Chronic Spontaneous Urticaria
Conditions
Keywords
Chronic spontaneous urticaria, Remibrutinib, Dupilumab, Urticaria control test, Urticaria control test 7 day recall
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.
Interventions
None listed
Sponsors
Novartis Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Urticaria Control Test - 7 Day Recall (UCT-7) Score at Week 4 in Patients Initiating Remibrutinib | 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
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in UCT-7 Score at Week 1 in Patients Initiating Remibrutinib | Baseline and Week 1 | 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. |
| Proportion of Patients With a UCT-7 Score ≥12 at Week 1 and Week 4 in Patients Initiating Remibrutinib | Week 1 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. |
| Treatment Satisfaction Questionnaire for Medication - Version 9 (TSQM-9) Domain Scores at Week 4 in Patients Initiating Remibrutinib | Week 4 | The TSQM-9 is a validated PRO tool used to determine patient perceptions of the benefits, convenience, and overall satisfaction with their CSU treatment. It asks about 3 domains: effectiveness, convenience, and global satisfaction. TSQM-9 domain scores range from 0 to 100, with higher scores indicating greater satisfaction for that domain. |
| Change From Baseline in TSQM-9 Domain Scores at Week 4 in Patients Initiating Remibrutinib | Baseline and Week 4 | The TSQM-9 is a validated PRO tool used to determine patient perceptions of the benefits, convenience, and overall satisfaction with their CSU treatment. It asks about 3 domains: effectiveness, convenience, and global satisfaction. TSQM-9 domain scores range from 0 to 100, with higher scores indicating greater satisfaction for that domain. A positive change from baseline indicates improvement. |
| Treatment Satisfaction Assessed by TSQM-9 Overall Score at Week 4 in Patients Initiating Remibrutinib | Week 4 | The TSQM-9 is a validated PRO tool used to determine patient perceptions of the benefits, convenience, and overall satisfaction with their CSU treatment. It asks about 3 domains: effectiveness, convenience, and global satisfaction. TSQM-9 domain scores range from 0 to 100, with higher scores indicating greater satisfaction for that domain. Scores are produced for each domain, and total scores are calculated and used to assess overall medication satisfaction. |
| Change From Baseline in TSQM-9 Overall Score at Week 4 in Patients Initiating Remibrutinib | Baseline and Week 4 | The TSQM-9 is a validated PRO tool used to determine patient perceptions of the benefits, convenience, and overall satisfaction with their CSU treatment. It asks about 3 domains: effectiveness, convenience, and global satisfaction. TSQM-9 domain scores range from 0 to 100, with higher scores indicating greater satisfaction for that domain. Scores are produced for each domain, and total scores are calculated and used to assess overall medication satisfaction. A positive change from baseline indicates improvement. |
Countries
United States
Contacts
CONTACTNovartis Pharmaceuticals
STUDY_DIRECTORNovartis Pharmaceuticals
Novartis Pharmaceuticals
Outcome results
None listed