AzTrials
AzTrials

PsoriasisPhase 3NCT01163253

A Long Term Study To Evaluate The Safety And Tolerability Of CP-690,550 For Patients With Moderate To Severe Chronic Plaque Psoriasis

A Phase 3 study testing CP-690,550 in people with Psoriasis, run by Pfizer at 323 sites in 36 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The main objective of this study is to evaluate the long-term safety of CP-690,550 in patients being treated for moderate to severe chronic plaque psoriasis. This is an open label extension study available to patients who participated in one of the qualifying studies with CP-690,550 providing entry criteria is met. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Psoriasis
What is being tested?
CP-690,550
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,867 participants
Where
323 sitesin 36 countries
Study dates
Sep 2010to Jun 2016
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Have participated in qualifying study with CP-690,550 and are 18 years or older with diagnosis of plaque-type psoriasis (psoriasis vulgaris).

Who cannot join

  • Non-plaque or drug induced forms of psoriasis;
  • Cannot discontinue current oral, injectable or topical therapy for psoriasis or cannot discontinue phototherapy (PUVA or UVB).
  • Any uncontrolled significant medical condition.

Trial locations and contacts

323 sites in 36 countries.

323 sites in 36 countries

United States101 sites

  • Atlanta Dermatology, Vein & Research Center, P.C.

    Alpharetta, Georgia, 30022

  • Arlington Research Center, Inc.

    Arlington, Texas, 76011

  • Altman Dermatology Associates

    Arlington Heights, Illinois, 60005

  • Advanced Medical Research, Inc.

    Atlanta, Georgia, 30342

  • Bakersfield Dermatology and Skin Cancer Medical Group

    Bakersfield, California, 93309

  • Centennial Center-Comprehensive Clinical Research

    Berlin, New Jersey, 08009

  • Radiant Research, Inc.

    Birmingham, Alabama, 35209

  • UAB Dermatology

    Birmingham, Alabama, 35233

  • Tufts Medical Center

    Boston, Massachusetts, 02111-1552

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • Massachusetts General Hospital - Clinical Unit for Research Trials and Outcomes in Skin

    Boston, Massachusetts, 02114

  • Mountain State Clinical Research

    Bridgeport, West Virginia, 26330

  • University of North Carolina at Chapel Hill- Hospital

    Chapel Hill, North Carolina, 27514

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27516

  • Jewish Hospital

    Cincinnati, Ohio, 45236

  • Radiant Research, Inc.

    Cincinnati, Ohio, 45249

  • IP ONLY: University Hospitals Case Medical Center

    Cleveland, Ohio, 44106

  • University Hospitals Case Medical Center/Dept. of Dermatology

    Cleveland, Ohio, 44106

  • University Hospitals Case Medical Center

    Cleveland, Ohio, 44106

  • Michigan Center for Research Corporation dba Michigan Center for Skin Care Research

    Clinton, Michigan, 48038

  • Florida Academic Dermatology Center

    Coral Gables, Florida, 33134

  • Dermatology Treatment & Research Center

    Dallas, Texas, 75230

  • Modern Research Associates, PLLC

    Dallas, Texas, 75231

  • Menter Dermatology Research Institute

    Dallas, Texas, 75246

  • Cherry Creek Research, Inc.

    Denver, Colorado, 80209

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Deaconess Clinic Downtown Research Institute

    Evansville, Indiana, 47713

  • Hudson Dermatology

    Evansville, Indiana, 47714

  • Hamzavi Dermatology

    Fort Gratiot, Michigan, 48059

  • Associates In Research, Inc.

    Fresno, California, 93720

  • Minnesota Clinical Study Center

    Fridley, Minnesota, 55432

  • Rivergate Dermatology Clinical Research Center, PLLC

    Goodlettsville, Tennessee, 37072

  • Office of John Michael Humeniuk, MD

    Greer, South Carolina, 29650

  • Radiant Research, Inc.

    Greer, South Carolina, 29650

  • Bettencourt Skin Center

    Henderson, Nevada, 89074

  • Dermatology Consulting Services

    High Point, North Carolina, 27262

  • Burke Pharmaceutical Research

    Hot Springs, Arkansas, 71913

  • Center for Clinical Studies

    Houston, Texas, 77004

  • Suzanne Bruce and Associates, PA

    Houston, Texas, 77056

  • Dawes Fretzin Clinical Research Group, LLC

    Indianapolis, Indiana, 46256

  • University of California Irvine

    Irvine, California, 92697

  • North Florida Dermatology Associates, PA

    Jacksonville, Florida, 32204

  • Clinical Partners, LLC

    Johnston, Rhode Island, 02919

  • Dermatology Associates of Knoxville PC

    Knoxville, Tennessee, 37917

  • Baker Allergy Asthma and Dermatology Research Center, LLC

    Lake Oswego, Oregon, 97035

  • Dartmouth-Hitchcock Medical Center-Norris Cotton Cancer Center

    Lebanon, New Hampshire, 03756

  • Dermatology Research Associates

    Los Angeles, California, 90045

  • DermResearch, PLLC

    Louisville, Kentucky, 40217

  • Madison Skin and Research, Inc.

    Madison, Wisconsin, 53719

  • International Dermatology Research, Inc.

    Miami, Florida, 33144

  • Horizon Research Group, Inc.

    Mobile, Alabama, 36608

  • Dermatology Research Associates

    Nashville, Tennessee, 37203

  • The Savin Center, P.C.

    New Haven, Connecticut, 06511

  • New York University (NYU) School of Medicine - Investigational Pharmacy (IP Shipment, Pharmacy)

    New York, New York, 10016

  • NYU Langone Medical Center, Ambulatory Care Center, Department of Dermatology, Clinical Studies Unit

    New York, New York, 10016

  • The Rockefeller University

    New York, New York, 10065 6307

  • MedaPhase Inc.

    Newnan, Georgia, 30263

  • Virginia Clinical Research, Inc.

    Norfolk, Virginia, 23502

  • Virginia Clinical Research, Inc.

    Norfolk, Virginia, 23507

  • Central Sooner Research

    Norman, Oklahoma, 73071

  • Renstar Medical Research

    Ocala, Florida, 34471

  • Dermatology Specialists, Inc.

    Oceanside, California, 92056

  • Skin Specialists, P.C

    Omaha, Nebraska, 68144

  • Park Avenue Dermatology, PA

    Orange Park, Florida, 32073

  • Leavitt Medical Associates of Florida dba Ameriderm Research

    Ormond Beach, Florida, 32174

  • University of Pittsburgh Medical Center - Department of Dermatology

    Pittsburgh, Pennsylvania, 15213

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213

  • Oregon Dermatology and Research Center

    Portland, Oregon, 97210

  • Oregon Health & Science University

    Portland, Oregon, 97239

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • Wake Dermatology Associates, LLC

    Raleigh, North Carolina, 27607

  • Wake Research Associates

    Raleigh, North Carolina, 27612

  • Health Concepts

    Rapid City, South Dakota, 57702

  • Office of Mark Lee, MD

    San Antonio, Texas, 78229

  • Progressive Clinical research, P.A.

