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

Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01163253
• Other study ID #: A3921061
• Secondary ID: 2010-020002-15
• Status: Terminated
• Phase: Phase 3
• First received: July 14, 2010
• Last updated: July 20, 2016
• Start date: September 2010
• Est. completion date: June 2016

Study information

• Verified date: July 2016
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2873
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• CP-690,550
5 mg oral BID
• CP-690,550
10 mg oral BID

Locations

Country	Name	City	State
Argentina	CENIT Centro de Neurociencias Investigacion y Tratamiento	Caba
Argentina	Centro De Investigaciones Dermatologicas	Caba
Australia	Dr. Glenn and Partners	Kogarah	New South Wales
Australia	Premier Dermatology	Kogarah	New South Wales
Australia	Malvern Diagnostic Imaging	Malvern	Victoria
Australia	Emeritus Research	Malvern East	Victoria
Australia	Skin And Cancer Foundation	Melbourne	Victoria
Austria	LKH Feldkirch	Feldkirch
Austria	LKH Salzburg, Landesklinik fuer Dermatologie	Salzburg
Belgium	Cliniques Universitaires Saint-Luc	Brussels
Bosnia and Herzegovina	UHC Sarajevo	Sarajevo
Brazil	Instituto de Dermatologia e Estetica do Brasil LTDA - IDERJ	Rio De Janeiro
Brazil	Hospital da Clinicas da Faculdade de Medicina da Universidade de Sao Paulo	Sao Paulo	SP
Brazil	Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo	Sao Paulo
Bulgaria	UMHAT "Dr Georgi Stranski"	Pleven
Bulgaria	UMHAT "Dr. Georgi Stranski" - II clinical base	Pleven
Bulgaria	MBAL na Voennomeditsinska Akademia	Sofia
Bulgaria	Mnogoprofilna Bolnitsa Za Aktivno Lechenie- Tokuda Bolnitsa	Sofia
Bulgaria	Tsentar za kozhno venericheski zaboliavania EOOD	Sofia
Bulgaria	UMBAL-Alexandrovska- Sofia Klinika po dermatologia i venerologia	Sofia
Canada	CCA Medical Research	Ajax	Ontario
Canada	The Waterside Clinic	Barrie	Ontario
Canada	Ultranova Skincare	Barrie	Ontario
Canada	Kirk Barber Research	Calgary	Alberta
Canada	Northwest Dermatology & Laser Centre	Calgary	Alberta
Canada	Co-Medica Research Network Inc.	Courtice	Ontario
Canada	Stratica Medical	Edmonton	Alberta
Canada	Eastern Canada Cutaneous Research Associates Ltd.	Halifax	Nova Scotia
Canada	Dermatrials Research, Inc.	Hamilton	Ontario
Canada	The Guenther Dermatology Research Centre	London	Ontario
Canada	Lynderm Research Inc.	Markham	Ontario
Canada	Innovaderm Research Inc	Montreal	Quebec
Canada	Siena Medical Research	Montreal	Quebec
Canada	North Bay Dermatology Centre	North Bay	Ontario
Canada	Oakville Dermatology Laser Centre	Oakville	Ontario
Canada	Dr. Tuppal's Privat Practice, Oshawa Clinic	Oshawa	Ontario
Canada	Office of Dr. Michael Robern	Ottawa	Ontario
Canada	SKiN Centre for Dermatology	Peterborough	Ontario
Canada	CRCMRGilbert Inc., Centre de Dermatologie Maizerets	Quebec
Canada	Centre de Recherche Dermatologique du Québec Métropolitain	Québec	Quebec
Canada	Office of Dr. Paul Adam (back-up location)	Scarborough	Ontario
Canada	Diex Research Sherbrooke Inc.	Sherbrooke	Quebec
Canada	Dr. Zohair Tomi PMC Inc. Paton Medical Centre	St. John's	Newfoundland and Labrador
Canada	NewLab Clinical Research Inc.	St. John's	Newfoundland and Labrador
Canada	Nexus Clinical Research	St. John's	Newfoundland and Labrador
Canada	Enverus Medical Research	Surrey	British Columbia
Canada	Derm Research @888 Inc	Vancouver	British Columbia
Canada	The Skin Centre	Vancouver	British Columbia
Canada	Percuro Clinical Research Limited	Victoria	British Columbia
Canada	K. Papp Clinical Research	Waterloo	Ontario
Canada	Windsor Clinical Research	Windsor	Ontario
