Tofacitinib In Psoriatic Arthritis Subjects With Inadequate Response to TNF Inhibitors

NCT ID: NCT01882439

Last Updated: 2017-09-15

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

395 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2016-04-30

Brief Summary

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To examine the safety and efficacy of tofacitinib in subjects with active psoriatic arthritis who have previously had an inadequate response to at least one TNF inhibitor either due to lack of efficacy or an adverse event.

Detailed Description

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Conditions

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Psoriatic Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Treatment Sequence A

Tofacitinib 5 mg BID for 6 months

Group Type EXPERIMENTAL

Tofacitinib

Intervention Type DRUG

tablets, 5 mg BID x 6 months

Treatment Sequence B

Tofacitinib 10 mg BID for 6 months

Group Type EXPERIMENTAL

Tofacitinib

Intervention Type DRUG

tablets, 10 mg BID x 6 months

Treatment Sequence C

Placebo for 3 months then tofacitinib 5 mg BID for 3 months

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

tablets, to match tofacitinib 5 mg BID x 3 months

Tofacitinib

Intervention Type DRUG

tablets, 5 mg BID x 3 months

Treatment Sequence D

Placebo for 3 months then tofacitinib 10 mg BID for 3 months

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

tablets, to match tofacitinib 10 mg BID x 3 months

Tofacitinib

Intervention Type DRUG

tablets, 10 mg BID x 3 months

Interventions

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Tofacitinib

tablets, 5 mg BID x 6 months

Intervention Type DRUG

Tofacitinib

tablets, 10 mg BID x 6 months

Intervention Type DRUG

Placebo

tablets, to match tofacitinib 5 mg BID x 3 months

Intervention Type OTHER

Tofacitinib

tablets, 5 mg BID x 3 months

Intervention Type DRUG

Placebo

tablets, to match tofacitinib 10 mg BID x 3 months

Intervention Type OTHER

Tofacitinib

tablets, 10 mg BID x 3 months

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Active arthritis at screening/baseline as indicated by \>/= 3 tender/painful and 3 swollen joints
* Active plaque psoriasis at screening
* Inadequate efficacy or lack of toleration to previously administered TNF inhibitor

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Rheumatology Associates P.C.

Birmingham, Alabama, United States

Site Status

Rheumatology Associates of North Alabama, PC

Huntsville, Alabama, United States

Site Status

Arizona Arthritis & Rheumatology Associates, P.C.

Glendale, Arizona, United States

Site Status

Medvin Clinical Research

Covina, California, United States

Site Status

St. Jude Hospital Yorba Linda DBA St. Joseph Heritage Healthcare

Fullerton, California, United States

Site Status

Ronald Reagan UCLA Medical Center, Drug Information Center

Los Angeles, California, United States

Site Status

UCLA David Geffen School of Medicine

Los Angeles, California, United States

Site Status

San Diego Arthritis Medical Clinic

San Diego, California, United States

Site Status

Stanford Hospital and Clinics

Stanford, California, United States

Site Status

New England Research Associates, LLC

Trumbull, Connecticut, United States

Site Status

Rheumatology Associates of Central Florida, PA

Orlando, Florida, United States

Site Status

Millennium Research

Ormond Beach, Florida, United States

Site Status

Arthritis Center, Inc.

Palm Harbor, Florida, United States

Site Status

Integral Rheumatology & Immunology Specialists (IRIS)

Plantation, Florida, United States

Site Status

Florida Medical Clinic, P.A.

Zephyrhills, Florida, United States

Site Status

St. Luke's Clinic - Rheumatology

Boise, Idaho, United States

Site Status

St. Luke's Intermountain Research Center

Boise, Idaho, United States

Site Status

Bluegrass Community Research, Inc

Lexington, Kentucky, United States

Site Status

Klein & Associates, M.D., P.A.

