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Study of Subcutaneous Golimumab in Chinese Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy

NCT01248780 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 264

Last updated 2013-09-06

Study results available
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Summary

The purpose of this study is to evaluate the safety and efficacy of golimumab in Chinese patients with rheumatoid arthritis.

Conditions

Interventions

DRUG

Golimumab

50 mg subcutaneous (SC) injection every 4 weeks for up to 48 weeks

DRUG

Placebo

Placebo SC injections at Weeks 0, 4, 8, 12, 16, and Week 20 followed by golimumab 50 mg SC injections at Week 24 and every 4 weeks thereafter up to Week 48.

DRUG

Methotrexate (MTX)

A stable dose of MTX (oral or injectable) will be administered to participants according to the local prescribing guidelines for up to 48 weeks.

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
2010-09-30
Primary Completion
2011-10-31
Completion
2012-07-31

Countries

  • China

Study Locations

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Entities

Drugs
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 NCT01248780 on ClinicalTrials.gov