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A Long Term Safety Study of Infliximab (Remicade) in in Ulcerative Colitis Patients

NCT00207688 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 505

Last updated 2018-07-06

No results posted yet for this study

Summary

The purpose of this study is to evaluate long-term safety information of infliximab in patients who have participated in infliximab clinical studies in ulcerative colitis.

Conditions

Interventions

DRUG

Infliximab 5 mg/kg

Patients who received infliximab 5 mg/kg from C0168T37, C0168T46, C0168T72 studies will be observed.

DRUG

Infliximab 10 mg/kg

Patients who received infliximab10 mg/kg from C0168T37, C0168T46, C0168T72 studies will be observed.

DRUG

Placebo

Patients who received placebo from C0168T37, C0168T46, C0168T72 studies will be observed.

Sponsors & Collaborators

  • Janssen Biologics BV

    collaborator UNKNOWN

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-08-31
Primary Completion
2015-09-09
Completion
2015-09-09
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Belgium
  • Canada
  • Czechia
  • Denmark
  • France
  • Germany
  • Israel
  • Netherlands
  • New Zealand
  • Switzerland
  • United Kingdom

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 NCT00207688 on ClinicalTrials.gov