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

NCT06089590 | Recruiting

• 1 other identifier: GETAID-2022-02
• Study Type: observational
• Target: 6,000
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

IBD; Ulcerative Colitis; Crohn Disease

Keywords

UC; CD

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Number of SAE declared by patients (cancer, serious infections, arterial and venous thrombotic events)

  4 to 7.5 years

• Treatment impact on IBD natural history

  4 to 7.5 years

• ePRO

  4 to 7.5 years

• Benefit-risk ratio

  4 to 7.5 years

• Number and duration of hospitalization, surgery, endoscopy and other imaging

  4 to 7.5 years

Study Arms (6)

Group Anti-IL23p19

Patients treated with anti-IL23p19 (risankizumab, guselkumab, mirikizumab, brazikumab)

Other: Non-interventional

Group Jak inhibitors

Patient treated with Jak inhibitors (tofacitinib, upadacitinib, filgotinib)

Other: Non-interventional

Group S1P Modulators

Patient treated with S1P modulators (ozanimod, etrasimod)

Other: Non-interventional

Group Anti TNF

Patient treated with anti-TNF (infliximab, adalimumab, golimumab) (with a maximal proportion of 25% as 1st first line biologic after conventional treatment (aminosalicylates, corticosteroids, thiopurines, methotrexate))

Other: Non-interventional

Group Anti integrins

Patient treated with anti-integrins (vedolizumab)

Other: Non-interventional

Group Anti IL12/23

Patient treated with anti-IL12/23 (ustekinumab)

Other: Non-interventional

Interventions

Non-interventional OTHER

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

Group Anti IL12/23; Group Anti TNF; Group Anti integrins; Group Anti-IL23p19; Group Jak inhibitors; Group S1P Modulators

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

IBD patients initiating a biologic treatment.

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives: lead
• Sanoia: collaborator

Study Sites (2)

CHU Amiens Picardie

Amiens, 80000, France

RECRUITING

APHP Hôpital Saint Antoine

Paris, 75012, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood plasma and serum

MeSH Terms

Conditions

Colitis, Ulcerative; Crohn Disease

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Julien Kirchgesner

  Hôpital Saint Antoine - APHP

  PRINCIPAL INVESTIGATOR

• Mathurin Fumery

  CHU Amiens-Picardie

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marie Coisnon

CONTACT

09 72 57 61 60; mcoisnon@getaid.org

Charlotte Mailhat

CONTACT

09 72 57 61 60; cmailhat@getaid.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2023
• First Posted: October 18, 2023
• Study Start: January 25, 2024
• Primary Completion (Estimated): March 1, 2031
• Study Completion (Estimated): March 1, 2031
• Last Updated: March 14, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)