    San Antonio, Texas, 78229

  • Stephen Miller, MD, PA

    San Antonio, Texas, 78249

  • MedDerm Associates

    San Diego, California, 92103

  • UCSD Dermatology

    San Diego, California, 92122

  • University of California San Diego

    San Diego, California, 92122

  • University of California San Francisco

    San Francisco, California, 94118

  • Clinical Science Institute

    Santa Monica, California, 90404

  • Schaumburg Dermatology

    Schaumburg, Illinois, 60173

  • NorthShore University Health System - Division of Dermatology

    Skokie, Illinois, 60077

  • Miami Research Associates, Inc.

    South Miami, Florida, 33143

  • Rockwood Research Center

    Spokane, Washington, 99202

  • Springfield Clinic

    Springfield, Illinois, 62703

  • Saint Louis University - Department of Dermatology

    St Louis, Missouri, 63104

  • Olympian Clinical Research

    Tampa, Florida, 33609

  • Healthcare Partners Medical Group

    Torrance, California, 90503

  • Somerset Skin Centre - Dermcenter

    Troy, Michigan, 48084

  • New England Research Associates, LLC

    Trumbull, Connecticut, 06611

  • Radiant Research, Inc.

    Tucson, Arizona, 85712

  • Center for Clinical Studies

    Webster, Texas, 77598

  • Wenatchee Valley Hospital & Clinics

    Wenatchee, Washington, 98801

  • Dundee Dermatology

    West Dundee, Illinois, 60118

  • Dermatology Associates

    Wilmington, North Carolina, 28401

  • PMG Research of Wilmington, LLC

    Wilmington, North Carolina, 28401

  • Piedmont Imaging

    Winston-Salem, North Carolina, 27103

  • PMG Research of Winston-Salem

    Winston-Salem, North Carolina, 27103

  • Triad Dermatology, PA

    Winston-Salem, North Carolina, 27103

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27104

Other trials in United States

Canada34 sites

  • CCA Medical Research

    Ajax, Ontario, L1S 7K8

  • The Waterside Clinic

    Barrie, Ontario, L4M 6L2

  • Ultranova Skincare

    Barrie, Ontario, L4M 6L2

  • Kirk Barber Research

    Calgary, Alberta, T2G 1B1

  • Northwest Dermatology & Laser Centre

    Calgary, Alberta, T3G 0B4

  • Co-Medica Research Network Inc.

    Courtice, Ontario, L1E 3C3

  • Stratica Medical

    Edmonton, Alberta, T5K 1X3

  • Eastern Canada Cutaneous Research Associates Ltd.

    Halifax, Nova Scotia, B3H 1Z2

  • Dermatrials Research, Inc.

    Hamilton, Ontario, L8N 1V6

  • The Guenther Dermatology Research Centre

    London, Ontario, N6A 3H7

  • Lynderm Research Inc.

    Markham, Ontario, L3P 1X2

  • Innovaderm Research Inc

    Montreal, Quebec, H2K 4L5

  • Siena Medical Research

    Montreal, Quebec, H3Z 2S6

  • North Bay Dermatology Centre

    North Bay, Ontario, P1B 3Z7

  • Oakville Dermatology Laser Centre

    Oakville, Ontario, L6J 7W5

  • Dr. Tuppal's Privat Practice, Oshawa Clinic

    Oshawa, Ontario, L1H 1B9

  • Office of Dr. Michael Robern

    Ottawa, Ontario, K2G 6E2

  • SKiN Centre for Dermatology

    Peterborough, Ontario, K9J 5K2

  • CRCMRGilbert Inc., Centre de Dermatologie Maizerets

    Québec, Quebec, G1J 1X7

  • Centre de Recherche Dermatologique du Québec Métropolitain

    Québec, Quebec, G1V 4X7

  • Office of Dr. Paul Adam (back-up location)

    Scarborough Village, Ontario, MlB 4Z8

  • Diex Research Sherbrooke Inc.

    Sherbrooke, Quebec, J1H 1Z1

  • Nexus Clinical Research

    St. John's, Newfoundland and Labrador, A1A 5E8

  • Dr. Zohair Tomi PMC Inc. Paton Medical Centre

    St. John's, Newfoundland and Labrador, A1B 4S8

  • NewLab Clinical Research Inc.

    St. John's, Newfoundland and Labrador, A1C 2H5

  • Enverus Medical Research

    Surrey, British Columbia, V3V 0C6

  • Derm Research @888 Inc

    Vancouver, British Columbia, V5Z 3Y1

  • The Skin Centre

    Vancouver, British Columbia, V5Z 4E8

  • Percuro Clinical Research Limited

    Victoria, British Columbia, V8V 3P9

  • K. Papp Clinical Research

    Waterloo, Ontario, N2J 1C4

  • XLR8 Medical Research

    Windsor, Ontario, N8W 1E6

  • Windsor Clinical Research

    Windsor, Ontario, N8W 5L7

  • Dermadvances Research

    Winnipeg, Manitoba, R3C 1R4

  • Wiseman Dermatology Research Inc.

    Winnipeg, Manitoba, R3M 3Z4

Other trials in Canada

Germany29 sites

  • Charité Universitätsmedizin Berlin

    Berlin, 10117

  • Klinische Forschung Berlin-Mitte GmbH

    Berlin, 10117

  • Facharzt fuer Dermatologie und Allergologie

    Berlin, 10435

  • MVZ Reichenberger Str., Aerztehaus "Rudolf Virchow"

