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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Kontakty a umístění
Studijní kontakt
- Jméno: Marie Coisnon
- Telefonní číslo: 09 72 57 61 60
- E-mail: mcoisnon@getaid.org
Studijní záloha kontaktů
- Jméno: Charlotte Mailhat
- Telefonní číslo: 09 72 57 61 60
- E-mail: cmailhat@getaid.org
Studijní místa
-
-
-
Amiens, Francie, 80000
- Nábor
- CHU Amiens Picardie
-
Kontakt:
- Mathurin FUMERY, PHD
- E-mail: Fumery.Mathurin@chu-amiens.fr
-
Vrchní vyšetřovatel:
- Mathurin FUMERY, PHD
-
Paris, Francie, 75012
- Nábor
- APHP Hôpital Saint Antoine
-
Kontakt:
- Julien Kirchgesner
- E-mail: julien.kirchgesner@aphp.fr
-
Vrchní vyšetřovatel:
- Julien Kirchgesner
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
IBD patients initiating a biologic treatment.
Popis
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)
Studijní plán
Jak je studie koncipována?
Detaily designu
- Observační modely: COHORT
- Časové perspektivy: PROSPECTIVE
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
|---|---|
|
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. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Number of SAE declared by patients (cancer, serious infections, arterial and venous thrombotic events)
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Number of SAE declared by patients (cancer, serious infections, arterial and venous thrombotic events)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 4 to 7.5 years
|
To assess the healthcare costs and cost-efficacy of current therapeutic strategies in IBD. |
4 to 7.5 years
|
Spolupracovníci a vyšetřovatelé
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Julien Kirchgesner, Hôpital Saint Antoine - APHP
- Vrchní vyšetřovatel: Mathurin Fumery, CHU Amiens-Picardie
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
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