Cold Agglutinin Disease Real World Evidence Registry (CADENCE)

Recordati

Status: Enrolling

Conditions: Cold Agglutinin Syndrome (CAS); Cold Agglutinin Disease (CAD)

Treatments: Drug: Sutimlimab

Study type: Observational

Funder types: Industry

Identifiers

NCT05791708

OBS16454

EUPAS47940 (Registry Identifier)

U1111-1287-7090 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patient aged ≥18 years
2. 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
3. Patient with a diagnosis of CAD or CAS as per Investigator judgment based on the diagnosis criteria listed in study protocol

Exclusion criteria

1. Patient with mixed warm and cold autoimmune hemolytic anemia, or warm autoimmune hemolytic anemia
2. 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.

Trial design

400 participants in 2 patient groups

cold agglutinin disease (CAD)

Description:

Patient with a diagnosis of CAD as per investigator judgment based on the diagnosis criteria listed in study protocol. In addition, this group includes a cohort of CAD patients treated with sutimlimab

Treatment:

Drug: Sutimlimab

cold agglutinin syndrome (CAS)

Description:

Patient with a diagnosis of CAS as per investigator judgment based on the diagnosis criteria listed in study protocol