Cold Agglutinin Disease Clinical Trial
Cold Agglutinin Disease Real World Evidence Registry
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.
Eligibility Criteria
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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There are 68 Locations for this study
Birmingham Alabama, 35205, United States
San Luis Obispo California, 93401, United States
Santa Maria California, 93454, United States
Washington District of Columbia, 20007, United States
Atlanta Georgia, 30290, United States
Skokie Illinois, 60077, United States
Sioux City Iowa, 51101, United States
Worcester Massachusetts, 01608, United States
Detroit Michigan, 48202, 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
Cleveland Ohio, 44195, United States
Columbus Ohio, 43210, United States
Medford Oregon, 97504, United States
Pittsburgh Pennsylvania, 15232, United States
Knoxville Tennessee, 37920, United States
Seattle Washington, 98109, United States
Salzburg , 5020, Austria
Wien , 1090, Austria
Amiens , 80054, France
Angers , 49933, France
Cesson Sevigne , 35510, France
CHALON SUR SAONE Cedex , 71100, France
Corbeil-Essonnes , 91100, France
Creteil , 94010, France
Dijon , 21079, France
Epagny Metz-Tessy , 74370, France
Paris , 75013, France
Pau , 64000, France
Pessac , 33600, France
Poitiers , 86021, France
Quimper , 2900, France
RENNES Cedex 09 , 35033, France
Saint Priest En Jarez , 42270, France
TOULOUSE Cedex 9 , 31059, France
Essen , 45147, Germany
Hannover , 30161, Germany
Landshut , 84036, Germany
Brescia Lombardia, 25123, Italy
Campobasso , 86100, Italy
Novara , 28100, Italy
Palermo , 90146, Italy
Pavia , 27100, Italy
Ravenna , 48121, Italy
Reggio Calabria , 89133, Italy
Roma , 00161, Italy
Terni , 05100, Italy
Fukushima-shi Fukushima, 960-1, Japan
Himeji-shi Hyogo, 670-0, Japan
Barcelona Barcelona [Barcelona], 8036, Spain
Madrid , 28034, Spain
Truro Cornwall, TR13L, United Kingdom
Carlisle Cumbria, CA2 7, United Kingdom
Gillingham Kent, ME75N, United Kingdom
London London, City Of, NW1 2, United Kingdom
Salford Manchester, M6 8H, United Kingdom
Airdrie North Lanarkshire, ML60J, United Kingdom
Tyne And Wear North Tyneside, NE29 , United Kingdom
Middlesbrough North Yorkshire, TS4 3, United Kingdom
Oxford Oxfordshire, OX3 7, United Kingdom
Taunton Somerset, TA1 5, United Kingdom
Birmingham , B15 2, United Kingdom
Harrow , HA1 3, United Kingdom
Leeds , LS9 7, United Kingdom
Liverpool , L7 8X, United Kingdom
London , E1 2E, United Kingdom
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