Cold Agglutinin Disease Real World Evidence Registry

Study on Cold Agglutinin Disease and Syndrome

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 24 Feb 2025. Study ID: NCT05791708

This study investigates cold agglutinin disease (CAD) and cold agglutinin syndrome (CAS). CAD and CAS are rare conditions where the immune system mistakenly attacks and destroys red blood cells, especially at lower temperatures. The purpose of this study is to collect data from patients with these conditions to better understand their experiences and outcomes.

Participants will be observed over time and data will be collected on their health and treatment responses. A group of patients treated with an investigational medication will also be included in the study. This will help researchers gather information on the long-term effects and safety of the treatment.

  • Who can participate: Adults aged 18 years and older with CAD or CAS can participate. They must understand the study, provide informed consent, and not be in other CAD or CAS trials.
  • Study details: Participants will take part in a registry where data about their condition and treatments will be collected over time. Some participants will have been treated with an investigational medication. A placebo is not involved in this study.

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