Effectiveness of DMF (Dimethyl Fumarate) and Its Impact on PROs (Patient Reported Outcomes) in Treatment-Naive or Suboptimal IFN (Interferon) or GA (Glatiramer Acetate) Responders With RRMS (ImPROve)

Biogen24 enrolled

Overview

The primary objective of the study is to estimate the annualized relapse rate (ARR) over a 12-month period in patients with Relapsing-Remitting Multiple Sclerosis (RRMS) who are treated with dimethyl fumarate (DMF) as their initial therapy (treatment-naïve), or switching from interferon (IFN) or glatiramer acetate (GA) (after suboptimal response defined as suboptimal efficacy, intolerance, or poor adherence to IFN or GA), as determined by the Prescribing Physician. 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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Multiple Sclerosis, Relapsing-Remitting Relapsing-Remitting Multiple Sclerosis

Interventions

dimethyl fumarateDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Key Inclusion Criteria: * Have access to the internet and are able to complete online assessments on a computer. * Have relapsing-remitting MS and satisfy the approved therapeutic indication for DMF per the Canadian Product Monograph. * Are either treatment-naïve or being treated for RRMS with IFN or GA but, per the Prescribing Physician, have a suboptimal response (e.g., suboptimal efficacy, intolerance, or poor adherence) to IFN or GA or have stopped treatment with IFN or GA for RRMS as a result of suboptimal response within 30-60 days of enrollment. Key Exclusion Criteria: * 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.) * Are receiving disease modifying therapies other than IFN or GA or have initiated treatment with a new disease modifying therapy since discontinuation of IFN or GA. NOTE: Other protocol-defined inclusion/exclusion criteria may apply.

Locations (10)

Research Site

Edmonton, Alberta, Canada

Research Site

Burnaby, British Columbia, Canada

Research Site

Saint John, New Brunswick, Canada

Research Site

St. John's, Newfoundland and Labrador, Canada

Research Site

Halifax, Nova Scotia, Canada

Research Site

Sydney, Nova Scotia, Canada

Research Site

Cambridge, Ontario, Canada

Research Site

London, Ontario, Canada

Research Site

Gatineau, Quebec, Canada

Research Site

Montreal, Quebec, Canada

Outcomes

Primary Outcomes

Annualized Relapse Rate (ARR) at month 12

Relapses are defined as new or recurrent neurologic symptoms not associated with fever, lasting at least 24 hours.

Time frame: Month 12

Secondary Outcomes

Change from baseline to Month 12 in the 14-item Treatment Satisfaction Questionnaire for Medication (TSQM-14) score

TSQM-14 is an instrument to assess patient's satisfaction with medication, providing scores on four scales: Side effects, effectiveness, convenience and global satisfaction.