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Evaluation of Histologic and Endoscopic Remission Induced by Infliximab in Moderate to Severe Ulcerative Colitis

NCT01408810 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2012-12-18

No results posted yet for this study

Summary

The aim of this study is to assess the relationship between microscopic Geboes index of inflammation and clinical course of ulcerative colitis in patients treated with infliximab. The investigators propose to test the hypothesis if infliximab is able to induce histological remission and then change the clinical course of ulcerative colitis.

Conditions

Interventions

DRUG

Infliximab

5 mg/Kg, I.V. at weeks 0, 2, 6 and every 8 weeks thereafter

Sponsors & Collaborators

  • Grupo de Estudo da Doença Inflamatória Intestinal

    lead OTHER

Principal Investigators

  • Susana Lopes, MD · Hospital de São João

  • Francisco Portela, MD · Hospitais da Universidade de Coimbra

  • Paula Lago, MD · General Hospital of Santo António

  • José Cotter, MD · Hospital Nossa Senhora da Oliveira - Guimarães

  • Paula Peixe, MD · Centro Hospitalar Lisboa Ocidental Hospital Egas Moniz

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2012-11-30
Completion
2012-11-30

Countries

  • Portugal

Study Locations

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Entities

Drugs
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 NCT01408810 on ClinicalTrials.gov