5460W-13 Effectiveness of DMF and its impact on PROs in Suboptimal GA Responders with RMS (RESPOND)

Effectiveness of DMF and its impact on PROs in Suboptimal GA Responders with RMS (RESPOND)

Type of Study
Neuroscience - Multiple Sclerosis
Short Description
The primary objective of the study is to estimate the annualized relapse rate (ARR) over a 12-month period in patients with relapsing forms of MS who are treated with dimethyl fumarate (DMF) after suboptimal response to glatiramer acetate (GA). 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.
 
Status
Open
Principal Investigator
Pavle Repovic, MD
Eligibility Notes
Inclusion Criteria:

 
  • Are aged ≥18 years.
  • Have access to the internet and are able to complete online assessments on a computer
  • Have a relapsing form of Multiple Sclerosis and satisfy the approved therapeutic indication for dimethyl fumarate (DMF) per the United States Prescribing Information (USPI).
  • Are being treated for relapsing forms of multiple sclerosis (MS) with glatiramer acetate (GA) but, per the Prescribing Physician, have a suboptimal response (e.g., suboptimal efficacy, intolerance, or poor adherence) to GA or have stopped treatment with GA for relapsing forms of MS as a result of suboptimal response within 30 days of enrollment.
     
Exclusion Criteria:
 
 
  • Are receiving concomitant disease modifying therapies other than glatiramer acetate (GA) or have initiated treatment with a new disease-modifying therapy since discontinuation of glatiramer acetate (GA).
  • Are currently enrolled in any other clinical studies, with the exception of the dimethyl fumarate (DMF) Pregnancy Registry.
  • Have received prior treatment with dimethyl fumarate (DMF).
Contact Name
Lauren Lennox & Mary Lessig
Phone
206-320-4355
Alternate Phone
206-386-6073
Email
Lauren.lennox@swedish.org
Alternate Email
Mary.lessig@swedish.org