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

Primary Purpose

Psoriasis

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
CP-690,550
CP-690,550
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis focused on measuring chronic, severe, treatment, safety, CP-690,55, Plaque Psoriasis, Psoriasis Vulgaris, Xeljanz, Tofacitinib

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Radiant Research, Inc.
  • UAB Dermatology
  • Horizon Research Group, Inc.
  • Radiant Research, Inc.
  • Burke Pharmaceutical Research
  • Bakersfield Dermatology and Skin Cancer Medical Group
  • Associates In Research, Inc.
  • University of California Irvine
  • Dermatology Research Associates
  • Dermatology Specialists, Inc.
  • MedDerm Associates
  • UCSD Dermatology
  • University of California San Diego
  • University of California San Francisco
  • Clinical Science Institute
  • Healthcare Partners Medical Group
  • Cherry Creek Research, Inc.
  • The Savin Center, P.C.
  • New England Research Associates, LLC
  • Florida Academic Dermatology Center
  • North Florida Dermatology Associates, PA
  • International Dermatology Research, Inc.
  • Renstar Medical Research
  • Park Avenue Dermatology, PA
  • Leavitt Medical Associates of Florida dba Ameriderm Research
  • Miami Research Associates, Inc.
  • Olympian Clinical Research
  • Atlanta Dermatology, Vein & Research Center, P.C.
  • Advanced Medical Research, Inc.
  • MedaPhase Inc.
  • Altman Dermatology Associates
  • Schaumburg Dermatology
  • NorthShore University Health System - Division of Dermatology
  • Springfield Clinic
  • Dundee Dermatology
  • Deaconess Clinic Downtown Research Institute
  • Hudson Dermatology
  • Dawes Fretzin Clinical Research Group, LLC
  • DermResearch, PLLC
  • Tufts Medical Center
  • Tufts Medical Center
  • Massachusetts General Hospital - Clinical Unit for Research Trials and Outcomes in Skin
  • Michigan Center for Research Corporation dba Michigan Center for Skin Care Research
  • Hamzavi Dermatology
  • Somerset Skin Centre - Dermcenter
  • Minnesota Clinical Study Center
  • Saint Louis University - Department of Dermatology
  • Skin Specialists, P.C
  • Bettencourt Skin Center
  • Dartmouth-Hitchcock Medical Center-Norris Cotton Cancer Center
  • Centennial Center-Comprehensive Clinical Research
  • New York University (NYU) School of Medicine - Investigational Pharmacy (IP Shipment, Pharmacy)
  • NYU Langone Medical Center, Ambulatory Care Center, Department of Dermatology, Clinical Studies Unit
  • The Rockefeller University
  • University of North Carolina at Chapel Hill- Hospital
  • University of North Carolina at Chapel Hill
  • Duke University Medical Center
  • Dermatology Consulting Services
  • Wake Dermatology Associates, LLC
  • Wake Research Associates
  • Dermatology Associates
  • PMG Research of Wilmington, LLC
  • Piedmont Imaging
  • PMG Research of Winston-Salem
  • Triad Dermatology, PA
  • Wake Forest University Health Sciences
  • Jewish Hospital
  • Radiant Research, Inc.
  • IP ONLY: University Hospitals Case Medical Center
  • University Hospitals Case Medical Center/Dept. of Dermatology
  • University Hospitals Case Medical Center
  • Central Sooner Research
  • Baker Allergy Asthma and Dermatology Research Center, LLC
  • Oregon Dermatology and Research Center
  • Oregon Health & Science University
  • University of Pittsburgh Medical Center - Department of Dermatology
  • University of Pittsburgh Medical Center
  • Clinical Partners, LLC
  • Rhode Island Hospital
  • Office of John Michael Humeniuk, MD
  • Radiant Research, Inc.
  • Health Concepts
  • Rivergate Dermatology Clinical Research Center, PLLC
  • Dermatology Associates of Knoxville PC
  • Dermatology Research Associates
  • Arlington Research Center, Inc.
  • Dermatology Treatment & Research Center
  • Modern Research Associates, PLLC
  • Menter Dermatology Research Institute
  • Center for Clinical Studies
  • Suzanne Bruce and Associates, PA
  • Office of Mark Lee, MD
  • Progressive Clinical research, P.A.
  • Stephen Miller, MD, PA
  • Center for Clinical Studies
  • Virginia Clinical Research, Inc.
  • Virginia Clinical Research, Inc.
  • Rockwood Research Center
  • Wenatchee Valley Hospital & Clinics
  • Mountain State Clinical Research
  • Madison Skin and Research, Inc.
  • Centro De Investigaciones Dermatologicas
  • CENIT Centro de Neurociencias Investigacion y Tratamiento
  • Dr. Glenn and Partners
  • Premier Dermatology
  • Emeritus Research
  • Malvern Diagnostic Imaging
  • Skin And Cancer Foundation
  • LKH Feldkirch
  • LKH Salzburg, Landesklinik fuer Dermatologie
  • Cliniques Universitaires Saint-Luc
  • UHC Sarajevo
