Cold Agglutinin Disease Real World Evidence Registry

  • STATUS
    Recruiting
  • End date
    Nov 2, 2028
  • participants needed
    400
  • sponsor
    Recordati Rare Diseases
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Updated on 23 May 2025
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Summary

This is a multinational, multi-center, observational, prospective, longitudinal disease registry designed to collect data on participants with cold agglutinin disease (CAD) or cold agglutinin syndrome (CAS). Among them, a minimum of 30 patients with CAD treated with sutimlimab are expected to take part in the sutimlimab cohort study. Patients with CAD who have been enrolled in previous sutimlimab clinical trials (e.g., BIVV009-01/LTS16214 [NCT02502903,CAD patients], BIVV009-03/EFC16215 [NCT03347396], and BIVV009-04/EFC16216 [NCT03347422]) and who either completed or discontinued the corresponding clinical trial are eligible to participate in the registry.

Details
Condition Cold Agglutinin Disease (CAD), Cold Agglutinin Syndrome (CAS)
Age 18years or above
Clinical Study IdentifierNCT05791708
SponsorRecordati Rare Diseases
Last Modified on23 May 2025

Eligibility

 Yes No Not Sure

Inclusion Criteria

Patient aged ≥18 years
Patient able to understand the purpose of the study and who (or whose legally authorized representative) provided signed and dated informed consent and authorization to use protected health information in accordance with national and local subject privacy regulations
Patient with a diagnosis of CAD or CAS as per Investigator judgment based on the diagnosis criteria listed in study protocol

Exclusion Criteria

Patient with mixed warm and cold autoimmune hemolytic anemia, or warm autoimmune hemolytic anemia
Patient actively participating in a CAD or CAS interventional clinical trial. After a patient completes participation in said trial, he/she may be eligible for enrollment in this registry
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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