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

Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT03963401
Collaborator
(none)
219
Enrollment
48
Locations
6
Arms
19.1
Actual Duration (Months)
4.6
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
219 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jun 13, 2019
Actual Primary Completion Date :
Apr 6, 2020
Actual Study Completion Date :
Jan 15, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: PF-06700841 60 mg once daily

PF-06700841 60 mg once daily for 52 weeks

Drug: 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.
Experimental: PF-06700841 30 mg once daily

PF-06700841 30 mg once daily for 52 weeks

Drug: 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.
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

Drug: 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.
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

Drug: 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.
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

Other: 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.
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

Other: 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.

Outcome Measures

Primary Outcome Measures

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

  1. Percentage of Participants Achieving an ACR20 Response at Week 16 in the Subgroup of Participants Who Were Tumor Necrosis Factor (TNF) α Inhibitor naïve [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.

  2. Percentage of Participants Achieving an ACR20 Response at Weeks 2, 4, 8, 12, 20, 28, 36, 44 and 52 [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).

  3. Percentage of Participants Achieving an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52 [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).

  4. Percentage of Participants Achieving an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52 [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).

  5. Change From Baseline in Tender/Painful Joint Count at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52 [Baseline, 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.

  6. Change From Baseline in Swollen Joint Count at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52 [Baseline, 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.

  7. Change From Baseline in Patient's Assessment of Arthritis Pain at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52 [Baseline, 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.

  8. Change From Baseline in Patient's Global Assessment of Arthritis at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52 [Baseline, 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.

  9. Change From Baseline in Physician's Global Assessment of Arthritis at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52 [Baseline, 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.

  10. Change From Baseline in Health Assessment Questionnaire (HAQ) Disability Index (DI) at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52 [Baseline, 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.

  11. Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52 [Baseline, 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.

  12. 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 [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.

  13. Percentage of Participants Achieving a PASI 90 Response at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52 [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.

  14. Percentage of Participants Achieving a PASI 100 Response at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52 [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.

  15. 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 [Baseline, 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.

  16. 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 [Baseline, 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.

  17. Change From Baseline in the Dactylitis Severity Score (DSS) at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52 [Baseline, 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.

  18. Change From Baseline in the Nail Psoriasis Severity Index (NAPSI) Score at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52 [Baseline, 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.

  19. 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 [Baseline, 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.

  20. 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 [Baseline, 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).

  21. 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 [Baseline, 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.

  22. Percentage of Participants Achieving Minimal Disease Activity (MDA) at Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52 [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.

  23. Percentage of Participants Achieving Very Low Disease Activity (VLDA) Response at Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52 [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.

  24. 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 [Baseline, 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.

  25. Percentage of Participants Achieving the Psoriatic Arthritis Response Criteria (PsARC) at Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52 [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.

  26. Change From Baseline in the Psoriatic Arthritis Disease Activity Score (PASDAS) at Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52 [Baseline, 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.

  27. Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) From Baseline (Day 1) Through Week 56 (All Causalities) [Baseline (Day 1) through Week 56]

    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.

  28. Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) From Baseline (Day 1) Through Week 56 (Treatment-related) [Baseline (Day 1) through Week 56]

    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.

  29. Number of Participants Who Discontinued From Study Due to Treatment-emergent AEs From Baseline (Day 1) Through Week 56 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Rheumatology Research Unit Maroochydore Queensland Australia 4558
2 Emeritus Research Melbourne Victoria Australia 3124
3 MHAT Trimontium OOD Plovdiv Bulgaria 4000
4 University Multiprofile Hospital for Active Treatment "Pulmed" Plovdiv Bulgaria 4002
5 University Multiprofile Hospital for Active Treatment ''Plovdiv'' AD Plovdiv Bulgaria 4027
6 Medical Center "Pirogov" Sofia Bulgaria 1000
7 "Diagnostic-Consulting Center XVII - Sofia" Sofia Bulgaria 1505
8 University Multiprofile Hospital for Active Treatment Sveti Ivan Rilski Sofia Bulgaria 1612
9 L.K.N. Arthrocentrum s.r.o. Hlucin Czechia 748 01
10 CCR Czech a.s. Pardubice Czechia 530 02
11 Revmatologicky ustav Praha 2 Czechia 128 50
12 CCR Prague s.r.o. Praha 3 Czechia 130 00
13 MEDICAL PLUS s.r.o. Uherske Hradiste Czechia 68601
14 Innomedica OU Tallinn Estonia 10117
15 Center for Clinical and Basic Research Tallinn Estonia 10128
16 East Tallinn Central Hospital Tallinn Estonia 11312
17 Qualiclinic Kft. Budapest Hungary 1036
18 VITAL MEDICAL CENTER Orvosi es Fogorvosi Kozpont Veszprem Hungary 8200
19 Hospital of Lithuanian University of Health Sciences, Kauno klinikos Kaunas Lithuania LT-50161
20 National Osteoporosis Center Vilnius Lithuania LT-09310
21 ZDROWIE Osteo-Medic s.c. L. I A. Racewicz, A. i J. Supronik Bialystok Poland 15-351
22 ClinicMed Daniluk Nowak Sp. Jawna Bialystok Poland 15-879
23 Zespol Poradni Specjalistycznych "REUMED" Filia nr 2 Lublin Poland 20-582
24 NZOZ Lecznica Mak-Med s.c. Nadarzyn Poland 05-830
25 Twoja Przychodnia - Centrum Medyczne Nowa Sol Nowa Sol Poland 67-100
26 Ai Centrum Medyczne Sp. z o.o. Sp. k. Poznan Poland 61-113
27 Prywatna Praktyka Lekarska Prof. UM dr hab. med. Pawel Hrycaj Poznan Poland 61-397
28 RCMed Oddzial Sochaczew Sochaczew Poland 96-500
29 NASZ LEKARZ Przychodnie Medyczne Torun Poland 87-100
30 REUMATIKA - Centrum Reumatologii NZOZ Warszawa Poland 02-691
31 LLC "Family Outpatient clinic #4" Korolev Moscow Region Russian Federation 141060
32 FGBOU VO "Orenburg State Medical University" of the Ministry of Health of the Russian Federation Orenburg Russian Federation 460000
33 GBUZ "Orenburg Regional Clinical Hospital" Orenburg Russian Federation 460018
34 SBHI of the Republic of Karelia "Republican Hospital n. a. V.A. Baranov" Petrozavodsk Russian Federation 185910
35 FSBEI of HE "Ryazan State Medical University n. a academician I.P.Pavlov" Ryazan Russian Federation 390026
36 SBI of Ryazan Region "Regional Clinical Hospital" Ryazan Russian Federation 390039
37 Limited Liability Company "Sanavita" Saint Petersburg Russian Federation 195257
38 GUZ "Regional Clinical Hospital" Saratov Russian Federation 410053
39 LLC "BioMed" Vladimir Russian Federation 600005
40 State Autonomous Healthcare Institution of Yaroslavl Region Yaroslavl Russian Federation 150003
41 Institute of Rheumatology Belgrade Serbia 11000
42 Institute for Treatment and Rehabilitation Niska Banja Niska Banja Serbia 18205
43 Narodny ustav reumatickych chorob Piestany Slovakia 921 12
44 MUDr. Zuzana Cizmarikova, s.r.o. Poprad Slovakia 058 01
45 REUMEX s.r.o. Rimavska Sobota Slovakia 979 01
46 Complejo Hospitalario Universitario de Santiago de Compostela Santiago de Compostela A Coruna Spain 15706
47 Hospital Universitario A Coruna A Coruna Spain 15006
48 Hospital Quironsalud Infanta Luisa Sevilla Spain 41010

Sponsors and Collaborators

  • Pfizer

Investigators

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

Study Documents (Full-Text)

More Information

Additional Information:

Publications

Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT03963401
Other Study ID Numbers:
  • B7931030
  • 2018-004241-16
First Posted:
May 24, 2019
Last Update Posted:
Aug 4, 2021
Last Verified:
Aug 1, 2021
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
Keywords provided by Pfizer
Spondyloarthritis
Additional relevant MeSH terms:
Arthritis
Arthritis, Psoriatic
PF-06700841

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail A total of 219 participants were enrolled in this study and 1 of them didn't receive any study treatment.
Arm/Group Title PF-06700841 60 mg QD -> PF-06700841 60 mg QD PF-06700841 30 mg QD -> PF-06700841 30 mg QD PF-06700841 10 mg QD -> PF-06700841 60 mg QD PF-06700841 10 mg QD -> PF-06700841 30 mg QD Placebo -> PF-06700841 60 mg QD Placebo -> PF-06700841 30 mg QD
Arm/Group Description PF-06700841 tablet was administered orally at 60 milligram (mg) once daily (QD) during both the initial period (from Day 1 to Week 16) and the extension period (Week 17 through Week 52). PF-06700841 tablet was administered orally at 30 mg QD during both the initial period (from Day 1 to Week 16) and the extension period (Week 17 through Week 52). PF-06700841 tablet was administered orally at 10 mg QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 60 mg QD during the extension period (Week 17 through Week 52). PF-06700841 tablet was administered orally at 10 mg QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 30 mg QD during the extension period (Week 17 through Week 52). Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 60 mg during the extension period (Week 17 through Week 52). Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 30 mg during the extension period (Week 17 through Week 52).
Period Title: Initial Period (Day 1 - Week 16)
STARTED 60 61 16 15 34 33
Treated 60 60 16 15 34 33
COMPLETED 57 57 14 13 31 31
NOT COMPLETED 3 4 2 2 3 2
Period Title: Initial Period (Day 1 - Week 16)
STARTED 57 57 14 13 31 31
COMPLETED 43 52 10 12 25 26
NOT COMPLETED 14 5 4 1 6 5

Baseline Characteristics

Arm/Group Title PF-06700841 60 mg QD -> PF-06700841 60 mg QD PF-06700841 30 mg QD -> PF-06700841 30 mg QD PF-06700841 10 mg QD -> PF-06700841 60 mg QD PF-06700841 10 mg QD -> PF-06700841 30 mg QD Placebo -> PF-06700841 60 mg QD Placebo -> PF-06700841 30 mg QD Total
Arm/Group Description PF-06700841 tablet was administered orally at 60 mg once daily (QD) during both the initial period (from Day 1 to Week 16) and the extension period (Week 17 through Week 52). PF-06700841 tablet was administered orally at 30 mg QD during both the initial period (from Day 1 to Week 16) and the extension period (Week 17 through Week 52). PF-06700841 tablet was administered orally at 10 mg QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 60 mg QD during the extension period (Week 17 through Week 52). PF-06700841 tablet was administered orally at 10 mg QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 30 mg QD during the extension period (Week 17 through Week 52). Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 60 mg during the extension period (Week 17 through Week 52). Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 30 mg during the extension period (Week 17 through Week 52). Total of all reporting groups
Overall Participants 60 60 16 15 34 33 218
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]
48.7
(11.47)
45.9
(10.23)
47.8
(14.16)
47.7
(12.95)
47.9
(12.58)
48.5
(11.84)
47.6
(11.62)
Age (Years) [Median (Full Range) ]
Median (Full Range) [Years]
50.0
46.0
43.5
47.0
48.0
50.0
48.0
Age, Customized (Number) [Number]
18-44
22
36.7%
26
43.3%
9
56.3%
6
40%
13
38.2%
14
42.4%
90
41.3%
45-64
35
58.3%
31
51.7%
5
31.3%
8
53.3%
17
50%
16
48.5%
112
51.4%
≥65
3
5%
3
5%
2
12.5%
1
6.7%
4
11.8%
3
9.1%
16
7.3%
Sex: Female, Male (Count of Participants)
Female
34
56.7%
32
53.3%
7
43.8%
7
46.7%
20
58.8%
16
48.5%
116
53.2%
Male
26
43.3%
28
46.7%
9
56.3%
8
53.3%
14
41.2%
17
51.5%
102
46.8%
Race/Ethnicity, Customized (Number) [Number]
White
59
98.3%
60
100%
16
100%
15
100%
34
100%
33
100%
217
99.5%
Asian
1
1.7%
0
0%
0
0%
0
0%
0
0%
0
0%
1
0.5%
Race/Ethnicity, Customized (Number) [Number]
Not Hispanic or Latino
60
100%
59
98.3%
16
100%
15
100%
33
97.1%
32
97%
215
98.6%
Not reported
0
0%
1
1.7%
0
0%
0
0%
1
2.9%
1
3%
3
1.4%

Outcome Measures

1. Primary Outcome
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

Outcome Measure Data

Analysis Population Description
All participants who received at least 1 dose of the randomized study treatment.
Arm/Group Title Placebo PF-06700841 10 mg QD PF-06700841 30 mg QD PF-06700841 60 mg QD
Arm/Group Description Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16). PF-06700841 tablet was administered orally at 10 mg QD during the initial period (from Day 1 to Week 16). PF-06700841 tablet was administered orally at 30 mg QD during the initial period (from Day 1 to Week 16). PF-06700841 tablet was administered orally at 60 mg QD during the initial period (from Day 1 to Week 16).
Measure Participants 67 31 60 59
Number (95% Confidence Interval) [Percentage of participants]
43.28
72.1%
64.52
107.5%
66.67
416.7%
74.58
497.2%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, PF-06700841 10 mg QD
Comments
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.1172
Comments
Method Normal approximation, Dunnett's method
Comments
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 21.23
Confidence Interval (2-Sided) 90%
3.94 to 38.52
Parameter Dispersion Type: Standard Error of the Mean
Value: 10.51
Estimation Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, PF-06700841 30 mg QD
Comments
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.0197
Comments
Method Normal approximation, Dunnett's Method
Comments
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 23.38
Confidence Interval (2-Sided) 90%
9.26 to 37.50
Parameter Dispersion Type: Standard Error of the Mean
Value: 8.58
Estimation Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, PF-06700841 60 mg QD
Comments
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.0006
Comments
Method Normal approximation, Dunnett's Method
Comments
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 31.29
Confidence Interval (2-Sided) 90%
17.65 to 44.93
Parameter Dispersion Type: Standard Error of the Mean
Value: 8.29
Estimation Comments
2. Secondary Outcome
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

