Efficacy and Safety of Tofacitinib in Subjects With Active Ankylosing Spondylitis (AS)
A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, STUDY OF THE EFFICACY AND SAFETY OF TOFACITINIB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS (AS)
3 other identifiers
interventional
270
14 countries
99
Brief Summary
The purpose of this study is to determine if tofacitinib is safe and effective in subjects with active ankylosing spondylitis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jun 2018
99 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 11, 2018
CompletedFirst Posted
Study publicly available on registry
April 18, 2018
CompletedStudy Start
First participant enrolled
June 7, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 19, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 20, 2020
CompletedResults Posted
Study results publicly available
January 11, 2021
CompletedSeptember 17, 2021
August 1, 2021
1.5 years
April 11, 2018
December 15, 2020
August 19, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Achieving Assessment of SpondyloArthritis International Society (ASAS)20 Response at Week 16
ASAS20 assess 4 domains: Patient Global Assessment of Disease (PGA) (assess disease activity on a scale of 0 \[not active\] to 10 \[very active\], high score=more disease activity), total back pain (scale of 0 \[no pain\] to 10 \[most severe pain\], high score=more severity), Function (Bath Ankylosing Spondylitis Functional Index \[BASFI\]; participant's level of ability on scale of 0 \[easy\] to 10 \[impossible\], low score= better functional health) and Inflammation (morning stiffness, Mean of Question \[Q\]5 and Q6 of Bath Ankylosing Spondylitis Disease Activity Index \[BASDAI\] defined as 6-item questionnaire measure disease activity on a scale of 0 \[none\] to 10 \[severe\], high score=more disease activity). ASAS20 response: greater than or equal to (\>=) 20 percent (%) improvement from baseline in disease activity and absolute change of \>=1 unit in \>=3 domains and no worsening of \>=20% and an absolute change of \>=1 unit in remaining domain.
Week 16
Secondary Outcomes (43)
Percentage of Participants Achieving Ankylosing Spondylitis (ASAS)40 Response at Week 16
Week 16
Number of Participants With Treatment Emergent Adverse Events (AEs)
Baseline up to Week 16 and Baseline up to Week 48
Number of Participants With Treatment Emergent Adverse Events (AEs) by Severity
Baseline up to Week 16 and Baseline up to Week 48
Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality)
Baseline up to Week 16 and Baseline up to Week 48
Number of Participants With Vital Signs Abnormalities
Baseline up to Week 16 and Baseline up to Week 48
- +38 more secondary outcomes
Study Arms (2)
Tofacitinib
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (99)
Rheumatology Associates of North Alabama, PC
Huntsville, Alabama, 35801, United States
Arizona Arthritis & Rheumatology Associates, P.C.
Gilbert, Arizona, 85297, United States
Medvin Clinical Research
Covina, California, 91722, United States
Rheumatology Center of San Diego PC
San Diego, California, 92128, United States
University of California, San Francisco Medical Center
San Francisco, California, 94143, United States
Robin K. Dore, MD, Inc.
Tustin, California, 92780, United States
New England Research Associates, LLC
Bridgeport, Connecticut, 06606, United States
Advanced Radiology
Stamford, Connecticut, 06902, United States
Stamford Therapeutics Consortium
Stamford, Connecticut, 06905, United States
Southcoast Research Center, Inc.
Miami, Florida, 33136, United States
Millennium Research
Ormond Beach, Florida, 32174, United States
Bluegrass Community Research, Inc
Lexington, Kentucky, 40504, United States
Center for Rheumatology and Bone Research
Wheaton, Maryland, 20902, United States
M3-Emerging Medical Research, LLC
Durham, North Carolina, 27704, United States
Paramount Medical Research and Consulting, LLC
Middleburg Heights, Ohio, 44130, United States
Oregon Health & Science University
Portland, Oregon, 97239, United States
Altoona Center For Clinical Research
Duncansville, Pennsylvania, 16635, United States
Articularis Healthcare Group, Inc d/b/a Low Country Rheumatology
Summerville, South Carolina, 29486, United States
Precision Comprehensive Clinical Research Solutions
Colleyville, Texas, 76034, United States
Adriana Pop-Moody MD - Clinic PA
Corpus Christi, Texas, 78404, United States
Metroplex Clinical Research Center
Dallas, Texas, 75231, United States
Clinical Research Unit
Houston, Texas, 77030, United States
Investigational Drug Services
Houston, Texas, 77030, United States
Memorial Hermann Hospital Imaging
Houston, Texas, 77030, United States
Southwest Rheumatology Research LLC
Mesquite, Texas, 75150, United States
Trinity Universal Research Associates, Inc.
Plano, Texas, 75024, United States
Advanced Rheumatology of Houston
The Woodlands, Texas, 77382, United States
Arthritis Northwest, PLLC
Spokane, Washington, 99204, United States
Pacific Radiology,
Maroochydore, Queensland, 4558, Australia
Rheumatology Research Unit Sunshine Coast
Maroochydore, Queensland, 4558, Australia
Emeritus Research Pty. Ltd.
Camberwell, Victoria, 3124, Australia
Melbourne Radiology Clinic
East Melbourne, Victoria, 3002, Australia
SKG Radiology
Subiaco, Western Australia, 6008, Australia
Western Cardiology
Subiaco, Western Australia, 6008, Australia
RK Will Pty Ltd
Victoria Park, Western Australia, 6100, Australia
Multiprofile Hospital for active treatment "Kaspela" EOOD
Plovdiv, 4002, Bulgaria
Diagnostic-Consulting Center XVII - Sofia
Sofia, 1505, Bulgaria
Medical Centre Synexus Sofia EOOD
Sofia, 1784, Bulgaria
G.R.M.O. (Groupe de recherche en maladies osseuses) Inc.
Québec, Quebec, G1V 3M7, Canada
Centre de Recherche Musculo-Squelettique
Trois-Rivières, Quebec, G8Z 1Y2, Canada
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510080, China
The Third Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, 510630, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009, China
The First Affiliated Hosptial of Wenzhou Medical University
Wenzhou, Zhejiang, 325000, China
Rheumatology and Immunology Department, Shanghai Changzheng Hospital
Shanghai, 200003, China
Lekarna Rezidence Nova Karolina
Ostrava, 702 00, Czechia
CCBR Ostrava s.r.o.
Ostrava, 70200, Czechia
BENU Lekarna
Pardubice, 530 02, Czechia
CCR, Czech a.s.
Pardubice, 530 02, Czechia
Lekarna Hradebni, s.r.o.
Uherské Hradiště, 686 01, Czechia
Uherskohradistska nemocnice, a.s.
Uherské Hradiště, 686 06, Czechia
Medical Plus s.r.o.
Uherské Hradiště, 68601, Czechia
CHRU de Tours, Hopital Trousseau
Tours, 37044, France
Qualiclinic K ft
Budapest, 1036, Hungary
Pest megyei Flór Ferenc Kórház, Reumatológia-és Fizioterápiás Osztály
Kistarcsa, 2143, Hungary
VITAL MEDICAL CENTER (VITÁL-MEDICINA Kft.)
Veszprém, 8200, Hungary
Barzilai Medical Center
Ashkelon, 7830604, Israel
Geo Medical Sp. z.o.o Szpital Geo Medical
Katowice, 40-042, Poland
Moja Przychodnia
Katowice, 40-057, Poland
C.M. Silmedic Sp. z o.o.
Katowice, 40-282, Poland
Malopolskie Badania Kliniczne Sp. z o.o. s.k.
Krakow, 30-040, Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej MSWiA
Krakow, 30-053, Poland
Centrum Medyczne Plejady
Krakow, 30-363, Poland
Centrum Medyczne LUX MED
Krakow, 30-415, Poland
Malopolskie Centrum Medyczne S.C.
