Observational Study of Persistence on Bafiertam Treatment in Routine Clinical Practice
Reason given: Business decision
Key facts
- Where
- Bethesda, Gilbert, Glen Burnie, Milwaukee, Phoenix, Scottsdale, Teaneck, and West Hollywood, United StatesSee the 9 sites
Where in United States
- Comprehensive Neurology Clinics of Bethesda Mid-Atlantic Epilepsy and Sleep CenterBethesda, United StatesNo longer taking part
- Gilbert NeurologyGilbert, United StatesNo longer taking part
- Maryland Center for Neurology and SleepGlen Burnie, United StatesNo longer taking part
- Medical College of WisconsinMilwaukee, United StatesNo longer taking part
- Center for Neurology and SpinePhoenix, United StatesNo longer taking part
- Clinical EndpointsScottsdale, United StatesNo longer taking part
- Perseverance Research Center, LLCScottsdale, United StatesNo longer taking part
- Holy Name Medical CenterTeaneck, United StatesNo longer taking part
- Regina Berkovich MD PhD IncWest Hollywood, United StatesNo longer taking part
Trial details
- Who runs it
- Banner Life Sciences LLC
- Trial code
- NCT05978531
- Record updated
- 6 March 2025
- Original description
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.Read full original descriptionShow less
A Prospective, Observational Study of Bafiertam Evaluating Persistence on Treatment, Safety, Tolerability, and Effectiveness in Routine Clinical Practice.
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.
Inclusion: 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.
Exclusion: 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; Known hypersensitivity to fumarates including dimethyl fumarate, Tecfidera, and/or diroximel fumarate (Vumerity) or Bafiertam.