CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 180 enrolled
Drug / intervention
Infliximab or adalimumab or golimumab or vedolizumab or ustekinumab or tofacitinibbiological
Likely dose
Infliximab or adalimumab or golimumab or vedolizumab or ustekinumab or tofacitinib 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/NCT03885713
NCT03885713Phase 4Completed
CompareCT.gov

Identification of Predictive Biomarkers for Response to Biologic Therapies and Tofacitinib in Inflammatory Bowel Disease by Proteomic and Mass Cytometry Approaches

Fundación de Investigación Biomédica - Hospital Universitario de La Princesa·interventional·Posted Mar 22, 2019·Updated Mar 17, 2025

In Brief

A Phase 4 clinical trial evaluating Infliximab or adalimumab or golimumab or vedolizumab or ustekinumab or tofacitinib for Inflammatory Bowel Diseases and 2 related conditions. Completed, enrolled 180 participants across 21 sites.

Detailed Summary

Prospective, multicentre trial which the biologic treatment will be initiated by clinical indication. The treatment selection anti-TNFα (infliximab, adalimumab or golimumab), vedolizumab, ustekinumab and tofacitinib will be made at the discretion of the clinician. There will be no random assignment of treatment. The drugs will be used in the approved indications and conditions of use.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInflammatory Bowel Diseases, Crohn Disease, Ulcerative Colitis
CountriesSpain
Collaborators--

Timeline

Phase 4CompletedFinished
2020202120222023202420252026
First PostedMar 22, 2019
Enrollment StartSep 10, 2019
Primary CompletionDec 31, 2024
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 7.3 years ago

Interventions

Infliximab or adalimumab or golimumab or vedolizumab or ustekinumab or tofacitinibbiological

Infliximab (Infusion 5mg/kg milligram(s)/Kilogram-Intravenous use) per clinical practice or adalimumab (Subcutaneus 40 mg milligram(s)) per clinical practice or golimumab (subcutaneus 50 mg milligram(s)-subcutaneus) per clinical practice or vedolizumab (infusion 300 mg milligram(s)) per clinical practice or ustekinumab (subcutaneous 90 mg milligram(s)) per clinical practice or tofacitinib (oral 5mg bid)