Krakow, 30-510, Poland
Szpital Uniwersytecki w Krakowie, Zaklad Radiologii
Krakow, 31-066, Poland
Top Medical
Lublin, 20-601, Poland
Zespol Poradni Specjalistycznych REUMED, Wallenroda Filia nr 1
Lublin, 20-607, Poland
NZOZ JAMED Pracownia Rentgenowska Jerema Antoszewski
Poznan, 61-397, Poland
Prywatna Praktyka Lekarska Prof. UM dr hab. med. Pawel Hrycaj
Poznan, 61-397, Poland
Klinika Alfa
Sochaczew, 96-500, Poland
RCMed Oddzial Sochaczew
Sochaczew, 96-500, Poland
Szpital Powiatowy w Sochaczewie
Sochaczew, 96-500, Poland
Szpital Sw. Elzbiety, Mokotowskie Centrum Medyczne, Zaklad Diagnostyki
Warsaw, 02-616, Poland
"Reumatika - Centrum Reumatologii" NZOZ
Warsaw, 02-691, Poland
Centrum Medyczne Oporow
Wroclaw, 52-416, Poland
Centrum Medyczne Medix
Wroclaw, 53-413, Poland
Limited Liability Company Medical Center "Rheuma-Med"
Kemerovo, 650070, Russia
State Budgetary Healthcare Institution "Orenburg Regional Clinical Hospital"
Orenburg, 460018, Russia
Limited Liability Company "Sanavita"
Saint Petersburg, 195257, Russia
State Healthcare Institution "Regional Clinical Hospital"
Saratov, 410053, Russia
RSBHI "Smolensk Regional Clinical Hospital"
Smolensk, 214018, Russia
Limited Liability Company "BioMed"
Vladimir, 600005, Russia
Chonnam National University Hospital
Gwangju, 61469, South Korea
Inha University Hospital
Incheon, 22332, South Korea
Hanyang University Seoul Hospital
Seoul, 04763, South Korea
Ankara Universitesi Tip Fakultesi Ibn-i Sina Hastanesi
Ankara, 06100, Turkey (Türkiye)
Ankara Universitesi Tip Fakultesi, Ibn-i Sina Hastanesi
Ankara, 06100, Turkey (Türkiye)
Hacettepe Universitesi Tip Fakultesi, Ic Hastaliklari Anabilim
Ankara, 06230, Turkey (Türkiye)
Istanbul Universitesi Istanbul Tip Fakultesi, Ic Hastaliklari
Istanbul, 34093, Turkey (Türkiye)
Istanbul Universitesi Istanbul Tip Fakultesi
Istanbul, 34093, Turkey (Türkiye)
Marmara Univ. Istanbul Pendik Egitim ve Arastirma Hastanesi
Istanbul, 34899, Turkey (Türkiye)
Izmir Katip Celebi Univ Ataturk Egitim ve Arastirma Hastanesi
Izmir, 35360, Turkey (Türkiye)
Izmir Katip Celebi Univ. Ataturk Egitim ve Arastirma Hastanesi
Izmir, 35360, Turkey (Türkiye)
Kyiv City Clinical Hospital # 3, Rheumatology Department
Kyiv, 02125, Ukraine
Lviv Communal Clinical Hospital #4, Rheumatology department
Lviv, 79011, Ukraine
Military-Medical Clinical Center (Clinical Hospital with 200 beds) of State Border Guard Service of
Lviv, 79014, Ukraine
Ternopil University Hospital, Department of Rheumatology,
Ternopil, 46002, Ukraine
Vinnytsia Regional Clinical Hospital n.a. M.I.Pyrohov, rheumatology department,
Vinnytsia, 21018, Ukraine
Related Publications (11)
Deodhar A, Akar S, Curtis JR, El-Zorkany B, Magrey M, Wang C, Wu J, Makgoeng SB, Vranic I, Menon S, Fleishaker DL, Diehl AM, Fallon L, Yndestad A, Landewe RBM. Integrated safety analysis of tofacitinib from Phase 2 and 3 trials of patients with ankylosing spondylitis. Adv Rheumatol. 2024 Dec 18;64(1):87. doi: 10.1186/s42358-024-00402-x.
PMID: 39695887DERIVEDGossec L, Walsh JA, Sengupta R, Bushmakin AG, Cappelleri JC, Yndestad A, Dina O, Cella D. Improvement of Fatigue in Patients with Ankylosing Spondylitis Receiving Tofacitinib: Analyses of a Phase 3 Randomized Controlled Trial. Rheumatol Ther. 2025 Feb;12(1):85-98. doi: 10.1007/s40744-024-00727-5. Epub 2024 Dec 13.
PMID: 39671076DERIVEDNorton H, Sliwinska-Stanczyk P, Hala T, El-Zorkany B, Stockert L, Mundayat R, Wang L, Ritchlin CT. Tofacitinib Efficacy/Safety in Patients with Ankylosing Spondylitis by Baseline Body Mass Index: A Post Hoc Analysis of Phase 2/3 Trials. Rheumatol Ther. 2025 Feb;12(1):67-84. doi: 10.1007/s40744-024-00726-6. Epub 2024 Dec 5.
