Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
6000 participants
OBSERVATIONAL
2024-01-25
2031-03-01
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Group Anti-IL23p19
Patients treated with anti-IL23p19 (risankizumab, guselkumab, mirikizumab, brazikumab)
Non-interventional
This study is non-interventional, patients will be enrolled when initiating a treatment through standard of care procedures.
Group Jak inhibitors
Patient treated with Jak inhibitors (tofacitinib, upadacitinib, filgotinib)
Non-interventional
This study is non-interventional, patients will be enrolled when initiating a treatment through standard of care procedures.
Group S1P Modulators
Patient treated with S1P modulators (ozanimod, etrasimod)
Non-interventional
This study is non-interventional, patients will be enrolled when initiating a treatment through standard of care procedures.
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))
Non-interventional
This study is non-interventional, patients will be enrolled when initiating a treatment through standard of care procedures.
Group Anti integrins
Patient treated with anti-integrins (vedolizumab)
Non-interventional
This study is non-interventional, patients will be enrolled when initiating a treatment through standard of care procedures.
Group Anti IL12/23
Patient treated with anti-IL12/23 (ustekinumab)
Non-interventional
This study is non-interventional, patients will be enrolled when initiating a treatment through standard of care procedures.
Interventions
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Non-interventional
This study is non-interventional, patients will be enrolled when initiating a treatment through standard of care procedures.
Eligibility Criteria
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Inclusion 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 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)
18 Years
75 Years
ALL
No
Sponsors
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Sanoia
OTHER
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
OTHER
Responsible Party
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Principal Investigators
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Julien Kirchgesner
Role: PRINCIPAL_INVESTIGATOR
Hôpital Saint Antoine - APHP
Mathurin Fumery
Role: PRINCIPAL_INVESTIGATOR
CHU Amiens-Picardie
Locations
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CHU Amiens Picardie
Amiens, , France
APHP Hôpital Saint Antoine
Paris, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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GETAID-2022-02
Identifier Type: -
Identifier Source: org_study_id
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