Observational Study of Persistence on Bafiertam Treatment in Routine Clinical Practice (SIMPLE)

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.

Study Overview

• Status: Terminated
• Conditions: Relapsing Remitting Multiple Sclerosis
• Intervention / Treatment: Drug: Monomethyl Fumarate

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.

• Study Type: Observational
• Enrollment (Actual): 25

Contacts and Locations

Study Locations

• Puerto Rico
  • San Juan, Puerto Rico
    • Caribbean Center for Clinical Research/San Juan MS Center
• United States
  • Arizona
    • Gilbert, Arizona, United States, 85297
      • Gilbert Neurology
    • Phoenix, Arizona, United States, 85032
      • Center for Neurology and Spine
    • Scottsdale, Arizona, United States, 85258
      • Clinical Endpoints
    • Scottsdale, Arizona, United States, 85253
      • Perseverance Research Center, LLC
  • California
    • West Hollywood, California, United States, 90048
      • Regina Berkovich MD PhD Inc.
  • Maryland
    • Bethesda, Maryland, United States, 20817
      • Comprehensive Neurology Clinics of Bethesda Mid-Atlantic Epilepsy and Sleep Center
    • Glen Burnie, Maryland, United States, 21061
      • Maryland Center for Neurology and Sleep
  • New Jersey
    • Teaneck, New Jersey, United States, 07666
      • Holy Name Medical Center
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population will be selected from existing patients known to the individual investigators.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of participants on treatment with Bafiertam at 1 Year.	Percentage of participants on treatment with Bafiertam at 1 Year.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants on Treatment with Bafiertam at 6 months	Percentage of Participants on Treatment with Bafiertam at 6 months	6 months
Treatment Satisfaction Questionnaire for Medication (TSQM-9)	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.	12 months
Number of Participants with Adverse Events (AEs) Leading to Treatment Discontinuation.	Number of Participants with AEs Leading to Treatment Discontinuation.	12 months

Collaborators and Investigators

• Sponsor: Banner Life Sciences LLC
• Investigators: Study Director: Thomas Lategan, PhD, Banner Life Sciences

Study record dates

Study Major Dates

• Study Start (Actual): August 17, 2023
• Primary Completion (Actual): February 24, 2025
• Study Completion (Actual): February 24, 2025

Study Registration Dates

• First Submitted: July 25, 2023
• First Submitted That Met QC Criteria: August 3, 2023
• First Posted (Actual): August 7, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 4, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Autoimmune Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting
• Other Study ID Numbers: BLS-11-404

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No