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A Study to Evaluate the Efficacy and Safety of PF-06700841 in Subjects With Active Psoriatic Arthritis

Primary Purpose

Psoriatic Arthritis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
PF-06700841
Placebo
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriatic Arthritis focused on measuring Spondyloarthritis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Active arthritis at screening/baseline as indicated by >/= 3 tender/painful and 3 swollen joints.
  • Active plaque psoriasis at screening and baseline.

Exclusion Criteria:

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

Sites / Locations

  • Rheumatology Research Unit
  • Emeritus Research
  • MHAT Trimontium OOD
  • University Multiprofile Hospital for Active Treatment "Pulmed"
  • University Multiprofile Hospital for Active Treatment ''Plovdiv'' AD
  • Medical Center "Pirogov"
  • "Diagnostic-Consulting Center XVII - Sofia"
  • University Multiprofile Hospital for Active Treatment Sveti Ivan Rilski
  • L.K.N. Arthrocentrum s.r.o.
  • CCR Czech a.s.
  • Revmatologicky ustav
  • CCR Prague s.r.o.
  • MEDICAL PLUS s.r.o.
  • Innomedica OU
  • Center for Clinical and Basic Research
  • East Tallinn Central Hospital
  • Qualiclinic Kft.
  • VITAL MEDICAL CENTER Orvosi es Fogorvosi Kozpont
  • Hospital of Lithuanian University of Health Sciences, Kauno klinikos
  • National Osteoporosis Center
  • ZDROWIE Osteo-Medic s.c. L. I A. Racewicz, A. i J. Supronik
  • ClinicMed Daniluk Nowak Sp. Jawna
  • Zespol Poradni Specjalistycznych "REUMED" Filia nr 2
  • NZOZ Lecznica Mak-Med s.c.
  • Twoja Przychodnia - Centrum Medyczne Nowa Sol
  • Ai Centrum Medyczne Sp. z o.o. Sp. k.
  • Prywatna Praktyka Lekarska Prof. UM dr hab. med. Pawel Hrycaj
  • RCMed Oddzial Sochaczew
  • NASZ LEKARZ Przychodnie Medyczne
  • REUMATIKA - Centrum Reumatologii NZOZ
  • LLC "Family Outpatient clinic #4"
  • FGBOU VO "Orenburg State Medical University" of the Ministry of Health of the Russian Federation
  • GBUZ "Orenburg Regional Clinical Hospital"
  • SBHI of the Republic of Karelia "Republican Hospital n. a. V.A. Baranov"
  • FSBEI of HE "Ryazan State Medical University n. a academician I.P.Pavlov"
  • SBI of Ryazan Region "Regional Clinical Hospital"
  • Limited Liability Company "Sanavita"
  • GUZ "Regional Clinical Hospital"
  • LLC "BioMed"
  • State Autonomous Healthcare Institution of Yaroslavl Region
  • Institute of Rheumatology
  • Institute for Treatment and Rehabilitation Niska Banja
  • Narodny ustav reumatickych chorob
  • MUDr. Zuzana Cizmarikova, s.r.o.
  • REUMEX s.r.o.
  • Complejo Hospitalario Universitario de Santiago de Compostela
  • Hospital Universitario A Coruna
  • Hospital Quironsalud Infanta Luisa

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Placebo Comparator

Arm Label

PF-06700841 60 mg once daily

PF-06700841 30 mg once daily

PF-06700841 10 mg once daily followed by 60 mg once daily

PF-06700841 10 mg once daily followed by 30 mg once daily

Placebo once daily followed by 60 mg once daily

Placebo once daily followed by 30 mg once daily

Arm Description

PF-06700841 60 mg once daily for 52 weeks

PF-06700841 30 mg once daily for 52 weeks

PF-06700841 10 mg once daily for 16 weeks, followed by 60 mg once daily until Week 52

PF-06700841 10 mg once daily for 16 weeks, followed by 30 mg once daily until Week 52

Placebo once daily for 16 weeks, followed by PF-06700841 60 mg once daily until Week 52

Placebo once daily for 16 weeks, followed by PF-06700841 30 mg once daily until Week 52

Outcomes

Primary Outcome Measures

Percentage of Participants Achieving an American College of Rheumatology 20 (ACR20) Response at Week 16
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.

