Efficacy And Safety Of Tofacitinib In Psoriatic Arthritis: Comparator Study (OPAL BROADEN)

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Of The Efficacy And Safety Of 2 Doses Of Tofacitinib (CP-690,550) Or Adalimumab In Subjects With Active Psoriatic Arthritis

This is a 12-month study investigating the effectiveness and safety of tofactinib in treating the signs and symptoms of active psoriatic arthritis and improving physical function and preserving bone structure in patients with an inadequate response to a traditional, nonbiologic disease-modifying antirheumatic drug. Adalimumab is used as a comparator.

Study Overview

• Status: Completed
• Conditions: Psoriatic Arthritis
• Intervention / Treatment: Drug: Tofacitinib 5 mg BID; Drug: Tofacitinib 10 mg BID; Drug: Adalimumab; Drug: Placebo; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 422
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • Queensland
    • Maroochydore, Queensland, Australia, 4558
      • Rheumatology Research Unit
    • Southport, Queensland, Australia, 4215
      • Pacific Private Clinic
  • Victoria
    • Clayton, Victoria, Australia, 3168
      • Monash Health, Monash Medical Centre
    • Clayton, Victoria, Australia, 3168
      • Pharmacy Clinical Trials
    • Fitzroy, Victoria, Australia, 3065
      • St. Vincent's Hospital (Melbourne)
    • Malvern East, Victoria, Australia, 3145
      • Emeritus Research Pty Ltd
• Belgium
  • Brussels, Belgium, 1070
    • Hopital Erasme - Clinique Universitaire de Bruxelles
  • Leuven, Belgium, 3000
    • University Hospital Leuven, Department of Rheumatology
• Bulgaria
  • Pleven, Bulgaria, 5800
    • UMHAT "Dr. G. Stranski" EAD
  • Plovdiv, Bulgaria, 4000
    • MHAT"Plovdiv" AD
  • Plovdiv, Bulgaria, 4002
    • MHAT "Kaspela" EOOD
  • Sofia, Bulgaria, 1612
    • UMHAT "Sv. Ivan Rilski" EAD
  • Stara Zagora, Bulgaria, 6003
    • MC "New rehabilitation center" EOOD, Rheumatology Cabinet
• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T5M 0H4
      • Rheumatology Research Associates
  • Ontario
    • Waterloo, Ontario, Canada, N2J 1C4
      • K. Papp Clinical Research
  • Quebec
    • Pointe-Claire, Quebec, Canada, H9R 3J1
      • West Island Rheumatology Research Associates
• Czechia
  • Brno, Czechia, 638 00
    • Revmatologie s.r.o.
  • Brno, Czechia, 602 00
    • Lekarna Na Lidicke (Pharmacy only)
  • Brno, Czechia, 61300
    • X-MEDICA s.r.o (radiology only)
  • Brno, Czechia, 63800
    • Stavovska s.r.o. (pharmacy only)
  • Ostrava, Czechia, 70200
    • Vesalion s.r.o.
  • Praha 1- Nove Mesto, Czechia, 110 00
    • MEDIGAP, s.r.o
  • Praha 2, Czechia, 128 50
    • Revmatologicky ustav
  • Praha 2, Czechia, 128 50
    • Revmatologicky ustav - Lekarna
  • Uherske Hradiste, Czechia, 68601
    • Medical Plus s.r.o. Lekarna Hradebni s. r.o
  • Czech Republic
    • Brno, Czech Republic, Czechia, 615 00
      • Revmacentrum MUDr. Mostera, s.r.o.
    • Praha 1 - Nove Mesto, Czech Republic, Czechia, 110 00
      • MEDIGAP, s.r.o. (radiology only)
    • Praha 2, Czech Republic, Czechia, 128 50
      • Revmatologicky Ustav - Lekarna (pharmacy only)
    • Praha 4, Czech Republic, Czechia, 140 00
      • Revmatologicka ambulance
• France
  • Corbeil Essonnes cedex, France, 91106
    • Centre Hospitalier Sud-Francilien - Secretariat de Rhumatologie
• Germany
  • Berlin, Germany, 12161
    • Rheumapraxis Steglitz
  • Berlin, Germany, 10117
    • Klinische Forschung Berlin-Mitte GmbH
  • Berlin, Germany, 10117
    • Charité Universitaetsmedizin Berlin
  • Koeln, Germany, 50937
    • University Hospital of Cologne
  • Schwerin, Germany, 19055
    • Klinische forschung Schwerin GmbH
• Hungary
  • Budapest, Hungary, 1027
    • Revita Reumatologiai Rendelo
  • Budapest, Hungary, 1036
    • Qualiclinic Kft.
  • Budapest, Hungary, 1062
    • Magyar Honvedseg Egeszsegugyi Kozpont,Reumatologiai osztaly
  • Veszprem, Hungary, 8200
    • Csolnoky Ferenc Korhaz, Radiologiai Osztaly X-Ray Only
  • Veszprem, Hungary, 8200
    • Csolnoky Ferenc Korhaz, Reumatologiai Osztaly
• Mexico
  • Chihuahua, Mexico, 31000
    • Investigacion y Biomedicina de Chihuahua SC
  • Mexico City, Mexico, 06700
    • Cliditer, S. A. de C. V
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44160
      • Centro Integral en Reumatologia SA de CV
  • Sinaloa
