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Cold Agglutinin Disease Real World Evidence Registry

Active, not recruiting · NCT05791708

Conditions: Cold Agglutinin Disease (CAD), Cold Agglutinin Syndrome (CAS)

At a glance

Research payments reported, 2025
$122,556
U.S. investigators named
19
Sites paid
20
Planned or actual enrollment
429

About the trial

Sponsor
RECORDATI GROUP
Tested
Sutimlimab (drug)
Dates
Started 2019-12-12; completion 2028-11-02
Results posted
Not yet

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.

From ClinicalTrials.gov, last updated 2026-04-22. Full record, eligibility and contacts (opens in a new tab)

Industry funding

Sanofi US Services Inc. reported $122,556 in research payments for this study in 2025 (67 payments).

Products named: Enjaymo

Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.

U.S. investigators named on this study

Clinicians the company named as principal investigators in its Open Payments reports.

Sites paid to run it

Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.