    Berlin, 13055

  • Hautarztpraxis Tegel

    Berlin, 13507

  • Klinik and Poliklinik fur Dermatologie and Allergologie der Universitaet Bonn

    Bonn, 53105

  • Klinik und Poliklinik fur Dermatologie und Allergologie der Universitaet Bonn

    Bonn, 53105

  • Dres. Kirsten Prepeneit und Volker Streit

    Buchholz, 21244

  • Universitaetsklinikum Koeln

    Cologne, 50937

  • Universitaetsklinik Carl Gustav Carus

    Dresden, 01307

  • Universitaetsklinikum Erlangen Hautklinik im Internistischen Zentrum

    Erlangen, 91054

  • Klinikum der Johann Wolfgang Goethe Universitaet

    Frankfurt am Main, 60590

  • Universitaetsklinik und Poliklinik fuer Dermatologie und Venerologie

    Halle, 06120

  • Universitaetsklinikum Hamburg-Eppendorf

    Hamburg, 20246

  • Klinische Forschung Hamburg GmbH

    Hamburg, 20253

  • Gemeinschaftspraxis Dres.Michael Ockenfels und Christoph Sauter

    Hanau, 63450

  • Universitaetsklinikum Heidelberg

    Heidelberg, 69120

  • Universitatsklinikum Schleswig-Holstein

    Kiel, Schleswig-Holstein, 24105

  • Universitaetsklinikum Schleswig-Holstein, Campus Kiel

    Kiel, 24105

  • Universitaetsklinikum Schleswig-Holstein Campus Luebeck

    Lübeck, 23538

  • Hautarztpraxis Dres. Scholz, Sebastian, Schilling

    Mahlow, 15831

  • Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KoeR

    Mainz, 55131

  • Technischen Universitaet Muenchen

    München, 80802

  • Universitaetsklinikum Muenster

    Münster, 48149

  • Klinische Forschung Schwerin GmbH

    Schwerin, 19055

  • Universitaets-Hautklinik Eberhard-Karls-Universitaet Tuebingen

    Tübingen, Baden-Wurttemberg, 72076

  • Eberhard-Karls-Universitaet Tuebingen Universitaetshautklinik

    Tübingen, 72076

  • HSK, Dr. Horst Schmidt Kliniken GmbH

    Wiesbaden, 65199

  • Hautarztpraxis Centrovital

    Witten, 58453

Other trials in Germany

France17 sites

  • Hôpital Jean Minjoz

    Besançon, 25000

  • CHU Jean-Minjoz

    Besançon, 25030

  • Chu Morvan

    Brest, Cedex, 29609

  • CHG Le Mans

    Le Mans, 72037

  • CHU Limoges - Hôpital Dupuytren - Pharmacie

    Limoges, Cedex, 87042

  • Hopital Dupuytren

    Limoges, 87042

  • CHU de Nantes - Hotel Dieu

    Nantes, 44035

  • CHU De Nice Hopital De L'Archet II

    Nice, 06202

  • Hopital Saint Louis

    Paris, Lle-de-france, 75010

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69310

  • Centre Hospitalier Lyon Sud - Pharmacie

    Pierre-Bénite, 69495

  • C.H.U. de Poitiers la Miletrie

    Poitiers, 86000

  • C.H.U de Reims

    Reims, 51092

  • Hôpital Robert Debre

    Reims, 51100

  • Hopital Nord

    Saint-Priest-en-Jarez, 42270

  • Hopital Larrey Departement de Dermatologie

    Toulouse, 31000

  • Hopital de Brabois / Batiment Philippe Canton

    Vandœuvre-lès-Nancy, 54511

Other trials in France

Poland16 sites

  • NZOZ Zdrowie Osteo-Medic

    Bialystok, 15-351

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, Pomeranian Voivodeship, 80-952

  • Klinika Dermatologii, Wenerologii i Alergologii Uniwersyteckiego Centrum Klinicznego

    Gdansk, 80-402

  • Krakowskie Centrum Medyczne NZOZ

    Krakow, 31-501

  • Specjalistyczne Gabinety Lekarskie "Dermed"

    Lodz, 90-265

  • Novum Instytut Dermatologii Leczniczej i Estetycznej

    Opole, 45-080

  • Solumed Centrum Medyczne

    Poznan, 60-529

  • Centrum Badan Klinicznych s.c. Wieslawa Porawska, Lukasz Porawski

    Poznan, 60773

  • Katedra i Klinika Chorob Skornych i Wenerycznych, Pomorski Uniwersytet Medyczny

    Szczecin, 70-111

  • Spolka Cywilna Andrzej Krolicki, Tomasz Kochanowski "Laser Clinic"

    Szczecin, 70-332

  • MTZ Clinical Research Sp. z o.o.

    Warsaw, 02-106

  • Klinika Dermatologii

    Warsaw, 04-141

  • Zaklad Radiologii Lekarskiej

    Warsaw, 04-141

  • Katedra i Klinika Dermatologii, Wenerologii i Alergologii Akademii Medycznej we Wroclawiu

    Wroclaw, 50-368

  • Oddzial Dermatologiczny

    Wroclaw, 51-124

  • Poradnia Dermatologiczna

    Wroclaw, 51-124

Other trials in Poland

Hungary12 sites

  • Synexus Magyarorszag Kft.

    Budapest, 1036

  • Debreceni Egyetem Klinikai Kozpont, Borgyogyaszati Klinika

    Debrecen, 4032

  • Bacs-Kiskun Megyei Korhaz Szegedi Tudomanyegyetem AOK Oktato Korhaza, Borgyogyaszati Osztaly

    Kecskemét, 6000

  • Miskolci Semmelweis Korhaz es Egyetemi Oktatokorhaz, Borgyogyaszati Osztaly

    Miskolc, 3529

  • Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz, Klinikai Kutatasi Osztaly

    Nyíregyháza, 4400

  • Szabolcs-Szatmar-Bereg Megyei Korjazak es Egyetemi Okatokorhaz, Borgyogyaszati Szakrendeles

    Nyíregyháza, 4400

  • Pecsi Tudomanyegyetem Aok Bor- Nemikortani Es Onkodermatologiai Klinika

    Pécs, H-7632

  • SZTE Szentgyorgyi Albert Klinikai Kozpont/Borgyogyaszati es Allergologiai Klinika

    Szeged, 6720

  • Tolna Megyei Balassa Janos Korhaz, Borgyogyaszati Osztaly

    Szekszárd, 7100

  • ALLERGO-DERM BAKOS Kft.

    Szolnok, 5000

  • Vas Megyei Markusovszky Korhaz/Borgyogyaszati Osztaly

    Szombathely, H-9700

  • Veszprem Megyei Csolnoky Ferenc Korhaz Borgyogyaszat

    Veszprém, H-8200

Other trials in Hungary

Russia10 sites

  • State Research Center of Dermatovenerology,

    Moscow, 107076

  • State Research Center of Dermatovenerology

    Moscow, 107076

  • Dermatovenerological dispensary #7

    Moscow, 121614

  • Rostov-on-Don regional dermatovenerologic dispensary

    Rostov-on-Don, 344007

  • Ryazan regional clinical dermatovenerologic dispensary

    Ryazan, 390046

  • Dermatovenerologic dispensary #10 of Vyborg region

    Saint Petersburg, 194021

  • Military Medical Academy N.A. S.M.Kirov

    Saint Petersburg, 194044

  • North-Western State Medical University I.I. Mechnikov

    Saint Petersburg, 195067

  • Smolensk State Medical Academy

    Smolensk, 214019

  • Clinical hospital of emergency care N.V. Soloviev

    Yaroslavl, 150003

Other trials in Russia

Czechia8 sites

  • Nemocnice Ceske Budejovice, a.s. Ustavni lekarna

    České Budějovice, Czech Republic, 370 01

  • Nemocnice Ceske Budejovice,a.s.

