Sutimlimab for Cold Agglutinin Disease
(CADENCE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial gathers real-world information about individuals with cold agglutinin disease (CAD) or cold agglutinin syndrome (CAS). It aims to understand how these conditions affect daily life and includes a group of CAD patients treated with sutimlimab, a medication designed to manage CAD symptoms. The trial focuses on those who have previously participated in other sutimlimab studies. Individuals with CAD or CAS who are not currently in another trial may be suitable candidates. As a Phase 4 trial, this research helps to understand how the FDA-approved treatment benefits more patients, offering valuable insights for those considering participation.
Do I have to stop taking my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What is the safety track record for sutimlimab?
Research shows that sutimlimab is generally safe for people with cold agglutinin disease (CAD). Studies found that patients taking sutimlimab experienced few serious side effects. The most common issues were mild, such as headaches and infections, and were not serious for most people.
Additionally, long-term studies indicate that sutimlimab remains safe and effective over time. Participants reported a better quality of life, suggesting that the benefits outweigh any minor side effects.
Overall, evidence suggests that sutimlimab is a safe option for treating CAD, based on previous research.12345Why are researchers excited about this trial?
Sutimlimab is unique because it targets the underlying cause of cold agglutinin disease (CAD) by inhibiting the C1s protein in the complement pathway, which is different from standard treatments like corticosteroids or rituximab that mainly manage symptoms. This targeted mechanism can potentially reduce hemolysis, or the destruction of red blood cells, more effectively and with fewer side effects. Researchers are excited about sutimlimab because it offers a more precise approach, potentially improving the quality of life for patients with CAD by directly addressing the disease process.
What is the effectiveness track record for sutimlimab in treating cold agglutinin disease?
Research has shown that sutimlimab effectively treats cold agglutinin disease (CAD). In this trial, participants with CAD will receive sutimlimab. Studies have found that it reduces the breakdown of red blood cells, anemia, and fatigue, leading to fewer blood transfusions. Reports indicate that sutimlimab also improves patients' overall quality of life. These findings suggest that sutimlimab can help manage symptoms and enhance daily life for those with CAD.24678
Who Is on the Research Team?
Ignacio Alvarez Rojo
Principal Investigator
RECORDATI GROUP
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Enrollment
Participants with CAD or CAS are enrolled in the registry to collect data on disease characteristics and treatment patterns
Follow-up
Participants are monitored for disease characteristics, treatment patterns, and health-resource utilization
What Are the Treatments Tested in This Trial?
Interventions
- Sutimlimab
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Patient with a diagnosis of CAS as per investigator judgment based on the diagnosis criteria listed in study protocol
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
Find a Clinic Near You
Who Is Running the Clinical Trial?
Recordati Rare Diseases
Lead Sponsor
RECORDATI GROUP
Lead Sponsor
Sanofi
Lead Sponsor
Paul Hudson
Sanofi
Chief Executive Officer since 2019
Degree in Economics from Manchester Metropolitan University
Christopher Corsico
Sanofi
Chief Medical Officer
MD from Cornell University, MPH in Chronic Disease Epidemiology from Yale University
Citations
Cost-effectiveness of sutimlimab in cold agglutinin disease
Exploratory threshold analyses showed that significant price reduction (>80%) or time-limited treatment (<18 months) followed by lifelong ...
CADENZA study Part B - eClinicalMedicine
The CADENZA Part B results support the sustained efficacy and safety of sutimlimab for treatment of CAD; however, upon discontinuation disease ...
3.
ashpublications.org
ashpublications.org/blood/article/140/9/980/485526/Sutimlimab-in-patients-with-cold-agglutininSutimlimab in patients with cold agglutinin disease: results of ...
Sutimlimab reduced hemolysis, anemia, and fatigue in patients with CAD without transfusion requirement. Sutimlimab treatment was generally well ...
Long-term sutimlimab improves quality of life for patients ...
Sutimlimab improves quality of life in patients with cold agglutinin disease: results of patient-reported outcomes from the CARDINAL study.
Cost‐effectiveness of sutimlimab in cold agglutinin disease
Sutimlimab in patients with cold agglutinin disease: results of the randomized placebo-controlled phase 3 CADENZA trial. Blood. 2022; 140(9): ...
6.
ashpublications.org
ashpublications.org/blood/article/142/Supplement%201/3833/499752/Combined-Safety-Data-for-Sutimlimab-in-ColdCombined Safety Data for Sutimlimab in Cold Agglutinin ...
Combined Safety Data for Sutimlimab in Cold Agglutinin Disease: A Post-Hoc Analysis of the Phase 3 Cardinal and Cadenza Studies Available.
Long-term safety profile of sutimlimab in adult Japanese ...
The results of global phase 3 clinical trials, CARDINAL and CADENZA, have demonstrated robust data that sutimlimab is effective and well ...
Sutimlimab in Cold Agglutinin Disease
We conducted a 26-week multicenter, open-label, single-group study to assess the efficacy and safety of intravenous sutimlimab in patients with cold agglutinin ...
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