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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05791708
Other study ID # OBS16454
Secondary ID EUPAS47940U1111-
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


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
See also
  Status Clinical Trial Phase
Completed NCT02502903 - Safety, Tolerability and Activity of BIVV009 in Healthy Volunteers and Patients With Complement Mediated Disorders Phase 1
Terminated NCT05086744 - Basket Study to Assess Efficacy, Safety and PK of Iptacopan (LNP023) in Autoimmune Benign Hematological Disorders Phase 2