  • Hospital da Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
  • Instituto de Dermatologia e Estetica do Brasil LTDA - IDERJ
  • Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
  • UMHAT "Dr Georgi Stranski"
  • UMHAT "Dr. Georgi Stranski" - II clinical base
  • Tsentar za kozhno venericheski zaboliavania EOOD
  • Mnogoprofilna Bolnitsa Za Aktivno Lechenie- Tokuda Bolnitsa
  • UMBAL-Alexandrovska- Sofia Klinika po dermatologia i venerologia
  • MBAL na Voennomeditsinska Akademia
  • Kirk Barber Research
  • Northwest Dermatology & Laser Centre
  • Stratica Medical
  • Enverus Medical Research
  • Derm Research @888 Inc
  • The Skin Centre
  • Percuro Clinical Research Limited
  • Dermadvances Research
  • Wiseman Dermatology Research Inc.
  • Nexus Clinical Research
  • Dr. Zohair Tomi PMC Inc. Paton Medical Centre
  • NewLab Clinical Research Inc.
  • Eastern Canada Cutaneous Research Associates Ltd.
  • CCA Medical Research
  • The Waterside Clinic
  • Ultranova Skincare
  • Co-Medica Research Network Inc.
  • Dermatrials Research, Inc.
  • The Guenther Dermatology Research Centre
  • Lynderm Research Inc.
  • North Bay Dermatology Centre
  • Oakville Dermatology Laser Centre
  • Dr. Tuppal's Privat Practice, Oshawa Clinic
  • Office of Dr. Michael Robern
  • SKiN Centre for Dermatology
  • Office of Dr. Paul Adam (back-up location)
  • K. Papp Clinical Research
  • XLR8 Medical Research
  • Windsor Clinical Research
  • Innovaderm Research Inc
  • Siena Medical Research
  • Centre de Recherche Dermatologique du Québec Métropolitain
  • Diex Research Sherbrooke Inc.
  • CRCMRGilbert Inc., Centre de Dermatologie Maizerets
  • Clinica Dermacross S.A.
  • Hospital Clinico Universidad de Chile
  • Centro Internacional de Estudios Clinicos, CIEC
  • Reumalab S.A.S.
  • Hospital Pablo Tobon Uribe
  • Centro Integral de Reumatologia del Caribe Cicaribe S.A.S
  • Riesgo De Fractura S.A
  • Riesgo De Fractura S.A
  • Colegio Mayor de Nuestra Señora del Rosario
  • Medicity S.A.S
  • University Hospital Center Osijek
  • University hospital center "Sestre milosrdnice" clinic for dermatology and venerology disease
  • University hospital center zagreb
  • Nemocnice Ceske Budejovice, a.s. Ustavni lekarna
  • Ustanvi lekarna
  • Nemocnice Ceske Budejovice,a.s.
  • Klinika nemoci koznich a pohlavnich
  • Fakultni nemocnice Plzen
  • Kozni ordinace
  • Lekarna U sv. Ignace
  • Krajska zdravotni a.s.,Masarykovy nemocnice o.z.
  • Aarhus University Hospital
  • Bispebjerg Hospital, University of Copenhagen
  • Gentofte Hospital
  • Hudklinikken Herning
  • Hudklinikken
  • Tampere Univeristy Hospital, Department of Dermatology and Venereology
  • Chu Morvan
  • CHU Limoges - Hôpital Dupuytren - Pharmacie
  • Hopital Saint Louis
  • Hôpital Jean Minjoz
  • CHU Jean-Minjoz
  • CHG Le Mans
  • Hopital Dupuytren
  • CHU de Nantes - Hotel Dieu
  • CHU De Nice Hopital De L'Archet II
  • Centre Hospitalier Lyon Sud - Pharmacie
  • Centre Hospitalier Lyon Sud
  • C.H.U. de Poitiers la Miletrie
  • C.H.U de Reims
  • Hôpital Robert Debre
  • Hopital Nord
  • Hopital Larrey Departement de Dermatologie
  • Hopital de Brabois / Batiment Philippe Canton
  • Universitaets-Hautklinik Eberhard-Karls-Universitaet Tuebingen
  • Universitatsklinikum Schleswig-Holstein
  • Charité Universitätsmedizin Berlin
  • Klinische Forschung Berlin-Mitte GmbH
  • Facharzt fuer Dermatologie und Allergologie
  • MVZ Reichenberger Str., Aerztehaus "Rudolf Virchow"
  • Hautarztpraxis Tegel
  • Klinik and Poliklinik fur Dermatologie and Allergologie der Universitaet Bonn
  • Klinik und Poliklinik fur Dermatologie und Allergologie der Universitaet Bonn
  • Dres. Kirsten Prepeneit und Volker Streit
  • Universitaetsklinik Carl Gustav Carus
  • Universitaetsklinikum Erlangen Hautklinik im Internistischen Zentrum
  • Klinikum der Johann Wolfgang Goethe Universitaet
  • Universitaetsklinik und Poliklinik fuer Dermatologie und Venerologie
  • Universitaetsklinikum Hamburg-Eppendorf
  • Klinische Forschung Hamburg GmbH
  • Gemeinschaftspraxis Dres.Michael Ockenfels und Christoph Sauter
  • Universitaetsklinikum Heidelberg
  • Universitaetsklinikum Schleswig-Holstein, Campus Kiel
  • Universitaetsklinikum Koeln
  • Universitaetsklinikum Schleswig-Holstein Campus Luebeck
  • Hautarztpraxis Dres. Scholz, Sebastian, Schilling
  • Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KoeR
  • Technischen Universitaet Muenchen
  • Universitaetsklinikum Muenster
  • Klinische Forschung Schwerin GmbH
  • Eberhard-Karls-Universitaet Tuebingen Universitaetshautklinik
  • HSK, Dr. Horst Schmidt Kliniken GmbH
  • Hautarztpraxis Centrovital
  • University Dermatology Clinic "Andreas Syggros" Hospital