Outcome Measure Data

Analysis Population Description
All participants who received at least 1 dose of the randomized study treatment with prior TNFα naïve.
Arm/Group Title Placebo PF-06700841 10 mg QD PF-06700841 30 mg QD PF-06700841 60 mg QD
Arm/Group Description Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16). PF-06700841 tablet was administered orally at 10 mg QD during the initial period (from Day 1 to Week 16). PF-06700841 tablet was administered orally at 30 mg QD during the initial period (from Day 1 to Week 16). PF-06700841 tablet was administered orally at 60 mg QD during the initial period (from Day 1 to Week 16).
Measure Participants 60 28 56 55
Number (95% Confidence Interval) [Percentage of participants]
43.33
72.2%
64.29
107.2%
69.64
435.3%
74.55
497%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, PF-06700841 10 mg QD
Comments
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.0588
Comments
Method Normal approximation method
Comments
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 20.95
Confidence Interval (2-Sided) 90%
2.72 to 39.19
Parameter Dispersion Type: Standard Error of the Mean
Value: 11.09
Estimation Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, PF-06700841 30 mg QD
Comments
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.0030
Comments
Method Normal approximation method
Comments
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 26.31
Confidence Interval (2-Sided) 90%
11.72 to 40.90
Parameter Dispersion Type: Standard Error of the Mean
Value: 8.87
Estimation Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, PF-06700841 60 mg QD
Comments
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.0003
Comments
Method Normal approximation method
Comments
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 31.21
Confidence Interval (2-Sided) 90%
16.93 to 45.50
Parameter Dispersion Type: Standard Error of the Mean
Value: 8.68
Estimation Comments
3. Secondary Outcome
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

Outcome Measure Data

Analysis Population Description
All participants who received at least 1 dose of the randomized study treatment.
Arm/Group Title PF-06700841 60 mg QD -> PF-06700841 60 mg QD PF-06700841 30 mg QD -> PF-06700841 30 mg QD PF-06700841 10 mg QD -> PF-06700841 60 mg QD PF-06700841 10 mg QD -> PF-06700841 30 mg QD Placebo -> PF-06700841 60 mg QD Placebo -> PF-06700841 30 mg QD
Arm/Group Description PF-06700841 tablet was administered orally at 60 mg once daily (QD) during both the initial period (from Day 1 to Week 16) and the extension period (Week 17 through Week 52). PF-06700841 tablet was administered orally at 30 mg QD during both the initial period (from Day 1 to Week 16) and the extension period (Week 17 through Week 52). PF-06700841 tablet was administered orally at 10 mg QD from Day 1 to Week 16. From Week 17 to Week 52, PF-06700841 tablet was administered orally at 60 mg QD. PF-06700841 tablet was administered orally at 10 mg QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 30 mg QD during the extension period (Week 17 through Week 52). Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 60 mg during the extension period (Week 17 through Week 52). Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 30 mg during the extension period (Week 17 through Week 52).
Measure Participants 60 60 16 15 34 33
Week 2
21.67
36.1%
18.33
30.6%
18.75
117.2%
3.13
20.9%
5.88
17.3%
18.18
55.1%
Week 4
45.00
75%
51.67
86.1%
31.25
195.3%
20.00
133.3%
14.71
43.3%
24.24
73.5%
Week 8
66.67
111.1%
55.00
91.7%
50.00
312.5%
40.00
266.7%
35.29
103.8%
42.42
128.5%
Week 12
70.00
116.7%
63.33
105.6%
56.25
351.6%
60.00
400%
44.12
129.8%
39.39
119.4%
Week 20
81.67
136.1%
80.00
133.3%
68.75
429.7%
60.00
400%
73.53
216.3%
75.76
229.6%
Week 28
73.33
122.2%
78.33
130.6%
68.75
429.7%
73.33
488.9%
64.71
190.3%
81.82
247.9%
Week 36
66.67
111.1%
78.33
130.6%
68.75
429.7%
80.00
533.3%
64.71
190.3%
81.82
247.9%
Week 44
68.33
113.9%
73.33
122.2%
62.50
390.6%
73.33
488.9%
67.65
199%
75.76
229.6%
Week 52
61.67
102.8%
70.00
116.7%
56.25
351.6%
60.00
400%
61.76
181.6%
66.67
202%
4. Secondary Outcome
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

Outcome Measure Data

Analysis Population Description
All participants who received at least 1 dose of the randomized study treatment.
Arm/Group Title PF-06700841 60 mg QD -> PF-06700841 60 mg QD PF-06700841 30 mg QD -> PF-06700841 30 mg QD PF-06700841 10 mg QD -> PF-06700841 60 mg QD PF-06700841 10 mg QD -> PF-06700841 30 mg QD Placebo -> PF-06700841 60 mg QD Placebo -> PF-06700841 30 mg QD
Arm/Group Description PF-06700841 tablet was administered orally at 60 mg once daily (QD) during both the initial period (from Day 1 to Week 16) and the extension period (Week 17 through Week 52). PF-06700841 tablet was administered orally at 30 mg QD during both the initial period (from Day 1 to Week 16) and the extension period (Week 17 through Week 52). PF-06700841 tablet was administered orally at 10 mg QD from Day 1 to Week 16. From Week 17 to Week 52, PF-06700841 tablet was administered orally at 60 mg QD. PF-06700841 tablet was administered orally at 10 mg QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 30 mg QD during the extension period (Week 17 through Week 52). Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 60 mg during the extension period (Week 17 through Week 52). Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 30 mg during the extension period (Week 17 through Week 52).
Measure Participants 60 60 16 15 34 33
Week 2
6.67
11.1%
1.67
2.8%
2.94
18.4%
3.13
20.9%
1.43
4.2%
1.47
4.5%
Week 4
13.33
22.2%
16.67
27.8%
2.94
18.4%
6.67
44.5%
2.94
8.6%
6.06
18.4%
Week 8
31.67
52.8%
25.00
41.7%
18.75
117.2%
13.33
88.9%
11.76
34.6%
15.15
45.9%
Week 12
43.33
72.2%
31.67
52.8%
31.25
195.3%
20.00
133.3%
23.53
69.2%
12.12
36.7%
Week 16
44.07
73.5%
48.33
80.6%
31.25
195.3%
33.33
222.2%
14.71
43.3%
6.06
18.4%
Week 20
61.67
102.8%
53.33
88.9%
37.50
234.4%
40.00
266.7%
44.12
129.8%
45.45
137.7%
Week 28
56.67
94.5%
51.67
86.1%
43.75
273.4%
53.33
355.5%
41.18
121.1%
66.67
202%
Week 36
53.33
88.9%
56.67
94.5%
50.00
312.5%
66.67
444.5%
50.00
147.1%
57.58
174.5%
Week 44
56.67
94.5%
55.00
91.7%
43.75
273.4%
60.00
400%
58.82
173%
63.64
192.8%
Week 52
46.67
77.8%
58.33
97.2%
43.75
273.4%
46.67
311.1%
41.18
121.1%
51.52
156.1%
5. Secondary Outcome
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

Outcome Measure Data

Analysis Population Description
All participants who received at least 1 dose of the randomized study treatment.
Arm/Group Title PF-06700841 60 mg QD -> PF-06700841 60 mg QD PF-06700841 30 mg QD -> PF-06700841 30 mg QD PF-06700841 10 mg QD -> PF-06700841 60 mg QD PF-06700841 10 mg QD -> PF-06700841 30 mg QD Placebo -> PF-06700841 60 mg QD Placebo -> PF-06700841 30 mg QD
Arm/Group Description PF-06700841 tablet was administered orally at 60 mg once daily (QD) during both the initial period (from Day 1 to Week 16) and the extension period (Week 17 through Week 52). PF-06700841 tablet was administered orally at 30 mg QD during both the initial period (from Day 1 to Week 16) and the extension period (Week 17 through Week 52). PF-06700841 tablet was administered orally at 10 mg QD from Day 1 to Week 16. From Week 17 to Week 52, PF-06700841 tablet was administered orally at 60 mg QD. PF-06700841 tablet was administered orally at 10 mg QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 30 mg QD during the extension period (Week 17 through Week 52). Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 60 mg during the extension period (Week 17 through Week 52). Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 30 mg during the extension period (Week 17 through Week 52).
Measure Participants 60 60 16 15 34 33
Week 2
3.33
5.6%
1.67
2.8%
2.94
18.4%
3.13
20.9%
1.43
4.2%
1.47
4.5%
Week 4
5.00
8.3%
5.00
8.3%
2.94
18.4%
3.13
20.9%
1.43
4.2%
1.47
4.5%
Week 8
11.67
19.5%
11.67
19.5%
6.25
39.1%
3.13
20.9%
2.94
8.6%
3.03
9.2%
Week 12
21.67
36.1%
18.33
30.6%
6.25
39.1%
6.67
44.5%
1.43
4.2%
9.09
27.5%
Week 16
23.73
39.6%
26.67
44.5%
6.25
39.1%
13.33
88.9%
1.43
4.2%
1.47
4.5%
Week 20
35.00
58.3%
30.00
50%
12.50
78.1%
20.00
133.3%
23.53
69.2%
27.27
82.6%
Week 28
36.67
61.1%
38.33
63.9%
18.75
117.2%
26.67
177.8%
23.53
69.2%
42.42
128.5%
Week 36
40.00
66.7%
35.00
58.3%
37.50
234.4%
26.67
177.8%
35.29
103.8%
39.39
119.4%
Week 44
46.67
77.8%
45.00
75%
37.50
234.4%
40.00
266.7%
23.53
69.2%
51.52
156.1%
Week 52
38.33
63.9%
45.00
75%
31.25
195.3%
26.67
177.8%
35.29
103.8%
42.42
128.5%
6. Secondary Outcome
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

Outcome Measure Data

Analysis Population Description
"Overall Number of Participants Analyzed" indicated the evaluable population and included all participants who were randomized to the study and received at least one dose of the randomized study treatment. "Number Analyzed" included participants available in the evaluable population at each specified visit.
Arm/Group Title PF-06700841 60 mg QD -> PF-06700841 60 mg QD PF-06700841 30 mg QD -> PF-06700841 30 mg QD PF-06700841 10 mg QD -> PF-06700841 60 mg QD PF-06700841 10 mg QD -> PF-06700841 30 mg QD Placebo -> PF-06700841 60 mg QD Placebo -> PF-06700841 30 mg QD
Arm/Group Description PF-06700841 tablet was administered orally at 60 mg once daily (QD) during both the initial period (from Day 1 to Week 16) and the extension period (Week 17 through Week 52). PF-06700841 tablet was administered orally at 30 mg QD during both the initial period (from Day 1 to Week 16) and the extension period (Week 17 through Week 52). PF-06700841 tablet was administered orally at 10 mg QD from Day 1 to Week 16. From Week 17 to Week 52, PF-06700841 tablet was administered orally at 60 mg QD. PF-06700841 tablet was administered orally at 10 mg QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 30 mg QD during the extension period (Week 17 through Week 52). Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 60 mg during the extension period (Week 17 through Week 52). Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 30 mg during the extension period (Week 17 through Week 52).
Measure Participants 60 60 16 15 34 33
Week 2
-3.33
(5.23)
-2.7
(4.49)
-4.7
(6.37)
0.0
(2.70)
-1.9
(3.27)
-2.1
(5.41)
Week 4
-6.3
(7.96)
-5.1
(5.43)
-5.6
(8.93)
-2.8
(4.49)
-3.4
(5.47)
-4.3
(8.25)
Week 8
-9.4
(7.69)
-6.8
(6.49)
-7.9
(7.89)
-4.4
(6.42)
-5.0
(6.46)
-4.6
(8.41)
Week 12
-9.8
(8.19)
-8.7
(7.27)
-11.3
(7.32)
-6.2
(8.43)
-6.5
(6.69)
-6.4
(9.40)
Week 16
-11.1
(8.01)
-10.1
(7.33)
-12.0
(8.80)
-10.4
(8.69)
-6.5
(5.78)
-6.5
(7.81)
Week 20
-12.2
(8.20)
-10.2
(6.60)
-13.6
(9.65)
-11.2
(10.95)
-8.8
(5.94)
-10.2
(7.41)
Week 28
-12.6
(8.38)
-10.4
(7.04)
-14.9
(9.99)
-13.5
(12.21)
-9.6
(6.39)
-11.4
(8.13)
Week 36
-12.5
(8.66)
-10.7
(7.00)
-16.2
(9.45)
-13.8
(11.89)
-10.4
(6.12)
-11.4
(8.82)
Week 44
-13.6
(8.54)
-11.6
(7.91)
-17.9
(10.07)
-12.6
(13.23)
-11.3
(6.47)
-12.5
(9.15)
Week 52
-13.6
(9.11)
-11.9
(7.69)
-18.9
(10.74)
-13.0
(12.25)
-10.8
(5.53)
-12.2
(9.81)
7. Secondary Outcome
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

Outcome Measure Data

Analysis Population Description
"Overall Number of Participants Analyzed" indicated the evaluable population and included all participants who were randomized to the study and received at least one dose of the randomized study treatment. "Number Analyzed" included participants available in the evaluable population at each specified visit.
Arm/Group Title PF-06700841 60 mg QD -> PF-06700841 60 mg QD PF-06700841 30 mg QD -> PF-06700841 30 mg QD PF-06700841 10 mg QD -> PF-06700841 60 mg QD PF-06700841 10 mg QD -> PF-06700841 30 mg QD Placebo -> PF-06700841 60 mg QD Placebo -> PF-06700841 30 mg QD
Arm/Group Description PF-06700841 tablet was administered orally at 60 mg once daily (QD) during both the initial period (from Day 1 to Week 16) and the extension period (Week 17 through Week 52). PF-06700841 tablet was administered orally at 30 mg QD during both the initial period (from Day 1 to Week 16) and the extension period (Week 17 through Week 52). PF-06700841 tablet was administered orally at 10 mg QD from Day 1 to Week 16. From Week 17 to Week 52, PF-06700841 tablet was administered orally at 60 mg QD. PF-06700841 tablet was administered orally at 10 mg QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 30 mg QD during the extension period (Week 17 through Week 52). Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 60 mg during the extension period (Week 17 through Week 52). Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 30 mg during the extension period (Week 17 through Week 52).
Measure Participants 60 60 16 15 34 33
Week 2
-2.3
(3.48)
-2.7
(3.73)
-4.6
(5.46)
-2.1
(3.31)
-2.0
(3.82)
-2.0
(3.95)
Week 4
-4.8
(4.42)
-4.3
(3.64)
-5.5
(5.51)
-5.2
(8.14)
-2.5
(3.11)
-3.6
(5.61)
Week 8
-6.5
(5.42)
-5.9
(4.50)
-7.9
(4.72)
-7.5
(7.54)
-4.4
(5.42)
-4.4
(5.95)
Week 12
-7.1
(5.89)
-6.7
(4.69)
-8.7
(6.97)
-8.7
(8.04)
-5.4
(5.26)
-4.7
(6.05)
Week 16
-8.0
(5.53)
-7.6
(5.10)
-8.9
(7.94)
-9.9
(8.98)
-6.7
(5.80)
-5.5
(6.74)
Week 20
-8.5
(5.31)
-8.3
(5.12)
-10.5
(8.42)
-10.8
(9.10)
-8.0
(6.29)
-7.6
(5.15)
Week 28
-8.2
(4.34)
-7.7
(5.27)
-10.0
(7.66)
-10.9
(9.00)
-7.2
(5.79)
-8.5
(5.83)
Week 36
-8.1
(4.35)
-8.1
(4.97)
-10.5
(7.55)
-11.1
(9.30)
-8.4
(5.60)
-8.9
(5.71)
Week 44
-8.3
(4.87)
-8.2
(5.05)
-10.5
(6.84)
-10.8
(9.93)
-8.3
(5.57)
-9.5
(5.51)
Week 52
-8.2
(4.84)
-8.1
(4.84)
-11.1
(7.68)
-10.7
(9.55)
-8.5
(5.76)
-9.2
(6.19)
8. Secondary Outcome
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

Outcome Measure Data

Analysis Population Description
"Overall Number of Participants Analyzed" indicated the evaluable population and included all participants who were randomized to the study and received at least one dose of the randomized study treatment. "Number Analyzed" included participants available in the evaluable population at each specified visit.
Arm/Group Title PF-06700841 60 mg QD -> PF-06700841 60 mg QD PF-06700841 30 mg QD -> PF-06700841 30 mg QD PF-06700841 10 mg QD -> PF-06700841 60 mg QD PF-06700841 10 mg QD -> PF-06700841 30 mg QD Placebo -> PF-06700841 60 mg QD Placebo -> PF-06700841 30 mg QD
Arm/Group Description PF-06700841 tablet was administered orally at 60 mg once daily (QD) during both the initial period (from Day 1 to Week 16) and the extension period (Week 17 through Week 52). PF-06700841 tablet was administered orally at 30 mg QD during both the initial period (from Day 1 to Week 16) and the extension period (Week 17 through Week 52). PF-06700841 tablet was administered orally at 10 mg QD from Day 1 to Week 16. From Week 17 to Week 52, PF-06700841 tablet was administered orally at 60 mg QD. PF-06700841 tablet was administered orally at 10 mg QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 30 mg QD during the extension period (Week 17 through Week 52). Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 60 mg during the extension period (Week 17 through Week 52). Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 30 mg during the extension period (Week 17 through Week 52).
Measure Participants 60 60 16 15 34 33
Week 2
-7.6
(19.13)
-8.0
(17.96)
-5.3
(12.87)
1.7
(21.20)
-2.3
(11.89)
-9.0
(17.52)
Week 4
-13.4
(23.39)
-18.5
(20.32)
-12.4
(22.60)
-7.9
(22.69)
-10.1
(18.67)
-9.6
(18.15)
Week 8
-20.6
(23.55)
-21.0
(22.46)
-14.3
(27.34)
-10.7
(25.94)
-16.9
(22.67)
-13.1
(22.88)
Week 12
-24.7
(25.72)
-22.8
(22.19)
-21.8
(24.25)
-14.9
(24.90)
-14.2
(24.54)
-12.3
(24.44)
Week 16
-28.4
(24.13)
-25.0
(22.58)
-26.5
(23.41)
-30.2
(20.55)
-13.7
(22.14)
-14.6
(20.16)
Week 20
-29.5
(24.12)
-30.9
(22.91)
-29.3
(24.07)
-25.5
(29.91)
-32.1
(22.84)
-27.7
(26.78)
Week 28
-29.7
(22.88)
-32.2
(25.21)
-34.6
(21.85)
-35.2
(24.79)
-29.6
(27.49)
-37.4
(25.54)
Week 36
-31.6
(25.14)
-31.3
(26.58)
-37.0
(29.87)
-33.5
(36.99)
-32.4
(21.11)
-38.5
(26.34)
Week 44
-32.8
(26.90)
-36.5
(26.87)
-41.6
(16.12)
-34.1
(39.69)
-35.0
(23.36)
-40.0
(26.21)
Week 52
-31.4
(26.39)
-35.5
(27.76)
-39.6
(21.95)
-34.9
(31.79)
-38.3
(22.84)
-38.5
(25.29)
9. Secondary Outcome
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

Outcome Measure Data

Analysis Population Description
"Overall Number of Participants Analyzed" indicated the evaluable population and included all participants who were randomized to the study and received at least one dose of the randomized study treatment. "Number Analyzed" included participants available in the evaluable population at each specified visit.
Arm/Group Title PF-06700841 60 mg QD -> PF-06700841 60 mg QD PF-06700841 30 mg QD -> PF-06700841 30 mg QD PF-06700841 10 mg QD -> PF-06700841 60 mg QD PF-06700841 10 mg QD -> PF-06700841 30 mg QD Placebo -> PF-06700841 60 mg QD Placebo -> PF-06700841 30 mg QD
Arm/Group Description PF-06700841 tablet was administered orally at 60 mg once daily (QD) during both the initial period (from Day 1 to Week 16) and the extension period (Week 17 through Week 52). PF-06700841 tablet was administered orally at 30 mg QD during both the initial period (from Day 1 to Week 16) and the extension period (Week 17 through Week 52). PF-06700841 tablet was administered orally at 10 mg QD from Day 1 to Week 16. From Week 17 to Week 52, PF-06700841 tablet was administered orally at 60 mg QD. PF-06700841 tablet was administered orally at 10 mg QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 30 mg QD during the extension period (Week 17 through Week 52). Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 60 mg during the extension period (Week 17 through Week 52). Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 30 mg during the extension period (Week 17 through Week 52).
Measure Participants 60 60 16 15 34 33
Week 2
-6.3
(21.52)
-10.9
(17.85)
-5.4
(17.59)
2.6
(19.66)
-0.1
(17.33)
-7.8
(17.02)
Week 4
-14.4
(25.55)
-20.5
(20.60)
-12.3
(18.09)
-8.9
(16.46)
-2.0
(20.76)
-3.3
(17.34)
Week 8
-19.4
(24.61)
-21.9
(24.29)
-14.0
(21.37)
-12.7
(19.88)
-11.0
(26.22)
-7.0
(22.38)
Week 12
-21.8
(26.15)
-26.2
(21.18)
-20.0
(24.36)
-12.4
(21.29)
-12.2
(26.00)
-8.0
(25.46)
Week 16
-27.8
(22.31)
-27.3
(21.62)
-26.1
(25.26)
-26.7
(19.05)
-9.3
(23.48)
-9.4
(21.11)
Week 20
-26.8
(23.84)
-31.4
(21.81)
-27.6
(23.49)
-22.8
(31.26)
-28.8
(25.44)
-25.5
(24.96)
Week 28
-29.4
(20.78)
-34.0
(23.87)
-33.9
(22.09)
-33.7
(23.46)
-31.7
(24.10)
-33.9
(23.79)
Week 36
-30.1
(23.65)
-34.1
(26.03)
-37.2
(29.10)
-30.7
(39.29)
-28.5
(21.25)
-34.9
(24.80)
Week 44
-31.5
(24.77)
-34.9
(24.41)
-38.2
(22.88)
-33.0
(39.17)
-28.7
(23.22)
-35.6
(26.55)
Week 52
-32.0
(24.63)
-35.2
(28.60)
-36.8
(23.09)
-29.6
(32.56)
-34.9
(25.24)
-32.1
(28.85)
10. Secondary Outcome
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

Outcome Measure Data

Analysis Population Description
"Overall Number of Participants Analyzed" indicated the evaluable population and included all participants who were randomized to the study and received at least one dose of the randomized study treatment. "Number Analyzed" included participants available in the evaluable population at each specified visit.
Arm/Group Title PF-06700841 60 mg QD -> PF-06700841 60 mg QD PF-06700841 30 mg QD -> PF-06700841 30 mg QD PF-06700841 10 mg QD -> PF-06700841 60 mg QD PF-06700841 10 mg QD -> PF-06700841 30 mg QD Placebo -> PF-06700841 60 mg QD Placebo -> PF-06700841 30 mg QD
Arm/Group Description PF-06700841 tablet was administered orally at 60 mg once daily (QD) during both the initial period (from Day 1 to Week 16) and the extension period (Week 17 through Week 52). PF-06700841 tablet was administered orally at 30 mg QD during both the initial period (from Day 1 to Week 16) and the extension period (Week 17 through Week 52). PF-06700841 tablet was administered orally at 10 mg QD from Day 1 to Week 16. From Week 17 to Week 52, PF-06700841 tablet was administered orally at 60 mg QD. PF-06700841 tablet was administered orally at 10 mg QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 30 mg QD during the extension period (Week 17 through Week 52). Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 60 mg during the extension period (Week 17 through Week 52). Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 30 mg during the extension period (Week 17 through Week 52).
Measure Participants 60 60 16 15 34 33
Week 2
-9.2
(15.59)
-9.0
(14.87)
-9.9
(14.55)
-1.9
(10.79)
-3.4
(11.92)
-7.2
(13.64)
Week 4
-19.8
(18.98)
-17.6
(18.37)
-18.3
(22.31)
-11.1
(13.99)
-8.8
(17.67)
-9.5
(18.08)
Week 8
-30.6
(19.43)
-25.0
(18.02)
-28.7
(15.73)
-16.4
(21.08)
-16.3
(20.97)
-11.9
(17.94)
Week 12
-35.2
(19.92)
-30.1
(16.85)
-31.1
(20.62)
-21.2
(22.01)
-16.5
(21.57)
-13.7
(22.30)
Week 16
-37.7
(20.59)
-33.7
(17.89)
-31.2
(20.00)
-32.5
(23.98)
-16.5
(23.34)
-14.4
(27.76)
Week 20
-41.8
(19.91)
-37.8
(19.48)
-38.7
(24.67)
-34.7
(26.16)
-31.0
(22.29)
-27.1
(25.41)
Week 28
-42.0
(21.42)
-36.7
(21.91)
-47.6
(21.44)
-42.4
(23.28)
-32.7
(22.03)
-38.8
(20.53)
Week 36
-42.7
(22.92)
-36.8
(23.05)
-46.3
(22.42)
-43.4
(20.30)
-38.0
(19.52)
-42.6
(20.41)
Week 44
-44.5
(20.15)
-40.6
(22.19)
-51.9
(15.81)
-43.2
(25.55)
-36.4
(20.54)
-44.9
(20.40)
Week 52
-46.6
(21.73)
-43.4
(20.36)
-54.1
(15.18)
-42.7
(23.34)
-36.3
(21.01)
-41.9
(22.66)
11. Secondary Outcome
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

Outcome Measure Data

Analysis Population Description
"Overall Number of Participants Analyzed" indicated the evaluable population and included all participants who were randomized to the study and received at least one dose of the randomized study treatment. "Number Analyzed" included participants available in the evaluable population at each specified visit.
Arm/Group Title PF-06700841 60 mg QD -> PF-06700841 60 mg QD PF-06700841 30 mg QD -> PF-06700841 30 mg QD PF-06700841 10 mg QD -> PF-06700841 60 mg QD PF-06700841 10 mg QD -> PF-06700841 30 mg QD Placebo -> PF-06700841 60 mg QD Placebo -> PF-06700841 30 mg QD
Arm/Group Description PF-06700841 tablet was administered orally at 60 mg once daily (QD) during both the initial period (from Day 1 to Week 16) and the extension period (Week 17 through Week 52). PF-06700841 tablet was administered orally at 30 mg QD during both the initial period (from Day 1 to Week 16) and the extension period (Week 17 through Week 52). PF-06700841 tablet was administered orally at 10 mg QD from Day 1 to Week 16. From Week 17 to Week 52, PF-06700841 tablet was administered orally at 60 mg QD. PF-06700841 tablet was administered orally at 10 mg QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 30 mg QD during the extension period (Week 17 through Week 52). Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 60 mg during the extension period (Week 17 through Week 52). Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 30 mg during the extension period (Week 17 through Week 52).
Measure Participants 60 60 16 15 34 33
Week 2
-0.133
(0.4273)
-0.177
(0.3489)
-0.195
(0.2886)
-0.117
(0.4212)
-0.030
(0.4572)
-0.170
(0.3091)
Week 4
-0.248
(0.5341)
-0.315
(0.3777)
-0.180
(0.2090)
-0.217
(0.3356)
-0.095
(0.4931)
-0.170
(0.3305)
Week 8
-0.343
(0.5690)
-0.421
(0.4103)
-0.188
(0.4472)
-0.277
(0.3609)
-0.184
(0.4959)
-0.249
(0.4465)
Week 12
-0.366
(0.5701)
-0.478
(0.4167)
-0.214
(0.4230)
-0.304
(0.2930)
-0.121
(0.4910)
-0.239
(0.4660)
Week 16
-0.474
(0.5158)
-0.509
(0.3994)
-0.321
(0.3914)
-0.375
(0.3385)
-0.109
(0.5271)
-0.246
(0.3729)
Week 20
-0.466
(0.5546)
-0.576
(0.4906)
-0.404
(0.4681)
-0.308
(0.4610)
-0.363
(0.4983)
-0.472
(0.4934)
Week 28
-0.524
(0.5412)
-0.583
(0.5262)
-0.519
(0.4531)
-0.490
(0.5064)
-0.422
(0.4811)
-0.517
(0.5520)
Week 36
-0.520
(0.6051)
-0.594
(0.4990)
-0.577
(0.5740)
-0.519
(0.5633)
-0.329
(0.3816)
-0.547
(0.5867)
Week 44
-0.521
(0.6197)
-0.581
(0.5321)
-0.563
(0.3830)
-0.510
(0.5576)
-0.370
(0.4210)
-0.576
(0.5757)
Week 52
-0.503
(0.6023)
-0.567
(0.4866)
-0.500
(0.5137)
-0.552
(0.5041)
-0.411
(0.3695)
-0.514
(0.5704)
12. Secondary Outcome
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

Outcome Measure Data

Analysis Population Description
"Overall Number of Participants Analyzed" included all the participants in the pharmacodynamic (PD) analysis population who received at least one dose of randomized study treatment and in whom at least one value of the PD parameter of interest was reported. "Number Analyzed" included participants available in the PD analysis population at each specified visit.
Arm/Group Title PF-06700841 60 mg QD -> PF-06700841 60 mg QD PF-06700841 30 mg QD -> PF-06700841 30 mg QD PF-06700841 10 mg QD -> PF-06700841 60 mg QD PF-06700841 10 mg QD -> PF-06700841 30 mg QD Placebo -> PF-06700841 60 mg QD Placebo -> PF-06700841 30 mg QD
Arm/Group Description PF-06700841 tablet was administered orally at 60 mg once daily (QD) during both the initial period (from Day 1 to Week 16) and the extension period (Week 17 through Week 52). PF-06700841 tablet was administered orally at 30 mg QD during both the initial period (from Day 1 to Week 16) and the extension period (Week 17 through Week 52). PF-06700841 tablet was administered orally at 10 mg QD from Day 1 to Week 16. From Week 17 to Week 52, PF-06700841 tablet was administered orally at 60 mg QD. PF-06700841 tablet was administered orally at 10 mg QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 30 mg QD during the extension period (Week 17 through Week 52). Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 60 mg during the extension period (Week 17 through Week 52). Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 30 mg during the extension period (Week 17 through Week 52).
Measure Participants 60 60 16 15 34 33
Week 2
-4.420
(8.9409)
-3.696
(11.9628)
-6.023
(19.1126)
-0.595
(1.4661)
-1.641
(10.4224)
1.462
(7.8966)
Week 4
-3.645
(11.8144)
-5.543
(11.9617)
-6.134
(19.5633)
-1.324
(1.9735)
0.010
(7.0206)
1.206
(5.4423)
Week 8
-3.828
(10.8093)
-5.102
(11.5408)
-6.029
(19.9534)
-0.573
(2.6595)
-2.598
(10.7270)
0.927
(6.2062)
Week 12
-3.759
(11.0481)
-5.881
(12.9484)
-7.335
(22.0149)
-1.177
(3.4854)
-1.061
(11.1944)
1.021
(6.6025)
Week 16
-3.695
(8.1064)
-5.809
(13.6463)
-5.420
(21.9622)
1.060
(8.7842)
-2.218
(11.6164)
-0.762
(6.5779)
Week 20
-4.581
(10.5026)
-6.014
(14.7723)
-7.879
(24.2763)
-0.989
(3.6969)
-5.982
(10.4711)
-4.718
(7.1896)
Week 28
-4.277
(12.9069)
-6.362
(13.6372)
-8.679
(24.9759)
-1.300
(3.7971)
-6.112
(10.6756)
-5.484
(10.0475)
Week 36
-4.899
(10.3015)
-5.940
(14.4219)
-9.461
(25.7767)
-1.814
(3.0658)
-6.247
(9.8145)
-5.029
(9.1947)
Week 44
-5.543
(11.7058)
-6.215
(14.2493)
-2.196
(2.2859)
-0.987
(3.7325)
-4.690
(9.9495)
-0.711
(13.7530)
Week 52
-5.167
(13.3963)
-4.880
(14.1148)
-1.586
(3.0576)
-2.028
(3.2177)
-4.324
(7.7335)
-4.722
(9.3318)
13. Secondary Outcome
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

Outcome Measure Data

Analysis Population Description
"Overall Number of Participants Analyzed" included a subgroup of participants in the evaluable population (participants who were randomized to the study and received at least one dose of the randomized study treatment) with baseline BSA ≥3% and PASI >0 . "Number Analyzed" included participants available in the evaluable population at each specified visit with baseline BSA ≥3% and PASI >0.
Arm/Group Title PF-06700841 60 mg QD -> PF-06700841 60 mg QD PF-06700841 30 mg QD -> PF-06700841 30 mg QD PF-06700841 10 mg QD -> PF-06700841 60 mg QD PF-06700841 10 mg QD -> PF-06700841 30 mg QD Placebo -> PF-06700841 60 mg QD Placebo -> PF-06700841 30 mg QD
Arm/Group Description PF-06700841 tablet was administered orally at 60 mg once daily (QD) during both the initial period (from Day 1 to Week 16) and the extension period (Week 17 through Week 52). PF-06700841 tablet was administered orally at 30 mg QD during both the initial period (from Day 1 to Week 16) and the extension period (Week 17 through Week 52). PF-06700841 tablet was administered orally at 10 mg QD from Day 1 to Week 16. From Week 17 to Week 52, PF-06700841 tablet was administered orally at 60 mg QD. PF-06700841 tablet was administered orally at 10 mg QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 30 mg QD during the extension period (Week 17 through Week 52). Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 60 mg during the extension period (Week 17 through Week 52). Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 30 mg during the extension period (Week 17 through Week 52).
Measure Participants 40 39 12 9 22 19
Week 2
5.00
8.3%
2.56
4.3%
3.85
24.1%
11.11
74.1%
2.17
6.4%
5.26
15.9%
Week 4
30.00
50%
12.82
21.4%
3.85
24.1%
11.11
74.1%
4.55
13.4%
5.26
15.9%
Week 8
45.00
75%
41.03
68.4%
25.00
156.3%
11.11
74.1%
9.09
26.7%
15.79
47.8%
Week 12
60.00
100%
48.72
81.2%
33.33
208.3%
33.33
222.2%
18.18
53.5%
21.05
63.8%
Week 16
69.23
115.4%
58.97
98.3%
58.33
364.6%
55.56
370.4%
22.73
66.9%
26.32
79.8%
Week 20
72.50
120.8%
61.54
102.6%
66.67
416.7%
55.56
370.4%
54.55
160.4%
36.84
111.6%
Week 28
70.00
116.7%
51.28
85.5%
91.67
572.9%
77.78
518.5%
63.64
187.2%
63.16
191.4%
Week 36
70.00
116.7%
64.10
106.8%
96.15
600.9%
88.89
592.6%
59.09
173.8%
47.37
143.5%
Week 44
75.00
125%
66.67
111.1%
75.00
468.8%
55.56
370.4%
63.64
187.2%
63.16
191.4%
Week 52
65.00
108.3%
66.67
111.1%
66.67
416.7%
66.67
444.5%
50.00
147.1%
57.89
175.4%
14. Secondary Outcome
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

Outcome Measure Data

Analysis Population Description
"Overall Number of Participants Analyzed" included a subgroup of participants in the evaluable population (participants who were randomized to the study and received at least one dose of the randomized study treatment) with baseline BSA ≥3% and PASI >0 . "Number Analyzed" included participants available in the evaluable population at each specified visit with baseline BSA ≥3% and PASI >0.
Arm/Group Title PF-06700841 60 mg QD -> PF-06700841 60 mg QD PF-06700841 30 mg QD -> PF-06700841 30 mg QD PF-06700841 10 mg QD -> PF-06700841 60 mg QD PF-06700841 10 mg QD -> PF-06700841 30 mg QD Placebo -> PF-06700841 60 mg QD Placebo -> PF-06700841 30 mg QD
Arm/Group Description PF-06700841 tablet was administered orally at 60 mg once daily (QD) during both the initial period (from Day 1 to Week 16) and the extension period (Week 17 through Week 52). PF-06700841 tablet was administered orally at 30 mg QD during both the initial period (from Day 1 to Week 16) and the extension period (Week 17 through Week 52). PF-06700841 tablet was administered orally at 10 mg QD from Day 1 to Week 16. From Week 17 to Week 52, PF-06700841 tablet was administered orally at 60 mg QD. PF-06700841 tablet was administered orally at 10 mg QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 30 mg QD during the extension period (Week 17 through Week 52). Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 60 mg during the extension period (Week 17 through Week 52). Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 30 mg during the extension period (Week 17 through Week 52).
Measure Participants 40 39 12 9 22 19
Week 2
1.22
2%
1.25
2.1%
3.85
24.1%
11.11
74.1%
2.17
6.4%
2.50
7.6%
Week 4
17.50
29.2%
5.13
8.6%
3.85
24.1%
11.11
74.1%
4.55
13.4%
2.50
7.6%
Week 8
35.00
58.3%
17.95
29.9%
16.67
104.2%
11.11
74.1%
2.17
6.4%
5.26
15.9%
Week 12
47.50
79.2%
25.64
42.7%
16.67
104.2%
22.22
148.1%
2.17
6.4%
10.53
31.9%
Week 16
53.85
89.8%
33.33
55.6%
33.33
208.3%
33.33
222.2%
9.09
26.7%
15.79
47.8%
Week 20
50.00
83.3%
43.59
72.7%
50.00
312.5%
44.44
296.3%
18.18
53.5%
26.32
79.8%
Week 28
52.50
87.5%
38.46
64.1%
58.33
364.6%
44.44
296.3%
50.00
147.1%
31.58
95.7%
Week 36
62.50
104.2%
48.72
81.2%
83.33
520.8%
66.67
444.5%
45.45
133.7%
36.84
111.6%
Week 44
52.50
87.5%
48.72
81.2%
66.67
416.7%
44.44
296.3%
50.00
147.1%
52.63
159.5%
Week 52
40.00
66.7%
56.41
94%
66.67
416.7%
55.56
370.4%
45.45
133.7%
47.37
143.5%
15. Secondary Outcome
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

Outcome Measure Data

Analysis Population Description
"Overall Number of Participants Analyzed" included a subgroup of participants in the evaluable population (participants who were randomized to the study and received at least one dose of the randomized study treatment) with baseline BSA ≥3% and PASI >0 . "Number Analyzed" included participants available in the evaluable population at each specified visit with baseline BSA ≥3% and PASI >0.
Arm/Group Title PF-06700841 60 mg QD -> PF-06700841 60 mg QD PF-06700841 30 mg QD -> PF-06700841 30 mg QD PF-06700841 10 mg QD -> PF-06700841 60 mg QD PF-06700841 10 mg QD -> PF-06700841 30 mg QD Placebo -> PF-06700841 60 mg QD Placebo -> PF-06700841 30 mg QD
Arm/Group Description PF-06700841 tablet was administered orally at 60 mg once daily (QD) during both the initial period (from Day 1 to Week 16) and the extension period (Week 17 through Week 52). PF-06700841 tablet was administered orally at 30 mg QD during both the initial period (from Day 1 to Week 16) and the extension period (Week 17 through Week 52). PF-06700841 tablet was administered orally at 10 mg QD from Day 1 to Week 16. From Week 17 to Week 52, PF-06700841 tablet was administered orally at 60 mg QD. PF-06700841 tablet was administered orally at 10 mg QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 30 mg QD during the extension period (Week 17 through Week 52). Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 60 mg during the extension period (Week 17 through Week 52). Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 30 mg during the extension period (Week 17 through Week 52).
Measure Participants 40 39 12 9 22 19
Week 2
1.22
2%
1.25
2.1%
3.85
24.1%
11.11
74.1%
2.17
6.4%
2.50
7.6%
Week 4
7.50
12.5%
1.25
2.1%
3.85
24.1%
5.00
33.3%
4.55
13.4%
2.50
7.6%
Week 8
20.00
33.3%
5.13
8.6%
8.33
52.1%
11.11
74.1%
2.17
6.4%
2.50
7.6%
Week 12
35.00
58.3%
7.69
12.8%
8.33
52.1%
11.11
74.1%
2.17
6.4%
5.26
15.9%
Week 16
35.90
59.8%
15.38
25.6%
16.67
104.2%
33.33
222.2%
9.09
26.7%
10.53
31.9%
Week 20
27.50
45.8%
35.90
59.8%
33.33
208.3%
44.44
296.3%
13.64
40.1%
10.53
31.9%
Week 28
35.00
58.3%
30.77
51.3%
50.00
312.5%
44.44
296.3%
40.91
120.3%
21.05
63.8%
Week 36
40.00
66.7%
35.90
59.8%
50.00
312.5%
55.56
370.4%
36.36
106.9%
21.05
63.8%
Week 44
30.00
50%
41.03
68.4%
58.33
364.6%
44.44
296.3%
31.82
93.6%
42.11
127.6%
Week 52
35.00
58.3%
38.46
64.1%
41.67
260.4%
33.33
222.2%
36.36
106.9%
42.11
127.6%
16. Secondary Outcome
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

Outcome Measure Data

Analysis Population Description
"Overall Number of Participants Analyzed" included all the participants in the evaluable population (participants who were randomized to the study and received at least one dose of the randomized study treatment) with baseline SPARCC enthesitis score>0. "Number Analyzed" included participants available in the evaluable population at each specified treatment timepoints with baseline SPARCC enthesitis score >0.
Arm/Group Title PF-06700841 60 mg QD -> PF-06700841 60 mg QD PF-06700841 30 mg QD -> PF-06700841 30 mg QD PF-06700841 10 mg QD -> PF-06700841 60 mg QD PF-06700841 10 mg QD -> PF-06700841 30 mg QD Placebo -> PF-06700841 60 mg QD Placebo -> PF-06700841 30 mg QD
Arm/Group Description PF-06700841 tablet was administered orally at 60 mg once daily (QD) during both the initial period (from Day 1 to Week 16) and the extension period (Week 17 through Week 52). PF-06700841 tablet was administered orally at 30 mg QD during both the initial period (from Day 1 to Week 16) and the extension period (Week 17 through Week 52). PF-06700841 tablet was administered orally at 10 mg QD from Day 1 to Week 16. From Week 17 to Week 52, PF-06700841 tablet was administered orally at 60 mg QD. PF-06700841 tablet was administered orally at 10 mg QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 30 mg QD during the extension period (Week 17 through Week 52). Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 60 mg during the extension period (Week 17 through Week 52). Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 30 mg during the extension period (Week 17 through Week 52).
Measure Participants 38 34 11 9 21 19
Week 2
-0.6
(1.55)
-0.3
(2.73)
-1.4
(1.86)
0.0
(1.12)
-0.2
(1.79)
-0.3
(2.67)
Week 4
-1.4
(2.41)
-0.9
(2.32)
-1.3
(2.37)
0.0
(1.41)
-1.0
(2.29)
-1.0
(2.81)
Week 8
-1.9
(2.11)
-1.9
(2.23)
-1.4
(1.80)
-1.0
(1.07)
-1.1
(2.50)
-1.2
(2.53)
Week 12
-2.1
(2.49)
-1.6
(2.22)
-2.7
(1.73)
-1.3
(1.04)
-1.7
(2.52)
-1.1
(3.00)
Week 16
-2.1
(2.68)
-1.3
(1.89)
-3.1
(1.27)
-0.3
(2.71)
-1.8
(2.94)
-1.2
(2.79)
Week 20
-2.3
(2.66)
-1.9
(2.29)
-3.2
(3.03)
-1.3
(0.89)
-2.1
(2.24)
-1.9
(2.71)
Week 28
-2.4
(2.68)
-2.3
(2.60)
-3.8
(2.05)
-1.4
(1.19)
-2.5
(2.97)
-3.1
(2.60)
Week 36
-2.6
(2.70)
-2.3
(2.28)
-3.8
(2.79)
-1.6
(1.06)
-2.1
(2.51)
-2.8
(2.60)
Week 44
-2.9
(2.56)
-2.4
(2.53)
-3.3
(1.67)
-1.6
(1.06)
-2.1
(2.57)
-3.2
(2.44)
Week 52
-3.1
(2.55)
-2.4
(2.34)
-4.8
(2.76)
-1.5
(0.76)
-2.2
(1.74)
-3.6
(2.59)
17. Secondary Outcome
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

Outcome Measure Data

Analysis Population Description
"Overall Number of Participants Analyzed" included all the participants in the evaluable population (participants who were randomized to the study and received at least one dose of the randomized study treatment) with baseline leeds enthesitis score>0. "Number Analyzed" included participants available in the evaluable population at each specified treatment timepoints with baseline leeds enthesitis score>0.
Arm/Group Title PF-06700841 60 mg QD -> PF-06700841 60 mg QD PF-06700841 30 mg QD -> PF-06700841 30 mg QD PF-06700841 10 mg QD -> PF-06700841 60 mg QD PF-06700841 10 mg QD -> PF-06700841 30 mg QD Placebo -> PF-06700841 60 mg QD Placebo -> PF-06700841 30 mg QD
Arm/Group Description PF-06700841 tablet was administered orally at 60 mg once daily (QD) during both the initial period (from Day 1 to Week 16) and the extension period (Week 17 through Week 52). PF-06700841 tablet was administered orally at 30 mg QD during both the initial period (from Day 1 to Week 16) and the extension period (Week 17 through Week 52). PF-06700841 tablet was administered orally at 10 mg QD from Day 1 to Week 16. From Week 17 to Week 52, PF-06700841 tablet was administered orally at 60 mg QD. PF-06700841 tablet was administered orally at 10 mg QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 30 mg QD during the extension period (Week 17 through Week 52). Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 60 mg during the extension period (Week 17 through Week 52). Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 30 mg during the extension period (Week 17 through Week 52).
Measure Participants 29 28 10 8 20 15
Week 2
-0.4
(0.95)
-0.4
(1.53)
-0.5
(1.27)
0.0
(0.53)
-0.1
(1.12)
-0.3
(0.82)
Week 4
-0.7
(1.56)
-0.9
(1.48)
-1.0
(1.25)
-0.1
(0.99)
-0.4
(0.75)
-0.9
(1.62)
Week 8
-1.3
(1.43)
-1.2
(1.47)
-0.5
(1.78)
-0.4
(0.98)
-0.5
(1.31)
-0.7
(1.49)
Week 12
-1.2
(1.93)
-1.5
(1.42)
-1.0
(1.22)
-1.1
(0.90)
-0.9
(0.94)
-0.9
(1.79)
Week 16
-1.4
(1.63)
-1.5
(1.45)
-1.2
(0.83)
-0.1
(2.12)
-0.9
(1.13)
-0.9
(1.54)
Week 20
-1.6
(1.52)
-1.3
(1.80)
-1.7
(2.65)
-0.9
(0.90)
-1.1
(0.90)
-1.4
(1.91)
Week 28
-1.4
(1.56)
-1.7
(1.57)
-1.9
(2.20)
-1.3
(0.76)
-1.1
(1.20)
-1.7
(1.54)
Week 36
-1.9
(1.36)
-1.8
(1.59)
-2.3
(1.50)
-1.1
(0.90)
-1.1
(1.17)
-1.7
(1.44)
Week 44
-1.8
(1.47)
-1.8
(1.65)
-2.3
(1.04)
-1.3
(0.76)
-1.2
(1.19)
-1.9
(1.41)
Week 52
-2.0
(1.54)
-1.7
(1.40)
-2.5
(0.93)
-1.0
(0.82)
-1.2
(0.73)
-1.8
(1.70)
18. Secondary Outcome
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

Outcome Measure Data

Analysis Population Description
"Overall Number of Participants Analyzed" included all the participants in evaluable population (participants who were randomized to the study and received at least one dose of the randomized study treatment) with baseline DSS >0. "Number Analyzed" included participants available in the evaluable population at each specified treatment timepoints with baseline DSS >0.
Arm/Group Title PF-06700841 60 mg QD -> PF-06700841 60 mg QD PF-06700841 30 mg QD -> PF-06700841 30 mg QD PF-06700841 10 mg QD -> PF-06700841 60 mg QD PF-06700841 10 mg QD -> PF-06700841 30 mg QD Placebo -> PF-06700841 60 mg QD Placebo -> PF-06700841 30 mg QD
Arm/Group Description PF-06700841 tablet was administered orally at 60 mg once daily (QD) during both the initial period (from Day 1 to Week 16) and the extension period (Week 17 through Week 52). PF-06700841 tablet was administered orally at 30 mg QD during both the initial period (from Day 1 to Week 16) and the extension period (Week 17 through Week 52). PF-06700841 tablet was administered orally at 10 mg QD from Day 1 to Week 16. From Week 17 to Week 52, PF-06700841 tablet was administered orally at 60 mg QD. PF-06700841 tablet was administered orally at 10 mg QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 30 mg QD during the extension period (Week 17 through Week 52). Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 60 mg during the extension period (Week 17 through Week 52). Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 30 mg during the extension period (Week 17 through Week 52).
Measure Participants 14 19 3 6 12 19
Week 2
-0.2
(2.36)
-0.7
(2.54)
-2.7
(4.62)
-0.5
(1.38)
-0.7
(1.61)
0.2
(2.28)
Week 4
-1.6
(3.30)
-2.2
(3.15)
-3.3
(3.21)
-0.8
(1.17)
-1.2
(2.59)
-0.3
(3.12)
Week 8
-3.5
(4.31)
-4.0
(3.22)
-4.3
(4.16)
-1.7
(1.37)
-2.5
(6.14)
-1.8
(2.82)
Week 12
-4.4
(3.34)
-4.5
(3.30)
-4.3
(4.93)
-3.2
(3.43)
-4.8
(7.07)
-2.8
(4.49)
Week 16
-3.7
(3.85)
-4.9
(4.06)
-4.7
(6.35)
-3.7
(4.13)
-5.4
(7.44)
-2.9
(6.01)
Week 20
-4.4
(3.31)
-4.6
(4.23)
-5.3
(5.86)
-3.7
(4.13)
-7.0
(7.44)
-4.4
(6.11)
Week 28
-3.8
(3.67)
-5.1
(4.08)
-5.3
(5.86)
-3.7
(4.13)
-6.6
(7.18)
-4.7
(7.05)
Week 36
-4.2
(4.02)
-5.1
(4.26)
-5.7
(5.69)
-3.7
(4.13)
-6.8
(7.34)
-5.3
(7.40)
Week 44
-5.0
(3.65)
-5.4
(4.01)
-5.7
(5.69)
-3.7
(4.13)
-6.8
(7.34)
-5.3
(7.40)
Week 52
-5.0
(3.65)
-5.4
(4.05)
-5.7
(5.69)
-3.7
(4.13)
-5.0
(5.40)
-5.7
(8.62)
19. Secondary Outcome
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

Outcome Measure Data

Analysis Population Description
"Overall Number of Participants Analyzed" included all the participants in evaluable population (participants who were randomized to the study and received at least one dose of the randomized study treatment) with baseline NAPSI>0. "Number Analyzed" included participants available in the evaluable population at each specified treatment timepoints with baseline NAPSI>0.
Arm/Group Title PF-06700841 60 mg QD -> PF-06700841 60 mg QD PF-06700841 30 mg QD -> PF-06700841 30 mg QD PF-06700841 10 mg QD -> PF-06700841 60 mg QD PF-06700841 10 mg QD -> PF-06700841 30 mg QD Placebo -> PF-06700841 60 mg QD Placebo -> PF-06700841 30 mg QD
Arm/Group Description PF-06700841 tablet was administered orally at 60 mg once daily (QD) during both the initial period (from Day 1 to Week 16) and the extension period (Week 17 through Week 52). PF-06700841 tablet was administered orally at 30 mg QD during both the initial period (from Day 1 to Week 16) and the extension period (Week 17 through Week 52). PF-06700841 tablet was administered orally at 10 mg QD from Day 1 to Week 16. From Week 17 to Week 52, PF-06700841 tablet was administered orally at 60 mg QD. PF-06700841 tablet was administered orally at 10 mg QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 30 mg QD during the extension period (Week 17 through Week 52). Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 60 mg during the extension period (Week 17 through Week 52). Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 30 mg during the extension period (Week 17 through Week 52).
Measure Participants 36 40 10 8 25 16
Week 2
-0.4
(1.55)
0.1
(0.65)
-0.4
(0.52)
0.3
(0.71)
-0.2
(1.04)
0.1
(0.25)
Week 4
-1.0
(2.09)
-0.5
(1.70)
-0.9
(1.10)
-0.3
(0.46)
-1.0
(2.16)
-0.3
(0.95)
Week 8
-2.0
(2.40)
-1.0
(1.49)
-1.1
(1.52)
-1.1
(1.57)
-1.3
(2.55)
-0.6
(1.55)
Week 12
-2.8
(2.54)
-1.8
(2.43)
-0.5
(2.88)
-1.9
(2.97)
-1.2
(2.62)
-1.3
(1.82)
Week 16
-3.2
(2.71)
-1.7
(2.54)
-1.5
(2.00)
-2.9
(3.08)
-1.4
(2.61)
-1.6
(1.76)
Week 20
-3.7
(2.82)
-2.3
(2.31)
-2.1
(2.41)
-3.1
(2.97)
-2.0
(2.61)
-1.9
(1.81)
Week 28
-3.9
(2.90)
-2.4
(2.56)
-3.1
(2.12)
-3.3
(2.93)
-2.2
(2.59)
-2.5
(1.83)
Week 36
-3.9
(3.06)
-2.5
(2.51)
-3.3
(1.98)
-3.3
(3.15)
-2.8
(2.71)
-2.9
(1.75)
Week 44
-4.2
(2.77)
-2.8
(2.47)
-4.2
(2.05)
-3.8
(3.19)
-2.8
(2.61)
-2.6
(1.71)
Week 52
-4.2
(2.62)
-2.6
(2.80)
-3.6
(2.07)
-3.7
(3.27)
-3.1
(2.91)
-2.7
(1.30)
20. Secondary Outcome
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

Outcome Measure Data

Analysis Population Description
"Overall Number of Participants Analyzed" indicated the evaluable population and included all participants who were randomized to the study and received at least one dose of the randomized study treatment. "Number Analyzed" included participants available in the evaluable population at each specified visit.
Arm/Group Title PF-06700841 60 mg QD -> PF-06700841 60 mg QD PF-06700841 30 mg QD -> PF-06700841 30 mg QD PF-06700841 10 mg QD -> PF-06700841 60 mg QD PF-06700841 10 mg QD -> PF-06700841 30 mg QD Placebo -> PF-06700841 60 mg QD Placebo -> PF-06700841 30 mg QD
Arm/Group Description PF-06700841 tablet was administered orally at 60 mg once daily (QD) during both the initial period (from Day 1 to Week 16) and the extension period (Week 17 through Week 52). PF-06700841 tablet was administered orally at 30 mg QD during both the initial period (from Day 1 to Week 16) and the extension period (Week 17 through Week 52). PF-06700841 tablet was administered orally at 10 mg QD from Day 1 to Week 16. From Week 17 to Week 52, PF-06700841 tablet was administered orally at 60 mg QD. PF-06700841 tablet was administered orally at 10 mg QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 30 mg QD during the extension period (Week 17 through Week 52). Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 60 mg during the extension period (Week 17 through Week 52). Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 30 mg during the extension period (Week 17 through Week 52).
Measure Participants 60 60 16 15 34 33
Week 2
-8.9
(26.88)
-11.6
(22.31)
-4.9
(12.42)
-0.5
(12.41)
-3.3
(14.50)
-7.1
(17.44)
Week 4
-17.0
(24.83)
-18.8
(25.42)
-13.2
(18.69)
-7.1
(21.61)
-11.6
(22.07)
-6.2
(24.53)
Week 8
-21.1
(26.95)
-19.7
(27.56)
-12.0
(26.52)
-16.4
(25.36)
-16.8
(26.21)
-8.1
(24.41)
Week 12
-25.1
(28.18)
-25.3
(23.75)
-18.0
(21.42)
-17.6
(23.70)
-14.4
(28.78)
-9.5
(23.74)
Week 16
-29.0
(24.78)
-24.5
(25.43)
-23.9
(21.10)
-27.8
(21.23)
-11.7
(23.36)
-9.9
(23.87)
Week 20
-29.1
(24.08)
-30.5
(23.29)
-27.3
(24.19)
-22.6
(27.92)
-36.3
(22.12)
-26.3
(29.72)
Week 28
-30.0
(24.53)
-29.7
(28.36)
-37.2
(22.80)
-38.8
(25.73)
-37.3
(25.35)
-37.2
(24.64)
Week 36
-29.1
(27.81)
-29.6
(27.90)
-42.0
(26.37)
-33.7
(27.04)
-36.0
(22.02)
-39.4
(26.35)
Week 44
-33.6
(28.52)
-32.4
(28.81)
-41.9
(19.08)
-36.8
(30.62)
-38.2
(26.65)
-42.1
(27.08)
Week 52
-33.3
(28.68)
-32.7
(29.77)
-35.6
(26.94)
-33.9
(33.45)
-39.1
(23.78)
-38.3
(30.58)
21. Secondary Outcome
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

Outcome Measure Data

Analysis Population Description
"Overall Number of Participants Analyzed" indicated the evaluable population and included all participants who were randomized to the study and received at least one dose of the randomized study treatment. "Number Analyzed" included participants available in the evaluable population at each specified visit.
Arm/Group Title PF-06700841 60 mg QD -> PF-06700841 60 mg QD PF-06700841 30 mg QD -> PF-06700841 30 mg QD PF-06700841 10 mg QD -> PF-06700841 60 mg QD PF-06700841 10 mg QD -> PF-06700841 30 mg QD Placebo -> PF-06700841 60 mg QD Placebo -> PF-06700841 30 mg QD
Arm/Group Description PF-06700841 tablet was administered orally at 60 mg once daily (QD) during both the initial period (from Day 1 to Week 16) and the extension period (Week 17 through Week 52). PF-06700841 tablet was administered orally at 30 mg QD during both the initial period (from Day 1 to Week 16) and the extension period (Week 17 through Week 52). PF-06700841 tablet was administered orally at 10 mg QD from Day 1 to Week 16. From Week 17 to Week 52, PF-06700841 tablet was administered orally at 60 mg QD. PF-06700841 tablet was administered orally at 10 mg QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 30 mg QD during the extension period (Week 17 through Week 52). Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 60 mg during the extension period (Week 17 through Week 52). Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 30 mg during the extension period (Week 17 through Week 52).
Measure Participants 60 60 16 15 34 33
Week 2
2.0
(5.82)
3.1
(5.85)
0.9
(2.60)
1.2
(6.45)
0.9
(6.95)
2.7
(6.07)
Week 4
2.4
(7.47)
5.7
(7.34)
3.7
(5.40)
3.7
(8.30)
3.0
(10.76)
2.5
(6.98)
Week 8
4.2
(8.03)
5.6
(8.44)
3.6
(5.78)
3.8
(6.24)
3.2
(10.31)
3.7
(9.92)
Week 12
4.7
(10.17)
7.3
(7.96)
3.2
(4.10)
6.1
(7.85)
5.5
(9.55)
3.8
(9.85)
Week 16
5.6
(7.74)
7.1
(9.41)
4.4
(5.40)
6.0
(6.89)
4.7
(8.10)
4.7
(8.99)
Week 20
6.6
(8.69)
9.5
(8.20)
7.2
(5.86)
7.0
(7.94)
8.9
(8.11)
9.3
(9.20)
Week 28
7.7
(9.67)
9.5
(8.22)
7.2
(7.73)
12.3
(11.48)
9.8
(10.02)
11.7
(10.41)
Week 36
7.4
(9.51)
8.4
(8.25)
7.3
(5.54)
10.6
(11.36)
9.6
(6.48)
11.3
(11.23)
Week 44
7.8
(9.00)
10.0
(9.52)
7.9
(5.07)
13.1
(11.10)
7.7
(7.89)
11.8
(11.35)
Week 52
7.8
(8.54)
10.4
(9.86)
9.4
(9.01)
12.3
(12.74)
10.5
(8.91)
10.5
(10.62)
22. Secondary Outcome
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

Outcome Measure Data

Analysis Population Description
"Overall Number of Participants Analyzed" indicated the evaluable population and included all participants who were randomized to the study and received at least one dose of the randomized study treatment. "Number Analyzed" included participants available in the evaluable population at each specified visit.
Arm/Group Title PF-06700841 60 mg QD -> PF-06700841 60 mg QD PF-06700841 30 mg QD -> PF-06700841 30 mg QD PF-06700841 10 mg QD -> PF-06700841 60 mg QD PF-06700841 10 mg QD -> PF-06700841 30 mg QD Placebo -> PF-06700841 60 mg QD Placebo -> PF-06700841 30 mg QD
Arm/Group Description PF-06700841 tablet was administered orally at 60 mg once daily (QD) during both the initial period (from Day 1 to Week 16) and the extension period (Week 17 through Week 52). PF-06700841 tablet was administered orally at 30 mg QD during both the initial period (from Day 1 to Week 16) and the extension period (Week 17 through Week 52). PF-06700841 tablet was administered orally at 10 mg QD from Day 1 to Week 16. From Week 17 to Week 52, PF-06700841 tablet was administered orally at 60 mg QD. PF-06700841 tablet was administered orally at 10 mg QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 30 mg QD during the extension period (Week 17 through Week 52). Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 60 mg during the extension period (Week 17 through Week 52). Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 30 mg during the extension period (Week 17 through Week 52).
Measure Participants 60 60 16 15 34 33
Week 4 (Physical Component Summary Score)
3.29
(7.092)
4.24
(7.602)
2.59
(5.263)
1.01
(3.944)
1.66
(5.845)
2.64
(6.299)
Week 8 (Physical Component Summary Score)
4.21
(8.297)
5.97
(8.261)
5.53
(9.387)
2.47
(3.675)
2.57
(6.457)
3.04
(5.529)
Week 12 (Physical Component Summary Score)
4.09
(8.403)
4.86
(9.010)
7.28
(7.232)
2.29
(4.283)
2.22
(6.205)
3.07
(7.330)
Week 16 (Physical Component Summary Score)
5.40
(8.239)
7.27
(8.627)
6.97
(7.223)
5.07
(4.763)
2.36
(6.842)
1.79
(6.101)
Week 20 (Physical Component Summary Score)
4.75
(8.579)
8.84
(8.231)
9.53
(8.434)
2.03
(6.756)
6.14
(7.513)
6.25
(8.447)
Week 28 (Physical Component Summary Score)
6.16
(8.691)
9.06
(9.597)
9.42
(7.751)
7.84
(7.127)
5.67
(7.933)
9.22
(8.890)
Week 36 (Physical Component Summary Score)
6.58
(9.510)
7.75
(9.223)
9.08
(9.789)
6.44
(7.245)
5.96
(6.738)
9.41
(8.940)
Week 44 (Physical Component Summary Score)
6.67
(9.541)
9.23
(9.477)
8.44
(9.527)
7.13
(6.759)
6.00
(6.937)
9.18
(8.199)
Week 52 (Physical Component Summary Score)
6.52
(9.818)
9.98
(9.150)
9.55
(9.536)
6.64
(7.925)
7.21
(8.130)
9.84
(9.347)
Week 4 (Mental Component Summary Score)
-0.28
(10.643)
3.79
(9.139)
1.24
(5.426)
3.99
(10.723)
0.45
(7.539)
-1.09
(9.805)
Week 8 (Mental Component Summary Score)
0.84
(9.810)
2.84
(10.894)
-2.05
(10.553)
6.91
(10.450)
0.29
(10.253)
0.75
(8.880)
Week 12 (Mental Component Summary Score)
0.85
(9.860)
4.99
(10.307)
0.78
(8.488)
5.15
(13.189)
1.37
(11.261)
1.50
(9.640)
Week 16 (Mental Component Summary Score)
2.25
(10.848)
2.12
(11.369)
1.01
(6.995)
4.78
(10.930)
2.83
(8.459)
3.03
(9.824)
Week 20 (Mental Component Summary Score)
2.44
(10.131)
3.59
(10.763)
2.76
(8.595)
6.58
(10.796)
4.99
(8.782)
6.72
(8.781)
Week 28 (Mental Component Summary Score)
3.85
(11.295)
3.64
(11.004)
3.54
(7.290)
8.95
(12.914)
6.08
(7.764)
6.57
(9.590)
Week 36 (Mental Component Summary Score)
3.98
(9.044)
5.41
(11.649)
4.74
(9.301)
8.53
(14.210)
6.58
(7.419)
5.47
(10.182)
Week 44 (Mental Component Summary Score)
5.14
(9.745)
4.43
(13.601)
4.29
(10.641)
7.70
(13.606)
6.33
(7.785)
4.98
(10.544)
Week 52 (Mental Component Summary Score)
4.12
(10.023)
4.33
(13.303)
3.63
(10.656)
8.69
(16.192)
5.68
(8.783)
4.35
(10.770)
23. Secondary Outcome
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

Outcome Measure Data

Analysis Population Description
"Overall Number of Participants Analyzed" indicated the evaluable population and included all participants who were randomized to the study and received at least one dose of the randomized study treatment. "Number Analyzed" included participants available in the evaluable population at each specified visit.
Arm/Group Title PF-06700841 60 mg QD -> PF-06700841 60 mg QD PF-06700841 30 mg QD -> PF-06700841 30 mg QD PF-06700841 10 mg QD -> PF-06700841 60 mg QD PF-06700841 10 mg QD -> PF-06700841 30 mg QD Placebo -> PF-06700841 60 mg QD Placebo -> PF-06700841 30 mg QD
Arm/Group Description PF-06700841 tablet was administered orally at 60 mg once daily (QD) during both the initial period (from Day 1 to Week 16) and the extension period (Week 17 through Week 52). PF-06700841 tablet was administered orally at 30 mg QD during both the initial period (from Day 1 to Week 16) and the extension period (Week 17 through Week 52). PF-06700841 tablet was administered orally at 10 mg QD from Day 1 to Week 16. From Week 17 to Week 52, PF-06700841 tablet was administered orally at 60 mg QD. PF-06700841 tablet was administered orally at 10 mg QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 30 mg QD during the extension period (Week 17 through Week 52). Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 60 mg during the extension period (Week 17 through Week 52). Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 30 mg during the extension period (Week 17 through Week 52).
Measure Participants 60 60 16 15 34 33
Week 4
8.33
13.9%
8.33
13.9%
6.25
39.1%
3.13
20.9%
1.43
4.2%
3.03
9.2%
Week 8
26.67
44.5%
21.67
36.1%
18.75
117.2%
6.67
44.5%
5.88
17.3%
12.12
36.7%
Week 12
31.67
52.8%
25.00
41.7%
18.75
117.2%
20.00
133.3%
5.88
17.3%
12.12
36.7%
Week 16
35.59
59.3%
35.00
58.3%
18.75
117.2%
20.00
133.3%
2.94
8.6%
3.03
9.2%
Week 20
45.00
75%
38.33
63.9%
25.00
156.3%
26.67
177.8%
29.41
86.5%
24.24
73.5%
Week 28
43.33
72.2%
46.67
77.8%
31.25
195.3%
33.33
222.2%
32.35
95.1%
45.45
137.7%
Week 36
43.33
72.2%
43.33
72.2%
50.00
312.5%
60.00
400%
29.41
86.5%
57.58
174.5%
Week 44
53.33
88.9%
50.00
83.3%
31.25
195.3%
46.67
311.1%
32.35
95.1%
51.52
156.1%
Week 52
46.67
77.8%
48.33
80.6%
31.25
195.3%
40.00
266.7%
41.18
121.1%
45.45
137.7%
24. Secondary Outcome
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

Outcome Measure Data

Analysis Population Description
"Overall Number of Participants Analyzed" indicated the evaluable population and included all participants who were randomized to the study and received at least one dose of the randomized study treatment. "Number Analyzed" included participants available in the evaluable population at each specified visit.
Arm/Group Title PF-06700841 60 mg QD -> PF-06700841 60 mg QD PF-06700841 30 mg QD -> PF-06700841 30 mg QD PF-06700841 10 mg QD -> PF-06700841 60 mg QD PF-06700841 10 mg QD -> PF-06700841 30 mg QD Placebo -> PF-06700841 60 mg QD Placebo -> PF-06700841 30 mg QD
Arm/Group Description PF-06700841 tablet was administered orally at 60 mg once daily (QD) during both the initial period (from Day 1 to Week 16) and the extension period (Week 17 through Week 52). PF-06700841 tablet was administered orally at 30 mg QD during both the initial period (from Day 1 to Week 16) and the extension period (Week 17 through Week 52). PF-06700841 tablet was administered orally at 10 mg QD from Day 1 to Week 16. From Week 17 to Week 52, PF-06700841 tablet was administered orally at 60 mg QD. PF-06700841 tablet was administered orally at 10 mg QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 30 mg QD during the extension period (Week 17 through Week 52). Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 60 mg during the extension period (Week 17 through Week 52). Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 30 mg during the extension period (Week 17 through Week 52).
Measure Participants 60 60 16 15 34 33
Week 4
0.82
1.4%
0.82
1.4%
2.94
18.4%
3.13
20.9%
1.43
4.2%
1.47
4.5%
Week 8
1.67
2.8%
1.67
2.8%
2.94
18.4%
3.13
20.9%
1.43
4.2%
1.47
4.5%
Week 12
0.82
1.4%
3.33
5.6%
2.94
18.4%
3.13
20.9%
1.43
4.2%
1.47
4.5%
Week 16
3.39
5.7%
5.00
8.3%
6.25
39.1%
3.13
20.9%
1.43
4.2%
1.47
4.5%
Week 20
6.67
11.1%
11.67
19.5%
12.50
78.1%
13.33
88.9%
2.94
8.6%
1.47
4.5%
Week 28
10.00
16.7%
10.00
16.7%
12.50
78.1%
6.67
44.5%
8.82
25.9%
6.06
18.4%
Week 36
15.00
25%
15.00
25%
12.50
78.1%
6.67
44.5%
5.88
17.3%
12.12
36.7%
Week 44
15.00
25%
16.67
27.8%
18.75
117.2%
20.00
133.3%
14.71
43.3%
15.15
45.9%
Week 52
20.00
33.3%
16.67
27.8%
25.00
156.3%
20.00
133.3%
11.76
34.6%
18.18
55.1%
25. Secondary Outcome
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

Outcome Measure Data

Analysis Population Description
"Overall Number of Participants Analyzed" included all the participants in the evaluable population (participants who were randomized to the study and received at least one dose of the randomized study treatment) with baseline DAREA/DAPSA. "Number Analyzed" included participants available in the evaluable population at each specified treatment timepoints with baseline DAREA/DAPSA.
Arm/Group Title PF-06700841 60 mg QD -> PF-06700841 60 mg QD PF-06700841 30 mg QD -> PF-06700841 30 mg QD PF-06700841 10 mg QD -> PF-06700841 60 mg QD PF-06700841 10 mg QD -> PF-06700841 30 mg QD Placebo -> PF-06700841 60 mg QD Placebo -> PF-06700841 30 mg QD
Arm/Group Description PF-06700841 tablet was administered orally at 60 mg once daily (QD) during both the initial period (from Day 1 to Week 16) and the extension period (Week 17 through Week 52). PF-06700841 tablet was administered orally at 30 mg QD during both the initial period (from Day 1 to Week 16) and the extension period (Week 17 through Week 52). PF-06700841 tablet was administered orally at 10 mg QD from Day 1 to Week 16. From Week 17 to Week 52, PF-06700841 tablet was administered orally at 60 mg QD. PF-06700841 tablet was administered orally at 10 mg QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 30 mg QD during the extension period (Week 17 through Week 52). Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 60 mg during the extension period (Week 17 through Week 52). Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 30 mg during the extension period (Week 17 through Week 52).
Measure Participants 60 60 16 15 34 33
Week 4
-14.05
(11.826)
-13.99
(10.166)
-14.15
(14.294)
-9.81
(13.841)
-7.11
(8.738)
-9.08
(12.074)
Week 8
-20.36
(11.211)
-17.55
(11.664)
-19.19
(11.720)
-14.33
(15.143)
-12.46
(12.905)
-10.98
(15.222)
Week 12
-21.93
(12.582)
-20.91
(11.985)
-24.91
(15.556)
-17.77
(18.471)
-14.68
(12.943)
-13.04
(15.072)
Week 16
-25.15
(12.582)
-23.55
(12.040)
-26.65
(16.982)
-25.89
(18.513)
-15.83
(12.918)
-14.45
(15.150)
Week 20
-26.75
(13.625)
-25.24
(12.152)
-30.63
(17.150)
-27.01
(22.334)
-23.53
(13.606)
-23.63
(13.640)
Week 28
-27.13
(12.807)
-25.38
(13.129)
-32.63
(18.437)
-31.41
(22.145)
-23.54
(12.375)
-27.55
(14.831)
Week 36
-27.21
(14.456)
-25.84
(13.170)
-34.98
(19.857)
-31.53
(24.046)
-25.57
(11.445)
-28.22
(15.793)
Week 44
-28.39
(14.445)
-27.54
(12.744)
-36.61
(14.597)
-30.22
(27.532)
-26.43
(10.880)
-29.59
(15.962)
Week 52
-28.56
(15.578)
-27.40
(13.429)
-37.81
(14.251)
-30.32
(22.795)
-26.45
(11.114)
-28.95
(17.706)
26. Secondary Outcome
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

Outcome Measure Data

Analysis Population Description
"Overall Number of Participants Analyzed" indicated the evaluable population and included all participants who were randomized to the study and received at least one dose of the randomized study treatment. "Number Analyzed" included participants available in the evaluable population at each specified treatment timepoints.
Arm/Group Title PF-06700841 60 mg QD -> PF-06700841 60 mg QD PF-06700841 30 mg QD -> PF-06700841 30 mg QD PF-06700841 10 mg QD -> PF-06700841 60 mg QD PF-06700841 10 mg QD -> PF-06700841 30 mg QD Placebo -> PF-06700841 60 mg QD Placebo -> PF-06700841 30 mg QD
Arm/Group Description PF-06700841 tablet was administered orally at 60 mg once daily (QD) during both the initial period (from Day 1 to Week 16) and the extension period (Week 17 through Week 52). PF-06700841 tablet was administered orally at 30 mg QD during both the initial period (from Day 1 to Week 16) and the extension period (Week 17 through Week 52). PF-06700841 tablet was administered orally at 10 mg QD from Day 1 to Week 16. From Week 17 to Week 52, PF-06700841 tablet was administered orally at 60 mg QD. PF-06700841 tablet was administered orally at 10 mg QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 30 mg QD during the extension period (Week 17 through Week 52). Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 60 mg during the extension period (Week 17 through Week 52). Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 30 mg during the extension period (Week 17 through Week 52).
Measure Participants 60 60 16 15 34 33
Week 4
50.00
83.3%
55.00
91.7%
50.00
312.5%
40.00
266.7%
26.47
77.9%
21.21
64.3%
Week 8
66.67
111.1%
60.00
100%
56.25
351.6%
40.00
266.7%
38.24
112.5%
45.45
137.7%
Week 12
66.67
111.1%
75.00
125%
62.50
390.6%
60.00
400%
52.94
155.7%
45.45
137.7%
Week 16
83.05
138.4%
75.00
125%
62.50
390.6%
66.67
444.5%
50.00
147.1%
48.48
146.9%
Week 20
78.33
130.6%
81.67
136.1%
56.25
351.6%
60.00
400%
70.59
207.6%
72.73
220.4%
Week 28
81.67
136.1%
80.00
133.3%
68.75
429.7%
73.33
488.9%
73.53
216.3%
75.76
229.6%
Week 36
66.67
111.1%
75.00
125%
68.75
429.7%
80.00
533.3%
67.65
199%
84.85
257.1%
Week 44
66.67
111.1%
78.33
130.6%
56.25
351.6%
73.33
488.9%
58.82
173%
75.76
229.6%
Week 52
58.33
97.2%
70.00
116.7%
56.25
351.6%
66.67
444.5%
64.71
190.3%
66.67
202%
27. Secondary Outcome
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

Outcome Measure Data

Analysis Population Description
"Overall Number of Participants Analyzed" indicated the evaluable population and included all participants who were randomized to the study and received at least one dose of the randomized study treatment. "Number Analyzed" included participants available in the evaluable population at each specified treatment timepoints.
Arm/Group Title PF-06700841 60 mg QD -> PF-06700841 60 mg QD PF-06700841 30 mg QD -> PF-06700841 30 mg QD PF-06700841 10 mg QD -> PF-06700841 60 mg QD PF-06700841 10 mg QD -> PF-06700841 30 mg QD Placebo -> PF-06700841 60 mg QD Placebo -> PF-06700841 30 mg QD
Arm/Group Description PF-06700841 tablet was administered orally at 60 mg once daily (QD) during both the initial period (from Day 1 to Week 16) and the extension period (Week 17 through Week 52). PF-06700841 tablet was administered orally at 30 mg QD during both the initial period (from Day 1 to Week 16) and the extension period (Week 17 through Week 52). PF-06700841 tablet was administered orally at 10 mg QD from Day 1 to Week 16. From Week 17 to Week 52, PF-06700841 tablet was administered orally at 60 mg QD. PF-06700841 tablet was administered orally at 10 mg QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 30 mg QD during the extension period (Week 17 through Week 52). Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 60 mg during the extension period (Week 17 through Week 52). Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 30 mg during the extension period (Week 17 through Week 52).
Measure Participants 60 60 16 15 34 33
Week 4
-1.22
(1.119)
-1.31
(1.090)
-0.94
(0.957)
-0.65
(0.653)
-0.56
(0.655)
-0.54
(0.897)
Week 8
-1.79
(1.295)
-1.65
(1.262)
-1.37
(1.127)
-1.14
(1.122)
-1.02
(0.988)
-0.67
(1.045)
Week 12
-2.10
(1.380)
-1.93
(1.278)
-1.67
(0.996)
-1.61
(1.106)
-1.04
(1.101)
-0.80
(1.158)
Week 16
-2.31
(1.302)
-2.20
(1.354)
-1.87
(1.024)
-2.18
(1.286)
-1.08
(1.127)
-0.90
(1.193)
Week 20
-2.48
(1.338)
-2.48
(1.474)
-2.49
(1.199)
-2.18
(1.441)
-2.37
(1.202)
-2.10
(1.367)
Week 28
-2.62
(1.354)
-2.60
(1.642)
-2.90
(1.279)
-3.18
(1.484)
-2.48
(1.181)
-2.81
(1.302)
Week 36
-2.73
(1.509)
-2.59
(1.644)
-3.08
(1.539)
-2.97
(1.550)
-2.69
(1.043)
-2.96
(1.425)
Week 44
-2.95
(1.421)
-2.85
(1.637)
-3.25
(0.819)
-3.23
(1.833)
-2.73
(1.157)
-3.23
(1.508)
Week 52
-3.03
(1.487)
-2.98
(1.568)
-3.36
(0.826)
-3.14
(1.461)
-2.84
(1.399)
-3.07
(1.775)
28. Secondary Outcome
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

Outcome Measure Data

Analysis Population Description
All participants who received at least one dose of the randomized study treatment.
Arm/Group Title PF-06700841 60 mg QD -> PF-06700841 60 mg QD PF-06700841 30 mg QD -> PF-06700841 30 mg QD PF-06700841 10 mg QD -> PF-06700841 60 mg QD PF-06700841 10 mg QD -> PF-06700841 30 mg QD Placebo -> PF-06700841 60 mg QD Placebo -> PF-06700841 30 mg QD
Arm/Group Description PF-06700841 tablet was administered orally at 60 mg once daily (QD) during both the initial period (from Day 1 to Week 16) and the extension period (Week 17 through Week 52). PF-06700841 tablet was administered orally at 30 mg QD during both the initial period (from Day 1 to Week 16) and the extension period (Week 17 through Week 52). PF-06700841 tablet was administered orally at 10 mg QD from Day 1 to Week 16. From Week 17 to Week 52, PF-06700841 tablet was administered orally at 60 mg QD. PF-06700841 tablet was administered orally at 10 mg QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 30 mg QD during the extension period (Week 17 through Week 52). Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 60 mg during the extension period (Week 17 through Week 52). Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 30 mg during the extension period (Week 17 through Week 52).
Measure Participants 60 60 16 15 34 33
Participants with AEs
46
76.7%
45
75%
10
62.5%
10
66.7%
24
70.6%
25
75.8%
Participants with SAEs
1
1.7%
8
13.3%
0
0%
0
0%
1
2.9%
2
6.1%
Participants with severe AEs
1
1.7%
6
10%
0
0%
0
0%
1
2.9%
2
6.1%
Participants with dose reduction or temporary discontinuation due to AEs
18
30%
14
23.3%
4
25%
3
20%
4
11.8%
8
24.2%
29. Secondary Outcome
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

Outcome Measure Data

Analysis Population Description
All participants who received at least one dose of the randomized study treatment.
Arm/Group Title PF-06700841 60 mg QD -> PF-06700841 60 mg QD PF-06700841 30 mg QD -> PF-06700841 30 mg QD PF-06700841 10 mg QD -> PF-06700841 60 mg QD PF-06700841 10 mg QD -> PF-06700841 30 mg QD Placebo -> PF-06700841 60 mg QD Placebo -> PF-06700841 30 mg QD
Arm/Group Description PF-06700841 tablet was administered orally at 60 mg once daily (QD) during both the initial period (from Day 1 to Week 16) and the extension period (Week 17 through Week 52). PF-06700841 tablet was administered orally at 30 mg QD during both the initial period (from Day 1 to Week 16) and the extension period (Week 17 through Week 52). PF-06700841 tablet was administered orally at 10 mg QD from Day 1 to Week 16. From Week 17 to Week 52, PF-06700841 tablet was administered orally at 60 mg QD. PF-06700841 tablet was administered orally at 10 mg QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 30 mg QD during the extension period (Week 17 through Week 52). Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 60 mg during the extension period (Week 17 through Week 52). Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 30 mg during the extension period (Week 17 through Week 52).
Measure Participants 60 60 16 15 34 33
Participants with AEs
17
28.3%
15
25%
6
37.5%
2
13.3%
11
32.4%
10
30.3%
Participants with SAEs
0
0%
1
1.7%
0
0%
0
0%
1
2.9%
1
3%
Participants with severe AEs
0
0%
1
1.7%
0
0%
0
0%
1
2.9%
1
3%
Participants with dose reduction or temporary discontinuation due to AEs
8
13.3%
5
8.3%
4
25%
1
6.7%
1
2.9%
3
9.1%
30. Secondary Outcome
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

Outcome Measure Data

Analysis Population Description
All participants who received at least one dose of the randomized study treatment.
Arm/Group Title PF-06700841 60 mg QD -> PF-06700841 60 mg QD PF-06700841 30 mg QD -> PF-06700841 30 mg QD PF-06700841 10 mg QD -> PF-06700841 60 mg QD PF-06700841 10 mg QD -> PF-06700841 30 mg QD Placebo -> PF-06700841 60 mg QD Placebo -> PF-06700841 30 mg QD
Arm/Group Description PF-06700841 tablet was administered orally at 60 mg once daily (QD) during both the initial period (from Day 1 to Week 16) and the extension period (Week 17 through Week 52). PF-06700841 tablet was administered orally at 30 mg QD during both the initial period (from Day 1 to Week 16) and the extension period (Week 17 through Week 52). PF-06700841 tablet was administered orally at 10 mg QD from Day 1 to Week 16. From Week 17 to Week 52, PF-06700841 tablet was administered orally at 60 mg QD. PF-06700841 tablet was administered orally at 10 mg QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 30 mg QD during the extension period (Week 17 through Week 52). Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 60 mg during the extension period (Week 17 through Week 52). Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 30 mg during the extension period (Week 17 through Week 52).
Measure Participants 60 60 16 15 34 33
Otitis media acute
0
0%
1
1.7%
0
0%
0
0%
0
0%
0
0%
Upper respiratory tract infection
0
0%
0
0%
0
0%
0
0%
0
0%
1
3%
Psoriasis
0
0%
0
0%
0
0%
0
0%
0
0%
1
3%

