Cold Agglutinin Disease Clinical Trial
Cold Agglutinin Disease Real World Evidence Registry
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.
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
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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There are 19 Locations for this study
Birmingham Alabama, 35205, United States
San Luis Obispo California, 93401, United States
Skokie Illinois, 60077, United States
Sioux City Iowa, 51101, United States
Worcester Massachusetts, 01608, United States
Lake Success New York, 11042, United States
New York New York, 10021, United States
Syracuse New York, 13210, United States
Greenville North Carolina, 27834, United States
Medford Oregon, 97504, United States
Salzburg , 5020, Austria
Angers , 49933, France
CHALON SUR SAONE Cedex , 71100, France
Corbeil-Essonnes , 91100, France
Creteil , 94010, France
Pau , 64000, France
Saint Priest En Jarez , 42270, France
Suresnes , 92150, France
Terni , 05100, Italy
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