Active — Not RecruitingNot Applicable

Cold Agglutinin Disease Real World Evidence Registry

United States, Austria, France429 participantsStarted 2019-12-12

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Patterns of CAD and CAS disease characteristics

Timeframe: Up to 6 years

Number of participants with CAD or CAS complications

Timeframe: Up to 6 years

Patterns of use of CAD and CAS treatments

Timeframe: Up to 6 years

Number of participants with health-resource utilization

Timeframe: Up to 6 years

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

Timeframe: Up to 6 years

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

Timeframe: Up to 6 years

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

Timeframe: Up to 6 years

Trial details

NCT IDNCT05791708

SponsorRECORDATI GROUP

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2028-11-02

View on ClinicalTrials.gov More Cold Agglutinin Disease (CAD) trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Patterns of CAD and CAS disease characteristics

Timeframe: Up to 6 years

Number of participants with CAD or CAS complications

Timeframe: Up to 6 years

Patterns of use of CAD and CAS treatments

Timeframe: Up to 6 years

Number of participants with health-resource utilization

Timeframe: Up to 6 years

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

Timeframe: Up to 6 years

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

Timeframe: Up to 6 years

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

Timeframe: Up to 6 years