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A Study of the Safety and Efficacy of Golimumab in Subjects With Active Ankylosing Spondylitis

NCT00265083 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 356

Last updated 2013-07-19

Study results available
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Summary

The purpose of this study is to evaluate the safety and efficacy of subcutaneous injections (under the skin) of golimumab for the treatment of active ankylosing spondylitis \[AS(arthritis of the spine)\]. Efficacy will be measured by reduction in the signs and symptoms of active AS, including effects on back pain and stiffness, physical function, range of motion in the spine, quality of life, and rate of spine damage or fusion on x-ray.

Conditions

  • Spondylitis, Ankylosing

Interventions

BIOLOGICAL

golimumab

100 mg sc injections every 4 wks from wk 0 up to 5 yrs

BIOLOGICAL

Golimumab (CNTO 148); placebo

SC injections every 4 wks thru wk 20 (unless early escape at wk 16);golimumab - if early escape, 50mg sc inj every 4wks from wk 16 up to 5yrs ;golimumab -50mg sc injection beginning wk 24 up to 5 yrs (unless early escape); golimumab- Dr's discretion after unblinding, dose adjust from 50 to 100mg

BIOLOGICAL

golimumab

50 mg sc injs every 4wks from wk 0 thru 5yrs (unless early escape at wk 16); golimumab - If early escape, 100mg sc injections every 4 wks beginning wk 16 up to 5 yrs ; golimumab - Dr's discretion after unblinding, dose adjust from 50 to 100mg

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
2007-03-31
Completion
2012-01-31

Countries

  • United States
  • Belgium
  • Canada
  • Finland
  • France
  • Germany
  • Netherlands
  • South Korea
  • Taiwan

Study Locations

More Related Trials

Entities

Drugs

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 NCT00265083 on ClinicalTrials.gov