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Recruiting NCT07642557

Remibrutinib in Real-world Clinical Practice - a Germany Sub-study (REASSERT)

— Observational Chronic Spontaneous Urticaria

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: from 18 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
Germany
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

Remibrutinib in Real-world Clinical Practice: a Prospective, Multi-country, Non-interventional, Effectiveness and Safety Study (REASSERT) - Local Adaptation in Germany From Global Umbrella Protocol (CLOU064A2402)

Overview

Prospective, non-interventional study in patients with CSU where the treatment decision prior enrolment has been made to 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.

Detailed description

This is a prospective, non-interventional study in patients with CSU where the treatment decision prior enrolment has been made to escalate/switch current treatment to remibrutinib. The primary aim of this study is to gather real-world effectiveness and safety data for remibrutinib, covering a broader, real-world clinical practice population. This local Germany study is part of an umbrella design which brings the evidence needs from multiple countries under the REASSERT global program (CLOU064A2402).

Primary outcome measures

  • Achievement of well-controlled disease (UCT7 ≥ 12) [Time frame: 12 weeks after initiating remibrutinib treatment]
Secondary outcome measures (12)
  • Number and proportion of participants with well-controlled disease and complete disease [Time frame: Up to 24 months]
  • Change from baseline (CFB) in UCT score [Time frame: Up to 24 months]
  • Change from Baseline in UAS7 score ≥ minimal important difference [Time frame: Up to 24 months]
  • Change from baseline in UAS7 score [Time frame: Up to 24 months]
  • Number of weeks without angioedema [Time frame: Up to 24 months]
  • Change in Angioedema Control Test (AECT) [Time frame: Baseline, up to 24 months]
  • Number of participants with rescue medication requirement [Time frame: Up to 24 months]
  • Characterize CSU relapse [Time frame: Up to 24 months]
  • UCT7 score [Time frame: Up to 12 weeks]
  • UAS7 score [Time frame: Up to 12 weeks]
  • Number of participants with administration of remibrutinib according to label [Time frame: Up to 24 weeks]
  • Number of participants with usage of concomitant sgH1-AHs and additional prescribed CSU treatments [Time frame: Up to 24 weeks]

Eligibility criteria

Inclusion criteria

7.2.1 Inclusion criteria Patients must meet all the following criteria to be eligible for inclusion in this study.

  • Patients with a confirmed diagnosis of primary CSU by the treating physician.
  • Aged at least 18 years on the date of enrollment.
  • Written informed consent of the patient to participate in the study and willingness to complete full follow-up period of 24 months.
  • Cohort-specific observational inclusion criteria:
  • Cohort 2: Inadequate control of CSU despite licensed dose or escalated sgH1-AH(s) (no other pre-treatment with exception of first generation H1-AH permitted) with decision (independent of study enrollment) to switch to remibrutinib treatment as per local label.
  • Cohort3: Any other treatment received in addition to H1-AH, any time during patients' CSU treatment history, with decision (independent of study enrollment) to switch to remibrutinib treatment as per local label. Note, occasional steroid rescue medication is out of scope for cohort definition. If a patient had been on continuous steroids for at least 3 weeks during treatment history, they will be included in cohort 3.

Exclusion criteria

Patients are excluded if they meet any of the following criteria:

  • Simultaneous participation in any investigational trial or simultaneous participation in another Novartis-sponsored non-interventional study with remibrutinib.
  • Patients within the safety follow-up phase of a previous interventional or non-interventional study.
  • Patients who received remibrutinib 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.
  • Patients who are treated with remibrutinib outside of the local label.

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

Germany · 1 center
  • Novartis Investigative Site — Düren

Identifiers

NCT: NCT07642557 · CLOU064ADE02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