Infections

All Conditions

Neoplasms

Blood and Lymph Conditions

Immune System Diseases

Symptoms and General Pathology

Rare Diseases

Lymphoma

Communicable Diseases

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Dermatologic Agents

All Drugs and Chemicals

Gastrointestinal Agents

Anti-Inflammatory Agents

Antirheumatic Agents

Analgesics

Ustekinumab

Vedolizumab

Mesalamine

without previous or ongoing exposure to IS or biologics, (5ASA and Steroids are allowed)

patients on vedolizumab (1 on vedolizumab alone and 1 on combination therapy)

patients on ustekinumab (alone or on combination therapy)

Non Interventional

Laurent Peyrin-Biroulet, MD, PhD

The primary objective of I-CARE is to assess prospectively the presence and the extent of safety concerns (cancers, especially, lymphoma, and serious infections risks) for anti-TNF alone or in combination with thiopurines among IBD patients.

We will stratify the risk of cancers and serious infections according to IBD phenotype and disease activity (clinical, radiologic and endoscopic).

The four main secondary objectives of the I-CARE project are:

* To investigate prospectively the impact of anti-TNF based 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 Patient Reported Outcome (ePRO) on a yearly basis and the impact of anti-TNF agents on ePRO in IBD
* To evaluate the benefit-risk ratio of strategies based on an earlier and wider use of anti-TNF therapy for IBD
* To assess the healthcare costs and cost-efficacy of current therapeutic strategies in IBD 5-ASA and Steroids across Europe At least 5000 IBD patients treated with 5-ASA or Steroids and FU for 3 years

  * use of 5-ASA and efficacy (persistence, switch, mucosal healing etc.)
  * chemoprevention of CRC: first study that will specifically and accurately address this question
  * use of budesonide mmx and efficacy (clinical efficacy, mucosal healing and potential for disease modification)
  * safety of steroids (infections etc)

STUDY DESIGN:

22 patients per investigator. Each Investigator will recruit and enrol 20 patients with imposed treatment stratification : Group 1: 5 without previous or ongoing exposure to IS or biologics, (5 ASA and Steroids are allowed) Group 2: 5 with on-going anti-TNF monotherapy Group 3: 5 with thiopurines monotherapy Group 4: 5 with on-going combination therapy Group 5: 2 patients on vedolizumab (on vedolizumab alone and 1 on combination therapy) (optionnal) Group 6: 5 patients treated with ustekinumab with or without any concomitant medications. (optional)

IBD Cancer and Serious Infection in Europe

assess prospectively the presence and the extent of safety concerns (cancers, especially, lymphoma, and serious infections risks) for anti-TNF alone or in combination with thiopurines among IBD patients.

To investigate prospectively the impact of anti-TNF based 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 hospitalisations

To assess the evolution of Patient Reported Outcome (ePRO) on a yearly basis and the impact of anti-TNF agents on ePRO in IBD

To evaluate the benefit-risk ratio of strategies based on an earlier and wider use of anti-TNF therapy for IBD

To assess the healthcare costs and cost-efficacy of current therapeutic strategies in IBD

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
IBD Cancer and Serious Infection in Europe	NCT02377258	IBD	Non Interventio...	18 Years -	Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
IBD Cancer and Serious Infection in Europe	NCT02377258	IBD	Non Interventio...	18 Years -	Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

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