Remibrutinib in real-world clinical practice: a prospective, multi-country, non-interventional, effectiveness and safety study (REASSERT)

Study identification

• EU PAS number:
  EUPAS1000000889
• Study ID:
  1000000889
• Official title and acronym:
  Remibrutinib in real-world clinical practice: a prospective, multi-country, non-interventional, effectiveness and safety study (REASSERT)
• DARWIN EU® study:
  No
• Study countries:
  Canada

  China

  Germany

  Italy

  Japan

  Korea, Republic of

  Spain

  United States
• Study description:
  This is a prospective, multi-country, 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, covering a broader, real-world clinical practice population. ; The study employs an umbrella design which brings the evidence needs from multiple countries under the REASSERT global program. ; Countries will generate local protocol to be used in their country; the local study documentation will be a minimised version of the global document, modified to align with country’s evidence needs, given local disparities in treatment guidelines, access, physician type and ePROs/eDiaries used. ; To achieve the core objectives the observation needs to include either the Urticaria Control Test (UCT) or Urticaria Activity Score over 7 days (UAS7) and the Dermatology Life Quality Index (DLQI). Data from all countries will be pooled and analyzed globally. In certain instances, some modifications of the global protocol may be permitted. For example, in countries where prospective monitoring of off-label antihistamines is prohibited, cohort 1 will not be enrolled.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Novartis Pharmaceuticals

Study timelines

Date when funding contract was signed

Planned:24/03/2025

Study start date

Planned:30/01/2026

Actual:02/02/2026

Data analysis start date

Planned:30/10/2031

Date of final study report

Planned:30/08/2032

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Novartis Pharma AG

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable

Other study registration identification numbers and links

CLOU064A2402