Canada	XLR8 Medical Research	Windsor	Ontario
Canada	Dermadvances Research	Winnipeg	Manitoba
Canada	Wiseman Dermatology Research Inc.	Winnipeg	Manitoba
Chile	Centro Internacional de Estudios Clinicos, CIEC	Santiago	Region Metropolitana
Chile	Clinica Dermacross S.A.	Santiago	Region Metropolitana
Chile	Hospital Clinico Universidad de Chile	Santiago	Region Metropolitana
Colombia	Centro Integral de Reumatologia del Caribe Cicaribe S.A.S	Barranquilla	Atlantico
Colombia	Riesgo De Fractura S.A	Bogota	Cundinamarca
Colombia	Riesgo De Fractura S.A	Bogota	Cundinamarca
Colombia	Colegio Mayor de Nuestra Señora del Rosario	Bogotá	Cundinamarca
Colombia	Medicity S.A.S	Bucaramanga	Santander
Colombia	Hospital Pablo Tobon Uribe	Medellin	Antioquia
Colombia	Reumalab S.A.S.	Medellin	Antioquia
Croatia	University Hospital Center Osijek	Osijek
Croatia	University hospital center "Sestre milosrdnice" clinic for dermatology and venerology disease	Zagreb
Croatia	University hospital center zagreb	Zagreb
Czech Republic	Nemocnice Ceske Budejovice, a.s. Ustavni lekarna	Ceske Budejovice
Czech Republic	Nemocnice Ceske Budejovice,a.s.	Ceske Budejovice
Czech Republic	Klinika nemoci koznich a pohlavnich	Hradec Kralove
Czech Republic	Ustanvi lekarna	Hradec Kralove
Czech Republic	Fakultni nemocnice Plzen	Plzen-Bory
Czech Republic	Kozni ordinace	Praha 1
Czech Republic	Lekarna U sv. Ignace	Praha 2
Czech Republic	Krajska zdravotni a.s.,Masarykovy nemocnice o.z.	Usti nad Labem
Denmark	Aarhus University Hospital	Aarhus C
Denmark	Bispebjerg Hospital, University of Copenhagen	Copenhagen NV
Denmark	Gentofte Hospital	Hellerup
Denmark	Hudklinikken Herning	Herning
Denmark	Hudklinikken	Svendborg
Finland	Tampere Univeristy Hospital, Department of Dermatology and Venereology	Tampere
France	CHU Jean-Minjoz	Besancon
France	Hôpital Jean Minjoz	Besancon
France	Chu Morvan	Brest	Cedex
France	CHG Le Mans	Le Mans, Cedex 09
France	CHU Limoges - Hôpital Dupuytren - Pharmacie	Limoges	Cedex
France	Hopital Dupuytren	Limoges
France	CHU de Nantes - Hotel Dieu	Nantes Cedex 01
France	CHU De Nice Hopital De L'Archet II	Nice
France	Hopital Saint Louis	Paris	Lle-de-france
France	Centre Hospitalier Lyon Sud - Pharmacie	Pierre Benite
France	Centre Hospitalier Lyon Sud	Pierre-Benite
France	C.H.U. de Poitiers la Miletrie	Poitiers
France	C.H.U de Reims	Reims
France	Hôpital Robert Debre	Reims
France	Hopital Nord	Saint Priest En Jarez
France	Hopital Larrey Departement de Dermatologie	Toulouse
France	Hopital de Brabois / Batiment Philippe Canton	Vandoeuvre les Nancy
Germany	Charité Universitätsmedizin Berlin	Berlin
Germany	Facharzt fuer Dermatologie und Allergologie	Berlin
Germany	Hautarztpraxis Tegel	Berlin
Germany	Klinische Forschung Berlin-Mitte GmbH	Berlin
Germany	MVZ Reichenberger Str., Aerztehaus "Rudolf Virchow"	Berlin
Germany	Klinik and Poliklinik fur Dermatologie and Allergologie der Universitaet Bonn	Bonn
Germany	Klinik und Poliklinik fur Dermatologie und Allergologie der Universitaet Bonn	Bonn
Germany	Dres. Kirsten Prepeneit und Volker Streit	Buchholz
Germany	Universitaetsklinik Carl Gustav Carus	Dresden
Germany	Universitaetsklinikum Erlangen Hautklinik im Internistischen Zentrum	Erlangen
Germany	Klinikum der Johann Wolfgang Goethe Universitaet	Frankfurt/Main
Germany	Universitaetsklinik und Poliklinik fuer Dermatologie und Venerologie	Halle
Germany	Klinische Forschung Hamburg GmbH	Hamburg
Germany	Universitaetsklinikum Hamburg-Eppendorf	Hamburg
Germany	Gemeinschaftspraxis Dres.Michael Ockenfels und Christoph Sauter	Hanau
Germany	Universitaetsklinikum Heidelberg	Heidelberg
Germany	Universitaetsklinikum Schleswig-Holstein, Campus Kiel	Kiel
Germany	Universitatsklinikum Schleswig-Holstein	Kiel	Schleswig-holstein
Germany	Universitaetsklinikum Koeln	Koeln
Germany	Universitaetsklinikum Schleswig-Holstein Campus Luebeck	Luebeck
Germany	Hautarztpraxis Dres. Scholz, Sebastian, Schilling	Mahlow
Germany	Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KoeR	Mainz
Germany	Technischen Universitaet Muenchen	Muenchen
Germany	Universitaetsklinikum Muenster	Muenster
Germany	Klinische Forschung Schwerin GmbH	Schwerin
Germany	Eberhard-Karls-Universitaet Tuebingen Universitaetshautklinik	Tuebingen
Germany	Universitaets-Hautklinik Eberhard-Karls-Universitaet Tuebingen	Tuebingen	Baden-wuerttemberg
Germany	HSK, Dr. Horst Schmidt Kliniken GmbH	Wiesbaden
Germany	Hautarztpraxis Centrovital	Witten
Greece	University Dermatology Clinic "Andreas Syggros" Hospital	Athens	Attiki
Greece	University General Hospital of Ioannina / Dermatology and Venereology Department	Ioannina
Greece	"Papageorgiou" General Hospital/B' Dermatology and Venereology Clinic of University of Thessaloniki	Thessaloniki
Hong Kong	The University of Hong Kong (HKU)-Queen Mary Hospital (QMH)	Hong Kong
Hungary	Synexus Magyarorszag Kft.	Budapest
Hungary	Debreceni Egyetem Klinikai Kozpont, Borgyogyaszati Klinika	Debrecen
Hungary	Bacs-Kiskun Megyei Korhaz Szegedi Tudomanyegyetem AOK Oktato Korhaza, Borgyogyaszati Osztaly	Kecskemet
Hungary	Miskolci Semmelweis Korhaz es Egyetemi Oktatokorhaz, Borgyogyaszati Osztaly	Miskolc
Hungary	Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz, Klinikai Kutatasi Osztaly	Nyiregyhaza
Hungary	Szabolcs-Szatmar-Bereg Megyei Korjazak es Egyetemi Okatokorhaz, Borgyogyaszati Szakrendeles	Nyiregyhaza
Hungary	Pecsi Tudomanyegyetem Aok Bor- Nemikortani Es Onkodermatologiai Klinika	Pecs
Hungary	SZTE Szentgyorgyi Albert Klinikai Kozpont/Borgyogyaszati es Allergologiai Klinika	Szeged
Hungary	Tolna Megyei Balassa Janos Korhaz, Borgyogyaszati Osztaly	Szekszard
Hungary	ALLERGO-DERM BAKOS Kft.	Szolnok
Hungary	Vas Megyei Markusovszky Korhaz/Borgyogyaszati Osztaly	Szombathely
Hungary	Veszprem Megyei Csolnoky Ferenc Korhaz Borgyogyaszat	Veszprem
Japan	Kobe University	Kobe	Hyogo
Japan	Kumamoto University Hospital	Kumamoto-city	Kumamoto
Japan	Gunma University Hospital	Maebashi-shi	Gunma
Japan	JR Sapporo hospital	Sapporo-City	Hokkaido
Japan	Tokyo Yamate Medical Center	Shinjuku-ku	Tokyo
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Yonsei University College of Medicine, Severance Hospital	Seoul
Mexico	Mexico Centre for Clinical Research S.A. de C.V.	Mexico	Distrito Federal
Mexico	Centro de Dermatologia de Monterrey	Monterrey	Nuevo Leon
Mexico	Centro Medico San Lucas	Monterrey	Nuevo Leon
Mexico	Instituto Dermatologico De Jalisco "Dr Jose Barba Rubio"	Zapopan	Jalisco
Netherlands	Academisch Medisch Centrum Universiteit van Amsterdam	Amsterdam	Noord-holland
Netherlands	PT&R	Beek
Poland	NZOZ Zdrowie Osteo-Medic	Bialystok
Poland	Klinika Dermatologii, Wenerologii i Alergologii Uniwersyteckiego Centrum Klinicznego	Gdansk
Poland	Uniwersyteckie Centrum Kliniczne	Gdansk	Pomorskie
Poland	Krakowskie Centrum Medyczne NZOZ	Krakow
Poland	Specjalistyczne Gabinety Lekarskie "Dermed"	Lodz
Poland	Novum Instytut Dermatologii Leczniczej i Estetycznej	Opole
Poland	Centrum Badan Klinicznych s.c. Wieslawa Porawska, Lukasz Porawski	Poznan
Poland	Solumed Centrum Medyczne	Poznan
Poland	Katedra i Klinika Chorob Skornych i Wenerycznych, Pomorski Uniwersytet Medyczny	Szczecin
Poland	Spolka Cywilna Andrzej Krolicki, Tomasz Kochanowski "Laser Clinic"	Szczecin
