To hear about similar clinical trials, please enter your email below
Trial Title:
Ibd CAncer and seRious Infections in France (I-CARE 2)
NCT ID:
NCT06089590
Condition:
IBD
Ulcerative Colitis
Crohn Disease
Conditions: Official terms:
Crohn Disease
Conditions: Keywords:
UC
CD
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
Non-interventional
Description:
This study is non-interventional, patients will be enrolled when initiating a treatment
through standard of care procedures.
Arm group label:
Group Anti IL12/23
Arm group label:
Group Anti TNF
Arm group label:
Group Anti integrins
Arm group label:
Group Anti-IL23p19
Arm group label:
Group Jak inhibitors
Arm group label:
Group S1P Modulators
Summary:
This is a French prospective longitudinal observational multicentre cohort study.
Primary objective : to assess prospectively the presence and the extent of safety
concerns (cancer, serious infections, arterial and venous thrombotic events) in patients
with CD and UC and treated with JAKi, anti-IL23p19, and S1p modulators.
Detailed description:
Number of patients : 6 000 at least Participating investigators : 250 at least
Recruitment period : 3 years 6 months
Primary objective : to assess prospectively the presence and the extent of safety
concerns (cancer, serious infections, arterial and venous thrombotic events) in patients
with CD and UC and treated with JAKi, anti-IL23p19, and S1p modulators.
Secondary objectives :
- To assess the presence and the extent of safety concerns in patients treated with
JAKi, anti-IL23p19, and S1p modulators for each outcome of interest separately
(cancer, serious infections, arterial thrombotic events, venous thrombotic events)
- To investigate prospectively the impact of JAKi, anti-IL23p19 and S1p modulators
strategies on the natural history of IBD and their potential for disease
modification by collecting validated surrogate markers such as mucosal healing and
disease complications such as bowel damage (strictures, fistulas, abscess),
surgeries, and hospitalizations
- To assess the evolution of ePROs on a trimester basis and the impact of JAKi,
anti-IL23p19, and S1p modulators on ePROs in IBD
- To evaluate the benefit-risk ratio of strategies based on a wider use of JAKi,
anti-IL23p19, and S1p modulators therapy for IBD
- To assess the healthcare costs and cost-efficacy of current therapeutic strategies
in IBD.
Criteria for eligibility:
Study pop:
IBD patients initiating a biologic treatment.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- Patient with an established diagnosis of Crohn's disease, ulcerative colitis or IBD
unclassified based on usual radiological, endoscopic or histological criteria.
- Patient aged 18 and older accepting to sign the informed participating consent form,
stating that he accepts to provide personal details (mobile and home phone number,
e-mail address), to complete the e-PRO as required and to be contacted by a Study
Coordinator and his gastroenterologist for the purpose of the study during the
entire study period and during follow up if required.
Exclusion Criteria:
- Patient unable to sign the informed consent form
- Patient with no regular access to internet
- Patient refusing to sign the informed consent form
- Patient enrolled in a Randomized Clinical Trial (If the investigational product
received was blinded, and if the treatment is unknown at time of enrolment in I-CARE
2)
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
CHU Amiens Picardie
Address:
City:
Amiens
Zip:
80000
Country:
France
Contact:
Last name:
Mathurin FUMERY, PHD
Email:
Fumery.Mathurin@chu-amiens.fr
Investigator:
Last name:
Mathurin FUMERY, PHD
Email:
Principal Investigator
Facility:
Name:
APHP Hôpital Saint Antoine
Address:
City:
Paris
Zip:
75012
Country:
France
Contact:
Last name:
Julien Kirchgesner
Email:
julien.kirchgesner@aphp.fr
Investigator:
Last name:
Julien Kirchgesner
Email:
Principal Investigator
Start date:
November 15, 2023
Completion date:
March 1, 2031
Lead sponsor:
Agency:
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Agency class:
Other
Collaborator:
Agency:
Sanoia
Agency class:
Other
Source:
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06089590
