Cold Agglutinin Disease Real World Evidence Registry

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.

Conditions

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

Talk to us

Study Overview

On this page

Study Details

Study 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.

Cold Agglutinin Disease Real World Evidence Registry

Cold Agglutinin Disease Real World Evidence Registry

Condition
Cold Agglutinin Disease (CAD)
Intervention / Treatment

-

Contacts and Locations

Birmingham

University of Alabama at Birmingham Site Number : 1230, Birmingham, Alabama, United States, 35205

San Luis Obispo

SLO Oncology and Hematology Site Number : 1235, San Luis Obispo, California, United States, 93401

Santa Maria

Mission Hope Medical Oncology Site Number : 1241, Santa Maria, California, United States, 93454

Washington

MedStar Georgetown University Hospital / Lombardi Comprehensive Cancer Center Site Number : 1208, Washington, District of Columbia, United States, 20007

Atlanta

Piedmont Cancer Institute, P.C Site Number : 1226, Atlanta, Georgia, United States, 30290

Skokie

Orchard Heathcare Research Inc. Site Number : 1202, Skokie, Illinois, United States, 60077

Sioux City

Siouxland Regional Cancer Center dba June E. Nylen Cancer Center Site Number : 1220, Sioux City, Iowa, United States, 51101

Worcester

Reliant Medical Group Site Number : 1205, Worcester, Massachusetts, United States, 01608

Detroit

Henry Ford Hospital Site Number : 1232, Detroit, Michigan, United States, 48202

Lake Success

Northwell Health-Monter Cancer Center-North Shore University Hospital and Steven and Alexandra Cohen Children's Medical Center of New York (Schneider Children's Hospital)-North Shore Long Island Jewis Site Number : 1231, Lake Success, New York, United States, 11042

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Sanofi,

Clinical Sciences & Operations, STUDY_DIRECTOR, Sanofi

Study Record Dates

2028-11-02