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An Efficacy and Safety Study of Golimumab in Participants With Ulcerative Colitis

NCT00488774 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 291

Last updated 2013-06-14

Study results available
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Summary

The purpose of this study is to assess the effects (good and bad) of golimumab (CNTO 148) therapy in participants with active ulcerative colitis (UC) (sores in the colon).

Conditions

  • Colitis, Ulcerative

Interventions

OTHER

Placebo

Matching placebo for golimumab, intravenous infusion administered at Week 0

DRUG

Golimumab 1 mg per kg

Golimumab 1 mg per kg intravenous (IV) infusion administered at Week 0

DRUG

Golimumab 2 mg per kg

Golimumab 2 mg per kg intravenous (IV) infusion administered at Week 0

DRUG

Golimumab 4 mg per kg

Golimumab 4 mg per kg intravenous (IV) infusion at Week 0

Sponsors & Collaborators

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-08-31
Primary Completion
2009-05-31
Completion
2009-05-31

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Bulgaria
  • Canada
  • France
  • Germany
  • Hungary
  • India
  • Israel
  • Latvia
  • Lithuania
  • Netherlands
  • New Zealand
  • Poland
  • Romania
  • Russia
  • Serbia
  • Slovakia
  • Sweden
  • Ukraine

Study Locations

More Related Trials

Entities

Companies

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 NCT00488774 on ClinicalTrials.gov