Cold Agglutinin Disease (CAD)CADENCENCT05791708
Cold Agglutinin Disease Real World Evidence Registry
An observational study of Cold Agglutinin Disease (CAD) and Cold Agglutinin Syndrome (CAS), run by RECORDATI GROUP at 68 sites in 8 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cold Agglutinin Disease (CAD), Cold Agglutinin Syndrome (CAS)
- What is being tested?
- Sutimlimab
- How many people
- 429 participants
- Where
- 68 sitesin 8 countries
- Study dates
- 12 Dec 2019to 2 Nov 2028
- How long will I take part?
- 6 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
68 sites in 8 countries.
68 sites in 8 countries
United States19 sites
Piedmont Cancer Institute, P.C Site Number : 1226
Atlanta, Georgia, 30290
University of Alabama at Birmingham Site Number : 1230
Birmingham, Alabama, 35205
Cleveland Clinic Foundation Site Number : 1207
Cleveland, Ohio, 44195
The Ohio State University Site Number : 1236
Columbus, Ohio, 43210
Henry Ford Hospital Site Number : 1232
Detroit, Michigan, 48202
Brody School of Medicine at East Carolina University Site Number : 1203
Greenville, North Carolina, 27834
UT Medical Center Cancer Institute Site Number : 1237
Knoxville, Tennessee, 37920
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
Hematology Oncology Associates, PC Site Number : 1211
Medford, Oregon, 97504
Center for Blood Disorders Site Number : 1214
New York, New York, 10021
University of Pittsburgh Medical Center-UPMC Hillman Cancer Center Site Number : 1210
Pittsburgh, Pennsylvania, 15232
SLO Oncology and Hematology Site Number : 1235
San Luis Obispo, California, 93401
Mission Hope Medical Oncology Site Number : 1241
Santa Maria, California, 93454
University of Washingtion Seattle Cancer Care Alliance Site Number : 1238
Seattle, Washington, 98109
Siouxland Regional Cancer Center dba June E. Nylen Cancer Center Site Number : 1220
Sioux City, Iowa, 51101
Orchard Heathcare Research Inc. Site Number : 1202
Skokie, Illinois, 60077
SUNY Upstate Medical University Site Number : 1221
Syracuse, New York, 13210
MedStar Georgetown University Hospital / Lombardi Comprehensive Cancer Center Site Number : 1208
Washington D.C., District of Columbia, 20007
Reliant Medical Group Site Number : 1205
Worcester, Massachusetts, 01608
France16 sites
Investigational Site Number : 3222
Amiens, 80054
Investigational Site Number : 3214
Angers, 49933
Investigational Site Number : 3204
Cesson-Sévigné, 35510
Investigational Site Number : 3211
Chalon-sur-Saône, 71100
Investigational Site Number : 3206
Corbeil-Essonnes, 91100
Investigational Site Number : 3201
Créteil, 94010
Investigational Site Number : 3219
Dijon, 21079
Investigational Site Number : 3221
Epagny-Metz-Tessy, 74370
Investigational Site Number : 3217
Paris, 75013
Investigational Site Number : 3213
Pau, 64000
Investigational Site Number : 3203
Pessac, 33600
Investigational Site Number : 3216
Poitiers, 86021
Investigational Site Number : 3202
Quimper, 2900
Investigational Site Number : 3220
Rennes, 35033
Investigational Site Number : 3205
Saint-Priest-en-Jarez, 42270
Investigational Site Number : 3218
Toulouse, 31059
United Kingdom15 sites
Investigational Site Number : 3623
Airdrie, North Lanarkshire, ML60JS
Investigational Site Number : 3618
Birmingham, B15 2GW
Investigational Site Number : 3617
Carlisle, Cumbria, CA2 7HY
Investigational Site Number : 3608
Gillingham, Kent, ME75NY
Investigational Site Number : 3620
Harrow, HA1 3UJ
Investigational Site Number : 3612
Leeds, LS9 7TF
Investigational Site Number : 3607
Liverpool, L7 8XP
Investigational Site Number : 3605
London, London, City of, NW1 2PG
Investigational Site Number : 3621
London, E1 2ES
Investigational Site Number : 3613
Middlesbrough, North Yorkshire, TS4 3BW
Investigational Site Number : 3601
Newcastle upon Tyne, North Tyneside, NE29 8NH
Investigational Site Number : 3611
Oxford, Oxfordshire, OX3 7LE
Investigational Site Number : 3602
Salford, Manchester, M6 8HD
Investigational Site Number : 3606
Taunton, Somerset, TA1 5DA
Investigational Site Number : 3603
Truro, Cornwall, TR13LJ
Italy9 sites
Investigational Site Number : 3413
Brescia, Lombardy, 25123
Investigational Site Number : 3410
Campobasso, 86100
Investigational Site Number : 3403
Novara, 28100
Investigational Site Number : 3411
Palermo, 90146
Investigational Site Number : 3415
Pavia, 27100
Investigational Site Number : 3412
Ravenna, 48121
Investigational Site Number : 3402
Reggio Calabria, 89133
Investigational Site Number : 3404
Roma, 00161
Investigational Site Number : 3405
Terni, 05100
Germany3 sites
Investigational Site Number : 3301
Essen, 45147
Investigational Site Number : 3306
Hanover, 30161
Investigational Site Number : 3302
Landshut, 84036
Austria2 sites
Investigational Site Number : 3101
Salzburg, 5020
Investigational Site Number : 3102
Vienna, 1090
Japan2 sites
Investigational Site Number : 2203
Fukushima, Fukushima, 960-1295
Investigational Site Number : 2204
Himeji-shi, Hyōgo, 670-0063
Spain2 sites
Investigational Site Number : 3701
Barcelona, Barcelona [Barcelona], 8036
Investigational Site Number : 3712
Madrid, 28034
About this study
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.
