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An Efficacy and Safety Study of Golimumab (CNTO 148) in Participants With Moderately to Severely Active Ulcerative Colitis

NCT00487539 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 1065

Last updated 2014-02-17

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 ulcerative colitis (UC).

Conditions

  • Colitis, Ulcerative

Interventions

BIOLOGICAL

Placebo

Placebo subcutaneous injection (given under the skin by way of a needle) matching to golimumab administered at Week 0 and Week 2.

BIOLOGICAL

Golimumab 100 mg

Golimumab 100 mg subcutaneous injection administered at Week 0 for Golimumab 100 mg -\> 50 mg arm group and at Week 2 for Golimumab 200 mg -\> 100 mg arm group.

BIOLOGICAL

Golimumab 200 mg

Golimumab 200 mg subcutaneous injection administered at Week 0 for Golimumab 200 mg -\> 100 mg arm group and at Week 2 for Golimumab 400 mg -\> 200 mg arm group.

BIOLOGICAL

Golimumab 400 mg

Golimumab 400 mg subcutaneous injection administered at Week 0 for Golimumab 400 mg -\> 200 mg arm group.

BIOLOGICAL

Golimumab 50 mg

Golimumab 50 mg subcutaneous injection administered at Week 2 for Golimumab 100 mg -\> 50 mg arm group.

Sponsors & Collaborators

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-08-31
Primary Completion
2010-10-31
Completion
2010-10-31

Countries

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

Study Locations

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Entities

Drugs
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 NCT00487539 on ClinicalTrials.gov