The CHUS Ranks First in the World for a Sanofi Study on a Rare Inflammatory Disease
The team lead by Dr. Hugues Allard-Chamard at the Centre de recherche du Centre hospitalier universitaire de Sherbrooke (CRCHUS) stood out on the international stage by becoming the first site worldwide to be activated, ahead of 97 other sites in 19 countries, for a phase III study by Sanofi on lgG4-related disease.
With authorization received in 7.6 weeks and a total activation time of 9 weeks, the CHUS, with the FAST TRACK Evaluation Service’s support, is being recognized as a key player in research on this rare and still poorly defined inflammatory condition.
“Sanofi Canada is proud to have partnered with CATALIS and Dr. Allard-Chamard’s team at the CHUS (Centre Hospitalier Universitaire de Sherbrooke) to achieve two remarkable milestones for the EFC17359 study in IgG4-related disease: the first site activated worldwide and the first randomized patient in Canada. Through the CATALIS FAST TRACK Evaluation Service, we were able to accelerate our clinical trial start-up and demonstrate once again that Quebec is a world-class destination for clinical research. This achievement reflects the exceptional dedication of our investigators and the power of collaboration in bringing innovative treatments to patients living with rare diseases as quickly as possible. ” – Jean-Francois Leger, M.Sc., Site Engagement Lead, Clinical Study Unit, Sanofi Canada
The CRCHUS Is Home to Canada’s Largest Rheumatology Biobank
The Centre de recherche du CHUS (CRCHUS) is home to Canada’s largest biobank dedicated to rheumatology, a specialty involving various chronic inflammatory diseases. These biological samples and clinical data help increase understanding of these diseases and improve the care provided to those affected.
Dr. Hugues Allard-Chamard, a rheumatologist and researcher at the CRCHUS, is particularly interested in a disease known as IgG4, a rare and complex inflammatory condition. His team is investigating the immune mechanisms responsible for the disease’s chronicity, while seeking to determine specific diagnostic criteria and explore new therapeutic options. Thanks to the CRCHUS’ biobank, their work is structured around exceptional biological and clinical resources that foster the discovery of more targeted and personalized treatments for people living with rheumatic diseases.
“This achievement, which allows us to stand out on the international stage, was possible thanks to the close collaboration between CATALIS’ FAST TRACK Evaluation Service’s team, our research professionals, and our research project authorization office and legal affairs teams! This bold initiative helps us to provide a new therapeutic offering that our patients with this rare form of rheumatological disease can access quickly, while helping redefine the standards of medicine.” – Dr André Carpentier, Scientific Director of the Centre de recherche du CHUS, CIUSSS de l’Estrie – CHUS
Assessing a Targeted Experimental Treatment for lgG4-Related Disease
Sanofi’s EFC17359 study aims to assess the effectiveness and safety of targeted treatment in people living with lgG4-related disease.
This rare inflammatory condition can affect many of the body’s organs, including the pancreas, kidneys, and salivary glands, the area around eyes, and the retroperitoneum, an area at the back of the abdominal cavity that contains the kidneys and some important blood vessels. It is the result of a breakdown in the immune system, which attacks healthy tissue.
Often underdiagnosed, IgG4 disease is sometimes mistaken for a malignant tumour because it causes similar lesions in the affected organs. Patients generally respond well to cortisone-based treatment, which slows the immune response. However, about 40% of them fail to achieve full remission and relapse within one year of treatment1. In addition, prolonged cortisone use can lead to many side effects which are difficult to tolerate, including an increased risk of infection and bone fragility.
The study therefore explores an innovative treatment that blocks the activity of a key protein involved in the functioning of certain immune cells responsible for the disease. After several weeks of treatment, the study will measure, among other things, how long before relapse occurs, the proportion of people who remain in remission, the degree to which the disease is controlled, and tolerance to treatment. The Sanofi study expects to recruit 124 patients worldwide, including 2 in Quebec.
“We all know that clinical research is a critical issue for people with rare and orphan diseases. CATALIS Quebec’s FAST TRACK Evaluation Service allows Quebec clinicians to open sites more easily and quickly. As a result, we hope to see more and more pharmaceutical companies using this service, so that patients can reap the benefits and have a better quality of life.” – Jonathan Pratt, Executive Director of the Regroupement québécois des maladies orphelines (Quebec coalition of orphan diseases)
Are you interested in participating in this clinical trial or in other clinical trials on rare diseases? We offer a free Personalized Support Service to help guide you in your search for clinical trials. You can also access Clinical Trials Quebec’s information and services hub. This site contains easy-to-understand educational content, animated infographics, and free tools which will help you to better understand clinical research and what happens during a clinical trial. Information on Sanofi’s EFC17359 clinical study is available through Quebec Health Research’s Public Clinical Trials Registry and the www.clinicaltrials.gov2 website.
The CATALIS Network Is Committed to Accelerating Access to Innovative Treatments Through its FAST TRACK Evaluation Service
Thanks to the commitment of healthcare institutions such as the CHUS and pharmaceutical companies such as Sanofi, CATALIS and its Network of Partners are delighted to stimulate innovation in clinical research and reduce clinical trials’ authorization times by nearly 75%, with the goal of accelerating the development of innovative treatments that improve the lives of patients in Quebec.
CATALIS would like to thank all its public and private partners for their trust, their participation in developing innovative clinical research approval methods, and their commitment to implementing accelerated clinical trials in their institutions.
If you would like more information about the FAST TRACK Evaluation Service, please write to us at: info@catalisquebec.com.
1Yue Z, et al. Risk factors for IgG4-related disease relapse: A systematic review and meta-analysis. Scandinavian Journal of Immunology. 2022;96(3). doi:10.1111/sji.13200.
2ClinicalTrials.gov (e.n.). Study NCT07190196. Available at: https://clinicaltrials.gov/study/NCT07190196
