Clinical trial NCT03963401: A Study to Evaluate the Efficacy and Safety of PF-06700841 in Subjects With Active Psoriatic Arthritis
Official title: A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF PF-06700841 TO EVALUATE THE EFFICACY AT 16 WEEKS AND TO EVALUATE THE SAFETY AND EFFICACY UP TO 1 YEAR IN SUBJECTS WITH ACTIVE PSORIATIC ARTHRITIS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Psoriatic Arthritis
Keywords: Spondyloarthritis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2019-05-24
Enrollment: 219
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Percentage of Participants Achieving an American College of Rheumatology 20 (ACR20) Response at Week 16
timeFrame: Week 16
Secondary outcomes:
measure: Percentage of Participants Achieving an ACR20 Response at Week 16 in the Subgroup of Participants Who Were Tumor Necrosis Factor (TNF) α Inhibitor naïve
timeFrame: Week 16
measure: Percentage of Participants Achieving an ACR20 Response at Weeks 2, 4, 8, 12, 20, 28, 36, 44 and 52
timeFrame: Weeks 2, 4, 8, 12, 20, 28, 36, 44 and 52
measure: Percentage of Participants Achieving an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
timeFrame: Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
measure: Percentage of Participants Achieving an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
timeFrame: Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
measure: Change From Baseline in Tender/Painful Joint Count at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
timeFrame: Baseline, Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
measure: Change From Baseline in Swollen Joint Count at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
timeFrame: Baseline, Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
measure: Change From Baseline in Patient's Assessment of Arthritis Pain at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
timeFrame: Baseline, Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
measure: Change From Baseline in Patient's Global Assessment of Arthritis at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
timeFrame: Baseline, Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
measure: Change From Baseline in Physician's Global Assessment of Arthritis at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
timeFrame: Baseline, Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
measure: Change From Baseline in Health Assessment Questionnaire (HAQ) Disability Index (DI) at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
timeFrame: Baseline, Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
measure: Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
timeFrame: Baseline, Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
measure: 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
timeFrame: Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
measure: Percentage of Participants Achieving a PASI 90 Response at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
timeFrame: Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
measure: Percentage of Participants Achieving a PASI 100 Response at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
timeFrame: Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
measure: 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
timeFrame: Baseline, Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
measure: 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
timeFrame: Baseline, Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
measure: Change From Baseline in the Dactylitis Severity Score (DSS) at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
timeFrame: Baseline, Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
measure: Change From Baseline in the Nail Psoriasis Severity Index (NAPSI) Score at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
timeFrame: Baseline, Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
measure: 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
timeFrame: Baseline, Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
measure: 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
timeFrame: Baseline, Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
measure: 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
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52
measure: Percentage of Participants Achieving Minimal Disease Activity (MDA) at Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52
timeFrame: Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52
measure: Percentage of Participants Achieving Very Low Disease Activity (VLDA) Response at Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52
timeFrame: Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52
measure: 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
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52
measure: Percentage of Participants Achieving the Psoriatic Arthritis Response Criteria (PsARC) at Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52
timeFrame: Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52
measure: Change From Baseline in the Psoriatic Arthritis Disease Activity Score (PASDAS) at Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52
measure: Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) From Baseline (Day 1) Through Week 56 (All Causalities)
timeFrame: Baseline (Day 1) through Week 56
measure: Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) From Baseline (Day 1) Through Week 56 (Treatment-related)
timeFrame: Baseline (Day 1) through Week 56
measure: Number of Participants Who Discontinued From Study Due to Treatment-emergent AEs From Baseline (Day 1) Through Week 56
timeFrame: Baseline (Day 1) through Week 56
Other outcomes:
Locations:
city: Maroochydore
country: Australia
facility: Rheumatology Research Unit
state: Queensland
city: Melbourne
country: Australia
facility: Emeritus Research
state: Victoria
city: Plovdiv
country: Bulgaria
facility: MHAT Trimontium OOD
city: Plovdiv
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment "Pulmed"
city: Plovdiv
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment ''Plovdiv'' AD
city: Sofia
country: Bulgaria
facility: Medical Center "Pirogov"
city: Sofia
country: Bulgaria
facility: "Diagnostic-Consulting Center XVII - Sofia"
city: Sofia
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment Sveti Ivan Rilski
city: Hlucin
country: Czechia
facility: L.K.N. Arthrocentrum s.r.o.
city: Pardubice
country: Czechia
facility: CCR Czech a.s.
city: Praha 2
country: Czechia
facility: Revmatologicky ustav
city: Praha 3
country: Czechia
facility: CCR Prague s.r.o.
city: Uherske Hradiste
country: Czechia
facility: MEDICAL PLUS s.r.o.
city: Tallinn
country: Estonia
facility: Innomedica OU
city: Tallinn
country: Estonia
facility: Center for Clinical and Basic Research
city: Tallinn
country: Estonia
facility: East Tallinn Central Hospital
city: Budapest
country: Hungary
facility: Qualiclinic Kft.
city: Veszprem
country: Hungary
facility: VITAL MEDICAL CENTER Orvosi es Fogorvosi Kozpont
city: Kaunas
country: Lithuania
facility: Hospital of Lithuanian University of Health Sciences, Kauno klinikos
city: Vilnius
country: Lithuania
facility: National Osteoporosis Center
city: Bialystok
country: Poland
facility: ZDROWIE Osteo-Medic s.c. L. I A. Racewicz, A. i J. Supronik
city: Bialystok
country: Poland
facility: ClinicMed Daniluk Nowak Sp. Jawna
city: Lublin
country: Poland
facility: Zespol Poradni Specjalistycznych "REUMED" Filia nr 2
city: Nadarzyn
country: Poland
facility: NZOZ Lecznica Mak-Med s.c.
city: Nowa Sol
country: Poland
facility: Twoja Przychodnia - Centrum Medyczne Nowa Sol
city: Poznan
country: Poland
facility: Ai Centrum Medyczne Sp. z o.o. Sp. k.
city: Poznan
country: Poland
facility: Prywatna Praktyka Lekarska Prof. UM dr hab. med. Pawel Hrycaj
city: Sochaczew
country: Poland
facility: RCMed Oddzial Sochaczew
city: Torun
country: Poland
facility: NASZ LEKARZ Przychodnie Medyczne
city: Warszawa
country: Poland
facility: REUMATIKA - Centrum Reumatologii NZOZ
city: Korolev
country: Russian Federation
facility: LLC "Family Outpatient clinic #4"
state: Moscow Region
city: Orenburg
country: Russian Federation
facility: FGBOU VO "Orenburg State Medical University" of the Ministry of Health of the Russian Federation
city: Orenburg
country: Russian Federation
facility: GBUZ "Orenburg Regional Clinical Hospital"
city: Petrozavodsk
country: Russian Federation
facility: SBHI of the Republic of Karelia "Republican Hospital n. a. V.A. Baranov"
city: Ryazan
country: Russian Federation
facility: FSBEI of HE "Ryazan State Medical University n. a academician I.P.Pavlov"
city: Ryazan
country: Russian Federation
facility: SBI of Ryazan Region "Regional Clinical Hospital"
city: Saint Petersburg
country: Russian Federation
facility: Limited Liability Company "Sanavita"
city: Saratov
country: Russian Federation
facility: GUZ "Regional Clinical Hospital"
city: Vladimir
country: Russian Federation
facility: LLC "BioMed"
city: Yaroslavl
country: Russian Federation
facility: State Autonomous Healthcare Institution of Yaroslavl Region
city: Belgrade
country: Serbia
facility: Institute of Rheumatology
city: Niska Banja
country: Serbia
facility: Institute for Treatment and Rehabilitation Niska Banja
city: Piestany
country: Slovakia
facility: Narodny ustav reumatickych chorob
city: Poprad
country: Slovakia
facility: MUDr. Zuzana Cizmarikova, s.r.o.
city: Rimavska Sobota
country: Slovakia
facility: REUMEX s.r.o.
city: Santiago de Compostela
country: Spain
facility: Complejo Hospitalario Universitario de Santiago de Compostela
state: A Coruna
city: A Coruna
country: Spain
facility: Hospital Universitario A Coruna
city: Sevilla
country: Spain
facility: Hospital Quironsalud Infanta Luisa
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Banfield C, Scaramozza M, Zhang W, Kieras E, Page KM, Fensome A, Vincent M, Dowty ME, Goteti K, Winkle PJ, Peeva E. The Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a TYK2/JAK1 Inhibitor (PF-06700841) in Healthy Subjects and Patients With Plaque Psoriasis. J Clin Pharmacol. 2018 Apr;58(4):434-447. doi: 10.1002/jcph.1046. Epub 2017 Dec 21.