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Registry for patients with Cold Agglutinin Disease

Cold Agglutinin Disease Real World Evidence Registry

Observational Recordati Rare Diseases · NCT05791708

This study is gathering information from adults with Cold Agglutinin Disease who have been treated with a specific medication to see how well it works and how the disease progresses over time.

Quick facts

Study typeObservational
Enrollment400 (estimated)
Ages18 Years and up
SexAll
SponsorRecordati Rare Diseases Industry-sponsored
Drugs / interventionssutimlimab
Locations68 sites (Birmingham, Alabama and 67 other locations)
Trial IDNCT05791708 on ClinicalTrials.gov

What this trial studies

This observational registry aims to collect real-world data on patients diagnosed with Cold Agglutinin Disease (CAD) or Cold Agglutinin Syndrome (CAS). It will include a cohort of at least 30 patients who have been treated with sutimlimab, allowing researchers to gather insights on treatment outcomes and disease progression. Participants must be at least 18 years old and provide informed consent, with eligibility based on specific diagnostic criteria. The registry will track patient data over time to better understand CAD and CAS in a real-world setting.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older diagnosed with Cold Agglutinin Disease or Cold Agglutinin Syndrome.

Not a fit: Patients with mixed warm and cold autoimmune hemolytic anemia or those currently participating in other interventional clinical trials may not benefit from this registry.

Why it matters

Potential benefit: If successful, this registry could enhance understanding of Cold Agglutinin Disease and improve treatment strategies for patients.

How similar studies have performed: While this registry approach is observational, previous studies involving sutimlimab have shown promise in treating CAD, suggesting potential for success in this context.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Birmingham, Alabama and 67 other locations

+18 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Cold Agglutinin DiseaseCold Agglutinin Syndrome
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.