Clinical trial NCT01882439: Tofacitinib In Psoriatic Arthritis Subjects With Inadequate Response to TNF Inhibitors
Official title: A Phase 3, Randomized, Double-blind, Placebo-controlled Study Of The Efficacy And Safety Of 2 Doses Of Tofacitinib (Cp-690,550) In Subjects With Active Psoriatic Arthritis And An Inadequate Response To At Least One Tnf Inhibitor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Psoriatic Arthritis
Keywords: psoriatic arthritis
tofacitinib
ACR20
HAQ-DI
TNF inhibitor failure
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2013-06-20
Enrollment: 395
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To examine the safety and efficacy of tofacitinib in subjects with active psoriatic arthritis who have previously had an inadequate response to at least one TNF inhibitor either due to lack of efficacy or an adverse event.


Eligibility criteria: Inclusion Criteria:

* Active arthritis at screening/baseline as indicated by \>/= 3 tender/painful and 3 swollen joints
* Active plaque psoriasis at screening
* Inadequate efficacy or lack of toleration to previously administered TNF inhibitor

Exclusion Criteria:

* Non-plaque forms of psoriasis (with exception of nail psoriasis)
* History of autoimmune rheumatic disease other than PsA; also prior history of or current, rheumatic inflammatory disease other than PsA

Primary outcomes:
measure: Percentage of Participants Meeting American College of Rheumatology Response Criteria Greater Than or Equal to (≥) 20% (ACR20): Month 3
timeFrame: Month 3
measure: Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score: Month 3
timeFrame: Month 3
Secondary outcomes:
measure: Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥50% (ACR50) at Week 2 and Months 1, 2, 3, 4, and 6
timeFrame: Week 2 and Months 1, 2, 3, 4, and 6
measure: Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥70% (ACR70) at Week 2 and Months 1, 2, 3, 4, and 6
timeFrame: Week 2 and Months 1, 2, 3, 4, and 6
measure: Percentage of Participants Meeting American College of Rheumatology Response Criteria Greater Than or Equal to (≥) 20% (ACR20): Week 2 and Months 1, 2, 4, and 6
timeFrame: Week 2 and Months 1, 2, 4, and 6
measure: Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score: Week 2 and Months 1, 2, 4, and 6
timeFrame: Week 2 and Months 1, 2, 4, and 6
measure: Change From Baseline in American College of Rheumatology (ACR) Response Criteria Components: C-reactive Protein (CRP) Levels: Month 3
timeFrame: Month 3
measure: Change From Baseline in American College of Rheumatology (ACR) Response Criteria Components Score: Patient's Assessment of Arthritis Pain: Month 3
timeFrame: Month 3
measure: Change From Baseline in American College of Rheumatology (ACR) Response Criteria Components Score: Patient's Global Assessment of Arthritis: Month 3
timeFrame: Month 3
measure: Change From Baseline in American College of Rheumatology (ACR) Response Criteria Components Score: Physician's Global Assessment of Arthritis: Month 3
timeFrame: Month 3
measure: Change From Baseline in American College of Rheumatology (ACR) Response Criteria Components Score: Swollen Joint Count: Month 3
timeFrame: Month 3
measure: Change From Baseline in American College of Rheumatology (ACR) Response Criteria Components Score: Tender/Painful Joint Count: Month 3
timeFrame: Month 3
measure: Percentage of Participants Meeting Psoriatic Arthritis Response Criteria (PsARC): Week 2, Months 1, 2, 3, 4, and 6
timeFrame: Week 2, Months 1, 2, 3, 4, and 6
measure: Change From Baseline in Physician's Global Assessment of Psoriasis (PGA-PsO) Response: Months 1, 3, and 6
timeFrame: Months 1, 3, and 6
measure: Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response: Months 1, 3, and 6
