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Cold Agglutinin Disease Real World Evidence Registry

NCT05791708 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 429

Last updated 2026-04-22

No results posted yet for this 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.

Conditions

  • Cold Agglutinin Disease (CAD)
  • Cold Agglutinin Syndrome (CAS)

Interventions

DRUG

Sutimlimab

CAD patients in Sutimlimab cohort must be treated according to routine clinical practice

Sponsors & Collaborators

  • RECORDATI GROUP

    lead INDUSTRY

Principal Investigators

  • Ignacio Alvarez Rojo · RECORDATI GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-12
Primary Completion
2028-11-02
Completion
2028-11-02

Countries

  • United States
  • Austria
  • France
  • Germany
  • Italy
  • Japan
  • Spain
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05791708 on ClinicalTrials.gov