Cold Agglutinin Disease Real World Evidence Registry (CADENCE)

April 17, 2026 updated by: RECORDATI GROUP
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 Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

429

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Salzburg, Austria, 5020
        • Investigational Site Number : 3101
      • Vienna, Austria, 1090
        • Investigational Site Number : 3102
  • France
      • Amiens, France, 80054
        • Investigational Site Number : 3222
      • Angers, France, 49933
        • Investigational Site Number : 3214
      • Cesson-Sévigné, France, 35510
        • Investigational Site Number : 3204
      • Chalon-sur-Saône, France, 71100
        • Investigational Site Number : 3211
      • Corbeil-Essonnes, France, 91100
        • Investigational Site Number : 3206
      • Créteil, France, 94010
        • Investigational Site Number : 3201
      • Dijon, France, 21079
        • Investigational Site Number : 3219
      • Epagny-Metz-Tessy, France, 74370
        • Investigational Site Number : 3221
      • Paris, France, 75013
        • Investigational Site Number : 3217
      • Pau, France, 64000
        • Investigational Site Number : 3213
      • Pessac, France, 33600
        • Investigational Site Number : 3203
      • Poitiers, France, 86021
        • Investigational Site Number : 3216
      • Quimper, France, 2900
        • Investigational Site Number : 3202
      • Rennes, France, 35033
        • Investigational Site Number : 3220
      • Saint-Priest-en-Jarez, France, 42270
        • Investigational Site Number : 3205
      • Toulouse, France, 31059
        • Investigational Site Number : 3218
  • Germany
      • Essen, Germany, 45147
        • Investigational Site Number : 3301
      • Hanover, Germany, 30161
        • Investigational Site Number : 3306
      • Landshut, Germany, 84036
        • Investigational Site Number : 3302
  • Italy
      • Campobasso, Italy, 86100
        • Investigational Site Number : 3410
      • Novara, Italy, 28100
        • Investigational Site Number : 3403
      • Palermo, Italy, 90146
        • Investigational Site Number : 3411
      • Pavia, Italy, 27100
        • Investigational Site Number : 3415
      • Ravenna, Italy, 48121
        • Investigational Site Number : 3412
      • Reggio Calabria, Italy, 89133
        • Investigational Site Number : 3402
      • Roma, Italy, 00161
        • Investigational Site Number : 3404
      • Terni, Italy, 05100
        • Investigational Site Number : 3405
    • Lombardy
      • Brescia, Lombardy, Italy, 25123
        • Investigational Site Number : 3413
  • Japan
    • Fukushima
      • Fukushima, Fukushima, Japan, 960-1295
        • Investigational Site Number : 2203
    • Hyōgo
      • Himeji-shi, Hyōgo, Japan, 670-0063
        • Investigational Site Number : 2204
  • Spain
      • Madrid, Spain, 28034
        • Investigational Site Number : 3712
    • Barcelona [Barcelona]
      • Barcelona, Barcelona [Barcelona], Spain, 8036
        • Investigational Site Number : 3701
  • United Kingdom
      • Birmingham, United Kingdom, B15 2GW
        • Investigational Site Number : 3618
      • Harrow, United Kingdom, HA1 3UJ
        • Investigational Site Number : 3620
      • Leeds, United Kingdom, LS9 7TF
        • Investigational Site Number : 3612
      • Liverpool, United Kingdom, L7 8XP
        • Investigational Site Number : 3607
      • London, United Kingdom, E1 2ES
        • Investigational Site Number : 3621
    • Cornwall
      • Truro, Cornwall, United Kingdom, TR13LJ
        • Investigational Site Number : 3603
    • Cumbria
      • Carlisle, Cumbria, United Kingdom, CA2 7HY
        • Investigational Site Number : 3617
    • Kent
      • Gillingham, Kent, United Kingdom, ME75NY
        • Investigational Site Number : 3608
    • London, City of
      • London, London, City of, United Kingdom, NW1 2PG
        • Investigational Site Number : 3605
    • Manchester
      • Salford, Manchester, United Kingdom, M6 8HD
        • Investigational Site Number : 3602
    • North Lanarkshire
      • Airdrie, North Lanarkshire, United Kingdom, ML60JS
        • Investigational Site Number : 3623
    • North Tyneside
      • Newcastle upon Tyne, North Tyneside, United Kingdom, NE29 8NH
        • Investigational Site Number : 3601
    • North Yorkshire
      • Middlesbrough, North Yorkshire, United Kingdom, TS4 3BW
        • Investigational Site Number : 3613
    • Oxfordshire
      • Oxford, Oxfordshire, United Kingdom, OX3 7LE
        • Investigational Site Number : 3611
    • Somerset
      • Taunton, Somerset, United Kingdom, TA1 5DA
        • Investigational Site Number : 3606
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • University of Alabama at Birmingham Site Number : 1230
    • California
      • San Luis Obispo, California, United States, 93401
        • SLO Oncology and Hematology Site Number : 1235
      • Santa Maria, California, United States, 93454
        • Mission Hope Medical Oncology Site Number : 1241
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20007
        • MedStar Georgetown University Hospital / Lombardi Comprehensive Cancer Center Site Number : 1208
    • Georgia
      • Atlanta, Georgia, United States, 30290
        • Piedmont Cancer Institute, P.C Site Number : 1226
    • Illinois
      • Skokie, Illinois, United States, 60077
        • Orchard Heathcare Research Inc. Site Number : 1202
    • Iowa
      • Sioux City, Iowa, United States, 51101
        • Siouxland Regional Cancer Center dba June E. Nylen Cancer Center Site Number : 1220
    • Massachusetts
      • Worcester, Massachusetts, United States, 01608
        • Reliant Medical Group Site Number : 1205
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital Site Number : 1232
    • New York
      • Lake Success, New York, United States, 11042
        • 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
      • New York, New York, United States, 10021
        • Center for Blood Disorders Site Number : 1214
      • Syracuse, New York, United States, 13210
        • SUNY Upstate Medical University Site Number : 1221
    • North Carolina
      • Greenville, North Carolina, United States, 27834
        • Brody School of Medicine at East Carolina University Site Number : 1203
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation Site Number : 1207
      • Columbus, Ohio, United States, 43210
        • The Ohio State University Site Number : 1236
    • Oregon
      • Medford, Oregon, United States, 97504
        • Hematology Oncology Associates, PC Site Number : 1211
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15232
        • University of Pittsburgh Medical Center-UPMC Hillman Cancer Center Site Number : 1210
    • Tennessee
      • Knoxville, Tennessee, United States, 37920
        • UT Medical Center Cancer Institute Site Number : 1237
    • Washington
      • Seattle, Washington, United States, 98109
        • University of Washingtion Seattle Cancer Care Alliance Site Number : 1238

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Drug: Sutimlimab
CAD patients in Sutimlimab cohort must be treated according to routine clinical practice
cold agglutinin syndrome (CAS)
Patient with a diagnosis of CAS as per investigator judgment based on the diagnosis criteria listed in study protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patterns of CAD and CAS disease characteristics
Time Frame: 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.
Up to 6 years
Number of participants with CAD or CAS complications
Time Frame: 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.
Up to 6 years
Patterns of use of CAD and CAS treatments
Time Frame: 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.
Up to 6 years
Number of participants with health-resource utilization
Time Frame: 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
Up to 6 years
Cold Agglutinin Disease Symptoms and Impact Questionnaire (CAD-SIQ)
Time Frame: Up to 6 years
Up to 6 years
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)
Time Frame: Up to 6 years
Up to 6 years
36-Item Short Form Survey Instrument (SF-36) v2
Time Frame: Up to 6 years
Up to 6 years
Sutimlimab cohort: Sutimlimab treatment patterns
Time Frame: Up to 6 years
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)
Time Frame: Up to 6 years
Up to 6 years
Sutimlimab cohort: change from baseline in hemoglobin
Time Frame: From baseline up to 6 years
From baseline up to 6 years
Sutimlimab cohort: change from baseline in bilirubin
Time Frame: From baseline up to 6 years
From baseline up to 6 years
Sutimlimab cohort: change from baseline in Lactate dehydrogenase (LDH)
Time Frame: From baseline up to 6 years
From baseline up to 6 years
Sutimlimab cohort: number of blood cells transfusions
Time Frame: Up to 6 years
Up to 6 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RECORDATI GROUP

Investigators

  • Study Director: Ignacio Alvarez Rojo, RECORDATI GROUP

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 12, 2019

Primary Completion (Estimated)

November 2, 2028

Study Completion (Estimated)

November 2, 2028

Study Registration Dates

First Submitted

February 15, 2023

First Submitted That Met QC Criteria

March 28, 2023

First Posted (Actual)

March 30, 2023

Study Record Updates

Last Update Posted (Actual)

April 22, 2026

Last Update Submitted That Met QC Criteria

April 17, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OBS16454
  • EUPAS47940 (Registry Identifier: ENCePP)
  • U1111-1287-7090 (Registry Identifier: ICTRP)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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