Cold Agglutinin Disease Real World Evidence Registry

RECORDATI GROUP400 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

400

Conditions

Cold Agglutinin Disease (CAD)Cold Agglutinin Syndrome (CAS)

Interventions

SutimlimabDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (68)

University of Alabama at Birmingham Site Number : 1230

Birmingham, Alabama, United States

RECRUITING

SLO Oncology and Hematology Site Number : 1235

San Luis Obispo, California, United States

RECRUITING

Mission Hope Medical Oncology Site Number : 1241

Santa Maria, California, United States

RECRUITING

MedStar Georgetown University Hospital / Lombardi Comprehensive Cancer Center Site Number : 1208

Washington D.C., District of Columbia, United States

Outcomes

Primary Outcomes

Patterns of CAD and CAS disease characteristics

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

Time frame: Up to 6 years

Number of participants with CAD or CAS complications

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.

Time frame: Up to 6 years

Patterns of use of CAD and CAS treatments

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.

Time frame: Up to 6 years

Number of participants with health-resource utilization

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

Time frame: Up to 6 years

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

Time frame: Up to 6 years

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

Time frame: Up to 6 years

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

Time frame: Up to 6 years

Sutimlimab cohort: Sutimlimab treatment patterns

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

Time frame: 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)

Time frame: Up to 6 years

Sutimlimab cohort: change from baseline in hemoglobin

Time frame: From baseline up to 6 years

Sutimlimab cohort: change from baseline in bilirubin

Time frame: From baseline up to 6 years

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

Time frame: From baseline up to 6 years

Sutimlimab cohort: number of blood cells transfusions

Time frame: Up to 6 years

Cold Agglutinin Disease Real World Evidence Registry

Overview

Conditions

Interventions

Eligibility

Locations (68)

Outcomes

Primary Outcomes

Central Contacts