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.
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Patterns of CAD and CAS disease characteristics
Timeframe: Up to 6 years
Number of participants with CAD or CAS complications
Timeframe: Up to 6 years
Patterns of use of CAD and CAS treatments
Timeframe: Up to 6 years
Number of participants with health-resource utilization
Timeframe: Up to 6 years
Cold Agglutinin Disease Symptoms and Impact Questionnaire (CAD-SIQ)
Timeframe: Up to 6 years
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)
Timeframe: Up to 6 years
36-Item Short Form Survey Instrument (SF-36) v2
Timeframe: Up to 6 years
Sutimlimab cohort: Sutimlimab treatment patterns
Timeframe: Up to 6 years
Sutimlimab cohort: Number of participants with adverse events, serious adverse events, adverse events of special interests (AESIs), other events of interests (e.g., Treatment emergent)
Timeframe: Up to 6 years
Sutimlimab cohort: change from baseline in hemoglobin
Timeframe: From baseline up to 6 years
Sutimlimab cohort: change from baseline in bilirubin
Timeframe: From baseline up to 6 years
Sutimlimab cohort: change from baseline in Lactate dehydrogenase (LDH)
Timeframe: From baseline up to 6 years
Sutimlimab cohort: number of blood cells transfusions
Timeframe: Up to 6 years