Cold Agglutinin Disease Real World Evidence Registry

Last updated: November 19, 2025
Sponsor: RECORDATI GROUP
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. Aftera patient completes participation in said trial, he/she may be eligible forenrollment in 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

    Site Not Available

  • Investigational Site Number : 3101

    Salzburg 2766824, 5020
    Austria

    Active - Recruiting

  • Investigational Site Number : 3102

    Vienna 2761369, 1090
    Austria

    Active - Recruiting

  • Investigational Site Number : 3102

    Wien, 1090
    Austria

    Site Not Available

  • Investigational Site Number : 3222

    Amiens, 80054
    France

    Site Not Available

  • Investigational Site Number : 3222

    Amiens 3037854, 80054
    France

    Active - Recruiting

  • Investigational Site Number : 3214

    Angers, 49933
    France

    Site Not Available

  • Investigational Site Number : 3214

    Angers 3037656, 49933
    France

    Active - Recruiting

  • Investigational Site Number : 3211

    CHALON SUR SAONE Cedex, 71100
    France

    Site Not Available

  • Investigational Site Number : 3204

    Cesson Sevigne, 35510
    France

    Site Not Available

  • Investigational Site Number : 3204

    Cesson-Sévigné 3027767, 35510
    France

    Active - Recruiting

  • Investigational Site Number : 3211

    Chalon-sur-Saône 3027484, 71100
    France

    Active - Recruiting

  • Investigational Site Number : 3206

    Corbeil-Essonnes, 91100
    France

    Site Not Available

  • Investigational Site Number : 3206

    Corbeil-Essonnes 3023763, 91100
    France

    Active - Recruiting

  • Investigational Site Number : 3201

    Creteil, 94010
    France

    Site Not Available

  • Investigational Site Number :3201

    Creteil, 94010
    France

    Active - Recruiting

  • Investigational Site Number : 3201

    Créteil 3022530, 94010
    France

    Active - Recruiting

  • Investigational Site Number : 3219

    Dijon, 21079
    France

    Site Not Available

  • Investigational Site Number : 3219

    Dijon 3021372, 21079
    France

    Active - Recruiting

  • Investigational Site Number : 3221

    Epagny Metz-Tessy, 74370
    France

    Site Not Available

  • Investigational Site Number : 3221

    Epagny-Metz-Tessy, 74370
    France

    Active - Recruiting

  • Investigational Site Number : 3217

    Paris, 75013
    France

    Site Not Available

  • Investigational Site Number : 3217

    Paris 2988507, 75013
    France

    Active - Recruiting

  • Investigational Site Number : 3213

    Pau, 64000
    France

    Site Not Available

  • Investigational Site Number : 3213

    Pau 2988358, 64000
    France

    Active - Recruiting

  • Investigational Site Number : 3203

    Pessac, 33600
    France

    Site Not Available

  • Investigational Site Number : 3203

    Pessac 2987805, 33600
    France

    Active - Recruiting

  • Investigational Site Number : 3216

    Poitiers, 86021
    France

    Site Not Available

  • Investigational Site Number : 3216

    Poitiers 2986495, 86021
    France

    Active - Recruiting

  • Investigational Site Number : 3202

    Quimper, 2900
    France

    Site Not Available

  • Investigational Site Number : 3202

    Quimper 2984701, 2900
    France

    Active - Recruiting

  • Investigational Site Number : 3220

    RENNES Cedex 09, 35033
    France

    Site Not Available

  • Investigational Site Number : 3220

    Rennes 2983990, 35033
    France

    Active - Recruiting

  • Investigational Site Number : 3205

    Saint Priest En Jarez, 42270
    France

    Site Not Available

  • Investigational Site Number :3205

    Saint Priest En Jarez, 42270
    France

    Active - Recruiting

  • Investigational Site Number : 3205

    Saint-Priest-en-Jarez 2977350, 42270
    France

    Active - Recruiting

  • Investigational Site Number : 3209

    Suresnes, 92150
    France

    Site Not Available

  • Investigational Site Number : 3218

    TOULOUSE Cedex 9, 31059
    France

