Clinical trial

Cold Agglutinin Disease Real World Evidence Registry

Name

OBS16454

Description

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.

Trial arms

Trial start

2019-12-12

Estimated PCD

2028-11-02

Trial end

2028-11-02

Status

Recruiting

Treatment

Sutimlimab

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

Arms:

cold agglutinin disease (CAD)

Size

400

Primary endpoint

Patterns of CAD and CAS disease characteristics

Up to 6 years

Number of participants with CAD or CAS complications

Up to 6 years

Patterns of use of CAD and CAS treatments

Up to 6 years

Number of participants with health-resource utilization

Up to 6 years

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

Up to 6 years

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

Up to 6 years

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

Up to 6 years

Sutimlimab cohort: Sutimlimab treatment patterns

Up to 6 years

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)

Up to 6 years

Sutimlimab cohort: change from baseline in hemoglobin

From baseline up to 6 years

Sutimlimab cohort: change from baseline in bilirubin

From baseline up to 6 years

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

From baseline up to 6 years

Sutimlimab cohort: number of blood cells transfusions

Up to 6 years

Eligibility 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.

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': True, 'targetDuration': '6 Years', 'designInfo': {'observationalModel': 'OTHER', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 400, 'type': 'ESTIMATED'}}

Updated at

2024-03-28

1 organization

1 product

2 indications

Organization

Sanofi

Product

Sutimlimab

Indication

Cold Agglutinin Disease

Indication

Cold Agglutinin Syndrome