Observational Study of Persistence on Bafiertam Treatment in Routine Clinical Practice

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-08-17

Study Completion Date

2025-02-24

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Relapsing Remitting Multiple Sclerosis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Monomethyl Fumarate

95 mg oral capsule, 190 mg (2 x 95 mg) twice daily

Intervention Type DRUG

Other Intervention Names

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Bafiertam BLS-11

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No