    České Budějovice, 37001

  • Ustanvi lekarna

    Hradec Králové, Czech Republic, 50005

  • Klinika nemoci koznich a pohlavnich

    Hradec Králové, 500 05

  • Fakultni nemocnice Plzen

    Plzen-Bory, 30599

  • Kozni ordinace

    Prague, 11000

  • Lekarna U sv. Ignace

    Prague, 120 00

  • Krajska zdravotni a.s.,Masarykovy nemocnice o.z.

    Ústí nad Labem, 40113

Other trials in Czechia

Ukraine8 sites

  • Municipal Institution of health Care

    Kharkiv, 61038

  • SI 'Institute for Dermatology and Venerology of AMS of Ukraine'

    Kharkiv, 61057

  • Kyiv Oleksandrivska Clin. Hosp., Dermatology department, NMU n.a. O.O. Bogomolets,

    Kyiv, 01601

  • Dept of Dermatology and Venerology of Lugansk State Medical University,

    Luhansk, 91047

  • Regional Municipal Dermatovenerologic Dispensary

    Lviv, 79013

  • Dept of Dermatology and Venerology of ONMU

    Odesa, 65006

  • Dept of Dermatology and Venerology of SI "Crimean State Medical University n.a. S.I.Georgiyevskyy"

    Simferopol, Autonomous Republic of Crimea, 95006

  • Ternopil Regional Municipal Clinical Dermatovenerologic Dispensary

    Ternopil, 46006

Other trials in Ukraine

Colombia7 sites

  • Centro Integral de Reumatologia del Caribe Cicaribe S.A.S

    Barranquilla, Atlántico, 08001000

  • Riesgo De Fractura S.A

    Bogota, Cundinamarca, 0000

  • Riesgo De Fractura S.A

    Bogota, Cundinamarca

  • Colegio Mayor de Nuestra Señora del Rosario

    Bogotá, Cundinamarca, 110221

  • Medicity S.A.S

    Bucaramanga, Santander Department, 680003

  • Reumalab S.A.S.

    Medellín, Antioquia, 0

  • Hospital Pablo Tobon Uribe

    Medellín, Antioquia

Other trials in Colombia

Bulgaria6 sites

  • UMHAT "Dr Georgi Stranski"

    Pleven, 5800

  • UMHAT "Dr. Georgi Stranski" - II clinical base

    Pleven, 5800

  • Tsentar za kozhno venericheski zaboliavania EOOD

    Sofia, 1404

  • Mnogoprofilna Bolnitsa Za Aktivno Lechenie- Tokuda Bolnitsa

    Sofia, 1407

  • UMBAL-Alexandrovska- Sofia Klinika po dermatologia i venerologia

    Sofia, 1431

  • MBAL na Voennomeditsinska Akademia

    Sofia, 1606

Other trials in Bulgaria

Spain6 sites

  • Hospital General Universitario de Alicante

    Alicante, 03010

  • Hospital Universitario La Princesa

    Madrid, 28006

  • Hospital 12 de Octubre

    Madrid, 28041

  • Hospital Universitario Fundacion Alcorcon

    Madrid, 28922

  • Hospital Universitario Puerta de Hierro

    Majadahonda, Madrid, 28222

  • Consorcio Hospital General Universitario de Valencia

    Valencia, 46014

Other trials in Spain

Sweden6 sites

  • Hudkliniken

    Falun, 791 82

  • Hermelinen Forskning AB

    Luleå, 972 33

  • Pharmacy: Sjukhusapoteket Lund

    Lund, 222 42

  • Hud kliniken- Skanes Universitetssjukhus i Malmo

    Malmö, Sverige, 205 02

  • Hudkliniken

    Stockholm, 118 83

  • Karolinska University Hospital- Solna

    Stockholm, 171 76

Other trials in Sweden

Taiwan6 sites

  • Chang Gung Medical Foundation Kaohsiung Branch

    Kaohsiung City, 833

  • Chung Shan Medical University Hospital

    Taichung, Taiwan Roc, 40201

  • National Cheng Kung University Hospital

    Tainan, 704

  • National Taiwan University Hospital

    Taipei, 100

  • Taipei Medical University-Shuang Ho Hospital

    Taipei, 235

  • Chang Gung Medical Foundation Linkou Branch

    Taoyuan, 333

Other trials in Taiwan

Australia5 sites

  • Dr. Glenn and Partners

    Kogarah, New South Wales, 02217

  • Premier Dermatology

    Kogarah, New South Wales, 02217

  • Malvern Diagnostic Imaging

    Malvern, Victoria, 3144

  • Emeritus Research

    Malvern East, Victoria, 3145

  • Skin And Cancer Foundation

    Melbourne, Victoria, 3053

Other trials in Australia

Denmark5 sites

  • Aarhus University Hospital

    Aarhus C, 8000

  • Bispebjerg Hospital, University of Copenhagen

    Copenhagen NV, 2400

  • Gentofte Hospital

    Hellerup, 2900

  • Hudklinikken Herning

    Herning, 7400

  • Hudklinikken

    Svendborg, 5700

Other trials in Denmark

Japan5 sites

  • Kobe University

    Kobe, Hyōgo, 6500017

  • Kumamoto University Hospital

    Kumamoto, Kumamoto, 860-8556

  • Gunma University Hospital

    Maebashi, Gunma, 3718511

  • JR Sapporo hospital

    Sapporo, Hokkaido, 060-0033

  • Tokyo Yamate Medical Center

    Shinjuku-ku, Tokyo, 169-0073

Other trials in Japan

Mexico4 sites

  • Mexico Centre for Clinical Research S.A. de C.V.

    Mexico City, Mexico City, 03100

  • Centro de Dermatologia de Monterrey

    Monterrey, Nuevo León, 64460

  • Centro Medico San Lucas

    Monterrey, Nuevo León, 64710

  • Instituto Dermatologico De Jalisco "Dr Jose Barba Rubio"

    Zapopan, Jalisco, 45190

Other trials in Mexico

United Kingdom4 sites

  • Whipps Cross University Hospital

    London, E11 1NR

  • Department of Dermatology

    Nuneaton, Warwickshire, CV10 7DJ

  • eRT

    Peterborough, PE 2 6UP

  • Salford Royal NHS Foundation Trust

    Salford, Manchester, M6 8HD

Other trials in United Kingdom

Brazil3 sites

  • Instituto de Dermatologia e Estetica do Brasil LTDA - IDERJ

    Rio de Janeiro, 22470-220

  • Hospital da Clinicas da Faculdade de Medicina da Universidade de Sao Paulo

    São Paulo, São Paulo, 05403-900

  • Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo

    São Paulo, 05403-000

Other trials in Brazil

Chile3 sites

  • Clinica Dermacross S.A.

