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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05791708




Registration number
NCT05791708
Ethics application status
Date submitted
15/02/2023
Date registered
30/03/2023
Date last updated
28/03/2024

Titles & IDs
Public title
Cold Agglutinin Disease Real World Evidence Registry
Scientific title
Cold Agglutinin Disease Real World Evidence Registry
Secondary ID [1] 0 0
EUPAS47940
Secondary ID [2] 0 0
OBS16454
Universal Trial Number (UTN)
Trial acronym
CADENCE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Condition category
Condition code
Blood 0 0 0 0
Anaemia
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Drugs - Sutimlimab

cold agglutinin disease (CAD) - 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

cold agglutinin syndrome (CAS) - Patient with a diagnosis of CAS as per investigator judgment based on the diagnosis criteria listed in study protocol


Treatment: Drugs: Sutimlimab
CAD patients in Sutimlimab cohort must be treated according to routine clinical practice
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Patterns of CAD and CAS disease characteristics
Timepoint [1] 0 0
Up to 6 years
Primary outcome [2] 0 0
Number of participants with CAD or CAS complications
Timepoint [2] 0 0
Up to 6 years
Primary outcome [3] 0 0
Patterns of use of CAD and CAS treatments
Timepoint [3] 0 0
Up to 6 years
Primary outcome [4] 0 0
Number of participants with health-resource utilization
Timepoint [4] 0 0
Up to 6 years
Primary outcome [5] 0 0
Cold Agglutinin Disease Symptoms and Impact Questionnaire (CAD-SIQ)
Timepoint [5] 0 0
Up to 6 years
Primary outcome [6] 0 0
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)
Timepoint [6] 0 0
Up to 6 years
Primary outcome [7] 0 0
36-Item Short Form Survey Instrument (SF-36) v2
Timepoint [7] 0 0
Up to 6 years
Primary outcome [8] 0 0
Sutimlimab cohort: Sutimlimab treatment patterns
Timepoint [8] 0 0
Up to 6 years
Primary outcome [9] 0 0
Sutimlimab cohort: Number of participants with adverse events, serious adverse events, adverse events of special interests (AESIs), other events of interests (e.g., Treatment emergent)
Timepoint [9] 0 0
Up to 6 years
Primary outcome [10] 0 0
Sutimlimab cohort: change from baseline in hemoglobin
Timepoint [10] 0 0
From baseline up to 6 years
Primary outcome [11] 0 0
Sutimlimab cohort: change from baseline in bilirubin
Timepoint [11] 0 0
From baseline up to 6 years
Primary outcome [12] 0 0
Sutimlimab cohort: change from baseline in Lactate dehydrogenase (LDH)
Timepoint [12] 0 0
From baseline up to 6 years
Primary outcome [13] 0 0
Sutimlimab cohort: number of blood cells transfusions
Timepoint [13] 0 0
Up to 6 years

Eligibility
Key inclusion criteria
1. Patient aged =18 years
2. Patient able to understand the purpose of the study and who (or whose legally authorized representative) provided signed and dated informed consent and authorization to use protected health information in accordance with national and local subject privacy regulations
3. Patient with a diagnosis of CAD or CAS as per Investigator judgment based on the diagnosis criteria listed in study protocol
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patient with mixed warm and cold autoimmune hemolytic anemia, or warm autoimmune hemolytic anemia
2. Patient actively participating in a CAD or CAS interventional clinical trial. After a patient completes participation in said trial, he/she may be eligible for enrollment in this registry.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
12/12/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
2/11/2028
Actual
Sample size
Target
400
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Illinois
Country [3] 0 0
United States of America
State/province [3] 0 0
Massachusetts
Country [4] 0 0
United States of America
State/province [4] 0 0
New York
Country [5] 0 0
United States of America
State/province [5] 0 0
North Carolina
Country [6] 0 0
United States of America
State/province [6] 0 0
Oregon
Country [7] 0 0
France
State/province [7] 0 0
Creteil
Country [8] 0 0
France
State/province [8] 0 0
Saint Priest En Jarez

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Sanofi
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/study/NCT05791708
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Clinical Sciences & Operations
Address 0 0
Sanofi
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Trial Transparency email recommended (Toll free number for US & Canada)
Address 0 0
Country 0 0
Phone 0 0
800-633-1610
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05791708