    Site Not Available

  • Investigational Site Number : 3218

    Toulouse 2972315, 31059
    France

    Active - Recruiting

  • Investigational Site Number : 3301

    Essen, 45147
    Germany

    Site Not Available

  • Investigational Site Number : 3301

    Essen 2928810, 45147
    Germany

    Active - Recruiting

  • Investigational Site Number : 3306

    Hannover, 30161
    Germany

    Site Not Available

  • Investigational Site Number : 3306

    Hanover 2910831, 30161
    Germany

    Active - Recruiting

  • Investigational Site Number : 3302

    Landshut, 84036
    Germany

    Site Not Available

  • Investigational Site Number : 3302

    Landshut 2881485, 84036
    Germany

    Active - Recruiting

  • Investigational Site Number : 3413

    Brescia, Lombardia 25123
    Italy

    Site Not Available

  • Investigational Site Number : 3413

    Brescia 3181554, Lombardy 3174618 25123
    Italy

    Active - Recruiting

  • Investigational Site Number : 3410

    Campobasso, 86100
    Italy

    Site Not Available

  • Investigational Site Number : 3410

    Campobasso 3180991, 86100
    Italy

    Active - Recruiting

  • Investigational Site Number : 3403

    Novara, 28100
    Italy

    Site Not Available

  • Investigational Site Number : 3403

    Novara 3172189, 28100
    Italy

    Active - Recruiting

  • Investigational Site Number : 3411

    Palermo, 90146
    Italy

    Site Not Available

  • Investigational Site Number : 3411

    Palermo 2523920, 90146
    Italy

    Active - Recruiting

  • Investigational Site Number : 3415

    Pavia, 27100
    Italy

    Site Not Available

  • Investigational Site Number : 3415

    Pavia 3171366, 27100
    Italy

    Active - Recruiting

  • Investigational Site Number : 3412

    Ravenna, 48121
    Italy

    Site Not Available

  • Investigational Site Number : 3412

    Ravenna 3169561, 48121
    Italy

    Active - Recruiting

  • Investigational Site Number : 3402

    Reggio Calabria, 89133
    Italy

    Site Not Available

  • Investigational Site Number : 3402

    Reggio Calabria 2523630, 89133
    Italy

    Active - Recruiting

  • Investigational Site Number : 3404

    Roma, 00161
    Italy

    Site Not Available

  • Investigational Site Number : 3404

    Roma 8957247, 00161
    Italy

    Active - Recruiting

  • Investigational Site Number : 3405

    Terni, 05100
    Italy

    Site Not Available

  • Investigational Site Number : 3405

    Terni 3165771, 05100
    Italy

    Active - Recruiting

  • Investigational Site Number : 2203

    Fukushima-shi, Fukushima 960-1295
    Japan

    Site Not Available

  • Investigational Site Number : 2203

    Fukushima 2112923, Fukushima 2112922 960-1295
    Japan

    Active - Recruiting

  • Investigational Site Number : 2204

    Himeji-shi, Hyōgo 1862047 670-0063
    Japan

    Active - Recruiting

  • Investigational Site Number : 3701

    Barcelona, Barcelona [Barcelona] 8036
    Spain

    Site Not Available

  • Investigational Site Number : 3701

    Barcelona 3128760, Barcelona [Barcelona] 8036
    Spain

    Active - Recruiting

  • Investigational Site Number : 3712

    Madrid, 28034
    Spain

    Site Not Available

  • Investigational Site Number : 3712

    Madrid 3117735, 28034
    Spain

    Active - Recruiting

  • Investigational Site Number : 3603

    Truro, Cornwall TR13LJ
    United Kingdom

    Site Not Available

  • Investigational Site Number : 3603

    Truro 2635412, Cornwall TR13LJ
    United Kingdom

    Active - Recruiting

  • Investigational Site Number : 3617

    Carlisle, Cumbria CA2 7HY
    United Kingdom

    Site Not Available

  • Investigational Site Number : 3617

    Carlisle 2653775, Cumbria CA2 7HY
    United Kingdom

    Active - Recruiting

  • Investigational Site Number : 3608

    Gillingham, Kent ME75NY
    United Kingdom

    Site Not Available

  • Investigational Site Number : 3608

    Gillingham 2648657, Kent ME75NY
    United Kingdom

    Active - Recruiting

  • Investigational Site Number : 3605

    London, London, City Of NW1 2PG
