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出境医 / 临床实验 / A Study to Evaluate the Efficacy and Safety of PF-06700841 in Subjects With Active Psoriatic Arthritis

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

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
Psoriatic Arthritis Drug: PF-06700841 Other: Placebo Phase 2

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
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 : June 13, 2019
Actual Primary Completion Date : April 6, 2020
Actual Study Completion Date : January 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. The proportion of subjects achieving an ACR20 response [ Time Frame: Week 16 ]
    The proportion of subjects achieving an American College of Rheumatology 20 (ACR20) response at Week 16.


Secondary Outcome Measures :
  1. The proportion of TNF-naive subjects achieving an ACR20 response [ Time Frame: Week 16 ]
    The proportion of subjects achieving an ACR20 response at Week 16 in the subgroup of subjects who are TNF-alpha inhibitor naïve.

  2. The proportion of subjects achieving an ACR20 response [ Time Frame: Week 2, 4, 8, 12, 20, 28, 36, 44, and 52 ]
    The proportion of subjects achieving an ACR20 response at all treatment timepoints except Week 16

  3. The proportion of subjects achieving an ACR50 response [ Time Frame: Week 2, 4, 8, 12, 16, 20, 28, 36, 44, and 52 ]
    The proportion of subjects achieving an ACR50 response at all treatment timepoints

  4. The proportion of subjects achieving an ACR70 response [ Time Frame: Week 2, 4, 8, 12, 16, 20, 28, 36, 44, and 52 ]
    The proportion of subjects achieving an ACR70 response at all treatment timepoints

  5. Change from baseline in the ACR response criteria components [ Time Frame: Week 2, 4, 8, 12, 16, 20, 28, 36, 44, and 52 ]
    Change from baseline in the ACR response criteria components (Tender/painful joint count, Swollen joint count, Patient's Assessment of Arthritis Pain, Patient's Global Assessment of Arthritis, Physician's Global Assessment of Arthritis, Health Assessment Questionnaire [HAQ] disability index [DI], and hsCRP)

  6. The proportion of subjects achieving a Psoriasis Area and Severity Index 75/90/100 (PASI75/90/100) response [ Time Frame: Week 2, 4, 8, 12, 16, 20, 28, 36, 44, and 52 ]
    The proportion of subjects achieving a Psoriasis Area and Severity Index 75/90/100 (PASI75/90/100) response at all treatment timepoints

  7. Change from baseline in the enthesitis score using the Spondyloarthritis Research Consortium of Canada [SPARCC] Enthesitis Index. [ Time Frame: Week 2, 4, 8, 12, 16, 20, 28, 36, 44, and 52 ]
    Change from baseline in the enthesitis score using the Spondyloarthritis Research Consortium of Canada [SPARCC] Enthesitis Index.

  8. Change from baseline in the enthesitis score using the Leeds Enthesitis Index. [ Time Frame: Week 2, 4, 8, 12, 16, 20, 28, 36, 44, and 52 ]
    Change from baseline in the enthesitis score using the Leeds Enthesitis Index.

  9. Change from baseline in the Dactylitis Severity Score [ Time Frame: Week 2, 4, 8, 12, 16, 20, 28, 36, 44, and 52 ]
    Change from baseline in the Dactylitis Severity Score at all treatment timepoints

  10. Change from baseline in the Nail Psoriasis Severity Index (NAPSI) Score [ Time Frame: Week 2, 4, 8, 12, 16, 20, 28, 36, 44, and 52 ]
    Change from baseline in the Nail Psoriasis Severity Index (NAPSI) Score at all treatment timepoints

  11. Change from baseline in the Patient's Global Joint and Skin Assessment Visual Analog Scale (PGJS VAS) [ Time Frame: Week 2, 4, 8, 12, 16, 20, 28, 36, 44, and 52 ]
    Change from baseline in the Patient's Global Joint and Skin Assessment Visual Analog Scale (PGJS VAS) at all treatment timepoints. Scale will be 100 mm in length.

  12. Change from baseline in the Functional Assessment of Chronic Illness Therapy Fatigue (FACIT Fatigue) [ Time Frame: Week 2, 4, 8, 12, 16, 20, 28, 36, 44, and 52 ]
    Change from baseline in the Functional Assessment of Chronic Illness Therapy Fatigue (FACIT Fatigue) at all treatment timepoints

  13. Change from baseline in the Short Form 36 Health Survey (SF 36) Version 2, Acute [ Time Frame: Week 4, 8, 12, 16, 20, 28, 36, 44, and 52 ]
    Change from baseline in the Short Form 36 Health Survey (SF 36) Version 2, Acute, at all treatment timepoints except Week 2