    • Culiacan, Sinaloa, Mexico, 80040
      • Sanatorio CEMSI Chapultepec (For Emergencies Only)
    • Culiacan, Sinaloa, Mexico, 80000
      • Centro de Investigacion de Tratamientos Innovadores de Sinaloa, S.C.
    • Culiacan, Sinaloa, Mexico, 80000
      • Laboratorios de Analisis Clinicos CEMSI
    • Culiacan, Sinaloa, Mexico, 80230
      • Hospital General de Culiacan Dr. Bernardo J. Gastelum
  • Yucatan
    • Merida, Yucatan, Mexico, 97070
      • Centro de Investigacion Clinica Pensiones
    • Merida, Yucatan, Mexico, 97133
      • Hospital Star Medica Merida (For Emergencies Only)
    • Merida, Yucatan, Mexico, 97130
      • Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en Yucatan
    • Merida, Yucatan, Mexico, 97000
      • Instituto Medico Panamericano, S.A. de C.V. (For Emergencies Only)
    • Merida, Yucatan, Mexico, 97000
      • Unidad Reumatologica Las Americas, S.C.P.
    • Merida, Yucatan, Mexico, 97133
      • HOSPITAL STAR MEDICA S.A DE C.V- (emergencies only)
• Poland
  • Bialystok, Poland, 15-879
    • ClinicMed Badurski i Wspolnicy Spolka Jawna
  • Bialystok, Poland, 15-351
    • ZDROWIE Osteo-Medic s.c. L. I A. Racewicz, A. i J. Supronik
  • Bialystok, Poland, 15-002
    • Niepubliczny Zaklad Opieki Zdrowotnej Przychodnia Chirurgiczna dla Dzieci "PriamaMed" Sp.P.,"
  • Bydgoszcz, Poland, 85-168
    • Szpital Uniwersytecki nr 2 im. dr Jana Biziela w Bydgoszczy,
  • Elblag, Poland, 82-300
    • Centrum Radiologii for X-Ray only
  • Elblag, Poland, 82-300
    • NZOZ Centrum Reumatologiczne Indywidualna Specjalistyczna Praktyka Lekarska Lek. Med. Barbara Bazela
  • Elblag, Poland, 82-300
    • Centrum Kliniczno-Badawcze J.Brzezicki, B.Gornikiewicz-Brzezicka Lekarze Spolka partnerska
  • Grodzisk Mazowiecki, Poland, 05-825
    • Przychodnia Specjalistyczna Lekarskiej Spoldzielni Pracy "Medica"
  • Lublin, Poland, 20-582
    • Zespol Poradni Specjalistycznych Reumed Filia Onyksowa
  • Nadarzyn, Poland, 05-830
    • NZOZ Lecznica MAK-MED S.C.
  • Poznan, Poland, 61-397
    • Prywatna Praktyka Lekarska Prof. UM dr hab. Pawel Hrycaj
  • Torun, Poland, 87-100
    • NZOZ Nasz Lekarz Praktyka Grupowa Lekarzy Rodzinnych z Przychodnia Specjalistyczna w Toruniu
  • Warsaw, Poland, 01-868
    • Medica Pro Familia Sp. z o.o. S.K.A.
  • Warszawa, Poland, 02-118
    • Rheuma Medicus Zaklad Opieki Zdrowotnej
  • Warszawa, Poland, 02-691
    • Reumatika Centrum Reumatologii
  • Warszawa, Poland, 02-758
    • Klinika Ambroziak Estederm Sp. z o.o. ,S.K.A
  • Wroclaw, Poland, 50-088
    • Synexus Polska Sp. z o.o. Oddz. we Wroclawiu
• Russian Federation
  • Moscow, Russian Federation, 119049
    • State Budgetary Institution of Healthcare of Moscow City Clinical Hospital
  • Novosibirsk, Russian Federation, 630099
    • Limited Liability Company Consultative Diagnostic Rheumatology Center "Healthy Joints"
  • Novosibirsk, Russian Federation, 630091
    • OOO City Neurological Centre "Sibneiromed"
  • Saratov, Russian Federation, 410053
    • State Institution of Healthcare "Regional Clinical Hospital"
  • Tomsk, Russian Federation, 634050
    • State Budget Educational Institution of Highest Professional Education
  • Yaroslavl, Russian Federation, 150003
    • State Institution of Healthcare of Yaroslavl Region
  • Yaroslavl, Russian Federation, 150003
    • State Healthcare Institution of Yaroslavl Region Clinical Emergency Hospital n.a. N.V. Solovyev
  • Karelia Republic
    • Petrozavodsk, Karelia Republic, Russian Federation, 185019
      • Regional State Budgetary Healthcare Institution of Karelia Republic
• Slovakia
  • Bratislava, Slovakia, 841 04
    • Neštátna Reumatologická Ambulancia
  • Rimavska Sobota, Slovakia, 979 01
    • Reumex s.r.o
  • Slovak Republic
    • Bratislava, Slovak Republic, Slovakia, 832 63
      • ROMJAN s.r.o., Reumatologicka ambulancia
    • Martin, Slovak Republic, Slovakia, 036 01
      • MEDMAN s.r.o. - reumatologicka ambulancia
• Spain
  • A Coruna, Spain, 15006
    • Complexo Hospitalario Universitario A Coruña
  • Sevilla, Spain, 41010
    • Hospital Infanta Luisa
  • Valencia, Spain, 46026
    • Hospital Universitario y Politécnico La FE
  • A Coruna
    • Santiago De Compostela, A Coruna, Spain, 15706
      • Hospital Clínico de Santiago
  • Barcelona
    • Sabadell, Barcelona, Spain, 08208
      • Corporacio Sanitaria Parc Tauli