- Being tested
- Sutimlimab
- Medical subject headings
- Anemia, Hemolytic, Autoimmune
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SutimlimabDrug
CAD patients in Sutimlimab cohort must be treated according to routine clinical practice
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Sutimlimab | |
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Up to 6 years
Cold Agglutinin Disease Symptoms and Impact Questionnaire (CAD-SIQ)
Measured: Up to 6 years
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)
Measured: Up to 6 years
36-Item Short Form Survey Instrument (SF-36) v2
Measured: Up to 6 years
Sutimlimab cohort: Sutimlimab treatment patterns
Sutimlimab dosing information, reasons for dose adjustments, reasons for discontinuation will be described.
Measured: 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)
Measured: Up to 6 years
Sutimlimab cohort: change from baseline in hemoglobin
Measured: From baseline up to 6 years
Sutimlimab cohort: change from baseline in bilirubin
Measured: From baseline up to 6 years
Sutimlimab cohort: change from baseline in Lactate dehydrogenase (LDH)
Measured: From baseline up to 6 years
Sutimlimab cohort: number of blood cells transfusions
Measured: Up to 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2023
- Study start12 Dec 2019
- Primary completion2 Nov 2028 (estimated)
- Study completion2 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cold Agglutinin Disease (CAD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 429 participants (actual)
- Target duration
- 6 Years
Sponsor and investigators
- Lead sponsor
- RECORDATI GROUP
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ignacio Alvarez Rojo, Study director, RECORDATI GROUP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05791708
- Sponsor's protocol ID
- OBS16454
- Other IDs
- EUPAS47940, U1111-1287-7090
- Acronym
- CADENCE
- Status last verified
- Apr 2026
- First submitted
- 15 Feb 2023
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cold Agglutinin Disease Real World Evidence Registry
- ClinicalTrials.gov ID
- NCT05791708
- Acronym / sponsor ID
- CADENCE / OBS16454
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 429 participants (actual)
- Lead sponsor
- RECORDATI GROUPIndustry (pharma, biotech, devices)
- Study start
- 12 Dec 2019 (actual)
- Primary completion
- 2 Nov 2028 (estimated)
- Study completion
- 2 Nov 2028 (estimated)
- First posted
- 30 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 6 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cold agglutinin disease (CAD) | – | Drug: SutimlimabPatient 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SutimlimabCAD patients in Sutimlimab cohort must be treated according to routine clinical practice | Drug | cold agglutinin disease (CAD) |
Primary outcome
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.
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.
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.
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
Cold Agglutinin Disease Symptoms and Impact Questionnaire (CAD-SIQ)
Time frame: Up to 6 years
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)
Time frame: Up to 6 years
36-Item Short Form Survey Instrument (SF-36) v2
Time frame: 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.
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
Sutimlimab cohort: change from baseline in hemoglobin
Time frame: From baseline up to 6 years
Sutimlimab cohort: change from baseline in bilirubin
Time frame: From baseline up to 6 years
Sutimlimab cohort: change from baseline in Lactate dehydrogenase (LDH)
Time frame: From baseline up to 6 years
Sutimlimab cohort: number of blood cells transfusions
Time frame: Up to 6 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Individual participant dataSharing planned: Yes. 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ignacio Alvarez Rojo study director
RECORDATI GROUP
68 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cold Agglutinin Disease (CAD) and Cold Agglutinin Syndrome (CAS), run by RECORDATI GROUP at 68 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 68 sites in United States, France, United Kingdom, Italy, Germany and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patterns of CAD and CAS disease characteristics (time frame: Up to 6 years). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.