  • University General Hospital of Ioannina / Dermatology and Venereology Department
  • "Papageorgiou" General Hospital/B' Dermatology and Venereology Clinic of University of Thessaloniki
  • The University of Hong Kong (HKU)-Queen Mary Hospital (QMH)
  • Synexus Magyarorszag Kft.
  • Debreceni Egyetem Klinikai Kozpont, Borgyogyaszati Klinika
  • Bacs-Kiskun Megyei Korhaz Szegedi Tudomanyegyetem AOK Oktato Korhaza, Borgyogyaszati Osztaly
  • Miskolci Semmelweis Korhaz es Egyetemi Oktatokorhaz, Borgyogyaszati Osztaly
  • Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz, Klinikai Kutatasi Osztaly
  • Szabolcs-Szatmar-Bereg Megyei Korjazak es Egyetemi Okatokorhaz, Borgyogyaszati Szakrendeles
  • Pecsi Tudomanyegyetem Aok Bor- Nemikortani Es Onkodermatologiai Klinika
  • SZTE Szentgyorgyi Albert Klinikai Kozpont/Borgyogyaszati es Allergologiai Klinika
  • Tolna Megyei Balassa Janos Korhaz, Borgyogyaszati Osztaly
  • ALLERGO-DERM BAKOS Kft.
  • Vas Megyei Markusovszky Korhaz/Borgyogyaszati Osztaly
  • Veszprem Megyei Csolnoky Ferenc Korhaz Borgyogyaszat
  • Gunma University Hospital
  • JR Sapporo hospital
  • Kobe University
  • Kumamoto University Hospital
  • Tokyo Yamate Medical Center
  • Seoul National University Hospital
  • Samsung Medical Center
  • Yonsei University College of Medicine, Severance Hospital
  • Mexico Centre for Clinical Research S.A. de C.V.
  • Instituto Dermatologico De Jalisco "Dr Jose Barba Rubio"
  • Centro de Dermatologia de Monterrey
  • Centro Medico San Lucas
  • Academisch Medisch Centrum Universiteit van Amsterdam
  • PT&R
  • Uniwersyteckie Centrum Kliniczne
  • NZOZ Zdrowie Osteo-Medic
  • Klinika Dermatologii, Wenerologii i Alergologii Uniwersyteckiego Centrum Klinicznego
  • Krakowskie Centrum Medyczne NZOZ
  • Specjalistyczne Gabinety Lekarskie "Dermed"
  • Novum Instytut Dermatologii Leczniczej i Estetycznej
  • Solumed Centrum Medyczne
  • Centrum Badan Klinicznych s.c. Wieslawa Porawska, Lukasz Porawski
  • Katedra i Klinika Chorob Skornych i Wenerycznych, Pomorski Uniwersytet Medyczny
  • Spolka Cywilna Andrzej Krolicki, Tomasz Kochanowski "Laser Clinic"
  • MTZ Clinical Research Sp. z o.o.
  • Klinika Dermatologii
  • Zaklad Radiologii Lekarskiej
  • Katedra i Klinika Dermatologii, Wenerologii i Alergologii Akademii Medycznej we Wroclawiu
  • Oddzial Dermatologiczny
  • Poradnia Dermatologiczna
  • Grupo Dermatologico De Carolina (Office of Dr. Alma Cruz MD)
  • State Research Center of Dermatovenerology,
  • State Research Center of Dermatovenerology
  • Dermatovenerological dispensary #7
  • Rostov-on-Don regional dermatovenerologic dispensary
  • Ryazan regional clinical dermatovenerologic dispensary
  • Dermatovenerologic dispensary #10 of Vyborg region
  • Military Medical Academy N.A. S.M.Kirov
  • North-Western State Medical University I.I. Mechnikov
  • Smolensk State Medical Academy
  • Clinical hospital of emergency care N.V. Soloviev
  • Clinical Hospital Center Zvezdara
  • Military Medical Academy
  • National Skin Centre
  • Changi General Hospital
  • Dermatovenerologicka klinika SZU, Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica
  • Oddelenie biologickej liecby, Narodny ustav reumatickych chorob
  • DOST-Dermatovenerologicke oddelenie sanatorneho typu, SANARE, spol. s r.o.
  • Hospital Universitario Puerta de Hierro
  • Hospital General Universitario de Alicante
  • Hospital Universitario La Princesa
  • Hospital 12 de Octubre
  • Hospital Universitario Fundacion Alcorcon
  • Consorcio Hospital General Universitario de Valencia
  • Hud kliniken- Skanes Universitetssjukhus i Malmo
  • Hudkliniken
  • Hermelinen Forskning AB
  • Pharmacy: Sjukhusapoteket Lund
  • Hudkliniken
  • Karolinska University Hospital- Solna
  • Kantonsspital St. Gallen
  • Chung Shan Medical University Hospital
  • Chang Gung Medical Foundation Kaohsiung Branch
  • National Cheng Kung University Hospital
  • National Taiwan University Hospital
  • Taipei Medical University-Shuang Ho Hospital
  • Chang Gung Medical Foundation Linkou Branch
  • Dept of Dermatology and Venerology of SI "Crimean State Medical University n.a. S.I.Georgiyevskyy"
  • Municipal Institution of health Care
  • SI 'Institute for Dermatology and Venerology of AMS of Ukraine'
  • Kyiv Oleksandrivska Clin. Hosp., Dermatology department, NMU n.a. O.O. Bogomolets,
  • Dept of Dermatology and Venerology of Lugansk State Medical University,
  • Regional Municipal Dermatovenerologic Dispensary
  • Dept of Dermatology and Venerology of ONMU
  • Ternopil Regional Municipal Clinical Dermatovenerologic Dispensary
  • Salford Royal NHS Foundation Trust
  • Department of Dermatology
  • Whipps Cross University Hospital
  • eRT

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Active Treatment

Arm Description

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

Outcomes

Primary Outcome Measures

Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 4 weeks after last dose (up to 67 months) that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events.
Number of Adverse Events (AEs) by Severity
An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs were classified according to the severity in 3 categories: a) mild: AEs did not interfere with participant's usual function; b) moderate: AEs interfered to some extent with participant's usual function; c) severe: AEs interfered significantly with participant's usual function.
Number of Participants With Laboratory Abnormalities
Abnormality criteria: hematology (hemoglobin, hematocrit, red blood cell <0.8*lower limit of normal [LLN]; reticulocyte<0.5*LLN,>1.5*ULN; platelets<0.5*LLN,>1.75* upper limit of normal [ULN]; WBC<0.6*LLN, >1.5*ULN; lymphocytes, neutrophils, basophils, eosinophils, monocytes<0.8*LLN; >1.2*ULN; coagulation (prothrombin [PT], PT ratio>1.1*ULN) liver function (bilirubin>1.5*ULN, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, gamma GT>0.3*ULN, protein, albumin<0.8*LLN; >1.2*ULN, globulin<0.5*LLN; >1.5*ULN); renal function (blood urea nitrogen, creatinine>1.3*ULN); electrolytes(sodium<0.95* LLN; >1.05* ULN, potassium, chloride, calcium, bicarbonate<0.9*LLN; >1.1*ULN), chemistry (glucose<0.6*LLN; >1.5* ULN), urinalysis (pH <4.5;>8, glucose, ketones, protein, blood, urobilinogen, nitrite, bilirubin, leukocyte esterase>=1; RBC, WBC>=20); lipids (cholesterol [C], LDL-C >1.3*ULN, HDL-C<0.8*LLN, triglycerides>1.3* ULN), hormones(T4, T3, T4, TSH<0.8* LLN; >1.2* ULN).
Change From Baseline in Hemoglobin Level at Month 1
Change From Baseline in Hemoglobin Level at Month 3
Change From Baseline in Hemoglobin Level at Month 6
Change From Baseline in Hemoglobin Level at Month 12
Change From Baseline in Hemoglobin Level at Month 24
Change From Baseline in Hemoglobin Level at Month 36
Change From Baseline in Hemoglobin Level at Month 48
Change From Baseline in Lymphocyte and Neutrophil Count at Month 1
Change From Baseline in Lymphocyte and Neutrophil Count at Month 3
Change From Baseline in Lymphocyte and Neutrophil Count at Month 6
Change From Baseline in Lymphocyte and Neutrophil Count at Month 12
Change From Baseline in Lymphocyte and Neutrophil Count at Month 24
Change From Baseline in Lymphocyte and Neutrophil Count at Month 36
Change From Baseline in Lymphocyte and Neutrophil Count at 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
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
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
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
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
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
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
Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 1
Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 3
Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 6
Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 12
Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 24
Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 36
Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 48
Number of Participants With Clinically Significant Change From Baseline in Physical Examination
Physical examinations included: general appearance; skin, head, eyes, ears, nose and throat; heart; lungs; abdomen; lower extremities (for the presence of peripheral edema) and lymph nodes. Clinical significance of change from baseline values in physical examination was based on investigator's discretion.
Number of Participants With Vital Sign Abnormalities
Criteria for abnormalities in vital signs included: Systolic blood pressure (SBP): less than (<) 90 millimeter of mercury (mmHg) and maximum increase from baseline (IFB) of greater than or equal to (>=) 30 mmHg; diastolic blood pressure (DBP): <50 and greater than (>) 120 mmHg and maximum IFB of >=20 mmHg; heart rate: <40 and >120 beats per minute.
Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 1
Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 3
Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 6
Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 12
Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 24
Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 36
Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 48
Change From Baseline in Heart Rate at Month 1
Change From Baseline in Heart Rate at Month 3
Change From Baseline in Heart Rate at Month 6
Change From Baseline in Heart Rate at Month 12
Change From Baseline in Heart Rate at Month 24
Change From Baseline in Heart Rate at Month 36
Change From Baseline in Heart Rate at Month 48
Number of Participants With Electrocardiogram (ECG) Abnormalities
Criteria for ECG abnormality: PR interval >=300 milliseconds (msec); QT interval >=500 msec; QTcB (Bazett's Correction) and QTcF (Fridericia's Correction) 450 to <480 msec, 480 to <500 msec and >=500 msec.
Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 6
Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 12
Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 24
Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 36
Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 48
Number of Participants With Adjudicated Cardiovascular Events
Adjudicated cardiovascular events were assessed by adjudication committee as independent reviewers based on event documentation including: hospital discharge summaries, operative reports, clinic notes, ECGs, diagnostic enzymes, results of other diagnostic tests, autopsy reports and death certificate information; as applicable.
Number of Participants With Malignancy Events
Malignancy events included lymphoma, and demyelinating neurologic events. Biopsies collected for malignancy events were submitted to the central laboratory for pathologist over-read.

