Observational Study of Persistence on Bafiertam Treatment in Routine Clinical Practice
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Registration Number
- NCT05978531
- Lead Sponsor
- Banner Life Sciences LLC
- Brief Summary
This is an open-label, multicenter, observational study of the adherence of patients with relapsing-remitting multiple sclerosis (RRMS) prescribed Bafiertam (monomethyl fumarate) as their treatment.
- Detailed Description
Monomethyl fumarate (MMF) is the active metabolite of the fumarate class of drugs used for the treatment of RRMS. Bafiertam is a formulation of MMF and does not require enzymatic conversion after oral administration. Adult participants with a diagnosis of RRMS who have been receiving continuous treatment with Bafiertam monotherapy per the approved product label for no more than 3 months (90 days) are eligible to enroll in the study. Their satisfaction with Bafiertam treatment will be assessed using a 9-Item Treatment Satisfaction Questionnaire for Medication (TSQM-9). To be included in the study, patients.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 25
- Male or non-pregnant female aged 18 years and older.
- Participants diagnosed with Relapsing forms of multiple sclerosis R(RMS) and satisfy the approved therapeutic indication for Bafiertam per the approved product labeling.
- Participants may enroll if they are within 90 days of initiating therapy with Bafiertam.
- Female participants of childbearing potential must practice effective contraception from Day -1 and be willing and able to continue contraception for the duration of the study.
- Willing and able to sign the informed consent form (ICF) approved by the Institutional Review Board (IRB).
- Willing and able to complete all the study procedures and communicate meaningfully with study personnel.
- Known hypersensitivity to fumarates including dimethyl fumarate, Tecfidera, and/or diroximel fumarate (Vumerity) or Bafiertam.
- Participated in another clinical trial within 30 days, suffered or still recovering from a medically significant event of surgery within 30 days, or previously participated in a clinical study with a similar investigational product.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of participants on treatment with Bafiertam at 1 Year. 12 months Percentage of participants on treatment with Bafiertam at 1 Year.
- Secondary Outcome Measures
Name Time Method Treatment Satisfaction Questionnaire for Medication (TSQM-9) 12 months Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM-9) Total Score (range 0 - 100) at Month 6 and 12 months.TSQM Version 9 is comprised of 9 questions that provide scores on four scales: effectiveness (3 items), convenience (3 items), and global satisfaction (3 items). The scale scores are transformed and range from 0 to 100. Higher scores indicate greater satisfaction.
Number of Participants with Adverse Events (AEs) Leading to Treatment Discontinuation. 12 months Number of Participants with AEs Leading to Treatment Discontinuation.
Percentage of Participants on Treatment with Bafiertam at 6 months 6 months Percentage of Participants on Treatment with Bafiertam at 6 months
Trial Locations
- Locations (10)
Gilbert Neurology
🇺🇸Gilbert, Arizona, United States
Center for Neurology and Spine
🇺🇸Phoenix, Arizona, United States
Perseverance Research Center, LLC
🇺🇸Scottsdale, Arizona, United States
Clinical Endpoints
🇺🇸Scottsdale, Arizona, United States
Regina Berkovich MD PhD Inc.
🇺🇸West Hollywood, California, United States
Comprehensive Neurology Clinics of Bethesda Mid-Atlantic Epilepsy and Sleep Center
🇺🇸Bethesda, Maryland, United States
Maryland Center for Neurology and Sleep
🇺🇸Glen Burnie, Maryland, United States
Holy Name Medical Center
🇺🇸Teaneck, New Jersey, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Caribbean Center for Clinical Research/San Juan MS Center
🇵🇷San Juan, Puerto Rico
Gilbert Neurology🇺🇸Gilbert, Arizona, United States