Cold Agglutinin Disease Real World Evidence Registry
Study Overview
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.
Eligibility Criteria
You may be eligible for this study if you meet the following criteria:
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Conditions:
Cold Agglutinin Disease (CAD), Cold Agglutinin Syndrome (CAS)
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Age: 18 Years
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Gender: All
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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