Clinical trial NCT01163253: 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
Overall status: TERMINATED
Phase: PHASE3
Conditions: Psoriasis
Keywords: chronic
severe
treatment
safety
CP-690,55
Plaque Psoriasis
Psoriasis Vulgaris
Xeljanz
Tofacitinib
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-07-15
Enrollment: 2867
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)
measure: Number of Adverse Events (AEs) by Severity
timeFrame: Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)
measure: Number of Participants With Laboratory Abnormalities
timeFrame: Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)
measure: Change From Baseline in Hemoglobin Level at Month 1
timeFrame: Baseline, Month 1
measure: Change From Baseline in Hemoglobin Level at Month 3
timeFrame: Baseline, Month 3
measure: Change From Baseline in Hemoglobin Level at Month 6
timeFrame: Baseline, Month 6
measure: Change From Baseline in Hemoglobin Level at Month 12
timeFrame: Baseline, Month 12
measure: Change From Baseline in Hemoglobin Level at Month 24
timeFrame: Baseline, Month 24
measure: Change From Baseline in Hemoglobin Level at Month 36
timeFrame: Baseline, Month 36
measure: Change From Baseline in Hemoglobin Level at Month 48
timeFrame: Baseline, Month 48
measure: Change From Baseline in Lymphocyte and Neutrophil Count at Month 1
timeFrame: Baseline, Month 1
measure: Change From Baseline in Lymphocyte and Neutrophil Count at Month 3
timeFrame: Baseline, Month 3
measure: Change From Baseline in Lymphocyte and Neutrophil Count at Month 6
timeFrame: Baseline, Month 6
measure: Change From Baseline in Lymphocyte and Neutrophil Count at Month 12
timeFrame: Baseline, Month 12
measure: Change From Baseline in Lymphocyte and Neutrophil Count at Month 24
timeFrame: Baseline, Month 24
measure: Change From Baseline in Lymphocyte and Neutrophil Count at Month 36
timeFrame: Baseline, Month 36
measure: Change From Baseline in Lymphocyte and Neutrophil Count at Month 48
timeFrame: Baseline, Month 48
measure: 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
timeFrame: Baseline, Month 1
measure: 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
timeFrame: Baseline, Month 3
measure: 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
timeFrame: Baseline, Month 6
measure: 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
timeFrame: Baseline, Month 12
measure: 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
timeFrame: Baseline, Month 24
measure: 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
timeFrame: Baseline, Month 36
measure: 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
timeFrame: Baseline, Month 48
measure: Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 1
timeFrame: Baseline, Month 1
measure: Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 3
timeFrame: Baseline, Month 3
measure: Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 6
timeFrame: Baseline, Month 6
measure: Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 12
timeFrame: Baseline, Month 12
measure: Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 24
timeFrame: Baseline, Month 24
measure: Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 36
timeFrame: Baseline, Month 36
measure: Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 48
timeFrame: Baseline, Month 48
measure: Number of Participants With Clinically Significant Change From Baseline in Physical Examination
timeFrame: Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)
measure: Number of Participants With Vital Sign Abnormalities
timeFrame: Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)
measure: Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 1
timeFrame: Baseline, Month 1
measure: Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 3
timeFrame: Baseline, Month 3
measure: Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 6
timeFrame: Baseline, Month 6
measure: Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 12
timeFrame: Baseline, Month 12
measure: Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 24
timeFrame: Baseline, Month 24
measure: Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 36
timeFrame: Baseline, Month 36
measure: Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 48
timeFrame: Baseline, Month 48
measure: Change From Baseline in Heart Rate at Month 1
timeFrame: Baseline, Month 1
measure: Change From Baseline in Heart Rate at Month 3
timeFrame: Baseline, Month 3
measure: Change From Baseline in Heart Rate at Month 6
timeFrame: Baseline, Month 6
measure: Change From Baseline in Heart Rate at Month 12
timeFrame: Baseline, Month 12
measure: Change From Baseline in Heart Rate at Month 24
timeFrame: Baseline, Month 24
measure: Change From Baseline in Heart Rate at Month 36
timeFrame: Baseline, Month 36
measure: Change From Baseline in Heart Rate at Month 48
timeFrame: Baseline, Month 48
measure: Number of Participants With Electrocardiogram (ECG) Abnormalities
timeFrame: Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)
measure: Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 6
timeFrame: Baseline, Month 6
measure: Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 12
timeFrame: Baseline, Month 12
measure: Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 24
timeFrame: Baseline, Month 24
measure: Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 36
timeFrame: Baseline, Month 36
measure: Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 48
timeFrame: Baseline, Month 48
measure: Number of Participants With Adjudicated Cardiovascular Events
timeFrame: Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)