    Santiago, Santiago Metropolitan, 7640881

  • Hospital Clinico Universidad de Chile

    Santiago, Santiago Metropolitan, 8380456

  • Centro Internacional de Estudios Clinicos, CIEC

    Santiago, Santiago Metropolitan, 8420383

Other trials in Chile

Croatia3 sites

  • University Hospital Center Osijek

    Osijek, 31000

  • University hospital center "Sestre milosrdnice" clinic for dermatology and venerology disease

    Zagreb, 10000

  • University hospital center zagreb

    Zagreb, 10000

Other trials in Croatia

Greece3 sites

  • University Dermatology Clinic "Andreas Syggros" Hospital

    Athens, Attica, 16121

  • University General Hospital of Ioannina / Dermatology and Venereology Department

    Ioannina, 45500

  • "Papageorgiou" General Hospital/B' Dermatology and Venereology Clinic of University of Thessaloniki

    Thessaloniki, 56403

Other trials in Greece

Slovakia3 sites

  • Dermatovenerologicka klinika SZU, Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica

    Banská Bystrica, 975 17

  • Oddelenie biologickej liecby, Narodny ustav reumatickych chorob

    Piešťany, 921 12

  • DOST-Dermatovenerologicke oddelenie sanatorneho typu, SANARE, spol. s r.o.

    Svidník, 089 01

Other trials in Slovakia

South Korea3 sites

  • Seoul National University Hospital

    Seoul, 03080

  • Samsung Medical Center

    Seoul, 06351

  • Yonsei University College of Medicine, Severance Hospital

    Seoul, 120-752

Other trials in South Korea

Argentina2 sites

  • Centro De Investigaciones Dermatologicas

    Caba, C1114AAP

  • CENIT Centro de Neurociencias Investigacion y Tratamiento

    CABA, C1125ABD

Other trials in Argentina

Austria2 sites

  • LKH Feldkirch

    Feldkirch, 6807

  • LKH Salzburg, Landesklinik fuer Dermatologie

    Salzburg, 5020

Other trials in Austria

Netherlands2 sites

  • Academisch Medisch Centrum Universiteit van Amsterdam

    Amsterdam, North Holland, 1105 AZ

  • PT&R

    Beek, 6191 JW

Other trials in Netherlands

Serbia2 sites

  • Clinical Hospital Center Zvezdara

    Belgrade, 11000

  • Military Medical Academy

    Belgrade, 11000

Other trials in Serbia

Singapore2 sites

  • National Skin Centre

    Singapore, 308205

  • Changi General Hospital

    Singapore, 529889

Other trials in Singapore

Belgium1 site

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200

Other trials in Belgium

Bosnia and Herzegovina1 site

  • UHC Sarajevo

    Sarajevo, 71000

Other trials in Bosnia and Herzegovina

Finland1 site

  • Tampere Univeristy Hospital, Department of Dermatology and Venereology

    Tampere, 33521

Other trials in Finland

Hong Kong1 site

  • The University of Hong Kong (HKU)-Queen Mary Hospital (QMH)

    Hong Kong

Other trials in Hong Kong

Puerto Rico1 site

  • Grupo Dermatologico De Carolina (Office of Dr. Alma Cruz MD)

    Carolina, 00985

Other trials in Puerto Rico

Switzerland1 site

  • Kantonsspital St. Gallen

    Sankt Gallen, 9007

Other trials in Switzerland

About this study

Official title: A Phase 3, Multi-Site, Open-Label Study Of The Long Term Safety And Tolerability Of 2 Oral Doses Of CP-690,550 In Subjects With Moderate To Severe Chronic Plaque Psoriasis

The main objective of this study is to evaluate the long-term safety of CP-690,550 in patients being treated for moderate to severe chronic plaque psoriasis. This is an open label extension study available to patients who participated in one of the qualifying studies with CP-690,550 providing entry criteria is met.

Read the detailed description

The study terminated on 08MAR2016 as it met its objectives of characterizing long term safety and tolerability. The study did not terminate due to safety concerns.

Conditions
Psoriasis
Being tested
CP-690,550
Keywords
chronic, severe, treatment, safety, CP-690,55, Plaque Psoriasis, Psoriasis Vulgaris, Xeljanz, Tofacitinib
Medical subject headings
Psoriasis, Bronchiolitis Obliterans Syndrome, Lymphoma, Follicular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CP-690,550Drug

    5 mg oral BID

  • CP-690,550Drug

    10 mg oral BID

Study groups in NCT01163253
Study groupRoleWhat they receive
Active TreatmentExperimentalThe study is anticipated to continue for up to at least 2 years post First Market Approval (FMA) in a global, major market. All subjects will receive 10 mg BID of CP-690,550 for first 3 months of trial. Study has the option for variable dosing with 5 mg or 10 mg BID after first 3-months of treatment based on PI discretion
Receives: Drug: CP-690,550

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 4 weeks after last dose (up to 67 months) that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events.

    Measured: Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)

  2. Number of Adverse Events (AEs) by Severity

    An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs were classified according to the severity in 3 categories: a) mild: AEs did not interfere with participant's usual function; b) moderate: AEs interfered to some extent with participant's usual function; c) severe: AEs interfered significantly with participant's usual function.

    Measured: Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)

  3. Number of Participants With Laboratory Abnormalities

    Abnormality criteria: hematology (hemoglobin, hematocrit, red blood cell <0.8*lower limit of normal [LLN]; reticulocyte<0.5*LLN,>1.5*ULN; platelets<0.5*LLN,>1.75* upper limit of normal [ULN]; WBC<0.6*LLN, >1.5*ULN; lymphocytes, neutrophils, basophils, eosinophils, monocytes<0.8*LLN; >1.2*ULN; coagulation (prothrombin [PT], PT ratio>1.1*ULN) liver function (bilirubin>1.5*ULN, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, gamma GT>0.3*ULN, protein, albumin<0.8*LLN; >1.2*ULN, globulin<0.5*LLN; >1.5*ULN); renal function (blood urea nitrogen, creatinine>1.3*ULN); electrolytes(sodium<0.95* LLN; >1.05* ULN, potassium, chloride, calcium, bicarbonate<0.9*LLN; >1.1*ULN), chemistry (glucose<0.6*LLN; >1.5* ULN), urinalysis (pH <4.5;>8, glucose, ketones, protein, blood, urobilinogen, nitrite, bilirubin, leukocyte esterase>=1; RBC, WBC>=20); lipids (cholesterol [C], LDL-C >1.3*ULN, HDL-C<0.8*LLN, triglycerides>1.3* ULN), hormones(T4, T3, T4, TSH<0.8* LLN; >1.2* ULN).

