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

May 30, 2017 updated by: Pfizer

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.

Study Overview

Status

Terminated

Conditions

Psoriasis

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

2867

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Argentina
- - Caba, Argentina, C1114AAP
    - Centro De Investigaciones Dermatologicas
  - Caba, Argentina, C1125ABD
    - CENIT Centro de Neurociencias Investigacion y Tratamiento
Australia
- New South Wales
  - Kogarah, New South Wales, Australia, 02217
    - Dr. Glenn and Partners
  - Kogarah, New South Wales, Australia, 02217
    - Premier Dermatology
- Victoria
  - Malvern, Victoria, Australia, 3144
    - Malvern Diagnostic Imaging
  - Malvern East, Victoria, Australia, 3145
    - Emeritus Research
  - Melbourne, Victoria, Australia, 3053
    - Skin and Cancer Foundation
Austria
- - Feldkirch, Austria, 6807
    - LKH Feldkirch
  - Salzburg, Austria, 5020
    - LKH Salzburg, Landesklinik fuer Dermatologie
Belgium
- - Brussels, Belgium, 1200
    - Cliniques universitaires Saint-Luc
Bosnia and Herzegovina
- - Sarajevo, Bosnia and Herzegovina, 71000
    - UHC Sarajevo
Brazil
- - Rio De Janeiro, Brazil, 22470-220
    - Instituto de Dermatologia e Estetica do Brasil LTDA - IDERJ
  - Sao Paulo, Brazil, 05403-000
    - Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
- SP
  - Sao Paulo, SP, Brazil, 05403-900
    - Hospital da Clinicas da Faculdade de Medicina da Universidade de São Paulo
Bulgaria
- - Pleven, Bulgaria, 5800
    - UMHAT "Dr Georgi Stranski"
  - Pleven, Bulgaria, 5800
    - UMHAT "Dr. Georgi Stranski" - II clinical base
  - Sofia, Bulgaria, 1404
    - Tsentar za kozhno venericheski zaboliavania EOOD
  - Sofia, Bulgaria, 1407
    - Mnogoprofilna Bolnitsa Za Aktivno Lechenie- Tokuda Bolnitsa
  - Sofia, Bulgaria, 1431
    - UMBAL-Alexandrovska- Sofia Klinika po dermatologia i venerologia
  - Sofia, Bulgaria, 1606
    - MBAL na Voennomeditsinska Akademia
Canada
- - Quebec, Canada, G1J 1X7
    - CRCMRGilbert Inc., Centre de Dermatologie Maizerets
- Alberta
  - Calgary, Alberta, Canada, T2G 1B1
    - Kirk Barber Research
  - Calgary, Alberta, Canada, T3G 0B4
    - Northwest Dermatology & Laser Centre
  - Edmonton, Alberta, Canada, T5K 1X3
    - Stratica Medical
- British Columbia
  - Surrey, British Columbia, Canada, V3V 0C6
    - Enverus Medical Research
  - Vancouver, British Columbia, Canada, V5Z 3Y1
    - Derm Research @888 Inc
  - Vancouver, British Columbia, Canada, V5Z 4E8
    - The Skin Centre
  - Victoria, British Columbia, Canada, V8V 3P9
    - PerCuro Clinical Research Limited
- Manitoba
  - Winnipeg, Manitoba, Canada, R3M 3Z4
    - Wiseman Dermatology Research Inc.
  - Winnipeg, Manitoba, Canada, R3C 1R4
    - Dermadvances Research
- Newfoundland and Labrador
  - St. John's, Newfoundland and Labrador, Canada, A1A 5E8
    - Nexus Clinical Research
  - St. John's, Newfoundland and Labrador, Canada, A1C 2H5
    - NewLab Clinical Research Inc.
  - St. John's, Newfoundland and Labrador, Canada, A1B 4S8
    - Dr. Zohair Tomi PMC Inc. Paton Medical Centre
- Nova Scotia
  - Halifax, Nova Scotia, Canada, B3H 1Z2
    - Eastern Canada Cutaneous Research Associates Ltd.
- Ontario
  - Ajax, Ontario, Canada, L1S 7K8
    - CCA Medical Research
  - Barrie, Ontario, Canada, L4M 6L2
    - Ultranova Skincare
  - Barrie, Ontario, Canada, L4M 6L2
    - The Waterside Clinic
  - Courtice, Ontario, Canada, L1E 3C3
    - Co-Medica Research Network Inc.
  - Hamilton, Ontario, Canada, L8N 1V6
    - Dermatrials Research, Inc.
  - London, Ontario, Canada, N6A 3H7
    - The Guenther Dermatology Research Centre
  - Markham, Ontario, Canada, L3P 1X2
    - Lynderm Research Inc.
  - North Bay, Ontario, Canada, P1B 3Z7
    - North Bay Dermatology Centre
  - Oakville, Ontario, Canada, L6J 7W5
    - Oakville Dermatology Laser Centre
  - Oshawa, Ontario, Canada, L1H 1B9
    - Dr. Tuppal's Privat Practice, Oshawa Clinic
  - Ottawa, Ontario, Canada, K2G 6E2
    - Office of Dr. Michael Robern
  - Peterborough, Ontario, Canada, K9J 5K2
    - Skin Centre for Dermatology
  - Scarborough, Ontario, Canada, MlB 4Z8
    - Office of Dr. Paul Adam (back-up location)
  - Waterloo, Ontario, Canada, N2J 1C4
    - K. Papp Clinical Research
  - Windsor, Ontario, Canada, N8W 1E6
    - XLR8 Medical Research
  - Windsor, Ontario, Canada, N8W 5L7
    - Windsor Clinical Research
- Quebec
  - Montreal, Quebec, Canada, H2K 4L5
    - Innovaderm Research Inc
  - Montreal, Quebec, Canada, H3Z 2S6
    - Siena Medical Research
  - Québec, Quebec, Canada, G1V 4X7
    - Centre De Recherche Dermatologique Du Quebec Metropolitain
  - Sherbrooke, Quebec, Canada, J1H 1Z1
    - Diex Research Sherbrooke Inc.
Chile
- Region Metropolitana
  - Santiago, Region Metropolitana, Chile, 8380456
    - Hospital Clínico Universidad de Chile
  - Santiago, Region Metropolitana, Chile, 7640881
    - Clinica Dermacross S.A.
  - Santiago, Region Metropolitana, Chile, 8420383
    - Centro Internacional de Estudios Clinicos, CIEC
Colombia
- Antioquia
  - Medellin, Antioquia, Colombia
    - Hospital Pablo Tobón Uribe
  - Medellin, Antioquia, Colombia
    - Reumalab S.A.S.
- Atlantico
  - Barranquilla, Atlantico, Colombia, 08001000
    - Centro Integral de Reumatologia del Caribe Cicaribe S.A.S
- Cundinamarca
  - Bogota, Cundinamarca, Colombia, 0000
    - Riesgo De Fractura S.A
  - Bogota, Cundinamarca, Colombia
    - Riesgo De Fractura S.A
  - Bogotá, Cundinamarca, Colombia, 110221
    - Colegio Mayor de Nuestra Señora del Rosario
- Santander
  - Bucaramanga, Santander, Colombia, 680003
    - Medicity S.A.S
Croatia
- - Osijek, Croatia, 31000