Secondary Outcome Measures

Percentage of Participants Achieving Physician Global Assessment (PGA) Response of 'Clear' or 'Almost Clear'
The PGA of psoriasis was scored on a 5-point scale, reflecting a global consideration of the erythema (E), induration (I), and scaling (S) across all psoriatic lesions in participants. The severity rating scores (Erythema: 0= no evidence of erythema to 4= dark, deep red; Induration: 0= no evidence of plaque elevation to 4= marked plaque elevation, hard/sharp borders; Scaling: 0= no evidence of scaling to 4= thick, coarse scale predominates) were summed (E + I + S = total) and the average (total/3) was taken. The total average was rounded to the nearest whole number score to determine the PGA. The 5-point scale for PGA was: 0= clear; 1= almost clear; 2= mild; 3= moderate; 4= severe, where higher score indicated more severity of psoriasis. Percentage of participants with response of 'clear' (score of '0') and 'almost clear' (score of '1') were reported.
Percentage of Participants Achieving Greater Than or Equal to (>=) 75 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores
PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Each component of severity, that is, erythema, induration and scaling was assessed separately for four body areas (head and neck [h], upper limbs [u], trunk [t] and lower limbs [l]) on a 5-point scale ranging from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity. Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head and neck: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4. Percentage of participants with >=75 percent (%) reduction from baseline in PASI scores were reported.
Psoriasis Area and Severity Index (PASI) Scores
PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Each component of severity, that is, erythema, induration and scaling was assessed separately for four body areas (head and neck [h], upper limbs [u], trunk [t] and lower limbs [l]) on a 5-point scale ranging from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity. Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head and neck: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4.
Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores at Month 1, 3, 6, 12, 24, 36 and 48
PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Each component of severity, that is, erythema, induration and scaling was assessed separately for four body areas (head and neck [h], upper limbs [u], trunk [t] and lower limbs [l]) on a 5-point scale ranging from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity. Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head and neck: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4.
Psoriasis Area and Severity Index (PASI) Component Scores: Erythema
PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Erythema was assessed separately for four body areas (head and neck, upper limbs, trunk and lower limbs) on a 5-point scale ranges from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity.
Psoriasis Area and Severity Index (PASI) Component Scores: Induration
PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Induration was assessed separately for four body areas (head and neck, upper limbs, trunk and lower limbs) on a 5-point scale ranges from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity.
Psoriasis Area and Severity Index (PASI) Component Scores: Scaling
PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Scaling was assessed separately for four body areas (head and neck, upper limbs, trunk and lower limbs) on a 5-point scale ranges from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity.
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Erythema at Month 1, 3, 6, 12, 24, 36 and 48
PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Erythema was assessed separately for four body areas (head and neck, upper limbs, trunk and lower limbs) on a 5-point scale ranges from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity.
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Induration at Month 1, 3, 6, 12, 24, 36 and 48
PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Induration was assessed separately for four body areas (head and neck, upper limbs, trunk and lower limbs) on a 5-point scale ranges from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity.
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Scaling at Month 1, 3, 6, 12, 24, 36 and 48
PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Scaling was assessed separately for four body areas (head and neck, upper limbs, trunk and lower limbs) on a 5-point scale ranges from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity.
Percentage of Participants Achieving Greater Than or Equal to (>=) 50 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores
PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Each component of severity, that is, erythema, induration and scaling was assessed separately for four body areas (head and neck [h], upper limbs [u], trunk [t] and lower limbs [l]) on a 5-point scale ranging from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity. Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head and neck: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4. Percentage of participants with >=50% reduction from baseline in PASI scores were reported.
Percentage of Participants Achieving Greater Than or Equal to (>=) 90 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores
PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Each component of severity, that is, erythema, induration and scaling was assessed separately for four body areas (head and neck [h], upper limbs [u], trunk [t] and lower limbs [l]) on a 5-point scale ranging from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity. Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head and neck: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4. Percentage of participants with >=90% reduction from baseline in PASI scores were reported.
Percentage of Participants Achieving Greater Than or Equal to (>=) 125 Percent Increase From Baseline in Psoriasis Area and Severity Index (PASI) Scores
PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Each component of severity, that is, erythema, induration and scaling was assessed separately for four body areas (head and neck [h], upper limbs [u], trunk [t] and lower limbs [l]) on a 5-point scale ranging from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity. Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head and neck: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4. Percentage of participants with >=125% increase from baseline in PASI scores were reported.
Itch Severity Item (ISI) Scores
ISI assessed severity of itching due to psoriasis. ISI was a single item, horizontal numeric rating scale. Participants were asked to rate their 'severity of itching' due to psoriasis over the past 24 hours on a numeric rating scale anchored by the terms '0=no itching' and '10=worst possible itching' at the ends. Higher scores indicated greater severity of itching.
Change From Baseline in Itch Severity Item (ISI) Scores at Month 1, 3, 6, 12, 24, 36 and 48
ISI assessed severity of itching due to psoriasis. ISI was a single item, horizontal numeric rating scale. Participants were asked to rate their 'severity of itching' due to psoriasis over the past 24 hours on a numeric rating scale anchored by the terms '0=no itching' and '10=worst possible itching' at the ends. Higher scores indicated greater severity of itching.
Dermatology Life Quality Index (DLQI) Scores
The DLQI was a validated, self-administered, 10-item quality-of-life questionnaire that consisted of 10 items that assessed the impact of skin disease on quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). Each question was scored on a scale of 0=not at all/not relevant to 3=very much. Response from all of the 10 questions were added to derive the DLQI total scores. Total DLQI scores ranges from 0=not at all to 30=very much, with higher scores indicating greater impairment in quality of life.
Change From Baseline in Dermatology Life Quality Index (DLQI) Scores at Month 1, 6, 12, 24, 36 and 48
The DLQI was a validated, self-administered, 10-item quality-of-life questionnaire that consisted of 10 items that assessed the impact of skin disease on quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). Each question was scored on a scale of 0=not at all/not relevant to 3=very much. Response from all of the 10 questions were added to derive the DLQI total scores. Total DLQI scores ranges from 0=not at all to 30=very much, with higher scores indicating greater impairment in quality of life.
36-Item Short-Form (SF-36) Health Survey Version 2, Acute: Physical Component Summary Scores
The SF-36 questionnaire, version 2, acute was a 36-item generic health status measure. SF-36 evaluated 8 health-related aspects of an individual: physical functioning, role-physical, bodily pain, social functioning, mental health, role emotional, vitality, and general health. The score range for each of the 8 health aspects ranged from 0 (worst) to 100 (best), with higher scores indicating good health condition. Two summary scale scores were computed from the 8 health aspect scores: physical component summary score and mental component summary score. Score range for both summary scales ranged from 0 (worst) to 100 (best), with higher scores indicating good health condition.
36-Item Short-Form (SF-36) Health Survey Version 2, Acute: Mental Component Summary Scores
The SF-36 questionnaire, version 2 was a 36-item generic health status measure. SF-36 evaluated 8 health-related aspects of an individual: physical functioning, role-physical, bodily pain, social functioning, mental health, role emotional, vitality, and general health. The score range for each of the 8 health aspects ranged from 0 (worst) to 100 (best), with higher scores indicating good health condition. Two summary scale scores were computed from the 8 health aspect scores: the Physical Component Summary and the Mental Component Summary. Score range for both summary scale ranged from 0 (worst) to 100 (best), with higher scores indicating good health condition.
Number of Participants With Patient Global Assessment (PtGA) Response of "Clear" or "Almost Clear"
The PtGA evaluated the overall skin disease of participants at that point in time on a single-item. Participants provided their response on a 5-point scale ranges from: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe. Higher score indicated greater severity of disease. Participants who provided their response as "clear (score of 0)" or "almost clear (score of 1)" in PtGA at each specified visit were reported in this outcome measure.
Euro Quality of Life- 5-Dimensions (EQ-5D)-Utility Scores
EQ-5D: participant rated 5-dimension (mobility, self-care, usual activities, pain and discomfort, and anxiety and depression) questionnaire to assess health-related quality of life in terms of a single utility score. Each dimension was assessed on a 3-point scale (1=no problems, 2=some problems, 3=extreme problems, where higher scores=worse health condition). The responses from the 5 dimensions were used to calculate a single utility index value. Scoring formula developed by EuroQol Group assigned a utility value for each dimension in the profile. Score was transformed and results in a total score range -0.594 to 1.000; higher score indicated a better health state.
Euro Quality of Life-5-Dimensions (EQ-5D)-Visual Analogue Scale Scores (VAS)
EQ-5D VAS was a participant rated questionnaire to assess health-related quality of life in terms of a single index value. It was a visual analogue scale that ranged from 0 (minimum) to 100 (maximum), with higher scores indicating a better health condition.
Number of Participants Who Answered Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU)
Ps-HCRU was a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work. In the first section, it assessed direct costs associated with healthcare resource use which included participant's interactions with healthcare providers such as general practitioners, dermatologists, cardiologists, gastroenterologists, psychiatrists, surgeons and nurses. When taking the evening dose of tofacitinib, participants were asked to answer the Ps-HCRU questionnaire only if they had an interaction with a healthcare provider or their work was impacted by psoriasis on that specified day. In this outcome measure, number of participants who answered Ps-HCRU at any specified visits were reported.

