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.
Przegląd badań
Status
Interwencja / Leczenie
Szczegółowy opis
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 studiów
Zapisy (Szacowany)
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Marie Coisnon
- Numer telefonu: 09 72 57 61 60
- E-mail: mcoisnon@getaid.org
Kopia zapasowa kontaktu do badania
- Nazwa: Charlotte Mailhat
- Numer telefonu: 09 72 57 61 60
- E-mail: cmailhat@getaid.org
Lokalizacje studiów
-
-
-
Amiens, Francja, 80000
- Rekrutacyjny
- CHU Amiens Picardie
-
Kontakt:
- Mathurin FUMERY, PHD
- E-mail: Fumery.Mathurin@chu-amiens.fr
-
Główny śledczy:
- Mathurin FUMERY, PHD
-
Paris, Francja, 75012
- Rekrutacyjny
- APHP Hôpital Saint Antoine
-
Kontakt:
- Julien Kirchgesner
- E-mail: julien.kirchgesner@aphp.fr
-
Główny śledczy:
- Julien Kirchgesner
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Metoda próbkowania
Badana populacja
IBD patients initiating a biologic treatment.
Opis
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)
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Modele obserwacyjne: COHORT
- Perspektywy czasowe: PROSPECTIVE
Kohorty i interwencje
Grupa / Kohorta |
Interwencja / Leczenie |
|---|---|
|
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 mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Number of SAE declared by patients (cancer, serious infections, arterial and venous thrombotic events)
Ramy czasowe: 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
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Number of SAE declared by patients (cancer, serious infections, arterial and venous thrombotic events)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 4 to 7.5 years
|
To assess the healthcare costs and cost-efficacy of current therapeutic strategies in IBD. |
4 to 7.5 years
|
Współpracownicy i badacze
Współpracownicy
Śledczy
- Główny śledczy: Julien Kirchgesner, Hôpital Saint Antoine - APHP
- Główny śledczy: Mathurin Fumery, CHU Amiens-Picardie
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- GETAID-2022-02
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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