Cold Agglutinin Disease Real World Evidence Registry
- Conditions
- Cold Agglutinin Disease (CAD)Cold Agglutinin Syndrome (CAS)
- Interventions
- Registration Number
- NCT05791708
- Lead Sponsor
- Recordati Rare Diseases
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 400
- 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
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description cold agglutinin disease (CAD) Sutimlimab Patient with a diagnosis of CAD as per investigator judgment based on the diagnosis criteria listed in study protocol. In addition, this group includes a cohort of CAD patients treated with sutimlimab
- Primary Outcome Measures
Name Time Method 36-Item Short Form Survey Instrument (SF-36) v2 Up to 6 years Sutimlimab cohort: number of blood cells transfusions Up to 6 years Patterns of use of CAD and CAS treatments Up to 6 years 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.
Cold Agglutinin Disease Symptoms and Impact Questionnaire (CAD-SIQ) Up to 6 years Patterns of CAD and CAS disease characteristics Up to 6 years CAD or CAS characteristics at diagnosis, enrollment, and during follow up (e.g., criteria used for diagnosis, symptoms, laboratory results) will be described.
Number of participants with health-resource utilization Up to 6 years 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
Sutimlimab cohort: Sutimlimab treatment patterns Up to 6 years Sutimlimab dosing information, reasons for dose adjustments, reasons for discontinuation will be described.
Number of participants with CAD or CAS complications Up to 6 years 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.
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) 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 Lactate dehydrogenase (LDH) From baseline up to 6 years Sutimlimab cohort: change from baseline in bilirubin From baseline up to 6 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (68)
Investigational Site Number : 3405
🇮🇹Terni, Italy
Investigational Site Number : 3203
🇫🇷Pessac, France
Investigational Site Number : 3412
🇮🇹Ravenna, Italy
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, 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
🇦🇹Wien, Austria
Investigational Site Number : 3222
🇫🇷Amiens, France
Investigational Site Number : 3214
🇫🇷Angers, France
Investigational Site Number : 3204
🇫🇷Cesson Sevigne, France
Investigational Site Number : 3211
🇫🇷CHALON SUR SAONE Cedex, France
Investigational Site Number : 3206
🇫🇷Corbeil-Essonnes, France
Investigational Site Number : 3201
🇫🇷Creteil, 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 : 3216
🇫🇷Poitiers, France
Investigational Site Number : 3202
🇫🇷Quimper, France
Investigational Site Number : 3220
🇫🇷RENNES Cedex 09, France
Investigational Site Number : 3205
🇫🇷Saint Priest En Jarez, France
Investigational Site Number : 3218
🇫🇷TOULOUSE Cedex 9, France
Investigational Site Number : 3301
🇩🇪Essen, Germany
Investigational Site Number : 3306
🇩🇪Hannover, Germany
Investigational Site Number : 3302
🇩🇪Landshut, Germany
Investigational Site Number : 3413
🇮🇹Brescia, Lombardia, 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 : 3402
🇮🇹Reggio Calabria, Italy
Investigational Site Number : 3404
🇮🇹Roma, Italy
Investigational Site Number : 2203
🇯🇵Fukushima-shi, Fukushima, Japan
Investigational Site Number : 2204
🇯🇵Himeji-shi, Hyogo, 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