    United Kingdom

    Active - Recruiting

  • Investigational Site Number : 3605

    London 2643743, London, City of NW1 2PG
    United Kingdom

    Active - Recruiting

  • Investigational Site Number : 3602

    Salford, Manchester M6 8HD
    United Kingdom

    Site Not Available

  • Investigational Site Number : 3602

    Salford 2638671, Manchester M6 8HD
    United Kingdom

    Active - Recruiting

  • Investigational Site Number : 3623

    Airdrie, North Lanarkshire ML60JS
    United Kingdom

    Site Not Available

  • Investigational Site Number : 3623

    Airdrie 2657613, North Lanarkshire ML60JS
    United Kingdom

    Active - Recruiting

  • Investigational Site Number : 3601

    Newcastle Upon Tyne, North Tyneside NE29 8NH
    United Kingdom

    Site Not Available

  • Investigational Site Number : 3601

    Newcastle upon Tyne 2641673, North Tyneside NE29 8NH
    United Kingdom

    Active - Recruiting

  • Investigational Site Number : 3601

    Tyne And Wear, North Tyneside NE29 8NH
    United Kingdom

    Site Not Available

  • Investigational Site Number : 3613

    Middlesbrough, North Yorkshire TS4 3BW
    United Kingdom

    Site Not Available

  • Investigational Site Number : 3613

    Middlesbrough 2642607, North Yorkshire TS4 3BW
    United Kingdom

    Active - Recruiting

  • Investigational Site Number : 3611

    Oxford, Oxfordshire OX3 7LE
    United Kingdom

    Site Not Available

  • Investigational Site Number : 3611

    Oxford 2640729, Oxfordshire OX3 7LE
    United Kingdom

    Active - Recruiting

  • Investigational Site Number : 3606

    Taunton, Somerset TA1 5DA
    United Kingdom

    Site Not Available

  • Investigational Site Number : 3606

    Taunton 2636177, Somerset TA1 5DA
    United Kingdom

    Active - Recruiting

  • Investigational Site Number : 3618

    Birmingham, B15 2GW
    United Kingdom

    Site Not Available

  • Investigational Site Number : 3618

    Birmingham 2655603, B15 2GW
    United Kingdom

    Active - Recruiting

  • Investigational Site Number : 3620

    Harrow, HA1 3UJ
    United Kingdom

    Site Not Available

  • Investigational Site Number : 3620

    Harrow 2647425, HA1 3UJ
    United Kingdom

    Active - Recruiting

  • Investigational Site Number : 3612

    Leeds, LS9 7TF
    United Kingdom

    Site Not Available

  • Investigational Site Number : 3612

    Leeds 2644688, LS9 7TF
    United Kingdom

    Active - Recruiting

  • Investigational Site Number : 3607

    Liverpool, L7 8XP
    United Kingdom

    Site Not Available

  • Investigational Site Number : 3607

    Liverpool 2644210, L7 8XP
    United Kingdom

    Active - Recruiting

  • Investigational Site Number : 3621

    London, E1 2ES
    United Kingdom

    Site Not Available

  • Investigational Site Number : 3621

    London 2643743, 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

  • University of Alabama at Birmingham Site Number : 1230

    Birmingham 4049979, Alabama 4829764 35205
    United States

    Active - Recruiting

  • SLO Oncology and Hematology Site Number : 1235

    San Luis Obispo, California 93401
    United States

    Site Not Available

  • Mission Hope Medical Oncology Site Number : 1241

    Santa Maria, California 93454
    United States

    Site Not Available

  • SLO Oncology and Hematology Site Number : 1235

    San Luis Obispo 5392323, California 5332921 93401
    United States

    Active - Recruiting

  • Mission Hope Medical Oncology Site Number : 1241

    Santa Maria 5393180, California 5332921 93454
    United States

    Active - Recruiting

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

    Washington, District of Columbia 20007
    United States

    Site Not Available

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

    Washington D.C. 4140963, District of Columbia 4138106 20007
    United States

    Active - Recruiting

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

    Atlanta, Georgia 30290
    United States

    Site Not Available

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

