Cold Agglutinin Disease Real World Evidence Registry

Cold Agglutinin Disease (CAD) Clinical Trial

— CADENCE  

Official title:

Cold Agglutinin Disease Real World Evidence Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05791708
• Other study ID #: OBS16454
• Secondary ID: EUPAS47940U1111-
• Status: Recruiting
• Start date: December 12, 2019
• Est. completion date: November 2, 2028

Study information

• Verified date: March 2024
• Source: Sanofi
• Contact: Trial Transparency email recommended (Toll free number for US &
• Phone: 800-633-1610
• Email: Contact-US[@]sanofi.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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). 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: November 2, 2028
• Est. primary completion date: November 2, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anemia, Hemolytic, Autoimmune
• Cold Agglutinin Disease (CAD)

Intervention

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

Locations

Country	Name	City	State
Austria	Investigational Site Number : 3101	Salzburg
Austria	Investigational Site Number : 3102	Wien
France	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 : 3203	Pessac
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
Germany	Investigational Site Number : 3301	Essen
Germany	Investigational Site Number : 3306	Hannover
Germany	Investigational Site Number : 3302	Landshut
Italy	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 : 3412	Ravenna
Italy	Investigational Site Number : 3402	Reggio Calabria
Italy	Investigational Site Number : 3404	Roma
Italy	Investigational Site Number : 3405	Terni
Japan	Investigational Site Number : 2203	Fukushima-shi	Fukushima
Japan	Investigational Site Number : 2204	Himeji-shi	Hyogo
Spain	Investigational Site Number : 3701	Barcelona	Barcelona [Barcelona]
Spain	Investigational Site Number : 3712	Madrid
United Kingdom	Investigational Site Number : 3623	Airdrie	North Lanarkshire
United Kingdom	Investigational Site Number : 3618	Birmingham
United Kingdom	Investigational Site Number : 3617	Carlisle	Cumbria
United Kingdom	Investigational Site Number : 3608	Gillingham	Kent
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 : 3605	London	London, City Of
United Kingdom	Investigational Site Number : 3621	London
United Kingdom	Investigational Site Number : 3613	Middlesbrough	North Yorkshire
United Kingdom	Investigational Site Number : 3611	Oxford	Oxfordshire
United Kingdom	Investigational Site Number : 3602	Salford	Manchester
United Kingdom	Investigational Site Number : 3606	Taunton	Somerset
United Kingdom	Investigational Site Number : 3603	Truro	Cornwall
United Kingdom	Investigational Site Number : 3601	Tyne And Wear	North Tyneside
United States	Piedmont Cancer Institute, P.C Site Number : 1226	Atlanta	Georgia
United States	University of Alabama at Birmingham Site Number : 1230	Birmingham	Alabama
United States	Cleveland Clinic Foundation Site Number : 1207	Cleveland	Ohio
United States	The Ohio State University Site Number : 1236	Columbus	Ohio
United States	Henry Ford Hospital Site Number : 1232	Detroit	Michigan
United States	Brody School of Medicine at East Carolina University Site Number : 1203	Greenville	North Carolina
United States	UT Medical Center Cancer Institute Site Number : 1237	Knoxville	Tennessee
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	Hematology Oncology Associates, PC Site Number : 1211	Medford	Oregon
United States	Center for Blood Disorders Site Number : 1214	New York	New York
United States	University of Pittsburgh Medical Center-UPMC Hillman Cancer Center Site Number : 1210	Pittsburgh	Pennsylvania
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	University of Washingtion Seattle Cancer Care Alliance Site Number : 1238	Seattle	Washington
United States	Siouxland Regional Cancer Center dba June E. Nylen Cancer Center Site Number : 1220	Sioux City	Iowa
United States	Orchard Heathcare Research Inc. Site Number : 1202	Skokie	Illinois
United States	SUNY Upstate Medical University Site Number : 1221	Syracuse	New York
United States	MedStar Georgetown University Hospital / Lombardi Comprehensive Cancer Center Site Number : 1208	Washington	District of Columbia
United States	Reliant Medical Group Site Number : 1205	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

United States,  Austria,  France,  Germany,  Italy,  Japan,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Cold Agglutinin Disease Symptoms and Impact Questionnaire (CAD-SIQ)		Up to 6 years
Primary	Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)		Up to 6 years
Primary	36-Item Short Form Survey Instrument (SF-36) v2		Up to 6 years
Primary	Sutimlimab cohort: Sutimlimab treatment patterns	Sutimlimab dosing information, reasons for dose adjustments, reasons for discontinuation will be described.	Up to 6 years
Primary	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
Primary	Sutimlimab cohort: change from baseline in hemoglobin		From baseline up to 6 years
Primary	Sutimlimab cohort: change from baseline in bilirubin		From baseline up to 6 years
Primary	Sutimlimab cohort: change from baseline in Lactate dehydrogenase (LDH)		From baseline up to 6 years
Primary	Sutimlimab cohort: number of blood cells transfusions		Up to 6 years