Poland	Klinika Dermatologii	Warszawa
Poland	MTZ Clinical Research Sp. z o.o.	Warszawa
Poland	Zaklad Radiologii Lekarskiej	Warszawa
Poland	Katedra i Klinika Dermatologii, Wenerologii i Alergologii Akademii Medycznej we Wroclawiu	Wroclaw
Poland	Oddzial Dermatologiczny	Wroclaw
Poland	Poradnia Dermatologiczna	Wroclaw
Puerto Rico	Grupo Dermatologico De Carolina (Office of Dr. Alma Cruz MD)	Carolina
Russian Federation	Dermatovenerological dispensary #7	Moscow
Russian Federation	State Research Center of Dermatovenerology	Moscow
Russian Federation	State Research Center of Dermatovenerology,	Moscow
Russian Federation	Rostov-on-Don regional dermatovenerologic dispensary	Rostov-on-Don
Russian Federation	Ryazan regional clinical dermatovenerologic dispensary	Ryazan
Russian Federation	Dermatovenerologic dispensary #10 of Vyborg region	Saint-Petersburg
Russian Federation	Military Medical Academy N.A. S.M.Kirov	Saint-Petersburg
Russian Federation	North-Western State Medical University I.I. Mechnikov	Saint-Petersburg
Russian Federation	Smolensk State Medical Academy	Smolensk
Russian Federation	Clinical hospital of emergency care N.V. Soloviev	Yaroslavl
Serbia	Clinical Hospital Center Zvezdara	Belgrade
Serbia	Military Medical Academy	Belgrade
Singapore	Changi General Hospital	Singapore
Singapore	National Skin Centre	Singapore
Slovakia	Dermatovenerologicka klinika SZU, Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica	Banska Bystrica
Slovakia	Oddelenie biologickej liecby, Narodny ustav reumatickych chorob	Piestany
Slovakia	DOST-Dermatovenerologicke oddelenie sanatorneho typu, SANARE, spol. s r.o.	Svidnik
Spain	Hospital General Universitario de Alicante	Alicante
Spain	Hospital 12 de Octubre	Madrid
Spain	Hospital Universitario Fundacion Alcorcon	Madrid
Spain	Hospital Universitario La Princesa	Madrid
Spain	Hospital Universitario Puerta de Hierro	Majadahonda	Madrid
Spain	Consorcio Hospital General Universitario de Valencia	Valencia
Sweden	Hudkliniken	Falun
Sweden	Hermelinen Forskning AB	Lulea
Sweden	Pharmacy: Sjukhusapoteket Lund	Lund
Sweden	Hud kliniken- Skanes Universitetssjukhus i Malmo	Malmo	Sverige
Sweden	Hudkliniken	Stockholm
Sweden	Karolinska University Hospital- Solna	Stockholm
Switzerland	Kantonsspital St. Gallen	St. Gallen
Taiwan	Chang Gung Medical Foundation Kaohsiung Branch	Kaohsiung
Taiwan	Chung Shan Medical University Hospital	Taichung	Taiwan Roc
Taiwan	National Cheng Kung University Hospital	Tainan
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Taipei Medical University-Shuang Ho Hospital	Taipei
Taiwan	Chang Gung Medical Foundation Linkou Branch	Taoyuan
Ukraine	Municipal Institution of health Care	Kharkiv
Ukraine	SI 'Institute for Dermatology and Venerology of AMS of Ukraine'	Kharkiv
Ukraine	Kyiv Oleksandrivska Clin. Hosp., Dermatology department, NMU n.a. O.O. Bogomolets,	Kyiv
Ukraine	Dept of Dermatology and Venerology of Lugansk State Medical University,	Lugansk
Ukraine	Regional Municipal Dermatovenerologic Dispensary	Lviv
Ukraine	Dept of Dermatology and Venerology of ONMU	Odessa
Ukraine	Dept of Dermatology and Venerology of SI "Crimean State Medical University n.a. S.I.Georgiyevskyy"	Simferopol,	Crimea
Ukraine	Ternopil Regional Municipal Clinical Dermatovenerologic Dispensary	Ternopil
United Kingdom	Whipps Cross University Hospital	London
United Kingdom	Department of Dermatology	Nuneaton	Warwickshire
United Kingdom	eRT	Peterbrough
United Kingdom	Salford Royal NHS Foundation Trust	Salford	Manchester
United States	Atlanta Dermatology, Vein & Research Center, P.C.	Alpharetta	Georgia
United States	Arlington Research Center, Inc.	Arlington	Texas