Hagerstown, Maryland, United States

Site Status

The Center For Rheumatology And Bone Research

Wheaton, Maryland, United States

Site Status

Brigham & Women's Hospital

Boston, Massachusetts, United States

Site Status

Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status

Clinical Pharmacology Study Group

Worcester, Massachusetts, United States

Site Status

St. Paul Rheumatology, PA

Eagan, Minnesota, United States

Site Status

Clayton Medical Research

St Louis, Missouri, United States

Site Status

Physician Research Collaboration, LLC

Lincoln, Nebraska, United States

Site Status

Dartmouth-Hitchcock Medical Center (DHMC)

Lebanon, New Hampshire, United States

Site Status

Cincinnati Rheumatic Disease Study Group, Inc.

Cincinnati, Ohio, United States

Site Status

University Hospitals Case Medical Center

Cleveland, Ohio, United States

Site Status

Paramount Medical Research & Consulting, LLC

Middleburg Heights, Ohio, United States

Site Status

East Penn Rheumatology Associates, PC

Bethlehem, Pennsylvania, United States

Site Status

Altoona Center for Clinical Research

Duncansville, Pennsylvania, United States

Site Status

Low Country Rheumatology, PA

Charleston, South Carolina, United States

Site Status

Arthritis Clinic

Jackson, Tennessee, United States

Site Status

West Tennessee Research Institute

Jackson, Tennessee, United States

Site Status

Adriana M. Pop-Moody, M.D., Clinic, P.A.

Corpus Christi, Texas, United States

Site Status

Pioneer Research Solutions, Inc.

Cypress, Texas, United States

Site Status

Metroplex Clinical Research Center

Dallas, Texas, United States

Site Status

Drug Shipment/Storage: Investigational Drug Services

Salt Lake City, Utah, United States

Site Status

University of Utah Hospital & Clinics

Salt Lake City, Utah, United States

Site Status

Dynacare Laboratories

Seattle, Washington, United States

Site Status

Seattle Rheumatology Associates

Seattle, Washington, United States

Site Status

Swedish Medical Center

Seattle, Washington, United States

Site Status

Royal Prince Alfred Hospital, Rheumatology Department

Camperdown, New South Wales, Australia

Site Status

Rheumatology Research Unit

Maroochydore, Queensland, Australia

Site Status

Emeritus Research Pty Ltd

Malvern East, Victoria, Australia

Site Status

Hospital Erasme - Clinique Universitaire de Bruxelles

Brussels, , Belgium

Site Status

ReumaClinic

Genk, , Belgium

Site Status

Universitair Ziekenhuis Gent

Ghent, , Belgium

Site Status

University Hospital Leuven, Department of Rheumatology

Leuven, , Belgium

Site Status

ZNA Jan Palfijn

Merksem, , Belgium

Site Status

CMIP: Centro Mineiro de Pesquisa Ltda /

Juiz de Fora, Minas Gerais, Brazil

Site Status

CETAC - DIAGNOSTICO POR IMAGEM (image only)

Curitiba, Paraná, Brazil

Site Status

EDUMED - Educacao em Saude SS LTDA.

Curitiba, Paraná, Brazil

Site Status

Hospital de Clinicas de Porto Alegre (HCPA) / UFRGS

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Clinica Medica Bonfiglioli Ltda. / Clinica Bonfiglioli

Campinas, São Paulo, Brazil

Site Status

Radiologia Clínica de Campinas - RCC (Images only)

Campinas, São Paulo, Brazil

Site Status

Medical Plus s.r.o.

Uherské Hradiště, , Czechia

Site Status

Centre Hospitalier Sud-Francilien - Secretariat de Rhumatologie

Corbeil-Essonnes, Cedex, France

Site Status

Hopital Avicenne

Bobigny, , France

Site Status

Rheumazentrum Prof. Dr. med Gunther Neeck

Bad Doberan, , Germany

Site Status

Charite Universitatsmedizin Berlin - Campus Charite Mitte

Berlin, , Germany

Site Status

Rheumapraxis Steglitz

Berlin, , Germany

Site Status

Schlosspark-Klinik

Berlin, , Germany

Site Status

University Hospital of Cologne

Cologne, , Germany

Site Status

Universitaetsklinikum Erlangen, Medizinische Klinik 3

Erlangen, , Germany

Site Status

CIRI - Centrum für innovative Diagnostik und Therapie Rheumatologie/Immunologie (GmbH)

Frankfurt am Main, , Germany

Site Status

Medizinische Universitatsklinik Freiburg

Freiburg im Breisgau, , Germany

Site Status

Universitaetsklinikum Des Saarlandes Und Medizinische Fakultaet Der Universitaet Des Saarlandes

Homburg, , Germany

Site Status

Elisabeth Klinik Bigge

Olsberg, , Germany

Site Status

Hospital Angeles Clinica Londres

Mexico City, D.F, Mexico

Site Status

Centro Integral en Reumatologia SA de CV

Guadalajara, Jalisco, Mexico

Site Status

Grupo Santa Bernardette S.A. de C.V.

Guadalajara, Jalisco, Mexico

Site Status

Grupo Medico Camino S.C.

Mexico City, Mexico City, Mexico

Site Status

CLIDITER, S.A. de C.V.

Mexico City, Mexico City, Mexico

Site Status

Universidad La Salle AC

Mexico City, Mexico City, Mexico

Site Status

Medica Sur, S.A.B. de C.V. (For Emergencies Only)

Mexico City, Mexico City, Mexico

Site Status

Centro de Investigacion de Tratamientos Innovadores de Sinaloa, S.C

Culiacán, Sinaloa, Mexico

Site Status

Sanatorio CEMSI Chapultepec (For Emergencies Only)

Culiacán, Sinaloa, Mexico

Site Status

Hospital General de Culiacan "Dr. Bernardo J. Gastelum"

Culiacán, Sinaloa, Mexico

Site Status

Star Medica S.A. de C.V. (For Emergencies Only)

Merdia, Yucatán, Mexico

Site Status

Institute Medico Panamericano, S.A. de C.V. (For Emergencies Only)

Mérida, Yucatán, Mexico

Site Status

Unidad Reumatologica Las Americas SCP

Mérida, Yucatán, Mexico

Site Status

Centro de Investigacion Clinica Pensiones

Mérida, Yucatán, Mexico

Site Status

Centro Multidisciplinario para el Desarrollo

Mérida, Yucatán, Mexico

Site Status

Hospital Star Medica Merida (For Emergencies Only)

Mérida, Yucatán, Mexico

Site Status

Christus Muguerza del parque, S.A de C.V

Chihuahua City, , Mexico

Site Status

Investigacion y Biomedicina de Chihuahua

Chihuahua City, , Mexico

Site Status

Centrum Kliniczno-Badawcze J.Brzezicki, B.Gornikiewicz-Brzez

Elblag, , Poland

Site Status

Centrum Radiologii for X-Ray only

Elblag, , Poland

Site Status

NZOZ Centrum Reumatologiczne Indywidualna Specjalistyczna Praktyka Lekarska Lek. Med. Barbara Bazela

Elblag, , Poland

Site Status

Wojewodzki Szpital Zespolony Zaklad Radiologii

Elblag, , Poland

Site Status

Przychodnia Specjalistyczna Lekarskiej Spozielni Pracy "Medica" for X-Ray Only

Grodzisk Mazowiecki, , Poland

Site Status

Specjalistyczne Gabinety Lekarskie "DERMED" Anna Kaszuba

Lodz, , Poland

Site Status

NZOZ Lecznica MAK-MED S.C.

Nadarzyn, , Poland

Site Status

Prywatna Praktyka Lekarska Prof. UM dr hab. Pawel Hrycaj

Poznan, , Poland

Site Status

Reumatika Centrum Reumatologii nzoz

Warsaw, , Poland

Site Status

Regional State Budgetary Healthcare Institution of Karelia Republic "Republic Hospital n.a.

