Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 100 Years
Eligible 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: 1. 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. 2. Manage CSU patients within their practice. 3. Enrolled in the research network or are referred HCPs who agree to participate. 4. 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: 5. ≥ 18 years of age. 6. Diagnosed with CSU by an HCP. 7. Have received a prescription for remibrutinib or dupilumab and are expected to initiate treatment. 8. Have access to an electronic device with internet capabilities. 9. Able to read and understand English. 10. Willing and able to provide consent for study participation. Exclusion criteria: Patients will be excluded if they meet any of the following criteria: 1. Unable to procure remibrutinib or dupilumab (through samples, commercially or patient assistance program). 2. Exposure to oral corticosteroid treatment in 14 days prior to consent. 3. Exposure to oral corticosteroid treatment in 14 days prior to initiating treatment with remibrutinib or dupilumab. 4. Prior participation in a remibrutinib or dupilumab clinical trial. 5. Cognitive impairment that impacts the patient's ability to participate.

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
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.

Recruiting Locations

Novartis
East Hanover 5097421, New Jersey 5101760 07936

More Details

Status
Recruiting
Sponsor
Novartis Pharmaceuticals

Study Contact

Novartis Pharmaceuticals
+41613241111
novartis.email@novartis.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.