timeFrame: Months 1, 3, and 6
measure: Change From Baseline in Dactylitis Severity Score (DSS): Months 1, 3, and 6
timeFrame: Months 1, 3, and 6
measure: Change From Baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index: Months 1, 3, and 6
timeFrame: Months 1, 3, and 6
measure: Change From Baseline in the Leeds Enthesitis Index (LEI): Months 1, 3, and 6
timeFrame: Months 1, 3, and 6
measure: Change From Baseline in the Short-Form-36 Health Survey Version 2, Acute Components (SF-36v2 Acute): Physical Component Summary Score: Months 1, 3, 6
timeFrame: Months 1, 3, 6
measure: Change From Baseline in the Short-Form-36 Health Survey Version 2, Acute Components (SF-36v2 Acute): Mental Component Summary Score: Months 1, 3, 6
timeFrame: Months 1, 3, 6
measure: Change From Baseline in the Short-Form-36 Health Survey Version 2, Acute Components (SF-36v2 Acute): Physical Functioning Domain: Months 1, 3, 6
timeFrame: Months 1, 3, 6
measure: Change From Baseline in the Short-Form-36 Health Survey Version 2, Acute Components (SF-36v2 Acute): Role-physical Domain: Months 1, 3, 6
timeFrame: Months 1, 3, 6
measure: Change From Baseline in the Short-Form-36 Health Survey Version 2, Acute Components (SF-36v2 Acute): Bodily Pain Domain: Months 1, 3, 6
timeFrame: Months 1, 3, 6
measure: Change From Baseline in the Short-Form-36 Health Survey Version 2, Acute Components (SF-36v2 Acute): General Health Domain: Months 1, 3, 6
timeFrame: Months 1, 3, 6
measure: Change From Baseline in the Short-Form-36 Health Survey Version 2, Acute Components (SF-36v2 Acute): Vitality Domain: Months 1, 3, 6
timeFrame: Months 1, 3, 6
measure: Change From Baseline in the Short-Form-36 Health Survey Version 2, Acute Components (SF-36v2 Acute): Social Functioning Domain: Months 1, 3, 6
timeFrame: Months 1, 3, 6
measure: Change From Baseline in the Short-Form-36 Health Survey Version 2, Acute Components (SF-36v2 Acute): Role-emotional Domain: Months 1, 3, 6
timeFrame: Months 1, 3, 6
measure: Change From Baseline in the Short-Form-36 Health Survey Version 2, Acute Components (SF-36v2 Acute): Mental Health Domain: Months 1, 3, 6
timeFrame: Months 1, 3, 6
measure: Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Mobility: Months 1, 3, 6
timeFrame: Months 1, 3, 6
measure: Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Self-Care: Months 1, 3, 6
timeFrame: Months 1, 3, 6
measure: Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Usual Activities: Months 1, 3, 6
timeFrame: Months 1, 3, 6
measure: Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Pain/Discomfort: Months 1, 3, 6
timeFrame: Months 1, 3, 6
measure: Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Anxiety/Depression: Months 1, 3, 6
timeFrame: Months 1, 3, 6
measure: Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Patient's Health State Today: Months 1, 3, 6
timeFrame: Months 1, 3, 6
measure: Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Total Score: Months 1, 3, 6
timeFrame: Months 1, 3, 6
measure: Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Experience Domain Score: Months 1, 3, 6
timeFrame: Months 1, 3, 6
measure: Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Impact Domain Score: Months 1, 3, 6
timeFrame: Months 1, 3, 6
measure: Change From Baseline in Score Evaluating Spondylitis Using the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI): Months 1, 3, 6
timeFrame: Months 1, 3, 6
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Rheumatology Associates P.C.
state: Alabama
city: Huntsville
country: United States
facility: Rheumatology Associates of North Alabama, PC
state: Alabama
city: Glendale
country: United States
facility: Arizona Arthritis & Rheumatology Associates, P.C.
state: Arizona
city: Covina
country: United States
facility: Medvin Clinical Research
state: California
city: Fullerton
country: United States
facility: St. Jude Hospital Yorba Linda DBA St. Joseph Heritage Healthcare
state: California
city: Los Angeles
country: United States
facility: Ronald Reagan UCLA Medical Center, Drug Information Center
state: California
city: Los Angeles
country: United States
facility: UCLA David Geffen School of Medicine
state: California
city: San Diego
country: United States
facility: San Diego Arthritis Medical Clinic
state: California
city: Stanford
country: United States
facility: Stanford Hospital and Clinics
state: California
city: Trumbull
country: United States
facility: New England Research Associates, LLC
state: Connecticut
city: Orlando
country: United States
facility: Rheumatology Associates of Central Florida, PA
state: Florida
city: Ormond Beach
country: United States
facility: Millennium Research
state: Florida
city: Palm Harbor
country: United States
facility: Arthritis Center, Inc.
state: Florida
city: Plantation
country: United States
facility: Integral Rheumatology & Immunology Specialists (IRIS)
state: Florida
city: Zephyrhills
country: United States
facility: Florida Medical Clinic, P.A.
state: Florida
city: Boise
country: United States
facility: St. Luke's Clinic - Rheumatology
state: Idaho
city: Boise
country: United States
facility: St. Luke's Intermountain Research Center
state: Idaho
city: Lexington
country: United States
facility: Bluegrass Community Research, Inc
state: Kentucky
city: Hagerstown
country: United States
facility: Klein & Associates, M.D., P.A.
state: Maryland
city: Wheaton
country: United States
facility: The Center For Rheumatology And Bone Research
state: Maryland
city: Boston
country: United States
facility: Brigham & Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Worcester
country: United States
facility: Clinical Pharmacology Study Group
state: Massachusetts
city: Eagan
country: United States
facility: St. Paul Rheumatology, PA
state: Minnesota
city: Saint Louis
country: United States
facility: Clayton Medical Research
state: Missouri
city: Lincoln
country: United States
facility: Physician Research Collaboration, LLC
state: Nebraska
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center (DHMC)
state: New Hampshire
city: Cincinnati
country: United States
facility: Cincinnati Rheumatic Disease Study Group, Inc.
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Case Medical Center
state: Ohio
city: Middleburg Heights
country: United States
facility: Paramount Medical Research & Consulting, LLC
state: Ohio
city: Bethlehem
country: United States
facility: East Penn Rheumatology Associates, PC
state: Pennsylvania
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
city: Charleston
country: United States
facility: Low Country Rheumatology, PA
state: South Carolina
city: Jackson
country: United States
facility: Arthritis Clinic
state: Tennessee
city: Jackson
country: United States
facility: West Tennessee Research Institute
state: Tennessee
city: Corpus Christi
country: United States
facility: Adriana M. Pop-Moody, M.D., Clinic, P.A.
state: Texas
city: Cypress
country: United States
facility: Pioneer Research Solutions, Inc.
state: Texas
city: Dallas
country: United States
facility: Metroplex Clinical Research Center
state: Texas
city: Salt Lake City
country: United States
facility: Drug Shipment/Storage: Investigational Drug Services
state: Utah
city: Salt Lake City
country: United States
facility: University of Utah Hospital & Clinics
state: Utah
city: Seattle
country: United States
facility: Dynacare Laboratories
state: Washington
city: Seattle
country: United States
facility: Seattle Rheumatology Associates
state: Washington
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital, Rheumatology Department
state: New South Wales
city: Maroochydore
country: Australia
facility: Rheumatology Research Unit
state: Queensland
city: Malvern East
country: Australia
facility: Emeritus Research Pty Ltd
state: Victoria
city: Brussels
country: Belgium
facility: Hospital Erasme - Clinique Universitaire de Bruxelles
city: Genk
country: Belgium
facility: ReumaClinic
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
city: Leuven
country: Belgium
facility: University Hospital Leuven, Department of Rheumatology
city: Merksem
country: Belgium
facility: ZNA Jan Palfijn
city: Juiz de Fora
country: Brazil
facility: CMIP: Centro Mineiro de Pesquisa Ltda /
state: MG
city: Curitiba
country: Brazil
facility: CETAC - DIAGNOSTICO POR IMAGEM (image only)
state: PR
city: Curitiba
country: Brazil
facility: EDUMED - Educacao em Saude SS LTDA.