Full Information

First Posted
July 14, 2010
Last Updated
May 30, 2017
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT01163253
Brief Title
A Long Term Study To Evaluate The Safety And Tolerability Of CP-690,550 For Patients With Moderate To Severe Chronic Plaque Psoriasis
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Terminated
Study Start Date
September 2010 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
Keywords
chronic, severe, treatment, safety, CP-690,55, Plaque Psoriasis, Psoriasis Vulgaris, Xeljanz, Tofacitinib

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2867 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active Treatment
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
CP-690,550
Intervention Description
5 mg oral BID
Intervention Type
Drug
Intervention Name(s)
CP-690,550
Intervention Description
10 mg oral BID
Primary Outcome Measure Information:
Title
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description
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.
Time Frame
Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)
Title
Number of Adverse Events (AEs) by Severity
Description
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.
Time Frame
Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)
Title
Number of Participants With Laboratory Abnormalities
Description
Abnormality criteria: hematology (hemoglobin, hematocrit, red blood cell <0.8*lower limit of normal [LLN]; reticulocyte<0.5*LLN,>1.5*ULN; platelets<0.5*LLN,>1.75* upper limit of normal [ULN]; WBC<0.6*LLN, >1.5*ULN; lymphocytes, neutrophils, basophils, eosinophils, monocytes<0.8*LLN; >1.2*ULN; coagulation (prothrombin [PT], PT ratio>1.1*ULN) liver function (bilirubin>1.5*ULN, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, gamma GT>0.3*ULN, protein, albumin<0.8*LLN; >1.2*ULN, globulin<0.5*LLN; >1.5*ULN); renal function (blood urea nitrogen, creatinine>1.3*ULN); electrolytes(sodium<0.95* LLN; >1.05* ULN, potassium, chloride, calcium, bicarbonate<0.9*LLN; >1.1*ULN), chemistry (glucose<0.6*LLN; >1.5* ULN), urinalysis (pH <4.5;>8, glucose, ketones, protein, blood, urobilinogen, nitrite, bilirubin, leukocyte esterase>=1; RBC, WBC>=20); lipids (cholesterol [C], LDL-C >1.3*ULN, HDL-C<0.8*LLN, triglycerides>1.3* ULN), hormones(T4, T3, T4, TSH<0.8* LLN; >1.2* ULN).
Time Frame
Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)
Title
Change From Baseline in Hemoglobin Level at Month 1
Time Frame
Baseline, Month 1
Title
Change From Baseline in Hemoglobin Level at Month 3
Time Frame
Baseline, Month 3
Title
Change From Baseline in Hemoglobin Level at Month 6
Time Frame
Baseline, Month 6
Title
Change From Baseline in Hemoglobin Level at Month 12
Time Frame
Baseline, Month 12
Title
Change From Baseline in Hemoglobin Level at Month 24
Time Frame
Baseline, Month 24
Title
Change From Baseline in Hemoglobin Level at Month 36
Time Frame
Baseline, Month 36
Title
Change From Baseline in Hemoglobin Level at Month 48
Time Frame
Baseline, Month 48
Title
Change From Baseline in Lymphocyte and Neutrophil Count at Month 1
Time Frame
Baseline, Month 1
Title
Change From Baseline in Lymphocyte and Neutrophil Count at Month 3
Time Frame
Baseline, Month 3
Title
Change From Baseline in Lymphocyte and Neutrophil Count at Month 6
Time Frame
Baseline, Month 6
Title
Change From Baseline in Lymphocyte and Neutrophil Count at Month 12
Time Frame
Baseline, Month 12
Title
Change From Baseline in Lymphocyte and Neutrophil Count at Month 24
Time Frame
Baseline, Month 24
Title
Change From Baseline in Lymphocyte and Neutrophil Count at Month 36
Time Frame
Baseline, Month 36
Title
Change From Baseline in Lymphocyte and Neutrophil Count at Month 48
Time Frame
Baseline, Month 48
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 1
Time Frame
Baseline, Month 1
Title
Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 3
Time Frame
Baseline, Month 3
Title
Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 6
Time Frame
Baseline, Month 6
Title
Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 12
Time Frame
Baseline, Month 12
Title
Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 24
Time Frame
Baseline, Month 24
Title
Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 36
Time Frame
Baseline, Month 36
Title
Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 48
Time Frame
Baseline, Month 48
Title
Number of Participants With Clinically Significant Change From Baseline in Physical Examination
Description
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.
Time Frame
Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)
Title
Number of Participants With Vital Sign Abnormalities
Description
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.
Time Frame
Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)
Title
Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 1
Time Frame
Baseline, Month 1
Title
Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 3
Time Frame
Baseline, Month 3
Title
Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 6
Time Frame
Baseline, Month 6
Title
Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 12
Time Frame
Baseline, Month 12
Title
Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 24
Time Frame
Baseline, Month 24
Title
Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 36
Time Frame
Baseline, Month 36
Title
Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 48
Time Frame
Baseline, Month 48
Title
Change From Baseline in Heart Rate at Month 1
Time Frame
Baseline, Month 1
Title
Change From Baseline in Heart Rate at Month 3
Time Frame
Baseline, Month 3
Title
Change From Baseline in Heart Rate at Month 6
Time Frame
Baseline, Month 6
Title
Change From Baseline in Heart Rate at Month 12
Time Frame
Baseline, Month 12
Title
Change From Baseline in Heart Rate at Month 24
Time Frame
Baseline, Month 24
Title
Change From Baseline in Heart Rate at Month 36
Time Frame
Baseline, Month 36
Title
Change From Baseline in Heart Rate at Month 48
Time Frame
Baseline, Month 48
Title
Number of Participants With Electrocardiogram (ECG) Abnormalities