    Measured: Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)

  4. Change From Baseline in Hemoglobin Level at Month 1

    Measured: Baseline, Month 1

  5. Change From Baseline in Hemoglobin Level at Month 3

    Measured: Baseline, Month 3

  6. Change From Baseline in Hemoglobin Level at Month 6

    Measured: Baseline, Month 6

  7. Change From Baseline in Hemoglobin Level at Month 12

    Measured: Baseline, Month 12

  8. Change From Baseline in Hemoglobin Level at Month 24

    Measured: Baseline, Month 24

  9. Change From Baseline in Hemoglobin Level at Month 36

    Measured: Baseline, Month 36

  10. Change From Baseline in Hemoglobin Level at Month 48

    Measured: Baseline, Month 48

  11. Change From Baseline in Lymphocyte and Neutrophil Count at Month 1

    Measured: Baseline, Month 1

  12. Change From Baseline in Lymphocyte and Neutrophil Count at Month 3

    Measured: Baseline, Month 3

  13. Change From Baseline in Lymphocyte and Neutrophil Count at Month 6

    Measured: Baseline, Month 6

  14. Change From Baseline in Lymphocyte and Neutrophil Count at Month 12

    Measured: Baseline, Month 12

  15. Change From Baseline in Lymphocyte and Neutrophil Count at Month 24

    Measured: Baseline, Month 24

  16. Change From Baseline in Lymphocyte and Neutrophil Count at Month 36

    Measured: Baseline, Month 36

  17. Change From Baseline in Lymphocyte and Neutrophil Count at Month 48

    Measured: Baseline, Month 48

  18. Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 1

    Measured: Baseline, Month 1

  19. Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 3

    Measured: Baseline, Month 3

  20. Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 6

    Measured: Baseline, Month 6

  21. Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 12

    Measured: Baseline, Month 12

  22. Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 24

    Measured: Baseline, Month 24

  23. Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 36

    Measured: Baseline, Month 36

  24. Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 48

    Measured: Baseline, Month 48

  25. Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 1

    Measured: Baseline, Month 1

  26. Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 3

    Measured: Baseline, Month 3

  27. Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 6

    Measured: Baseline, Month 6

  28. Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 12

    Measured: Baseline, Month 12

  29. Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 24

    Measured: Baseline, Month 24

  30. Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 36

    Measured: Baseline, Month 36

  31. Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 48

    Measured: Baseline, Month 48

  32. Number of Participants With Clinically Significant Change From Baseline in Physical Examination

    Physical examinations included: general appearance; skin, head, eyes, ears, nose and throat; heart; lungs; abdomen; lower extremities (for the presence of peripheral edema) and lymph nodes. Clinical significance of change from baseline values in physical examination was based on investigator's discretion.

    Measured: Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)

  33. Number of Participants With Vital Sign Abnormalities

    Criteria for abnormalities in vital signs included: Systolic blood pressure (SBP): less than (<) 90 millimeter of mercury (mmHg) and maximum increase from baseline (IFB) of greater than or equal to (>=) 30 mmHg; diastolic blood pressure (DBP): <50 and greater than (>) 120 mmHg and maximum IFB of >=20 mmHg; heart rate: <40 and >120 beats per minute.

    Measured: Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)

  34. Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 1

    Measured: Baseline, Month 1

  35. Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 3

    Measured: Baseline, Month 3

  36. Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 6

    Measured: Baseline, Month 6

  37. Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 12

    Measured: Baseline, Month 12

  38. Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 24

    Measured: Baseline, Month 24

  39. Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 36

    Measured: Baseline, Month 36

  40. Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 48

    Measured: Baseline, Month 48

  41. Change From Baseline in Heart Rate at Month 1

    Measured: Baseline, Month 1

  42. Change From Baseline in Heart Rate at Month 3

    Measured: Baseline, Month 3

  43. Change From Baseline in Heart Rate at Month 6

    Measured: Baseline, Month 6

  44. Change From Baseline in Heart Rate at Month 12

    Measured: Baseline, Month 12

  45. Change From Baseline in Heart Rate at Month 24

    Measured: Baseline, Month 24

  46. Change From Baseline in Heart Rate at Month 36

    Measured: Baseline, Month 36

  47. Change From Baseline in Heart Rate at Month 48

    Measured: Baseline, Month 48

  48. Number of Participants With Electrocardiogram (ECG) Abnormalities

    Criteria for ECG abnormality: PR interval >=300 milliseconds (msec); QT interval >=500 msec; QTcB (Bazett's Correction) and QTcF (Fridericia's Correction) 450 to <480 msec, 480 to <500 msec and >=500 msec.

    Measured: Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)

  49. Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 6

    Measured: Baseline, Month 6

  50. Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 12

    Measured: Baseline, Month 12

  51. Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 24

    Measured: Baseline, Month 24

  52. Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 36

    Measured: Baseline, Month 36

  53. Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 48

    Measured: Baseline, Month 48

  54. Number of Participants With Adjudicated Cardiovascular Events

    Adjudicated cardiovascular events were assessed by adjudication committee as independent reviewers based on event documentation including: hospital discharge summaries, operative reports, clinic notes, ECGs, diagnostic enzymes, results of other diagnostic tests, autopsy reports and death certificate information; as applicable.

    Measured: Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)

  55. Number of Participants With Malignancy Events

    Malignancy events included lymphoma, and demyelinating neurologic events. Biopsies collected for malignancy events were submitted to the central laboratory for pathologist over-read.

    Measured: Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)

Secondary outcomes (23)

  1. Percentage of Participants Achieving Physician Global Assessment (PGA) Response of 'Clear' or 'Almost Clear'

    The PGA of psoriasis was scored on a 5-point scale, reflecting a global consideration of the erythema (E), induration (I), and scaling (S) across all psoriatic lesions in participants. The severity rating scores (Erythema: 0= no evidence of erythema to 4= dark, deep red; Induration: 0= no evidence of plaque elevation to 4= marked plaque elevation, hard/sharp borders; Scaling: 0= no evidence of scaling to 4= thick, coarse scale predominates) were summed (E + I + S = total) and the average (total/3) was taken. The total average was rounded to the nearest whole number score to determine the PGA. The 5-point scale for PGA was: 0= clear; 1= almost clear; 2= mild; 3= moderate; 4= severe, where higher score indicated more severity of psoriasis. Percentage of participants with response of 'clear' (score of '0') and 'almost clear' (score of '1') were reported.

