Cold Agglutinin Disease Real World Evidence Registry (Cadence)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/47941
• EU PAS number:
  EUPAS47940
• Study ID:
  47941
• Official title and acronym:
  Cold Agglutinin Disease Real World Evidence Registry (Cadence)
• DARWIN EU® study:
  No
• Study countries:
  Austria

  France

  Germany

  Italy

  Japan

  Spain

  United Kingdom

  United States
• Study description:
  The aim of the Cadence registry is to develop a large, international database of patients with cold agglutinin disease (CAD) or cold agglutinin syndrome (CAS, previously known as secondary CAD) to prospectively collect longitudinal data and better understand patient and clinical characteristics, complications, long-term clinical and patient-reported outcomes associated with the different CAD and CAS treatments and health-resource utilization. This registry will also improve the understanding of the natural history of CAD and CAS and will help raise awareness of CAD and CAS and their management. In addition, the registry will include a cohort study to assess the safety and the effectiveness of sutimlimab in patients with CAD in a real-world setting.
• Study status:
  Planned

Research institutions and networks

Institutions

Prof Alexander Röth

Study timelines

Date when funding contract was signed

Planned: 01/01/2019

Study start date

Planned: 30/06/2022

Data analysis start date

Planned: 01/09/2023

Date of interim report, if expected

Planned: 29/12/2023

Date of final study report

Planned: 31/12/2031

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Sanofi US Services Inc.

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)