A Study to Evaluate the Efficacy and Safety of PF-06700841 in Subjects With Active Psoriatic Arthritis
NCT ID: NCT03963401
Last Updated: 2021-08-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
219 participants
INTERVENTIONAL
2019-06-13
2021-01-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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PF-06700841 60 mg once daily
PF-06700841 60 mg once daily for 52 weeks
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.
PF-06700841 30 mg once daily
PF-06700841 30 mg once daily for 52 weeks
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.
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
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.
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
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 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
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 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
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.
Interventions
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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
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.
Eligibility Criteria
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Inclusion Criteria
* Active plaque psoriasis at screening and baseline.
Exclusion Criteria
* History of autoimmune rheumatic disease other than PsA; also prior history of or current, rheumatic inflammatory disease other than PsA.
18 Years
75 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Rheumatology Research Unit
Maroochydore, Queensland, Australia
Emeritus Research
Melbourne, Victoria, Australia
MHAT Trimontium OOD
Plovdiv, , Bulgaria
University Multiprofile Hospital for Active Treatment "Pulmed"
Plovdiv, , Bulgaria
University Multiprofile Hospital for Active Treatment ''Plovdiv'' AD
Plovdiv, , Bulgaria
Medical Center "Pirogov"
Sofia, , Bulgaria
"Diagnostic-Consulting Center XVII - Sofia"
Sofia, , Bulgaria
University Multiprofile Hospital for Active Treatment Sveti Ivan Rilski
Sofia, , Bulgaria
L.K.N. Arthrocentrum s.r.o.
Hlučín, , Czechia
CCR Czech a.s.
Pardubice, , Czechia
Revmatologicky ustav
Prague, , Czechia
CCR Prague s.r.o.
Prague, , Czechia
MEDICAL PLUS s.r.o.
Uherské Hradiště, , Czechia
Innomedica OU
Tallinn, , Estonia
Center for Clinical and Basic Research
Tallinn, , Estonia
East Tallinn Central Hospital
Tallinn, , Estonia
Qualiclinic Kft.
Budapest, , Hungary
VITAL MEDICAL CENTER Orvosi es Fogorvosi Kozpont
Veszprém, , Hungary
Hospital of Lithuanian University of Health Sciences, Kauno klinikos
Kaunas, , Lithuania
National Osteoporosis Center
Vilnius, , Lithuania
ZDROWIE Osteo-Medic s.c. L. I A. Racewicz, A. i J. Supronik
Bialystok, , Poland
ClinicMed Daniluk Nowak Sp. Jawna
Bialystok, , Poland
Zespol Poradni Specjalistycznych "REUMED" Filia nr 2
Lublin, , Poland
NZOZ Lecznica Mak-Med s.c.
Nadarzyn, , Poland
Twoja Przychodnia - Centrum Medyczne Nowa Sol
Nowa Sól, , Poland
Ai Centrum Medyczne Sp. z o.o. Sp. k.
Poznan, , Poland
Prywatna Praktyka Lekarska Prof. UM dr hab. med. Pawel Hrycaj
Poznan, , Poland
RCMed Oddzial Sochaczew
Sochaczew, , Poland
NASZ LEKARZ Przychodnie Medyczne
Torun, , Poland
REUMATIKA - Centrum Reumatologii NZOZ
Warsaw, , Poland
LLC "Family Outpatient clinic #4"
Korolyov, Moscow Oblast, Russia
FGBOU VO "Orenburg State Medical University" of the Ministry of Health of the Russian Federation
Orenburg, , Russia
GBUZ "Orenburg Regional Clinical Hospital"
Orenburg, , Russia
SBHI of the Republic of Karelia "Republican Hospital n. a. V.A. Baranov"
Petrozavodsk, , Russia
FSBEI of HE "Ryazan State Medical University n. a academician I.P.Pavlov"
Ryazan, , Russia
SBI of Ryazan Region "Regional Clinical Hospital"
Ryazan, , Russia
Limited Liability Company "Sanavita"
Saint Petersburg, , Russia
GUZ "Regional Clinical Hospital"
Saratov, , Russia
LLC "BioMed"
Vladimir, , Russia
State Autonomous Healthcare Institution of Yaroslavl Region
Yaroslavl, , Russia
Institute of Rheumatology
Belgrade, , Serbia
Institute for Treatment and Rehabilitation Niska Banja
Niška Banja, , Serbia
Narodny ustav reumatickych chorob
Piešťany, , Slovakia
MUDr. Zuzana Cizmarikova, s.r.o.
Poprad, , Slovakia
REUMEX s.r.o.
Rimavská Sobota, , Slovakia
Complejo Hospitalario Universitario de Santiago de Compostela
Santiago de Compostela, A Coruna, Spain
Hospital Universitario A Coruna
A Coruña, , Spain
Hospital Quironsalud Infanta Luisa
Seville, , Spain
Countries
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References
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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.
Mease P, Helliwell P, Silwinska-Stanczyk P, Miakisz M, Ostor A, Peeva E, Vincent MS, Sun Q, Sikirica V, Winnette R, Qiu R, Li G, Feng G, Beebe JS, Martin DA. Efficacy and Safety of the TYK2/JAK1 Inhibitor Brepocitinib for Active Psoriatic Arthritis: A Phase IIb Randomized Controlled Trial. Arthritis Rheumatol. 2023 Aug;75(8):1370-1380. doi: 10.1002/art.42519. Epub 2023 Jun 22.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2018-004241-16
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
B7931030
Identifier Type: -
Identifier Source: org_study_id
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