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

• ClinicalTrials.gov Identifier: NCT01882439
• Recruitment Status: Completed
• First Posted: June 20, 2013
• Results First Posted: September 15, 2017
• Last Update Posted: September 15, 2017
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

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.

Condition or disease	Intervention/treatment	Phase
Psoriatic Arthritis	Drug: Tofacitinib; Other: Placebo	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 395 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, 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) In Subjects With Active Psoriatic Arthritis And An Inadequate Response To At Least One Tnf Inhibitor
• Actual Study Start Date: August 2013
• Actual Primary Completion Date: April 2016
• Actual Study Completion Date: April 2016

Arms and Interventions

Arm	Intervention/treatment
Experimental: Treatment Sequence A; Tofacitinib 5 mg BID for 6 months	Drug: Tofacitinib; tablets, 5 mg BID x 6 months
Experimental: Treatment Sequence B; Tofacitinib 10 mg BID for 6 months	Drug: Tofacitinib; tablets, 10 mg BID x 6 months
Placebo Comparator: Treatment Sequence C; Placebo for 3 months then tofacitinib 5 mg BID for 3 months	Other: Placebo; tablets, to match tofacitinib 5 mg BID x 3 months; Drug: Tofacitinib; tablets, 5 mg BID x 3 months
Placebo Comparator: Treatment Sequence D; Placebo for 3 months then tofacitinib 10 mg BID for 3 months	Other: Placebo; tablets, to match tofacitinib 10 mg BID x 3 months; Drug: Tofacitinib; tablets, 10 mg BID x 3 months

Outcome Measures

Primary Outcome Measures :

1. Percentage of Participants Meeting American College of Rheumatology Response Criteria Greater Than or Equal to (≥) 20% (ACR20): Month 3 [ Time Frame: 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).
2. Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score: Month 3 [ Time Frame: 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 :

1. Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥50% (ACR50) at Week 2 and Months 1, 2, 3, 4, and 6 [ Time Frame: 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.
2. Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥70% (ACR70) at Week 2 and Months 1, 2, 3, 4, and 6 [ Time Frame: 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.
3. 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 [ Time Frame: 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.
4. Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score: Week 2 and Months 1, 2, 4, and 6 [ Time Frame: Week 2 and Months 1, 2, 4, and 6 ]
   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. n=number of participants evaluable at each visit.
5. Change From Baseline in American College of Rheumatology (ACR) Response Criteria Components: C-reactive Protein (CRP) Levels: Month 3 [ Time Frame: 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.
6. Change From Baseline in American College of Rheumatology (ACR) Response Criteria Components Score: Patient's Assessment of Arthritis Pain: Month 3 [ Time Frame: 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.
7. Change From Baseline in American College of Rheumatology (ACR) Response Criteria Components Score: Patient's Global Assessment of Arthritis: Month 3 [ Time Frame: 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).
8. Change From Baseline in American College of Rheumatology (ACR) Response Criteria Components Score: Physician's Global Assessment of Arthritis: Month 3 [ Time Frame: 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).
9. Change From Baseline in American College of Rheumatology (ACR) Response Criteria Components Score: Swollen Joint Count: Month 3 [ Time Frame: 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.
10. Change From Baseline in American College of Rheumatology (ACR) Response Criteria Components Score: Tender/Painful Joint Count: Month 3 [ Time Frame: 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.
11. Percentage of Participants Meeting Psoriatic Arthritis Response Criteria (PsARC): Week 2, Months 1, 2, 3, 4, and 6 [ Time Frame: 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.
12. Change From Baseline in Physician's Global Assessment of Psoriasis (PGA-PsO) Response: Months 1, 3, and 6 [ Time Frame: 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.
13. Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response: Months 1, 3, and 6 [ Time Frame: 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.
14. Change From Baseline in Dactylitis Severity Score (DSS): Months 1, 3, and 6 [ Time Frame: 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.
15. Change From Baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index: Months 1, 3, and 6 [ Time Frame: 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.
16. Change From Baseline in the Leeds Enthesitis Index (LEI): Months 1, 3, and 6 [ Time Frame: 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.
17. 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 [ Time Frame: 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.
18. 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 [ Time Frame: 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.
19. Change From Baseline in the Short-Form-36 Health Survey Version 2, Acute Components (SF-36v2 Acute): Physical Functioning Domain: Months 1, 3, 6 [ Time Frame: 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.
20. Change From Baseline in the Short-Form-36 Health Survey Version 2, Acute Components (SF-36v2 Acute): Role-physical Domain: Months 1, 3, 6 [ Time Frame: 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.
21. Change From Baseline in the Short-Form-36 Health Survey Version 2, Acute Components (SF-36v2 Acute): Bodily Pain Domain: Months 1, 3, 6 [ Time Frame: 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.
22. Change From Baseline in the Short-Form-36 Health Survey Version 2, Acute Components (SF-36v2 Acute): General Health Domain: Months 1, 3, 6 [ Time Frame: 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.
23. Change From Baseline in the Short-Form-36 Health Survey Version 2, Acute Components (SF-36v2 Acute): Vitality Domain: Months 1, 3, 6 [ Time Frame: 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.
24. Change From Baseline in the Short-Form-36 Health Survey Version 2, Acute Components (SF-36v2 Acute): Social Functioning Domain: Months 1, 3, 6 [ Time Frame: 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.
25. Change From Baseline in the Short-Form-36 Health Survey Version 2, Acute Components (SF-36v2 Acute): Role-emotional Domain: Months 1, 3, 6 [ Time Frame: 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.
26. Change From Baseline in the Short-Form-36 Health Survey Version 2, Acute Components (SF-36v2 Acute): Mental Health Domain: Months 1, 3, 6 [ Time Frame: 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.
27. 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 [ Time Frame: 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.
28. Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Self-Care: Months 1, 3, 6 [ Time Frame: 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.
29. Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Usual Activities: Months 1, 3, 6 [ Time Frame: 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.
30. Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Pain/Discomfort: Months 1, 3, 6 [ Time Frame: 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.
31. Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Anxiety/Depression: Months 1, 3, 6 [ Time Frame: 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.
32. 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 [ Time Frame: 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.
33. Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Total Score: Months 1, 3, 6 [ Time Frame: 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.
34. Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Experience Domain Score: Months 1, 3, 6 [ Time Frame: 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.
35. Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Impact Domain Score: Months 1, 3, 6 [ Time Frame: 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.
36. Change From Baseline in Score Evaluating Spondylitis Using the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI): Months 1, 3, 6 [ Time Frame: 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.

Eligibility Criteria

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

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

Contacts and Locations

Locations

United States, Alabama

Rheumatology Associates P.C.

Birmingham, Alabama, United States, 35205

Rheumatology Associates of North Alabama, PC

Huntsville, Alabama, United States, 35801-4414

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

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

Fullerton, California, United States, 92835

Ronald Reagan UCLA Medical Center, Drug Information Center

Los Angeles, California, United States, 90095

UCLA David Geffen School of Medicine

Los Angeles, California, United States, 90095

San Diego Arthritis Medical Clinic

San Diego, California, United States, 92108

Stanford Hospital and Clinics

Stanford, California, United States, 94305

United States, Connecticut

New England Research Associates, LLC

Trumbull, Connecticut, United States, 06611

United States, Florida

Rheumatology Associates of Central Florida, PA

Orlando, Florida, United States, 32806

Millennium Research

Ormond Beach, Florida, United States, 32174

Arthritis Center, Inc.

Palm Harbor, Florida, United States, 34684

Integral Rheumatology & Immunology Specialists (IRIS)

Plantation, Florida, United States, 33324

Florida Medical Clinic, P.A.

Zephyrhills, Florida, United States, 33542

United States, Idaho

St. Luke's Clinic - Rheumatology

Boise, Idaho, United States, 83702

St. Luke's Intermountain Research Center

Boise, Idaho, United States, 83702

United States, Kentucky

Bluegrass Community Research, Inc

Lexington, Kentucky, United States, 40504

United States, Maryland

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

Hagerstown, Maryland, United States, 21740

The Center For Rheumatology And Bone Research

Wheaton, Maryland, United States, 20902

United States, Massachusetts

Brigham & Women's Hospital

Boston, Massachusetts, United States, 02115

Brigham and Women's Hospital

Boston, Massachusetts, United States, 02115

Clinical Pharmacology Study Group

Worcester, Massachusetts, United States, 01605

United States, Minnesota

St. Paul Rheumatology, PA

Eagan, Minnesota, United States, 55121

United States, Missouri

Clayton Medical Research

Saint Louis, Missouri, United States, 63117

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

Cincinnati Rheumatic Disease Study Group, Inc.

Cincinnati, Ohio, United States, 45219

University Hospitals Case Medical Center

Cleveland, Ohio, United States, 44106

Paramount Medical Research & Consulting, LLC

Middleburg Heights, Ohio, United States, 44130

United States, Pennsylvania

East Penn Rheumatology Associates, PC

Bethlehem, Pennsylvania, United States, 18015

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, Tennessee

Arthritis Clinic

Jackson, Tennessee, United States, 38305

West Tennessee Research Institute

Jackson, Tennessee, United States, 38305

United States, Texas

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

Corpus Christi, Texas, United States, 78404

Pioneer Research Solutions, Inc.

Cypress, Texas, United States, 77429

Metroplex Clinical Research Center

Dallas, Texas, United States, 75231

United States, Utah

Drug Shipment/Storage: Investigational Drug Services

Salt Lake City, Utah, United States, 84112

University of Utah Hospital & Clinics

Salt Lake City, Utah, United States, 84132

United States, Washington

Dynacare Laboratories

Seattle, Washington, United States, 98122

Seattle Rheumatology Associates

Seattle, Washington, United States, 98122

Swedish Medical Center

Seattle, Washington, United States, 98122

Australia, New South Wales

Royal Prince Alfred Hospital, Rheumatology Department

Camperdown, New South Wales, Australia, 2050

Australia, Queensland

Rheumatology Research Unit

Maroochydore, Queensland, Australia, 4558

Australia, Victoria

Emeritus Research Pty Ltd

Malvern East, Victoria, Australia, 3145

Belgium

Hospital Erasme - Clinique Universitaire de Bruxelles

Brussels, Belgium, 1070

ReumaClinic

Genk, Belgium, 3600

Universitair Ziekenhuis Gent

Gent, Belgium, 9000

University Hospital Leuven, Department of Rheumatology

Leuven, Belgium, 3000

ZNA Jan Palfijn

Merksem, Belgium, 2170

Brazil

CMIP: Centro Mineiro de Pesquisa Ltda /

Juiz de Fora, MG, Brazil, 36010-570

CETAC - DIAGNOSTICO POR IMAGEM (image only)

Curitiba, PR, Brazil, 80240-160

EDUMED - Educacao em Saude SS LTDA.

Curitiba, PR, Brazil, 80440-080

Hospital de Clinicas de Porto Alegre (HCPA) / UFRGS

Porto Alegre, RS, Brazil, 90035-003

Clinica Medica Bonfiglioli Ltda. / Clinica Bonfiglioli

Campinas, SP, Brazil, 13015-001

Radiologia Clínica de Campinas - RCC (Images only)

Campinas, São Paulo, Brazil, 13015-240

Czechia

Medical Plus s.r.o.

Uherske Hradiste, Czechia, 68601

France

Centre Hospitalier Sud-Francilien - Secretariat de Rhumatologie

Corbeil-Essonnes, Cedex, France, 91106

Hopital Avicenne

Bobigny, France, 93000

Germany

Rheumazentrum Prof. Dr. med Gunther Neeck

Bad Doberan, Germany, 18209

Charite Universitatsmedizin Berlin - Campus Charite Mitte

Berlin, Germany, 10117

Rheumapraxis Steglitz

Berlin, Germany, 12161

Schlosspark-Klinik

Berlin, Germany, 14059

Universitaetsklinikum Erlangen, Medizinische Klinik 3

Erlangen, Germany, 91054

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

Frankfurt am Main, Germany, 60528

Medizinische Universitatsklinik Freiburg

Freiburg, Germany, 79106

Universitaetsklinikum Des Saarlandes Und Medizinische Fakultaet Der Universitaet Des Saarlandes

Homburg, Germany, 66421

University Hospital of Cologne

Koeln, Germany, 50937

Elisabeth Klinik Bigge

Olsberg, Germany, 59939

Mexico

Hospital Angeles Clinica Londres

Mexico City, D.F, Mexico, 06700

Grupo Medico Camino S.C.

Mexico City, Distrito Federal, Mexico, 03310

CLIDITER, S.A. de C.V.

Mexico, Distrito Federal, Mexico, 06700

Universidad La Salle AC

Mexico, Distrito Federal, Mexico, 14000

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

Mexico, Distrito Federal, Mexico, 14050

Centro Integral en Reumatologia SA de CV

Guadalajara, Jalisco, Mexico, 44160

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

Guadalajara, Jalisco, Mexico, 44200

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

Culiacan, Sinaloa, Mexico, 80000

Sanatorio CEMSI Chapultepec (For Emergencies Only)

Culiacan, Sinaloa, Mexico, 80040

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

Culiacan, Sinaloa, Mexico, 80230

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

Merdia, Yucatan, Mexico, 97133

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

Merida, Yucatan, Mexico, 97000

Unidad Reumatologica Las Americas SCP

Merida, Yucatan, Mexico, 97000

Centro de Investigacion Clinica Pensiones

Merida, Yucatan, Mexico, 97070

Centro Multidisciplinario para el Desarrollo

Merida, Yucatan, Mexico, 97130

Hospital Star Medica Merida (For Emergencies Only)

Merida, Yucatan, Mexico, 97133

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

Chihuahua, Mexico, 31000

Investigacion y Biomedicina de Chihuahua

Chihuahua, Mexico, 31000

Poland

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

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

Wojewodzki Szpital Zespolony Zaklad Radiologii

Elblag, Poland, 82-300

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

Grodzisk Mazowiecki, Poland, 05-825

Specjalistyczne Gabinety Lekarskie "DERMED" Anna Kaszuba

Lodz, Poland, 90-265

NZOZ Lecznica MAK-MED S.C.

Nadarzyn, Poland, 05-830

Prywatna Praktyka Lekarska Prof. UM dr hab. Pawel Hrycaj

Poznan, Poland, 61-397

Reumatika Centrum Reumatologii nzoz

Warszawa, Poland, 02-691

Russian Federation

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

Petrozavodsk, Karelia Republic, Russian Federation, 185019

State Autonomic Healthcare Institution City Clinical Hospital # 7

Kazan, Republic of Tatarstan, Russia, Russian Federation, 420103

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

Moscow, Russian Federation, 119049

City Neurological Centre "SibNeyroMed", LLC

Novosibirsk, Russian Federation, 630091

Limited Liability Company Consultative Diagnostic Rheumatology Center "Healthy Joints"

Novosibirsk, Russian Federation, 630099

State Budget Educational Institution of Highest Professional Education

Tomsk, Russian Federation, 634050

State Institution of Healthcare of Yaroslavl Region

Yaroslavl, Russian Federation, 150003

Slovakia

MEDMAN s.r.o. - reumatologicka ambulancia

Martin, Slovakia, 036 01

Spain

Hospital Clinico de Santiago

Santiago De Compostela, A Coruna, Spain, 15706

Corporacio Sanitaria Parc Tauli

Sabadell, Barcelona, Spain, 08208

Hospital Universitario Marques de Valdecilla

Santander, Cantabria, Spain, 39008

Hospital Sierrallana

Torrelavega, Cantabria, Spain, 39300

Complejo Hospitalario Universitario A Coruna

A Coruna, Spain, 15006

Hospital Universitari Vall d'Hebron

Barcelona, Spain, 08035

Hospital Universitario Virgen Macarena

Sevilla, Spain, 41009

Hospital Universitaro 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 City, Taiwan, 83301

Chung Shan Medical University Hospital

Taichung, Taiwan, 40201

China Medical University Hospital

Taichung, Taiwan, 40447

United Kingdom

Barking Havering and Redbridge University Hospitals NHS Trust

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 Royal Infirmary, BTHFT

Bradford, West Yorkeshire, United Kingdom, BD9 6RJ

Royal United Hospitals NHS Foundation Trust

Bath, United Kingdom, BA1 1RL

Bradford Teaching Hospitals NHS Foundation Trust

Bradford, United Kingdom, BD5 0NA

York Hospital, York Teaching Hospital NHS Foundation Trust

York, United Kingdom, YO31 8HE

Sponsors and Collaborators

Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

More Information

Additional Information:

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

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.

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.

Cella D, Wilson H, Shalhoub H, Revicki DA, Cappelleri JC, Bushmakin AG, Kudlacz E, Hsu MA. Content validity and psychometric evaluation of Functional Assessment of Chronic Illness Therapy-Fatigue in patients with psoriatic arthritis. J Patient Rep Outcomes. 2019 Jan 24;3(1):5. doi: 10.1186/s41687-019-0094-5.

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.

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.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT01882439
• Other Study ID Numbers: A3921125; 2013-001368-46 ( EudraCT Number )
• First Posted: June 20, 2013
• Results First Posted: September 15, 2017
• Last Update Posted: September 15, 2017
• Last Verified: September 2017

Keywords provided by Pfizer:

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

Additional relevant MeSH terms:

Arthritis; Arthritis, Psoriatic; Joint Diseases; Musculoskeletal Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Tofacitinib; Janus Kinase Inhibitors; Protein Kinase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action