Efficacy and Safety of Tofacitinib in Subjects With Active Ankylosing Spondylitis (AS)



Status:Recruiting
Conditions:Arthritis, Neurology, Neurology
Therapuetic Areas:Neurology, Rheumatology
Healthy:No
Age Range:18 - Any
Updated:4/6/2019
Start Date:June 7, 2018
End Date:September 2, 2020
Contact:Pfizer CT.gov Call Center
Email:ClinicalTrials.gov_Inquiries@pfizer.com
Phone:1-800-718-1021

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A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, STUDY OF THE EFFICACY AND SAFETY OF TOFACITINIB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS (AS)

The purpose of this study is to determine if tofacitinib is safe and effective in subjects
with active ankylosing spondylitis.


Inclusion Criteria:

- Has a diagnosis of Ankylosing Spondylitis (AS) based on the Modified New York Criteria
for AS (1984).

- Must have a radiograph of SI joints (AP Pelvis) documenting diagnosis of AS.

- Has active disease despite nonsteroidal anti-inflammatory drug (NSAID) therapy or
intolerant to NSAIDs.

Exclusion Criteria:

- History of known or suspected complete ankylosis of the spine.

- History of allergies, intolerance or hypersensitivity to lactose or tofacitinib.

- History of any other rheumatic disease.

- Any subject with condition affecting oral drug absorption.
We found this trial at
33
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Lexington, Kentucky 40504
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Birmingham, Alabama 35205
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4641 Main Street
Bridgeport, Connecticut 06606
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Columbia, Maryland 21046
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Corpus Christi, Texas 78404
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Covina, California 91723
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Dallas, TX
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Duncansville, Pennsylvania 16635
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Durham, North Carolina 27704
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Eagan, Minnesota 55121
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215 South Hickory Street
Escondido, California 92025
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Gilbert, AZ
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Houston, Texas 77030
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Houston, Texas 77030
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Houston, Texas 77030
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Lansing, Michigan 48917
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Maroochydore, Queensland
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Mesquite, Texas 75150
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Miami, Florida 33144
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Middleburg Heights, Ohio 44130
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Ormond Beach, Florida 32174
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505 Parnassus Ave
San Francisco, California 94143
(415) 476-1000
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Spokane, Washington 99204
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Stamford, Connecticut 06095
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Stamford, Connecticut 06902
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Summerville, SC
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6707 Sterling Ridge Drive
The Woodlands, Texas 77382
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Tustin, California 92780
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Wheaton, MD
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