Cold Agglutinin Disease Real World Evidence Registry

Status: Recruiting
Location: See all (68) locations...
Intervention Type: Drug
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Alabama
University of Alabama at Birmingham Site Number : 1230
RECRUITING
Birmingham
California
SLO Oncology and Hematology Site Number : 1235
RECRUITING
San Luis Obispo
Mission Hope Medical Oncology Site Number : 1241
RECRUITING
Santa Maria
Washington, D.c.
MedStar Georgetown University Hospital / Lombardi Comprehensive Cancer Center Site Number : 1208
RECRUITING
Washington D.c.
Georgia
Piedmont Cancer Institute, P.C Site Number : 1226
RECRUITING
Atlanta
Iowa
Siouxland Regional Cancer Center dba June E. Nylen Cancer Center Site Number : 1220
RECRUITING
Sioux City
Illinois
Orchard Heathcare Research Inc. Site Number : 1202
RECRUITING
Skokie
Massachusetts
Reliant Medical Group Site Number : 1205
RECRUITING
Worcester
Michigan
Henry Ford Hospital Site Number : 1232
RECRUITING
Detroit
North Carolina
Brody School of Medicine at East Carolina University Site Number : 1203
RECRUITING
Greenville
New York
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
RECRUITING
Lake Success
Center for Blood Disorders Site Number : 1214
RECRUITING
New York
SUNY Upstate Medical University Site Number : 1221
RECRUITING
Syracuse
Ohio
Cleveland Clinic Foundation Site Number : 1207
RECRUITING
Cleveland
The Ohio State University Site Number : 1236
RECRUITING
Columbus
Oregon
Hematology Oncology Associates, PC Site Number : 1211
RECRUITING
Medford
Pennsylvania
University of Pittsburgh Medical Center-UPMC Hillman Cancer Center Site Number : 1210
RECRUITING
Pittsburgh
Tennessee
UT Medical Center Cancer Institute Site Number : 1237
RECRUITING
Knoxville
Washington
University of Washingtion Seattle Cancer Care Alliance Site Number : 1238
RECRUITING
Seattle
Other Locations
Austria
Investigational Site Number : 3101
RECRUITING
Salzburg
Investigational Site Number : 3102
RECRUITING
Vienna
France
Investigational Site Number : 3222
RECRUITING
Amiens
Investigational Site Number : 3214
RECRUITING
Angers
Investigational Site Number : 3204
RECRUITING
Cesson-sévigné
Investigational Site Number : 3211
RECRUITING
Chalon-sur-saône
Investigational Site Number : 3206
RECRUITING
Corbeil-essonnes
Investigational Site Number : 3201
RECRUITING
Créteil
Investigational Site Number : 3219
RECRUITING
Dijon
Investigational Site Number : 3221
RECRUITING
Epagny-metz-tessy
Investigational Site Number : 3217
RECRUITING
Paris
Investigational Site Number : 3213
RECRUITING
Pau
Investigational Site Number : 3203
RECRUITING
Pessac
Investigational Site Number : 3216
RECRUITING
Poitiers
Investigational Site Number : 3202
RECRUITING
Quimper
Investigational Site Number : 3220
RECRUITING
Rennes
Investigational Site Number : 3205
RECRUITING
Saint-priest-en-jarez
Investigational Site Number : 3218
RECRUITING
Toulouse
Germany
Investigational Site Number : 3301
RECRUITING
Essen
Investigational Site Number : 3306
RECRUITING
Hanover
Investigational Site Number : 3302
RECRUITING
Landshut
Italy
Investigational Site Number : 3413
RECRUITING
Brescia
Investigational Site Number : 3410
RECRUITING
Campobasso
Investigational Site Number : 3403
RECRUITING
Novara
Investigational Site Number : 3411
RECRUITING
Palermo
Investigational Site Number : 3415
RECRUITING
Pavia
Investigational Site Number : 3412
RECRUITING
Ravenna
Investigational Site Number : 3402
RECRUITING
Reggio Calabria
Investigational Site Number : 3404
RECRUITING
Roma
Investigational Site Number : 3405
RECRUITING
Terni
Japan
Investigational Site Number : 2203
RECRUITING
Fukushima
Investigational Site Number : 2204
RECRUITING
Himeji-shi
Spain
Investigational Site Number : 3701
RECRUITING
Barcelona
Investigational Site Number : 3712
RECRUITING
Madrid
United Kingdom
Investigational Site Number : 3623
RECRUITING
Airdrie
Investigational Site Number : 3618
RECRUITING
Birmingham
Investigational Site Number : 3617
RECRUITING
Carlisle
Investigational Site Number : 3608
RECRUITING
Gillingham
Investigational Site Number : 3620
RECRUITING
Harrow
Investigational Site Number : 3612
RECRUITING
Leeds
Investigational Site Number : 3607
RECRUITING
Liverpool
Investigational Site Number : 3605
RECRUITING
London
Investigational Site Number : 3621
RECRUITING
London
Investigational Site Number : 3613
RECRUITING
Middlesbrough
Investigational Site Number : 3601
RECRUITING
Newcastle Upon Tyne
Investigational Site Number : 3611
RECRUITING
Oxford
Investigational Site Number : 3602
RECRUITING
Salford
Investigational Site Number : 3606
RECRUITING
Taunton
Investigational Site Number : 3603
RECRUITING
Truro
Contact Information
Primary
Ignacio Alvarez Rojo, MD
ignacio.alvarez@recordati.com
+34677614858
Backup
Beatrice Martin
martin.be@recordati.com
Time Frame
Start Date: 2019-12-12
Estimated Completion Date: 2028-11-02
Participants
Target number of participants: 400
Treatments
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
Sponsors
Leads: Recordati Rare Diseases

This content was sourced from clinicaltrials.gov