PMID: 39636343DERIVEDOgdie A, Kristensen LE, Soriano ER, Akar S, Sun Y, Gruben D, Fallon L, Kinch CD, Gladman DD. Efficacy and Safety of Tofacitinib in Patients with Psoriatic Arthritis or Ankylosing Spondylitis by Cigarette Smoking Status. Rheumatol Ther. 2024 Dec;11(6):1649-1664. doi: 10.1007/s40744-024-00711-z. Epub 2024 Sep 25.
PMID: 39320582DERIVEDDeodhar A, Baraliakos X, Magrey M, Gensler LS, Thorat AV, Pemmaraju SK, Cadatal MJ, Nash P. Efficacy and Safety of Tofacitinib in Ankylosing Spondylitis by Baseline C-Reactive Protein Level: Post Hoc Analysis of Phase II and Phase III Clinical Trials. J Rheumatol. 2024 Aug 1;51(8):772-780. doi: 10.3899/jrheum.2023-1198.
PMID: 38825359DERIVEDNavarro-Compan V, Deodhar A, Bahiri R, Bushmakin AG, Cappelleri JC, Rammaoui J. Time to improvement of pain, morning stiffness, fatigue, and disease activity in patients with ankylosing spondylitis treated with tofacitinib: a post hoc analysis. Arthritis Res Ther. 2024 May 24;26(1):105. doi: 10.1186/s13075-024-03313-w.
PMID: 38790040DERIVEDKristensen LE, Deodhar A, Leung YY, Vranic I, Mortezavi M, Fallon L, Yndestad A, Kinch CD, Gladman DD. Risk Stratification of Patients with Psoriatic Arthritis and Ankylosing Spondylitis for Treatment with Tofacitinib: A Review of Current Clinical Data. Rheumatol Ther. 2024 Jun;11(3):487-499. doi: 10.1007/s40744-024-00662-5. Epub 2024 May 2.
PMID: 38696034DERIVEDMagrey M, Wei JC, Yndestad A, Bushmakin AG, Cappelleri JC, Dina O, Deodhar A. Relationships of Work Productivity and Activity Impairment With Patient-Reported Outcomes in Ankylosing Spondylitis: Results From Two Trials. Arthritis Care Res (Hoboken). 2024 Mar;76(3):359-365. doi: 10.1002/acr.25267. Epub 2024 Jan 5.
PMID: 37909386DERIVEDCella D, Lenderking WR, Chongpinitchai P, Bushmakin AG, Dina O, Wang L, Cappelleri JC, Navarro-Compan V. Functional Assessment of Chronic Illness Therapy-Fatigue is a reliable and valid measure in patients with active ankylosing spondylitis. J Patient Rep Outcomes. 2022 Sep 23;6(1):100. doi: 10.1186/s41687-022-00508-0.
PMID: 36138330DERIVEDNavarro-Compan V, Wei JC, Van den Bosch F, Magrey M, Wang L, Fleishaker D, Cappelleri JC, Wang C, Wu J, Dina O, Fallon L, Strand V. Effect of tofacitinib on pain, fatigue, health-related quality of life and work productivity in patients with active ankylosing spondylitis: results from a phase III, randomised, double-blind, placebo-controlled trial. RMD Open. 2022 Jun;8(2):e002253. doi: 10.1136/rmdopen-2022-002253.
PMID: 35654457DERIVEDDeodhar A, Sliwinska-Stanczyk P, Xu H, Baraliakos X, Gensler LS, Fleishaker D, Wang L, Wu J, Menon S, Wang C, Dina O, Fallon L, Kanik KS, van der Heijde D. Tofacitinib for the treatment of ankylosing spondylitis: a phase III, randomised, double-blind, placebo-controlled study. Ann Rheum Dis. 2021 Aug;80(8):1004-1013. doi: 10.1136/annrheumdis-2020-219601. Epub 2021 Apr 27.
PMID: 33906853DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 11, 2018
First Posted
April 18, 2018
Study Start
June 7, 2018
Primary Completion
December 19, 2019
Study Completion
August 20, 2020
Last Updated
September 17, 2021
Results First Posted
January 11, 2021
Record last verified: 2021-08
Data Sharing
- IPD Sharing
- Will share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.