    Atlanta 4180439, Georgia 4197000 30290
    United States

    Active - Recruiting

  • Orchard Heathcare Research Inc. Site Number : 1202

    Skokie, Illinois 60077
    United States

    Site Not Available

  • Orchard Heathcare Research Inc.-Site Number:1202

    Skokie, Illinois 60077
    United States

    Active - Recruiting

  • Orchard Heathcare Research Inc. Site Number : 1202

    Skokie 4911600, Illinois 4896861 60077
    United States

    Active - Recruiting

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

    Sioux City, Iowa 51101
    United States

    Site Not Available

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

    Sioux City 4876523, Iowa 4862182 51101
    United States

    Active - Recruiting

  • Reliant Medical Group Site Number : 1205

    Worcester, Massachusetts 01608
    United States

    Site Not Available

  • Reliant Medical Group-Site Number:1205

    Worcester, Massachusetts 01608
    United States

    Active - Recruiting

  • Reliant Medical Group Site Number : 1205

    Worcester 4956184, Massachusetts 6254926 01608
    United States

    Active - Recruiting

  • Henry Ford Hospital Site Number : 1232

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Henry Ford Hospital Site Number : 1232

    Detroit 4990729, Michigan 5001836 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

    Site Not Available

  • Center for Blood Disorders Site Number : 1214

    New York, New York 10021
    United States

    Site Not Available

  • 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

    Site Not Available

  • 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 5123853, New York 5128638 11042
    United States

    Active - Recruiting

  • Center for Blood Disorders Site Number : 1214

    New York 5128581, New York 5128638 10021
    United States

    Active - Recruiting

  • SUNY Upstate Medical University Site Number : 1221

    Syracuse 5140405, New York 5128638 13210
    United States

    Active - Recruiting

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

    Greenville, North Carolina 27834
    United States

    Site Not Available

  • 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 4469160, North Carolina 4482348 27834
    United States

    Active - Recruiting

  • Cleveland Clinic Foundation Site Number : 1207

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • The Ohio State University Site Number : 1236

    Columbus, Ohio 43210
    United States

    Site Not Available

  • Cleveland Clinic Foundation Site Number : 1207

    Cleveland 5150529, Ohio 5165418 44195
    United States

    Active - Recruiting

  • The Ohio State University Site Number : 1236

    Columbus 4509177, Ohio 5165418 43210
    United States

    Active - Recruiting

  • Hematology Oncology Associates, PC Site Number : 1211

    Medford, Oregon 97504
    United States

    Site Not Available

  • Hematology Oncology Associates, PC-Site Number:1211

    Medford, Oregon 97504
    United States

    Active - Recruiting

  • Hematology Oncology Associates, PC Site Number : 1211

    Medford 5740099, Oregon 5744337 97504
    United States

    Active - Recruiting

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

    Pittsburgh, Pennsylvania 15232
    United States

    Site Not Available

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

    Pittsburgh 5206379, Pennsylvania 6254927 15232
    United States

    Active - Recruiting

  • UT Medical Center Cancer Institute Site Number : 1237

    Knoxville, Tennessee 37920
    United States

    Site Not Available

  • UT Medical Center Cancer Institute Site Number : 1237

    Knoxville 4634946, Tennessee 4662168 37920
    United States

    Active - Recruiting

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

    Seattle, Washington 98109
    United States

    Site Not Available

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

    Seattle 5809844, Washington 5815135 98109
    United States

    Active - Recruiting

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