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

Completed · Phase 3 · Has a placebo group

Conditions studied: Ankylosing Spondylitis

In brief

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

Key facts

Study ID

NCT03502616

Run by

Pfizer

People needed

270

Starts

2018-06-07

Expected to finish

2020-08-20

Last updated by the study team

2021-09-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Arizona Arthritis & Rheumatology Associates, P.C. — Gilbert, Arizona, United States
• Medvin Clinical Research — Covina, California, United States
• Rheumatology Center of San Diego PC — San Diego, California, United States
• University of California, San Francisco Medical Center — San Francisco, California, United States
• Robin K. Dore, MD, Inc. — Tustin, California, United States
• New England Research Associates, LLC — Bridgeport, Connecticut, United States
• Advanced Radiology — Stamford, Connecticut, United States
• Stamford Therapeutics Consortium — Stamford, Connecticut, United States
• Southcoast Research Center, Inc. — Miami, Florida, United States
• Millennium Research — Ormond Beach, Florida, United States
• Bluegrass Community Research, Inc — Lexington, Kentucky, United States
• Center for Rheumatology and Bone Research — Wheaton, Maryland, United States
• M3-Emerging Medical Research, LLC — Durham, North Carolina, United States
• Paramount Medical Research and Consulting, LLC — Middleburg Heights, Ohio, United States
• Oregon Health & Science University — Portland, Oregon, United States
• Altoona Center For Clinical Research — Duncansville, Pennsylvania, United States
• Articularis Healthcare Group, Inc d/b/a Low Country Rheumatology — Summerville, South Carolina, United States
• Precision Comprehensive Clinical Research Solutions — Colleyville, Texas, United States
• Adriana Pop-Moody MD - Clinic PA — Corpus Christi, Texas, United States
• Metroplex Clinical Research Center — Dallas, Texas, United States
• Clinical Research Unit — Houston, Texas, United States
• Investigational Drug Services — Houston, Texas, United States
• Memorial Hermann Hospital Imaging — Houston, Texas, United States
• Southwest Rheumatology Research LLC — Mesquite, Texas, United States
• Rheumatology Associates of North Alabama, PC — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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