Multiple Sclerosis Clinical Trial

Observational Study of Persistence on Bafiertam Treatment In Routine Clinical Practice

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.

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Full 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.

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Eligibility Criteria

Inclusion Criteria:

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 Criteria:

Known hypersensitivity to fumarates including dimethyl fumarate, Tecfidera, and/or diroximel fumarate (Vumerity) or Bafiertam.
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 is for people with:

Multiple Sclerosis

Estimated Enrollment:

100

Study ID:

NCT05978531

Recruitment Status:

Enrolling by invitation

Sponsor:

Banner Life Sciences LLC

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There are 3 Locations for this study

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Arizona Neuroscience Research, LLC
Phoenix Arizona, 85032, United States
Regina Berkovich, MD, PhD Inc.
West Hollywood California, 90048, United States
Caribbean Center for Clinical Research
Guaynabo , 00968, Puerto Rico

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Study is for people with:

Multiple Sclerosis

Estimated Enrollment:

100

Study ID:

NCT05978531

Recruitment Status:

Enrolling by invitation

Sponsor:


Banner Life Sciences LLC

How clear is this clinincal trial information?

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