Relapsing Remitting Multiple Sclerosis
Conditions
Brief 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.
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.
Interventions
95 mg oral capsule, 190 mg (2 x 95 mg) twice daily
Sponsors
Banner Life Sciences LLC
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants on treatment with Bafiertam at 1 Year. | 12 months | Percentage of participants on treatment with Bafiertam at 1 Year. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants on Treatment with Bafiertam at 6 months | 6 months | Percentage of Participants on Treatment with Bafiertam at 6 months |
| Treatment Satisfaction Questionnaire for Medication (TSQM-9) | 12 months | 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. |
| Number of Participants with Adverse Events (AEs) Leading to Treatment Discontinuation. | 12 months | Number of Participants with AEs Leading to Treatment Discontinuation. |
Countries
Puerto Rico, United States
Outcome results
None listed