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Identification of Predictive Biomarkers for Response to Biologic Therapies and Tofacitinib in Inflammatory Bowel Disease

NCT03885713 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2025-03-17

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

Infliximab or adalimumab or golimumab or vedolizumab or ustekinumab or tofacitinib

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)

Sponsors & Collaborators

  • Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

    lead OTHER

Principal Investigators

  • Javier P Gisbert · Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-09-10
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03885713 on ClinicalTrials.gov