  • Cantabria
    • Santander, Cantabria, Spain, 39008
      • Hospital Universitario Marqués de Valdecilla
• Taiwan
  • Chia-Yi, Taiwan, 62247
    • Buddhist Dalin Tzu Chi General Hospital
  • Kaohsiung, Taiwan, 83301
    • Chang Gung Medical Foundation-Kaohsiung Branch
  • Taichung, Taiwan, 40201
    • Chung Shan Medical University Hospital
  • Taiwan Roc
    • Taipei, Taiwan Roc, Taiwan, 11217
      • Taipei Veterans General Hospital
• United Kingdom
  • York, United Kingdom, YO31 8HE
    • York Teaching Hospital NHS Foundation Trust
  • Essex
    • Goodmayes, Essex, United Kingdom, IG3 8YB
      • Barking Havering and Redbridge University Hospital NHS Trust-King George Hospital
    • Romford, Essex, United Kingdom, RM7 0AG
      • Barking, Havering and Redbridge University Hospitals NHS Trust
  • West Midlands
    • Dudley, West Midlands, United Kingdom, DY1 2HQ
      • The Dudley Group NHS Foundation Trust
  • West Yorkshire
    • Bradford, West Yorkshire, United Kingdom, BD5 0NA
      • Bradford Teaching Hospitals NHS Foundation Trust
    • Bradford, West Yorkshire, United Kingdom, BD9 6RJ
      • Bradford Royal Infirmary, BTHFT
  • Wirral
    • Upton, Wirral, United Kingdom, CH49 5PE
      • Wirral University Teaching Hospital NHS Foundation Trust
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • Rheumatology Associates, Pc
    • Huntsville, Alabama, United States, 35801
      • Rheumatology Associates of North Alabama, PC
  • Arizona
    • Glendale, Arizona, United States, 85306
      • Arizona Arthritis & Rheumatology Associates, P.C.
  • California
    • Covina, California, United States, 91723
      • Medvin Clinical Research
    • Palm Desert, California, United States, 92260
      • Desert Medical Advances
    • Rancho Mirage, California, United States, 92270
      • Advances In Medicine (X-Rays)
    • San Diego, California, United States, 92108
      • San Diego Arthritis Medical Clinic
  • Florida
    • Ormond Beach, Florida, United States, 32174
      • Millennium Research
    • Palm Harbor, Florida, United States, 34684
      • Arthritis Center, Inc.
  • Maryland
    • Hagerstown, Maryland, United States, 21740
      • Klein & Associates, M.D., P.A.
  • Massachusetts
    • Worcester, Massachusetts, United States, 01605
      • Clinical Pharmacology Study Group
  • Minnesota
    • Eagan, Minnesota, United States, 55121
      • St. Paul Rheumatology, PA
  • Nebraska
    • Lincoln, Nebraska, United States, 68516
      • Physician Research Collaboration, LLC
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth-Hitchcock Medical Center (DHMC)
  • Ohio
    • Middleburg Heights, Ohio, United States, 44130
      • Paramount Medical Research & Consulting, LLC
  • Pennsylvania
    • Duncansville, Pennsylvania, United States, 16635
      • Altoona Center for Clinical Research
  • South Carolina
    • Charleston, South Carolina, United States, 29406
      • Low Country Rheumatology, PA
  • Texas
    • Houston, Texas, United States, 77008
      • Pioneer Research Solutions, Inc.
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • University of Utah Hospital & Clinics
    • Salt Lake City, Utah, United States, 84112
      • Drug Shipment/Storage: Huntsman Cancer Hospital at the University of Utah
  • Washington
    • Seattle, Washington, United States, 98122
      • Swedish Medical Center
    • Seattle, Washington, United States, 98122
      • Seattle Rheumatology Associates
    • Seattle, Washington, United States, 98122
      • Dynacare Laboratories (Specimen processing for shipment)
    • Seattle, Washington, United States, 98122
      • Investigational Drug Service Pharmacy, Swedish Medical Center.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Males or females, aged >= 18 years at time of consent.
• Have a diagnosis of Psoriatic arthritis (PsA) of >= 6 months
• Meet the Classification Criteria of PsA (CASPAR) at time of screening
• Must not have been adequately treated with a a traditional non-biologic disease modifying anti-rheumatic drug (DMARD).
• Concurrent treatment with methotrexate, leflunomide, or sulfasalazine allowed and required
• Must not have taken a biologic Tumour Necrosis Factor Inhibitor
• Must have 3 or more swollen joints AND 3 or more tender joints
• Must have active psoriasis skin lesions

