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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05791708
Registration number
NCT05791708
Ethics application status
Date submitted
15/02/2023
Date registered
30/03/2023
Date last updated
21/08/2023
Titles & IDs
Public title
Cold Agglutinin Disease Real World Evidence Registry
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Scientific title
Cold Agglutinin Disease Real World Evidence Registry
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Secondary ID [1]
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EUPAS47940
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Secondary ID [2]
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OBS16454
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Universal Trial Number (UTN)
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Trial acronym
CADENCE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Condition category
Condition code
Blood
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Anaemia
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Inflammatory and Immune System
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Autoimmune diseases
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Intervention/exposure
Study type
Observational [Patient Registry]
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Patient registry
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Target follow-up duration
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Target follow-up type
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Patterns of CAD and CAS disease characteristics
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Assessment method [1]
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CAD or CAS characteristics at diagnosis, enrollment, and during follow up (e.g., criteria used for diagnosis, symptoms, laboratory results) will be described.
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Timepoint [1]
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Up to 6 years
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Primary outcome [2]
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Number of participants with CAD or CAS complications
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Assessment method [2]
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Thromboembolic events (venous, arterial or cerebral), deaths related to CAD or CAS, other CAD/CAS complications (e.g., acute hemolytic crisis, hemolysis-related complications), and other comorbid conditions occurring before enrollment, at enrollment, and during follow up will be described.
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Timepoint [2]
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Up to 6 years
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Primary outcome [3]
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Patterns of use of CAD and CAS treatments
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Assessment method [3]
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CAD or CAS treatments received before enrollment, at enrollment, and during the follow up period will be summarized. CAD or CAS symptoms and complications, autoimmune disorders or lymphoproliferative disorders, physician assessment of treatment status, and changes in laboratory results will be described by CAD or CAS treatments.
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Timepoint [3]
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Up to 6 years
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Primary outcome [4]
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Number of participants with health-resource utilization
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Assessment method [4]
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Health resource utilization may include hospitalizations (including length of stay), outpatient visits, emergency room visits, specific transfusion visits, nursing home/rehabilitation center stays, and home healthcare visits during registry follow-up period
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Timepoint [4]
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Up to 6 years
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Primary outcome [5]
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Cold Agglutinin Disease Symptoms and Impact Questionnaire (CAD-SIQ)
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Assessment method [5]
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Timepoint [5]
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Up to 6 years
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Primary outcome [6]
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Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)
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Assessment method [6]
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Timepoint [6]
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Up to 6 years
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Primary outcome [7]
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36-Item Short Form Survey Instrument (SF-36) v2
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Assessment method [7]
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Timepoint [7]
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Up to 6 years
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Primary outcome [8]
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Sutimlimab cohort: Sutimlimab treatment patterns
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Assessment method [8]
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Sutimlimab dosing information, reasons for dose adjustments, reasons for discontinuation will be described.
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Timepoint [8]
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Up to 6 years
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Primary outcome [9]
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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)
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Assessment method [9]
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Timepoint [9]
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Up to 6 years
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Primary outcome [10]
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Sutimlimab cohort: change from baseline in hemoglobin
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Assessment method [10]
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Timepoint [10]
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From baseline up to 6 years
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Primary outcome [11]
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Sutimlimab cohort: change from baseline in bilirubin
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Assessment method [11]
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Timepoint [11]
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From baseline up to 6 years
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Primary outcome [12]
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Sutimlimab cohort: change from baseline in Lactate dehydrogenase (LDH)
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Assessment method [12]
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Timepoint [12]
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From baseline up to 6 years
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Primary outcome [13]
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Sutimlimab cohort: number of blood cells transfusions
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Assessment method [13]
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Timepoint [13]
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Up to 6 years
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
12/12/2019
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
2/11/2028
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Actual
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Sample size
Target
400
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Alabama
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Country [2]
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United States of America
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State/province [2]
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Illinois
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Country [3]
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United States of America
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State/province [3]
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Massachusetts
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Country [4]
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United States of America
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State/province [4]
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New York
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Country [5]
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United States of America
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State/province [5]
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North Carolina
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Country [6]
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United States of America
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State/province [6]
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Oregon
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Country [7]
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France
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State/province [7]
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Creteil
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Country [8]
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France
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State/province [8]
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Saint Priest En Jarez
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Sanofi
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Address
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Country
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05791708
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Trial related presentations / publications
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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
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Contacts
Principal investigator
Name
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Clinical Sciences & Operations
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Address
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Sanofi
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Trial Transparency email recommended (Toll free number for US & Canada)
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Address
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Country
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Phone
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800-633-1610
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Fax
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Email
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[email protected]
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/ct2/show/NCT05791708
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