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Clinical Trial Summary

This study will be a multicentre prospective randomized trial to assess the percentage of patients with IBD who, after stopping anti-TNF treatment, have sustained clinical remission at one year compared to those in which the treatment is continued at stable doses


Clinical Trial Description

A multicentre prospective randomized trial. Hypothesis: The discontinuation of anti-TNF treatment in inflammatory bowel disease (IBD) patients in clinical remission is associated with an increased risk of recurrence compared with maintaining such treatment. Main objective: To assess the percentage of patients with IBD who, after stopping anti-TNF treatment, have sustained clinical remission at one year compared to those in which the treatment is continued at stable doses Secondary objectives: To compare treatment discontinuation vs. treatment continuation of anti-TNF agents in patients with Crohn´s disease or ulcerative colitis in terms of: 1. remission (relapse-free) time, 2. phenotype changes with both strategies 3. mucosal healing, 4. radiologic healing 5. impact on quality of life and productivity 6. safety 7. to identify relapse predictive factors. 8. To identify relapse predictive factors after anti-TNF drug discontinuation 9. Determining the profile of serum cytokines in patients with both strategies, depending on drug exposure and if maintained clinical remission or relapse. Planned number of subject to be included: 194 The participation of at 50 hospitals in Spain with an inclusion of about 5 patients per hospital is required.. Case report Form was designed on REDCap (a free, secure, web-based application designed to support data capture for research studies). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02994836
Study type Interventional
Source Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Contact
Status Active, not recruiting
Phase Phase 4
Start date April 21, 2017
Completion date December 31, 2022

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