Cold Agglutinin Disease Real World Evidence Registry

Last updated: March 27, 2024
Sponsor: Sanofi
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Sutimlimab

Clinical Study ID

NCT05791708
OBS16454
U1111-1287-7090
EUPAS47940
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  1. Patient aged ≥18 years
  2. Patient able to understand the purpose of the study and who (or whose legallyauthorized representative) provided signed and dated informed consent andauthorization to use protected health information in accordance with national andlocal subject privacy regulations
  3. Patient with a diagnosis of CAD or CAS as per Investigator judgment based on thediagnosis criteria listed in study protocol

Exclusion

Exclusion Criteria:

  1. Patient with mixed warm and cold autoimmune hemolytic anemia, or warm autoimmunehemolytic anemia
  2. Patient actively participating in a CAD or CAS interventional clinical trial. After apatient completes participation in said trial, he/she may be eligible for enrollmentin this registry.

Study Design

Total Participants: 400
Treatment Group(s): 1
Primary Treatment: Sutimlimab
Phase:
Study Start date:
December 12, 2019
Estimated Completion Date:
November 02, 2028

Connect with a study center

  • Investigational Site Number : 3101

    Salzburg, 5020
    Austria

    Active - Recruiting

  • Investigational Site Number : 3102

    Wien, 1090
    Austria

    Active - Recruiting

  • Investigational Site Number : 3222

    Amiens, 80054
    France

    Active - Recruiting

  • Investigational Site Number : 3214

    Angers, 49933
    France

    Active - Recruiting

  • Investigational Site Number : 3211

    CHALON SUR SAONE Cedex, 71100
    France

    Active - Recruiting

  • Investigational Site Number : 3204

    Cesson Sevigne, 35510
    France

    Active - Recruiting

  • Investigational Site Number : 3206

    Corbeil-Essonnes, 91100
    France

    Active - Recruiting

  • Investigational Site Number : 3201

    Creteil, 94010
    France

    Active - Recruiting

  • Investigational Site Number :3201

    Creteil, 94010
    France

    Active - Recruiting

  • Investigational Site Number : 3219

    Dijon, 21079
    France

    Active - Recruiting

  • Investigational Site Number : 3221

    Epagny Metz-Tessy, 74370
    France

    Active - Recruiting

  • Investigational Site Number : 3217

    Paris, 75013
    France

    Active - Recruiting

  • Investigational Site Number : 3213

    Pau, 64000
    France

    Active - Recruiting

  • Investigational Site Number : 3203

    Pessac, 33600
    France

    Active - Recruiting

  • Investigational Site Number : 3216

    Poitiers, 86021
    France

    Active - Recruiting

  • Investigational Site Number : 3202

    Quimper, 2900
    France

    Active - Recruiting

  • Investigational Site Number : 3220

    RENNES Cedex 09, 35033
    France

    Active - Recruiting

  • Investigational Site Number : 3205

    Saint Priest En Jarez, 42270
    France

    Active - Recruiting

  • Investigational Site Number :3205

    Saint Priest En Jarez, 42270
    France

    Active - Recruiting

  • Investigational Site Number : 3209

    Suresnes, 92150
    France

    Site Not Available

  • Investigational Site Number : 3218

    TOULOUSE Cedex 9, 31059
    France

    Active - Recruiting

  • Investigational Site Number : 3301

    Essen, 45147
    Germany

    Active - Recruiting

  • Investigational Site Number : 3306

    Hannover, 30161
    Germany

    Active - Recruiting

  • Investigational Site Number : 3302

    Landshut, 84036
    Germany

    Active - Recruiting

  • Investigational Site Number : 3413

    Brescia, Lombardia 25123
    Italy

    Active - Recruiting

  • Investigational Site Number : 3410

    Campobasso, 86100
    Italy

    Active - Recruiting

  • Investigational Site Number : 3403

    Novara, 28100
    Italy

    Active - Recruiting

  • Investigational Site Number : 3411

    Palermo, 90146
    Italy

    Active - Recruiting

  • Investigational Site Number : 3415

    Pavia, 27100
    Italy

    Active - Recruiting

  • Investigational Site Number : 3412

    Ravenna, 48121
    Italy

    Active - Recruiting

  • Investigational Site Number : 3402

    Reggio Calabria, 89133
    Italy

    Active - Recruiting

  • Investigational Site Number : 3404

    Roma, 00161
    Italy

    Active - Recruiting

  • Investigational Site Number : 3405

    Terni, 05100
    Italy

    Active - Recruiting

  • Investigational Site Number : 2203

    Fukushima-shi, Fukushima 960-1295
    Japan

    Active - Recruiting

  • Investigational Site Number : 2204

    Himeji-shi, Hyogo 670-0063
    Japan

    Active - Recruiting

  • Investigational Site Number : 3701

    Barcelona, Barcelona [Barcelona] 8036
    Spain

    Active - Recruiting

  • Investigational Site Number : 3712

    Madrid, 28034
    Spain

    Active - Recruiting

  • Investigational Site Number : 3603

    Truro, Cornwall TR13LJ
    United Kingdom

    Active - Recruiting

