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)

• Register: ClinicalTrials.gov
• Last refreshed on: 18 April 2016
• Main ID: NCT02323269
• Date of registration: 18/12/2014
• Prospective Registration: Yes
• Primary sponsor: Biogen
• Public title: 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) IMPROVE
• 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-Remitting Multiple Sclerosis, Who Are Either Treatment-Naïve or Switching From an Interferon or Glatiramer Acetate After Suboptimal Response (ImPROve)
• Date of first enrolment: May 2015
• Target sample size: 24
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02323269
• Study type: Observational
• Study design: Observational Model: Cohort, Time Perspective: Prospective
• Phase: N/A

Countries of recruitment

Canada

Contacts

• Name: Medical Director
• Affiliation: Biogen

Key inclusion & exclusion criteria

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.



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

Health Condition(s) or Problem(s) studied

Multiple Sclerosis, Relapsing-Remitting

Relapsing-Remitting Multiple Sclerosis

Intervention(s)

Drug: dimethyl fumarate

Primary Outcome(s)

Annualized Relapse Rate (ARR) at month 12 [Time Frame: Month 12]

Secondary Outcome(s)

Change from baseline to Month 12 in the Beck Depression Inventory (BDI-7) scores [Time Frame: Baseline and month 12]

Change from baseline to Month 12 in the Modified Fatigue Impact Scale (MFIS-5) scores [Time Frame: Baseline and month 12]

Change from baseline to Month 12 in the Morisky 8-item Medication Adherence Scale (MMAS-8) scores [Time Frame: Baseline and month 12]

Change from baseline to Month 12 in patient-reported Expanded Disability Status Scale (patient-reported EDSS) scores [Time Frame: Baseline and month 12]

Proportion of patients with relapses associated with steroid use at Month 12 [Time Frame: Month 12]

Change from baseline to Month 12 in the 14-item Treatment Satisfaction Questionnaire for Medication (TSQM-14) score [Time Frame: Baseline and month 12]

Change from baseline to Month 12 in the Work Productivity and Impairment Questionnaire: Multiple Sclerosis (WPAI-MS) scores [Time Frame: Baseline and month 12]

Change from baseline to Month 12 in the Short-Form 36 (SF-36) scores [Time Frame: Baseline and month 12]

Proportion of patients with relapses associated with hospitalizations at Month 12 [Time Frame: Month 12]

Proportion of patients relapsing at Month 12 [Time Frame: Month 12]

Secondary ID(s)

109MS415

CAN-BGT-14-10614

Source(s) of Monetary Support

Please refer to primary and secondary sponsors