Status:
TERMINATED
A Study of ARRY-371797 in Patients With Active Ankylosing Spondylitis
Lead Sponsor:
Pfizer
Conditions:
Ankylosing Spondylitis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a Phase 2 study, involving a 12-week treatment period, designed to evaluate the effectiveness of investigational study drug ARRY-371797 (versus placebo) in treating ankylosing spondylitis, and...
Eligibility Criteria
Inclusion
- Key
- Diagnosis of ankylosing spondylitis according to the Modified New York Criteria (1984).
- Inadequate response to at least 2 weeks of continuous treatment with NSAIDs, or unable to receive ≥ 2 full weeks of continuous treatment with NSAIDs because of intolerance.
- If previously treated with a biological agent, patient must not have failed due to lack of efficacy, and must have completed an appropriate washout period prior to first dose of study drug.
- Patients may continue on specified stable background therapies for ankylosing spondylitis (doses should be stable for at least 4 weeks prior to the first dose of study drug).
- Additional criteria exist.
- Key
Exclusion
- Diagnosis of any other active or uncontrolled inflammatory or non-inflammatory articular disease that may interfere with disease activity assessments.
- Previously treated with intravenous immunoglobulins within 6 months prior to first dose of study drug.
- Patients requiring prohibited concomitant medications including moderate or strong CYP3A inhibitors, CYP3A inducers and Biologic Response Modifiers (BRMs) while on study.
- Trauma or other major surgeries within 8 weeks prior to first dose of study drug.
- Specific abnormal laboratory values or electrocardiogram abnormalities.
- Known positive serology for human immunodeficiency virus (HIV), hepatitis C, and/or hepatitis B.
- Additional criteria exist.
Key Trial Info
Start Date :
December 16 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 29 2009
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00811499
Start Date
December 16 2008
End Date
September 29 2009
Last Update
October 19 2020
Active Locations (12)
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1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
2
Northwestern University
Chicago, Illinois, United States, 60611
3
Westroads Medical Group
Omaha, Nebraska, United States, 68114
4
Lynn Health Science Institute
Oklahoma City, Oklahoma, United States, 73112