Efficacy and Safety of Tofacitinib in Subjects With Active Ankylosing Spondylitis (AS)
NCT03502616
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- 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.
- 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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Descriptive Information | |||||||
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Brief Title ICMJE | Efficacy and Safety of Tofacitinib in Subjects With Active Ankylosing Spondylitis (AS) | ||||||
Official Title ICMJE | A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, STUDY OF THE EFFICACY AND SAFETY OF TOFACITINIB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS (AS) | ||||||
Brief Summary | The purpose of this study is to determine if tofacitinib is safe and effective in subjects with active ankylosing spondylitis. | ||||||
Detailed Description | Not Provided | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 3 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment | ||||||
Condition ICMJE | Ankylosing Spondylitis | ||||||
Intervention ICMJE | Drug: Tofacitinib
Oral administration twice per day | ||||||
Study Arms ICMJE |
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||
Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE | 270 | ||||||
Original Estimated Enrollment ICMJE | 240 | ||||||
Actual Study Completion Date ICMJE | August 20, 2020 | ||||||
Actual Primary Completion Date | December 19, 2019 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | Australia, Bulgaria, Canada, China, Czechia, France, Hungary, Israel, Korea, Republic of, Poland, Russian Federation, Turkey, Ukraine, United States | ||||||
Removed Location Countries | Slovakia, Spain, Taiwan | ||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT03502616 | ||||||
Other Study ID Numbers ICMJE | A3921120 AS ( Other Identifier: Alias Study Number ) 2018-000226-58 ( EudraCT Number ) | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Pfizer | ||||||
Study Sponsor ICMJE | Pfizer | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | Pfizer | ||||||
Verification Date | December 2020 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |