Cold Agglutinin Disease Real World Evidence Registry

The purpose of this study is to collect information from people who have a condition called cold agglutinin disease (CAD) or cold agglutinin syndrome (CAS), and we would like to learn more about them. CAD is a rare autoimmune disease that can be identified by high concentrations of circulating cold sensitive antibodies and is also a form of autoimmune hemolytic anemia. The purpose of this study is also to collect safety and effectiveness information on a medicine called Enjaymo® used in the treatment of CAD.

In order to participate you must meet the following criteria:

• Are 18 years of age or older.
• Are able to understand the purpose of the study and have (or have a legally authorized representative who has) provided signed and dated informed consent and authorization to use protected health information in accordance with national and local subject privacy regulations.
• Have a diagnosis of CAD or CAS as per Investigator judgment based on the following diagnosis criteria:
  • CAD diagnostic criteria:
    • Monospecific direct antiglobulin test (DAT) strongly positive for C3d and negative or weakly positive for IgG and a cold agglutinin titer of 64 or greater. There may be occasional cases with cold agglutinin titer < 64, and those patients can still be enrolled at treating physicians’ discretion.
    • Additionally, patients may have a B-cell clonal lymphoproliferative disorder detectable in blood or bone marrow (regardless of the percentage of marrow involvement) as long as there is no overt evidence of malignancy. Overt malignancy is defined as any clinical or radiological evidence of lymphoma/malignancy.
  • CAS diagnostic criteria:
    • Meet CAD diagnostic criteria. Additionally, patients must have one of the following associated conditions identified as the cause of their CAS: infection, autoimmune disorder, overt malignancy including overt evidence of a B-cell lymphoproliferative disease. Overt disease is defined as any clinical or radiological evidence of lymphoma/malignancy. Should associated conditions be diagnosed after enrollment in the registry, they should be documented in the e-CRF, and initial diagnosis of CAD should be reclassified into CAS, if relevant.

You will be excluded from the study if any of the following criteria apply to you:

• Have mixed warm and cold autoimmune hemolytic anemia, or warm autoimmune hemolytic anemia.
• Are actively participating in a cold agglutinin disease or cold agglutinin syndrome interventional clinical trial. After a patient completes participation in said trial, he/she may be eligible for enrollment in this registry.

This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.