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Study Investigating Tailored Treatment With Infliximab for Active Crohn's Disease

NCT01442025 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 121

Last updated 2015-08-11

No results posted yet for this study

Summary

To investigate whether sustained trough levels of IFX can be achieved using IFX (Infliximab) trough level measurements and adjustment of dosing based upon these levels by means of two different standardized algorithms in comparison with 'standard of care' IFX treatment and its effects on clinical and endoscopic outcomes.

Conditions

Interventions

DRUG

Infliximab

Perfusion of IFX 5mg/kg to be increased to 10 mg/kg based on clinical symptoms

DRUG

Infliximab

Perfusion of IFX 5mg/kg or 10 mg/kg if dose increase criteria are met (biological)

DRUG

Infliximab

Perfusion of IFX 5mg/kg or 7,5 mg/kg if dose increase criteria are met (biological)and 10mg/kg if dose increase criteria are met for a second time

Sponsors & Collaborators

  • Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

    lead OTHER

Principal Investigators

  • Geert D'Haens, PhD · Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

  • David Laharie · Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2015-07-31
Completion
2015-07-31

Countries

  • France

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 NCT01442025 on ClinicalTrials.gov