    - University Hospital Center Osijek
  - Zagreb, Croatia, 10000
    - University hospital center Zagreb
  - Zagreb, Croatia, 10000
    - University hospital center "Sestre milosrdnice" clinic for dermatology and venerology disease
Czechia
- - Ceske Budejovice, Czechia, 37001
    - Nemocnice Ceske Budejovice,a.s.
  - Hradec Kralove, Czechia, 500 05
    - Klinika nemoci koznich a pohlavnich
  - Plzen-Bory, Czechia, 30599
    - Fakultni Nemocnice Plzen
  - Praha 1, Czechia, 11000
    - Kozni ordinace
  - Praha 2, Czechia, 120 00
    - Lekarna U sv. Ignace
  - Usti nad Labem, Czechia, 40113
    - Krajska zdravotni a.s.,Masarykovy nemocnice o.z.
- Czech Republic
  - Ceske Budejovice, Czech Republic, Czechia, 370 01
    - Nemocnice Ceske Budejovice, a.s. Ustavni lekarna
  - Hradec Kralove, Czech Republic, Czechia, 50005
    - Ustanvi lekarna
Denmark
- - Aarhus C, Denmark, 8000
    - Aarhus University Hospital
  - Copenhagen NV, Denmark, 2400
    - Bispebjerg Hospital, University of Copenhagen
  - Hellerup, Denmark, 2900
    - Gentofte Hospital
  - Herning, Denmark, 7400
    - Hudklinikken Herning
  - Svendborg, Denmark, 5700
    - Hudklinikken
Finland
- - Tampere, Finland, 33521
    - Tampere Univeristy Hospital, Department of Dermatology and Venereology
France
- - Besancon, France, 25000
    - Hôpital Jean Minjoz
  - Besancon, France, 25030
    - CHU Jean-Minjoz
  - Le Mans, Cedex 09, France, 72037
    - CHG Le Mans
  - Limoges, France, 87042
    - Hopital Dupuytren
  - Nantes Cedex 01, France, 44035
    - CHU de Nantes - Hotel Dieu
  - Nice, France, 06202
    - CHU De Nice Hopital De L'Archet II
  - Pierre Benite, France, 69495
    - Centre Hospitalier Lyon Sud - Pharmacie
  - Pierre-Benite, France, 69310
    - Centre Hospitalier Lyon Sud
  - Poitiers, France, 86000
    - C.H.U. de Poitiers la Miletrie
  - Reims, France, 51100
    - Hopital Robert Debre
  - Reims, France, 51092
    - C.H.U de Reims
  - Saint Priest En Jarez, France, 42270
    - Hopital Nord
  - Toulouse, France, 31000
    - Hopital Larrey Departement de Dermatologie
  - Vandoeuvre les Nancy, France, 54511
    - Hopital de Brabois / Batiment Philippe Canton
- Cedex
  - Brest, Cedex, France, 29609
    - CHU Morvan
  - Limoges, Cedex, France, 87042
    - CHU Limoges - Hôpital Dupuytren - Pharmacie
- Lle-de-france
  - Paris, Lle-de-france, France, 75010
    - Hopital Saint Louis
Germany
- - Berlin, Germany, 10117
    - Charité Universitätsmedizin Berlin
  - Berlin, Germany, 10117
    - Klinische Forschung Berlin-Mitte GmbH
  - Berlin, Germany, 10435
    - Facharzt fuer Dermatologie und Allergologie
  - Berlin, Germany, 13055
    - MVZ Reichenberger Str., Aerztehaus "Rudolf Virchow"
  - Berlin, Germany, 13507
    - Hautarztpraxis Tegel
  - Bonn, Germany, 53105
    - Klinik and Poliklinik fur Dermatologie and Allergologie der Universitaet Bonn
  - Bonn, Germany, 53105
    - Klinik und Poliklinik fur Dermatologie und Allergologie der Universitaet Bonn
  - Buchholz, Germany, 21244
    - Dres. Kirsten Prepeneit und Volker Streit
  - Dresden, Germany, 01307
    - Universitaetsklinik Carl Gustav Carus
  - Erlangen, Germany, 91054
    - Universitaetsklinikum Erlangen Hautklinik im Internistischen Zentrum
  - Frankfurt/Main, Germany, 60590
    - Klinikum der Johann Wolfgang Goethe Universitaet
  - Halle, Germany, 06120
    - Universitaetsklinik Und Poliklinik Fuer Dermatologie Und Venerologie
  - Hamburg, Germany, 20246
    - Universitaetsklinikum Hamburg-Eppendorf
  - Hamburg, Germany, 20253
    - Klinische Forschung Hamburg GmbH
  - Hanau, Germany, 63450
    - Gemeinschaftspraxis Dres.Michael Ockenfels und Christoph Sauter
  - Heidelberg, Germany, 69120
    - Universitaetsklinikum Heidelberg
  - Kiel, Germany, 24105
    - Universitaetsklinikum Schleswig-Holstein, Campus Kiel
  - Koeln, Germany, 50937
    - Universitaetsklinikum Koeln
  - Luebeck, Germany, 23538
    - Universitaetsklinikum Schleswig-Holstein Campus Luebeck
  - Mahlow, Germany, 15831
    - Hautarztpraxis Dres. Scholz, Sebastian, Schilling
  - Mainz, Germany, 55131
    - Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KoeR
  - Muenchen, Germany, 80802
    - Technischen Universitaet Muenchen
  - Muenster, Germany, 48149
    - Universitaetsklinikum Muenster
  - Schwerin, Germany, 19055
    - Klinische Forschung Schwerin GmbH
  - Tuebingen, Germany, 72076
    - Eberhard-Karls-Universitaet Tuebingen Universitaetshautklinik
  - Wiesbaden, Germany, 65199
    - HSK, Dr. Horst Schmidt Kliniken GmbH
  - Witten, Germany, 58453
    - Hautarztpraxis Centrovital
- Baden-wuerttemberg
  - Tuebingen, Baden-wuerttemberg, Germany, 72076
    - Universitaets-Hautklinik Eberhard-Karls-Universitaet Tuebingen
- Schleswig-holstein
  - Kiel, Schleswig-holstein, Germany, 24105
    - Universitätsklinikum Schleswig-Holstein
Greece
- - Ioannina, Greece, 45500
    - University General Hospital of Ioannina / Dermatology and Venereology Department
  - Thessaloniki, Greece, 56403
    - "Papageorgiou" General Hospital/B' Dermatology and Venereology Clinic of University of Thessaloniki
- Attiki
  - Athens, Attiki, Greece, 16121
    - University Dermatology Clinic "Andreas Syggros" Hospital
Hong Kong
- - Hong Kong, Hong Kong
    - The University of Hong Kong (HKU)-Queen Mary Hospital (QMH)
Hungary
- - Budapest, Hungary, 1036
    - Synexus Magyarorszag Kft.
  - Debrecen, Hungary, 4032
    - Debreceni Egyetem Klinikai Kozpont, Borgyogyaszati Klinika
  - Kecskemet, Hungary, 6000
    - Bacs-Kiskun Megyei Korhaz Szegedi Tudomanyegyetem AOK Oktato Korhaza, Borgyogyaszati Osztaly
  - Miskolc, Hungary, 3529
    - Miskolci Semmelweis Korhaz es Egyetemi Oktatokorhaz, Borgyogyaszati Osztaly
  - Nyiregyhaza, Hungary, 4400
    - Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz, Klinikai Kutatasi Osztaly
  - Nyiregyhaza, Hungary, 4400
    - Szabolcs-Szatmar-Bereg Megyei Korjazak es Egyetemi Okatokorhaz, Borgyogyaszati Szakrendeles
  - Pecs, Hungary, H-7632
    - Pecsi Tudomanyegyetem Aok Bor- Nemikortani Es Onkodermatologiai Klinika
  - Szeged, Hungary, 6720
    - SZTE Szentgyorgyi Albert Klinikai Kozpont/Borgyogyaszati es Allergologiai Klinika
  - Szekszard, Hungary, 7100
    - Tolna Megyei Balassa Janos Korhaz, Borgyogyaszati Osztaly
  - Szolnok, Hungary, 5000
    - Allergo-Derm Bakos Kft.
  - Szombathely, Hungary, H-9700
    - Vas Megyei Markusovszky Korhaz/Borgyogyaszati Osztaly
  - Veszprem, Hungary, H-8200
    - Veszprem Megyei Csolnoky Ferenc Korhaz Borgyogyaszat
Japan
- Gunma
  - Maebashi-shi, Gunma, Japan, 3718511
    - Gunma University Hospital
- Hokkaido
  - Sapporo-City, Hokkaido, Japan, 060-0033
    - JR Sapporo Hospital
- Hyogo
  - Kobe, Hyogo, Japan, 6500017
    - Kobe University
- Kumamoto
  - Kumamoto-city, Kumamoto, Japan, 860-8556
    - Kumamoto University Hospital
- Tokyo
  - Shinjuku-ku, Tokyo, Japan, 169-0073
    - Tokyo Yamate Medical Center
Korea, Republic of
- - Seoul, Korea, Republic of, 03080
    - Seoul National University Hospital
  - Seoul, Korea, Republic of, 06351
    - Samsung Medical Center
  - Seoul, Korea, Republic of, 120-752
    - Yonsei University College of Medicine, Severance Hospital
Mexico
- Distrito Federal
  - Mexico, Distrito Federal, Mexico, 03100
    - Mexico Centre for Clinical Research S.A. de C.V.
- Jalisco
  - Zapopan, Jalisco, Mexico, 45190
    - Instituto Dermatologico De Jalisco "Dr Jose Barba Rubio"
- Nuevo Leon
  - Monterrey, Nuevo Leon, Mexico, 64460
    - Centro de Dermatologia de Monterrey
  - Monterrey, Nuevo Leon, Mexico, 64710
    - Centro Medico San Lucas
Netherlands
- - Beek, Netherlands, 6191 JW
    - PT&R
- Noord-holland
  - Amsterdam, Noord-holland, Netherlands, 1105 AZ
    - Academisch Medisch Centrum Universiteit van Amsterdam
Poland
- - Bialystok, Poland, 15-351
    - Nzoz Zdrowie Osteo-Medic
  - Gdansk, Poland, 80-402
    - Klinika Dermatologii, Wenerologii i Alergologii Uniwersyteckiego Centrum Klinicznego
  - Krakow, Poland, 31-501
    - Krakowskie Centrum Medyczne NZOZ
  - Lodz, Poland, 90-265
    - Specjalistyczne Gabinety Lekarskie "Dermed"
  - Opole, Poland, 45-080
    - Novum Instytut Dermatologii Leczniczej i Estetycznej
  - Poznan, Poland, 60-529
    - Solumed Centrum Medyczne
  - Poznan, Poland, 60773
    - Centrum Badan Klinicznych S.C. Wieslawa Porawska, Lukasz Porawski
  - Szczecin, Poland, 70-111
    - Katedra i Klinika Chorob Skornych i Wenerycznych, Pomorski Uniwersytet Medyczny
  - Szczecin, Poland, 70-332
    - Spolka Cywilna Andrzej Krolicki, Tomasz Kochanowski "Laser Clinic"
  - Warszawa, Poland, 02-106
    - MTZ Clinical Research Sp. z o.o.
  - Warszawa, Poland, 04-141
    - Klinika Dermatologii
  - Warszawa, Poland, 04-141
    - Zaklad Radiologii Lekarskiej
  - Wroclaw, Poland, 50-368
    - Katedra i Klinika Dermatologii, Wenerologii i Alergologii Akademii Medycznej we Wroclawiu
  - Wroclaw, Poland, 51-124
    - Oddzial Dermatologiczny
  - Wroclaw, Poland, 51-124
    - Poradnia Dermatologiczna
- Pomorskie
  - Gdansk, Pomorskie, Poland, 80-952
    - Uniwersyteckie Centrum Kliniczne
Puerto Rico
- - Carolina, Puerto Rico, 00985
    - Grupo Dermatologico De Carolina (Office of Dr. Alma Cruz MD)
Russian Federation
- - Moscow, Russian Federation, 107076
    - State Research Center of Dermatovenerology,
  - Moscow, Russian Federation, 107076
    - State Research Center of Dermatovenerology
  - Moscow, Russian Federation, 121614
    - Dermatovenerological dispensary #7
  - Rostov-on-Don, Russian Federation, 344007
    - Rostov-on-Don regional dermatovenerologic dispensary
  - Ryazan, Russian Federation, 390046
    - Ryazan regional clinical dermatovenerologic dispensary
  - Saint-Petersburg, Russian Federation, 194021
    - Dermatovenerologic dispensary #10 of Vyborg region
  - Saint-Petersburg, Russian Federation, 194044
    - Military Medical Academy n.a. S.M.Kirov
  - Saint-Petersburg, Russian Federation, 195067
    - North-Western State Medical University I.I. Mechnikov
  - Smolensk, Russian Federation, 214019
    - Smolensk State Medical Academy
  - Yaroslavl, Russian Federation, 150003
    - Clinical Hospital of Emergency Care N.V. Soloviev
Serbia
- - Belgrade, Serbia, 11000
    - Military Medical Academy
  - Belgrade, Serbia, 11000
    - Clinical Hospital Center Zvezdara
Singapore
- - Singapore, Singapore, 529889
    - Changi General Hospital
  - Singapore, Singapore, 308205
    - National Skin Centre
Slovakia
- - Banska Bystrica, Slovakia, 975 17
    - Dermatovenerologicka klinika SZU, Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica
  - Piestany, Slovakia, 921 12
    - Oddelenie biologickej liecby, Narodny ustav reumatickych chorob
  - Svidnik, Slovakia, 089 01
    - DOST-Dermatovenerologicke oddelenie sanatorneho typu, SANARE, spol. s r.o.
Spain
- - Alicante, Spain, 03010
    - Hospital General Universitario de Alicante
  - Madrid, Spain, 28006
    - Hospital Universitario La Princesa
  - Madrid, Spain, 28041
    - Hospital 12 de Octubre
  - Madrid, Spain, 28922
    - Hospital Universitario Fundación Alcorcón
  - Valencia, Spain, 46014
    - Consorcio Hospital General Universitario de Valencia
- Madrid
  - Majadahonda, Madrid, Spain, 28222
    - Hospital Universitario Puerta de Hierro
Sweden
- - Falun, Sweden, 791 82
    - Hudkliniken
  - Lulea, Sweden, 972 33
    - Hermelinen Forskning AB
  - Lund, Sweden, 222 42
    - Pharmacy: Sjukhusapoteket Lund
  - Stockholm, Sweden, 118 83
    - Hudkliniken
  - Stockholm, Sweden, 171 76
    - Karolinska University Hospital- Solna
- Sverige
  - Malmo, Sverige, Sweden, 205 02
    - Hud kliniken- Skanes Universitetssjukhus i Malmo
Switzerland
- - St. Gallen, Switzerland, 9007
    - Kantonsspital St. Gallen
Taiwan
- - Kaohsiung, Taiwan, 833
    - Chang Gung Medical Foundation Kaohsiung Branch
  - Tainan, Taiwan, 704
    - National Cheng Kung University Hospital
  - Taipei, Taiwan, 100
    - National Taiwan University Hospital
  - Taipei, Taiwan, 235
    - Taipei Medical University-Shuang Ho Hospital
  - Taoyuan, Taiwan, 333
    - Chang Gung Medical Foundation Linkou Branch
- Taiwan Roc
  - Taichung, Taiwan Roc, Taiwan, 40201
    - Chung Shan Medical University Hospital
Ukraine
- - Kharkiv, Ukraine, 61038
    - Municipal Institution of health Care
  - Kharkiv, Ukraine, 61057
    - SI 'Institute for Dermatology and Venerology of AMS of Ukraine'
  - Kyiv, Ukraine, 01601
    - Kyiv Oleksandrivska Clin. Hosp., Dermatology department, NMU n.a. O.O. Bogomolets,
  - Lugansk, Ukraine, 91047
    - Dept of Dermatology and Venerology of Lugansk State Medical University,
  - Lviv, Ukraine, 79013
    - Regional Municipal Dermatovenerologic Dispensary
  - Odessa, Ukraine, 65006
    - Dept of Dermatology and Venerology of ONMU
  - Ternopil, Ukraine, 46006
    - Ternopil Regional Municipal Clinical Dermatovenerologic Dispensary
- Crimea
  - Simferopol,, Crimea, Ukraine, 95006
    - Dept of Dermatology and Venerology of SI "Crimean State Medical University n.a. S.I.Georgiyevskyy"
United Kingdom
- - London, United Kingdom, E11 1NR
    - Whipps Cross University Hospital
  - Peterbrough, United Kingdom, PE 2 6UP
    - Ert
- Manchester
  - Salford, Manchester, United Kingdom, M6 8HD
    - Salford Royal NHS Foundation Trust
- Warwickshire
  - Nuneaton, Warwickshire, United Kingdom, CV10 7DJ
    - Department of Dermatology
United States
- Alabama
  - Birmingham, Alabama, United States, 35209
    - Radiant Research, Inc.
  - Birmingham, Alabama, United States, 35233
    - UAB Dermatology
  - Mobile, Alabama, United States, 36608
    - Horizon Research Group, Inc.
- Arizona
  - Tucson, Arizona, United States, 85712
    - Radiant Research, Inc.
- Arkansas
  - Hot Springs, Arkansas, United States, 71913
    - Burke Pharmaceutical Research
- California
  - Bakersfield, California, United States, 93309
    - Bakersfield Dermatology and Skin Cancer Medical Group
  - Fresno, California, United States, 93720
    - Associates In Research, Inc.
  - Irvine, California, United States, 92697
    - University of California Irvine
  - Los Angeles, California, United States, 90045
    - Dermatology Research Associates
  - Oceanside, California, United States, 92056
    - Dermatology Specialists, Inc.
  - San Diego, California, United States, 92122
    - UCSD Dermatology
  - San Diego, California, United States, 92103
    - MedDerm Associates
  - San Diego, California, United States, 92122
    - University of California San Diego
  - San Francisco, California, United States, 94118
    - University of California San Francisco
  - Santa Monica, California, United States, 90404
    - Clinical Science Institute
  - Torrance, California, United States, 90503
    - HealthCare Partners Medical Group
- Colorado
  - Denver, Colorado, United States, 80209
    - Cherry Creek Research, Inc.
- Connecticut
  - New Haven, Connecticut, United States, 06511
    - The Savin Center, P.C.
  - Trumbull, Connecticut, United States, 06611
    - New England Research Associates, LLC
- Florida
  - Coral Gables, Florida, United States, 33134
    - Florida Academic Dermatology Center
  - Jacksonville, Florida, United States, 32204
    - North Florida Dermatology Associates, PA
  - Miami, Florida, United States, 33144
    - International Dermatology Research, Inc.
  - Ocala, Florida, United States, 34471
    - Renstar Medical Research
  - Orange Park, Florida, United States, 32073
    - Park Avenue Dermatology, PA
  - Ormond Beach, Florida, United States, 32174
    - Leavitt Medical Associates of Florida dba Ameriderm Research
  - South Miami, Florida, United States, 33143
    - Miami Research Associates, Inc.
  - Tampa, Florida, United States, 33609
    - Olympian Clinical Research
- Georgia
  - Alpharetta, Georgia, United States, 30022
    - Atlanta Dermatology, Vein & Research Center, P.C.
  - Atlanta, Georgia, United States, 30342
    - Advanced Medical Research, Inc.
  - Newnan, Georgia, United States, 30263
    - MedaPhase Inc.
- Illinois
  - Arlington Heights, Illinois, United States, 60005
    - Altman Dermatology Associates
  - Schaumburg, Illinois, United States, 60173
    - Schaumburg Dermatology
  - Skokie, Illinois, United States, 60077
    - NorthShore University Health System - Division of Dermatology
  - Springfield, Illinois, United States, 62703
    - Springfield Clinic
  - West Dundee, Illinois, United States, 60118
    - Dundee Dermatology
- Indiana
  - Evansville, Indiana, United States, 47714
    - Hudson Dermatology
  - Evansville, Indiana, United States, 47713
    - Deaconess Clinic Downtown Research Institute
  - Indianapolis, Indiana, United States, 46256
    - Dawes Fretzin Clinical Research Group, LLC
- Kentucky
  - Louisville, Kentucky, United States, 40217
    - DermResearch, PLLC
- Massachusetts
  - Boston, Massachusetts, United States, 02111
    - Tufts Medical Center
  - Boston, Massachusetts, United States, 02114
    - Massachusetts General Hospital - Clinical Unit for Research Trials and Outcomes in Skin
  - Boston, Massachusetts, United States, 02111-1552
    - Tufts Medical Center
- Michigan
  - Clinton, Michigan, United States, 48038
