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.
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