Exclusion Criteria:

• Have non-plaque forms of psoriasis, eg erythrodermic, guttate or pustular, with the exception of nail psoriasis which is allowed
• Pregnant or breast feeding, females of child-bearing potential not using highly effective contraception
• New York Heart Association Class III and IV congestive heart failure
• History of hypersensitivity or infusion reaction to biologic agents
• Infection with HIV, hepatitis B virus, hepatitis C virus, or other chronic infection

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tofacitinib 5 mgBID x 12 months	Drug: Tofacitinib 5 mg BID; Tofacitinib orally (po) 1 tablet of 5 mg and placebo po 1 tablet BID x 12 months Placebo injections subcu every 2 weeks x 12 months
Experimental: Tofacitinib 10 mg BID x 12 months	Drug: Tofacitinib 10 mg BID; Tofacitinib po 2 tablets of 5 mg BID x 12 months Placebo injections subcu every 2 weeks x 12 months
Active Comparator: Adalimumab 40 mg q2 weeks x 12 months	Drug: Adalimumab; Placebo po 2 tablets BIDx 12 months Adalimumab 40 mg subcu injections every 2 weeks x 12 months
Placebo Comparator: Placebo x3 months, then tofacitinib 5 mg BIDx 9 months	Drug: Placebo; Placebo po 2 tablets BIDx 3 months followed by tofacitinib po 1 tablet of 5 mg and placebo po 1 tablet BID x 9 months Placebo injections every 2 weeks x 12 months; Drug: Placebo; Placebo po 2 tablets BIDx 3 months followed by tofacitinib po 2 tablets (5 mg) BID x 9 months Placebo injections every 2 weeks x 12 months
Placebo Comparator: Placebo x 3 months, then tofacitinib 10 mg BID x 9 months	Drug: Placebo; Placebo po 2 tablets BIDx 3 months followed by tofacitinib po 1 tablet of 5 mg and placebo po 1 tablet BID x 9 months Placebo injections every 2 weeks x 12 months; Drug: Placebo; Placebo po 2 tablets BIDx 3 months followed by tofacitinib po 2 tablets (5 mg) BID x 9 months Placebo injections every 2 weeks x 12 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥20% (ACR20): Month 3	ACR20 was calculated as a ≥20% improvement from baseline in tender/painful and swollen joint counts and ≥20% improvement from baseline in 3 of the 5 remaining ACR core set measures: patient's global assessment of arthritis, physician's global assessment of arthritis, patient's assessment of arthritis pain, health assessment questionnaire - disability index (HAQ-DI), and C-reactive protein (CRP).	At end of Month 3
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score	The HAQ-DI assesses the difficulty a participant has had in the past week in 8 domains of daily living activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consists of 2-3 items. For each question, level of difficulty is scored from 0 to 3 with 0=no difficulty, 1=some difficulty, 2=much difficulty, and 3=unable to do. The score for each domain is the maximum (worst) score from the items/questions within the domain. Higher score indicates greater disability.	From Baseline to Month 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in the Van Der Heijdel Modified Total Sharp Score (mTSS) for Psoriatic Arthritis	Assessment of joint damage includes a joint erosion score (range 0-320) and a joint space narrowing (JSN) score (range 0-208). The mTSS is the sum of the erosion and JSN scores (range 0-528). A higher score indicates more severe disease status. If a component score is missing, the mTSS will be missing.	From Baseline to Month 12
Percentage of Participants With Progressed Modified Total Sharp Score (mTSS) at Month 12	Assessment of joint damage includes a joint erosion score (range 0-320) and a JSN score (range 0-208). The mTSS is the sum of the erosion and JSN scores (range 0-528). A higher score indicates more severe disease status. If a component score is missing, the mTSS will be missing. Progressor is defined as an increase in mTSS >0.5 from baseline.	At Month 12
Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥50% (ACR50) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12	ACR50 was calculated as a ≥50% improvement from baseline in tender/painful and swollen joint counts and ≥50% improvement from baseline in 3 of the 5 remaining ACR core set measures: patient's global assessment of arthritis, physician's global assessment of arthritis, patient's assessment of arthritis pain, HAQ-DI, and CRP.	At Week 2 and Months 1, 2, 3, 4, 6, 9, and 12
Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥70% (ACR70) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12	ACR70 was calculated as a ≥70% improvement from baseline in tender/painful and swollen joint counts and ≥70% improvement from baseline in 3 of the 5 remaining ACR core set measures: patient's global assessment of arthritis, physician's global assessment of arthritis, patient's assessment of arthritis pain, HAQ-DI, and CRP. .	At Week 2 and Months 1, 2, 3, 4, 6, 9, and 12
Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥20% (ACR20) at Week 2 and Months 1, 2, 4, 6, 9, and 12	ACR20 was calculated as a ≥20% improvement from baseline in tender/painful and swollen joint counts and ≥20% improvement from baseline in 3 of the 5 remaining ACR core set measures: patient's global assessment of arthritis, physician's global assessment of arthritis, patient's assessment of arthritis pain, HAQ-DI, and CRP.	At Week 2 and Months 1, 2, 4, 6, 9, and 12
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score	The HAQ-DI assesses the difficulty a participant has had in the past week in 8 domains of daily living activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consists of 2-3 items. For each question, level of difficulty is scored from 0 to 3 with 0=no difficulty, 1=some difficulty, 2=much difficulty, and 3=unable to do. The score for each domain is the maximum (worst) score from the items/questions within the domain. Higher score indicates greater disability.	From Baseline to Week 2 and Months 1, 2, 4, 6, 9, and 12
Change From Baseline in American College of Rheumatology Response Criteria Components: C-reactive Protein Levels	The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.	From Baseline to end of Month 3
Change From Baseline in American College of Rheumatology Response Criteria Components Score: Patient's Assessment of Arthritis Pain	Participants assessed the severity of their arthritis pain using a 100-mm visual analog scale (VAS) by placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which corresponded to the magnitude of their pain.	From Baseline to end of Month 3
Change From Baseline in American College of Rheumatology Response Criteria Components Score: Patient's Global Assessment of Arthritis	Participant answered the following question, "Considering all the ways your arthritis affects you, how are you feeling today?" The participant's response was recorded using a 100 mm VAS by placing a mark on the scale between 0 (very well) and 100 (very poorly).	From Baseline to end of Month 3
Change From Baseline in American College of Rheumatology Response Criteria Components Score: Physician's Global Assessment of Arthritis	The blinded investigator or qualified assessor assessed how the participant's overall arthritis appeared at the time of the visit. This was an evaluation based on the participant's disease signs, functional capacity and physical examination, and was independent of the Patient's Global Assessment of Arthritis. The investigator's response was recorded using a 100 mm VAS by placing a mark on the scale between 0 (very good) and 100 (very poor).	From Baseline to end of Month 3