    Measured: Month 1, 3, 6, 12, 24, 36, 48

  2. Percentage of Participants Achieving Greater Than or Equal to (>=) 75 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores

    PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Each component of severity, that is, erythema, induration and scaling was assessed separately for four body areas (head and neck [h], upper limbs [u], trunk [t] and lower limbs [l]) on a 5-point scale ranging from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity. Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head and neck: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4. Percentage of participants with >=75 percent (%) reduction from baseline in PASI scores were reported.

    Measured: Baseline, Month 1, 3, 6, 12, 24, 36, 48

  3. Psoriasis Area and Severity Index (PASI) Scores

    PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Each component of severity, that is, erythema, induration and scaling was assessed separately for four body areas (head and neck [h], upper limbs [u], trunk [t] and lower limbs [l]) on a 5-point scale ranging from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity. Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head and neck: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4.

    Measured: Baseline, Month 1, 3, 6, 12, 24, 36, 48

  4. Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores at Month 1, 3, 6, 12, 24, 36 and 48

    PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Each component of severity, that is, erythema, induration and scaling was assessed separately for four body areas (head and neck [h], upper limbs [u], trunk [t] and lower limbs [l]) on a 5-point scale ranging from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity. Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head and neck: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4.

    Measured: Baseline, Month 1, 3, 6, 12, 24, 36, 48

  5. Psoriasis Area and Severity Index (PASI) Component Scores: Erythema

    PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Erythema was assessed separately for four body areas (head and neck, upper limbs, trunk and lower limbs) on a 5-point scale ranges from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity.

    Measured: Baseline, Month 1, 3, 6, 12, 24, 36, 48

  6. Psoriasis Area and Severity Index (PASI) Component Scores: Induration

    PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Induration was assessed separately for four body areas (head and neck, upper limbs, trunk and lower limbs) on a 5-point scale ranges from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity.

    Measured: Baseline, Month 1, 3, 6, 12, 24, 36, 48

  7. Psoriasis Area and Severity Index (PASI) Component Scores: Scaling

    PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Scaling was assessed separately for four body areas (head and neck, upper limbs, trunk and lower limbs) on a 5-point scale ranges from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity.

    Measured: Baseline, Month 1, 3, 6, 12, 24, 36, 48

  8. Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Erythema at Month 1, 3, 6, 12, 24, 36 and 48

    PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Erythema was assessed separately for four body areas (head and neck, upper limbs, trunk and lower limbs) on a 5-point scale ranges from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity.

    Measured: Baseline, Month 1, 3, 6, 12, 24, 36, 48

  9. Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Induration at Month 1, 3, 6, 12, 24, 36 and 48

    PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Induration was assessed separately for four body areas (head and neck, upper limbs, trunk and lower limbs) on a 5-point scale ranges from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity.

    Measured: Baseline, Month 1, 3, 6, 12, 24, 36, 48

  10. Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Scaling at Month 1, 3, 6, 12, 24, 36 and 48

    PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Scaling was assessed separately for four body areas (head and neck, upper limbs, trunk and lower limbs) on a 5-point scale ranges from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity.

    Measured: Baseline, Month 1, 3, 6, 12, 24, 36, 48

  11. Percentage of Participants Achieving Greater Than or Equal to (>=) 50 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores

    PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Each component of severity, that is, erythema, induration and scaling was assessed separately for four body areas (head and neck [h], upper limbs [u], trunk [t] and lower limbs [l]) on a 5-point scale ranging from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity. Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head and neck: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4. Percentage of participants with >=50% reduction from baseline in PASI scores were reported.

    Measured: Baseline, Month 1, 3, 6, 12, 24, 36, 48

  12. Percentage of Participants Achieving Greater Than or Equal to (>=) 90 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores

    PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Each component of severity, that is, erythema, induration and scaling was assessed separately for four body areas (head and neck [h], upper limbs [u], trunk [t] and lower limbs [l]) on a 5-point scale ranging from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity. Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head and neck: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4. Percentage of participants with >=90% reduction from baseline in PASI scores were reported.

    Measured: Baseline, Month 1, 3, 6, 12, 24, 36, 48

  13. Percentage of Participants Achieving Greater Than or Equal to (>=) 125 Percent Increase From Baseline in Psoriasis Area and Severity Index (PASI) Scores

    PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Each component of severity, that is, erythema, induration and scaling was assessed separately for four body areas (head and neck [h], upper limbs [u], trunk [t] and lower limbs [l]) on a 5-point scale ranging from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity. Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head and neck: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4. Percentage of participants with >=125% increase from baseline in PASI scores were reported.

    Measured: Baseline, Month 1, 3, 6, 12, 24, 36, 48

  14. Itch Severity Item (ISI) Scores

    ISI assessed severity of itching due to psoriasis. ISI was a single item, horizontal numeric rating scale. Participants were asked to rate their 'severity of itching' due to psoriasis over the past 24 hours on a numeric rating scale anchored by the terms '0=no itching' and '10=worst possible itching' at the ends. Higher scores indicated greater severity of itching.

    Measured: Baseline, Month 1, 3, 6, 12, 24, 36, 48

  15. Change From Baseline in Itch Severity Item (ISI) Scores at Month 1, 3, 6, 12, 24, 36 and 48

    ISI assessed severity of itching due to psoriasis. ISI was a single item, horizontal numeric rating scale. Participants were asked to rate their 'severity of itching' due to psoriasis over the past 24 hours on a numeric rating scale anchored by the terms '0=no itching' and '10=worst possible itching' at the ends. Higher scores indicated greater severity of itching.

    Measured: Baseline, Month 1, 3, 6, 12, 24, 36, 48

  16. Dermatology Life Quality Index (DLQI) Scores

    The DLQI was a validated, self-administered, 10-item quality-of-life questionnaire that consisted of 10 items that assessed the impact of skin disease on quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). Each question was scored on a scale of 0=not at all/not relevant to 3=very much. Response from all of the 10 questions were added to derive the DLQI total scores. Total DLQI scores ranges from 0=not at all to 30=very much, with higher scores indicating greater impairment in quality of life.

    Measured: Baseline, Month 1, 6, 12, 24, 36, 48

  17. Change From Baseline in Dermatology Life Quality Index (DLQI) Scores at Month 1, 6, 12, 24, 36 and 48

    The DLQI was a validated, self-administered, 10-item quality-of-life questionnaire that consisted of 10 items that assessed the impact of skin disease on quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). Each question was scored on a scale of 0=not at all/not relevant to 3=very much. Response from all of the 10 questions were added to derive the DLQI total scores. Total DLQI scores ranges from 0=not at all to 30=very much, with higher scores indicating greater impairment in quality of life.

    Measured: Baseline, Month 1, 6, 12, 24, 36, 48

  18. 36-Item Short-Form (SF-36) Health Survey Version 2, Acute: Physical Component Summary Scores

    The SF-36 questionnaire, version 2, acute was a 36-item generic health status measure. SF-36 evaluated 8 health-related aspects of an individual: physical functioning, role-physical, bodily pain, social functioning, mental health, role emotional, vitality, and general health. The score range for each of the 8 health aspects ranged from 0 (worst) to 100 (best), with higher scores indicating good health condition. Two summary scale scores were computed from the 8 health aspect scores: physical component summary score and mental component summary score. Score range for both summary scales ranged from 0 (worst) to 100 (best), with higher scores indicating good health condition.

    Measured: Baseline, Month 6, 12, 24, 36, 48

  19. 36-Item Short-Form (SF-36) Health Survey Version 2, Acute: Mental Component Summary Scores

    The SF-36 questionnaire, version 2 was a 36-item generic health status measure. SF-36 evaluated 8 health-related aspects of an individual: physical functioning, role-physical, bodily pain, social functioning, mental health, role emotional, vitality, and general health. The score range for each of the 8 health aspects ranged from 0 (worst) to 100 (best), with higher scores indicating good health condition. Two summary scale scores were computed from the 8 health aspect scores: the Physical Component Summary and the Mental Component Summary. Score range for both summary scale ranged from 0 (worst) to 100 (best), with higher scores indicating good health condition.

    Measured: Baseline, Month 6, 12, 24, 36, 48

  20. Number of Participants With Patient Global Assessment (PtGA) Response of "Clear" or "Almost Clear"

    The PtGA evaluated the overall skin disease of participants at that point in time on a single-item. Participants provided their response on a 5-point scale ranges from: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe. Higher score indicated greater severity of disease. Participants who provided their response as "clear (score of 0)" or "almost clear (score of 1)" in PtGA at each specified visit were reported in this outcome measure.

    Measured: Baseline, Month 1, 3, 6, 12, 24, 36, 48

  21. Euro Quality of Life- 5-Dimensions (EQ-5D)-Utility Scores

    EQ-5D: participant rated 5-dimension (mobility, self-care, usual activities, pain and discomfort, and anxiety and depression) questionnaire to assess health-related quality of life in terms of a single utility score. Each dimension was assessed on a 3-point scale (1=no problems, 2=some problems, 3=extreme problems, where higher scores=worse health condition). The responses from the 5 dimensions were used to calculate a single utility index value. Scoring formula developed by EuroQol Group assigned a utility value for each dimension in the profile. Score was transformed and results in a total score range -0.594 to 1.000; higher score indicated a better health state.

    Measured: Baseline, Month 6, 12, 24, 36, 48

  22. Euro Quality of Life-5-Dimensions (EQ-5D)-Visual Analogue Scale Scores (VAS)

    EQ-5D VAS was a participant rated questionnaire to assess health-related quality of life in terms of a single index value. It was a visual analogue scale that ranged from 0 (minimum) to 100 (maximum), with higher scores indicating a better health condition.

    Measured: Baseline, Month 6, 12, 24, 36, 48

  23. Number of Participants Who Answered Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU)

    Ps-HCRU was a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work. In the first section, it assessed direct costs associated with healthcare resource use which included participant's interactions with healthcare providers such as general practitioners, dermatologists, cardiologists, gastroenterologists, psychiatrists, surgeons and nurses. When taking the evening dose of tofacitinib, participants were asked to answer the Ps-HCRU questionnaire only if they had an interaction with a healthcare provider or their work was impacted by psoriasis on that specified day. In this outcome measure, number of participants who answered Ps-HCRU at any specified visits were reported.

    Measured: Baseline, Month 1, 3, 6, 12, 24, 36, 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jul 2010 (estimated)
  2. Study startSep 2010
  3. Primary completionJun 2016
  4. Study completionJun 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
2,867 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01163253
Sponsor's protocol ID
A3921061
Other IDs
2010-020002-15
Status last verified
May 2017
First submitted
14 Jul 2010
Last updated
26 Jun 2017
Data monitoring committee
Yes
Individual data sharing
Yes: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical\_trials/trial\_data\_and\_results/data\_requests

Publications

  • Kristensen LE, Deodhar A, Leung YY, Vranic I, Mortezavi M, Fallon L, Yndestad A, Kinch CD, Gladman DD. Risk Stratification of Patients with Psoriatic Arthritis and Ankylosing Spondylitis for Treatment with Tofacitinib: A Review of Current Clinical Data. Rheumatol Ther. 2024 Jun;11(3):487-499. doi: 10.1007/s40744-024-00662-5. Epub 2024 May 2.

    PubMed 38696034

  • Kristensen LE, Strober B, Poddubnyy D, Leung YY, Jo H, Kwok K, Vranic I, Fleishaker DL, Fallon L, Yndestad A, Gladman DD. Association between baseline cardiovascular risk and incidence rates of major adverse cardiovascular events and malignancies in patients with psoriatic arthritis and psoriasis receiving tofacitinib. Ther Adv Musculoskelet Dis. 2023 Feb 7;15:1759720X221149965. doi: 10.1177/1759720X221149965. eCollection 2023.

    PubMed 36777695

  • Panaccione R, Isaacs JD, Chen LA, Wang W, Marren A, Kwok K, Wang L, Chan G, Su C. Characterization of Creatine Kinase Levels in Tofacitinib-Treated Patients with Ulcerative Colitis: Results from Clinical Trials. Dig Dis Sci. 2021 Aug;66(8):2732-2743. doi: 10.1007/s10620-020-06560-4. Epub 2020 Aug 20.

    PubMed 32816215

  • Valenzuela F, Korman NJ, Bissonnette R, Bakos N, Tsai TF, Harper MK, Ports WC, Tan H, Tallman A, Valdez H, Gardner AC. Tofacitinib in patients with moderate-to-severe chronic plaque psoriasis: long-term safety and efficacy in an open-label extension study. Br J Dermatol. 2018 Oct;179(4):853-862. doi: 10.1111/bjd.16798. Epub 2018 Aug 13.

    PubMed 29782642

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing CP-690,550 in people with Psoriasis, run by Pfizer at 323 sites in 36 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 26 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 323 sites in United States, Canada, Germany, France, Poland and 31 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)). The study lists 55 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01163253, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2017.

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