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

NCT02994836 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 139

Last updated 2023-03-01

No results posted yet for this study

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

Conditions

Interventions

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).

Sponsors & Collaborators

  • Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

    lead OTHER

Principal Investigators

  • Javier MD Perez Gisbert, PhD · Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-21
Primary Completion
2021-12-31
Completion
2022-12-31

Countries

  • Spain

Study Locations

More Related Trials

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 NCT02994836 on ClinicalTrials.gov