Ibd CAncer and seRious Infections in France (I-CARE 2)

Ulcerative Colitis Clinical Trial

— I-CARE 2  

Official title:

Ibd CAncer and seRious Infections in France (I-CARE 2)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06089590
• Other study ID #: GETAID-2022-02
• Status: Not yet recruiting
• Start date: November 15, 2023
• Est. completion date: March 1, 2031

Study information

• Verified date: October 2023
• Source: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
• Contact: Marie Coisnon
• Phone: 09 72 57 61 60
• Email: mcoisnon[@]getaid.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 6000
• Est. completion date: March 1, 2031
• Est. primary completion date: March 1, 2031
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Crohn Disease
• IBD
• Ulcerative Colitis

Intervention

Other:
• Non-interventional
This study is non-interventional, patients will be enrolled when initiating a treatment through standard of care procedures.

Locations

Country	Name	City	State
France	CHU Amiens Picardie	Amiens
France	APHP Hôpital Saint Antoine	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives	Sanoia

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of SAE declared by patients (cancer, serious infections, arterial and venous thrombotic events)	The primary objective of I-CARE 2 is 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.; The risk of cancers, serious infections and vascular events will be stratified according to IBD phenotype, disease activity (clinical, radiologic and endoscopic) and main comorbidities at baseline.	4 to 7.5 years
Secondary	Number of SAE declared by patients (cancer, serious infections, arterial and venous thrombotic events)	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	4 to 7.5 years
Secondary	Treatment impact on IBD natural history	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	4 to 7.5 years
Secondary	ePRO	To assess the evolution of ePROs on a trimester basis and the impact of JAKi, anti-IL23p19, and S1p modulators on ePROs in IBD	4 to 7.5 years
Secondary	Benefit-risk ratio	To evaluate the benefit-risk ratio of strategies based on a wider use of JAKi, anti-IL23p19, and S1p modulators therapy for IBD	4 to 7.5 years
Secondary	Number and duration of hospitalization, surgery, endoscopy and other imaging	To assess the healthcare costs and cost-efficacy of current therapeutic strategies in IBD.	4 to 7.5 years