States	Research Site	Round Rock	Texas
United States	Research Site	Sacramento	California
United States	Research Site	Salt Lake City	Utah
United States	Research Site	San Jose	California
United States	Research Site	Savannah	Georgia
United States	Research Site	Seattle	Washington
United States	Research Site	Springfield	Massachusetts
United States	Research Site	St. Petersburg	Florida
United States	Research Site	Tacoma	Washington
United States	Research Site	Tampa	Florida
United States	Research Site	Tuscon	Arizona
United States	Research Site	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Annualized Relapse Rate		12 months	No
Secondary	Change in 14-item Treatment Satisfaction Questionnaire for Medication (TSQM-14) scores.	TSQM-14 is an instrument to assess patient's satisfaction with medication, providing scores on four scales: Side effects, effectiveness, convenience and global satisfaction.	Baseline to 12 months	No
Secondary	Change in Short-Form 36 (SF-36) scores.	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.	Baseline to 12 months	No
Secondary	Change in Modified Fatigue Impact Scale (MFIS-5) scores.	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.	Baseline to 12 months	No
Secondary	Change in Beck Depression Inventory (BDI-7) scores.	BDI-7 is a self-report inventory for measuring the severity of depression on a 7-item scale.	Baseline to 12 months	No
Secondary	Change in Work Productivity and Impairment Questionnaire: Multiple Sclerosis (WPAI-MS) scores.	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.	Baseline to 12 months	No
Secondary	Change in Morisky 8-item Medication Adherence Scale (MMAS-8) scores.	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.	Baseline to 12 months	No
Secondary	Change in Patient-reported Expanded Disability Status Scale (patient-reported EDSS) scores.	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.	Baseline to 12 months	No
Secondary	Proportion of patients experiencing a relapse.		Baseline to 12 months	No
Secondary	Proportion of patients with relapses associated with hospitalizations.		Baseline to 12 months	No
Secondary	Proportion of patients with relapses associated with steroid use.		Baseline to 12 months	No