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 13 Dec 2024. Study ID: NCT05791708

The purpose of this study is to investigate cold agglutinin disease (CAD) and cold agglutinin syndrome (CAS). These conditions involve the immune system mistakenly attacking red blood cells at cold temperatures. The study will collect data on individuals with CAD or CAS to better understand these conditions.

Participants in the study will have their medical information collected over time. This includes those who have been treated with an investigational medication in previous studies. The study will help gather important data about the health and treatment of people with CAD or CAS.

  • Who can participate: Adults aged 18 and older diagnosed with CAD or CAS can participate if they provide informed consent, excluding those with mixed warm and cold autoimmune hemolytic anemia.
  • Study details: Participants will have their health information collected as part of the study to help researchers understand CAD and CAS better. If applicable, a placebo may be used, or participants may have taken part in previous studies involving an investigational medication.

Find a Study Location to Connect

What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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