Petrozavodsk, Karelia Republic, Russia

Site Status

State Autonomic Healthcare Institution City Clinical Hospital # 7

Kazan', Republic of Tatarstan, Russia, Russia

Site Status

SBIH of Moscow "City Clinical Hospital#1 n. a. N.I. Pirogov" of the Healthcare Department of Moscow

Moscow, , Russia

Site Status

City Neurological Centre "SibNeyroMed", LLC

Novosibirsk, , Russia

Site Status

Limited Liability Company Consultative Diagnostic Rheumatology Center "Healthy Joints"

Novosibirsk, , Russia

Site Status

State Budget Educational Institution of Highest Professional Education

Tomsk, , Russia

Site Status

State Institution of Healthcare of Yaroslavl Region

Yaroslavl, , Russia

Site Status

MEDMAN s.r.o. - reumatologicka ambulancia

Martin, , Slovakia

Site Status

Hospital Clinico de Santiago

Santiago de Compostela, A Coruna, Spain

Site Status

Corporacio Sanitaria Parc Tauli

Sabadell, Barcelona, Spain

Site Status

Hospital Universitario Marques de Valdecilla

Santander, Cantabria, Spain

Site Status

Hospital Sierrallana

Torrelavega, Cantabria, Spain

Site Status

Complejo Hospitalario Universitario A Coruna

A Coruña, , Spain

Site Status

Hospital Universitari Vall d'Hebron

Barcelona, , Spain

Site Status

Hospital Universitario Virgen Macarena

Seville, , Spain

Site Status

Hospital Universitaro Y Politecnico La Fe

Valencia, , Spain

Site Status

Taipei Veterans General Hospital

Taipei, Taiwan Roc, Taiwan

Site Status

Buddhist Dalin Tzu Chi General Hospital

Chiayi City, , Taiwan

Site Status

Chang Gung Medical Foundation-Kaohsiung Branch

Kaohsiung City, , Taiwan

Site Status

Chung Shan Medical University Hospital

Taichung, , Taiwan

Site Status

China Medical University Hospital

Taichung, , Taiwan

Site Status

Barking Havering and Redbridge University Hospitals NHS Trust

Goodmayes, Essex, United Kingdom

Site Status

Barking, Havering and Redbridge University Hospitals NHS Trust

Romford, Essex, United Kingdom

Site Status

The Dudley Group NHS Foundation Trust

Dudley, West Midlands, United Kingdom

Site Status

Bradford Royal Infirmary, BTHFT

Bradford, West Yorkeshire, United Kingdom

Site Status

Royal United Hospitals NHS Foundation Trust

Bath, , United Kingdom

Site Status

Bradford Teaching Hospitals NHS Foundation Trust

Bradford, , United Kingdom

Site Status

York Hospital, York Teaching Hospital NHS Foundation Trust

York, , United Kingdom

Site Status

Countries

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United States Australia Belgium Brazil Czechia France Germany Mexico Poland Russia Slovakia Spain Taiwan United Kingdom

References

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Gossec L, Sellas A, Gruben DC, Valderrama M, Gomez S, Kinch C, Citera G. Response to Tofacitinib in Patients with Psoriatic Arthritis and Probable Anxiety/Depressive Disorder: A Post Hoc Analysis of Phase 3 Trials. Rheumatol Ther. 2025 Oct 28. doi: 10.1007/s40744-025-00800-7. Online ahead of print.

Reference Type DERIVED
PMID: 41148555 (View on PubMed)

Gladman D, Tillett W, Gruben D, Coates LC, Hahne S, Volkov M. Identification of distinct disease activity trajectories in patients with psoriatic arthritis receiving tofacitinib: a post hoc analysis of two phase 3 studies. RMD Open. 2025 Jun 3;11(2):e005250. doi: 10.1136/rmdopen-2024-005250.

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Gladman DD, Dougados M, Marzo-Ortega H, Cadatal MJ, Agarwal E, Kinch CD, Nash P. Long-term tofacitinib efficacy and safety in psoriatic arthritis with or without prior biologic DMARD exposure: a post hoc analysis. Rheumatol Adv Pract. 2025 Jan 21;9(2):rkaf008. doi: 10.1093/rap/rkaf008. eCollection 2025.

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Schneeberger EE, Citera G, Nash P, Smolen JS, Mease PJ, Soriano ER, Helling C, Szumski AE, Mundayat R, de Leon DP. Comparison of disease activity index for psoriatic arthritis (DAPSA) and minimal disease activity (MDA) targets for patients with psoriatic arthritis: A post hoc analysis of data from phase 3 tofacitinib studies. Semin Arthritis Rheum. 2023 Feb;58:152134. doi: 10.1016/j.semarthrit.2022.152134. Epub 2022 Nov 13.

