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Tofacitinib In Psoriatic Arthritis Subjects With Inadequate Response to TNF Inhibitors (OPAL BEYOND)

Primary Purpose

Psoriatic Arthritis

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Tofacitinib

Placebo

Tofacitinib

Placebo

Tofacitinib

About this trial

This is an interventional treatment trial for Psoriatic Arthritis focused on measuring psoriatic arthritis, tofacitinib, ACR20, HAQ-DI, TNF inhibitor failure

Eligibility Criteria

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

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Rheumatology Associates P.C.
Rheumatology Associates of North Alabama, PC
Arizona Arthritis & Rheumatology Associates, P.C.
Medvin Clinical Research
St. Jude Hospital Yorba Linda DBA St. Joseph Heritage Healthcare
Ronald Reagan UCLA Medical Center, Drug Information Center
UCLA David Geffen School of Medicine
San Diego Arthritis Medical Clinic
Stanford Hospital and Clinics
New England Research Associates, LLC
Rheumatology Associates of Central Florida, PA
Millennium Research
Arthritis Center, Inc.
Integral Rheumatology & Immunology Specialists (IRIS)
Florida Medical Clinic, P.A.
St. Luke's Clinic - Rheumatology
St. Luke's Intermountain Research Center
Bluegrass Community Research, Inc
Klein & Associates, M.D., P.A.
The Center For Rheumatology And Bone Research
Brigham & Women's Hospital
Brigham and Women's Hospital
Clinical Pharmacology Study Group
St. Paul Rheumatology, PA
Clayton Medical Research
Physician Research Collaboration, LLC
Dartmouth-Hitchcock Medical Center (DHMC)
Cincinnati Rheumatic Disease Study Group, Inc.
University Hospitals Case Medical Center
Paramount Medical Research & Consulting, LLC
East Penn Rheumatology Associates, PC
Altoona Center for Clinical Research
Low Country Rheumatology, PA
Arthritis Clinic
West Tennessee Research Institute
Adriana M. Pop-Moody, M.D., Clinic, P.A.
Pioneer Research Solutions, Inc.
Metroplex Clinical Research Center
Drug Shipment/Storage: Investigational Drug Services
University of Utah Hospital & Clinics
Dynacare Laboratories
Seattle Rheumatology Associates
Swedish Medical Center
Royal Prince Alfred Hospital, Rheumatology Department
Rheumatology Research Unit
Emeritus Research Pty Ltd
Hospital Erasme - Clinique Universitaire de Bruxelles
ReumaClinic
Universitair Ziekenhuis Gent
University Hospital Leuven, Department of Rheumatology
ZNA Jan Palfijn
CMIP: Centro Mineiro de Pesquisa Ltda /
CETAC - DIAGNOSTICO POR IMAGEM (image only)
EDUMED - Educacao em Saude SS LTDA.
Hospital de Clinicas de Porto Alegre (HCPA) / UFRGS
Clinica Medica Bonfiglioli Ltda. / Clinica Bonfiglioli
Radiologia Clínica de Campinas - RCC (Images only)
Medical Plus s.r.o.
Centre Hospitalier Sud-Francilien - Secretariat de Rhumatologie
Hopital Avicenne
Rheumazentrum Prof. Dr. med Gunther Neeck
Charite Universitatsmedizin Berlin - Campus Charite Mitte
Rheumapraxis Steglitz
Schlosspark-Klinik
Universitaetsklinikum Erlangen, Medizinische Klinik 3
CIRI - Centrum für innovative Diagnostik und Therapie Rheumatologie/Immunologie (GmbH)
Medizinische Universitatsklinik Freiburg
Universitaetsklinikum Des Saarlandes Und Medizinische Fakultaet Der Universitaet Des Saarlandes
University Hospital of Cologne
Elisabeth Klinik Bigge
Hospital Angeles Clinica Londres
Grupo Medico Camino S.C.
CLIDITER, S.A. de C.V.
Universidad La Salle AC
Medica Sur, S.A.B. de C.V. (For Emergencies Only)
Centro Integral en Reumatologia SA de CV
Grupo Santa Bernardette S.A. de C.V.
Centro de Investigacion de Tratamientos Innovadores de Sinaloa, S.C
Sanatorio CEMSI Chapultepec (For Emergencies Only)
Hospital General de Culiacan "Dr. Bernardo J. Gastelum"
Star Medica S.A. de C.V. (For Emergencies Only)
Institute Medico Panamericano, S.A. de C.V. (For Emergencies Only)
Unidad Reumatologica Las Americas SCP
Centro de Investigacion Clinica Pensiones
Centro Multidisciplinario para el Desarrollo
Hospital Star Medica Merida (For Emergencies Only)
Christus Muguerza del parque, S.A de C.V
Investigacion y Biomedicina de Chihuahua
Centrum Kliniczno-Badawcze J.Brzezicki, B.Gornikiewicz-Brzez
Centrum Radiologii for X-Ray only
NZOZ Centrum Reumatologiczne Indywidualna Specjalistyczna Praktyka Lekarska Lek. Med. Barbara Bazela
Wojewodzki Szpital Zespolony Zaklad Radiologii
Przychodnia Specjalistyczna Lekarskiej Spozielni Pracy "Medica" for X-Ray Only
Specjalistyczne Gabinety Lekarskie "DERMED" Anna Kaszuba
NZOZ Lecznica MAK-MED S.C.
Prywatna Praktyka Lekarska Prof. UM dr hab. Pawel Hrycaj
Reumatika Centrum Reumatologii nzoz
Regional State Budgetary Healthcare Institution of Karelia Republic "Republic Hospital n.a.
State Autonomic Healthcare Institution City Clinical Hospital # 7
SBIH of Moscow "City Clinical Hospital#1 n. a. N.I. Pirogov" of the Healthcare Department of Moscow
City Neurological Centre "SibNeyroMed", LLC
Limited Liability Company Consultative Diagnostic Rheumatology Center "Healthy Joints"
State Budget Educational Institution of Highest Professional Education
State Institution of Healthcare of Yaroslavl Region
MEDMAN s.r.o. - reumatologicka ambulancia
Hospital Clinico de Santiago
Corporacio Sanitaria Parc Tauli
Hospital Universitario Marques de Valdecilla
Hospital Sierrallana
Complejo Hospitalario Universitario A Coruna
Hospital Universitari Vall d'Hebron
Hospital Universitario Virgen Macarena
Hospital Universitaro 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
China Medical University Hospital
Barking Havering and Redbridge University Hospitals NHS Trust
Barking, Havering and Redbridge University Hospitals NHS Trust
The Dudley Group NHS Foundation Trust
Bradford Royal Infirmary, BTHFT
Royal United Hospitals NHS Foundation Trust
Bradford Teaching Hospitals NHS Foundation Trust
York Hospital, York Teaching Hospital NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

Treatment Sequence A

Treatment Sequence B

Treatment Sequence C

Treatment Sequence D

Arm Description

Tofacitinib 5 mg BID for 6 months

Tofacitinib 10 mg BID for 6 months

Placebo for 3 months then tofacitinib 5 mg BID for 3 months

Placebo for 3 months then tofacitinib 10 mg BID for 3 months

Outcomes

Primary Outcome Measures

Percentage of Participants Meeting American College of Rheumatology Response Criteria Greater Than or Equal to (≥) 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: Month 3

The HAQ-DI assesses the difficulty a patient 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. Overall score was computed as the sum of the domain scores divided by the number of domains answered. The total possible score ranged from 0 to 3 where 0 = least difficulty and 3 = extreme difficulty. Higher overall score indicates greater disability.

Secondary Outcome Measures

Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥50% (ACR50) at Week 2 and Months 1, 2, 3, 4, and 6

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. n=number of responders.

Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥70% (ACR70) at Week 2 and Months 1, 2, 3, 4, and 6

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. n=number of responders.

Percentage of Participants Meeting American College of Rheumatology Response Criteria Greater Than or Equal to (≥) 20% (ACR20): Week 2 and Months 1, 2, 4, and 6

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. n=number of responders.

Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score: Week 2 and Months 1, 2, 4, and 6

Change From Baseline in American College of Rheumatology (ACR) Response Criteria Components: C-reactive Protein (CRP) Levels: Month 3

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 (ACR) Response Criteria Components Score: Patient's Assessment of Arthritis Pain: Month 3

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 (ACR) Response Criteria Components Score: Patient's Global Assessment of Arthritis: Month 3

Participants 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 (ACR) Response Criteria Components Score: Physician's Global Assessment of Arthritis: Month 3

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 (ACR) Response Criteria Components Score: Swollen Joint Count: Month 3

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 (ACR) Response Criteria Components Score: Tender/Painful Joint Count: Month 3

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): Week 2, Months 1, 2, 3, 4, and 6

The PsARC covers 4 measures: Tender 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. n=number of responders.

Change From Baseline in Physician's Global Assessment of Psoriasis (PGA-PsO) Response: Months 1, 3, and 6

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 the PGA-PsO score on a scale of 0 to 4 (0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe). n=number of participants evaluable at each visit.

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

PASI determines psoriasis severity based on lesion severity and percentage of body surface area (BSA) affected. Lesion severity is assessed for erythema, induration, and scaling evaluated separately for the head and neck, upper limbs, trunk, and lower limbs and then 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 and is assigned a numerical score: 0=no involvement; 1=0% to 9%; 2=10% to 29%; 3=30% to 49%; 4=50% to 69%; 5=70% to 89%; 6=90% to 100%. In each area, the sum of the severity rating scores is multiplied by the score representing the percentage of this 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 the numbers obtained for each of the 4 body areas is the PASI. PASI75 is defined as a 75% reduction from baseline in PASI. n=number of responders.

Change From Baseline in Dactylitis Severity Score (DSS): Months 1, 3, and 6

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=tenderness and 3=extreme tenderness in each digit of the hands and feet. The range of total dactylitis scores for a participant is 0-60. Higher score indicates greater degree of tenderness. n=number of participants evaluable at each visit.

Change From Baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index: Months 1, 3, and 6

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. n=number of participants evaluable at each visit.

Change From Baseline in the Leeds Enthesitis Index (LEI): Months 1, 3, and 6

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 a total score of 0-6. Higher score indicates greater severity of enthesitis. n=number of participants evaluable at each visit.

Change From Baseline in the Short-Form-36 Health Survey Version 2, Acute Components (SF-36v2 Acute): Physical Component Summary Score: Months 1, 3, 6

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. The health domains are aggregated into two summary scores known as the physical component summary (PCS) score and the mental component summary (MCS) score. Normalized domain scores, PCS and MCS scores are used in the analyses. The component and domain scores were scored using the United States (US) 1998 general population norms. The resulting norm-based T-scores for both the SF36 version 2 and SF36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher PCS score represents better physical health status. n=number of participants evaluable at each visit.

Change From Baseline in the Short-Form-36 Health Survey Version 2, Acute Components (SF-36v2 Acute): Mental Component Summary Score: Months 1, 3, 6

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. The health domains are aggregated into two summary scores known as the PCS score and the MCS score. Normalized domain scores, PCS and MCS scores are used in the analyses. The component and domain scores were scored using the US 1998 general population norms. The resulting norm-based T-scores for both the SF36 version 2 and SF36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher MCS score represents better mental health status. n=number of participants evaluable at each visit.

Change From Baseline in the Short-Form-36 Health Survey Version 2, Acute Components (SF-36v2 Acute): Physical Functioning Domain: Months 1, 3, 6

SF-36v2 acute is a 36-item measure evaluating 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health. The 10 items of the physical functioning scale represent levels & kinds of limitations between extremes of physical activities, including lifting & carrying groceries; climbing stairs; bending, kneeling, or stooping; walking moderate distances; self-care limitations. The physical functioning items capture the presence & extent of physical limitations using a 3-level response continuum. The domain scores were scored using the US 1998 general population norms. The resulting norm-based T-scores for both the SF36 version 2 & SF36 health domain scales & component summary measures have means of 50 & standard deviations of 10. A higher physical functioning domain score represents better physical functioning. n=number of participants evaluable at each visit.

Change From Baseline in the Short-Form-36 Health Survey Version 2, Acute Components (SF-36v2 Acute): Role-physical Domain: Months 1, 3, 6

SF-36v2 acute is a 36-item measure evaluating 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health. The 4-item role-physical scale covers an array of physical health-related role limitations, including: a) limitations in the kind of work or other usual activities; b) reductions in the amount of time spent on work or other usual activities; c) difficulty performing work or other usual activities; & d) accomplishing less. Items in the role-physical scale are answered on a 5-point scale. The domain scores were scored using the US 1998 general population norms. The resulting norm-based T-scores for both the SF36 version 2 & SF36 health domain scales & component summary measures have means of 50 & standard deviations of 10. A higher role-physical domain score represents better role-physical functioning. n=number of participants evaluable at each visit.

Change From Baseline in the Short-Form-36 Health Survey Version 2, Acute Components (SF-36v2 Acute): Bodily Pain Domain: Months 1, 3, 6

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. The bodily pain scale comprises of 2 items pertaining to the intensity of bodily pain and extent of interference with normal work activities. The domain scores were scored using the US 1998 general population norms. The resulting norm-based T-scores for both the SF36 version 2 & SF36 health domain scales & component summary measures have means of 50 & standard deviations of 10. A higher bodily pain domain score represents less bodily pain. n=number of participants evaluable at each visit.

Change From Baseline in the Short-Form-36 Health Survey Version 2, Acute Components (SF-36v2 Acute): General Health Domain: Months 1, 3, 6

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. The general health scale consists of 5 items including a rating of health and 4 items addressing the respondent's view and expectations of his or her health. The domain scores were scored using the US 1998 general population norms. The resulting norm-based T-scores for both the SF36 version 2 & SF36 health domain scales & component summary measures have means of 50 & standard deviations of 10. A higher general health domain score represents better general health perceptions. n=number of participants evaluable at each visit.

Change From Baseline in the Short-Form-36 Health Survey Version 2, Acute Components (SF-36v2 Acute): Vitality Domain: Months 1, 3, 6

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. The 4-item measure of vitality captures a broad range of subjective evaluations of well-being from feelings of tiredness and being worn out to feeling full of energy all or most of the time. The domain scores were scored using the US 1998 general population norms. The resulting norm-based T-scores for both the SF36 version 2 & SF36 health domain scales & component summary measures have means of 50 & standard deviations of 10. A higher vitality domain score represents better vitality. n=number of participants evaluable at each visit.

Change From Baseline in the Short-Form-36 Health Survey Version 2, Acute Components (SF-36v2 Acute): Social Functioning Domain: Months 1, 3, 6

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. The 2-item social functioning scale assesses health-related effects on quantity and quality of social activities. The domain scores were scored using the US 1998 general population norms. The resulting norm-based T-scores for both the SF36 version 2 & SF36 health domain scales & component summary measures have means of 50 & standard deviations of 10. A higher social functioning domain score represents better social functioning. n=number of participants evaluable at each visit.

Change From Baseline in the Short-Form-36 Health Survey Version 2, Acute Components (SF-36v2 Acute): Role-emotional Domain: Months 1, 3, 6

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. The 3-item role-emotional scale assesses mental health-related role limitations in terms of a) time spent in work or other usual activities; b) amount of work or activities accomplished; c) care with which work or other activities were performed. All 3 items are answered on a 5-point scale. The domain scores were scored using the US 1998 general population norms. The resulting norm-based T-scores for both the SF36 version 2 & SF36 health domain scales & component summary measures have means of 50 & standard deviations of 10. A higher role-emotional domain score represents better role-emotional functioning. n=number of participants evaluable at each visit.

Change From Baseline in the Short-Form-36 Health Survey Version 2, Acute Components (SF-36v2 Acute): Mental Health Domain: Months 1, 3, 6

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. The 5-item mental health scale includes 1 or more items from each of 4 major mental health dimensions: anxiety, depression, loss of behavioral/emotional control, and psychological well-being. All items are answered on a 5-point scale. The domain scores were scored using the US 1998 general population norms. The resulting norm-based T-scores for both the SF36 version 2 & SF36 health domain scales & component summary measures have means of 50 & standard deviations of 10. A higher mental health domain score represents better mental health functioning. n=number of participants evaluable at each visit.

Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Mobility: Months 1, 3, 6

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/some or moderate problems/extreme problems) within a particular EQ-5D dimension. Standard vertical 0 to 100 mm VAS (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. n=number of participants evaluable at each visit.

Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Patient's Health State Today: Months 1, 3, 6

Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Total Score: Months 1, 3, 6

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 fatigue status. n=number of participants evaluable at each visit.

Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Experience Domain Score: Months 1, 3, 6

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. n=number of participants evaluable at each visit.

Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Impact Domain Score: Months 1, 3, 6

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. n=number of participants evaluable at each visit.

Change From Baseline in Score Evaluating Spondylitis Using the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI): Months 1, 3, 6

BASDAI is a validated self-assessment tool used to determine disease activity in participants with ankylosing spondylitis. Utilizing a VAS of 0-10 (0=none and 10=very severe) participants answered 6 questions measuring discomfort, pain, and fatigue. The final BASDAI score averaged the individual assessments for a final score ranging 0-10cm, with higher scores representing more severe ankylosing spondylitis disease activity. n=number of participants evaluable at each visit.

Full Information

NCT ID

NCT01882439

First Posted

June 18, 2013

Last Updated

September 8, 2017

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT01882439

Brief Title

Tofacitinib In Psoriatic Arthritis Subjects With Inadequate Response to TNF Inhibitors

Acronym

OPAL BEYOND

Official Title

A Phase 3, Randomized, Double-blind, Placebo-controlled Study Of The Efficacy And Safety Of 2 Doses Of Tofacitinib (Cp-690,550) In Subjects With Active Psoriatic Arthritis And An Inadequate Response To At Least One Tnf Inhibitor

Study Type

Interventional

2. Study Status

Record Verification Date

September 2017

Overall Recruitment Status

Completed

Study Start Date

August 2013 (Actual)

Primary Completion Date

April 2016 (Actual)

Study Completion Date

April 2016 (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

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

6. Conditions and Keywords

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

Psoriatic Arthritis

Keywords

psoriatic arthritis, tofacitinib, ACR20, HAQ-DI, TNF inhibitor failure

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

395 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment Sequence A

Arm Type

Experimental

Arm Description

Tofacitinib 5 mg BID for 6 months

Arm Title

Treatment Sequence B

Arm Type

Experimental

Arm Description

Tofacitinib 10 mg BID for 6 months

Arm Title

Treatment Sequence C

Arm Type

Placebo Comparator

Arm Description

Placebo for 3 months then tofacitinib 5 mg BID for 3 months

Arm Title

Treatment Sequence D

Arm Type

Placebo Comparator

Arm Description

Placebo for 3 months then tofacitinib 10 mg BID for 3 months

Intervention Type

Drug

Intervention Name(s)

Tofacitinib

Intervention Description

tablets, 5 mg BID x 6 months

Intervention Type

Drug

Intervention Name(s)

Tofacitinib

Intervention Description

tablets, 10 mg BID x 6 months

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

tablets, to match tofacitinib 5 mg BID x 3 months

Intervention Type

Drug

Intervention Name(s)

Tofacitinib

Intervention Description

tablets, 5 mg BID x 3 months

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

tablets, to match tofacitinib 10 mg BID x 3 months

Intervention Type

Drug

Intervention Name(s)

Tofacitinib

Intervention Description

tablets, 10 mg BID x 3 months

Primary Outcome Measure Information:

Title

Percentage of Participants Meeting American College of Rheumatology Response Criteria Greater Than or Equal to (≥) 20% (ACR20): Month 3

Description

Time Frame

Month 3

Title

Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score: Month 3

Description

Time Frame

Month 3

Secondary Outcome Measure Information:

Title

Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥50% (ACR50) at Week 2 and Months 1, 2, 3, 4, and 6

Description

Time Frame

Week 2 and Months 1, 2, 3, 4, and 6

Title

Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥70% (ACR70) at Week 2 and Months 1, 2, 3, 4, and 6

Description

Time Frame

Week 2 and Months 1, 2, 3, 4, and 6

Title

Percentage of Participants Meeting American College of Rheumatology Response Criteria Greater Than or Equal to (≥) 20% (ACR20): Week 2 and Months 1, 2, 4, and 6

Description

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. n=number of responders.

Time Frame

Week 2 and Months 1, 2, 4, and 6

Title

Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score: Week 2 and Months 1, 2, 4, and 6

Description

Time Frame

Week 2 and Months 1, 2, 4, and 6

Title

Change From Baseline in American College of Rheumatology (ACR) Response Criteria Components: C-reactive Protein (CRP) Levels: Month 3

Description

Time Frame

Month 3

Title

Change From Baseline in American College of Rheumatology (ACR) Response Criteria Components Score: Patient's Assessment of Arthritis Pain: Month 3

Description

Time Frame

Month 3

Title

Change From Baseline in American College of Rheumatology (ACR) Response Criteria Components Score: Patient's Global Assessment of Arthritis: Month 3

Description

Time Frame

Month 3

Title

Change From Baseline in American College of Rheumatology (ACR) Response Criteria Components Score: Physician's Global Assessment of Arthritis: Month 3

Description

Time Frame

Month 3

Title

Change From Baseline in American College of Rheumatology (ACR) Response Criteria Components Score: Swollen Joint Count: Month 3

Description

Time Frame

Month 3

Title

Change From Baseline in American College of Rheumatology (ACR) Response Criteria Components Score: Tender/Painful Joint Count: Month 3

Description

Time Frame

Month 3

Title

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

Description

Time Frame

Week 2, Months 1, 2, 3, 4, and 6

Title

Change From Baseline in Physician's Global Assessment of Psoriasis (PGA-PsO) Response: Months 1, 3, and 6

Description

Time Frame

Months 1, 3, and 6

Title

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

Description

Time Frame

Months 1, 3, and 6

Title

Change From Baseline in Dactylitis Severity Score (DSS): Months 1, 3, and 6

Description

Time Frame

Months 1, 3, and 6

Title

Change From Baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index: Months 1, 3, and 6

Description

Time Frame

Months 1, 3, and 6

Title

Change From Baseline in the Leeds Enthesitis Index (LEI): Months 1, 3, and 6

Description

Time Frame

Months 1, 3, and 6

Title

Change From Baseline in the Short-Form-36 Health Survey Version 2, Acute Components (SF-36v2 Acute): Physical Component Summary Score: Months 1, 3, 6

Description

Time Frame

Months 1, 3, 6

Title

Change From Baseline in the Short-Form-36 Health Survey Version 2, Acute Components (SF-36v2 Acute): Mental Component Summary Score: Months 1, 3, 6

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. The health domains are aggregated into two summary scores known as the PCS score and the MCS score. Normalized domain scores, PCS and MCS scores are used in the analyses. The component and domain scores were scored using the US 1998 general population norms. The resulting norm-based T-scores for both the SF36 version 2 and SF36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher MCS score represents better mental health status. n=number of participants evaluable at each visit.

Time Frame

Months 1, 3, 6

Title

Change From Baseline in the Short-Form-36 Health Survey Version 2, Acute Components (SF-36v2 Acute): Physical Functioning Domain: Months 1, 3, 6

Description

Time Frame

Months 1, 3, 6

Title

Change From Baseline in the Short-Form-36 Health Survey Version 2, Acute Components (SF-36v2 Acute): Role-physical Domain: Months 1, 3, 6

Description

SF-36v2 acute is a 36-item measure evaluating 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health. The 4-item role-physical scale covers an array of physical health-related role limitations, including: a) limitations in the kind of work or other usual activities; b) reductions in the amount of time spent on work or other usual activities; c) difficulty performing work or other usual activities; & d) accomplishing less. Items in the role-physical scale are answered on a 5-point scale. The domain scores were scored using the US 1998 general population norms. The resulting norm-based T-scores for both the SF36 version 2 & SF36 health domain scales & component summary measures have means of 50 & standard deviations of 10. A higher role-physical domain score represents better role-physical functioning. n=number of participants evaluable at each visit.

Time Frame

Months 1, 3, 6

Title

Change From Baseline in the Short-Form-36 Health Survey Version 2, Acute Components (SF-36v2 Acute): Bodily Pain Domain: Months 1, 3, 6

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. The bodily pain scale comprises of 2 items pertaining to the intensity of bodily pain and extent of interference with normal work activities. The domain scores were scored using the US 1998 general population norms. The resulting norm-based T-scores for both the SF36 version 2 & SF36 health domain scales & component summary measures have means of 50 & standard deviations of 10. A higher bodily pain domain score represents less bodily pain. n=number of participants evaluable at each visit.

Time Frame

Months 1, 3, 6

Title

Change From Baseline in the Short-Form-36 Health Survey Version 2, Acute Components (SF-36v2 Acute): General Health Domain: Months 1, 3, 6

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. The general health scale consists of 5 items including a rating of health and 4 items addressing the respondent's view and expectations of his or her health. The domain scores were scored using the US 1998 general population norms. The resulting norm-based T-scores for both the SF36 version 2 & SF36 health domain scales & component summary measures have means of 50 & standard deviations of 10. A higher general health domain score represents better general health perceptions. n=number of participants evaluable at each visit.

Time Frame

Months 1, 3, 6

Title

Change From Baseline in the Short-Form-36 Health Survey Version 2, Acute Components (SF-36v2 Acute): Vitality Domain: Months 1, 3, 6

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. The 4-item measure of vitality captures a broad range of subjective evaluations of well-being from feelings of tiredness and being worn out to feeling full of energy all or most of the time. The domain scores were scored using the US 1998 general population norms. The resulting norm-based T-scores for both the SF36 version 2 & SF36 health domain scales & component summary measures have means of 50 & standard deviations of 10. A higher vitality domain score represents better vitality. n=number of participants evaluable at each visit.

Time Frame

Months 1, 3, 6

Title

Change From Baseline in the Short-Form-36 Health Survey Version 2, Acute Components (SF-36v2 Acute): Social Functioning Domain: Months 1, 3, 6

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. The 2-item social functioning scale assesses health-related effects on quantity and quality of social activities. The domain scores were scored using the US 1998 general population norms. The resulting norm-based T-scores for both the SF36 version 2 & SF36 health domain scales & component summary measures have means of 50 & standard deviations of 10. A higher social functioning domain score represents better social functioning. n=number of participants evaluable at each visit.

Time Frame

Months 1, 3, 6

Title

Change From Baseline in the Short-Form-36 Health Survey Version 2, Acute Components (SF-36v2 Acute): Role-emotional Domain: Months 1, 3, 6

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. The 3-item role-emotional scale assesses mental health-related role limitations in terms of a) time spent in work or other usual activities; b) amount of work or activities accomplished; c) care with which work or other activities were performed. All 3 items are answered on a 5-point scale. The domain scores were scored using the US 1998 general population norms. The resulting norm-based T-scores for both the SF36 version 2 & SF36 health domain scales & component summary measures have means of 50 & standard deviations of 10. A higher role-emotional domain score represents better role-emotional functioning. n=number of participants evaluable at each visit.

Time Frame

Months 1, 3, 6

Title

Change From Baseline in the Short-Form-36 Health Survey Version 2, Acute Components (SF-36v2 Acute): Mental Health Domain: Months 1, 3, 6

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. The 5-item mental health scale includes 1 or more items from each of 4 major mental health dimensions: anxiety, depression, loss of behavioral/emotional control, and psychological well-being. All items are answered on a 5-point scale. The domain scores were scored using the US 1998 general population norms. The resulting norm-based T-scores for both the SF36 version 2 & SF36 health domain scales & component summary measures have means of 50 & standard deviations of 10. A higher mental health domain score represents better mental health functioning. n=number of participants evaluable at each visit.

Time Frame

Months 1, 3, 6

Title

Description

Time Frame

Months 1, 3, 6

Title

Description

Time Frame

Months 1, 3, 6

Title

Description

Time Frame

Months 1, 3, 6

Title

Description

Time Frame

Months 1, 3, 6

Title

Description

Time Frame

Months 1, 3, 6

Title

Description

Time Frame

Months 1, 3, 6

Title

Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Total Score: Months 1, 3, 6

Description

Time Frame

Months 1, 3, 6

Title

Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Experience Domain Score: Months 1, 3, 6

Description

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. n=number of participants evaluable at each visit.

Time Frame

Months 1, 3, 6

Title

Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Impact Domain Score: Months 1, 3, 6

Description

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. n=number of participants evaluable at each visit.

Time Frame

Months 1, 3, 6

Title

Change From Baseline in Score Evaluating Spondylitis Using the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI): Months 1, 3, 6

Description

Time Frame

Months 1, 3, 6

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Active arthritis at screening/baseline as indicated by >/= 3 tender/painful and 3 swollen joints Active plaque psoriasis at screening Inadequate efficacy or lack of toleration to previously administered TNF inhibitor Exclusion Criteria: Non-plaque forms of psoriasis (with exception of nail psoriasis) History of autoimmune rheumatic disease other than PsA; also prior history of or current, rheumatic inflammatory disease other than PsA

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 P.C.

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

35801-4414

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

St. Jude Hospital Yorba Linda DBA St. Joseph Heritage Healthcare

City

Fullerton

State/Province

California

ZIP/Postal Code

92835

Country

United States

Facility Name

Ronald Reagan UCLA Medical Center, Drug Information Center

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095

Country

United States

Facility Name

UCLA David Geffen School of Medicine

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095

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

Stanford Hospital and Clinics

City

Stanford

State/Province

California

ZIP/Postal Code

94305

Country

United States

Facility Name

New England Research Associates, LLC

City

Trumbull

State/Province

Connecticut

ZIP/Postal Code

06611

Country

United States

Facility Name

Rheumatology Associates of Central Florida, PA

City

Orlando

State/Province

Florida

ZIP/Postal Code

32806

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

Integral Rheumatology & Immunology Specialists (IRIS)

City

Plantation

State/Province

Florida

ZIP/Postal Code

33324

Country

United States

Facility Name

Florida Medical Clinic, P.A.

City

Zephyrhills

State/Province

Florida

ZIP/Postal Code

33542

Country

United States

Facility Name

St. Luke's Clinic - Rheumatology

City

Boise

State/Province

Idaho

ZIP/Postal Code

83702

Country

United States

Facility Name

St. Luke's Intermountain Research Center

City

Boise

State/Province

Idaho

ZIP/Postal Code

83702

Country

United States

Facility Name

Bluegrass Community Research, Inc

City

Lexington

State/Province

Kentucky

ZIP/Postal Code

40504

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

The Center For Rheumatology And Bone Research

City

Wheaton

State/Province

Maryland

ZIP/Postal Code

20902

Country

United States

Facility Name

Brigham & Women's Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

Facility Name

Brigham and Women's Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

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

Clayton Medical Research

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63117

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

Cincinnati Rheumatic Disease Study Group, Inc.

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45219

Country

United States

Facility Name

University Hospitals Case Medical Center

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44106

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

East Penn Rheumatology Associates, PC

City

Bethlehem

State/Province

Pennsylvania

ZIP/Postal Code

18015

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

Arthritis Clinic

City

Jackson

State/Province

Tennessee

ZIP/Postal Code

38305

Country

United States

Facility Name

West Tennessee Research Institute

City

Jackson

State/Province

Tennessee

ZIP/Postal Code

38305

Country

United States

Facility Name

Adriana M. Pop-Moody, M.D., Clinic, P.A.

City

Corpus Christi

State/Province

Texas

ZIP/Postal Code

78404

Country

United States

Facility Name

Pioneer Research Solutions, Inc.

City

Cypress

State/Province

Texas

ZIP/Postal Code

77429

Country

United States

Facility Name

Metroplex Clinical Research Center

City

Dallas

State/Province

Texas

ZIP/Postal Code

75231

Country

United States

Facility Name

Drug Shipment/Storage: Investigational Drug Services

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

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

Royal Prince Alfred Hospital, Rheumatology Department

City

Camperdown

State/Province

New South Wales

ZIP/Postal Code

2050

Country

Australia

Facility Name

Rheumatology Research Unit

City

Maroochydore

State/Province

Queensland

ZIP/Postal Code

4558

Country

Australia

Facility Name

Emeritus Research Pty Ltd

City

Malvern East

State/Province

Victoria

ZIP/Postal Code

3145

Country

Australia

Facility Name

Hospital Erasme - Clinique Universitaire de Bruxelles

City

Brussels

ZIP/Postal Code

1070

Country

Belgium

Facility Name

ReumaClinic

City

Genk

ZIP/Postal Code

3600

Country

Belgium

Facility Name

Universitair Ziekenhuis Gent

City

Gent

ZIP/Postal Code

9000

Country

Belgium

Facility Name

University Hospital Leuven, Department of Rheumatology

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

ZNA Jan Palfijn

City

Merksem

ZIP/Postal Code

2170

Country

Belgium

Facility Name

CMIP: Centro Mineiro de Pesquisa Ltda /

City

Juiz de Fora

State/Province

ZIP/Postal Code

36010-570

Country

Brazil

Facility Name

CETAC - DIAGNOSTICO POR IMAGEM (image only)

City

Curitiba

State/Province

ZIP/Postal Code

80240-160

Country

Brazil

Facility Name

EDUMED - Educacao em Saude SS LTDA.

City

Curitiba

State/Province

ZIP/Postal Code

80440-080

Country

Brazil

Facility Name

Hospital de Clinicas de Porto Alegre (HCPA) / UFRGS

City

Porto Alegre

State/Province

ZIP/Postal Code

90035-003

Country

Brazil

Facility Name

Clinica Medica Bonfiglioli Ltda. / Clinica Bonfiglioli

City

Campinas

State/Province

ZIP/Postal Code

13015-001

Country

Brazil

Facility Name

Radiologia Clínica de Campinas - RCC (Images only)

City

Campinas

State/Province

São Paulo

ZIP/Postal Code

13015-240

Country

Brazil

Facility Name

Medical Plus s.r.o.

City

Uherske Hradiste

ZIP/Postal Code

68601

Country

Czechia

Facility Name

Centre Hospitalier Sud-Francilien - Secretariat de Rhumatologie

City

Corbeil-Essonnes

State/Province

Cedex

ZIP/Postal Code

91106

Country

France

Facility Name

Hopital Avicenne

City

Bobigny

ZIP/Postal Code

93000

Country

France

Facility Name

Rheumazentrum Prof. Dr. med Gunther Neeck

City

Bad Doberan

ZIP/Postal Code

18209

Country

Germany

Facility Name

Charite Universitatsmedizin Berlin - Campus Charite Mitte

City

Berlin

ZIP/Postal Code

10117

Country

Germany

Facility Name

Rheumapraxis Steglitz

City

Berlin

ZIP/Postal Code

12161

Country

Germany

Facility Name

Schlosspark-Klinik

City

Berlin

ZIP/Postal Code

14059

Country

Germany

Facility Name

Universitaetsklinikum Erlangen, Medizinische Klinik 3

City

Erlangen

ZIP/Postal Code

91054

Country

Germany

Facility Name

CIRI - Centrum für innovative Diagnostik und Therapie Rheumatologie/Immunologie (GmbH)

City

Frankfurt am Main

ZIP/Postal Code

60528

Country

Germany

Facility Name

Medizinische Universitatsklinik Freiburg

City

Freiburg

ZIP/Postal Code

79106

Country

Germany

Facility Name

Universitaetsklinikum Des Saarlandes Und Medizinische Fakultaet Der Universitaet Des Saarlandes

City

Homburg

ZIP/Postal Code

66421

Country

Germany

Facility Name

University Hospital of Cologne

City

Koeln

ZIP/Postal Code

50937

Country

Germany

Facility Name

Elisabeth Klinik Bigge

City

Olsberg

ZIP/Postal Code

59939

Country

Germany

Facility Name

Hospital Angeles Clinica Londres

City

Mexico City

State/Province

D.F

ZIP/Postal Code

06700

Country

Mexico

Facility Name

Grupo Medico Camino S.C.

City

Mexico City

State/Province

Distrito Federal

ZIP/Postal Code

03310

Country

Mexico

Facility Name

CLIDITER, S.A. de C.V.

City

Mexico

State/Province

Distrito Federal

ZIP/Postal Code

06700

Country

Mexico

Facility Name

Universidad La Salle AC

City

Mexico

State/Province

Distrito Federal

ZIP/Postal Code

14000

Country

Mexico

Facility Name

Medica Sur, S.A.B. de C.V. (For Emergencies Only)

City

Mexico

State/Province

Distrito Federal

ZIP/Postal Code

14050

Country

Mexico

Facility Name

Centro Integral en Reumatologia SA de CV

City

Guadalajara

State/Province

Jalisco

ZIP/Postal Code

44160

Country

Mexico

Facility Name

Grupo Santa Bernardette S.A. de C.V.

City

Guadalajara

State/Province

Jalisco

ZIP/Postal Code

44200

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

Sanatorio CEMSI Chapultepec (For Emergencies Only)

City

Culiacan

State/Province

Sinaloa

ZIP/Postal Code

80040

Country

Mexico

Facility Name

Hospital General de Culiacan "Dr. Bernardo J. Gastelum"

City

Culiacan

State/Province

Sinaloa

ZIP/Postal Code

80230

Country

Mexico

Facility Name

Star Medica S.A. de C.V. (For Emergencies Only)

City

Merdia

State/Province

Yucatan

ZIP/Postal Code

97133

Country

Mexico

Facility Name

Institute 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 SCP

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

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

Christus Muguerza del parque, S.A de C.V

City

Chihuahua

ZIP/Postal Code

31000

Country

Mexico

Facility Name

Investigacion y Biomedicina de Chihuahua

City

Chihuahua

ZIP/Postal Code

31000

Country

Mexico

Facility Name

Centrum Kliniczno-Badawcze J.Brzezicki, B.Gornikiewicz-Brzez

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

Wojewodzki Szpital Zespolony Zaklad Radiologii

City

Elblag

ZIP/Postal Code

82-300

Country

Poland

Facility Name

Przychodnia Specjalistyczna Lekarskiej Spozielni Pracy "Medica" for X-Ray Only

City

Grodzisk Mazowiecki

ZIP/Postal Code

05-825

Country

Poland

Facility Name

Specjalistyczne Gabinety Lekarskie "DERMED" Anna Kaszuba

City

Lodz

ZIP/Postal Code

90-265

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

Reumatika Centrum Reumatologii nzoz

City

Warszawa

ZIP/Postal Code

02-691

Country

Poland

Facility Name

Regional State Budgetary Healthcare Institution of Karelia Republic "Republic Hospital n.a.

City

Petrozavodsk

State/Province

Karelia Republic

ZIP/Postal Code

185019

Country

Russian Federation

Facility Name

State Autonomic Healthcare Institution City Clinical Hospital # 7

City

Kazan

State/Province

Republic of Tatarstan, Russia

ZIP/Postal Code

420103

Country

Russian Federation

Facility Name

SBIH of Moscow "City Clinical Hospital#1 n. a. N.I. Pirogov" of the Healthcare Department of Moscow

City

Moscow

ZIP/Postal Code

119049

Country

Russian Federation

Facility Name

City Neurological Centre "SibNeyroMed", LLC

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 Budget Educational Institution of Highest Professional Education

City

Tomsk

ZIP/Postal Code

634050

Country

Russian Federation

Facility Name

State Institution of Healthcare of Yaroslavl Region

City

Yaroslavl

ZIP/Postal Code

150003

Country

Russian Federation

Facility Name

MEDMAN s.r.o. - reumatologicka ambulancia

City

Martin

ZIP/Postal Code

036 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

Corporacio 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

Hospital Sierrallana

City

Torrelavega

State/Province

Cantabria

ZIP/Postal Code

39300

Country

Spain

Facility Name

Complejo Hospitalario Universitario A Coruna

City

A Coruna

ZIP/Postal Code

15006

Country

Spain

Facility Name

Hospital Universitari Vall d'Hebron

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

Facility Name

Hospital Universitario Virgen Macarena

City

Sevilla

ZIP/Postal Code

41009

Country

Spain

Facility Name

Hospital Universitaro 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 City

ZIP/Postal Code

83301

Country

Taiwan

Facility Name

Chung Shan Medical University Hospital

City

Taichung

ZIP/Postal Code

40201

Country

Taiwan

Facility Name

China Medical University Hospital

City

Taichung

ZIP/Postal Code

40447

Country

Taiwan

Facility Name

Barking Havering and Redbridge University Hospitals NHS Trust

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 Royal Infirmary, BTHFT

City

Bradford

State/Province

West Yorkeshire

ZIP/Postal Code

BD9 6RJ

Country

United Kingdom

Facility Name

Royal United Hospitals NHS Foundation Trust

City

Bath

ZIP/Postal Code

BA1 1RL

Country

United Kingdom

Facility Name

Bradford Teaching Hospitals NHS Foundation Trust

City

Bradford

ZIP/Postal Code

BD5 0NA

Country

United Kingdom

Facility Name

York Hospital, York Teaching Hospital NHS Foundation Trust

City

York

ZIP/Postal Code

YO31 8HE

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

36076054

Citation

de Vlam K, Mease PJ, Bushmakin AG, Fleischmann R, Ogdie A, Azevedo VF, Merola JF, Woolcott J, Cappelleri JC, Fallon L, Taylor PC. Identifying and Quantifying the Role of Inflammation in Pain Reduction for Patients With Psoriatic Arthritis Treated With Tofacitinib: A Mediation Analysis. Rheumatol Ther. 2022 Oct;9(5):1451-1464. doi: 10.1007/s40744-022-00482-5. Epub 2022 Sep 8.

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PubMed Identifier

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Citation

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.

Results Reference

derived

PubMed Identifier

35385361

Citation

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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PubMed Identifier

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Citation

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.

Results Reference

derived

PubMed Identifier

34921355

Citation

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.

Results Reference

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PubMed Identifier

34870800

Citation

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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PubMed Identifier

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Citation

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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Citation

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.

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PubMed Identifier

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Citation

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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derived

PubMed Identifier

32910531

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.

Results Reference

derived

PubMed Identifier

32816215

Citation

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

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.

Results Reference

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PubMed Identifier

31111255

Citation

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.

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PubMed Identifier

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Citation

Strand V, de Vlam K, Covarrubias-Cobos JA, Mease PJ, Gladman DD, Chen L, Kudlacz E, Wu J, Cappelleri JC, Hendrikx T, Hsu MA. Effect of tofacitinib on patient-reported outcomes in patients with active psoriatic arthritis and an inadequate response to tumour necrosis factor inhibitors in the phase III, randomised controlled trial: OPAL Beyond. RMD Open. 2019 Jan 11;5(1):e000808. doi: 10.1136/rmdopen-2018-000808. eCollection 2019.

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PubMed Identifier

30680661

Citation

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PubMed Identifier

30414064

Citation

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.

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PubMed Identifier

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Citation

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.

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PubMed Identifier

29045207

Citation

Gladman D, Rigby W, Azevedo VF, Behrens F, Blanco R, Kaszuba A, Kudlacz E, Wang C, Menon S, Hendrikx T, Kanik KS. Tofacitinib for Psoriatic Arthritis in Patients with an Inadequate Response to TNF Inhibitors. N Engl J Med. 2017 Oct 19;377(16):1525-1536. doi: 10.1056/NEJMoa1615977.

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Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3921125&StudyName=Tofacitinib%20In%20Psoriatic%20Arthritis%20Subjects%20With%20Inadequate%20Response%20to%20TNF%20Inhibitors

Description

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Learn more about this trial

Tofacitinib In Psoriatic Arthritis Subjects With Inadequate Response to TNF Inhibitors

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