Cold Agglutinin Disease Real World Evidence Registry
Study on Conditions Affecting Red Blood Cells in Cold Temperatures
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:
- Conditions: Cold Agglutinin Disease (CAD), Cold Agglutinin Syndrome (CAS)
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Age: 18 years or above
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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.
This study investigates cold agglutinin disease (CAD) and cold agglutinin syndrome (CAS), which are conditions where the body's immune system mistakenly attacks its own red blood cells, causing them to clump together at low temperatures. The purpose of this observational study is to gather data on individuals with CAD or CAS to better understand these conditions.
Participants in this study will have their health data collected as they receive routine care. The study is observational, meaning that participants will not receive any specific treatments as part of the study, but their experiences with CAD or CAS will be documented to provide insights into the conditions.
- Who can participate: Adults aged 18 and older diagnosed with CAD or CAS who can understand the study and provide informed consent are eligible, except those with mixed warm and cold autoimmune hemolytic anemia or currently in an interventional trial.
- Study details: Participants will be observed as they continue their routine care, and their medical data will be collected for analysis. This study does not involve any investigational medication or treatment changes.
