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Study of the Safety and Efficacy of Golimumab in Chinese Patients With Ankylosing Spondylitis

NCT01248793 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 213

Last updated 2013-03-20

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 ankylosing spondylitis

Conditions

Interventions

DRUG

Placebo

Placebo subcutaneous (SC) injections at Weeks 0, 4, 8, 12, 16, and 20

DRUG

Golimumab

Golimumab 50 mg SC injection every 4 weeks for 48 weeks

DRUG

Golimumab (placebo group)

Golimumab with early escape at Week 16, 50 mg SC injections at Week 24 and every 4 weeks thereafter through Week 48

Sponsors & Collaborators

  • 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
2010-10-31
Primary Completion
2011-05-31
Completion
2012-03-31

Countries

  • China

Study Locations

More Related Trials

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 NCT01248793 on ClinicalTrials.gov