    - Michigan Center for Research Corporation dba Michigan Center for Skin Care Research
  - Fort Gratiot, Michigan, United States, 48059
    - Hamzavi Dermatology
  - Troy, Michigan, United States, 48084
    - Somerset Skin Centre - Dermcenter
- Minnesota
  - Fridley, Minnesota, United States, 55432
    - Minnesota Clinical Study Center
- Missouri
  - Saint Louis, Missouri, United States, 63104
    - Saint Louis University - Department of Dermatology
- Nebraska
  - Omaha, Nebraska, United States, 68144
    - Skin Specialists, P.C
- Nevada
  - Henderson, Nevada, United States, 89074
    - Bettencourt Skin Center
- New Hampshire
  - Lebanon, New Hampshire, United States, 03756
    - Dartmouth-Hitchcock Medical Center-Norris Cotton Cancer Center
- New Jersey
  - Berlin, New Jersey, United States, 08009
    - Centennial Center-Comprehensive Clinical Research
- New York
  - New York, New York, United States, 10016
    - New York University (NYU) School of Medicine - Investigational Pharmacy (IP Shipment, Pharmacy)
  - New York, New York, United States, 10016
    - NYU Langone Medical Center, Ambulatory Care Center, Department of Dermatology, Clinical Studies Unit
  - New York, New York, United States, 10065 6307
    - The Rockefeller University
- North Carolina
  - Chapel Hill, North Carolina, United States, 27516
    - University of North Carolina At Chapel Hill
  - Chapel Hill, North Carolina, United States, 27514
    - University of North Carolina at Chapel Hill- Hospital
  - Durham, North Carolina, United States, 27710
    - Duke University Medical Center
  - High Point, North Carolina, United States, 27262
    - Dermatology Consulting Services
  - Raleigh, North Carolina, United States, 27612
    - Wake Research Associates
  - Raleigh, North Carolina, United States, 27607
    - Wake Dermatology Associates, LLC
  - Wilmington, North Carolina, United States, 28401
    - PMG Research of Wilmington, LLC
  - Wilmington, North Carolina, United States, 28401
    - Dermatology Associates
  - Winston-Salem, North Carolina, United States, 27104
    - Wake Forest University Health Sciences
  - Winston-Salem, North Carolina, United States, 27103
    - PMG Research of Winston-Salem
  - Winston-Salem, North Carolina, United States, 27103
    - Piedmont Imaging
  - Winston-Salem, North Carolina, United States, 27103
    - Triad Dermatology, PA
- Ohio
  - Cincinnati, Ohio, United States, 45236
    - Jewish Hospital
  - Cincinnati, Ohio, United States, 45249
    - Radiant Research, Inc.
  - Cleveland, Ohio, United States, 44106
    - University Hospitals Case Medical Center
  - Cleveland, Ohio, United States, 44106
    - IP ONLY: University Hospitals Case Medical Center
  - Cleveland, Ohio, United States, 44106
    - University Hospitals Case Medical Center/Dept. of Dermatology
- Oklahoma
  - Norman, Oklahoma, United States, 73071
    - Central Sooner Research
- Oregon
  - Lake Oswego, Oregon, United States, 97035
    - Baker Allergy Asthma and Dermatology Research Center, LLC
  - Portland, Oregon, United States, 97210
    - Oregon Dermatology and Research Center
  - Portland, Oregon, United States, 97239
    - Oregon Health & Science University
- Pennsylvania
  - Pittsburgh, Pennsylvania, United States, 15213
    - University of Pittsburgh Medical Center
  - Pittsburgh, Pennsylvania, United States, 15213
    - University of Pittsburgh Medical Center - Department of Dermatology
- Rhode Island
  - Johnston, Rhode Island, United States, 02919
    - Clinical Partners, LLC
  - Providence, Rhode Island, United States, 02903
    - Rhode Island Hospital
- South Carolina
  - Greer, South Carolina, United States, 29650
    - Radiant Research, Inc.
  - Greer, South Carolina, United States, 29650
    - Office of John Michael Humeniuk, MD
- South Dakota
  - Rapid City, South Dakota, United States, 57702
    - Health Concepts
- Tennessee
  - Goodlettsville, Tennessee, United States, 37072
    - Rivergate Dermatology Clinical Research Center, PLLC
  - Knoxville, Tennessee, United States, 37917
    - Dermatology Associates of Knoxville PC
  - Nashville, Tennessee, United States, 37203
    - Dermatology Research Associates
- Texas
  - Arlington, Texas, United States, 76011
    - Arlington Research Center, Inc.
  - Dallas, Texas, United States, 75231
    - Modern Research Associates, PLLC
  - Dallas, Texas, United States, 75246
    - Menter Dermatology Research Institute
  - Dallas, Texas, United States, 75230
    - Dermatology Treatment & Research Center
  - Houston, Texas, United States, 77004
    - Center for Clinical Studies
  - Houston, Texas, United States, 77056
    - Suzanne Bruce and Associates, PA
  - San Antonio, Texas, United States, 78249
    - Stephen Miller, MD, PA
  - San Antonio, Texas, United States, 78229
    - Progressive Clinical Research, P.A.
  - San Antonio, Texas, United States, 78229
    - Office of Mark Lee, MD
  - Webster, Texas, United States, 77598
    - Center for Clinical Studies
- Virginia
  - Norfolk, Virginia, United States, 23507
    - Virginia Clinical Research, Inc.
  - Norfolk, Virginia, United States, 23502
    - Virginia Clinical Research, Inc.
- Washington
  - Spokane, Washington, United States, 99202
    - Rockwood Research Center
  - Wenatchee, Washington, United States, 98801
    - Wenatchee Valley Hospital & Clinics
- West Virginia
  - Bridgeport, West Virginia, United States, 26330
    - Mountain State Clinical Research
- Wisconsin
  - Madison, Wisconsin, United States, 53719
    - Madison Skin and Research, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active Treatment The 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	Drug: CP-690,550 10 mg oral BID Drug: CP-690,550 5 mg oral BID