  • Investigational Site Number : 3617

    Carlisle, Cumbria CA2 7HY
    United Kingdom

    Active - Recruiting

  • Investigational Site Number : 3608

    Gillingham, Kent ME75NY
    United Kingdom

    Active - Recruiting

  • Investigational Site Number : 3605

    London, London, City Of NW1 2PG
    United Kingdom

    Active - Recruiting

  • Investigational Site Number : 3602

    Salford, Manchester M6 8HD
    United Kingdom

    Active - Recruiting

  • Investigational Site Number : 3623

    Airdrie, North Lanarkshire ML60JS
    United Kingdom

    Active - Recruiting

  • Investigational Site Number : 3601

    Tyne And Wear, North Tyneside NE29 8NH
    United Kingdom

    Active - Recruiting

  • Investigational Site Number : 3613

    Middlesbrough, North Yorkshire TS4 3BW
    United Kingdom

    Active - Recruiting

  • Investigational Site Number : 3611

    Oxford, Oxfordshire OX3 7LE
    United Kingdom

    Active - Recruiting

  • Investigational Site Number : 3606

    Taunton, Somerset TA1 5DA
    United Kingdom

    Active - Recruiting

  • Investigational Site Number : 3618

    Birmingham, B15 2GW
    United Kingdom

    Active - Recruiting

  • Investigational Site Number : 3620

    Harrow, HA1 3UJ
    United Kingdom

    Active - Recruiting

  • Investigational Site Number : 3612

    Leeds, LS9 7TF
    United Kingdom

    Active - Recruiting

  • Investigational Site Number : 3607

    Liverpool, L7 8XP
    United Kingdom

    Active - Recruiting

  • Investigational Site Number : 3621

    London, E1 2ES
    United Kingdom

    Active - Recruiting

  • University of Alabama at Birmingham Site Number : 1230

    Birmingham, Alabama 35205
    United States

    Active - Recruiting

  • University of Alabama at Birmingham-Site Number:1230

    Birmingham, Alabama 35205
    United States

    Active - Recruiting

  • SLO Oncology and Hematology Site Number : 1235

    San Luis Obispo, California 93401
    United States

    Active - Recruiting

  • Mission Hope Medical Oncology Site Number : 1241

    Santa Maria, California 93454
    United States

    Active - Recruiting

  • MedStar Georgetown University Hospital / Lombardi Comprehensive Cancer Center Site Number : 1208

    Washington, District of Columbia 20007
    United States

    Active - Recruiting

  • Piedmont Cancer Institute, P.C Site Number : 1226

    Atlanta, Georgia 30290
    United States

    Active - Recruiting

  • Orchard Heathcare Research Inc. Site Number : 1202

    Skokie, Illinois 60077
    United States

    Active - Recruiting

  • Orchard Heathcare Research Inc.-Site Number:1202

    Skokie, Illinois 60077
    United States

    Active - Recruiting

  • Siouxland Regional Cancer Center dba June E. Nylen Cancer Center Site Number : 1220

    Sioux City, Iowa 51101
    United States

    Active - Recruiting

  • Reliant Medical Group Site Number : 1205

    Worcester, Massachusetts 01608
    United States

    Active - Recruiting

  • Reliant Medical Group-Site Number:1205

    Worcester, Massachusetts 01608
    United States

    Active - Recruiting

  • Henry Ford Hospital Site Number : 1232

    Detroit, Michigan 48202
    United States

    Active - Recruiting

  • 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
    United States

    Active - Recruiting

  • Center for Blood Disorders Site Number : 1214

    New York, New York 10021
    United States

    Active - Recruiting

  • Center for Blood Disorders-Site Number:1214

    New York, New York 10021
    United States

    Active - Recruiting

  • SUNY Upstate Medical University Site Number : 1221

    Syracuse, New York 13210
    United States

    Active - Recruiting

  • Brody School of Medicine at East Carolina University Site Number : 1203

    Greenville, North Carolina 27834
    United States

    Active - Recruiting

  • Brody School of Medicine at East Carolina University-Site Number:1203

    Greenville, North Carolina 27834
    United States

    Active - Recruiting

  • Cleveland Clinic Foundation Site Number : 1207

    Cleveland, Ohio 44195
    United States

    Active - Recruiting

  • The Ohio State University Site Number : 1236

    Columbus, Ohio 43210
    United States

    Active - Recruiting

  • Hematology Oncology Associates, PC Site Number : 1211

    Medford, Oregon 97504
    United States

    Active - Recruiting

  • Hematology Oncology Associates, PC-Site Number:1211

    Medford, Oregon 97504
    United States

    Active - Recruiting

  • University of Pittsburgh Medical Center-UPMC Hillman Cancer Center Site Number : 1210

    Pittsburgh, Pennsylvania 15232
    United States

    Active - Recruiting

  • UT Medical Center Cancer Institute Site Number : 1237

    Knoxville, Tennessee 37920
    United States

    Active - Recruiting

  • University of Washingtion Seattle Cancer Care Alliance Site Number : 1238

    Seattle, Washington 98109
    United States

    Active - Recruiting

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