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

NCT03963401 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: B79310302018-004241-16
• Study Type: interventional
• Target: 219
• Locations: 10 countries
• Sites: 45

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.

Conditions

Psoriatic Arthritis

Keywords

Spondyloarthritis

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Achieving an American College of Rheumatology 20 (ACR20) Response at Week 16

  ACR 20 was calculated as a ≥20% improvement in tender and swollen joint counts and ≥20% improvement in 3 of the 5 remaining ACR core set measures: patient pain assessment (a horizontal visual analog scale assessment of the patient's level of pain), patient global assessment (the patient's overall assessment of how the arthritis was doing by a visual analog scale), physician global assessment (a horizontal visual analog scale measure of the physician's assessment of the patient's current disease activity), patient self-assessed disability (a validated and reliable patient self-assessment instrument which measured physical functions in rheumatoid arthritis patients) and an acute-phase reactant (C-reactive protein level). The participants receiving placebo in the initial period (Day 1 - Week 16) were combined into a single placebo group, while those who received PF-06700841 (10 mg QD) in the initial period were combined into a single PF-06700841 10 mg QD group.

  Week 16

Secondary Outcomes (29)

• Percentage of Participants Achieving an ACR20 Response at Week 16 in the Subgroup of Participants Who Were Tumor Necrosis Factor (TNF) α Inhibitor naïve

  Week 16

• Percentage of Participants Achieving an ACR20 Response at Weeks 2, 4, 8, 12, 20, 28, 36, 44 and 52

  Weeks 2, 4, 8, 12, 20, 28, 36, 44 and 52

• Percentage of Participants Achieving an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52

  Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52

• Percentage of Participants Achieving an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52

  Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52

• Change From Baseline in Tender/Painful Joint Count at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52

  Baseline, Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52

Study Arms (6)

PF-06700841 60 mg once daily

EXPERIMENTAL

PF-06700841 60 mg once daily for 52 weeks

Drug: PF-06700841

PF-06700841 30 mg once daily

EXPERIMENTAL

PF-06700841 30 mg once daily for 52 weeks

Drug: PF-06700841

PF-06700841 10 mg once daily followed by 60 mg once daily

EXPERIMENTAL

PF-06700841 10 mg once daily for 16 weeks, followed by 60 mg once daily until Week 52

Drug: PF-06700841

PF-06700841 10 mg once daily followed by 30 mg once daily

EXPERIMENTAL

PF-06700841 10 mg once daily for 16 weeks, followed by 30 mg once daily until Week 52

Drug: PF-06700841

Placebo once daily followed by 60 mg once daily

PLACEBO COMPARATOR

Placebo once daily for 16 weeks, followed by PF-06700841 60 mg once daily until Week 52

Other: Placebo

Placebo once daily followed by 30 mg once daily

PLACEBO COMPARATOR

Placebo once daily for 16 weeks, followed by PF-06700841 30 mg once daily until Week 52

Other: Placebo

Interventions

PF-06700841 DRUG

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 followed by 60 mg once daily; PF-06700841 30 mg once daily; PF-06700841 60 mg once daily

Placebo OTHER

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 followed by 60 mg once daily

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (48)

Rheumatology Research Unit

Maroochydore, Queensland, 4558, Australia

Location

Emeritus Research

Melbourne, Victoria, 3124, Australia

Location

MHAT Trimontium OOD

Plovdiv, 4000, Bulgaria

Location

University Multiprofile Hospital for Active Treatment "Pulmed"

Plovdiv, 4002, Bulgaria

Location

University Multiprofile Hospital for Active Treatment ''Plovdiv'' AD

Plovdiv, 4027, Bulgaria

Location

Medical Center "Pirogov"

Sofia, 1000, Bulgaria

Location

"Diagnostic-Consulting Center XVII - Sofia"

Sofia, 1505, Bulgaria

Location

University Multiprofile Hospital for Active Treatment Sveti Ivan Rilski

Sofia, 1612, Bulgaria

Location

L.K.N. Arthrocentrum s.r.o.

Hlučín, 748 01, Czechia

Location

CCR Czech a.s.

Pardubice, 530 02, Czechia

Location

Revmatologicky ustav

Prague, 128 50, Czechia

Location

CCR Prague s.r.o.

Prague, 130 00, Czechia

Location

MEDICAL PLUS s.r.o.

