Status:
COMPLETED
Safety and Efficacy of Adalimumab in Patients With Active Ankylosing Spondylitis
Lead Sponsor:
Abbott
Conditions:
Ankylosing Spondylitis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of the study is to assess the safety and clinical efficacy of adalimumab in subjects with active ankylosing spondylitis
Eligibility Criteria
Inclusion
- Subject was age 18 or older and in relatively good health (Investigator discretion) with a recent stable medical history.
- Subject met the definition of AS based on the Modified New York Criteria.
- Subject had an inadequate response to or intolerance to one or more NSAIDs as defined by the Investigator
Exclusion
- Subject had previously received anti-TNF therapy.
- Subject considered by the investigator, for any reason, to be an unsuitable candidate for the study
- Female subject who is pregnant or breast-feeding or considering becoming pregnant
Key Trial Info
Start Date :
December 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT00195819
Start Date
December 1 2003
End Date
June 1 2009
Last Update
June 28 2011
Active Locations (9)
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1
Site Ref # / Investigator 74
Calgary, Alberta, Canada, T2N 4N1
2
Site Ref # / Investigator 70
Edmonton, Alberta, Canada, T6G 2S2
3
Site Ref # / Investigator 79
Vancouver, British Columbia, Canada, V5Z 1L7
4
Site Ref # / Investigator 64
Winnipeg, Manitoba, Canada, R3N OK6