Adverse Events

Time Frame From the time the participants received the study treatment up to 28 days after the last treatment administration (approximately 56 weeks).
Adverse Event Reporting Description The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment. The participants were analyzed according to the study treatment they actually received.
Arm/Group Title PF-06700841 60 mg QD -> PF-06700841 60 mg QD PF-06700841 30 mg QD -> PF-06700841 30 mg QD PF-06700841 10 mg QD -> PF-06700841 60 mg QD PF-06700841 10 mg QD -> PF-06700841 30 mg QD Placebo -> PF-06700841 60 mg QD Placebo -> PF-06700841 30 mg QD
Arm/Group Description PF-06700841 tablet was administered orally at 60 mg once daily (QD) during both the initial period (from Day 1 to Week 16) and the extension period (Week 17 through Week 52). PF-06700841 tablet was administered orally at 30 mg QD during both the initial period (from Day 1 to Week 16) and the extension period (Week 17 through Week 52). PF-06700841 tablet was administered orally at 10 mg QD from Day 1 to Week 16. From Week 17 to Week 52, PF-06700841 tablet was administered orally at 60 mg QD. PF-06700841 tablet was administered orally at 10 mg QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 30 mg QD during the extension period (Week 17 through Week 52). Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 60 mg during the extension period (Week 17 through Week 52). Placebo matched to PF-06700841 tablet was administered orally QD during the initial period (from Day 1 to Week 16) and PF-06700841 tablet was administered orally at 30 mg during the extension period (Week 17 through Week 52).
All Cause Mortality
PF-06700841 60 mg QD -> PF-06700841 60 mg QD PF-06700841 30 mg QD -> PF-06700841 30 mg QD PF-06700841 10 mg QD -> PF-06700841 60 mg QD PF-06700841 10 mg QD -> PF-06700841 30 mg QD Placebo -> PF-06700841 60 mg QD Placebo -> PF-06700841 30 mg QD
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/60 (0%) 0/60 (0%) 0/16 (0%) 0/15 (0%) 0/34 (0%) 0/33 (0%)
Serious Adverse Events
PF-06700841 60 mg QD -> PF-06700841 60 mg QD PF-06700841 30 mg QD -> PF-06700841 30 mg QD PF-06700841 10 mg QD -> PF-06700841 60 mg QD PF-06700841 10 mg QD -> PF-06700841 30 mg QD Placebo -> PF-06700841 60 mg QD Placebo -> PF-06700841 30 mg QD
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 1/60 (1.7%) 8/60 (13.3%) 0/16 (0%) 0/15 (0%) 1/34 (2.9%) 2/33 (6.1%)
Gastrointestinal disorders
Duodenal ulcer 1/60 (1.7%) 0/60 (0%) 0/16 (0%) 0/15 (0%) 0/34 (0%) 0/33 (0%)
Hepatobiliary disorders
Cholecystitis chronic 1/60 (1.7%) 0/60 (0%) 0/16 (0%) 0/15 (0%) 0/34 (0%) 0/33 (0%)
Infections and infestations
Appendicitis 0/60 (0%) 1/60 (1.7%) 0/16 (0%) 0/15 (0%) 0/34 (0%) 0/33 (0%)
COVID-19 pneumonia 0/60 (0%) 0/60 (0%) 0/16 (0%) 0/15 (0%) 1/34 (2.9%) 0/33 (0%)
Otitis media acute 0/60 (0%) 1/60 (1.7%) 0/16 (0%) 0/15 (0%) 0/34 (0%) 0/33 (0%)
Pneumonia 0/60 (0%) 1/60 (1.7%) 0/16 (0%) 0/15 (0%) 0/34 (0%) 0/33 (0%)
Pneumonia viral 0/60 (0%) 0/60 (0%) 0/16 (0%) 0/15 (0%) 0/34 (0%) 1/33 (3%)
Varicella 0/60 (0%) 1/60 (1.7%) 0/16 (0%) 0/15 (0%) 0/34 (0%) 0/33 (0%)
Injury, poisoning and procedural complications
Radius fracture 0/60 (0%) 1/60 (1.7%) 0/16 (0%) 0/15 (0%) 0/34 (0%) 0/33 (0%)
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder 0/60 (0%) 1/60 (1.7%) 0/16 (0%) 0/15 (0%) 0/34 (0%) 0/33 (0%)
Synovitis 0/60 (0%) 1/60 (1.7%) 0/16 (0%) 0/15 (0%) 0/34 (0%) 0/33 (0%)
Nervous system disorders
Lumbar radiculopathy 0/60 (0%) 1/60 (1.7%) 0/16 (0%) 0/15 (0%) 0/34 (0%) 0/33 (0%)
Neuralgia 0/60 (0%) 1/60 (1.7%) 0/16 (0%) 0/15 (0%) 0/34 (0%) 0/33 (0%)
Vascular encephalopathy 0/60 (0%) 1/60 (1.7%) 0/16 (0%) 0/15 (0%) 0/34 (0%) 0/33 (0%)
Skin and subcutaneous tissue disorders
Psoriasis 0/60 (0%) 0/60 (0%) 0/16 (0%) 0/15 (0%) 0/34 (0%) 1/33 (3%)
Other (Not Including Serious) Adverse Events
PF-06700841 60 mg QD -> PF-06700841 60 mg QD PF-06700841 30 mg QD -> PF-06700841 30 mg QD PF-06700841 10 mg QD -> PF-06700841 60 mg QD PF-06700841 10 mg QD -> PF-06700841 30 mg QD Placebo -> PF-06700841 60 mg QD Placebo -> PF-06700841 30 mg QD
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 37/60 (61.7%) 34/60 (56.7%) 10/16 (62.5%) 10/15 (66.7%) 18/34 (52.9%) 20/33 (60.6%)
Blood and lymphatic system disorders
Anaemia 2/60 (3.3%) 2/60 (3.3%) 0/16 (0%) 0/15 (0%) 3/34 (8.8%) 1/33 (3%)
Leukopenia 1/60 (1.7%) 0/60 (0%) 0/16 (0%) 1/15 (6.7%) 0/34 (0%) 0/33 (0%)
Neutropenia 3/60 (5%) 0/60 (0%) 0/16 (0%) 1/15 (6.7%) 1/34 (2.9%) 0/33 (0%)
Gastrointestinal disorders
Abdominal pain upper 4/60 (6.7%) 0/60 (0%) 0/16 (0%) 1/15 (6.7%) 0/34 (0%) 0/33 (0%)
Aphthous ulcer 0/60 (0%) 0/60 (0%) 1/16 (6.3%) 0/15 (0%) 0/34 (0%) 0/33 (0%)
Constipation 1/60 (1.7%) 0/60 (0%) 1/16 (6.3%) 0/15 (0%) 0/34 (0%) 0/33 (0%)
Dyspepsia 1/60 (1.7%) 0/60 (0%) 1/16 (6.3%) 1/15 (6.7%) 0/34 (0%) 1/33 (3%)
Nausea 4/60 (6.7%) 1/60 (1.7%) 0/16 (0%) 0/15 (0%) 3/34 (8.8%) 1/33 (3%)
General disorders
Fatigue 3/60 (5%) 1/60 (1.7%) 1/16 (6.3%) 0/15 (0%) 1/34 (2.9%) 0/33 (0%)
Hepatobiliary disorders
Liver disorder 0/60 (0%) 0/60 (0%) 1/16 (6.3%) 0/15 (0%) 0/34 (0%) 0/33 (0%)
Infections and infestations
Bronchitis 4/60 (6.7%) 0/60 (0%) 1/16 (6.3%) 2/15 (13.3%) 1/34 (2.9%) 1/33 (3%)
COVID-19 1/60 (1.7%) 2/60 (3.3%) 0/16 (0%) 1/15 (6.7%) 1/34 (2.9%) 2/33 (6.1%)
Cystitis 1/60 (1.7%) 0/60 (0%) 0/16 (0%) 0/15 (0%) 2/34 (5.9%) 0/33 (0%)
Gastroenteritis 2/60 (3.3%) 1/60 (1.7%) 0/16 (0%) 1/15 (6.7%) 0/34 (0%) 0/33 (0%)
Herpes zoster 1/60 (1.7%) 1/60 (1.7%) 1/16 (6.3%) 0/15 (0%) 0/34 (0%) 0/33 (0%)
Nasopharyngitis 8/60 (13.3%) 5/60 (8.3%) 0/16 (0%) 2/15 (13.3%) 1/34 (2.9%) 4/33 (12.1%)
Oral herpes 2/60 (3.3%) 2/60 (3.3%) 1/16 (6.3%) 1/15 (6.7%) 0/34 (0%) 0/33 (0%)
Pharyngitis 2/60 (3.3%) 2/60 (3.3%) 0/16 (0%) 0/15 (0%) 0/34 (0%) 2/33 (6.1%)
Pneumonia 2/60 (3.3%) 1/60 (1.7%) 1/16 (6.3%) 0/15 (0%) 0/34 (0%) 1/33 (3%)
Respiratory tract infection 0/60 (0%) 0/60 (0%) 0/16 (0%) 1/15 (6.7%) 0/34 (0%) 1/33 (3%)
Upper respiratory tract infection 7/60 (11.7%) 5/60 (8.3%) 0/16 (0%) 0/15 (0%) 2/34 (5.9%) 3/33 (9.1%)
Urinary tract infection 4/60 (6.7%) 4/60 (6.7%) 1/16 (6.3%) 1/15 (6.7%) 1/34 (2.9%) 0/33 (0%)
Vulvovaginal mycotic infection 0/60 (0%) 0/60 (0%) 1/16 (6.3%) 0/15 (0%) 0/34 (0%) 0/33 (0%)
Investigations
Alanine aminotransferase increased 5/60 (8.3%) 7/60 (11.7%) 1/16 (6.3%) 1/15 (6.7%) 2/34 (5.9%) 0/33 (0%)
Aspartate aminotransferase increased 3/60 (5%) 3/60 (5%) 0/16 (0%) 1/15 (6.7%) 2/34 (5.9%) 1/33 (3%)
Blood creatine phosphokinase increased 4/60 (6.7%) 4/60 (6.7%) 1/16 (6.3%) 0/15 (0%) 1/34 (2.9%) 2/33 (6.1%)
Electrocardiogram QT prolonged 1/60 (1.7%) 0/60 (0%) 1/16 (6.3%) 0/15 (0%) 2/34 (5.9%) 0/33 (0%)
Hepatic enzyme increased 2/60 (3.3%) 0/60 (0%) 1/16 (6.3%) 0/15 (0%) 0/34 (0%) 0/33 (0%)
Transaminases increased 1/60 (1.7%) 0/60 (0%) 1/16 (6.3%) 0/15 (0%) 0/34 (0%) 0/33 (0%)
Weight increased 1/60 (1.7%) 1/60 (1.7%) 0/16 (0%) 0/15 (0%) 2/34 (5.9%) 0/33 (0%)
Musculoskeletal and connective tissue disorders
Back pain 0/60 (0%) 1/60 (1.7%) 1/16 (6.3%) 0/15 (0%) 0/34 (0%) 2/33 (6.1%)
Psoriatic arthropathy 1/60 (1.7%) 1/60 (1.7%) 0/16 (0%) 0/15 (0%) 1/34 (2.9%) 2/33 (6.1%)
Spinal pain 1/60 (1.7%) 1/60 (1.7%) 1/16 (6.3%) 1/15 (6.7%) 0/34 (0%) 1/33 (3%)
Nervous system disorders
Headache 5/60 (8.3%) 4/60 (6.7%) 2/16 (12.5%) 1/15 (6.7%) 1/34 (2.9%) 3/33 (9.1%)
Vertebrobasilar insufficiency 0/60 (0%) 0/60 (0%) 0/16 (0%) 1/15 (6.7%) 0/34 (0%) 0/33 (0%)
Psychiatric disorders
Depression 0/60 (0%) 0/60 (0%) 1/16 (6.3%) 0/15 (0%) 0/34 (0%) 0/33 (0%)
Respiratory, thoracic and mediastinal disorders
Respiratory disorder 0/60 (0%) 1/60 (1.7%) 0/16 (0%) 1/15 (6.7%) 0/34 (0%) 0/33 (0%)
Upper respiratory tract inflammation 0/60 (0%) 0/60 (0%) 1/16 (6.3%) 0/15 (0%) 0/34 (0%) 0/33 (0%)
Skin and subcutaneous tissue disorders
Acne 1/60 (1.7%) 2/60 (3.3%) 1/16 (6.3%) 0/15 (0%) 1/34 (2.9%) 0/33 (0%)
Psoriasis 1/60 (1.7%) 0/60 (0%) 1/16 (6.3%) 0/15 (0%) 1/34 (2.9%) 2/33 (6.1%)
Rash 2/60 (3.3%) 0/60 (0%) 1/16 (6.3%) 0/15 (0%) 0/34 (0%) 0/33 (0%)
Skin mass 0/60 (0%) 0/60 (0%) 1/16 (6.3%) 0/15 (0%) 0/34 (0%) 0/33 (0%)
Urticaria 0/60 (0%) 0/60 (0%) 0/16 (0%) 0/15 (0%) 0/34 (0%) 2/33 (6.1%)
Vascular disorders
Hypertension 5/60 (8.3%) 2/60 (3.3%) 1/16 (6.3%) 0/15 (0%) 1/34 (2.9%) 1/33 (3%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.

Results Point of Contact

Name/Title Pfizer ClinicalTrials.gov Call Center
Organization Pfizer, Inc.
Phone 1-800-718-1021
Email ClinicalTrials.gov_Inquiries@pfizer.com
Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT03963401
Other Study ID Numbers:
  • B7931030
  • 2018-004241-16
First Posted:
May 24, 2019
Last Update Posted:
Aug 4, 2021
Last Verified:
Aug 1, 2021