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)

Multiple Sclerosis, Relapsing-Remitting Clinical Trial

— IMPROVE  

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-Remitting Multiple Sclerosis, Who Are Either Treatment-Naïve or Switching From an Interferon or Glatiramer Acetate After Suboptimal Response (ImPROve)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02323269
• Other study ID #: 109MS415
• Secondary ID: CAN-BGT-14-10614
• Status: Terminated
• Phase: N/A
• First received: December 18, 2014
• Last updated: April 7, 2016
• Start date: May 2015
• Est. completion date: March 2016

Study information

• Verified date: April 2016
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• 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-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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 24
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Relapsing-Remitting Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• dimethyl fumarate
administered according to the local product label (i.e., Canadian Product Monograph).

Locations

Country	Name	City	State
Canada	Research Site	Burnaby	British Columbia
Canada	Research Site	Cambridge	Ontario
Canada	Research Site	Edmonton	Alberta
Canada	Research Site	Gatineau	Quebec
Canada	Research Site	Halifax	Nova Scotia
Canada	Research Site	London	Ontario
Canada	Research Site	Montreal	Quebec
Canada	Research Site	St. John	New Brunswick
Canada	Research Site	St. John's	Newfoundland and Labrador
Canada	Research Site	Sydney	Nova Scotia

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Month 12	No
Secondary	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.	Baseline and month 12	No
Secondary	Change from baseline to Month 12 in the 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 and month 12	No
Secondary	Change from baseline to Month 12 in the Modified Fatigue Impact Scale (MFIS-5) scores	MFIS-5 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 and month 12	No
Secondary	Change from baseline to Month 12 in the Beck Depression Inventory (BDI-7) scores	BDI-7 is is a self-report inventory for measuring the severity of depression on a 7-item scale.	Baseline and month 12	No
Secondary	Change from baseline to Month 12 in the Work Productivity and Impairment Questionnaire: Multiple Sclerosis (WPAI-MS) scores	WPAI-MS is a patient-reported quantitative assessment of the amount of absenteeism, presenteeism and daily activity impairment attributable to Multiple Sclerosis	Baseline and month 12	No
Secondary	Change from baseline to Month 12 in the 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 and month 12	No
Secondary	Change from baseline to Month 12 in patient-reported Expanded Disability Status Scale (patient-reported EDSS) scores	The patient reported EDSS measures disability status on a scale ranging from 0 to 10, with higher scores indicating more disability. Scoring is based on measures of impairment in eight functional systems.	Baseline and month 12	No
Secondary	Proportion of patients relapsing at Month 12	Relapses are defined as new or recurrent neurologic symptoms not associated with fever, lasting at least 24 hours.	Month 12	No
Secondary	Proportion of patients with relapses associated with hospitalizations at Month 12		Month 12	No
Secondary	Proportion of patients with relapses associated with steroid use at Month 12		Month 12	No