United States	Altman Dermatology Associates	Arlington Heights	Illinois
United States	Advanced Medical Research, Inc.	Atlanta	Georgia
United States	Bakersfield Dermatology and Skin Cancer Medical Group	Bakersfield	California
United States	Centennial Center-Comprehensive Clinical Research	Berlin	New Jersey
United States	Radiant Research, Inc.	Birmingham	Alabama
United States	UAB Dermatology	Birmingham	Alabama
United States	Massachusetts General Hospital - Clinical Unit for Research Trials and Outcomes in Skin	Boston	Massachusetts
United States	Tufts Medical Center	Boston	Massachusetts
United States	Tufts Medical Center	Boston	Massachusetts
United States	Mountain State Clinical Research	Bridgeport	West Virginia
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	University of North Carolina at Chapel Hill- Hospital	Chapel Hill	North Carolina
United States	Jewish Hospital	Cincinnati	Ohio
United States	Radiant Research, Inc.	Cincinnati	Ohio
United States	IP ONLY: University Hospitals Case Medical Center	Cleveland	Ohio
United States	University Hospitals Case Medical Center	Cleveland	Ohio
United States	University Hospitals Case Medical Center/Dept. of Dermatology	Cleveland	Ohio
United States	Michigan Center for Research Corporation dba Michigan Center for Skin Care Research	Clinton Township	Michigan
United States	Florida Academic Dermatology Center	Coral Gables	Florida
United States	Dermatology Treatment & Research Center	Dallas	Texas
United States	Menter Dermatology Research Institute	Dallas	Texas
United States	Modern Research Associates, PLLC	Dallas	Texas
United States	Cherry Creek Research, Inc.	Denver	Colorado
United States	Duke University Medical Center	Durham	North Carolina
United States	Deaconess Clinic Downtown Research Institute	Evansville	Indiana
United States	Hudson Dermatology	Evansville	Indiana
United States	Hamzavi Dermatology	Fort Gratiot	Michigan
United States	Associates In Research, Inc.	Fresno	California
United States	Minnesota Clinical Study Center	Fridley	Minnesota
United States	Rivergate Dermatology Clinical Research Center, PLLC	Goodlettsville	Tennessee
United States	Office of John Michael Humeniuk, MD	Greer	South Carolina
United States	Radiant Research, Inc.	Greer	South Carolina
United States	Bettencourt Skin Center	Henderson	Nevada
United States	Dermatology Consulting Services	High Point	North Carolina
United States	Burke Pharmaceutical Research	Hot Springs	Arkansas
United States	Center for Clinical Studies	Houston	Texas
United States	Suzanne Bruce and Associates, PA	Houston	Texas
United States	Dawes Fretzin Clinical Research Group, LLC	Indianapolis	Indiana
United States	University of California Irvine	Irvine	California
United States	North Florida Dermatology Associates, PA	Jacksonville	Florida
United States	Clinical Partners, LLC	Johnston	Rhode Island
United States	Dermatology Associates of Knoxville PC	Knoxville	Tennessee
United States	Baker Allergy Asthma and Dermatology Research Center, LLC	Lake Oswego	Oregon
United States	Dartmouth-Hitchcock Medical Center-Norris Cotton Cancer Center	Lebanon	New Hampshire
United States	Dermatology Research Associates	Los Angeles	California
United States	DermResearch, PLLC	Louisville	Kentucky
United States	Madison Skin and Research, Inc.	Madison	Wisconsin
United States	International Dermatology Research, Inc.	Miami	Florida
United States	Horizon Research Group, Inc.	Mobile	Alabama
United States	Dermatology Research Associates	Nashville	Tennessee
United States	The Savin Center, P.C.	New Haven	Connecticut
