Status:
COMPLETED
A Study of Adalimumab in Japanese Subjects With Active Ankylosing Spondylitis
Lead Sponsor:
Abbott
Collaborating Sponsors:
Eisai Co., Ltd.
Conditions:
Ankylosing Spondylitis
Eligibility:
All Genders
15+ years
Phase:
PHASE3
Brief Summary
To evaluate efficacy, safety and pharmacokinetics of adalimumab in Japanese subjects with active ankylosing spondylitis
Detailed Description
It is reported that the prevalence of Ankylosing Spondylitis (AS) in Japanese patients is extremely lower than that of Caucasians; therefore, a controlled, double-blind study with similar sample size ...
Eligibility Criteria
Inclusion
- Subject who meets the definition of Ankylosing Spondylitis based on the Modified New York Criteria, has a diagnosis of active Ankylosing Spondylitis and has had an inadequate response to or intolerance to one or more nonsteroidal anti-inflammatory drugs
Exclusion
- History of cancer, lymphoma, leukemia or lymphoproliferative disease, active TB, HIV
- Previously received anti-TNF therapy
- Spinal surgery or joint surgery involving joints to be assessed within 2 months prior to the Screening
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT00667355
Start Date
February 1 2008
End Date
January 1 2011
Last Update
January 26 2012
Active Locations (19)
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1
Site Reference # / Investigator 46791
Aichi, Japan
2
Site Reference # / Investigator 46789
Fukui, Japan
3
Site Reference # / Investigator 46798
Fukuoka, Japan
4
Site Reference # / Investigator 46799
Fukuoka, Japan