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Golimumab in Rheumatoid Arthritis Participants With an Inadequate Response to Etanercept (ENBREL) or Adalimumab (HUMIRA)

NCT01004432 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 433

Last updated 2015-04-30

Study results available
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Summary

The purpose of this study is to evaluate the efficacy and safety of switching rheumatoid arthritis (RA) participants who have an inadequate response to their current treatment with either etanercept + methotrexate or adalimumab + methotrexate to treatment with golimumab 50 milligram (mg) subcutaneous (SC) injection (a needle inserted under the skin in the back of upper arm, upper thigh or stomach area) every 4 weeks + methotrexate. This study is also designed to evaluate the benefit and safety of switching participants from treatment with golimumab 50 mg subcutaneous injection every 4 weeks + methotrexate to golimumab 2 milligram per kilogram (mg/kg) intravenous every 8 weeks + methotrexate, for those who do not achieve a marked improvement of their RA at Week 16.

Conditions

Interventions

DRUG

Golimumab 50 mg SC

Golimumab 50 milligram (mg) subcutaneous (SC) injection every 4 weeks.

DRUG

Golimumab 2 mg/kg IV

Golimumab 2 milligram per kilogram (mg/kg) intravenous infusion every 8 weeks.

DRUG

Methotrexate (MTX)

Participants will continue taking their current Methotrexate (MTX) treatment regimen.

DRUG

Placebo SC

Placebo matched to golimumab SC injection every 4 weeks.

DRUG

Placebo IV

Placebo matched to golimumab intravenous infusion every 8 weeks.

Sponsors & Collaborators

Principal Investigators

  • Janssen Biotech, Inc. Clinical Trial · Janssen Biotech, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2013-07-31
Completion
2013-10-31

Countries

  • United States
  • Austria
  • Belgium
  • Canada
  • Germany
  • Greece
  • Sweden
  • United Kingdom

Study Locations

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Entities

Diseases
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 NCT01004432 on ClinicalTrials.gov