state: PR
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre (HCPA) / UFRGS
state: RS
city: Campinas
country: Brazil
facility: Clinica Medica Bonfiglioli Ltda. / Clinica Bonfiglioli
state: SP
city: Campinas
country: Brazil
facility: Radiologia Clínica de Campinas - RCC (Images only)
state: São Paulo
city: Uherske Hradiste
country: Czechia
facility: Medical Plus s.r.o.
city: Corbeil-Essonnes
country: France
facility: Centre Hospitalier Sud-Francilien - Secretariat de Rhumatologie
state: Cedex
city: Bobigny
country: France
facility: Hopital Avicenne
city: Bad Doberan
country: Germany
facility: Rheumazentrum Prof. Dr. med Gunther Neeck
city: Berlin
country: Germany
facility: Charite Universitatsmedizin Berlin - Campus Charite Mitte
city: Berlin
country: Germany
facility: Rheumapraxis Steglitz
city: Berlin
country: Germany
facility: Schlosspark-Klinik
city: Erlangen
country: Germany
facility: Universitaetsklinikum Erlangen, Medizinische Klinik 3
city: Frankfurt am Main
country: Germany
facility: CIRI - Centrum für innovative Diagnostik und Therapie Rheumatologie/Immunologie (GmbH)
city: Freiburg
country: Germany
facility: Medizinische Universitatsklinik Freiburg
city: Homburg
country: Germany
facility: Universitaetsklinikum Des Saarlandes Und Medizinische Fakultaet Der Universitaet Des Saarlandes
city: Koeln
country: Germany
facility: University Hospital of Cologne
city: Olsberg
country: Germany
facility: Elisabeth Klinik Bigge
city: Mexico City
country: Mexico
facility: Hospital Angeles Clinica Londres
state: D.F
city: Mexico City
country: Mexico
facility: Grupo Medico Camino S.C.
state: Distrito Federal
city: Mexico
country: Mexico
facility: CLIDITER, S.A. de C.V.
state: Distrito Federal
city: Mexico
country: Mexico
facility: Universidad La Salle AC
state: Distrito Federal
city: Mexico
country: Mexico
facility: Medica Sur, S.A.B. de C.V. (For Emergencies Only)
state: Distrito Federal
city: Guadalajara
country: Mexico
facility: Centro Integral en Reumatologia SA de CV
state: Jalisco
city: Guadalajara
country: Mexico
facility: Grupo Santa Bernardette S.A. de C.V.
state: Jalisco
city: Culiacan
country: Mexico
facility: Centro de Investigacion de Tratamientos Innovadores de Sinaloa, S.C
state: Sinaloa
city: Culiacan
country: Mexico
facility: Sanatorio CEMSI Chapultepec (For Emergencies Only)
state: Sinaloa
city: Culiacan
country: Mexico
facility: Hospital General de Culiacan "Dr. Bernardo J. Gastelum"
state: Sinaloa
city: Merdia
country: Mexico
facility: Star Medica S.A. de C.V. (For Emergencies Only)
state: Yucatan
city: Merida
country: Mexico
facility: Institute Medico Panamericano, S.A. de C.V. (For Emergencies Only)
state: Yucatan
city: Merida
country: Mexico
facility: Unidad Reumatologica Las Americas SCP
state: Yucatan
city: Merida
country: Mexico
facility: Centro de Investigacion Clinica Pensiones
state: Yucatan
city: Merida
country: Mexico
facility: Centro Multidisciplinario para el Desarrollo
state: Yucatan
city: Merida
country: Mexico
facility: Hospital Star Medica Merida (For Emergencies Only)
state: Yucatan
city: Chihuahua
country: Mexico
facility: Christus Muguerza del parque, S.A de C.V
city: Chihuahua
country: Mexico
facility: Investigacion y Biomedicina de Chihuahua
city: Elblag
country: Poland
facility: Centrum Kliniczno-Badawcze J.Brzezicki, B.Gornikiewicz-Brzez
city: Elblag
country: Poland
facility: Centrum Radiologii for X-Ray only
city: Elblag
country: Poland
facility: NZOZ Centrum Reumatologiczne Indywidualna Specjalistyczna Praktyka Lekarska Lek. Med. Barbara Bazela
city: Elblag
country: Poland
facility: Wojewodzki Szpital Zespolony Zaklad Radiologii
city: Grodzisk Mazowiecki
country: Poland
facility: Przychodnia Specjalistyczna Lekarskiej Spozielni Pracy "Medica" for X-Ray Only
city: Lodz
country: Poland
facility: Specjalistyczne Gabinety Lekarskie "DERMED" Anna Kaszuba
city: Nadarzyn
country: Poland
facility: NZOZ Lecznica MAK-MED S.C.
