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Observational Study of Persistence on Bafiertam Treatment in Routine Clinical Practice

TerminatedN/A

Sponsor: Banner Life Sciences LLC

Conditions: Relapsing Remitting Multiple Sclerosis

Interventions: Monomethyl Fumarate

Countries: United States, Puerto Rico

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

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.

Locations (10)

Gilbert, Arizona, United States
Phoenix, Arizona, United States
Scottsdale, Arizona, United States
Scottsdale, Arizona, United States
West Hollywood, California, United States
Bethesda, Maryland, United States
Glen Burnie, Maryland, United States
Teaneck, New Jersey, United States
Milwaukee, Wisconsin, United States
San Juan, Puerto Rico