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A Study of the Safety and Efficacy of Golimumab in Subjects With Rheumatoid Arthritis That Are Methotrexate-naive

NCT00264537 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 637

Last updated 2014-09-05

Study results available
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Summary

The purpose of this study is to evaluate the efficacy and safety of golimumab, alone or in combination with methotrexate, as compared to methotrexate alone in rheumatoid arthritis subjects who have not been previously treated with methotrexate.

Conditions

Interventions

DRUG

Placebo injections

SC injections

DRUG

Placebo capsules

Placebo capsules will be filled with microcrystalline cellulose (Avicel PH 102).

DRUG

Methotrexate capsules

Methotrexate capsules will be filled with microcrystalline cellulose (Avicel PH 102) and a 2.5 mg methotrexate tablet.

BIOLOGICAL

Golimumab 50 mg injections

SC injections

BIOLOGICAL

Golimumab 100 mg injections

SC injections

Sponsors & Collaborators

  • Schering-Plough

    collaborator INDUSTRY

  • Centocor, Inc.

    lead INDUSTRY

Principal Investigators

  • Centocor, Inc. Clinical Trial · Centocor, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-12-31
Primary Completion
2008-04-30
Completion
2012-06-30

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Belgium
  • Canada
  • Chile
  • Hungary
  • India
  • Malaysia
  • New Zealand
  • Philippines
  • Poland
  • Russia
  • Singapore
  • South Korea
  • Spain
  • Taiwan
  • Thailand
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

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 NCT00264537 on ClinicalTrials.gov