  14. The proportion of subjects achieving Minimal Disease Activity (MDA) and Very Low Disease Activity (VLDA) response [ Time Frame: Week 4, 8, 12, 16, 20, 28, 36, 44, and 52 ]
    The proportion of subjects achieving Minimal Disease Activity (MDA) and Very Low Disease Activity (VLDA) response at all treatment timepoints except Week 2

  15. Change from baseline in the Disease Activity Index for Reactive Arthritis/PsA (DAREA/DAPSA) [ Time Frame: Week 4, 8, 12, 16, 20, 28, 36, 44, and 52 ]
    Change from baseline in the Disease Activity Index for Reactive Arthritis/PsA (DAREA/DAPSA)

  16. The proportion of subjects achieving the Psoriatic Arthritis Response Criteria (PsARC) [ Time Frame: Week 4, 8, 12, 16, 20, 28, 36, 44, and 52 ]
    The proportion of subjects achieving the Psoriatic Arthritis Response Criteria (PsARC) at all treatment timepoints except Week 2

  17. Change from baseline in the Psoriatic Arthritis Disease Activity Score (PASDAS) [ Time Frame: Week 4, 8, 12, 16, 20, 28, 36, 44, and 52 ]
    Change from baseline in the Psoriatic Arthritis Disease Activity Score (PASDAS) at all treatment timepoints except Week 2

  18. Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline through Week 56 ]
  19. Number of Participants Who Discontinued From the Study Due to Treatment-Emergent AEs [ Time Frame: Baseline through Week 56 ]

Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Active arthritis at screening/baseline as indicated by >/= 3 tender/painful and 3 swollen joints.
  • Active plaque psoriasis at screening 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
Show Show 48 study locations
Sponsors and Collaborators
Pfizer
Investigators
Layout table for investigator information
Study Director: Pfizer CT.gov Call Center Pfizer
Tracking Information
First Submitted Date  ICMJE May 15, 2019
First Posted Date  ICMJE May 24, 2019
Last Update Posted Date April 22, 2021
Actual Study Start Date  ICMJE June 13, 2019
Actual Primary Completion Date April 6, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 23, 2019) 		The proportion of subjects achieving an ACR20 response [ Time Frame: Week 16 ]
The proportion of subjects achieving an American College of Rheumatology 20 (ACR20) response at Week 16.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 23, 2019)
  • The proportion of TNF-naive subjects achieving an ACR20 response [ Time Frame: Week 16 ]
    The proportion of subjects achieving an ACR20 response at Week 16 in the subgroup of subjects who are TNF-alpha inhibitor naïve.
  • The proportion of subjects achieving an ACR20 response [ Time Frame: Week 2, 4, 8, 12, 20, 28, 36, 44, and 52 ]
    The proportion of subjects achieving an ACR20 response at all treatment timepoints except Week 16
  • The proportion of subjects achieving an ACR50 response [ Time Frame: Week 2, 4, 8, 12, 16, 20, 28, 36, 44, and 52 ]
    The proportion of subjects achieving an ACR50 response at all treatment timepoints
  • The proportion of subjects achieving an ACR70 response [ Time Frame: Week 2, 4, 8, 12, 16, 20, 28, 36, 44, and 52 ]
    The proportion of subjects achieving an ACR70 response at all treatment timepoints
  • Change from baseline in the ACR response criteria components [ Time Frame: Week 2, 4, 8, 12, 16, 20, 28, 36, 44, and 52 ]
    Change from baseline in the ACR response criteria components (Tender/painful joint count, Swollen joint count, Patient's Assessment of Arthritis Pain, Patient's Global Assessment of Arthritis, Physician's Global Assessment of Arthritis, Health Assessment Questionnaire [HAQ] disability index [DI], and hsCRP)
  • The proportion of subjects achieving a Psoriasis Area and Severity Index 75/90/100 (PASI75/90/100) response [ Time Frame: Week 2, 4, 8, 12, 16, 20, 28, 36, 44, and 52 ]
    The proportion of subjects achieving a Psoriasis Area and Severity Index 75/90/100 (PASI75/90/100) response at all treatment timepoints
  • Change from baseline in the enthesitis score using the Spondyloarthritis Research Consortium of Canada [SPARCC] Enthesitis Index. [ Time Frame: Week 2, 4, 8, 12, 16, 20, 28, 36, 44, and 52 ]
    Change from baseline in the enthesitis score using the Spondyloarthritis Research Consortium of Canada [SPARCC] Enthesitis Index.
  • Change from baseline in the enthesitis score using the Leeds Enthesitis Index. [ Time Frame: Week 2, 4, 8, 12, 16, 20, 28, 36, 44, and 52 ]
    Change from baseline in the enthesitis score using the Leeds Enthesitis Index.
  • Change from baseline in the Dactylitis Severity Score [ Time Frame: Week 2, 4, 8, 12, 16, 20, 28, 36, 44, and 52 ]
    Change from baseline in the Dactylitis Severity Score at all treatment timepoints
  • Change from baseline in the Nail Psoriasis Severity Index (NAPSI) Score [ Time Frame: Week 2, 4, 8, 12, 16, 20, 28, 36, 44, and 52 ]
    Change from baseline in the Nail Psoriasis Severity Index (NAPSI) Score at all treatment timepoints
  • Change from baseline in the Patient's Global Joint and Skin Assessment Visual Analog Scale (PGJS VAS) [ Time Frame: Week 2, 4, 8, 12, 16, 20, 28, 36, 44, and 52 ]
    Change from baseline in the Patient's Global Joint and Skin Assessment Visual Analog Scale (PGJS VAS) at all treatment timepoints. Scale will be 100 mm in length.
  • Change from baseline in the Functional Assessment of Chronic Illness Therapy Fatigue (FACIT Fatigue) [ Time Frame: Week 2, 4, 8, 12, 16, 20, 28, 36, 44, and 52 ]
    Change from baseline in the Functional Assessment of Chronic Illness Therapy Fatigue (FACIT Fatigue) at all treatment timepoints
  • Change from baseline in the Short Form 36 Health Survey (SF 36) Version 2, Acute [ Time Frame: Week 4, 8, 12, 16, 20, 28, 36, 44, and 52 ]
    Change from baseline in the Short Form 36 Health Survey (SF 36) Version 2, Acute, at all treatment timepoints except Week 2
  • The proportion of subjects achieving Minimal Disease Activity (MDA) and Very Low Disease Activity (VLDA) response [ Time Frame: Week 4, 8, 12, 16, 20, 28, 36, 44, and 52 ]
    The proportion of subjects achieving Minimal Disease Activity (MDA) and Very Low Disease Activity (VLDA) response at all treatment timepoints except Week 2
  • Change from baseline in the Disease Activity Index for Reactive Arthritis/PsA (DAREA/DAPSA) [ Time Frame: Week 4, 8, 12, 16, 20, 28, 36, 44, and 52 ]
    Change from baseline in the Disease Activity Index for Reactive Arthritis/PsA (DAREA/DAPSA)
  • The proportion of subjects achieving the Psoriatic Arthritis Response Criteria (PsARC) [ Time Frame: Week 4, 8, 12, 16, 20, 28, 36, 44, and 52 ]
    The proportion of subjects achieving the Psoriatic Arthritis Response Criteria (PsARC) at all treatment timepoints except Week 2
  • Change from baseline in the Psoriatic Arthritis Disease Activity Score (PASDAS) [ Time Frame: Week 4, 8, 12, 16, 20, 28, 36, 44, and 52 ]
    Change from baseline in the Psoriatic Arthritis Disease Activity Score (PASDAS) at all treatment timepoints except Week 2
  • Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline through Week 56 ]
  • Number of Participants Who Discontinued From the Study Due to Treatment-Emergent AEs [ Time Frame: Baseline through Week 56 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Efficacy and Safety of PF-06700841 in Subjects With Active Psoriatic Arthritis
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Psoriatic Arthritis
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • Experimental: PF-06700841 60 mg once daily
    PF-06700841 60 mg once daily for 52 weeks
    Intervention: Drug: PF-06700841
  • Experimental: PF-06700841 30 mg once daily
    PF-06700841 30 mg once daily for 52 weeks
    Intervention: Drug: PF-06700841
  • 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
    Intervention: Drug: PF-06700841
  • 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
    Intervention: Drug: PF-06700841
  • 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
    Intervention: Other: Placebo
  • 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
    Intervention: Other: Placebo
Publications * Banfield C, Scaramozza M, Zhang W, Kieras E, Page KM, Fensome A, Vincent M, Dowty ME, Goteti K, Winkle PJ, Peeva E. The Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a TYK2/JAK1 Inhibitor (PF-06700841) in Healthy Subjects and Patients With Plaque Psoriasis. J Clin Pharmacol. 2018 Apr;58(4):434-447. doi: 10.1002/jcph.1046. Epub 2017 Dec 21.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 4, 2021) 		219
Original Estimated Enrollment  ICMJE
 (submitted: May 23, 2019) 		196
Actual Study Completion Date  ICMJE January 15, 2021
Actual Primary Completion Date April 6, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Bulgaria,   Czechia,   Estonia,   Hungary,   Lithuania,   Poland,   Russian Federation,   Serbia,   Slovakia,   Spain
Removed Location Countries Belarus
 
Administrative Information
NCT Number  ICMJE NCT03963401
Other Study ID Numbers  ICMJE B7931030
2018-004241-16 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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