Description
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.
Time Frame
Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)
Title
Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 6
Time Frame
Baseline, Month 6
Title
Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 12
Time Frame
Baseline, Month 12
Title
Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 24
Time Frame
Baseline, Month 24
Title
Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 36
Time Frame
Baseline, Month 36
Title
Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 48
Time Frame
Baseline, Month 48
Title
Number of Participants With Adjudicated Cardiovascular Events
Description
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.
Time Frame
Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)
Title
Number of Participants With Malignancy Events
Description
Malignancy events included lymphoma, and demyelinating neurologic events. Biopsies collected for malignancy events were submitted to the central laboratory for pathologist over-read.
Time Frame
Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)
Secondary Outcome Measure Information:
Title
Percentage of Participants Achieving Physician Global Assessment (PGA) Response of 'Clear' or 'Almost Clear'
Description
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.
Time Frame
Month 1, 3, 6, 12, 24, 36, 48
Title
Percentage of Participants Achieving Greater Than or Equal to (>=) 75 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores
Description
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.
Time Frame
Baseline, Month 1, 3, 6, 12, 24, 36, 48
Title
Psoriasis Area and Severity Index (PASI) Scores
Description
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.
Time Frame
Baseline, Month 1, 3, 6, 12, 24, 36, 48
Title
Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores at Month 1, 3, 6, 12, 24, 36 and 48
Description
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.
Time Frame
Baseline, Month 1, 3, 6, 12, 24, 36, 48
Title
Psoriasis Area and Severity Index (PASI) Component Scores: Erythema
Description
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.
Time Frame
Baseline, Month 1, 3, 6, 12, 24, 36, 48
Title
Psoriasis Area and Severity Index (PASI) Component Scores: Induration
Description
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.
Time Frame
Baseline, Month 1, 3, 6, 12, 24, 36, 48
Title
Psoriasis Area and Severity Index (PASI) Component Scores: Scaling
Description
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.
Time Frame
Baseline, Month 1, 3, 6, 12, 24, 36, 48
Title
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Erythema at Month 1, 3, 6, 12, 24, 36 and 48
Description
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.
Time Frame
Baseline, Month 1, 3, 6, 12, 24, 36, 48
Title
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Induration at Month 1, 3, 6, 12, 24, 36 and 48
Description
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.
Time Frame
Baseline, Month 1, 3, 6, 12, 24, 36, 48
Title
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Scaling at Month 1, 3, 6, 12, 24, 36 and 48
Description
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.
Time Frame
Baseline, Month 1, 3, 6, 12, 24, 36, 48
Title
Percentage of Participants Achieving Greater Than or Equal to (>=) 50 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores
Description
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.
Time Frame
Baseline, Month 1, 3, 6, 12, 24, 36, 48
Title
Percentage of Participants Achieving Greater Than or Equal to (>=) 90 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores
Description
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.
Time Frame
Baseline, Month 1, 3, 6, 12, 24, 36, 48
Title
Percentage of Participants Achieving Greater Than or Equal to (>=) 125 Percent Increase From Baseline in Psoriasis Area and Severity Index (PASI) Scores
Description
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.
Time Frame
Baseline, Month 1, 3, 6, 12, 24, 36, 48
Title
Itch Severity Item (ISI) Scores
Description
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.
Time Frame
Baseline, Month 1, 3, 6, 12, 24, 36, 48
Title
Change From Baseline in Itch Severity Item (ISI) Scores at Month 1, 3, 6, 12, 24, 36 and 48
Description
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.
Time Frame
Baseline, Month 1, 3, 6, 12, 24, 36, 48
Title
Dermatology Life Quality Index (DLQI) Scores
Description
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.
Time Frame
Baseline, Month 1, 6, 12, 24, 36, 48
Title
Change From Baseline in Dermatology Life Quality Index (DLQI) Scores at Month 1, 6, 12, 24, 36 and 48
Description
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.
Time Frame
Baseline, Month 1, 6, 12, 24, 36, 48
Title
36-Item Short-Form (SF-36) Health Survey Version 2, Acute: Physical Component Summary Scores
Description
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.
Time Frame
Baseline, Month 6, 12, 24, 36, 48
Title
36-Item Short-Form (SF-36) Health Survey Version 2, Acute: Mental Component Summary Scores
Description
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.
Time Frame
Baseline, Month 6, 12, 24, 36, 48
Title
Number of Participants With Patient Global Assessment (PtGA) Response of "Clear" or "Almost Clear"
Description
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.
Time Frame
Baseline, Month 1, 3, 6, 12, 24, 36, 48
Title
Euro Quality of Life- 5-Dimensions (EQ-5D)-Utility Scores
Description
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.
Time Frame
Baseline, Month 6, 12, 24, 36, 48
Title
Euro Quality of Life-5-Dimensions (EQ-5D)-Visual Analogue Scale Scores (VAS)
Description
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.
Time Frame
Baseline, Month 6, 12, 24, 36, 48
Title
Number of Participants Who Answered Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU)
Description
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.
Time Frame
Baseline, Month 1, 3, 6, 12, 24, 36, 48

