Observational Study of Persistence on Bafiertam Treatment In Routine Clinical Practice

Relapsing Remitting Multiple Sclerosis Clinical Trial

— SIMPLE  

Official title:

A Prospective, Observational Study of Bafiertam Evaluating Persistence on Treatment, Safety, Tolerability, And Effectiveness In Routine Clinical Practice.

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05978531
• Other study ID #: BLS-11-404
• Status: Enrolling by invitation
• Start date: August 17, 2023
• Est. completion date: January 31, 2025

Study information

• Verified date: August 2023
• Source: Banner Life Sciences LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: January 31, 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Relapsing Remitting Multiple Sclerosis

Intervention

Drug:
• Monomethyl Fumarate
95 mg oral capsule, 190 mg (2 x 95 mg) twice daily

Locations

Country	Name	City	State
Puerto Rico	Caribbean Center for Clinical Research	Guaynabo
United States	Arizona Neuroscience Research, LLC	Phoenix	Arizona
United States	Regina Berkovich, MD, PhD Inc.	West Hollywood	California

Sponsors (1)

Lead Sponsor	Collaborator
Banner Life Sciences LLC

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants on treatment with Bafiertam at 1 Year.	Percentage of participants on treatment with Bafiertam at 1 Year.	12 months
Secondary	Percentage of Participants on Treatment with Bafiertam at 6 months	Percentage of Participants on Treatment with Bafiertam at 6 months	6 months
Secondary	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
Secondary	Number of Participants with Adverse Events (AEs) Leading to Treatment Discontinuation.	Number of Participants with AEs Leading to Treatment Discontinuation.	12 months