Remibrutinib in Real-world Clinical Practice - a US Sub-study
ConditionChronic Spontaneous Urticaria
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorNovartis Pharmaceuticals
About this trial
Prospective, non-interventional study in patients with CSU where the treatment decision prior enrolment has been made to either escalate current sgH1-AHs treatment or escalate/switch current treatment to remibrutinib. The primary aim of this study is to gather real-world effectiveness and safety data for remibrutinib, a new treatment option, covering a broader, real-world clinical practice population.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with a confirmed diagnosis of primary CSU by the treating physician.
Aged at least 18 years on the date of enrolment.
Written informed consent of the patient to participate in the study (according to country specifications) and willingness to complete full follow-up period of 24 months.
Cohort 1: Inadequate control of CSU despite licensed dose of sgH1-AH (no other pre-treatments permitted) and decision (independent of study enrolment) to escalate sgH1-AH treatment.
Disqualifiers
Currently enrolled in a clinical trial or on any experimental treatment.
Patients within the safety follow-up phase of a previous interventional or non-interventional study.
Patients who received remibrutinib as an investigational medical product during a remibrutinib interventional study or MAP/PSDS at any time in the past.
Patients not capable or willing to continuously provide ePRO/eDiary data via electronic means throughout the duration of the study.
Trial population
Patients with CSU where the treatment decision prior enrolment has been made to either escalate current sgH1-AHs treatment or escalate/switch current treatment to remibrutinib
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
505 Participants
are grouped into 3 trial groupsGroup A: Cohort 1
Group B: Cohort 2
Group C: Cohort 3
Trial outcomes
Primary outcomes
1
UAS7 score
Urticaria Activity Score over 7 days UAS7 is based on 2 daily questions scored 0-3 per day, ranging from 0 (complete control) to 42 (poor control)
Time frame
12 weeks after initiating remibrutinib treatmentSecondary outcomes
1
UCT7 score
Urticaria Control Test is looking retrospectively for 7 days (UCT7) and consists of 4 questions. Each question is scored 0-4, with a total score range of 0 (poor control) to 16 (well controlled).
Time frame
12 weeks after initiating remibrutinib treatment2
Number and proportion of participants with well-controlled disease and complete disease
Proportion of patients with UCT score ≥12 and UAS7 score ≤6. Urticaria Control Test (UCT) consists of 4 questions scored 0 (very much) to 4 (not at all), with a total score range of 0 to 16. High scores indicates better disease control. Urticaria Activity Score over 7 days (UAS7) is based on 2 daily questions, with daily score of 0 to 6 and weekly score of 0 to 42. Lower scores suggests urticaria free and well controlled urticaria.
Time frame
Up to 24 months3
Change from baseline (CFB) in UCT score
Change in UCT score over time. Urticaria Control Test (UCT) consists of 4 questions scored 0 (very much) to 4 (not at all), with a total score range of 0 to 16. Highest scores indicates better disease control. The study is not powered to detect any specific difference and the purpose is to estimate any observed difference descriptively.
Time frame
Up to 24 months4
Change from Baseline in UAS7 score ≥ minimal important difference
Urticaria Activity Score over 7 days (UAS7) is based on 2 daily questions, with daily score of 0 to 6 and weekly score of 0 to 42. Lower scores suggests urticaria free and well controlled urticaria. The study is not powered to detect any specific difference and the purpose is to estimate any observed difference descriptively.
Time frame
Up to 24 monthsSponsors and contacts
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Source ClinicalTrials.gov