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.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Marie Coisnon
- 電話番号：09 72 57 61 60
- メール：mcoisnon@getaid.org
研究連絡先のバックアップ
- 名前：Charlotte Mailhat
- 電話番号：09 72 57 61 60
- メール：cmailhat@getaid.org
研究場所
-
-
-
Amiens、フランス、80000
- 募集
- CHU Amiens Picardie
-
コンタクト：
- Mathurin FUMERY, PHD
- メール：Fumery.Mathurin@chu-amiens.fr
-
主任研究者：
- Mathurin FUMERY, PHD
-
Paris、フランス、75012
- 募集
- APHP Hôpital Saint Antoine
-
コンタクト：
- Julien Kirchgesner
- メール：julien.kirchgesner@aphp.fr
-
主任研究者：
- Julien Kirchgesner
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
IBD patients initiating a biologic treatment.
説明
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)
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：COHORT
- 時間の展望：PROSPECTIVE
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of SAE declared by patients (cancer, serious infections, arterial and venous thrombotic events)
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of SAE declared by patients (cancer, serious infections, arterial and venous thrombotic events)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：4 to 7.5 years
|
To assess the healthcare costs and cost-efficacy of current therapeutic strategies in IBD. |
4 to 7.5 years
|
協力者と研究者
協力者
捜査官
- 主任研究者：Julien Kirchgesner、Hôpital Saint Antoine - APHP
- 主任研究者：Mathurin Fumery、CHU Amiens-Picardie
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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