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

Primary Purpose

Psoriatic Arthritis

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Tofacitinib 5 mg BID

Tofacitinib 10 mg BID

Adalimumab

Placebo

About this trial

This is an interventional treatment trial for Psoriatic Arthritis focused on measuring psoriatic arthritis, radiographic changes, active comparator, tofacitinib

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Rheumatology Associates, PC
Rheumatology Associates of North Alabama, PC
Arizona Arthritis & Rheumatology Associates, P.C.
Medvin Clinical Research
Desert Medical Advances
Advances In Medicine (X-Rays)
San Diego Arthritis Medical Clinic
Millennium Research
Arthritis Center, Inc.
Klein & Associates, M.D., P.A.
Clinical Pharmacology Study Group
St. Paul Rheumatology, PA
Physician Research Collaboration, LLC
Dartmouth-Hitchcock Medical Center (DHMC)
Paramount Medical Research & Consulting, LLC
Altoona Center for Clinical Research
Low Country Rheumatology, PA
Pioneer Research Solutions, Inc.
Drug Shipment/Storage: Huntsman Cancer Hospital at the University of Utah
University of Utah Hospital & Clinics
Dynacare Laboratories (Specimen processing for shipment)
Investigational Drug Service Pharmacy, Swedish Medical Center.
Seattle Rheumatology Associates
Swedish Medical Center
Rheumatology Research Unit
Pacific Private Clinic
Monash Health, Monash Medical Centre
Pharmacy Clinical Trials
St. Vincent's Hospital (Melbourne)
Emeritus Research Pty Ltd
Hopital Erasme - Clinique Universitaire de Bruxelles
University Hospital Leuven, Department of Rheumatology
UMHAT "Dr. G. Stranski" EAD
MHAT"Plovdiv" AD
MHAT "Kaspela" EOOD
UMHAT "Sv. Ivan Rilski" EAD
MC "New rehabilitation center" EOOD, Rheumatology Cabinet
Rheumatology Research Associates
K. Papp Clinical Research
West Island Rheumatology Research Associates
Revmacentrum MUDr. Mostera, s.r.o.
MEDIGAP, s.r.o. (radiology only)
Revmatologicky Ustav - Lekarna (pharmacy only)
Revmatologicka ambulance
Lekarna Na Lidicke (Pharmacy only)
X-MEDICA s.r.o (radiology only)
Revmatologie s.r.o.
Stavovska s.r.o. (pharmacy only)
Vesalion s.r.o.
MEDIGAP, s.r.o
Revmatologicky ustav - Lekarna
Revmatologicky ustav
Medical Plus s.r.o. Lekarna Hradebni s. r.o
Centre Hospitalier Sud-Francilien - Secretariat de Rhumatologie
Charite Universitaetsmedizin Berlin
Klinische Forschung Berlin-Mitte GmbH
Rheumapraxis Steglitz
University Hospital of Cologne
Klinische Forschung Schwerin GmbH
Revita Reumatologiai Rendelo
Qualiclinic Kft.
Magyar Honvedseg Egeszsegugyi Kozpont,Reumatologiai osztaly
Csolnoky Ferenc Korhaz, Radiologiai Osztaly X-Ray Only
Csolnoky Ferenc Korhaz, Reumatologiai Osztaly
Centro Integral en Reumatologia SA de CV
Centro de Investigacion de Tratamientos Innovadores de Sinaloa, S.C.
Laboratorios de Analisis Clinicos CEMSI
Sanatorio CEMSI Chapultepec (For Emergencies Only)