city: Poznan
country: Poland
facility: Prywatna Praktyka Lekarska Prof. UM dr hab. Pawel Hrycaj
city: Warszawa
country: Poland
facility: Reumatika Centrum Reumatologii nzoz
city: Petrozavodsk
country: Russian Federation
facility: Regional State Budgetary Healthcare Institution of Karelia Republic "Republic Hospital n.a.
state: Karelia Republic
city: Kazan
country: Russian Federation
facility: State Autonomic Healthcare Institution City Clinical Hospital # 7
state: Republic of Tatarstan, Russia
city: Moscow
country: Russian Federation
facility: SBIH of Moscow "City Clinical Hospital#1 n. a. N.I. Pirogov" of the Healthcare Department of Moscow
city: Novosibirsk
country: Russian Federation
facility: City Neurological Centre "SibNeyroMed", LLC
city: Novosibirsk
country: Russian Federation
facility: Limited Liability Company Consultative Diagnostic Rheumatology Center "Healthy Joints"
city: Tomsk
country: Russian Federation
facility: State Budget Educational Institution of Highest Professional Education
city: Yaroslavl
country: Russian Federation
facility: State Institution of Healthcare of Yaroslavl Region
city: Martin
country: Slovakia
facility: MEDMAN s.r.o. - reumatologicka ambulancia
city: Santiago De Compostela
country: Spain
facility: Hospital Clinico de Santiago
state: A Coruna
city: Sabadell
country: Spain
facility: Corporacio Sanitaria Parc Tauli
state: Barcelona
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla
state: Cantabria
city: Torrelavega
country: Spain
facility: Hospital Sierrallana
state: Cantabria
city: A Coruna
country: Spain
facility: Complejo Hospitalario Universitario A Coruna
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Valencia
country: Spain
facility: Hospital Universitaro Y Politecnico La Fe
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
state: Taiwan Roc
city: Chia-Yi
country: Taiwan
facility: Buddhist Dalin Tzu Chi General Hospital
city: Kaohsiung City
country: Taiwan
facility: Chang Gung Medical Foundation-Kaohsiung Branch
city: Taichung
country: Taiwan
facility: Chung Shan Medical University Hospital
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Goodmayes
country: United Kingdom
facility: Barking Havering and Redbridge University Hospitals NHS Trust
state: Essex
city: Romford
country: United Kingdom
facility: Barking, Havering and Redbridge University Hospitals NHS Trust
state: Essex
city: Dudley
country: United Kingdom
facility: The Dudley Group NHS Foundation Trust
state: West Midlands
city: Bradford
country: United Kingdom
facility: Bradford Royal Infirmary, BTHFT
state: West Yorkeshire
city: Bath
country: United Kingdom
facility: Royal United Hospitals NHS Foundation Trust
city: Bradford
country: United Kingdom
facility: Bradford Teaching Hospitals NHS Foundation Trust
city: York
country: United Kingdom
facility: York Hospital, York Teaching Hospital NHS Foundation Trust
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: de Vlam K, Mease PJ, Bushmakin AG, Fleischmann R, Ogdie A, Azevedo VF, Merola JF, Woolcott J, Cappelleri JC, Fallon L, Taylor PC. Identifying and Quantifying the Role of Inflammation in Pain Reduction for Patients With Psoriatic Arthritis Treated With Tofacitinib: A Mediation Analysis. Rheumatol Ther. 2022 Oct;9(5):1451-1464. doi: 10.1007/s40744-022-00482-5. Epub 2022 Sep 8.
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