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Infliximab for the Prevention of Recurrent Crohn's Disease After Surgery

NCT00688636 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2016-09-26

Study results available
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Summary

A randomized, placebo-controlled pilot study to determine endoscopic recurrence of Crohn's disease 12 months after curative, resective ileal or ileocolonic surgery in patients receiving post-operative infliximab or placebo

Conditions

Interventions

DRUG

infliximab

5 mg/kg IV at baseline, 2 weeks, 6 weeks and then every 8 weeks x 6

DRUG

placebo

placebo IV at baseline, 2 weeks, 6 weeks and then every 8 weeks x 6

Sponsors & Collaborators

  • Centocor, Inc.

    collaborator INDUSTRY

  • University of Pittsburgh

    lead OTHER

Principal Investigators

  • Miguel D Regueiro, M.D. · University of Pittsburgh

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2005-01-31
Primary Completion
2008-08-31
Completion
2009-01-31

Countries

  • United States

Study Locations

More Related Trials

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 NCT00688636 on ClinicalTrials.gov