Clinical Trial

Cold Agglutinin Disease Real World Evidence Registry

Study acronym: CADENCE
Active, Not Recruiting
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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.
Protocol Amendment History 9 amendments
This ClinicalTrials.gov record has been amended 9 times since 2023-03-28; most recent amendment 2026-04-17.
Status change: Recruiting → Active, Not Recruiting 2026-04-17
Trial Details
NCT Number NCT05791708
Lead Sponsor RECORDATI GROUP
Conditions Cold Agglutinin Disease (CAD), Cold Agglutinin Syndrome (CAS)
Enrollment 429 participants
Start Date 2019-12-12
Primary Completion 2028-11-02 (estimated)
Study Completion 2028-11-02 (estimated)
Updated on ClinicalTrials.gov 2026-04-22