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Cold Agglutinin Disease Real World Evidence Registry (CADENCE Trial)
N/A
Recruiting
Research Sponsored by Sanofi
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 years
Awards & highlights
No Placebo-Only Group
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.
Eligible Conditions
- Cold agglutinin disease
- Cold Agglutinin Syndrome
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 6 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of participants with CAD or CAS complications
Number of participants with health-resource utilization
Patterns of CAD and CAS disease characteristics
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: cold agglutinin syndrome (CAS)Experimental Treatment0 Interventions
Patient with a diagnosis of CAS as per investigator judgment based on the diagnosis criteria listed in study protocol
Group II: cold agglutinin disease (CAD)Experimental Treatment1 Intervention
Patient with a diagnosis of CAD as per investigator judgment based on the diagnosis criteria listed in study protocol. In addition, this group includes a cohort of CAD patients treated with sutimlimab
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Who is running the clinical trial?
SanofiLead Sponsor
2,215 Previous Clinical Trials
4,046,736 Total Patients Enrolled
Clinical Sciences & OperationsStudy DirectorSanofi
876 Previous Clinical Trials
2,021,268 Total Patients Enrolled