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Cold Agglutinin Disease Real World Evidence Registry

Study acronym: CADENCE
StatusActive, Not Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 400 to confirmed 429
    • Site details revised at 68 of 68 sites
    v10
  2. 2 versions Re-verified since Oct 9, 2025, no change to tracked fieldsv8-v9
  3. Lead sponsor: Sanofi to RECORDATI GROUP
    • Site details revised at 2 of 68 sites
    v7
  4. Study sites: 63 to 68v6
  5. Study sites: 19 to 63v5
Show 3 earlier versionsHide 3 earlier versions
  1. Study sites: 8 to 19v4
  2. Re-verified, no change to tracked fieldsv3
  3. Primary and study completion dates: May 26, 2028 to Nov 2, 2028v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05791708
Lead Sponsor RECORDATI GROUP
Conditions
(from sponsor)		 Cold Agglutinin Disease (CAD), Cold Agglutinin Syndrome (CAS)
Related terms Anemia, Hemolytic, Autoimmune
Enrollment 429 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov