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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01877668
First Posted: June 14, 2013
Last Update Posted: July 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pfizer
  Purpose
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 Intervention Phase
Psoriatic Arthritis Drug: Tofacitinib 5 mg BID Drug: Tofacitinib 10 mg BID Drug: Adalimumab Drug: Placebo Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

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.


  • 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.


Enrollment: 422
Actual Study Start Date: January 20, 2014
Study Completion Date: December 18, 2015
Primary Completion Date: December 18, 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Information from the National Library of Medicine

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


  Show 123 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01877668     History of Changes
Other Study ID Numbers: A3921091
2011-003668-55 ( EudraCT Number )
First Submitted: June 12, 2013
First Posted: June 14, 2013
Results First Submitted: December 4, 2016
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:
Arthritis
Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Adalimumab
Tofacitinib
Anti-Inflammatory Agents
Antirheumatic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action