CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 139 enrolled
Drug / intervention
Anti-TNF: Infliximab (Infusion) +3 morebiological
Likely dose
Anti-TNF: Infliximab (Infusion) 5mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02994836
NCT02994836Phase 4Completed
CompareCT.gov

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

Fundación de Investigación Biomédica - Hospital Universitario de La Princesa·interventional·Posted Dec 16, 2016·Updated Mar 1, 2023

In Brief

A Phase 4 clinical trial evaluating Anti-TNF: Infliximab (Infusion), Anti-TNF discontinuation: Physiological saline solution, and 1 other intervention for Crohn's Disease and 2 related conditions. Completed, enrolled 139 participants across 1 site.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCrohn's Disease, Inflammatory Bowel Disease, Ulcerative Colitis
CountriesSpain
Collaborators--

Timeline

Phase 4CompletedFinished
2017201820192020202120222023202420252026
First PostedDec 16, 2016
Enrollment StartApr 21, 2017
Primary CompletionDec 31, 2021
Study CompletionDec 31, 2022
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 9.5 years ago

Interventions

Anti-TNF: Infliximab (Infusion)biological

Infliximab (Infusion 5mg/kg milligram(s)/Kilogram-Intravenous use)(Visit1,visit 3,visit 4,visit 5, visit 6 and visit 7)

Anti-TNF discontinuation: Physiological saline solutiondrug

Physiological saline solution (Infusion-Intravenous use)(Visit1,visit 3,visit 4,visit 5, visit 6 and visit 7)

Anti-TNF:Adalimumab (Subcutaneus)biological

Adalimumab (Subcutaneus 40 mg milligram(s)-subcutaneus)(Visit 1,visit 2,visit 3,visit 4,visit 5, visit 6 and visit 7).

Anti-TNF discontinuation: Physiological saline solutiondrug

Physiological saline solution (Injection-subcutaneous use)(Visit 1,visit 2,visit 3,visit 4,visit 5, visit 6 and visit 7).