Change From Baseline in American College of Rheumatology Response Criteria Components Score: Swollen Joint Count	Swollen joint counts are considered the most specific quantitative clinical measure used to assess the status of participants with inflammatory types of arthritis. Sixty six (66) joints were assessed by a blinded assessor to determine the number of joints that were considered swelling.	From Baseline to end of Month 3
Change From Baseline in American College of Rheumatology Response Criteria Components Score: Tender/Painful Joint Count	Tender/painful joint counts are considered the most specific quantitative clinical measure used to assess the status of participants with inflammatory types of arthritis. Sixty eight (68) joints were assessed by a blinded assessor to determine the number of joints that were considered tender or painful.	From Baseline to end of Month 3
Percentage of Participants Meeting Psoriatic Arthritis Response Criteria (PsARC) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12	The PsARC covers 4 measures: Tender/painful joint count, swollen joint count, the Physician's Global Assessment of Arthritis, and the Patient's Global Assessment of Arthritis. The PsARC response is defined as improvement in 2 of 4 items, 1 of which must be joint pain or swelling, without worsening in any measure. Improvement criteria: ≥20% improvement in Physician's Global Assessment of Arthritis; ≥20% improvement in Patient's Global Assessment of Arthritis; ≥30% improvement in tender joint count; and ≥30% improvement in swollen joint count.	At Week 2 and Months 1, 2, 3, 4, 6, 9, and 12
Change From Baseline in Physician's Global Assessment of Psoriasis (PGA-PsO) Response	The PGA-PsO is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are rated separately over the whole body according to a 5-point severity scale, scored as 0=none; 1, 2, 3, or 4=most severe. The severity rating scores are summed and the average taken; the total average is rounded to the nearest whole number score to determine a PGA-PsO score on a scale of 0 to 4 (0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe).	From Baseline to Months 1, 3, 6, 9, and 12
Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response at Months 1, 3, 6, 9, and 12	PASI determines psoriasis severity based on lesion severity & percentage body surface area (BSA) affected. Lesion severity is assessed for erythema, induration, & scaling, evaluated separately for head & neck, upper limbs, trunk, & lower limbs & rated for each body area according to a 5 point scale: 0=no involvement; 1=slight; 2=moderate; 3=marked; 4=very marked. BSA involvement is the extent (%) of body area affected by psoriasis & is assigned a score: 0=no involvement; 1=0-9%; 2=10-29%; 3=30-49%; 4=50-69%; 5=70-89%; 6=90-100%. In each area, sum of severity rating scores is multiplied by the score representing the percentage of area involved by psoriasis, multiplied by a weighting factor (head 0.1; upper limbs 0.2; trunk 0.3; lower limbs 0.4). The sum of numbers obtained for the 4 body areas is the PASI score & can vary in increments of 0.1 & range from 0.0 to 72.0, higher scores represent greater severity of psoriasis. PASI75 is defined as a 75% reduction from baseline in PASI.	At Months 1, 3, 6, 9, and 12
Change From Baseline in Dactylitis Severity Score (DSS)	Dactylitis is characterized by swelling of the entire finger or toe. The DSS is a function of finger circumference and tenderness, assessed and summed across all dactylitic digits. The severity of dactylitis is scored on a scale of 0-3, where 0=no tenderness and 3=extreme tenderness in each digit of the hands and feet. The range of total dactylitis scores for a patient is 0-60. Higher score indicates greater degree of tenderness.	From Baseline to Months 1, 3, 6, 9, and 12
Change From Baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index	The SPARCC Enthesitis Index identifies the presence or absence of tenderness at 16 enthesial sites, including the bilateral Achilles tendons, plantar fascia insertion at the calcaneus, patellar tendon insertion at the base of the patella, quadriceps insertion into the superior border of the patella, supraspinatus insertion into the greater tuberosity of the humerus, and medial and lateral epicondyles. On examination, tenderness is recorded as present (1) or absent (0) for each of the 16 sites, with an overall total score ranging from 0 to 16. Higher score indicates a greater number of sites that are affected by enthesitis.	From Baseline to Months 1, 3, 6, 9, and 12
Change From Baseline in the Leeds Enthesitis Index (LEI)	Enthesitis is inflammation in the tendon, ligament, and joint capsule fiber insertion into bone. The LEI assesses enthesitis in 6 sites. Tenderness is recorded as either present (1) or absent (0) for each of the 6 sites, for an total score of 0-6. Higher score indicates a greater number of sites that are affected by enthesitis.	From Baseline to Months 1, 3, 6, 9, and 12
Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2) Acute, Physical Component Summary Score	The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the physical component summary (PCS) score and the mental component summary (MCS) score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a standard deviation (SD) of 10 points, and ranges from minus infinity to plus infinity. A higher PCS score represents better physical health status.	From Baseline to Months 1, 3, 6, 9, and 12
Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute, Mental Component Summary Score	The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher MCS score represents better mental health status.	From Baseline to Months 1, 3, 6, 9, and 12
Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Physical Functioning Domain	The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher physical functioning domain score represents better physical functioning.	From Baseline to Months 1, 3, 6, 9, and 12
Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Role-Physical Domain	The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher role-physical domain score represents better role-physical functioning.	From Baseline to Months 1, 3, 6, 9, and 12
Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Bodily Pain Domain	The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher bodily pain domain score represents less bodily pain.	From Baseline to Months 1, 3, 6, 9, and 12
Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: General Health Domain	The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher general health domain score represents better general health perceptions.	From Baseline to Months 1, 3, 6, 9, and 12
Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Vitality Domain	The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher vitality domain score represents better vitality.	From Baseline to Months 1, 3, 6, 9, and 12
Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Social Functioning Domain	The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher social functioning domain score represents better social functioning.	From Baseline to Months 1, 3, 6, 9, and 12
Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Role-Emotional Domain	The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher role-emotional domain score represents better role-emotional functioning.	From Baseline to Months 1, 3, 6, 9, and 12
Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Mental Health Domain	The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher mental health domain score represents better mental health functioning.	From Baseline to Months 1, 3, 6, 9, and 12
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	The EQ-5D is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take 1 of 3 responses. The responses record 3 levels of severity (no problems [1], some or moderate problems [2], or extreme problems [3]) within a particular EQ-5D dimension. Standard vertical 0 to 100 mm visual analogue scale (similar to a thermometer) for recording an individual's rating for their current health-related quality of life state, with a higher value representing better health status.	From Baseline to Months 1, 3, 6, 9, and 12
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	The EQ-5D is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take 1 of 3 responses. The responses record 3 levels of severity (no problems [1], some or moderate problems [2], or extreme problems [3]) within a particular EQ-5D dimension. Standard vertical 0 to 100 mm visual analogue scale (similar to a thermometer) for recording an individual's rating for their current health-related quality of life state, with a higher value representing better health status.	From Baseline to Months 1, 3, 6, 9, and 12
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	The EQ-5D is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take 1 of 3 responses. The responses record 3 levels of severity (no problems [1], some or moderate problems [2], or extreme problems [3]) within a particular EQ-5D dimension. Standard vertical 0 to 100 mm visual analogue scale (similar to a thermometer) for recording an individual's rating for their current health-related quality of life state, with a higher value representing better health status.	From Baseline to Months 1, 3, 6, 9, and 12
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	The EQ-5D is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take 1 of 3 responses. The responses record 3 levels of severity (no problems [1], some or moderate problems [2], or extreme problems [3]) within a particular EQ-5D dimension. Standard vertical 0 to 100 mm visual analogue scale (similar to a thermometer) for recording an individual's rating for their current health-related quality of life state, with a higher value representing better health status.	From Baseline to Months 1, 3, 6, 9, and 12
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	The EQ-5D is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take 1 of 3 responses. The responses record 3 levels of severity (no problems [1], some or moderate problems [2], or extreme problems [3]) within a particular EQ-5D dimension. Standard vertical 0 to 100 mm visual analogue scale (similar to a thermometer) for recording an individual's rating for their current health-related quality of life state, with a higher value representing better health status.	From Baseline to Months 1, 3, 6, 9, and 12
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): Patient's Health State Today	The EQ-5D is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take 1 of 3 responses. The responses record 3 levels of severity (no problems [1], some or moderate problems [2], or extreme problems [3]) within a particular EQ-5D dimension. Standard vertical 0 (worst imaginable health state) to 100 mm (best imaginable health state) visual analogue scale (similar to a thermometer) for recording an individual's rating for their current health-related quality of life state; higher scores indicate a better health state, with a higher value representing better health status.	From Baseline to Months 1, 3, 6, 9, and 12
Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Total Score	FACIT-F is a 13-item questionnaire, with each item scored on a 5-point scale ranging from 0 (not at all) to 4 (very much). Three endpoints are derived: change in FACIT-F total score, change in FACIT-F experience domain score, and change in FACIT-F impact domain score. FACIT-F total score (range 0 to 52) is calculated by summing the 13 items. FACIT-F experience domain score (range 0-20) is calculated by summing 5 items : I feel fatigued, I feel weak all over, I feel listless ("washed out"), I feel tired, and I have energy, while FACIT-F impact domain score (range 0-32) is calculated by summing the remaining 8 items. All responses are added with equal weight to obtain the total score. Higher scores represent better fatigue status.	From Baseline to Months 1, 3, 6, 9, and 12
Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Experience Domain Score	FACIT-F is a 13-item questionnaire, with each item score ranging from 0 to 4. Three endpoints are derived: change in FACIT-F total score, change in FACIT-F experience domain score, and change in FACIT-F impact domain score. FACIT-F total score (range 0-52) is calculated by summing the 13 items. FACIT-F experience domain score (range 0-20) is calculated by summing 5 items : I feel fatigued, I feel weak all over, I feel listless ("washed out"), I feel tired, and I have energy, while FACIT-F impact domain score (range 0-32) is calculated by summing the remaining 8 items. All responses are added with equal weight to obtain the total score. Higher scores represent better (less) fatigue experience.	From Baseline to Months 1, 3, 6, 9, and 12
Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Impact Domain Score	FACIT-F is a 13-item questionnaire, with each item score ranging from 0 to 4. Three endpoints are derived: change in FACIT-F total score, change in FACIT-F experience domain score, and change in FACIT-F impact domain score. FACIT-F total score (range 0-52) is calculated by summing the 13 items. FACIT-F experience domain score (range 0-20) is calculated by summing 5 items : I feel fatigued, I feel weak all over, I feel listless ("washed out"), I feel tired, and I have energy, while FACIT-F impact domain score (range 0-32) is calculated by summing the remaining 8 items. All responses are added with equal weight to obtain the total score. Higher scores represent better (less) fatigue impact on daily functioning.	From Baseline to Months 1, 3, 6, 9, and 12
Change From Baseline in Scores Evaluating Spondylitis Using the Bath Anklyosing Spondylitis Disease Activity Index (BASDAI)	BASDAI is a validated self-assessment tool used to determine disease activity in participants with ankylosing spondylitis. Utilizing a visual analog scale of 0-100mm (0=none and 100=very severe) participants answer 6 questions measuring discomfort, pain, and fatigue. The final BASDAI score averages the individual assessments for a final score ranging 0-10cm, with higher scores representing more severe ankylosing spondylitis disease activity.	From Baseline to Months 1, 3, 6, 9, and 12