Hospital General de Culiacán Dr. Bernardo J. Gastélum
Instituto Medico Panamericano, S.A. de C.V. (For Emergencies Only)
Unidad Reumatologica Las Americas, S.C.P.
Centro de Investigacion Clinica Pensiones
Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en Yucatan
Hospital Star Medica Merida (For Emergencies Only)
HOSPITAL STAR MEDICA S.A DE C.V- (emergencies only)
Investigacion y Biomedicina de Chihuahua SC
Cliditer, S. A. de C. V
Niepubliczny Zaklad Opieki Zdrowotnej Przychodnia Chirurgiczna dla Dzieci "PriamaMed" Sp.P.,"
ZDROWIE OSTEO-MEDIC s.c. L. i A. Racewicz, A. i J. Supronik
ClinicMed Badurski i wspolnicy Spolka Jawna
Szpital Uniwersytecki nr 2 im. dr Jana Biziela w Bydgoszczy,
Centrum Kliniczno-Badawcze J.Brzezicki, B.Gornikiewicz-Brzezicka Lekarze Spolka Partnerska
Centrum Radiologii for X-Ray only
NZOZ Centrum Reumatologiczne Indywidualna Specjalistyczna Praktyka Lekarska Lek. Med. Barbara Bazela
Przychodnia Specjalistyczna Lekarskiej Spoldzielni Pracy "Medica"
Zespol Poradni Specjalistycznych Reumed Filia Onyksowa
NZOZ Lecznica MAK-MED S.C.
Prywatna Praktyka Lekarska Prof. UM dr hab. Pawel Hrycaj
NZOZ Nasz Lekarz Praktyka Grupowa Lekarzy Rodzinnych z Przychodnia Specjalistyczna w Toruniu
Medica Pro Familia Sp. z o.o. S.K.A.
Rheuma Medicus Zaklad Opieki Zdrowotnej
Reumatika Centrum Reumatologii
Klinika Ambroziak Estederm Sp. z o.o. ,S.K.A
Synexus Polska Sp. z o.o. Oddz. we Wroclawiu
Regional State Budgetary Healthcare Institution of Karelia Republic
State Budgetary Institution of Healthcare of Moscow City Clinical Hospital
OOO City Neurological Centre "Sibneiromed"
Limited Liability Company Consultative Diagnostic Rheumatology Center "Healthy Joints"
State Institution of Healthcare "Regional Clinical Hospital"
State Budget Educational Institution of Highest Professional Education
State Healthcare Institution of Yaroslavl Region Clinical Emergency Hospital n.a. N.V. Solovyev
State Institution of Healthcare of Yaroslavl Region
ROMJAN s.r.o., Reumatologicka ambulancia
MEDMAN s.r.o. - reumatologicka ambulancia
Nestatna reumatologicka ambulancia
Reumex s.r.o
Hospital Clinico de Santiago
Corporació Sanitaria Parc Tauli
Hospital Universitario Marques de Valdecilla
Complexo Hospitalario Universitario A Coruna
Hospital Infanta Luisa
Hospital Universitario y Politecnico La Fe
Taipei Veterans General Hospital
Buddhist Dalin Tzu Chi General Hospital
Chang Gung Medical Foundation-Kaohsiung Branch
Chung Shan Medical University Hospital
Barking Havering and Redbridge University Hospital NHS Trust-King George Hospital
Barking, Havering and Redbridge University Hospitals NHS Trust
The Dudley Group NHS Foundation Trust
Bradford Teaching Hospitals NHS Foundation Trust
Bradford Royal Infirmary, BTHFT
Wirral University Teaching Hospital NHS Foundation Trust
York Teaching Hospital NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Tofacitinib 5 mgBID x 12 months

