Cold Agglutinin Disease Real World Evidence Registry
CADENCE
3 other identifiers
observational
429
8 countries
68
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2019
Longer than P75 for all trials
68 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 12, 2019
CompletedFirst Submitted
Initial submission to the registry
February 15, 2023
CompletedFirst Posted
Study publicly available on registry
March 30, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 2, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 2, 2028
April 22, 2026
April 1, 2026
8.9 years
February 15, 2023
April 17, 2026
Conditions
Outcome Measures
Primary Outcomes (13)
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.
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.
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.
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
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
Sutimlimab dosing information, reasons for dose adjustments, reasons for discontinuation will be described.
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
Study Arms (2)
cold agglutinin disease (CAD)
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
cold agglutinin syndrome (CAS)
Patient with a diagnosis of CAS as per investigator judgment based on the diagnosis criteria listed in study protocol
Interventions
CAD patients in Sutimlimab cohort must be treated according to routine clinical practice
Eligibility Criteria
All patients with CAD or CAS will be eligible, regardless of the type of CAD or CAS-specific therapy they are receiving. In addition, the Cadence registry will include a sutimlimab cohort study whose objective is to assess the safety and the effectiveness of sutimlimab in patients with CAD in a real-world setting.
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- RECORDATI GROUPlead
Study Sites (68)
University of Alabama at Birmingham Site Number : 1230
Birmingham, Alabama, 35205, United States
SLO Oncology and Hematology Site Number : 1235
San Luis Obispo, California, 93401, United States
Mission Hope Medical Oncology Site Number : 1241
Santa Maria, California, 93454, United States
MedStar Georgetown University Hospital / Lombardi Comprehensive Cancer Center Site Number : 1208
Washington D.C., District of Columbia, 20007, United States
Piedmont Cancer Institute, P.C Site Number : 1226
Atlanta, Georgia, 30290, United States
Orchard Heathcare Research Inc. Site Number : 1202
Skokie, Illinois, 60077, United States
Siouxland Regional Cancer Center dba June E. Nylen Cancer Center Site Number : 1220
Sioux City, Iowa, 51101, United States
Reliant Medical Group Site Number : 1205
Worcester, Massachusetts, 01608, United States
Henry Ford Hospital Site Number : 1232
Detroit, Michigan, 48202, 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, 11042, United States
Center for Blood Disorders Site Number : 1214
New York, New York, 10021, United States
SUNY Upstate Medical University Site Number : 1221
Syracuse, New York, 13210, United States
Brody School of Medicine at East Carolina University Site Number : 1203
Greenville, North Carolina, 27834, United States
Cleveland Clinic Foundation Site Number : 1207
Cleveland, Ohio, 44195, United States
The Ohio State University Site Number : 1236
Columbus, Ohio, 43210, United States
Hematology Oncology Associates, PC Site Number : 1211
Medford, Oregon, 97504, United States
University of Pittsburgh Medical Center-UPMC Hillman Cancer Center Site Number : 1210
Pittsburgh, Pennsylvania, 15232, United States
UT Medical Center Cancer Institute Site Number : 1237
Knoxville, Tennessee, 37920, United States
University of Washingtion Seattle Cancer Care Alliance Site Number : 1238
Seattle, Washington, 98109, United States
Investigational Site Number : 3101
Salzburg, 5020, Austria
Investigational Site Number : 3102
Vienna, 1090, Austria
Investigational Site Number : 3222
Amiens, 80054, France
Investigational Site Number : 3214
Angers, 49933, France
Investigational Site Number : 3204
Cesson-Sévigné, 35510, France
Investigational Site Number : 3211
Chalon-sur-Saône, 71100, France
Investigational Site Number : 3206
Corbeil-Essonnes, 91100, France
Investigational Site Number : 3201
Créteil, 94010, France
Investigational Site Number : 3219
Dijon, 21079, France
Investigational Site Number : 3221
Epagny-Metz-Tessy, 74370, France
Investigational Site Number : 3217
Paris, 75013, France
Investigational Site Number : 3213
Pau, 64000, France
Investigational Site Number : 3203
Pessac, 33600, France
Investigational Site Number : 3216
Poitiers, 86021, France
Investigational Site Number : 3202
Quimper, 2900, France
Investigational Site Number : 3220
Rennes, 35033, France
Investigational Site Number : 3205
Saint-Priest-en-Jarez, 42270, France
Investigational Site Number : 3218
Toulouse, 31059, France
Investigational Site Number : 3301
Essen, 45147, Germany
Investigational Site Number : 3306
Hanover, 30161, Germany
Investigational Site Number : 3302
Landshut, 84036, Germany
Investigational Site Number : 3413
Brescia, Lombardy, 25123, Italy
Investigational Site Number : 3410
Campobasso, 86100, Italy
Investigational Site Number : 3403
Novara, 28100, Italy
Investigational Site Number : 3411
Palermo, 90146, Italy
Investigational Site Number : 3415
Pavia, 27100, Italy
Investigational Site Number : 3412
Ravenna, 48121, Italy
Investigational Site Number : 3402
Reggio Calabria, 89133, Italy
Investigational Site Number : 3404
Roma, 00161, Italy
Investigational Site Number : 3405
Terni, 05100, Italy
Investigational Site Number : 2203
Fukushima, Fukushima, 960-1295, Japan
Investigational Site Number : 2204
Himeji-shi, Hyōgo, 670-0063, Japan
Investigational Site Number : 3701
Barcelona, Barcelona [Barcelona], 8036, Spain
Investigational Site Number : 3712
Madrid, 28034, Spain
Investigational Site Number : 3603
Truro, Cornwall, TR13LJ, United Kingdom
Investigational Site Number : 3617
Carlisle, Cumbria, CA2 7HY, United Kingdom
Investigational Site Number : 3608
Gillingham, Kent, ME75NY, United Kingdom
Investigational Site Number : 3605
London, London, City of, NW1 2PG, United Kingdom
Investigational Site Number : 3602
Salford, Manchester, M6 8HD, United Kingdom
Investigational Site Number : 3623
Airdrie, North Lanarkshire, ML60JS, United Kingdom
Investigational Site Number : 3601
Newcastle upon Tyne, North Tyneside, NE29 8NH, United Kingdom
Investigational Site Number : 3613
Middlesbrough, North Yorkshire, TS4 3BW, United Kingdom
Investigational Site Number : 3611
Oxford, Oxfordshire, OX3 7LE, United Kingdom
Investigational Site Number : 3606
Taunton, Somerset, TA1 5DA, United Kingdom
Investigational Site Number : 3618
Birmingham, B15 2GW, United Kingdom
Investigational Site Number : 3620
Harrow, HA1 3UJ, United Kingdom
Investigational Site Number : 3612
Leeds, LS9 7TF, United Kingdom
Investigational Site Number : 3607
Liverpool, L7 8XP, United Kingdom
Investigational Site Number : 3621
London, E1 2ES, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ignacio Alvarez Rojo
RECORDATI GROUP
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Target Duration
- 6 Years
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 15, 2023
First Posted
March 30, 2023
Study Start
December 12, 2019
Primary Completion (Estimated)
November 2, 2028
Study Completion (Estimated)
November 2, 2028
Last Updated
April 22, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org.