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

General Publications

• Panaccione R, Isaacs JD, Chen LA, Wang W, Marren A, Kwok K, Wang L, Chan G, Su C. Characterization of Creatine Kinase Levels in Tofacitinib-Treated Patients with Ulcerative Colitis: Results from Clinical Trials. Dig Dis Sci. 2021 Aug;66(8):2732-2743. doi: 10.1007/s10620-020-06560-4. Epub 2020 Aug 20. Erratum In: Dig Dis Sci. 2020 Oct 10;:
• 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.
• Orbai AM, Mease PJ, Helliwell PS, FitzGerald O, Fleishaker DL, Mundayat R, Young P. Effect of tofacitinib on dactylitis and patient-reported outcomes in patients with active psoriatic arthritis: post-hoc analysis of phase III studies. BMC Rheumatol. 2022 Sep 1;6(1):68. doi: 10.1186/s41927-022-00298-4.
• Taylor PC, Bushmakin AG, Cappelleri JC, Young P, Germino R, Merola JF, Yosipovitch G. Relationships of dermatologic symptoms and quality of life in patients with psoriatic arthritis: analysis of two tofacitinib phase III studies. J Dermatolog Treat. 2022 Aug;33(5):2614-2620. doi: 10.1080/09546634.2022.2060924. Epub 2022 Apr 11.
• Gladman DD, Coates LC, Wu J, Fallon L, Bacci ED, Cappelleri JC, Bushmakin AG, Helliwell PS. Time to response for clinical and patient-reported outcomes in patients with psoriatic arthritis treated with tofacitinib, adalimumab, or placebo. Arthritis Res Ther. 2022 Feb 9;24(1):40. doi: 10.1186/s13075-022-02721-0.
• Dikranian A, Gold D, Bessette L, Nash P, Azevedo VF, Wang L, Woolcott J, Shapiro AB, Szumski A, Fleishaker D, Wollenhaupt J. Frequency and Duration of Early Non-serious Adverse Events in Patients with Rheumatoid Arthritis and Psoriatic Arthritis Treated with Tofacitinib. Rheumatol Ther. 2022 Apr;9(2):411-433. doi: 10.1007/s40744-021-00405-w. Epub 2021 Dec 17.
• Winthrop KL, Curtis JR, Yamaoka K, Lee EB, Hirose T, Rivas JL, Kwok K, Burmester GR. Clinical Management of Herpes Zoster in Patients With Rheumatoid Arthritis or Psoriatic Arthritis Receiving Tofacitinib Treatment. Rheumatol Ther. 2022 Feb;9(1):243-263. doi: 10.1007/s40744-021-00390-0. Epub 2021 Dec 6.
• Kivitz AJ, FitzGerald O, Nash P, Pang S, Azevedo VF, Wang C, Takiya L. Efficacy and safety of tofacitinib by background methotrexate dose in psoriatic arthritis: post hoc exploratory analysis from two phase III trials. Clin Rheumatol. 2022 Feb;41(2):499-511. doi: 10.1007/s10067-021-05894-2. Epub 2021 Sep 12.
• Coates LC, Bushmakin AG, FitzGerald O, Gladman DD, Fallon L, Cappelleri JC, Hsu MA, Helliwell PS. Relationships between psoriatic arthritis composite measures of disease activity with patient-reported outcomes in phase 3 studies of tofacitinib. Arthritis Res Ther. 2021 Mar 26;23(1):94. doi: 10.1186/s13075-021-02474-2.
• Ritchlin CT, Giles JT, Ogdie A, Gomez-Reino JJ, Helliwell P, Young P, Wang C, Wu J, Romero AB, Woolcott J, Stockert L. Tofacitinib in Patients With Psoriatic Arthritis and Metabolic Syndrome: A Post hoc Analysis of Phase 3 Studies. ACR Open Rheumatol. 2020 Oct;2(10):543-554. doi: 10.1002/acr2.11166. Epub 2020 Sep 10.
• Burmester GR, Curtis JR, Yun H, FitzGerald O, Winthrop KL, Azevedo VF, Rigby WFC, Kanik KS, Wang C, Biswas P, Jones T, Palmetto N, Hendrikx T, Menon S, Rojo R. An Integrated Analysis of the Safety of Tofacitinib in Psoriatic Arthritis across Phase III and Long-Term Extension Studies with Comparison to Real-World Observational Data. Drug Saf. 2020 Apr;43(4):379-392. doi: 10.1007/s40264-020-00904-9.
• Gladman DD, Charles-Schoeman C, McInnes IB, Veale DJ, Thiers B, Nurmohamed M, Graham D, Wang C, Jones T, Wolk R, DeMasi R. Changes in Lipid Levels and Incidence of Cardiovascular Events Following Tofacitinib Treatment in Patients With Psoriatic Arthritis: A Pooled Analysis Across Phase III and Long-Term Extension Studies. Arthritis Care Res (Hoboken). 2019 Oct;71(10):1387-1395. doi: 10.1002/acr.23930.
