RecruitingNCT05791708

Cold Agglutinin Disease Real World Evidence Registry

Sponsor

RECORDATI GROUP

Enrollment

400 participants

Start Date

Dec 12, 2019

Study Type

OBSERVATIONAL

Conditions

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

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is establishing a real-world data registry for patients with cold agglutinin disease (CAD) and cold agglutinin syndrome (CAS) — rare autoimmune blood disorders in which the immune system produces abnormal antibodies (called cold agglutinins) that attack red blood cells when the body temperature drops slightly, causing hemolytic anemia. Symptoms include fatigue, jaundice, and episodes of dark urine, and can be seriously debilitating. Because CAD and CAS are rare, there is limited real-world data on how patients are diagnosed, treated, and how they do over time. Participants must be adults (18 and older) diagnosed with CAD or CAS by their physician, who are able to provide informed consent and authorize the use of their health information. Patients with mixed warm-and-cold or pure warm autoimmune hemolytic anemia are excluded, as are those actively participating in an interventional CAD or CAS clinical trial (though they may join after completing such a trial). Participating patients contribute their health data — including diagnosis history, treatments received, and outcomes — to the registry, which will be analyzed over time. This research is valuable because building a large real-world dataset for rare diseases is the only way to understand how these conditions truly behave in practice, which treatment strategies work best, and where gaps in care exist — ultimately improving the standard of care for all patients with CAD and CAS.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSutimlimab

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

Locations(68)

University of Alabama at Birmingham Site Number : 1230

Birmingham, Alabama, United States

SLO Oncology and Hematology Site Number : 1235

San Luis Obispo, California, United States

Mission Hope Medical Oncology Site Number : 1241

Santa Maria, California, United States

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

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

Piedmont Cancer Institute, P.C Site Number : 1226

Atlanta, Georgia, United States

Orchard Heathcare Research Inc. Site Number : 1202

Skokie, Illinois, United States

Siouxland Regional Cancer Center dba June E. Nylen Cancer Center Site Number : 1220

Sioux City, Iowa, United States

Reliant Medical Group Site Number : 1205

Worcester, Massachusetts, United States

Henry Ford Hospital Site Number : 1232

Detroit, Michigan, United States

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

Center for Blood Disorders Site Number : 1214

New York, New York, United States

SUNY Upstate Medical University Site Number : 1221

Syracuse, New York, United States

Brody School of Medicine at East Carolina University Site Number : 1203

Greenville, North Carolina, United States

Cleveland Clinic Foundation Site Number : 1207

Cleveland, Ohio, United States

The Ohio State University Site Number : 1236

Columbus, Ohio, United States

Hematology Oncology Associates, PC Site Number : 1211

Medford, Oregon, United States

University of Pittsburgh Medical Center-UPMC Hillman Cancer Center Site Number : 1210

Pittsburgh, Pennsylvania, United States

UT Medical Center Cancer Institute Site Number : 1237

Knoxville, Tennessee, United States

University of Washingtion Seattle Cancer Care Alliance Site Number : 1238

Seattle, Washington, United States

Investigational Site Number : 3101

Salzburg, Austria

Investigational Site Number : 3102

Vienna, Austria

Investigational Site Number : 3222

Amiens, France

Investigational Site Number : 3214

Angers, France

Investigational Site Number : 3204

Cesson-Sévigné, France

Investigational Site Number : 3211

Chalon-sur-Saône, France

Investigational Site Number : 3206

Corbeil-Essonnes, France

Investigational Site Number : 3201

Créteil, France

Investigational Site Number : 3219

Dijon, France

Investigational Site Number : 3221

Epagny-Metz-Tessy, France

Investigational Site Number : 3217

Paris, France

Investigational Site Number : 3213

Pau, France

Investigational Site Number : 3203

Pessac, France

Investigational Site Number : 3216

Poitiers, France

Investigational Site Number : 3202

Quimper, France

Investigational Site Number : 3220

Rennes, France

Investigational Site Number : 3205

Saint-Priest-en-Jarez, France

Investigational Site Number : 3218

Toulouse, France

Investigational Site Number : 3301

Essen, Germany

Investigational Site Number : 3306

Hanover, Germany

Investigational Site Number : 3302

Landshut, Germany

Investigational Site Number : 3413

Brescia, Lombardy, Italy

Investigational Site Number : 3410

Campobasso, Italy

Investigational Site Number : 3403

Novara, Italy

Investigational Site Number : 3411

Palermo, Italy

Investigational Site Number : 3415

Pavia, Italy

Investigational Site Number : 3412

Ravenna, Italy

Investigational Site Number : 3402

Reggio Calabria, Italy

Investigational Site Number : 3404

Roma, Italy

Investigational Site Number : 3405

Terni, Italy

Investigational Site Number : 2203

Fukushima, Fukushima, Japan

Investigational Site Number : 2204

Himeji-shi, Hyōgo, Japan

Investigational Site Number : 3701

Barcelona, Barcelona [Barcelona], Spain

Investigational Site Number : 3712

Madrid, Spain

Investigational Site Number : 3603

Truro, Cornwall, United Kingdom

Investigational Site Number : 3617

Carlisle, Cumbria, United Kingdom

Investigational Site Number : 3608

Gillingham, Kent, United Kingdom

Investigational Site Number : 3605

London, London, City of, United Kingdom

Investigational Site Number : 3602

Salford, Manchester, United Kingdom

Investigational Site Number : 3623

Airdrie, North Lanarkshire, United Kingdom

Investigational Site Number : 3601

Newcastle upon Tyne, North Tyneside, United Kingdom

Investigational Site Number : 3613

Middlesbrough, North Yorkshire, United Kingdom

Investigational Site Number : 3611

Oxford, Oxfordshire, United Kingdom

Investigational Site Number : 3606

Taunton, Somerset, United Kingdom

Investigational Site Number : 3618

Birmingham, United Kingdom

Investigational Site Number : 3620

Harrow, United Kingdom

Investigational Site Number : 3612

Leeds, United Kingdom

Investigational Site Number : 3607

Liverpool, United Kingdom

Investigational Site Number : 3621

London, United Kingdom

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NCT05791708