10. Eligibility

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

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
Citations:
PubMed Identifier
32816215
Citation
Panaccione R, Isaacs JD, Chen LA, Wang W, Marren A, Kwok K, Wang L, Chan G, Su C. Characterization of Creatine Kinase Levels in Tofacitinib-Treated Patients with Ulcerative Colitis: Results from Clinical Trials. Dig Dis Sci. 2021 Aug;66(8):2732-2743. doi: 10.1007/s10620-020-06560-4. Epub 2020 Aug 20. Erratum In: Dig Dis Sci. 2020 Oct 10;:
Results Reference
derived
PubMed Identifier
29782642
Citation
Valenzuela F, Korman NJ, Bissonnette R, Bakos N, Tsai TF, Harper MK, Ports WC, Tan H, Tallman A, Valdez H, Gardner AC. Tofacitinib in patients with moderate-to-severe chronic plaque psoriasis: long-term safety and efficacy in an open-label extension study. Br J Dermatol. 2018 Oct;179(4):853-862. doi: 10.1111/bjd.16798. Epub 2018 Aug 13.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3921061&StudyName=A%20Long%20Term%20Study%20To%20Evaluate%20The%20Safety%20And%20Tolerability%20Of%20CP-690%2C550%20For%20Patients%20With%20Moderate%20To%20Severe%20Chronic%20Plaque%20Psoriasi
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

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

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