RELIEF: Remibrutinib in Chronic Spontaneous Urticaria: Early Real World Effectiveness and Satisfaction Survey
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Novartis Pharmaceuticals
- Enrollment
- 350
- Locations
- 1
- Primary Endpoint
- Change From Baseline in Urticaria Control Test - 7 Day Recall (UCT-7) Score at Week 4 in Patients Initiating Remibrutinib
Overview
Brief Summary
This is a United States (US) based, prospective, non-interventional, provider-referral study to evaluate the real-world effectiveness and patient-centered outcomes of remibrutinib in chronic spontaneous urticaria (CSU) patients using validated patient reported outcome (PRO) tools.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Healthcare provider (HCP) participants eligible to refer patients for inclusion in this study must meet all the following criteria:
- •Have an active medical license and be board certified/board eligible allergist or dermatologist in the US. Nurse practitioners and physician assistant practicing in allergy and dermatology are eligible.
- •Manage CSU patients within their practice.
- •Enrolled in the research network or are referred HCPs who agree to participate.
- •Have the requisite patient population based on study inclusion/
Exclusion Criteria
- •Patients eligible for inclusion in this study must meet all of the following criteria:
- •≥ 18 years of age.
- •Diagnosed with CSU by an HCP.
- •Have received a prescription for remibrutinib or dupilumab and are expected to initiate treatment.
- •Have access to an electronic device with internet capabilities.
- •Able to read and understand English.
- •Willing and able to provide consent for study participation.
- •Exclusion criteria:
- •Patients will be excluded if they meet any of the following criteria:
- •Unable to procure remibrutinib or dupilumab (through samples, commercially or patient assistance program).
Arms & Interventions
Remibrutinib Cohort
Adult patients with CSU who are prescribed and initiating treatment with remibrutinib.
Dupilumab Cohort
Adult patients with CSU who are prescribed and initiating treatment with dupilumab.
Outcomes
Primary Outcomes
Change From Baseline in Urticaria Control Test - 7 Day Recall (UCT-7) Score at Week 4 in Patients Initiating Remibrutinib
Time Frame: Baseline and Week 4
UCT-7 is a validated PRO tool designed to assess disease control over a 7-day recall period. It evaluates symptom burden, quality of life impact, treatment adequacy, and overall disease control. It consists of 4 questions, each of which is scored 0-4, with a total score range of 0-16. A score of \<12 indicates poor disease control, 12-15 = partial control, and 16 indicates complete control.
Secondary Outcomes
- Change From Baseline in UCT-7 Score at Week 1 in Patients Initiating Remibrutinib(Baseline and Week 1)
- Proportion of Patients With a UCT-7 Score ≥12 at Week 1 and Week 4 in Patients Initiating Remibrutinib(Week 1 and Week 4)
- Treatment Satisfaction Questionnaire for Medication - Version 9 (TSQM-9) Domain Scores at Week 4 in Patients Initiating Remibrutinib(Week 4)
- Change From Baseline in TSQM-9 Domain Scores at Week 4 in Patients Initiating Remibrutinib(Baseline and Week 4)
- Treatment Satisfaction Assessed by TSQM-9 Overall Score at Week 4 in Patients Initiating Remibrutinib(Week 4)
- Change From Baseline in TSQM-9 Overall Score at Week 4 in Patients Initiating Remibrutinib(Baseline and Week 4)