NCT02994836

GIS-SUSANTI-TNF-2015 (Anti-TNF Discontinuation )

Anti-TNF Discontinuation in Patients With Inflammatory Bowel Disease: Multicentre, Prospective, Randomized Clinical Trial and Economic Evaluation

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 139 (actual)
• Sponsor: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed 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).

Conditions

• Crohn's Disease
• Inflammatory Bowel Disease
• Ulcerative Colitis

Interventions

Type	Name	Description
BIOLOGICAL	Anti-TNF: Infliximab (Infusion)	Infliximab (Infusion 5mg/kg milligram(s)/Kilogram-Intravenous use)(Visit1,visit 3,visit 4,visit 5, visit 6 and visit 7)
DRUG	Anti-TNF discontinuation: Physiological saline solution	Physiological saline solution (Infusion-Intravenous use)(Visit1,visit 3,visit 4,visit 5, visit 6 and visit 7)
BIOLOGICAL	Anti-TNF:Adalimumab (Subcutaneus)	Adalimumab (Subcutaneus 40 mg milligram(s)-subcutaneus)(Visit 1,visit 2,visit 3,visit 4,visit 5, visit 6 and visit 7).
DRUG	Anti-TNF discontinuation: Physiological saline solution	Physiological saline solution (Injection-subcutaneous use)(Visit 1,visit 2,visit 3,visit 4,visit 5, visit 6 and visit 7).

Timeline

• Start date: 2017-04-21
• Primary completion: 2021-12-31
• Completion: 2022-12-31
• First posted: 2016-12-16
• Last updated: 2023-03-01

Locations

1 site across 1 country: Spain