Cold Agglutinin Disease Real World Evidence Registry

Investigation of Cold Agglutinin Disease (CAD) and Syndrome (CAS) - Conditions Affecting Red Blood Cells

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). These are conditions where the immune system mistakenly attacks red blood cells at low temperatures, causing them to clump together. The purpose of this study is to collect data on participants with these conditions to better understand their experiences and health outcomes.

Participants in this study will be observed over time to gather information about their condition and treatment. The study will include a specific group of patients who have been treated with an investigational medication. This will help researchers collect valuable data on how these conditions are managed in a real-world setting.

  • Who can participate: Adults aged 18 and older who have been diagnosed with CAD or CAS can participate. They must be able to understand the study and provide consent. Patients currently in other interventional trials are not eligible until they complete those trials.
  • Study details: Participants will be observed and data will be collected about their health and treatment experiences. This study includes a cohort of patients treated with the investigational medication, sutimlimab. Participants will not receive any specific treatment as part of this study.

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