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)

NCT02323269 | Terminated

• 2 other identifiers: 109MS415CAN-BGT-14-10614
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 10

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.

Conditions

Multiple Sclerosis, Relapsing-Remitting; Relapsing-Remitting Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (10)

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

  Baseline and month 12

• Change from baseline to Month 12 in the Short-Form 36 (SF-36) scores

  Baseline and month 12

• Change from baseline to Month 12 in the Modified Fatigue Impact Scale (MFIS-5) scores

  Baseline and month 12

• Change from baseline to Month 12 in the Beck Depression Inventory (BDI-7) scores

  Baseline and month 12

• Change from baseline to Month 12 in the Work Productivity and Impairment Questionnaire: Multiple Sclerosis (WPAI-MS) scores

  Baseline and month 12

Study Arms (2)

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

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

Interventions

dimethyl fumarate DRUG

administered according to the local product label (i.e., Canadian Product Monograph).

Also known as: DMF, BG00012, Tecfidera

Switch to dimethyl fumarate; Treatment naive to dimethyl fumarate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biogen: lead

Study Sites (10)

Research Site

Edmonton, Alberta, T6G 2G3, Canada

Location

Research Site

Burnaby, British Columbia, V5G 2X6, Canada

Location

Research Site

Saint John, New Brunswick, E2L 4L2, Canada

Location

Research Site

St. John's, Newfoundland and Labrador, A1B 3V6, Canada

Location

Research Site

Halifax, Nova Scotia, B3H 4K4, Canada

Location

Research Site

Sydney, Nova Scotia, B1P 1P3, Canada

Location

Research Site

Cambridge, Ontario, N1R 7L6, Canada

Location

Research Site

London, Ontario, N6A 5A5, Canada

Location

Research Site

Gatineau, Quebec, J9J 0A5, Canada

Location

Research Site

Montreal, Quebec, H3A 2B4, Canada

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Interventions

Dimethyl Fumarate

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Fumarates; Dicarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Medical Director

  Biogen

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2014
• First Posted: December 23, 2014
• Study Start: May 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: April 8, 2016

Record last verified: 2016-04

Locations

CA (10)