United States	New York University (NYU) School of Medicine - Investigational Pharmacy (IP Shipment, Pharmacy)	New York	New York
United States	NYU Langone Medical Center, Ambulatory Care Center, Department of Dermatology, Clinical Studies Unit	New York	New York
United States	The Rockefeller University	New York	New York
United States	MedaPhase Inc.	Newnan	Georgia
United States	Virginia Clinical Research, Inc.	Norfolk	Virginia
United States	Virginia Clinical Research, Inc.	Norfolk	Virginia
United States	Central Sooner Research	Norman	Oklahoma
United States	Renstar Medical Research	Ocala	Florida
United States	Dermatology Specialists, Inc.	Oceanside	California
United States	Skin Specialists, P.C	Omaha	Nebraska
United States	Park Avenue Dermatology, PA	Orange Park	Florida
United States	Leavitt Medical Associates of Florida dba Ameriderm Research	Ormond Beach	Florida
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	University of Pittsburgh Medical Center - Department of Dermatology	Pittsburgh	Pennsylvania
United States	Oregon Dermatology and Research Center	Portland	Oregon
United States	Oregon Health & Science University	Portland	Oregon
United States	Rhode Island Hospital	Providence	Rhode Island
United States	Wake Dermatology Associates, LLC	Raleigh	North Carolina
United States	Wake Research Associates	Raleigh	North Carolina
United States	Health Concepts	Rapid City	South Dakota
United States	Saint Louis University - Department of Dermatology	Saint Louis	Missouri
United States	Office of Mark Lee, MD	San Antonio	Texas
United States	Progressive Clinical research, P.A.	San Antonio	Texas
United States	Stephen Miller, MD, PA	San Antonio	Texas
United States	MedDerm Associates	San Diego	California
United States	UCSD Dermatology	San Diego	California
United States	University of California San Diego	San Diego	California
United States	University of California San Francisco	San Francisco	California
United States	Clinical Science Institute	Santa Monica	California
United States	Schaumburg Dermatology	Schaumburg	Illinois
United States	NorthShore University Health System - Division of Dermatology	Skokie	Illinois
United States	Miami Research Associates, Inc.	South Miami	Florida
United States	Rockwood Research Center	Spokane	Washington
United States	Springfield Clinic	Springfield	Illinois
United States	Olympian Clinical Research	Tampa	Florida
United States	Healthcare Partners Medical Group	Torrance	California
United States	Somerset Skin Centre - Dermcenter	Troy	Michigan
United States	New England Research Associates, LLC	Trumbull	Connecticut
United States	Radiant Research, Inc.	Tucson	Arizona
United States	Center for Clinical Studies	Webster	Texas
United States	Wenatchee Valley Hospital & Clinics	Wenatchee	Washington
United States	Dundee Dermatology	West Dundee	Illinois
United States	Dermatology Associates	Wilmington	North Carolina
United States	PMG Research of Wilmington, LLC	Wilmington	North Carolina
United States	Piedmont Imaging	Winston-Salem	North Carolina
United States	PMG Research of Winston-Salem	Winston-Salem	North Carolina
United States	Triad Dermatology, PA	Winston-Salem	North Carolina
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Bosnia and Herzegovina,  Brazil,  Bulgaria,  Canada,  Chile,  Colombia,  Croatia,  Czech Republic,  Denmark,  Finland,  France,  Germany,  Greece,  Hong Kong,  Hungary,  Japan,  Korea, Republic of,  Mexico,  Netherlands,  Poland,  Puerto Rico,  Russian Federation,  Serbia,  Singapore,  Slovakia,  Spain,  Sweden,  Switzerland,  Taiwan,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and severity of adverse events during treatment.		Month 1, month 3, and every three months thereafter until approximately June 2016	Yes
Primary	Incidence of clinical laboratory abnormalities and change from baseline (in this and/or prior study) in clinical laboratory values during treatment.		Month 1, month 3, and every three months thereafter until approximately June 2016	Yes
Primary	Incidence of investigator-reported clinically significant changes in physical examination from baseline (in this and/or prior study) during treatment.		Month 1, month 3, and every three months thereafter until approximately June 2016	Yes
Primary	Incidence of vital sign (blood pressure and heart rate) abnormalities and change from baseline (in this and/or prior study) in vital sign measures during treatment.		Month 1, month 3, and every three months thereafter until approximately June 2016	Yes
Primary	Summary of adjudicated cardiovascular endpoints. Summary of malignancies confirmed by central laboratory pathologist over read of biopsies.		Month 1, month 3, and every three months thereafter until approximately June 2016	Yes
Primary	Incidence of electrocardiogram (ECG) abnormalities and change from baseline (in this and/or prior study) in ECG measurements during treatment.		Month 6, and every 6 months thereafter until approxinmately June 2016	Yes
Secondary	Physician's Global Assessment (PGA) response ie, the proportion of participants achieving a PGA of "clear" or "almost clear" at various time points.		Month 1, month 3, and every three months thereafter until approximately June 2016	No
Secondary	Psoriasis Area and Severity Index 75 (PASI75) response ie, the proportion of participants achieving at least a 75% reduction in PASI relative to baseline (in this and/or prior study) at various time points.		Month 1, month 3, and every three months thereafter until approximately June 2016	No
Secondary	Actual and change from baseline (in this and/or prior study) in PASI and PASI component scores at various time points.		Month 1, month 3, and every three months thereafter until approximately June 2016	No
Secondary	Proportion of participants achieving at least a 50% and 90% reduction in PASI relative to baseline (in this and/or prior study) (ie, PASI50 and PASI90, respectively) at various time points.		Month 1, month 3, and every three months thereafter until approximately June 2016	No
Secondary	Proportion of participants with a PASI score >= 125% of the baseline PASI score (in this and/or prior study) at any time point.		Month 1, month 3, and every three months thereafter until approximately June 2016	No
Secondary	Actual and change from baseline (in this and/or prior study) in the Itch Severity Item (ISI) score		Month 1, month 3, and every three months thereafter until approximately June 2016	No
Secondary	Actual and change from baseline (in this and/or prior study) on the Dermatology Life Quality Index (DLQI) score.		Month 1, Month 6, and every six months thereafter until approximately June 2016	No
Secondary	Short Form-36 Health Survey (SF-36) - (Version 2, Acute)		Month 6, and then every 6 months thereafter until approximately June 2016	No
Secondary	Patient Global Assessment (PtGA)		Month 1, month 3, and every three months thereafter until approximately June 2016	No
Secondary	Euro-Qol 5 Dimensions (EQ-5D)		Month 6, and then every 6 months thereafter until approximately June 2016	No
Secondary	Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU)		Month 6, and then every 6 months thereafter until approximately June 2016	No

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