measure: Number of Participants With Malignancy Events
timeFrame: Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)
Secondary outcomes:
measure: Percentage of Participants Achieving Physician Global Assessment (PGA) Response of 'Clear' or 'Almost Clear'
timeFrame: Month 1, 3, 6, 12, 24, 36, 48
measure: Percentage of Participants Achieving Greater Than or Equal to (>=) 75 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores
timeFrame: Baseline, Month 1, 3, 6, 12, 24, 36, 48
measure: Psoriasis Area and Severity Index (PASI) Scores
timeFrame: Baseline, Month 1, 3, 6, 12, 24, 36, 48
measure: Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores at Month 1, 3, 6, 12, 24, 36 and 48
timeFrame: Baseline, Month 1, 3, 6, 12, 24, 36, 48
measure: Psoriasis Area and Severity Index (PASI) Component Scores: Erythema
timeFrame: Baseline, Month 1, 3, 6, 12, 24, 36, 48
measure: Psoriasis Area and Severity Index (PASI) Component Scores: Induration
timeFrame: Baseline, Month 1, 3, 6, 12, 24, 36, 48
measure: Psoriasis Area and Severity Index (PASI) Component Scores: Scaling
timeFrame: Baseline, Month 1, 3, 6, 12, 24, 36, 48
measure: Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Erythema at Month 1, 3, 6, 12, 24, 36 and 48
timeFrame: Baseline, Month 1, 3, 6, 12, 24, 36, 48
measure: Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Induration at Month 1, 3, 6, 12, 24, 36 and 48
timeFrame: Baseline, Month 1, 3, 6, 12, 24, 36, 48
measure: Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Scaling at Month 1, 3, 6, 12, 24, 36 and 48
timeFrame: Baseline, Month 1, 3, 6, 12, 24, 36, 48
measure: Percentage of Participants Achieving Greater Than or Equal to (>=) 50 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores
timeFrame: Baseline, Month 1, 3, 6, 12, 24, 36, 48
measure: Percentage of Participants Achieving Greater Than or Equal to (>=) 90 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores
timeFrame: Baseline, Month 1, 3, 6, 12, 24, 36, 48
measure: Percentage of Participants Achieving Greater Than or Equal to (>=) 125 Percent Increase From Baseline in Psoriasis Area and Severity Index (PASI) Scores
timeFrame: Baseline, Month 1, 3, 6, 12, 24, 36, 48
measure: Itch Severity Item (ISI) Scores
timeFrame: Baseline, Month 1, 3, 6, 12, 24, 36, 48
measure: Change From Baseline in Itch Severity Item (ISI) Scores at Month 1, 3, 6, 12, 24, 36 and 48
timeFrame: Baseline, Month 1, 3, 6, 12, 24, 36, 48
measure: Dermatology Life Quality Index (DLQI) Scores
timeFrame: Baseline, Month 1, 6, 12, 24, 36, 48
measure: Change From Baseline in Dermatology Life Quality Index (DLQI) Scores at Month 1, 6, 12, 24, 36 and 48
timeFrame: Baseline, Month 1, 6, 12, 24, 36, 48
measure: 36-Item Short-Form (SF-36) Health Survey Version 2, Acute: Physical Component Summary Scores
timeFrame: Baseline, Month 6, 12, 24, 36, 48
measure: 36-Item Short-Form (SF-36) Health Survey Version 2, Acute: Mental Component Summary Scores
timeFrame: Baseline, Month 6, 12, 24, 36, 48
measure: Number of Participants With Patient Global Assessment (PtGA) Response of "Clear" or "Almost Clear"
timeFrame: Baseline, Month 1, 3, 6, 12, 24, 36, 48
measure: Euro Quality of Life- 5-Dimensions (EQ-5D)-Utility Scores
timeFrame: Baseline, Month 6, 12, 24, 36, 48
measure: Euro Quality of Life-5-Dimensions (EQ-5D)-Visual Analogue Scale Scores (VAS)
timeFrame: Baseline, Month 6, 12, 24, 36, 48
measure: Number of Participants Who Answered Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU)
timeFrame: Baseline, Month 1, 3, 6, 12, 24, 36, 48
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Radiant Research, Inc.
state: Alabama
city: Birmingham
country: United States
facility: UAB Dermatology
state: Alabama
city: Mobile
country: United States
facility: Horizon Research Group, Inc.
state: Alabama
city: Tucson
country: United States
facility: Radiant Research, Inc.
state: Arizona
city: Hot Springs
country: United States
facility: Burke Pharmaceutical Research
state: Arkansas
city: Bakersfield
country: United States
facility: Bakersfield Dermatology and Skin Cancer Medical Group
state: California
city: Fresno
country: United States
facility: Associates In Research, Inc.
state: California
city: Irvine
country: United States
facility: University of California Irvine
state: California
city: Los Angeles
country: United States
facility: Dermatology Research Associates
state: California
city: Oceanside
country: United States
facility: Dermatology Specialists, Inc.
state: California
city: San Diego
country: United States
facility: MedDerm Associates
state: California
city: San Diego
country: United States
facility: UCSD Dermatology
state: California
city: San Diego
country: United States
facility: University of California San Diego
state: California
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: Santa Monica
country: United States
facility: Clinical Science Institute
state: California
city: Torrance
country: United States
facility: Healthcare Partners Medical Group
state: California
city: Denver
country: United States
facility: Cherry Creek Research, Inc.
state: Colorado
city: New Haven
country: United States
facility: The Savin Center, P.C.
state: Connecticut
city: Trumbull
country: United States
facility: New England Research Associates, LLC
state: Connecticut
city: Coral Gables
country: United States
facility: Florida Academic Dermatology Center
state: Florida
city: Jacksonville
country: United States
facility: North Florida Dermatology Associates, PA
state: Florida
city: Miami
country: United States
facility: International Dermatology Research, Inc.
