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NCT Number: NCT05791708

Cold Agglutinin Disease Real World Evidence Registry

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Cold Agglutinin Disease (CAD) Anemia Anemia, Hemolytic Anemia, Hemolytic, Autoimmune Autoimmune Diseases Cold Agglutinin Syndrome (CAS) Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Investigational Site Number : 3101, Salzburg, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient aged ≥18 years
  • 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
  • Patient with a diagnosis of CAD or CAS as per Investigator judgment based on the diagnosis criteria listed in study protocol

Exclusion criteria

  • Patient with mixed warm and cold autoimmune hemolytic anemia, or warm autoimmune hemolytic anemia
  • 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.

Treatment and study plan

Sutimlimab

Drug

CAD patients in Sutimlimab cohort must be treated according to routine clinical practice

Primary outcomes

  1. Patterns of CAD and CAS disease characteristics

    Time frame: Up to 6 years

    CAD or CAS characteristics at diagnosis, enrollment, and during follow up (e.g., criteria used for diagnosis, symptoms, laboratory results) will be described.

  2. Number of participants with CAD or CAS complications

    Time frame: Up to 6 years

    Thromboembolic events (venous, arterial or cerebral), deaths related to CAD or CAS, other CAD/CAS complications (e.g., acute hemolytic crisis, hemolysis-related complications), and other comorbid conditions occurring before enrollment, at enrollment, and during follow up will be described.

  3. Patterns of use of CAD and CAS treatments

    Time frame: Up to 6 years

    CAD or CAS treatments received before enrollment, at enrollment, and during the follow up period will be summarized. CAD or CAS symptoms and complications, autoimmune disorders or lymphoproliferative disorders, physician assessment of treatment status, and changes in laboratory results will be described by CAD or CAS treatments.

  4. Number of participants with health-resource utilization

    Time frame: Up to 6 years

    Health resource utilization may include hospitalizations (including length of stay), outpatient visits, emergency room visits, specific transfusion visits, nursing home/rehabilitation center stays, and home healthcare visits during registry follow-up period

  5. Cold Agglutinin Disease Symptoms and Impact Questionnaire (CAD-SIQ)

    Time frame: Up to 6 years

  6. Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)

    Time frame: Up to 6 years

  7. 36-Item Short Form Survey Instrument (SF-36) v2

    Time frame: Up to 6 years

  8. Sutimlimab cohort: Sutimlimab treatment patterns

    Time frame: Up to 6 years

    Sutimlimab dosing information, reasons for dose adjustments, reasons for discontinuation will be described.

  9. Sutimlimab cohort: Number of participants with adverse events, serious adverse events, adverse events of special interests (AESIs), other events of interests (e.g., Treatment emergent)

    Time frame: Up to 6 years

  10. Sutimlimab cohort: change from baseline in hemoglobin

    Time frame: From baseline up to 6 years

  11. Sutimlimab cohort: change from baseline in bilirubin

    Time frame: From baseline up to 6 years

  12. Sutimlimab cohort: change from baseline in Lactate dehydrogenase (LDH)

    Time frame: From baseline up to 6 years

  13. Sutimlimab cohort: number of blood cells transfusions

    Time frame: Up to 6 years

Sponsors and collaborators

Lead sponsor

RECORDATI GROUP

Industry

Registry information

Acronym: CADENCE

Important dates

Study start
2019
Primary completion
2028
Study completion
2028
First posted
Mar 30, 2023
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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