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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.	Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)
Number of Adverse Events (AEs) by Severity Time Frame: Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)	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.	Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)
Number of Participants With Laboratory Abnormalities Time Frame: Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)	Abnormality criteria: hematology (hemoglobin, hematocrit, red blood cell <0.8lower limit of normal [LLN]; reticulocyte<0.5LLN,>1.5ULN; platelets<0.5LLN,>1.75* upper limit of normal [ULN]; WBC<0.6LLN, >1.5ULN; lymphocytes, neutrophils, basophils, eosinophils, monocytes<0.8LLN; >1.2ULN; coagulation (prothrombin [PT], PT ratio>1.1ULN) liver function (bilirubin>1.5ULN, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, gamma GT>0.3ULN, protein, albumin<0.8LLN; >1.2ULN, globulin<0.5LLN; >1.5ULN); renal function (blood urea nitrogen, creatinine>1.3ULN); electrolytes(sodium<0.95* LLN; >1.05* ULN, potassium, chloride, calcium, bicarbonate<0.9LLN; >1.1ULN), chemistry (glucose<0.6LLN; >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 >1.3ULN, HDL-C<0.8LLN, triglycerides>1.3* ULN), hormones(T4, T3, T4, TSH<0.8* LLN; >1.2* ULN).	Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)
Change From Baseline in Hemoglobin Level at Month 1 Time Frame: Baseline, Month 1		Baseline, Month 1
Change From Baseline in Hemoglobin Level at Month 3 Time Frame: Baseline, Month 3		Baseline, Month 3
Change From Baseline in Hemoglobin Level at Month 6 Time Frame: Baseline, Month 6		Baseline, Month 6
Change From Baseline in Hemoglobin Level at Month 12 Time Frame: Baseline, Month 12		Baseline, Month 12
Change From Baseline in Hemoglobin Level at Month 24 Time Frame: Baseline, Month 24		Baseline, Month 24
Change From Baseline in Hemoglobin Level at Month 36 Time Frame: Baseline, Month 36		Baseline, Month 36
Change From Baseline in Hemoglobin Level at Month 48 Time Frame: Baseline, Month 48		Baseline, Month 48
Change From Baseline in Lymphocyte and Neutrophil Count at Month 1 Time Frame: Baseline, Month 1		Baseline, Month 1
Change From Baseline in Lymphocyte and Neutrophil Count at Month 3 Time Frame: Baseline, Month 3		Baseline, Month 3
Change From Baseline in Lymphocyte and Neutrophil Count at Month 6 Time Frame: Baseline, Month 6		Baseline, Month 6
Change From Baseline in Lymphocyte and Neutrophil Count at Month 12 Time Frame: Baseline, Month 12		Baseline, Month 12
Change From Baseline in Lymphocyte and Neutrophil Count at Month 24 Time Frame: Baseline, Month 24		Baseline, Month 24
Change From Baseline in Lymphocyte and Neutrophil Count at Month 36 Time Frame: Baseline, Month 36		Baseline, Month 36
Change From Baseline in Lymphocyte and Neutrophil Count at Month 48 Time Frame: Baseline, Month 48		Baseline, Month 48
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 Time Frame: Baseline, Month 1		Baseline, Month 1
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 Time Frame: Baseline, Month 3		Baseline, Month 3
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 Time Frame: Baseline, Month 6		Baseline, Month 6
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 Time Frame: Baseline, Month 12		Baseline, Month 12
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 Time Frame: Baseline, Month 24		Baseline, Month 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 36 Time Frame: Baseline, Month 36		Baseline, Month 36
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 Time Frame: Baseline, Month 48		Baseline, Month 48
Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 1 Time Frame: Baseline, Month 1		Baseline, Month 1
Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 3 Time Frame: Baseline, Month 3		Baseline, Month 3
Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 6 Time Frame: Baseline, Month 6		Baseline, Month 6
Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 12 Time Frame: Baseline, Month 12		Baseline, Month 12
Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 24 Time Frame: Baseline, Month 24		Baseline, Month 24
Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 36 Time Frame: Baseline, Month 36		Baseline, Month 36
Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 48 Time Frame: Baseline, Month 48		Baseline, Month 48
Number of Participants With Clinically Significant Change From Baseline in Physical Examination Time Frame: Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)	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.	Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)
Number of Participants With Vital Sign Abnormalities Time Frame: Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)	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.	Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)
Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 1 Time Frame: Baseline, Month 1		Baseline, Month 1
Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 3 Time Frame: Baseline, Month 3		Baseline, Month 3
Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 6 Time Frame: Baseline, Month 6		Baseline, Month 6
Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 12 Time Frame: Baseline, Month 12		Baseline, Month 12
Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 24 Time Frame: Baseline, Month 24		Baseline, Month 24
Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 36 Time Frame: Baseline, Month 36		Baseline, Month 36
Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 48 Time Frame: Baseline, Month 48		Baseline, Month 48
Change From Baseline in Heart Rate at Month 1 Time Frame: Baseline, Month 1		Baseline, Month 1
Change From Baseline in Heart Rate at Month 3 Time Frame: Baseline, Month 3		Baseline, Month 3
Change From Baseline in Heart Rate at Month 6 Time Frame: Baseline, Month 6		Baseline, Month 6
Change From Baseline in Heart Rate at Month 12 Time Frame: Baseline, Month 12		Baseline, Month 12
Change From Baseline in Heart Rate at Month 24 Time Frame: Baseline, Month 24		Baseline, Month 24
Change From Baseline in Heart Rate at Month 36 Time Frame: Baseline, Month 36		Baseline, Month 36
Change From Baseline in Heart Rate at Month 48 Time Frame: Baseline, Month 48		Baseline, Month 48
Number of Participants With Electrocardiogram (ECG) Abnormalities Time Frame: Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)	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.	Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)
Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 6 Time Frame: Baseline, Month 6		Baseline, Month 6
Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 12 Time Frame: Baseline, Month 12		Baseline, Month 12
Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 24 Time Frame: Baseline, Month 24		Baseline, Month 24
Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 36 Time Frame: Baseline, Month 36		Baseline, Month 36
Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 48 Time Frame: Baseline, Month 48		Baseline, Month 48
Number of Participants With Adjudicated Cardiovascular Events Time Frame: Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)	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.	Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)
Number of Participants With Malignancy Events Time Frame: Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)	Malignancy events included lymphoma, and demyelinating neurologic events. Biopsies collected for malignancy events were submitted to the central laboratory for pathologist over-read.	Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)

