IBD Clinical Trial - IBD Cancer & Serious Infection in Europe

Status Completed

Clinical Trial Summary

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).

Clinical Trial Description

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) ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02377258
Study type	Observational
Source	Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Contact
Status	Completed
Phase
Start date	March 4, 2016
Completion date	May 16, 2022

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

IBD Cancer and Serious Infection in Europe — I-CARE

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms