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| Name | Class |
|---|---|
| Sanoia | OTHER |
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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.
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 :
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group Anti-IL23p19 | Patients treated with anti-IL23p19 (risankizumab, guselkumab, mirikizumab, brazikumab) |
| |
| Group Jak inhibitors | Patient treated with Jak inhibitors (tofacitinib, upadacitinib, filgotinib) |
| |
| Group S1P Modulators | Patient treated with S1P modulators (ozanimod, etrasimod) |
| |
| 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)) |
| |
| Group Anti integrins | Patient treated with anti-integrins (vedolizumab) |
| |
| Group Anti IL12/23 | Patient treated with anti-IL12/23 (ustekinumab) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-interventional | Other | This study is non-interventional, patients will be enrolled when initiating a treatment through standard of care procedures. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of SAE declared by patients (cancer, serious infections, arterial and venous thrombotic events) | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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IBD patients initiating a biologic treatment.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marie Coisnon | Contact | 09 72 57 61 60 | mcoisnon@getaid.org | |
| Charlotte Mailhat | Contact | 09 72 57 61 60 | cmailhat@getaid.org |
| Name | Affiliation | Role |
|---|---|---|
| Julien Kirchgesner | Hôpital Saint Antoine - APHP | Principal Investigator |
| Mathurin Fumery | CHU Amiens-Picardie | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Amiens Picardie | Recruiting | Amiens | 80000 | France |
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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Blood plasma and serum
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| Treatment impact on IBD natural history | 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 | 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 | 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 | To assess the healthcare costs and cost-efficacy of current therapeutic strategies in IBD. | 4 to 7.5 years |
| APHP Hôpital Saint Antoine | Recruiting | Paris | 75012 | France |
|
| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |