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

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ClinicalTrials.gov Identifier: NCT01877668

Recruitment Status : Completed

First Posted : June 14, 2013

Results First Posted : July 6, 2017

Last Update Posted : July 6, 2017

View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Pfizer

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.

Condition or disease	Intervention/treatment	Phase
Psoriatic Arthritis	Drug: Tofacitinib 5 mg BID Drug: Tofacitinib 10 mg BID Drug: Adalimumab Drug: Placebo	Phase 3

Study Design

Layout table for study information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	422 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
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
Actual Study Start Date :	January 20, 2014
Actual Primary Completion Date :	December 18, 2015
Actual Study Completion Date :	December 18, 2015

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Psoriatic arthritis

MedlinePlus related topics: Arthritis Psoriatic Arthritis

Drug Information available for: Adalimumab Tofacitinib Tofacitinib citrate

Genetic and Rare Diseases Information Center resources: Spondylarthropathy

U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥20% (ACR20): Month 3 [ Time Frame: At end of 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 [ Time Frame: From Baseline to Month 3 ]
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 [ Time Frame: From Baseline to Month 12 ]
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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.

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Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥20% (ACR20) at Week 2 and Months 1, 2, 4, 6, 9, and 12 [ Time Frame: At Week 2 and Months 1, 2, 4, 6, 9, and 12 ]
ACR20 was calculated as a ≥20% improvement from baseline in tender/painful and swollen joint counts and ≥20% improvement from baseline in 3 of the 5 remaining ACR core set measures: patient's global assessment of arthritis, physician's global assessment of arthritis, patient's assessment of arthritis pain, HAQ-DI, and CRP.
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score [ Time Frame: From Baseline to Week 2 and Months 1, 2, 4, 6, 9, and 12 ]
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.
Change From Baseline in American College of Rheumatology Response Criteria Components: C-reactive Protein Levels [ Time Frame: From Baseline to end of 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 Response Criteria Components Score: Patient's Assessment of Arthritis Pain [ Time Frame: From Baseline to end of 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 Response Criteria Components Score: Patient's Global Assessment of Arthritis [ Time Frame: From Baseline to end of Month 3 ]
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 [ Time Frame: From Baseline to end of 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 Response Criteria Components Score: Swollen Joint Count [ Time Frame: From Baseline to end of 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 Response Criteria Components Score: Tender/Painful Joint Count [ Time Frame: From Baseline to end of 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) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 [ Time Frame: 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 [ Time Frame: From Baseline to Months 1, 3, 6, 9, and 12 ]
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 [ Time Frame: 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) [ Time Frame: From Baseline to Months 1, 3, 6, 9, and 12 ]
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 [ Time Frame: From Baseline to Months 1, 3, 6, 9, and 12 ]
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) [ Time Frame: From Baseline to Months 1, 3, 6, 9, and 12 ]
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 [ Time Frame: From Baseline to Months 1, 3, 6, 9, and 12 ]
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 [ Time Frame: From Baseline to Months 1, 3, 6, 9, and 12 ]
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 [ Time Frame: From Baseline to Months 1, 3, 6, 9, and 12 ]
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 [ Time Frame: From Baseline to Months 1, 3, 6, 9, and 12 ]
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 [ Time Frame: From Baseline to Months 1, 3, 6, 9, and 12 ]
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 [ Time Frame: From Baseline to Months 1, 3, 6, 9, and 12 ]
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 [ Time Frame: From Baseline to Months 1, 3, 6, 9, and 12 ]
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 [ Time Frame: From Baseline to Months 1, 3, 6, 9, and 12 ]
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 [ Time Frame: From Baseline to Months 1, 3, 6, 9, and 12 ]
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 [ Time Frame: From Baseline to Months 1, 3, 6, 9, and 12 ]
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 [ Time Frame: From Baseline to Months 1, 3, 6, 9, and 12 ]
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.
Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Self-care [ Time Frame: From Baseline to Months 1, 3, 6, 9, and 12 ]
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.
Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Usual Activities [ Time Frame: From Baseline to Months 1, 3, 6, 9, and 12 ]
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.
Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Pain/Discomfort [ Time Frame: From Baseline to Months 1, 3, 6, 9, and 12 ]
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.
Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Anxiety/Depression [ Time Frame: From Baseline to Months 1, 3, 6, 9, and 12 ]
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.
Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Patient's Health State Today [ Time Frame: From Baseline to Months 1, 3, 6, 9, and 12 ]
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 [ Time Frame: From Baseline to Months 1, 3, 6, 9, and 12 ]
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 [ Time Frame: From Baseline to Months 1, 3, 6, 9, and 12 ]
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 [ Time Frame: From Baseline to Months 1, 3, 6, 9, and 12 ]
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.
Change From Baseline in Scores Evaluating Spondylitis Using the Bath Anklyosing Spondylitis Disease Activity Index (BASDAI) [ Time Frame: From Baseline to Months 1, 3, 6, 9, and 12 ]
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.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01877668

Locations

Show 123 study locations

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

Sponsors and Collaborators

Pfizer

Investigators

Layout table for investigator information

Study Director:	Pfizer CT.gov Call Center	Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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

Orbai AM, Mease PJ, Helliwell PS, FitzGerald O, Fleishaker DL, Mundayat R, Young P. Effect of tofacitinib on dactylitis and patient-reported outcomes in patients with active psoriatic arthritis: post-hoc analysis of phase III studies. BMC Rheumatol. 2022 Sep 1;6(1):68. doi: 10.1186/s41927-022-00298-4.

Taylor PC, Bushmakin AG, Cappelleri JC, Young P, Germino R, Merola JF, Yosipovitch G. Relationships of dermatologic symptoms and quality of life in patients with psoriatic arthritis: analysis of two tofacitinib phase III studies. J Dermatolog Treat. 2022 Aug;33(5):2614-2620. doi: 10.1080/09546634.2022.2060924. Epub 2022 Apr 11.

Gladman DD, Coates LC, Wu J, Fallon L, Bacci ED, Cappelleri JC, Bushmakin AG, Helliwell PS. Time to response for clinical and patient-reported outcomes in patients with psoriatic arthritis treated with tofacitinib, adalimumab, or placebo. Arthritis Res Ther. 2022 Feb 9;24(1):40. doi: 10.1186/s13075-022-02721-0.

Dikranian A, Gold D, Bessette L, Nash P, Azevedo VF, Wang L, Woolcott J, Shapiro AB, Szumski A, Fleishaker D, Wollenhaupt J. Frequency and Duration of Early Non-serious Adverse Events in Patients with Rheumatoid Arthritis and Psoriatic Arthritis Treated with Tofacitinib. Rheumatol Ther. 2022 Apr;9(2):411-433. doi: 10.1007/s40744-021-00405-w. Epub 2021 Dec 17.

Winthrop KL, Curtis JR, Yamaoka K, Lee EB, Hirose T, Rivas JL, Kwok K, Burmester GR. Clinical Management of Herpes Zoster in Patients With Rheumatoid Arthritis or Psoriatic Arthritis Receiving Tofacitinib Treatment. Rheumatol Ther. 2022 Feb;9(1):243-263. doi: 10.1007/s40744-021-00390-0. Epub 2021 Dec 6.

Kivitz AJ, FitzGerald O, Nash P, Pang S, Azevedo VF, Wang C, Takiya L. Efficacy and safety of tofacitinib by background methotrexate dose in psoriatic arthritis: post hoc exploratory analysis from two phase III trials. Clin Rheumatol. 2022 Feb;41(2):499-511. doi: 10.1007/s10067-021-05894-2. Epub 2021 Sep 12.

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.

Coates LC, Bushmakin AG, FitzGerald O, Gladman DD, Fallon L, Cappelleri JC, Hsu MA, Helliwell PS. Relationships between psoriatic arthritis composite measures of disease activity with patient-reported outcomes in phase 3 studies of tofacitinib. Arthritis Res Ther. 2021 Mar 26;23(1):94. doi: 10.1186/s13075-021-02474-2.

Ritchlin CT, Giles JT, Ogdie A, Gomez-Reino JJ, Helliwell P, Young P, Wang C, Wu J, Romero AB, Woolcott J, Stockert L. Tofacitinib in Patients With Psoriatic Arthritis and Metabolic Syndrome: A Post hoc Analysis of Phase 3 Studies. ACR Open Rheumatol. 2020 Oct;2(10):543-554. doi: 10.1002/acr2.11166. Epub 2020 Sep 10.

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;:

Burmester GR, Curtis JR, Yun H, FitzGerald O, Winthrop KL, Azevedo VF, Rigby WFC, Kanik KS, Wang C, Biswas P, Jones T, Palmetto N, Hendrikx T, Menon S, Rojo R. An Integrated Analysis of the Safety of Tofacitinib in Psoriatic Arthritis across Phase III and Long-Term Extension Studies with Comparison to Real-World Observational Data. Drug Saf. 2020 Apr;43(4):379-392. doi: 10.1007/s40264-020-00904-9.

Gladman DD, Charles-Schoeman C, McInnes IB, Veale DJ, Thiers B, Nurmohamed M, Graham D, Wang C, Jones T, Wolk R, DeMasi R. Changes in Lipid Levels and Incidence of Cardiovascular Events Following Tofacitinib Treatment in Patients With Psoriatic Arthritis: A Pooled Analysis Across Phase III and Long-Term Extension Studies. Arthritis Care Res (Hoboken). 2019 Oct;71(10):1387-1395. doi: 10.1002/acr.23930.

Cella D, Wilson H, Shalhoub H, Revicki DA, Cappelleri JC, Bushmakin AG, Kudlacz E, Hsu MA. Content validity and psychometric evaluation of Functional Assessment of Chronic Illness Therapy-Fatigue in patients with psoriatic arthritis. J Patient Rep Outcomes. 2019 May 20;3(1):30. doi: 10.1186/s41687-019-0115-4.

van der Heijde D, Gladman DD, FitzGerald O, Kavanaugh A, Graham D, Wang C, Fallon L. Radiographic Progression According to Baseline C-reactive Protein Levels and Other Risk Factors in Psoriatic Arthritis Treated with Tofacitinib or Adalimumab. J Rheumatol. 2019 Sep;46(9):1089-1096. doi: 10.3899/jrheum.180971. Epub 2019 Mar 1.

Strand V, de Vlam K, Covarrubias-Cobos JA, Mease PJ, Gladman DD, Graham D, Wang C, Cappelleri JC, Hendrikx T, Hsu MA. Tofacitinib or adalimumab versus placebo: patient-reported outcomes from OPAL Broaden-a phase III study of active psoriatic arthritis in patients with an inadequate response to conventional synthetic disease-modifying antirheumatic drugs. RMD Open. 2019 Jan 11;5(1):e000806. doi: 10.1136/rmdopen-2018-000806. eCollection 2019.

Retraction in: J Patient Rep Outcomes. 2019 May 28;3(1):32

Nash P, Coates LC, Fleischmann R, Papp KA, Gomez-Reino JJ, Kanik KS, Wang C, Wu J, Menon S, Hendrikx T, Ports WC. Efficacy of Tofacitinib for the Treatment of Psoriatic Arthritis: Pooled Analysis of Two Phase 3 Studies. Rheumatol Ther. 2018 Dec;5(2):567-582. doi: 10.1007/s40744-018-0131-5. Epub 2018 Nov 9.

Helliwell P, Coates LC, FitzGerald O, Nash P, Soriano ER, Elaine Husni M, Hsu MA, Kanik KS, Hendrikx T, Wu J, Kudlacz E. Disease-specific composite measures for psoriatic arthritis are highly responsive to a Janus kinase inhibitor treatment that targets multiple domains of disease. Arthritis Res Ther. 2018 Oct 29;20(1):242. doi: 10.1186/s13075-018-1739-0.

Mease P, Hall S, FitzGerald O, van der Heijde D, Merola JF, Avila-Zapata F, Cieslak D, Graham D, Wang C, Menon S, Hendrikx T, Kanik KS. Tofacitinib or Adalimumab versus Placebo for Psoriatic Arthritis. N Engl J Med. 2017 Oct 19;377(16):1537-1550. doi: 10.1056/NEJMoa1615975.

Layout table for additonal information

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT01877668
Other Study ID Numbers:	A3921091 2011-003668-55 ( EudraCT Number )
First Posted:	June 14, 2013 Key Record Dates
Results First Posted:	July 6, 2017
Last Update Posted:	July 6, 2017
Last Verified:	June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Yes
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

Keywords provided by Pfizer:


psoriatic arthritis radiographic changes active comparator tofacitinib

Additional relevant MeSH terms:

Layout table for MeSH terms

Arthritis Arthritis, Psoriatic Joint Diseases Musculoskeletal Diseases Spondylarthropathies Spondylarthritis Spondylitis Spinal Diseases Bone Diseases Psoriasis Skin Diseases, Papulosquamous	Skin Diseases Adalimumab Tofacitinib Tumor Necrosis Factor Inhibitors Anti-Inflammatory Agents Antirheumatic Agents Janus Kinase Inhibitors Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action

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