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An Efficacy and Safety Study of Golimumab in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy

NCT00264550 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 444

Last updated 2014-04-29

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 (MTX), as compared to methotrexate alone in rheumatoid arthritis (RA) patients who have active rheumatoid arthritis despite treatment with MTX.

Conditions

Interventions

DRUG

Golimumab 100 mg

Participants will receive subcutaneous (SC) injections of golimumab 100 mg every 4 weeks.

DRUG

Golimumab 50 mg

Participants will receive subcutaneous (SC) injections of golimumab 50 mg every 4 weeks.

DRUG

Methotrexate

Participants will receive methotrexate capsules weekly.

DRUG

Placebo injection

Participants will receive subcutaneous (SC) injections of placebo every 4 weeks.

DRUG

Placebo capsules

Participants will receive placebo capsules weekly

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
2007-09-30
Completion
2012-05-31

Countries

  • United States
  • Argentina
  • Australia
  • Canada
  • Chile
  • Germany
  • Hungary
  • Mexico
  • New Zealand
  • Poland
  • South Korea
  • Taiwan

Study Locations

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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 NCT00264550 on ClinicalTrials.gov