• Cella D, Wilson H, Shalhoub H, Revicki DA, Cappelleri JC, Bushmakin AG, Kudlacz E, Hsu MA. Content validity and psychometric evaluation of Functional Assessment of Chronic Illness Therapy-Fatigue in patients with psoriatic arthritis. J Patient Rep Outcomes. 2019 May 20;3(1):30. doi: 10.1186/s41687-019-0115-4.
• Cella D, Wilson H, Shalhoub H, Revicki DA, Cappelleri JC, Bushmakin AG, Kudlacz E, Hsu MA. Content validity and psychometric evaluation of Functional Assessment of Chronic Illness Therapy-Fatigue in patients with psoriatic arthritis. J Patient Rep Outcomes. 2019 Jan 24;3(1):5. doi: 10.1186/s41687-019-0094-5.
• Nash P, Coates LC, Fleischmann R, Papp KA, Gomez-Reino JJ, Kanik KS, Wang C, Wu J, Menon S, Hendrikx T, Ports WC. Efficacy of Tofacitinib for the Treatment of Psoriatic Arthritis: Pooled Analysis of Two Phase 3 Studies. Rheumatol Ther. 2018 Dec;5(2):567-582. doi: 10.1007/s40744-018-0131-5. Epub 2018 Nov 9.
• Helliwell P, Coates LC, FitzGerald O, Nash P, Soriano ER, Elaine Husni M, Hsu MA, Kanik KS, Hendrikx T, Wu J, Kudlacz E. Disease-specific composite measures for psoriatic arthritis are highly responsive to a Janus kinase inhibitor treatment that targets multiple domains of disease. Arthritis Res Ther. 2018 Oct 29;20(1):242. doi: 10.1186/s13075-018-1739-0.
• de Vlam K, Ogdie A, Bushmakin AG, Cappelleri JC, Fleischmann R, Taylor PC, Azevedo V, Fallon L, Woolcott J, Mease PJ. Median time to pain improvement and the impact of baseline pain severity on pain response in patients with psoriatic arthritis treated with tofacitinib. RMD Open. 2021 Jul;7(2):e001609. doi: 10.1136/rmdopen-2021-001609.
• van der Heijde D, Gladman DD, FitzGerald O, Kavanaugh A, Graham D, Wang C, Fallon L. Radiographic Progression According to Baseline C-reactive Protein Levels and Other Risk Factors in Psoriatic Arthritis Treated with Tofacitinib or Adalimumab. J Rheumatol. 2019 Sep;46(9):1089-1096. doi: 10.3899/jrheum.180971. Epub 2019 Mar 1.
• Strand V, de Vlam K, Covarrubias-Cobos JA, Mease PJ, Gladman DD, Graham D, Wang C, Cappelleri JC, Hendrikx T, Hsu MA. Tofacitinib or adalimumab versus placebo: patient-reported outcomes from OPAL Broaden-a phase III study of active psoriatic arthritis in patients with an inadequate response to conventional synthetic disease-modifying antirheumatic drugs. RMD Open. 2019 Jan 11;5(1):e000806. doi: 10.1136/rmdopen-2018-000806. eCollection 2019.
• Mease P, Hall S, FitzGerald O, van der Heijde D, Merola JF, Avila-Zapata F, Cieslak D, Graham D, Wang C, Menon S, Hendrikx T, Kanik KS. Tofacitinib or Adalimumab versus Placebo for Psoriatic Arthritis. N Engl J Med. 2017 Oct 19;377(16):1537-1550. doi: 10.1056/NEJMoa1615975.

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2014
• Primary Completion (Actual): December 18, 2015
• Study Completion (Actual): December 18, 2015

Study Registration Dates

• First Submitted: June 12, 2013
• First Submitted That Met QC Criteria: June 12, 2013
• First Posted (Estimate): June 14, 2013

Study Record Updates

• Last Update Posted (Actual): July 6, 2017
• Last Update Submitted That Met QC Criteria: June 6, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: tofacitinib; psoriatic arthritis; radiographic changes; active comparator
• Additional Relevant MeSH Terms: Skin Diseases; Joint Diseases; Musculoskeletal Diseases; Skin Diseases, Papulosquamous; Spinal Diseases; Bone Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Psoriasis; Arthritis; Arthritis, Psoriatic; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Anti-Inflammatory Agents; Antirheumatic Agents; Protein Kinase Inhibitors; Adalimumab; Tofacitinib
• Other Study ID Numbers: A3921091; 2011-003668-55 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Information relating to our policy on data sharing and the process for requesting data can be found at the following link:

http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests