Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03963401
Registration number
NCT03963401
Ethics application status
Date submitted
15/05/2019
Date registered
24/05/2019
Date last updated
4/08/2021
Titles & IDs
Public title
A Study to Evaluate the Efficacy and Safety of PF-06700841 in Subjects With Active Psoriatic Arthritis
Query!
Scientific title
A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF PF-06700841 TO EVALUATE THE EFFICACY AT 16 WEEKS AND TO EVALUATE THE SAFETY AND EFFICACY UP TO 1 YEAR IN SUBJECTS WITH ACTIVE PSORIATIC ARTHRITIS
Query!
Secondary ID [1]
0
0
2018-004241-16
Query!
Secondary ID [2]
0
0
B7931030
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Psoriatic Arthritis
0
0
Query!
Condition category
Condition code
Musculoskeletal
0
0
0
0
Query!
Osteoarthritis
Query!
Inflammatory and Immune System
0
0
0
0
Query!
Rheumatoid arthritis
Query!
Inflammatory and Immune System
0
0
0
0
Query!
Other inflammatory or immune system disorders
Query!
Musculoskeletal
0
0
0
0
Query!
Other muscular and skeletal disorders
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - PF-06700841
Other interventions - Placebo
Experimental: PF-06700841 60 mg once daily - PF-06700841 60 mg once daily for 52 weeks
Experimental: PF-06700841 30 mg once daily - PF-06700841 30 mg once daily for 52 weeks
Experimental: PF-06700841 10 mg once daily followed by 60 mg once daily - PF-06700841 10 mg once daily for 16 weeks, followed by 60 mg once daily until Week 52
Experimental: PF-06700841 10 mg once daily followed by 30 mg once daily - PF-06700841 10 mg once daily for 16 weeks, followed by 30 mg once daily until Week 52
Placebo Comparator: Placebo once daily followed by 60 mg once daily - Placebo once daily for 16 weeks, followed by PF-06700841 60 mg once daily until Week 52
Placebo Comparator: Placebo once daily followed by 30 mg once daily - Placebo once daily for 16 weeks, followed by PF-06700841 30 mg once daily until Week 52
Treatment: Drugs: PF-06700841
Starting after the Week 16 visit, subjects receiving PF-06700841 10 mg once daily will start to randomly receive either the 60 mg QD dose or 30 mg QD dose until Week 52, as predetermined at randomization. All subjects will receive blinded dosing throughout the 52 weeks study treatment period in order to maintain the study blind.
Other interventions: Placebo
Starting after the Week 16 visit, subjects receiving placebo will start to randomly receive either the 60 mg QD dose or 30 mg QD dose until Week 52, as predetermined at randomization. All subjects will receive blinded dosing throughout the 52 weeks study treatment period in order to maintain the study blind.
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Intervention code [2]
0
0
Other interventions
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Percentage of Participants Achieving an American College of Rheumatology 20 (ACR20) Response at Week 16
Query!
Assessment method [1]
0
0
ACR 20 was calculated as a =20% improvement in tender and swollen joint counts and =20% improvement in 3 of the 5 remaining ACR core set measures: patient pain assessment (a horizontal visual analog scale assessment of the patient's level of pain), patient global assessment (the patient's overall assessment of how the arthritis was doing by a visual analog scale), physician global assessment (a horizontal visual analog scale measure of the physician's assessment of the patient's current disease activity), patient self-assessed disability (a validated and reliable patient self-assessment instrument which measured physical functions in rheumatoid arthritis patients) and an acute-phase reactant (C-reactive protein level). The participants receiving placebo in the initial period (Day 1 - Week 16) were combined into a single placebo group, while those who received PF-06700841 (10 mg QD) in the initial period were combined into a single PF-06700841 10 mg QD group.
Query!
Timepoint [1]
0
0
Week 16
Query!
Secondary outcome [1]
0
0
Percentage of Participants Achieving an ACR20 Response at Week 16 in the Subgroup of Participants Who Were Tumor Necrosis Factor (TNF) a Inhibitor naïve
Query!
Assessment method [1]
0
0
ACR 20 was calculated as a =20% improvement in tender and swollen joint counts and =20% improvement in 3 of the 5 remaining ACR core set measures: patient pain assessment (a horizontal visual analog scale assessment of the patient's level of pain), patient global assessment (the patient's overall assessment of how the arthritis was doing by a visual analog scale), physician global assessment (a horizontal visual analog scale measure of the physician's assessment of the patient's current disease activity), patient self-assessed disability (a validated and reliable patient self-assessment instrument which measured physical functions in rheumatoid arthritis patients) and an acute-phase reactant (C-reactive protein level). The participants receiving placebo in the initial period (Day 1 - Week 16) were combined into a single placebo group, while those who received PF-06700841 (10 mg QD) in the initial period were combined into a single PF-06700841 10 mg QD group.
Query!
Timepoint [1]
0
0
Week 16
Query!
Secondary outcome [2]
0
0
Percentage of Participants Achieving an ACR20 Response at Weeks 2, 4, 8, 12, 20, 28, 36, 44 and 52
Query!
Assessment method [2]
0
0
The American College of Rheumatology's definition for calculating improvement in rheumatoid arthritis (ACR20) was calculated as a =20% improvement in tender and swollen joint counts and =20% improvement in 3 of the 5 remaining ACR core set measures: patient pain assessment (a horizontal visual analog scale assessment of the patient's level of pain), patient global assessment (the patient's overall assessment of how the arthritis was doing by a visual analog scale), physician global assessment (a horizontal visual analog scale measure of the physician's assessment of the patient's current disease activity), patient self-assessed disability (a validated and reliable patient self-assessment instrument which measured physical functions in rheumatoid arthritis patients) and an acute-phase reactant (C-reactive protein level).
Query!
Timepoint [2]
0
0
Weeks 2, 4, 8, 12, 20, 28, 36, 44 and 52
Query!
Secondary outcome [3]
0
0
Percentage of Participants Achieving an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Query!
Assessment method [3]
0
0
The American College of Rheumatology's definition for calculating improvement in rheumatoid arthritis (ACR50) was calculated as a =50% improvement in tender and swollen joint counts and =50% improvement in 3 of the 5 remaining ACR core set measures: patient pain assessment (a horizontal visual analog scale assessment of the patient's level of pain), patient global assessment (the patient's overall assessment of how the arthritis was doing by a visual analog scale), physician global assessment (a horizontal visual analog scale measure of the physician's assessment of the patient's current disease activity), patient self-assessed disability (a validated and reliable patient self-assessment instrument which measured physical functions in rheumatoid arthritis patients) and an acute-phase reactant (C-reactive protein level).
Query!
Timepoint [3]
0
0
Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Query!
Secondary outcome [4]
0
0
Percentage of Participants Achieving an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Query!
Assessment method [4]
0
0
The American College of Rheumatology's definition for calculating improvement in rheumatoid arthritis (ACR70) was calculated as a =70% improvement in tender and swollen joint counts and =70% improvement in 3 of the 5 remaining ACR core set measures: patient pain assessment (a horizontal visual analog scale assessment of the patient's level of pain), patient global assessment (the patient's overall assessment of how the arthritis was doing by a visual analog scale), physician global assessment (a horizontal visual analog scale measure of the physician's assessment of the patient's current disease activity), patient self-assessed disability (a validated and reliable patient self-assessment instrument which measured physical functions in rheumatoid arthritis patients) and an acute-phase reactant (C-reactive protein level).
Query!
Timepoint [4]
0
0
Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Query!
Secondary outcome [5]
0
0
Change From Baseline in Tender/Painful Joint Count at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Query!
Assessment method [5]
0
0
The tender/painful joints were assessed by a blinded assessor to determine the number of joints that were considered tender/painful using the following scale: Present/Absent/Not Done/Not Applicable (used for artificial or missing joints). Artificial joints was not assessed. Injected joints was counted according to their pre-injection status for the remainder of the study. The assessment was based on 68 joints. The score range was 0 to 68, with a higher score indicating a greater degree of tenderness. A negative change from baseline represents improvement.
Query!
Timepoint [5]
0
0
Baseline, Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Query!
Secondary outcome [6]
0
0
Change From Baseline in Swollen Joint Count at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Query!
Assessment method [6]
0
0
The swollen joints were assessed by a blinded assessor to determine the number of joints that were considered swollen using the following scale: Present/Absent/Not Done/Not Applicable (used for artificial or missing joints). Artificial joints was not assessed. Injected joints was counted according to their pre-injection status for the remainder of the study. The assessment was based on 66 joints. The score range was 0 to 66, with a higher score indicating a greater degree of swelling. A negative change from baseline represents improvement.
Query!
Timepoint [6]
0
0
Baseline, Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Query!
Secondary outcome [7]
0
0
Change From Baseline in Patient's Assessment of Arthritis Pain at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Query!
Assessment method [7]
0
0
Participants assessed the severity of their arthritis pain using a 100 millimeter (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. VAS data was rescaled prior to any calculation and analysis. Rescaled VAS score (mm) = (100 mm) × (length at mark in mm/overall length of line in mm). The score range was 0 mm to 100 mm, with a higher score indicating a higher degree of pain. A negative change from baseline represents improvement.
Query!
Timepoint [7]
0
0
Baseline, Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Query!
Secondary outcome [8]
0
0
Change From Baseline in Patient's Global Assessment of Arthritis at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Query!
Assessment method [8]
0
0
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 visual analog scale (VAS) by placing a mark on the scale between 0 (very well) and 100 (very poorly). VAS data was rescaled prior to any calculation and analysis. Rescaled VAS score (mm) = (100 mm) × (length at mark in mm/overall length of line in mm). The score range was 0 mm to 100 mm, and a negative change from baseline represents improvement.
Query!
Timepoint [8]
0
0
Baseline, Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Query!
Secondary outcome [9]
0
0
Change From Baseline in Physician's Global Assessment of Arthritis at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Query!
Assessment method [9]
0
0
The blinded assessor assessed the participant's overall arthritis appears at the time of each 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 visual analog scale (VAS) by placing a mark on the scale between 0 (very good) and 100 (very poor). VAS data was rescaled prior to any calculation and analysis. Rescaled VAS score (mm) = (100 mm) × (length at mark in mm/overall length of line in mm). The score range was 0 mm to 100 mm, and a negative change from baseline represents improvement.
Query!
Timepoint [9]
0
0
Baseline, Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Query!
Secondary outcome [10]
0
0
Change From Baseline in Health Assessment Questionnaire (HAQ) Disability Index (DI) at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Query!
Assessment method [10]
0
0
The HAQ-DI assessed the degree of difficulty a participant experienced 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 in the questionnaire, the level of difficulty is scored from 0 to 3 with 0 representing "no difficulty," 1 as "some difficulty," 2 as "much difficulty," and 3 as "unable to do". Any activity that requires assistance from another individual or requires the use of an assistive device adjusts to a minimum score of 2 to represent a more limited functional status. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range was 0 to 3, with a higher score indicating more difficulty in performing daily living activities. A negative change from baseline represents improvement.
Query!
Timepoint [10]
0
0
Baseline, Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Query!
Secondary outcome [11]
0
0
Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Query!
Assessment method [11]
0
0
C-reactive protein (hsCRP) is an acute phase reactant, which is indicative of inflammation and of its severity. Blood samples were obtained at Baseline, Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52 for determination of hsCRP.
Query!
Timepoint [11]
0
0
Baseline, Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Query!
Secondary outcome [12]
0
0
Percentage of Participants Achieving a Psoriasis Area and Severity Index 75 (PASI 75) Response at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Query!
Assessment method [12]
0
0
The PASI quantifies the severity of a participant's psoriasis based on both lesion severity and the percentage of body surface area (BSA) affected. Assessments of lesion Severity Score and Area Score are performed separately for each of the four body regions: head (including neck), upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). In each body region, the sum of the lesion Severity Scores for erythema, induration and scaling is multiplied by the Area Score which represents 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 PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 75 indicates a 75% or greater reduction in PASI scores from baseline.
Query!
Timepoint [12]
0
0
Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Query!
Secondary outcome [13]
0
0
Percentage of Participants Achieving a PASI 90 Response at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Query!
Assessment method [13]
0
0
The PASI quantifies the severity of a participant's psoriasis based on both lesion severity and the percentage of body surface area (BSA) affected. Assessments of lesion Severity Score and Area Score are performed separately for each of the four body regions: head (including neck), upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). In each body region, the sum of the lesion Severity Scores for erythema, induration and scaling is multiplied by the Area Score which represents 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 PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 90 indicates a 90% or greater reduction in PASI scores from baseline.
Query!
Timepoint [13]
0
0
Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Query!
Secondary outcome [14]
0
0
Percentage of Participants Achieving a PASI 100 Response at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Query!
Assessment method [14]
0
0
The PASI quantifies the severity of a participant's psoriasis based on both lesion severity and the percentage of body surface area (BSA) affected. Assessments of lesion Severity Score and Area Score are performed separately for each of the four body regions: head (including neck), upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). In each body region, the sum of the lesion Severity Scores for erythema, induration and scaling is multiplied by the Area Score which represents 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 PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 100 indicates a 100% reduction in PASI scores from baseline.
Query!
Timepoint [14]
0
0
Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Query!
Secondary outcome [15]
0
0
Change From Baseline in the Enthesitis Score (Using the Spondyloarthritis Research Consortium of Canada [SPARCC] Enthesitis Index) at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Query!
Assessment method [15]
0
0
The SPARCC Enthesitis Index examines tenderness at sixteen sites: medial epicondyle humerus, lateral epicondyle humerus, supraspinatus insertion into greater tuberosity of humerus, greater trochanter, quadriceps insertion into superior border of patella, patellar ligament insertion into inferior pole of patella or tibial tubercle (considered 1 site for scoring purposes), Achilles tendon insertion into calcaneum and plantar fascia insertion into calcaneum. Each site is classified on a dichotomous basis as either tender (score=1) or not tender (score=0). The SPARCC Enthesitis Index scores range from 0-16, with higher scores indicating higher disease activity.
Query!
Timepoint [15]
0
0
Baseline, Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Query!
Secondary outcome [16]
0
0
Change From Baseline in the Enthesitis Score (Using the Leeds Enthesitis Index) at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Query!
Assessment method [16]
0
0
The Leeds Enthesitis Index (LEI) examines tenderness at six sites: lateral epicondyle humerus, medial femoral condyle and Achilles tendon insertion. Each site is assessed as either tender (score=1) or not tender (score=0). The LEI scores range from 0-6, with higher scores indicating higher disease activity.
Query!
Timepoint [16]
0
0
Baseline, Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Query!
Secondary outcome [17]
0
0
Change From Baseline in the Dactylitis Severity Score (DSS) at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Query!
Assessment method [17]
0
0
The number of digits in hands and feet with dactylitis was evaluated by a blinded assessor. In addition, dactylitis severity was scored based upon digit tenderness using a scale of 0-3, where 0 = no tenderness to 3 = extreme tenderness, in each digit of the hands and feet. The range of total dactylitis scores was 0-60, with higher scores indicating greater severity. A negative change from baseline represents improvement.
Query!
Timepoint [17]
0
0
Baseline, Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Query!
Secondary outcome [18]
0
0
Change From Baseline in the Nail Psoriasis Severity Index (NAPSI) Score at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Query!
Assessment method [18]
0
0
A target finger nail was evaluated by the blinded assessor using the NAPSI scale. At the baseline visit, the worst case fingernail was chosen and the same nail was evaluated consistently through the entire study. Each quadrant of the target nail was graded for nail matrix psoriasis (including any of the following parameters: pitting, leukonychia, red spots in lunula, nail plate crumbling) and nail bed psoriasis (including any of the following parameters: onycholysis, splinter hemorrhages, oil drop (salmon patch) discoloration, nail bed hyperkeratosis). The target nail NAPSI scores range from 0 to 8, with higher scores indicating higher disease activity.
Query!
Timepoint [18]
0
0
Baseline, Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Query!
Secondary outcome [19]
0
0
Change From Baseline in the Patient's Global Joint and Skin Assessment-Visual Analog Scale (PGJS-VAS) at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Query!
Assessment method [19]
0
0
Participant's perception of disease was assessed using a 100 mm visual analog scale (VAS) by placing a mark on the scale between 0 (excellent) and 100 (poor). The rating corresponded to the way in which the participant felt over the past week in terms of how they were affected by their: 1) psoriasis and arthritis (global, PGA); 2) arthritis only (PJA) and 3) psoriasis only (PSA). Rescaled VAS score was used. Rescaled VAS score (mm) = (100 mm) × (length at mark in mm/overall length of line in mm). A negative change from baseline represents improvement.
Query!
Timepoint [19]
0
0
Baseline, Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Query!
Secondary outcome [20]
0
0
Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Query!
Assessment method [20]
0
0
The FACIT-F Scale is a patient completed questionnaire consisting of 13 items that assess fatigue. Participants responded to each item on a 5-point scale based on their experience of fatigue during the past 7 days (0 = not at all; 1 = a little bit; 2 =somewhat; 3 = quite a bit; 4 = very much). Instrument scoring yielded a range from 0 to 52 (negatively worded items were reversed during analysis), with higher scores representing better participant status (less fatigue).
Query!
Timepoint [20]
0
0
Baseline, Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Query!
Secondary outcome [21]
0
0
Change From Baseline in the Short-Form-36 Health Survey (SF-36) Version 2, Acute at Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52
Query!
Assessment method [21]
0
0
The SF-36 version 2 (Acute version) is a 36-item generic health status measure. It measures 8 general health concepts or domains: Physical Functioning (PF), Role-Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role-Emotional (RE), and Mental Health (MH). These 8 domains can also be summarized as physical and mental component scores. The summary component scores, Physical Component Summary (PCS) and Mental Component Summary (MCS), are based on a normalized sum of the 8 scale scores PF, RP, BP, GH, VT, SF, RE, and MH. All domains and summary components are scored such that a higher score indicates a higher functioning or health level. The minimum and maximum scores of the PCS Score are 22 and 59 respectively. The minimum and maximum scores of the MCS Score are 11 and 62 respectively.
Query!
Timepoint [21]
0
0
Baseline, Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52
Query!
Secondary outcome [22]
0
0
Percentage of Participants Achieving Minimal Disease Activity (MDA) at Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52
Query!
Assessment method [22]
0
0
A psoriatic arthritis participant was defined as having MDA response when 5 of the 7 following criteria were met: 1) tender joint count =1; 2) swollen joint count =1; 3) Psoriasis Area and Severity Index (quantifying the severity of a participant's psoriasis based on both lesion severity and the percentage of body surface area affected) score =1 or Body Surface Area (assessment of body surface area involved in psoriasis) =3%; 4) Patient's Assessment of Arthritis Pain (assessment of the patient's level of pain using a horizontal 100 mm visual analog scale) =15 mm; 5) Patient's Global Arthritis Assessment (patient's overall assessment of how the arthritis was doing by a 100 mm visual analog scale) =20 mm; 6) Health Assessment Questionnaire - Disability Index (assessment of the degree of difficulty a patient experienced) score =0.5; 7) tender entheseal points (assessment of tenderness using Leed's Enthesitis Index) =1.
Query!
Timepoint [22]
0
0
Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52
Query!
Secondary outcome [23]
0
0
Percentage of Participants Achieving Very Low Disease Activity (VLDA) Response at Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52
Query!
Assessment method [23]
0
0
A participant was in VLDA when all the 7 following criteria were met: 1) tender joint count =1; 2) swollen joint count =1; 3) Psoriasis Area and Severity Index (quantifying the severity of a participant's psoriasis based on both lesion severity and the percentage of body surface area affected) score =1 or Body Surface Area (assessment of body surface area involved in psoriasis) =3%; 4) Patient's Assessment of Arthritis Pain (assessment of the patient's level of pain using a horizontal 100 mm visual analog scale) =15 mm; 5) Patient's Global Arthritis Assessment (patient's overall assessment of how the arthritis was doing by a 100 mm visual analog scale) =20 mm; 6) Health Assessment Questionnaire - Disability Index (assessment of the degree of difficulty a patient experienced) score =0.5; 7) tender entheseal points (assessment of tenderness using Leed's Enthesitis Index) =1.
Query!
Timepoint [23]
0
0
Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52
Query!
Secondary outcome [24]
0
0
Change From Baseline in the Disease Activity Index for Reactive Arthritis/PsA (DAREA/DAPSA) at Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52
Query!
Assessment method [24]
0
0
DAREA/DAPSA is a composite instrument to assess peripheral joint involvement that is based upon numerical summation of 5 variables of disease activity: tender/painful joint count + swollen joint count (using SJC66/ TJC68 assessments), Patient's Global Assessment of Arthritis (PtGA in cm), Patient's Assessment of Arthritis Pain (PAIN in cm) and C-reactive protein (CRP) (in mg/dL). Since DAREA reflects domains found important in PsA, it has been proposed to serve as a Disease Activity Index for Psoriatic Arthritis (DAPSA). DAREA/DAPSA was calculated as follows: DAREA/DAPSA= SJC66 + TJC68 + PtGA + PAIN + CRP. A negative change from baseline represents improvement.
Query!
Timepoint [24]
0
0
Baseline, Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52
Query!
Secondary outcome [25]
0
0
Percentage of Participants Achieving the Psoriatic Arthritis Response Criteria (PsARC) at Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52
Query!
Assessment method [25]
0
0
The PsARC response was defined as improvement in two of the following 4 criteria, one of which must be joint pain or swelling, without worsening in any measure: (1) =20% improvement in Physician's Global Assessment of Arthritis (a horizontal visual analog scale measure of the physician's assessment of the patient's current disease activity); (2) =20% improvement in Patient's Global Assessment of Arthritis (the patient's overall assessment of how the arthritis was doing by a visual analog scale); (3) =30% improvement in tender joint count (68); and (4) =30% improvement in swollen joint count.
Query!
Timepoint [25]
0
0
Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52
Query!
Secondary outcome [26]
0
0
Change From Baseline in the Psoriatic Arthritis Disease Activity Score (PASDAS) at Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52
Query!
Assessment method [26]
0
0
PASDAS is a composite psoriatic arthritis disease activity score that includes the following components: patient's global joint and skin assessment (visual analog scale in mm), physician's global psoriatic arthritis assessment (visual analog scale in mm), swollen (66 joints) and tender joint counts (68 joints), Leeds Enthesitis Index score, tender dactylitic digit score, physical component summary score (PCS) of Short Form 36 Health Survey and C-reactive protein (mg/L). Any missing component would result in PASDAS as missing. A higher PASDAS score indicates a higher disease activity.
Query!
Timepoint [26]
0
0
Baseline, Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52
Query!
Secondary outcome [27]
0
0
Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) From Baseline (Day 1) Through Week 56 (All Causalities)
Query!
Assessment method [27]
0
0
Treatment-emergent AEs are those with initial onset or that worsen in severity after the first dose of the study medication. All AEs in the table below were treatment-emergent AEs. An SAE is any untoward medical occurrence at any dose that: results in death; is life threatening (immediate risk of death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); results in congenital anomaly/birth defect; or that is considered to be an important medical event that may jeopardize the participant or may require intervention to prevent one of the other AE outcomes. Severe AEs were defined as AEs that interfered significantly with participant's usual function. Both SAEs and severe AEs were according to the investigator's assessment.
Query!
Timepoint [27]
0
0
Baseline (Day 1) through Week 56
Query!
Secondary outcome [28]
0
0
Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) From Baseline (Day 1) Through Week 56 (Treatment-related)
Query!
Assessment method [28]
0
0
Treatment-emergent AEs are those with initial onset or that worsen in severity after the first dose of the study medication. All AEs in the table below were treatment-emergent AEs. An SAE is any untoward medical occurrence at any dose that: results in death; is life threatening (immediate risk of death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); results in congenital anomaly/birth defect; or that is considered to be an important medical event that may jeopardize the participant or may require intervention to prevent one of the other AE outcomes. Severe AEs were defined as AEs that interfered significantly with participant's usual function. Both SAEs and severe AEs were according to the investigator's assessment. Treatment-related AEs were also determined by the investigator.
Query!
Timepoint [28]
0
0
Baseline (Day 1) through Week 56
Query!
Secondary outcome [29]
0
0
Number of Participants Who Discontinued From Study Due to Treatment-emergent AEs From Baseline (Day 1) Through Week 56
Query!
Assessment method [29]
0
0
An AE is any untoward medical occurrence in a study participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. Treatment-emergent AEs were those with initial onset or that worsen in severity after the first dose of the study medication.
Query!
Timepoint [29]
0
0
Baseline (Day 1) through Week 56
Query!
Eligibility
Key inclusion criteria
- Active arthritis at screening/baseline as indicated by >/= 3 tender/painful and 3
swollen joints.
- Active plaque psoriasis at screening and baseline.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
75
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key 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.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 2
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
13/06/2019
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
15/01/2021
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
219
Query!
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Query!
Recruitment hospital [1]
0
0
Rheumatology Research Unit - Maroochydore
Query!
Recruitment hospital [2]
0
0
Emeritus Research - Melbourne
Query!
Recruitment postcode(s) [1]
0
0
4558 - Maroochydore
Query!
Recruitment postcode(s) [2]
0
0
3124 - Melbourne
Query!
Recruitment outside Australia
Country [1]
0
0
Bulgaria
Query!
State/province [1]
0
0
Plovdiv
Query!
Country [2]
0
0
Bulgaria
Query!
State/province [2]
0
0
Sofia
Query!
Country [3]
0
0
Czechia
Query!
State/province [3]
0
0
Hlucin
Query!
Country [4]
0
0
Czechia
Query!
State/province [4]
0
0
Pardubice
Query!
Country [5]
0
0
Czechia
Query!
State/province [5]
0
0
Praha 2
Query!
Country [6]
0
0
Czechia
Query!
State/province [6]
0
0
Praha 3
Query!
Country [7]
0
0
Czechia
Query!
State/province [7]
0
0
Uherske Hradiste
Query!
Country [8]
0
0
Estonia
Query!
State/province [8]
0
0
Tallinn
Query!
Country [9]
0
0
Hungary
Query!
State/province [9]
0
0
Budapest
Query!
Country [10]
0
0
Hungary
Query!
State/province [10]
0
0
Veszprem
Query!
Country [11]
0
0
Lithuania
Query!
State/province [11]
0
0
Kaunas
Query!
Country [12]
0
0
Lithuania
Query!
State/province [12]
0
0
Vilnius
Query!
Country [13]
0
0
Poland
Query!
State/province [13]
0
0
Bialystok
Query!
Country [14]
0
0
Poland
Query!
State/province [14]
0
0
Lublin
Query!
Country [15]
0
0
Poland
Query!
State/province [15]
0
0
Nadarzyn
Query!
Country [16]
0
0
Poland
Query!
State/province [16]
0
0
Nowa Sol
Query!
Country [17]
0
0
Poland
Query!
State/province [17]
0
0
Poznan
Query!
Country [18]
0
0
Poland
Query!
State/province [18]
0
0
Sochaczew
Query!
Country [19]
0
0
Poland
Query!
State/province [19]
0
0
Torun
Query!
Country [20]
0
0
Poland
Query!
State/province [20]
0
0
Warszawa
Query!
Country [21]
0
0
Russian Federation
Query!
State/province [21]
0
0
Moscow Region
Query!
Country [22]
0
0
Russian Federation
Query!
State/province [22]
0
0
Orenburg
Query!
Country [23]
0
0
Russian Federation
Query!
State/province [23]
0
0
Petrozavodsk
Query!
Country [24]
0
0
Russian Federation
Query!
State/province [24]
0
0
Ryazan
Query!
Country [25]
0
0
Russian Federation
Query!
State/province [25]
0
0
Saint Petersburg
Query!
Country [26]
0
0
Russian Federation
Query!
State/province [26]
0
0
Saratov
Query!
Country [27]
0
0
Russian Federation
Query!
State/province [27]
0
0
Vladimir
Query!
Country [28]
0
0
Russian Federation
Query!
State/province [28]
0
0
Yaroslavl
Query!
Country [29]
0
0
Serbia
Query!
State/province [29]
0
0
Belgrade
Query!
Country [30]
0
0
Serbia
Query!
State/province [30]
0
0
Niska Banja
Query!
Country [31]
0
0
Slovakia
Query!
State/province [31]
0
0
Piestany
Query!
Country [32]
0
0
Slovakia
Query!
State/province [32]
0
0
Poprad
Query!
Country [33]
0
0
Slovakia
Query!
State/province [33]
0
0
Rimavska Sobota
Query!
Country [34]
0
0
Spain
Query!
State/province [34]
0
0
A Coruna
Query!
Country [35]
0
0
Spain
Query!
State/province [35]
0
0
Sevilla
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Pfizer
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
This is a 52 week Phase 2b study designed to evaluate the efficacy at 16 weeks and to
evaluate the safety and efficacy up to 1 year in subjects with active psoriatic arthritis.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT03963401
Query!
Trial related presentations / publications
Banfield C, Scaramozza M, Zhang W, Kieras E, Page KM, Fensome A, Vincent M, Dowty ME, Goteti K, Winkle PJ, Peeva E. The Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a TYK2/JAK1 Inhibitor (PF-06700841) in Healthy Subjects and Patients With Plaque Psoriasis. J Clin Pharmacol. 2018 Apr;58(4):434-447. doi: 10.1002/jcph.1046. Epub 2017 Dec 21.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Pfizer CT.gov Call Center
Query!
Address
0
0
Pfizer
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03963401
Download to PDF