Tofacitinib 10 mg BID x 12 months

Adalimumab 40 mg q2 weeks x 12 months

Placebo x3 months, then tofacitinib 5 mg BIDx 9 months

Placebo x 3 months, then tofacitinib 10 mg BID x 9 months

Arm Description

Outcomes

Primary Outcome Measures

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).

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.

Secondary Outcome Measures

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.

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.

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.

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. .

Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥20% (ACR20) at Week 2 and Months 1, 2, 4, 6, 9, and 12

Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score

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.

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.

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).

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).

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.

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.

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.

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).

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Impact Domain Score

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.

Full Information

NCT ID

NCT01877668

First Posted

June 12, 2013

Last Updated

June 6, 2017

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT01877668

Brief Title

Efficacy And Safety Of Tofacitinib In Psoriatic Arthritis: Comparator Study

Acronym

OPAL BROADEN

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2017

Overall Recruitment Status

Completed

Study Start Date

January 20, 2014 (Actual)

Primary Completion Date

December 18, 2015 (Actual)

Study Completion Date

December 18, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Psoriatic Arthritis

Keywords

psoriatic arthritis, radiographic changes, active comparator, tofacitinib

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

422 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Tofacitinib 5 mgBID x 12 months

Arm Type

Experimental

Arm Title

Tofacitinib 10 mg BID x 12 months

Arm Type

Experimental

Arm Title

Adalimumab 40 mg q2 weeks x 12 months

Arm Type

Active Comparator

Arm Title

Placebo x3 months, then tofacitinib 5 mg BIDx 9 months

Arm Type

Placebo Comparator

Arm Title

Placebo x 3 months, then tofacitinib 10 mg BID x 9 months

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Tofacitinib 5 mg BID

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Tofacitinib 10 mg BID

Intervention Description

Tofacitinib po 2 tablets of 5 mg BID x 12 months Placebo injections subcu every 2 weeks x 12 months

Intervention Type

Drug

Intervention Name(s)

Adalimumab

Intervention Description

Placebo po 2 tablets BIDx 12 months Adalimumab 40 mg subcu injections every 2 weeks x 12 months

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥20% (ACR20): Month 3

Description

Time Frame

At end of Month 3

Title

Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score

Description

Time Frame

From Baseline to Month 3

Secondary Outcome Measure Information:

Title

Change From Baseline in the Van Der Heijdel Modified Total Sharp Score (mTSS) for Psoriatic Arthritis

Description

Time Frame

From Baseline to Month 12

Title

Percentage of Participants With Progressed Modified Total Sharp Score (mTSS) at Month 12

Description

Time Frame

At Month 12

Title

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

Description

Time Frame

At Week 2 and Months 1, 2, 3, 4, 6, 9, and 12

Title

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

Description

Time Frame

At Week 2 and Months 1, 2, 3, 4, 6, 9, and 12

Title

Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥20% (ACR20) at Week 2 and Months 1, 2, 4, 6, 9, and 12

Description

Time Frame

At Week 2 and Months 1, 2, 4, 6, 9, and 12

Title

Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score

Description

Time Frame

From Baseline to Week 2 and Months 1, 2, 4, 6, 9, and 12

Title

Change From Baseline in American College of Rheumatology Response Criteria Components: C-reactive Protein Levels

Description

Time Frame

From Baseline to end of Month 3

Title

Change From Baseline in American College of Rheumatology Response Criteria Components Score: Patient's Assessment of Arthritis Pain

Description

Time Frame

From Baseline to end of Month 3

Title

Change From Baseline in American College of Rheumatology Response Criteria Components Score: Patient's Global Assessment of Arthritis

Description

Time Frame

From Baseline to end of Month 3

Title

Change From Baseline in American College of Rheumatology Response Criteria Components Score: Physician's Global Assessment of Arthritis

Description

Time Frame

From Baseline to end of Month 3

Title

Change From Baseline in American College of Rheumatology Response Criteria Components Score: Swollen Joint Count

Description

Time Frame

From Baseline to end of Month 3

Title

Change From Baseline in American College of Rheumatology Response Criteria Components Score: Tender/Painful Joint Count

Description

Time Frame

From Baseline to end of Month 3

Title

Percentage of Participants Meeting Psoriatic Arthritis Response Criteria (PsARC) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12

Description

Time Frame

At Week 2 and Months 1, 2, 3, 4, 6, 9, and 12

Title

Change From Baseline in Physician's Global Assessment of Psoriasis (PGA-PsO) Response

Description

Time Frame

From Baseline to Months 1, 3, 6, 9, and 12

Title

Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response at Months 1, 3, 6, 9, and 12

Description

Time Frame

At Months 1, 3, 6, 9, and 12

Title

Change From Baseline in Dactylitis Severity Score (DSS)

Description

Time Frame

From Baseline to Months 1, 3, 6, 9, and 12

Title

Change From Baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index

Description

Time Frame

From Baseline to Months 1, 3, 6, 9, and 12

Title

Change From Baseline in the Leeds Enthesitis Index (LEI)

Description

Time Frame

From Baseline to Months 1, 3, 6, 9, and 12

Title

Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2) Acute, Physical Component Summary Score

Description

Time Frame

From Baseline to Months 1, 3, 6, 9, and 12

Title

Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute, Mental Component Summary Score

Description

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.

Time Frame

From Baseline to Months 1, 3, 6, 9, and 12

Title

Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Physical Functioning Domain

Description

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.

Time Frame

From Baseline to Months 1, 3, 6, 9, and 12

Title

Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Role-Physical Domain

Description

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.

Time Frame

From Baseline to Months 1, 3, 6, 9, and 12

Title

Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Bodily Pain Domain

Description

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.

Time Frame

From Baseline to Months 1, 3, 6, 9, and 12

Title

Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: General Health Domain

Description

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.

Time Frame

From Baseline to Months 1, 3, 6, 9, and 12

Title

Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Vitality Domain

Description

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.

Time Frame

From Baseline to Months 1, 3, 6, 9, and 12

Title

Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Social Functioning Domain

Description

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.

Time Frame

From Baseline to Months 1, 3, 6, 9, and 12

Title

Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Role-Emotional Domain

Description

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.

Time Frame

From Baseline to Months 1, 3, 6, 9, and 12

Title

Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Mental Health Domain

Description

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.

Time Frame

From Baseline to Months 1, 3, 6, 9, and 12

Title

Description

Time Frame

From Baseline to Months 1, 3, 6, 9, and 12

Title

Description

Time Frame

From Baseline to Months 1, 3, 6, 9, and 12

Title

Description

Time Frame

From Baseline to Months 1, 3, 6, 9, and 12

Title

Description

Time Frame

From Baseline to Months 1, 3, 6, 9, and 12

Title

Description

Time Frame

From Baseline to Months 1, 3, 6, 9, and 12

Title

Description

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.

Time Frame

From Baseline to Months 1, 3, 6, 9, and 12

Title

Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Total Score

Description

Time Frame

From Baseline to Months 1, 3, 6, 9, and 12

Title

Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Experience Domain Score

Description

Time Frame

From Baseline to Months 1, 3, 6, 9, and 12

Title

Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Impact Domain Score

Description

Time Frame

From Baseline to Months 1, 3, 6, 9, and 12

Title

Change From Baseline in Scores Evaluating Spondylitis Using the Bath Anklyosing Spondylitis Disease Activity Index (BASDAI)

Description

Time Frame

From Baseline to Months 1, 3, 6, 9, and 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

Rheumatology Associates, PC

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35205

Country

United States

Facility Name

Rheumatology Associates of North Alabama, PC

City

Huntsville

State/Province

Alabama

ZIP/Postal Code

35801

Country

United States

Facility Name

Arizona Arthritis & Rheumatology Associates, P.C.

City

Glendale

State/Province

Arizona

ZIP/Postal Code

85306

Country

United States

Facility Name

Medvin Clinical Research

City

Covina

State/Province

California

ZIP/Postal Code

91723

Country

United States

Facility Name

Desert Medical Advances

City

Palm Desert

State/Province

California

ZIP/Postal Code

92260

Country

United States

Facility Name

Advances In Medicine (X-Rays)

City

Rancho Mirage

State/Province

California

ZIP/Postal Code

92270

Country

United States

Facility Name

San Diego Arthritis Medical Clinic

City

San Diego

State/Province

California

ZIP/Postal Code

92108

Country

United States

Facility Name

Millennium Research

City

Ormond Beach

State/Province

Florida

ZIP/Postal Code

32174

Country

United States

Facility Name

Arthritis Center, Inc.

City

Palm Harbor

State/Province

Florida

ZIP/Postal Code

34684

Country

United States

Facility Name

Klein & Associates, M.D., P.A.

City

Hagerstown

State/Province

Maryland

ZIP/Postal Code

21740

Country

United States

Facility Name

Clinical Pharmacology Study Group

City

Worcester

State/Province

Massachusetts

ZIP/Postal Code

01605

Country

United States

Facility Name

St. Paul Rheumatology, PA

City

Eagan

State/Province

Minnesota

ZIP/Postal Code

55121

Country

United States

Facility Name

Physician Research Collaboration, LLC

City

Lincoln

State/Province

Nebraska

ZIP/Postal Code

68516

Country

United States

Facility Name

Dartmouth-Hitchcock Medical Center (DHMC)

City

Lebanon

State/Province

New Hampshire

ZIP/Postal Code

03756

Country

United States

Facility Name

Paramount Medical Research & Consulting, LLC

City

Middleburg Heights

State/Province

Ohio

ZIP/Postal Code

44130

Country

United States

Facility Name

Altoona Center for Clinical Research

City

Duncansville

State/Province

Pennsylvania

ZIP/Postal Code

16635

Country

United States

Facility Name

Low Country Rheumatology, PA

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29406

Country

United States

Facility Name

Pioneer Research Solutions, Inc.

City

Houston

State/Province

Texas

ZIP/Postal Code

77008

Country

United States

Facility Name

Drug Shipment/Storage: Huntsman Cancer Hospital at the University of Utah

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84112

Country

United States

Facility Name

University of Utah Hospital & Clinics

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84132

Country

United States

Facility Name

Dynacare Laboratories (Specimen processing for shipment)

City

Seattle

State/Province

Washington

ZIP/Postal Code

98122

Country

United States

Facility Name

Investigational Drug Service Pharmacy, Swedish Medical Center.

City

Seattle

State/Province

Washington

ZIP/Postal Code

98122

Country

United States

Facility Name

Seattle Rheumatology Associates

City

Seattle

State/Province

Washington

ZIP/Postal Code

98122

Country

United States

Facility Name

Swedish Medical Center

City

Seattle

State/Province

Washington

ZIP/Postal Code

98122

Country

United States

Facility Name

Rheumatology Research Unit

City

Maroochydore

State/Province

Queensland

ZIP/Postal Code

4558

Country

Australia

Facility Name

Pacific Private Clinic

City

Southport

State/Province

Queensland

ZIP/Postal Code

4215

Country

Australia

Facility Name

Monash Health, Monash Medical Centre

City

Clayton

State/Province

Victoria

ZIP/Postal Code

3168

Country

Australia

Facility Name

Pharmacy Clinical Trials

City

Clayton

State/Province

Victoria

ZIP/Postal Code

3168

Country

Australia

Facility Name

St. Vincent's Hospital (Melbourne)

City

Fitzroy

State/Province

Victoria

ZIP/Postal Code

3065

Country

Australia

Facility Name

Emeritus Research Pty Ltd

City

Malvern East

State/Province

Victoria

ZIP/Postal Code

3145

Country

Australia

Facility Name

Hopital Erasme - Clinique Universitaire de Bruxelles

City

Brussels

ZIP/Postal Code

1070

Country

Belgium

Facility Name

University Hospital Leuven, Department of Rheumatology

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

UMHAT "Dr. G. Stranski" EAD

City

Pleven

ZIP/Postal Code

5800

Country

Bulgaria

Facility Name

MHAT"Plovdiv" AD

City

Plovdiv

ZIP/Postal Code

4000

Country

Bulgaria

Facility Name

MHAT "Kaspela" EOOD

City

Plovdiv

ZIP/Postal Code

4002

Country

Bulgaria

Facility Name

UMHAT "Sv. Ivan Rilski" EAD

City

Sofia

ZIP/Postal Code

1612

Country

Bulgaria

Facility Name

MC "New rehabilitation center" EOOD, Rheumatology Cabinet

City

Stara Zagora

ZIP/Postal Code

6003

Country

Bulgaria

Facility Name

Rheumatology Research Associates

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T5M 0H4

Country

Canada

Facility Name

K. Papp Clinical Research

City

Waterloo

State/Province

Ontario

ZIP/Postal Code

N2J 1C4

Country

Canada

Facility Name

West Island Rheumatology Research Associates

City

Pointe-Claire

State/Province

Quebec

ZIP/Postal Code

H9R 3J1

Country

Canada

Facility Name

Revmacentrum MUDr. Mostera, s.r.o.

City

Brno

State/Province

Czech Republic

ZIP/Postal Code

615 00

Country

Czechia

Facility Name

MEDIGAP, s.r.o. (radiology only)

City

Praha 1 - Nove Mesto

State/Province

Czech Republic

ZIP/Postal Code

110 00

Country

Czechia

Facility Name

Revmatologicky Ustav - Lekarna (pharmacy only)

City

Praha 2

State/Province

Czech Republic

ZIP/Postal Code

128 50

Country

Czechia

Facility Name

Revmatologicka ambulance

City

Praha 4

State/Province

Czech Republic

ZIP/Postal Code

140 00

Country

Czechia

Facility Name

Lekarna Na Lidicke (Pharmacy only)

City

Brno

ZIP/Postal Code

602 00

Country

Czechia

Facility Name

X-MEDICA s.r.o (radiology only)

City

Brno

ZIP/Postal Code

61300

Country

Czechia

Facility Name

Revmatologie s.r.o.

City

Brno

ZIP/Postal Code

638 00

Country

Czechia

Facility Name

Stavovska s.r.o. (pharmacy only)

City

Brno

ZIP/Postal Code

63800

Country

Czechia

Facility Name

Vesalion s.r.o.

City

Ostrava

ZIP/Postal Code

70200

Country

Czechia

Facility Name

MEDIGAP, s.r.o

City

Praha 1- Nove Mesto

ZIP/Postal Code

110 00

Country

Czechia

Facility Name

Revmatologicky ustav - Lekarna

City

Praha 2

ZIP/Postal Code

128 50

Country

Czechia

Facility Name

Revmatologicky ustav

City

Praha 2

ZIP/Postal Code

128 50

Country

Czechia

Facility Name

Medical Plus s.r.o. Lekarna Hradebni s. r.o

City

Uherske Hradiste

ZIP/Postal Code

68601

Country

Czechia

Facility Name

Centre Hospitalier Sud-Francilien - Secretariat de Rhumatologie

City

Corbeil Essonnes cedex

ZIP/Postal Code

91106

Country

France

Facility Name

Charite Universitaetsmedizin Berlin

City

Berlin

ZIP/Postal Code

10117

Country

Germany

Facility Name

Klinische Forschung Berlin-Mitte GmbH

City

Berlin

ZIP/Postal Code

10117

Country

Germany

Facility Name

Rheumapraxis Steglitz

City

Berlin

ZIP/Postal Code

12161

Country

Germany

Facility Name

University Hospital of Cologne

City

Koeln

ZIP/Postal Code

50937

Country

Germany

Facility Name

Klinische Forschung Schwerin GmbH

City

Schwerin

ZIP/Postal Code

19055

Country

Germany

Facility Name

Revita Reumatologiai Rendelo

City

Budapest

ZIP/Postal Code

1027

Country

Hungary

Facility Name

Qualiclinic Kft.

City

Budapest

ZIP/Postal Code

1036

Country

Hungary

Facility Name

Magyar Honvedseg Egeszsegugyi Kozpont,Reumatologiai osztaly

City

Budapest

ZIP/Postal Code

1062

Country

Hungary

Facility Name

Csolnoky Ferenc Korhaz, Radiologiai Osztaly X-Ray Only

City

Veszprem

ZIP/Postal Code

8200

Country

Hungary

Facility Name

Csolnoky Ferenc Korhaz, Reumatologiai Osztaly

City

Veszprem

ZIP/Postal Code

8200

Country

Hungary

Facility Name

Centro Integral en Reumatologia SA de CV

City

Guadalajara

State/Province

Jalisco

ZIP/Postal Code

44160

Country

Mexico

Facility Name

Centro de Investigacion de Tratamientos Innovadores de Sinaloa, S.C.

City

Culiacan

State/Province

Sinaloa

ZIP/Postal Code

80000

Country

Mexico

Facility Name

Laboratorios de Analisis Clinicos CEMSI

City

Culiacan

State/Province

Sinaloa

ZIP/Postal Code

80000

Country

Mexico

Facility Name

Sanatorio CEMSI Chapultepec (For Emergencies Only)

City

Culiacan

State/Province

Sinaloa

ZIP/Postal Code

80040

Country

Mexico

Facility Name

Hospital General de Culiacán Dr. Bernardo J. Gastélum

City

Culiacan

State/Province

Sinaloa

ZIP/Postal Code

80230

Country

Mexico

Facility Name

Instituto Medico Panamericano, S.A. de C.V. (For Emergencies Only)

City

Merida

State/Province

Yucatan

ZIP/Postal Code

97000

Country

Mexico

Facility Name

Unidad Reumatologica Las Americas, S.C.P.

City

Merida

State/Province

Yucatan

ZIP/Postal Code

97000

Country

Mexico

Facility Name

Centro de Investigacion Clinica Pensiones

City

Merida

State/Province

Yucatan

ZIP/Postal Code

97070

Country

Mexico

Facility Name

Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en Yucatan

City

Merida

State/Province

Yucatan

ZIP/Postal Code

97130

Country

Mexico

Facility Name

Hospital Star Medica Merida (For Emergencies Only)

City

Merida

State/Province

Yucatan

ZIP/Postal Code

97133

Country

Mexico

Facility Name

HOSPITAL STAR MEDICA S.A DE C.V- (emergencies only)

City

Merida

State/Province

Yucatan

ZIP/Postal Code

97133

Country

Mexico

Facility Name

Investigacion y Biomedicina de Chihuahua SC

City

Chihuahua

ZIP/Postal Code

31000

Country

Mexico

Facility Name

Cliditer, S. A. de C. V

City

Mexico City

ZIP/Postal Code

06700

Country

Mexico

Facility Name

Niepubliczny Zaklad Opieki Zdrowotnej Przychodnia Chirurgiczna dla Dzieci "PriamaMed" Sp.P.,"

City

Bialystok

ZIP/Postal Code

15-002

Country

Poland

Facility Name

ZDROWIE OSTEO-MEDIC s.c. L. i A. Racewicz, A. i J. Supronik

City

Bialystok

ZIP/Postal Code

15-351

Country

Poland

Facility Name

ClinicMed Badurski i wspolnicy Spolka Jawna

City

Bialystok

ZIP/Postal Code

15-879

Country

Poland

Facility Name

Szpital Uniwersytecki nr 2 im. dr Jana Biziela w Bydgoszczy,

City

Bydgoszcz

ZIP/Postal Code

85-168

Country

Poland

Facility Name

Centrum Kliniczno-Badawcze J.Brzezicki, B.Gornikiewicz-Brzezicka Lekarze Spolka Partnerska

City

Elblag

ZIP/Postal Code

82-300

Country

Poland

Facility Name

Centrum Radiologii for X-Ray only

City

Elblag

ZIP/Postal Code

82-300

Country

Poland

Facility Name

NZOZ Centrum Reumatologiczne Indywidualna Specjalistyczna Praktyka Lekarska Lek. Med. Barbara Bazela

City

Elblag

ZIP/Postal Code

82-300

Country

Poland

Facility Name

Przychodnia Specjalistyczna Lekarskiej Spoldzielni Pracy "Medica"

City

Grodzisk Mazowiecki

ZIP/Postal Code

05-825

Country

Poland

Facility Name

Zespol Poradni Specjalistycznych Reumed Filia Onyksowa

City

Lublin

ZIP/Postal Code

20-582

Country

Poland

Facility Name

NZOZ Lecznica MAK-MED S.C.

City

Nadarzyn

ZIP/Postal Code

05-830

Country

Poland

Facility Name

Prywatna Praktyka Lekarska Prof. UM dr hab. Pawel Hrycaj

City

Poznan

ZIP/Postal Code

61-397

Country

Poland

Facility Name

NZOZ Nasz Lekarz Praktyka Grupowa Lekarzy Rodzinnych z Przychodnia Specjalistyczna w Toruniu

City

Torun

ZIP/Postal Code

87-100

Country

Poland

Facility Name

Medica Pro Familia Sp. z o.o. S.K.A.

City

Warsaw

ZIP/Postal Code

01-868

Country

Poland

Facility Name

Rheuma Medicus Zaklad Opieki Zdrowotnej

City

Warszawa

ZIP/Postal Code

02-118

Country

Poland

Facility Name

Reumatika Centrum Reumatologii

City

Warszawa

ZIP/Postal Code

02-691

Country

Poland

Facility Name

Klinika Ambroziak Estederm Sp. z o.o. ,S.K.A

City

Warszawa

ZIP/Postal Code

02-758

Country

Poland

Facility Name

Synexus Polska Sp. z o.o. Oddz. we Wroclawiu

City

Wroclaw

ZIP/Postal Code

50-088

Country

Poland

Facility Name

Regional State Budgetary Healthcare Institution of Karelia Republic

City

Petrozavodsk

State/Province

Karelia Republic

ZIP/Postal Code

185019

Country

Russian Federation

Facility Name

State Budgetary Institution of Healthcare of Moscow City Clinical Hospital

City

Moscow

ZIP/Postal Code

119049

Country

Russian Federation

Facility Name

OOO City Neurological Centre "Sibneiromed"

City

Novosibirsk

ZIP/Postal Code

630091

Country

Russian Federation

Facility Name

Limited Liability Company Consultative Diagnostic Rheumatology Center "Healthy Joints"

City

Novosibirsk

ZIP/Postal Code

630099

Country

Russian Federation

Facility Name

State Institution of Healthcare "Regional Clinical Hospital"

City

Saratov

ZIP/Postal Code

410053

Country

Russian Federation

Facility Name

State Budget Educational Institution of Highest Professional Education

City

Tomsk

ZIP/Postal Code

634050

Country

Russian Federation

Facility Name

State Healthcare Institution of Yaroslavl Region Clinical Emergency Hospital n.a. N.V. Solovyev

City

Yaroslavl

ZIP/Postal Code

150003

Country

Russian Federation

Facility Name

State Institution of Healthcare of Yaroslavl Region

City

Yaroslavl

ZIP/Postal Code

150003

Country

Russian Federation

Facility Name

ROMJAN s.r.o., Reumatologicka ambulancia

City

Bratislava

State/Province

Slovak Republic

ZIP/Postal Code

832 63

Country

Slovakia

Facility Name

MEDMAN s.r.o. - reumatologicka ambulancia

City

Martin

State/Province

Slovak Republic

ZIP/Postal Code

036 01

Country

Slovakia

Facility Name

Nestatna reumatologicka ambulancia

City

Bratislava

ZIP/Postal Code

841 04

Country

Slovakia

Facility Name

Reumex s.r.o

City

Rimavska Sobota

ZIP/Postal Code

979 01

Country

Slovakia

Facility Name

Hospital Clinico de Santiago

City

Santiago De Compostela

State/Province

A Coruna

ZIP/Postal Code

15706

Country

Spain

Facility Name

Corporació Sanitaria Parc Tauli

City

Sabadell

State/Province

Barcelona

ZIP/Postal Code

08208

Country

Spain

Facility Name

Hospital Universitario Marques de Valdecilla

City

Santander

State/Province

Cantabria

ZIP/Postal Code

39008

Country

Spain

Facility Name

Complexo Hospitalario Universitario A Coruna

City

A Coruna

ZIP/Postal Code

15006

Country

Spain

Facility Name

Hospital Infanta Luisa

City

Sevilla

ZIP/Postal Code

41010

Country

Spain

Facility Name

Hospital Universitario y Politecnico La Fe

City

Valencia

ZIP/Postal Code

46026

Country

Spain

Facility Name

Taipei Veterans General Hospital

City

Taipei

State/Province

Taiwan Roc

ZIP/Postal Code

11217

Country

Taiwan

Facility Name

Buddhist Dalin Tzu Chi General Hospital

City

Chia-Yi

ZIP/Postal Code

62247

Country

Taiwan

Facility Name

Chang Gung Medical Foundation-Kaohsiung Branch

City

Kaohsiung

ZIP/Postal Code

83301

Country

Taiwan

Facility Name

Chung Shan Medical University Hospital

City

Taichung

ZIP/Postal Code

40201

Country

Taiwan

Facility Name

Barking Havering and Redbridge University Hospital NHS Trust-King George Hospital

City

Goodmayes

State/Province

Essex

ZIP/Postal Code

IG3 8YB

Country

United Kingdom

Facility Name

Barking, Havering and Redbridge University Hospitals NHS Trust

City

Romford

State/Province

Essex

ZIP/Postal Code

RM7 0AG

Country

United Kingdom

Facility Name

The Dudley Group NHS Foundation Trust

City

Dudley

State/Province

West Midlands

ZIP/Postal Code

DY1 2HQ

Country

United Kingdom

Facility Name

Bradford Teaching Hospitals NHS Foundation Trust

City

Bradford

State/Province

West Yorkshire

ZIP/Postal Code

BD5 0NA

Country

United Kingdom

Facility Name

Bradford Royal Infirmary, BTHFT

City

Bradford

State/Province

West Yorkshire

ZIP/Postal Code

BD9 6RJ

Country

United Kingdom

Facility Name

Wirral University Teaching Hospital NHS Foundation Trust

City

Upton

State/Province

Wirral

ZIP/Postal Code

CH49 5PE

Country

United Kingdom

Facility Name

York Teaching Hospital NHS Foundation Trust

City

York

ZIP/Postal Code

YO31 8HE

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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

Citations:

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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.

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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.

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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.

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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.

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PubMed Identifier

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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.

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PubMed Identifier

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Citation

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.

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PubMed Identifier

32816215

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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;:

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PubMed Identifier

32006348

Citation

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.

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PubMed Identifier

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Citation

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Citation

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Citation

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PubMed Identifier

29045212

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Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3921091&StudyName=Efficacy%20And%20Safety%20Of%20Tofacitinib%20In%20Psoriatic%20Arthritis%3A%20Comparator%20Study

Description

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Learn more about this trial

Efficacy And Safety Of Tofacitinib In Psoriatic Arthritis: Comparator Study

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