A Study of ARRY-371797 in Patients With Active Ankylosing Spondylitis
NCT ID: NCT00811499
Last Updated: 2020-10-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
25 participants
INTERVENTIONAL
2008-12-16
2009-09-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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ARRY-371797 (Schedule 1)
ARRY-371797, p38 inhibitor; oral
multiple dose, single schedule
ARRY-371797 (Schedule 2)
ARRY-371797, p38 inhibitor; oral
multiple dose, single schedule
Placebo; oral
multiple dose, single schedule
Placebo
Placebo; oral
matching placebo
Interventions
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ARRY-371797, p38 inhibitor; oral
multiple dose, single schedule
Placebo; oral
matching placebo
Placebo; oral
multiple dose, single schedule
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Cedars-Sinai Medical Center
Los Angeles, California, United States
Northwestern University
Chicago, Illinois, United States
Westroads Medical Group
Omaha, Nebraska, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, United States
Oregon Health & Science University
Portland, Oregon, United States
Low Country Rheumatology
Charleston, South Carolina, United States
Arthritis Northwest
Spokane, Washington, United States
Rheumatology Research Associates Group
Edmonton, Alberta, Canada
University of Manitoba
Winnipeg, Manitoba, Canada
Credit Valley Rheumatology
Mississauga, Ontario, Canada
Center de Recherche Musculo-Squelettique
Trois-Rivières, Quebec, Canada
University of Saskatchewan
Saskatoon, Saskatchewan, Canada
Countries
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Other Identifiers
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C4411006
Identifier Type: OTHER
Identifier Source: secondary_id
ARRAY-797-201
Identifier Type: -
Identifier Source: org_study_id
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