Uherské Hradiště, 68601, Czechia

Location

Innomedica OU

Tallinn, 10117, Estonia

Location

Center for Clinical and Basic Research

Tallinn, 10128, Estonia

Location

East Tallinn Central Hospital

Tallinn, 11312, Estonia

Location

Qualiclinic Kft.

Budapest, 1036, Hungary

Location

VITAL MEDICAL CENTER Orvosi es Fogorvosi Kozpont

Veszprém, 8200, Hungary

Location

Hospital of Lithuanian University of Health Sciences, Kauno klinikos

Kaunas, LT-50161, Lithuania

Location

National Osteoporosis Center

Vilnius, LT-09310, Lithuania

Location

ZDROWIE Osteo-Medic s.c. L. I A. Racewicz, A. i J. Supronik

Bialystok, 15-351, Poland

Location

ClinicMed Daniluk Nowak Sp. Jawna

Bialystok, 15-879, Poland

Location

Zespol Poradni Specjalistycznych "REUMED" Filia nr 2

Lublin, 20-582, Poland

Location

NZOZ Lecznica Mak-Med s.c.

Nadarzyn, 05-830, Poland

Location

Twoja Przychodnia - Centrum Medyczne Nowa Sol

Nowa Sól, 67-100, Poland

Location

Ai Centrum Medyczne Sp. z o.o. Sp. k.

Poznan, 61-113, Poland

Location

Prywatna Praktyka Lekarska Prof. UM dr hab. med. Pawel Hrycaj

Poznan, 61-397, Poland

Location

RCMed Oddzial Sochaczew

Sochaczew, 96-500, Poland

Location

NASZ LEKARZ Przychodnie Medyczne

Torun, 87-100, Poland

Location

REUMATIKA - Centrum Reumatologii NZOZ

Warsaw, 02-691, Poland

Location

LLC "Family Outpatient clinic #4"

Korolyov, Moscow Oblast, 141060, Russia

Location

FGBOU VO "Orenburg State Medical University" of the Ministry of Health of the Russian Federation

Orenburg, 460000, Russia

Location

GBUZ "Orenburg Regional Clinical Hospital"

Orenburg, 460018, Russia

Location

SBHI of the Republic of Karelia "Republican Hospital n. a. V.A. Baranov"

Petrozavodsk, 185910, Russia

Location

FSBEI of HE "Ryazan State Medical University n. a academician I.P.Pavlov"

Ryazan, 390026, Russia

Location

SBI of Ryazan Region "Regional Clinical Hospital"

Ryazan, 390039, Russia

Location

Limited Liability Company "Sanavita"

Saint Petersburg, 195257, Russia

Location

GUZ "Regional Clinical Hospital"

Saratov, 410053, Russia

Location

LLC "BioMed"

Vladimir, 600005, Russia

Location

State Autonomous Healthcare Institution of Yaroslavl Region

Yaroslavl, 150003, Russia

Location

Institute of Rheumatology

Belgrade, 11000, Serbia

Location

Institute for Treatment and Rehabilitation Niska Banja

Niška Banja, 18205, Serbia

Location

Narodny ustav reumatickych chorob

Piešťany, 921 12, Slovakia

Location

MUDr. Zuzana Cizmarikova, s.r.o.

Poprad, 058 01, Slovakia

Location

REUMEX s.r.o.

Rimavská Sobota, 979 01, Slovakia

Location

Complejo Hospitalario Universitario de Santiago de Compostela

Santiago de Compostela, A Coruna, 15706, Spain

Location

Hospital Universitario A Coruna

A Coruña, 15006, Spain

Location

Hospital Quironsalud Infanta Luisa

Seville, 41010, Spain

Location

Related Publications (2)

• 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.

  PMID: 29266308 BACKGROUND

• 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.

  PMID: 37194394 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Arthritis, Psoriatic; Spondylarthritis

Interventions

PF-06700841

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2019
• First Posted: May 24, 2019
• Study Start: June 13, 2019
• Primary Completion: April 6, 2020
• Study Completion: January 15, 2021
• Last Updated: August 4, 2021
• Results First Posted: August 4, 2021

Record last verified: 2021-08

Locations

PL (10); AU (2); LI (2); SL (3); CZ (5); BU (6); RU (10); ES (3); SE (2); HU (2)