MedTrace Logo

Discontinuation of Infliximab Therapy in Patients With Crohn's Disease During Sustained Complete Remission

NCT01817426 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 115

Last updated 2022-03-24

No results posted yet for this study

Summary

The purpose of this study is to determine whether infliximab can favourably and safely be discontinued in patients with Crohn's disease in sustained complete clinical, biochemical, and endoscopic remission on infliximab.

Further to examine the clinical utility of measuring levels/activity of infliximab and activity of anti-infliximab Ab in patients in sustained complete remission, in order to investigate whether pharmacoimmunological data can predict the clinical outcome and rationalize therapeutic management of these patients with respect to continuation or discontinuation of infliximab therapy. Additional, to investigate the optimal time-point, out of three, to measure this activity.

Conditions

  • Crohn Disease

Interventions

DRUG

Infliximab

OTHER

Placebo

Sponsors & Collaborators

  • Copenhagen University Hospital at Herlev

    lead OTHER

Principal Investigators

  • Mark Ainsworth, MD.PHD.,DMSc · Herlev Hospital, dep. of gastroenterology medical section.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2020-05-31
Completion
2020-05-31

Countries

  • Denmark
  • Finland
  • Norway
  • Sweden

Study Locations

More Related Trials

Entities

Drugs

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 NCT01817426 on ClinicalTrials.gov