Status:
COMPLETED
Study of the Safety and Efficacy of Golimumab in Chinese Patients With Ankylosing Spondylitis
Lead Sponsor:
Centocor, Inc.
Conditions:
Ankylosing Spondylitis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of golimumab in Chinese patients with ankylosing spondylitis
Detailed Description
Golimumab is a type of tumor necrosis factor (TNF) inhibitor. TNF is a naturally occurring substance in the body, and this substance may cause long-term inflammation. Golimumab may help fight disease ...
Eligibility Criteria
Inclusion
- \- Have a diagnosis of definite akylosing spondylitis for at least 3 months
- Have symptoms of active disease at screening and at baseline
- no active infections
Exclusion
- Have other inflammatory diseases that might confound the evaluations of benefit from the golimumab therapy
- Have complete ankylosis of the spine
- Have a history of latent or active granulomatous infection
- Have had a serious infection, or have been hospitalized for an infection, or have been treated with intravenous (IV) antibiotics for an infection within 2 months prior to first administration of study agent.
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
213 Patients enrolled
Trial Details
Trial ID
NCT01248793
Start Date
October 1 2010
End Date
March 1 2012
Last Update
March 20 2013
Active Locations (7)
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1
Beijing, China
2
Chengdu, China
3
Guangzhou, China
4
Hefei, China