Cold Agglutinin Disease Real World Evidence Registry

Observational Study of Cold Agglutinin Disease and Syndrome Through a Patient Registry

Recruiting
18 years or above
All
Phase N/A
400 participants needed
19 Locations

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)
  • Age: 18 years or above
  • Gender: All

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.

Updated on 28 Mar 2024. Study ID: NCT05791708

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 collect data from participants with these conditions to better understand their treatment and progression.

Participants will be observed over time without altering their treatment. This is an observational study, meaning it does not involve experimental treatments. Some participants may be part of a specific group receiving an investigational medication called sutimlimab, which is being studied for its effects on CAD. An observational study is a type of research study where data is collected by observing participants receiving routine care, without changing their treatment, which may focus on people using specific medications or having certain conditions to better understand how treatments work.

  • Who can participate: Adults aged 18 years or older with a diagnosis of CAD or CAS can participate if they understand the study and consent to share their health information.
  • Study details: Participants will provide their health data over time, contributing to a registry that helps researchers understand CAD and CAS. This study does not involve any changes to current treatments, focusing instead on observing existing care.

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