Secondary Outcome Measures

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

July 14, 2010

First Submitted That Met QC Criteria

July 14, 2010

First Posted (Estimate)

July 15, 2010

Study Record Updates

Last Update Posted (Actual)

June 26, 2017

Last Update Submitted That Met QC Criteria

May 30, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

A3921061
2010-020002-15 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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United States, Canada, Australia, Germany, Spain, Hungary, Japan, Bulgaria, Poland, Czechia, Estonia, Latvia, Puerto Rico, Portugal, South Korea, France
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A Study to Test the Efficacy and Safety of Certolizumab Pegol in Japanese Subjects With Moderate to Severe Chronic Psoriasis

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Apremilast Safety and PK Study in Recalcitrant Plaque Psoriasis

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A Study of Ixekizumab (LY2439821) in Participants in Japan With Generalized Pustular Psoriasis and Erythrodermic Psoriasis

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Clinical Trials on CP-690,550

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A Study Of CP-690,550 In Stable Kidney Transplant Patients

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A Phase 1 Study To Evaluate The Pharmacokinetics And Safety Of Three Modified Release And One Immediate Release Formulations Of Tofacitinib (CP-690,550) In Healthy Volunteers

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Completed

A One-Year Study To Evaluate The Effects And Safety Of CP-690,550 In Patients With Moderate To Severe Chronic Plaque Psoriasis

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United States, Canada, Germany, Colombia, Hungary, Japan, Mexico, Poland, Serbia, Taiwan, Ukraine
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Completed

A One-Year Study To Evaluate The Efficacy And Safety Of CP-690,550 For Patients With Moderate To Severe Chronic Plaque Psoriasis

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Completed

CP-690-550 Ointment For Chronic Plaque Psoriasis

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Completed

A Long Term Study To Evaluate The Safety, Tolerability And Efficacy Of CP-690,550 In Patients With Moderate To Severe Plaque Psoriasis And/Or Psoriatic Arthritis

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Japan
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A Phase 3 Study Comparing 2 Doses Of CP-690,550 And The Active Comparator, Humira (Adalimumab) Vs. Placebo For Treatment Of Rheumatoid Arthritis

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United States, Costa Rica, Czech Republic, Germany, Croatia, Canada, Korea, Republic of, Spain, Bosnia and Herzegovina, Australia, Bulgaria, Mexico, Slovakia, Poland, Philippines, Chile, Denmark, Dominican Republic, Finland, T... and more
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A Study To Evaluate The Effects And Safety Of Treatment, Treatment Withdrawal, Followed By Re-Treatment With CP-690,550 In Subjects With Moderate To Severe Chronic Plaque Psoriasis

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Completed

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Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving Physician Global Assessment (PGA) Response of 'Clear' or 'Almost Clear' Time Frame: Month 1, 3, 6, 12, 24, 36, 48	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.	Month 1, 3, 6, 12, 24, 36, 48
Percentage of Participants Achieving Greater Than or Equal to (>=) 75 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores Time Frame: Baseline, Month 1, 3, 6, 12, 24, 36, 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. Percentage of participants with >=75 percent (%) reduction from baseline in PASI scores were reported.	Baseline, Month 1, 3, 6, 12, 24, 36, 48
Psoriasis Area and Severity Index (PASI) Scores Time Frame: Baseline, Month 1, 3, 6, 12, 24, 36, 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.	Baseline, Month 1, 3, 6, 12, 24, 36, 48
Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores at Month 1, 3, 6, 12, 24, 36 and 48 Time Frame: Baseline, Month 1, 3, 6, 12, 24, 36, 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.	Baseline, Month 1, 3, 6, 12, 24, 36, 48
Psoriasis Area and Severity Index (PASI) Component Scores: Erythema Time Frame: Baseline, Month 1, 3, 6, 12, 24, 36, 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.	Baseline, Month 1, 3, 6, 12, 24, 36, 48
Psoriasis Area and Severity Index (PASI) Component Scores: Induration Time Frame: Baseline, Month 1, 3, 6, 12, 24, 36, 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.	Baseline, Month 1, 3, 6, 12, 24, 36, 48
Psoriasis Area and Severity Index (PASI) Component Scores: Scaling Time Frame: Baseline, Month 1, 3, 6, 12, 24, 36, 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.	Baseline, Month 1, 3, 6, 12, 24, 36, 48
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Erythema at Month 1, 3, 6, 12, 24, 36 and 48 Time Frame: Baseline, Month 1, 3, 6, 12, 24, 36, 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.	Baseline, Month 1, 3, 6, 12, 24, 36, 48
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Induration at Month 1, 3, 6, 12, 24, 36 and 48 Time Frame: Baseline, Month 1, 3, 6, 12, 24, 36, 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.	Baseline, Month 1, 3, 6, 12, 24, 36, 48
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Scaling at Month 1, 3, 6, 12, 24, 36 and 48 Time Frame: Baseline, Month 1, 3, 6, 12, 24, 36, 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.	Baseline, Month 1, 3, 6, 12, 24, 36, 48
Percentage of Participants Achieving Greater Than or Equal to (>=) 50 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores Time Frame: Baseline, Month 1, 3, 6, 12, 24, 36, 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. Percentage of participants with >=50% reduction from baseline in PASI scores were reported.	Baseline, Month 1, 3, 6, 12, 24, 36, 48
Percentage of Participants Achieving Greater Than or Equal to (>=) 90 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores Time Frame: Baseline, Month 1, 3, 6, 12, 24, 36, 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. Percentage of participants with >=90% reduction from baseline in PASI scores were reported.	Baseline, Month 1, 3, 6, 12, 24, 36, 48
Percentage of Participants Achieving Greater Than or Equal to (>=) 125 Percent Increase From Baseline in Psoriasis Area and Severity Index (PASI) Scores Time Frame: Baseline, Month 1, 3, 6, 12, 24, 36, 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. Percentage of participants with >=125% increase from baseline in PASI scores were reported.	Baseline, Month 1, 3, 6, 12, 24, 36, 48
Itch Severity Item (ISI) Scores Time Frame: Baseline, Month 1, 3, 6, 12, 24, 36, 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.	Baseline, Month 1, 3, 6, 12, 24, 36, 48
Change From Baseline in Itch Severity Item (ISI) Scores at Month 1, 3, 6, 12, 24, 36 and 48 Time Frame: Baseline, Month 1, 3, 6, 12, 24, 36, 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.	Baseline, Month 1, 3, 6, 12, 24, 36, 48
Dermatology Life Quality Index (DLQI) Scores Time Frame: Baseline, Month 1, 6, 12, 24, 36, 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.	Baseline, Month 1, 6, 12, 24, 36, 48
Change From Baseline in Dermatology Life Quality Index (DLQI) Scores at Month 1, 6, 12, 24, 36 and 48 Time Frame: Baseline, Month 1, 6, 12, 24, 36, 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.	Baseline, Month 1, 6, 12, 24, 36, 48
36-Item Short-Form (SF-36) Health Survey Version 2, Acute: Physical Component Summary Scores Time Frame: Baseline, Month 6, 12, 24, 36, 48	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.	Baseline, Month 6, 12, 24, 36, 48
36-Item Short-Form (SF-36) Health Survey Version 2, Acute: Mental Component Summary Scores Time Frame: Baseline, Month 6, 12, 24, 36, 48	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.	Baseline, Month 6, 12, 24, 36, 48
Number of Participants With Patient Global Assessment (PtGA) Response of "Clear" or "Almost Clear" Time Frame: Baseline, Month 1, 3, 6, 12, 24, 36, 48	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.	Baseline, Month 1, 3, 6, 12, 24, 36, 48
Euro Quality of Life- 5-Dimensions (EQ-5D)-Utility Scores Time Frame: Baseline, Month 6, 12, 24, 36, 48	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.	Baseline, Month 6, 12, 24, 36, 48
Euro Quality of Life-5-Dimensions (EQ-5D)-Visual Analogue Scale Scores (VAS) Time Frame: Baseline, Month 6, 12, 24, 36, 48	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.	Baseline, Month 6, 12, 24, 36, 48
Number of Participants Who Answered Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) Time Frame: Baseline, Month 1, 3, 6, 12, 24, 36, 48	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.	Baseline, Month 1, 3, 6, 12, 24, 36, 48

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, 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

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