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de Vlam K, Mease PJ, Bushmakin AG, Fleischmann R, Ogdie A, Azevedo VF, Merola JF, Woolcott J, Cappelleri JC, Fallon L, Taylor PC. Identifying and Quantifying the Role of Inflammation in Pain Reduction for Patients With Psoriatic Arthritis Treated With Tofacitinib: A Mediation Analysis. Rheumatol Ther. 2022 Oct;9(5):1451-1464. doi: 10.1007/s40744-022-00482-5. Epub 2022 Sep 8.

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Orbai AM, Mease PJ, Helliwell PS, FitzGerald O, Fleishaker DL, Mundayat R, Young P. Effect of tofacitinib on dactylitis and patient-reported outcomes in patients with active psoriatic arthritis: post-hoc analysis of phase III studies. BMC Rheumatol. 2022 Sep 1;6(1):68. doi: 10.1186/s41927-022-00298-4.

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Taylor PC, Bushmakin AG, Cappelleri JC, Young P, Germino R, Merola JF, Yosipovitch G. Relationships of dermatologic symptoms and quality of life in patients with psoriatic arthritis: analysis of two tofacitinib phase III studies. J Dermatolog Treat. 2022 Aug;33(5):2614-2620. doi: 10.1080/09546634.2022.2060924. Epub 2022 Apr 11.

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Winthrop KL, Curtis JR, Yamaoka K, Lee EB, Hirose T, Rivas JL, Kwok K, Burmester GR. Clinical Management of Herpes Zoster in Patients With Rheumatoid Arthritis or Psoriatic Arthritis Receiving Tofacitinib Treatment. Rheumatol Ther. 2022 Feb;9(1):243-263. doi: 10.1007/s40744-021-00390-0. Epub 2021 Dec 6.

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Kivitz AJ, FitzGerald O, Nash P, Pang S, Azevedo VF, Wang C, Takiya L. Efficacy and safety of tofacitinib by background methotrexate dose in psoriatic arthritis: post hoc exploratory analysis from two phase III trials. Clin Rheumatol. 2022 Feb;41(2):499-511. doi: 10.1007/s10067-021-05894-2. Epub 2021 Sep 12.

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Coates LC, Bushmakin AG, FitzGerald O, Gladman DD, Fallon L, Cappelleri JC, Hsu MA, Helliwell PS. Relationships between psoriatic arthritis composite measures of disease activity with patient-reported outcomes in phase 3 studies of tofacitinib. Arthritis Res Ther. 2021 Mar 26;23(1):94. doi: 10.1186/s13075-021-02474-2.

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Cella D, Wilson H, Shalhoub H, Revicki DA, Cappelleri JC, Bushmakin AG, Kudlacz E, Hsu MA. Content validity and psychometric evaluation of Functional Assessment of Chronic Illness Therapy-Fatigue in patients with psoriatic arthritis. J Patient Rep Outcomes. 2019 May 20;3(1):30. doi: 10.1186/s41687-019-0115-4.

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Cella D, Wilson H, Shalhoub H, Revicki DA, Cappelleri JC, Bushmakin AG, Kudlacz E, Hsu MA. Content validity and psychometric evaluation of Functional Assessment of Chronic Illness Therapy-Fatigue in patients with psoriatic arthritis. J Patient Rep Outcomes. 2019 Jan 24;3(1):5. doi: 10.1186/s41687-019-0094-5.

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Gladman D, Rigby W, Azevedo VF, Behrens F, Blanco R, Kaszuba A, Kudlacz E, Wang C, Menon S, Hendrikx T, Kanik KS. Tofacitinib for Psoriatic Arthritis in Patients with an Inadequate Response to TNF Inhibitors. N Engl J Med. 2017 Oct 19;377(16):1525-1536. doi: 10.1056/NEJMoa1615977.

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Other Identifiers

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2013-001368-46

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

A3921125

Identifier Type: -

Identifier Source: org_study_id