Secondary Outcome Measures

Percentage of Participants Achieving an ACR20 Response at Week 16 in the Subgroup of Participants Who Were Tumor Necrosis Factor (TNF) α Inhibitor naïve
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.
Percentage of Participants Achieving an ACR20 Response at Weeks 2, 4, 8, 12, 20, 28, 36, 44 and 52
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).
Percentage of Participants Achieving an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
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).
Percentage of Participants Achieving an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
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).
Change From Baseline in Tender/Painful Joint Count at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
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.
Change From Baseline in Swollen Joint Count at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
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.
Change From Baseline in Patient's Assessment of Arthritis Pain at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
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.
Change From Baseline in Patient's Global Assessment of Arthritis at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
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.
Change From Baseline in Physician's Global Assessment of Arthritis at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
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.
Change From Baseline in Health Assessment Questionnaire (HAQ) Disability Index (DI) at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
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.
Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
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.
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
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.
Percentage of Participants Achieving a PASI 90 Response at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
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.
Percentage of Participants Achieving a PASI 100 Response at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
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.
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
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.
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
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.
Change From Baseline in the Dactylitis Severity Score (DSS) at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
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.
Change From Baseline in the Nail Psoriasis Severity Index (NAPSI) Score at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
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.
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
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.
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
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).
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
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.
Percentage of Participants Achieving Minimal Disease Activity (MDA) at Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52
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.
Percentage of Participants Achieving Very Low Disease Activity (VLDA) Response at Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52
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.
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
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.
Percentage of Participants Achieving the Psoriatic Arthritis Response Criteria (PsARC) at Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52
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.
Change From Baseline in the Psoriatic Arthritis Disease Activity Score (PASDAS) at Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52
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.
Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) From Baseline (Day 1) Through Week 56 (All Causalities)
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.
Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) From Baseline (Day 1) Through Week 56 (Treatment-related)
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.
Number of Participants Who Discontinued From Study Due to Treatment-emergent AEs From Baseline (Day 1) Through Week 56
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.

Full Information

First Posted
May 15, 2019
Last Updated
August 2, 2021
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT03963401
Brief Title
A Study to Evaluate the Efficacy and Safety of PF-06700841 in Subjects With Active Psoriatic Arthritis
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
June 13, 2019 (Actual)
Primary Completion Date
April 6, 2020 (Actual)
Study Completion Date
January 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriatic Arthritis
Keywords
Spondyloarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
219 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PF-06700841 60 mg once daily
Arm Type
Experimental
Arm Description
PF-06700841 60 mg once daily for 52 weeks
Arm Title
PF-06700841 30 mg once daily
Arm Type
Experimental
Arm Description
PF-06700841 30 mg once daily for 52 weeks
Arm Title
PF-06700841 10 mg once daily followed by 60 mg once daily
Arm Type
Experimental
Arm Description
PF-06700841 10 mg once daily for 16 weeks, followed by 60 mg once daily until Week 52
Arm Title
PF-06700841 10 mg once daily followed by 30 mg once daily
Arm Type
Experimental
Arm Description
PF-06700841 10 mg once daily for 16 weeks, followed by 30 mg once daily until Week 52
Arm Title
Placebo once daily followed by 60 mg once daily
Arm Type
Placebo Comparator
Arm Description
Placebo once daily for 16 weeks, followed by PF-06700841 60 mg once daily until Week 52
Arm Title
Placebo once daily followed by 30 mg once daily
Arm Type
Placebo Comparator
Arm Description
Placebo once daily for 16 weeks, followed by PF-06700841 30 mg once daily until Week 52
Intervention Type
Drug
Intervention Name(s)
PF-06700841
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of Participants Achieving an American College of Rheumatology 20 (ACR20) Response at Week 16
Description
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.
Time Frame
Week 16
Secondary Outcome Measure Information:
Title
Percentage of Participants Achieving an ACR20 Response at Week 16 in the Subgroup of Participants Who Were Tumor Necrosis Factor (TNF) α Inhibitor naïve
Description
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.
Time Frame
Week 16
Title
Percentage of Participants Achieving an ACR20 Response at Weeks 2, 4, 8, 12, 20, 28, 36, 44 and 52
Description
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).
Time Frame
Weeks 2, 4, 8, 12, 20, 28, 36, 44 and 52
Title
Percentage of Participants Achieving an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Description
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).
Time Frame
Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Title
Percentage of Participants Achieving an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Description
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).
Time Frame
Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Title
Change From Baseline in Tender/Painful Joint Count at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Description
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.
Time Frame
Baseline, Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Title
Change From Baseline in Swollen Joint Count at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Description
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.
Time Frame
Baseline, Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Title
Change From Baseline in Patient's Assessment of Arthritis Pain at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Description
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.
Time Frame
Baseline, Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Title
Change From Baseline in Patient's Global Assessment of Arthritis at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Description
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.
Time Frame
Baseline, Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Title
Change From Baseline in Physician's Global Assessment of Arthritis at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Description
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.
Time Frame
Baseline, Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Title
Change From Baseline in Health Assessment Questionnaire (HAQ) Disability Index (DI) at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Description
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.
Time Frame
Baseline, Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Title
Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Description
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.
Time Frame
Baseline, Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Title
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
Description
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.
Time Frame
Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Title
Percentage of Participants Achieving a PASI 90 Response at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Description
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.
Time Frame
Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Title
Percentage of Participants Achieving a PASI 100 Response at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Description
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.
Time Frame
Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Title
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
Description
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.
Time Frame
Baseline, Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Title
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
Description
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.
Time Frame
Baseline, Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Title
Change From Baseline in the Dactylitis Severity Score (DSS) at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Description
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.
Time Frame
Baseline, Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Title
Change From Baseline in the Nail Psoriasis Severity Index (NAPSI) Score at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Description
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.
Time Frame
Baseline, Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Title
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
Description
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.
Time Frame
Baseline, Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Title
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
Description
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).
Time Frame
Baseline, Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Title
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
Description
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.
Time Frame
Baseline, Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52
Title
Percentage of Participants Achieving Minimal Disease Activity (MDA) at Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52
Description
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.
Time Frame
Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52
Title
Percentage of Participants Achieving Very Low Disease Activity (VLDA) Response at Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52
Description
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.
Time Frame
Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52
Title
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
Description
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.
Time Frame
Baseline, Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52
Title
Percentage of Participants Achieving the Psoriatic Arthritis Response Criteria (PsARC) at Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52
Description
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.
Time Frame
Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52
Title
Change From Baseline in the Psoriatic Arthritis Disease Activity Score (PASDAS) at Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52
Description
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.
Time Frame
Baseline, Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52
Title
Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) From Baseline (Day 1) Through Week 56 (All Causalities)
Description
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.
Time Frame
Baseline (Day 1) through Week 56
Title
Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) From Baseline (Day 1) Through Week 56 (Treatment-related)
Description
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.
Time Frame
Baseline (Day 1) through Week 56
Title
Number of Participants Who Discontinued From Study Due to Treatment-emergent AEs From Baseline (Day 1) Through Week 56
Description
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.
Time Frame
Baseline (Day 1) through Week 56

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Active arthritis at screening/baseline as indicated by >/= 3 tender/painful and 3 swollen joints. Active plaque psoriasis at screening and baseline. Exclusion Criteria: Non-plaque forms of psoriasis (with exception of nail psoriasis). History of autoimmune rheumatic disease other than PsA; also prior history of or current, rheumatic inflammatory disease other than PsA.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Rheumatology Research Unit
City
Maroochydore
State/Province
Queensland
ZIP/Postal Code
4558
Country
Australia
Facility Name
Emeritus Research
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3124
Country
Australia
Facility Name
MHAT Trimontium OOD
City
Plovdiv
ZIP/Postal Code
4000
Country
Bulgaria
Facility Name
University Multiprofile Hospital for Active Treatment "Pulmed"
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
Facility Name
University Multiprofile Hospital for Active Treatment ''Plovdiv'' AD
City
Plovdiv
ZIP/Postal Code
4027
Country
Bulgaria
Facility Name
Medical Center "Pirogov"
City
Sofia
ZIP/Postal Code
1000
Country
Bulgaria
Facility Name
"Diagnostic-Consulting Center XVII - Sofia"
City
Sofia
ZIP/Postal Code
1505
Country
Bulgaria
Facility Name
University Multiprofile Hospital for Active Treatment Sveti Ivan Rilski
City
Sofia
ZIP/Postal Code
1612
Country
Bulgaria
Facility Name
L.K.N. Arthrocentrum s.r.o.
City
Hlucin
ZIP/Postal Code
748 01
Country
Czechia
Facility Name
CCR Czech a.s.
City
Pardubice
ZIP/Postal Code
530 02
Country
Czechia
Facility Name
Revmatologicky ustav
City
Praha 2
ZIP/Postal Code
128 50
Country
Czechia
Facility Name
CCR Prague s.r.o.
City
Praha 3
ZIP/Postal Code
130 00
Country
Czechia
Facility Name
MEDICAL PLUS s.r.o.
City
Uherske Hradiste
ZIP/Postal Code
68601
Country
Czechia
Facility Name
Innomedica OU
City
Tallinn
ZIP/Postal Code
10117
Country
Estonia
Facility Name
Center for Clinical and Basic Research
City
Tallinn
ZIP/Postal Code
10128
Country
Estonia
Facility Name
East Tallinn Central Hospital
City
Tallinn
ZIP/Postal Code
11312
Country
Estonia
Facility Name
Qualiclinic Kft.
City
Budapest
ZIP/Postal Code
1036
Country
Hungary
Facility Name
VITAL MEDICAL CENTER Orvosi es Fogorvosi Kozpont
City
Veszprem
ZIP/Postal Code
8200
Country
Hungary
Facility Name
Hospital of Lithuanian University of Health Sciences, Kauno klinikos
City
Kaunas
ZIP/Postal Code
LT-50161
Country
Lithuania
Facility Name
National Osteoporosis Center
City
Vilnius
ZIP/Postal Code
LT-09310
Country
Lithuania
Facility Name
ZDROWIE Osteo-Medic s.c. L. I A. Racewicz, A. i J. Supronik
City
Bialystok
ZIP/Postal Code
15-351
Country
Poland
Facility Name
ClinicMed Daniluk Nowak Sp. Jawna
City
Bialystok
ZIP/Postal Code
15-879
Country
Poland
Facility Name
Zespol Poradni Specjalistycznych "REUMED" Filia nr 2
City
Lublin
ZIP/Postal Code
20-582
Country
Poland
Facility Name
NZOZ Lecznica Mak-Med s.c.
City
Nadarzyn
ZIP/Postal Code
05-830
Country
Poland
Facility Name
Twoja Przychodnia - Centrum Medyczne Nowa Sol
City
Nowa Sol
ZIP/Postal Code
67-100
Country
Poland
Facility Name
Ai Centrum Medyczne Sp. z o.o. Sp. k.
City
Poznan
ZIP/Postal Code
61-113
Country
Poland
Facility Name
Prywatna Praktyka Lekarska Prof. UM dr hab. med. Pawel Hrycaj
City
Poznan
ZIP/Postal Code
61-397
Country
Poland
Facility Name
RCMed Oddzial Sochaczew
City
Sochaczew
ZIP/Postal Code
96-500
Country
Poland
Facility Name
NASZ LEKARZ Przychodnie Medyczne
City
Torun
ZIP/Postal Code
87-100
Country
Poland
Facility Name
REUMATIKA - Centrum Reumatologii NZOZ
City
Warszawa
ZIP/Postal Code
02-691
Country
Poland
Facility Name
LLC "Family Outpatient clinic #4"
City
Korolev
State/Province
Moscow Region
ZIP/Postal Code
141060
Country
Russian Federation
Facility Name
FGBOU VO "Orenburg State Medical University" of the Ministry of Health of the Russian Federation
City
Orenburg
ZIP/Postal Code
460000
Country
Russian Federation
Facility Name
GBUZ "Orenburg Regional Clinical Hospital"
City
Orenburg
ZIP/Postal Code
460018
Country
Russian Federation
Facility Name
SBHI of the Republic of Karelia "Republican Hospital n. a. V.A. Baranov"
City
Petrozavodsk
ZIP/Postal Code
185910
Country
Russian Federation
Facility Name
FSBEI of HE "Ryazan State Medical University n. a academician I.P.Pavlov"
City
Ryazan
ZIP/Postal Code
390026
Country
Russian Federation
Facility Name
SBI of Ryazan Region "Regional Clinical Hospital"
City
Ryazan
ZIP/Postal Code
390039
Country
Russian Federation
Facility Name
Limited Liability Company "Sanavita"
City
Saint Petersburg
ZIP/Postal Code
195257
Country
Russian Federation
Facility Name
GUZ "Regional Clinical Hospital"
City
Saratov
ZIP/Postal Code
410053
Country
Russian Federation
Facility Name
LLC "BioMed"
City
Vladimir
ZIP/Postal Code
600005
Country
Russian Federation
Facility Name
State Autonomous Healthcare Institution of Yaroslavl Region
City
Yaroslavl
ZIP/Postal Code
150003
Country
Russian Federation
Facility Name
Institute of Rheumatology
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Institute for Treatment and Rehabilitation Niska Banja
City
Niska Banja
ZIP/Postal Code
18205
Country
Serbia
Facility Name
Narodny ustav reumatickych chorob
City
Piestany
ZIP/Postal Code
921 12
Country
Slovakia
Facility Name
MUDr. Zuzana Cizmarikova, s.r.o.
City
Poprad
ZIP/Postal Code
058 01
Country
Slovakia
Facility Name
REUMEX s.r.o.
City
Rimavska Sobota
ZIP/Postal Code
979 01
Country
Slovakia
Facility Name
Complejo Hospitalario Universitario de Santiago de Compostela
City
Santiago de Compostela
State/Province
A Coruna
ZIP/Postal Code
15706
Country
Spain
Facility Name
Hospital Universitario A Coruna
City
A Coruna
ZIP/Postal Code
15006
Country
Spain
Facility Name
Hospital Quironsalud Infanta Luisa
City
Sevilla
ZIP/Postal Code
41010
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
29266308
Citation
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.
Results Reference
background
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=B7931030
Description
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Learn more about this trial

A Study to Evaluate the Efficacy and Safety of PF-06700841 in Subjects With Active Psoriatic Arthritis

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