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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)

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ClinicalTrials.gov Identifier: NCT02323269
Recruitment Status : Terminated (109MS415 ImPROve study was terminated due to patient enrollment challenges and feasibility . The decision was not a result of safety concerns.)
First Posted : December 23, 2014
Last Update Posted : April 8, 2016
Sponsor:
Information provided by (Responsible Party):
Biogen

Brief 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.

Condition or disease Intervention/treatment
Multiple Sclerosis, Relapsing-Remitting Relapsing-Remitting Multiple Sclerosis Drug: dimethyl fumarate

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Study Type : Observational
Actual Enrollment : 24 participants
Observational Model: Cohort
Time Perspective: Prospective
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)
Study Start Date : May 2015
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Treatment naive to dimethyl fumarate
Participants who are prescribed dimethyl fumarate as their initial therapy will receive 120 mg tablet administered orally twice a day for 7 days, then switch to maintenance dose of 240 mg tablet twice daily.
Drug: dimethyl fumarate
administered according to the local product label (i.e., Canadian Product Monograph).
Other Names:
  • DMF
  • BG00012
  • Tecfidera

Switch to dimethyl fumarate
Participants who are prescribed dimethyl fumarate after suboptimal response to IFN or GA will receive 120 mg tablet administered orally twice a day for 7 days, then switch to maintenance dose of 240 mg tablet twice daily.
Drug: dimethyl fumarate
administered according to the local product label (i.e., Canadian Product Monograph).
Other Names:
  • DMF
  • BG00012
  • Tecfidera




Primary Outcome Measures :
  1. Annualized Relapse Rate (ARR) at month 12 [ Time Frame: Month 12 ]
    Relapses are defined as new or recurrent neurologic symptoms not associated with fever, lasting at least 24 hours.


Secondary Outcome Measures :
  1. Change from baseline to Month 12 in the 14-item Treatment Satisfaction Questionnaire for Medication (TSQM-14) score [ Time Frame: Baseline and month 12 ]
    TSQM-14 is an instrument to assess patient's satisfaction with medication, providing scores on four scales: Side effects, effectiveness, convenience and global satisfaction.

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

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

  4. Change from baseline to Month 12 in the Beck Depression Inventory (BDI-7) scores [ Time Frame: Baseline and month 12 ]
    BDI-7 is is a self-report inventory for measuring the severity of depression on a 7-item scale.

  5. Change from baseline to Month 12 in the Work Productivity and Impairment Questionnaire: Multiple Sclerosis (WPAI-MS) scores [ Time Frame: Baseline and month 12 ]
    WPAI-MS is a patient-reported quantitative assessment of the amount of absenteeism, presenteeism and daily activity impairment attributable to Multiple Sclerosis

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

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

  8. Proportion of patients relapsing at Month 12 [ Time Frame: Month 12 ]
    Relapses are defined as new or recurrent neurologic symptoms not associated with fever, lasting at least 24 hours.

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


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
This study will be conducted in male and female patients with relapsing-remitting MS who satisfy the therapeutic indication for DMF per the Canadian Product Monograph, and who are either treatment-naïve or responding suboptimally to MS platform therapies (e.g., IFN or GA), as determined by the Prescribing Physician.
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02323269


Locations
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Canada, Alberta
Research Site
Edmonton, Alberta, Canada, T6G 2G3
Canada, British Columbia
Research Site
Burnaby, British Columbia, Canada, V5G 2X6
Canada, New Brunswick
Research Site
St. John, New Brunswick, Canada, E2L 4L2
Canada, Newfoundland and Labrador
Research Site
St. John's, Newfoundland and Labrador, Canada, A1B 3V6
Canada, Nova Scotia
Research Site
Halifax, Nova Scotia, Canada, B3H 4K4
Research Site
Sydney, Nova Scotia, Canada, B1P 1P3
Canada, Ontario
Research Site
Cambridge, Ontario, Canada, N1R 7L6
Research Site
London, Ontario, Canada, N6A 5A5
Canada, Quebec
Research Site
Gatineau, Quebec, Canada, J9J 0A5
Research Site
Montreal, Quebec, Canada, H3A 2B4
Sponsors and Collaborators
Biogen
Investigators
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Study Director: Medical Director Biogen

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Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT02323269     History of Changes
Other Study ID Numbers: 109MS415
CAN-BGT-14-10614 ( Other Identifier: Sponsor )
First Posted: December 23, 2014    Key Record Dates
Last Update Posted: April 8, 2016
Last Verified: April 2016
Additional relevant MeSH terms:
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Glatiramer Acetate
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Interferons
Dimethyl Fumarate
(T,G)-A-L
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents
Antirheumatic Agents
Dermatologic Agents