Clinical trial NCT05978531: Observational Study of Persistence on Bafiertam Treatment in Routine Clinical Practice
Official title: A Prospective, Observational Study of Bafiertam Evaluating Persistence on Treatment, Safety, Tolerability, and Effectiveness in Routine Clinical Practice.
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Relapsing Remitting Multiple Sclerosis
Lead sponsor: Banner Life Sciences LLC
Sponsor class: INDUSTRY
First posted: 2023-08-07
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will be selected from existing patients known to the individual investigators.

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.

Eligibility criteria: Inclusion Criteria:

1. Male or non-pregnant female aged 18 years and older.
2. Participants diagnosed with Relapsing forms of multiple sclerosis R(RMS) and satisfy the approved therapeutic indication for Bafiertam per the approved product labeling.
3. Participants may enroll if they are within 90 days of initiating therapy with Bafiertam.
4. 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.
5. Willing and able to sign the informed consent form (ICF) approved by the Institutional Review Board (IRB).
6. Willing and able to complete all the study procedures and communicate meaningfully with study personnel.

Exclusion Criteria:

1. Known hypersensitivity to fumarates including dimethyl fumarate, Tecfidera, and/or diroximel fumarate (Vumerity) or Bafiertam.
2. 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.

Primary outcomes:
measure: Percentage of participants on treatment with Bafiertam at 1 Year.
timeFrame: 12 months
Secondary outcomes:
measure: Percentage of Participants on Treatment with Bafiertam at 6 months
timeFrame: 6 months
measure: Treatment Satisfaction Questionnaire for Medication (TSQM-9)
timeFrame: 12 months
measure: Number of Participants with Adverse Events (AEs) Leading to Treatment Discontinuation.
timeFrame: 12 months
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: Gilbert Neurology
state: Arizona
city: Phoenix
country: United States
facility: Center for Neurology and Spine
state: Arizona
city: Scottsdale
country: United States
facility: Perseverance Research Center, LLC
state: Arizona
city: Scottsdale
country: United States
facility: Clinical Endpoints
state: Arizona
city: West Hollywood
country: United States
facility: Regina Berkovich MD PhD Inc.
state: California
city: Bethesda
country: United States
facility: Comprehensive Neurology Clinics of Bethesda Mid-Atlantic Epilepsy and Sleep Center
state: Maryland
city: Glen Burnie
country: United States
facility: Maryland Center for Neurology and Sleep
state: Maryland
city: Teaneck
country: United States
facility: Holy Name Medical Center
state: New Jersey
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: San Juan
country: Puerto Rico
facility: Caribbean Center for Clinical Research/San Juan MS Center
Study officials:
affiliation: Banner Life Sciences
name: Thomas Lategan, PhD
role: STUDY_DIRECTOR
References: