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Trial record 20 of 39 for:    "Spinal Disease" | "Benzocaine"

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

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ClinicalTrials.gov Identifier: NCT03963401
Recruitment Status : Recruiting
First Posted : May 24, 2019
Last Update Posted : September 20, 2019
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)
Estimated Enrollment : 196 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
Estimated Primary Completion Date : July 20, 2020
Estimated Study Completion Date : April 27, 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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


Contacts
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Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
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Australia, Queensland
Rheumatology Research Unit Recruiting
Maroochydore, Queensland, Australia, 4558
Australia, Victoria
Emeritus Research Recruiting
Camberwell, Victoria, Australia, 3124
Cabrini Hospital Recruiting
Malvern, Victoria, Australia, 3124
Czechia
L.K.N. Arthrocentrum s.r.o. Not yet recruiting
Hlucin, Czechia, 748 01
BENU Lekarna Not yet recruiting
Pardubice, Czechia, 530 02
CCR Czech a.s. Not yet recruiting
Pardubice, Czechia, 530 02
CCR Prague s.r.o. Not yet recruiting
Praha 3, Czechia, 130 00
MEDICAL PLUS s.r.o. Not yet recruiting
Uherske Hradiste, Czechia, 68601
Estonia
Innomedica OU Not yet recruiting
Tallinn, Estonia, 10117
East Tallinn Central Hospital Not yet recruiting
Tallinn, Estonia, 11312
Lithuania
Hospital of Lithuanian University of Health Sciences, Kauno klinikos Recruiting
Kaunas, Lithuania, LT-50161
Vilnius University Hospital Santaros Klinikos Not yet recruiting
Vilnius, Lithuania, LT-08661
National Osteoporosis Center Not yet recruiting
Vilnius, Lithuania, LT-09310
Poland
ZDROWIE Osteo-Medic s.c. L. I A. Racewicz, A. i J. Supronik Not yet recruiting
Bialystok, Poland, 15-351
ClinicMed Daniluk Nowak Sp. Jawna Not yet recruiting
Bialystok, Poland, 15-879
Centrum Kliniczno-Badawcze J. Brzezicki B. Gornikiewicz-Brzezicka Lekarze Spolka Partnerska Not yet recruiting
Elblag, Poland, 82-300
NZOZ Lecznica MAK-MED s.c. Not yet recruiting
Nadarzyn, Poland, 05-830
Ai Centrum Medyczne Sp. z o.o. Sp. k. Recruiting
Poznan, Poland, 61-113
Prywatna Praktyka Lekarska Prof. UM dr hab. med. Pawel Hrycaj Not yet recruiting
Poznan, Poland, 61-397
RCMed Oddzial Sochaczew Recruiting
Sochaczew, Poland, 96-500
Nasz Lekarz Przychodnie Medyczne Recruiting
Torun, Poland, 87-100
REUMATIKA - Centrum Reumatologii NZOZ Not yet recruiting
Warszawa, Poland, 02-691
Russian Federation
SBHI of the Republic of Karelia "Republican Hospital n. a. V.A. Baranov" Not yet recruiting
Petrozavodsk, Russian Federation, 185910
GUZ "Regional Clinical Hospital" Not yet recruiting
Saratov, Russian Federation, 410053
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     History of Changes
Other Study ID Numbers: B7931030
First Posted: May 24, 2019    Key Record Dates
Last Update Posted: September 20, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pfizer:
Spondyloarthritis
Additional relevant MeSH terms:
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Spinal Diseases
Arthritis
Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Bone Diseases
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases