NCT05791708

Cold Agglutinin Disease Real World Evidence Registry

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 400 (estimated)
• Sponsor: RECORDATI GROUP · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cold Agglutinin Disease (CAD)
• Cold Agglutinin Syndrome (CAS)

Interventions

Type	Name	Description
DRUG	Sutimlimab	CAD patients in Sutimlimab cohort must be treated according to routine clinical practice

Timeline

• Start date: 2019-12-12
• Primary completion: 2028-11-02
• Completion: 2028-11-02
• First posted: 2023-03-30
• Last updated: 2025-11-20

Locations

68 sites across 8 countries: United States, Austria, France, Germany, Italy, Japan, Spain, United Kingdom