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

• Register: ClinicalTrials.gov
• Last refreshed on: 8 August 2016
• Main ID: NCT01903291
• Date of registration: 17/07/2013
• Prospective Registration: Yes
• Primary sponsor: Biogen
• Public title: Effectiveness of DMF and Its Impact on PROs in Suboptimal GA Responders With RMS RESPOND
• Scientific 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
• Date of first enrolment: August 2013
• Target sample size: 333
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01903291
• Study type: Observational
• Study design: Observational Model: Cohort, Time Perspective: Prospective
• Phase: N/A

Countries of recruitment

United States

Contacts

• Name: Medical Director
• Affiliation: Biogen

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Relapsing Forms of Multiple Sclerosis

Intervention(s)

Drug: dimethyl fumarate

Primary Outcome(s)

Annualized Relapse Rate [Time Frame: 12 months]

Secondary Outcome(s)

Change in Beck Depression Inventory (BDI-7) scores. [Time Frame: Baseline to 12 months]

Change in Short-Form 36 (SF-36) scores. [Time Frame: Baseline to 12 months]

Change in 14-item Treatment Satisfaction Questionnaire for Medication (TSQM-14) scores. [Time Frame: Baseline to 12 months]

Change in Patient-reported Expanded Disability Status Scale (patient-reported EDSS) scores. [Time Frame: Baseline to 12 months]

Change in Work Productivity and Impairment Questionnaire: Multiple Sclerosis (WPAI-MS) scores. [Time Frame: Baseline to 12 months]

Proportion of patients with relapses associated with hospitalizations. [Time Frame: Baseline to 12 months]

Proportion of patients with relapses associated with steroid use. [Time Frame: Baseline to 12 months]

Proportion of patients experiencing a relapse. [Time Frame: Baseline to 12 months]

Change in Modified Fatigue Impact Scale (MFIS-5) scores. [Time Frame: Baseline to 12 months]

Change in Morisky 8-item Medication Adherence Scale (MMAS-8) scores. [Time Frame: Baseline to 12 months]

Secondary ID(s)

109MS404

Source(s) of Monetary Support

Please refer to primary and secondary sponsors