A Real-world Study of Remibrutinib in Chronic Spontaneous Urticaria Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Chronic Spontaneous Urticaria. Basic parameters: 18 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
RELIEF: Remibrutinib in Chronic Spontaneous Urticaria: Early Real World Effectiveness and Satisfaction Survey
Overview
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.
Primary outcome measures
- 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]
Secondary outcome measures (6)
- Change From Baseline in UCT-7 Score at Week 1 in Patients Initiating Remibrutinib [Time frame: Baseline and Week 1]
- Proportion of Patients With a UCT-7 Score ≥12 at Week 1 and Week 4 in Patients Initiating Remibrutinib [Time frame: Week 1 and Week 4]
- Treatment Satisfaction Questionnaire for Medication - Version 9 (TSQM-9) Domain Scores at Week 4 in Patients Initiating Remibrutinib [Time frame: Week 4]
- Change From Baseline in TSQM-9 Domain Scores at Week 4 in Patients Initiating Remibrutinib [Time frame: Baseline and Week 4]
- Treatment Satisfaction Assessed by TSQM-9 Overall Score at Week 4 in Patients Initiating Remibrutinib [Time frame: Week 4]
- Change From Baseline in TSQM-9 Overall Score at Week 4 in Patients Initiating Remibrutinib [Time frame: Baseline and Week 4]
Eligibility criteria
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).
- Exposure to oral corticosteroid treatment in 14 days prior to consent.
- Exposure to oral corticosteroid treatment in 14 days prior to initiating treatment with remibrutinib or dupilumab.
- Prior participation in a remibrutinib or dupilumab clinical trial.
- Cognitive impairment that impacts the patient's ability to participate.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Novartis — East Hanover
Identifiers
NCT: NCT07408219 · CLOU064AUS05