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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03963401
Recruitment Status : Active, not recruiting
First Posted : May 24, 2019
Last Update Posted : June 18, 2020
Sponsor:
Information provided by (Responsible Party):
Pfizer

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 217 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
Estimated Study Completion Date : January 12, 2021

Resource links provided by the National Library of Medicine


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.




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 ]


Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03963401


Locations
Show Show 48 study locations
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
Publications:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03963401    
Other Study ID Numbers: B7931030
2018-004241-16 ( EudraCT Number )
First Posted: May 24, 2019    Key Record Dates
Last Update Posted: June 18, 2020
Last Verified: June 2020

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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:
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Arthritis
Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases