Ibd CAncer and seRious Infections in France (I-CARE 2) (I-CARE 2)
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Marie Coisnon
- Telefonnummer: 09 72 57 61 60
- E-mail: mcoisnon@getaid.org
Undersøgelse Kontakt Backup
- Navn: Charlotte Mailhat
- Telefonnummer: 09 72 57 61 60
- E-mail: cmailhat@getaid.org
Studiesteder
-
-
-
Amiens, Frankrig, 80000
- Rekruttering
- CHU Amiens Picardie
-
Kontakt:
- Mathurin FUMERY, PHD
- E-mail: Fumery.Mathurin@chu-amiens.fr
-
Ledende efterforsker:
- Mathurin FUMERY, PHD
-
Paris, Frankrig, 75012
- Rekruttering
- APHP Hôpital Saint Antoine
-
Kontakt:
- Julien Kirchgesner
- E-mail: julien.kirchgesner@aphp.fr
-
Ledende efterforsker:
- Julien Kirchgesner
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
IBD patients initiating a biologic treatment.
Beskrivelse
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)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: COHORT
- Tidsperspektiver: PROSPECTIVE
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
Group Anti-IL23p19
Patients treated with anti-IL23p19 (risankizumab, guselkumab, mirikizumab, brazikumab) |
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) |
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) |
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)) |
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) |
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) |
This study is non-interventional, patients will be enrolled when initiating a treatment through standard of care procedures. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of SAE declared by patients (cancer, serious infections, arterial and venous thrombotic events)
Tidsramme: 4 to 7.5 years
|
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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of SAE declared by patients (cancer, serious infections, arterial and venous thrombotic events)
Tidsramme: 4 to 7.5 years
|
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
|
4 to 7.5 years
|
|
Treatment impact on IBD natural history
Tidsramme: 4 to 7.5 years
|
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
|
|
ePRO
Tidsramme: 4 to 7.5 years
|
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
|
|
Benefit-risk ratio
Tidsramme: 4 to 7.5 years
|
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
|
|
Number and duration of hospitalization, surgery, endoscopy and other imaging
Tidsramme: 4 to 7.5 years
|
To assess the healthcare costs and cost-efficacy of current therapeutic strategies in IBD. |
4 to 7.5 years
|
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Julien Kirchgesner, Hôpital Saint Antoine - APHP
- Ledende efterforsker: Mathurin Fumery, CHU Amiens-Picardie
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- GETAID-2022-02
Plan for individuelle deltagerdata (IPD)
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