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Orange Park
country: United States
facility: Park Avenue Dermatology, PA
state: Florida
city: Ormond Beach
country: United States
facility: Leavitt Medical Associates of Florida dba Ameriderm Research
state: Florida
city: South Miami
country: United States
facility: Miami Research Associates, Inc.
state: Florida
city: Tampa
country: United States
facility: Olympian Clinical Research
state: Florida
city: Alpharetta
country: United States
facility: Atlanta Dermatology, Vein & Research Center, P.C.
state: Georgia
city: Atlanta
country: United States
facility: Advanced Medical Research, Inc.
state: Georgia
city: Newnan
country: United States
facility: MedaPhase Inc.
state: Georgia
city: Arlington Heights
country: United States
facility: Altman Dermatology Associates
state: Illinois
city: Schaumburg
country: United States
facility: Schaumburg Dermatology
state: Illinois
city: Skokie
country: United States
facility: NorthShore University Health System - Division of Dermatology
state: Illinois
city: Springfield
country: United States
facility: Springfield Clinic
state: Illinois
city: West Dundee
country: United States
facility: Dundee Dermatology
state: Illinois
city: Evansville
country: United States
facility: Deaconess Clinic Downtown Research Institute
state: Indiana
city: Evansville
country: United States
facility: Hudson Dermatology
state: Indiana
city: Indianapolis
country: United States
facility: Dawes Fretzin Clinical Research Group, LLC
state: Indiana
city: Louisville
country: United States
facility: DermResearch, PLLC
state: Kentucky
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts General Hospital - Clinical Unit for Research Trials and Outcomes in Skin
state: Massachusetts
city: Clinton
country: United States
facility: Michigan Center for Research Corporation dba Michigan Center for Skin Care Research
state: Michigan
city: Fort Gratiot
country: United States
facility: Hamzavi Dermatology
state: Michigan
city: Troy
country: United States
facility: Somerset Skin Centre - Dermcenter
state: Michigan
city: Fridley
country: United States
facility: Minnesota Clinical Study Center
state: Minnesota
city: Saint Louis
country: United States
facility: Saint Louis University - Department of Dermatology
state: Missouri
city: Omaha
country: United States
facility: Skin Specialists, P.C
state: Nebraska
city: Henderson
country: United States
facility: Bettencourt Skin Center
state: Nevada
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center-Norris Cotton Cancer Center
state: New Hampshire
city: Berlin
country: United States
facility: Centennial Center-Comprehensive Clinical Research
state: New Jersey
city: New York
country: United States
facility: New York University (NYU) School of Medicine - Investigational Pharmacy (IP Shipment, Pharmacy)
state: New York
city: New York
country: United States
facility: NYU Langone Medical Center, Ambulatory Care Center, Department of Dermatology, Clinical Studies Unit
state: New York
city: New York
country: United States
facility: The Rockefeller University
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill- Hospital
state: North Carolina
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: High Point
country: United States
facility: Dermatology Consulting Services
state: North Carolina
city: Raleigh
country: United States
facility: Wake Dermatology Associates, LLC
state: North Carolina
city: Raleigh
country: United States
facility: Wake Research Associates
state: North Carolina
city: Wilmington
country: United States
facility: Dermatology Associates
state: North Carolina
city: Wilmington
country: United States
facility: PMG Research of Wilmington, LLC
state: North Carolina
city: Winston-Salem
country: United States
facility: Piedmont Imaging
state: North Carolina
city: Winston-Salem
country: United States
facility: PMG Research of Winston-Salem
state: North Carolina
city: Winston-Salem
country: United States
facility: Triad Dermatology, PA
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
city: Cincinnati
country: United States
facility: Jewish Hospital
state: Ohio
city: Cincinnati
country: United States
facility: Radiant Research, Inc.
state: Ohio
city: Cleveland
country: United States
facility: IP ONLY: University Hospitals Case Medical Center
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Case Medical Center/Dept. of Dermatology
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Case Medical Center
state: Ohio
city: Norman
country: United States
facility: Central Sooner Research
state: Oklahoma
city: Lake Oswego
country: United States
facility: Baker Allergy Asthma and Dermatology Research Center, LLC
state: Oregon
city: Portland
country: United States
facility: Oregon Dermatology and Research Center
state: Oregon
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center - Department of Dermatology
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Johnston
country: United States
facility: Clinical Partners, LLC
state: Rhode Island
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Greer
country: United States
facility: Office of John Michael Humeniuk, MD
state: South Carolina
city: Greer
country: United States
facility: Radiant Research, Inc.
state: South Carolina
city: Rapid City
country: United States
facility: Health Concepts
state: South Dakota
city: Goodlettsville
country: United States
facility: Rivergate Dermatology Clinical Research Center, PLLC
state: Tennessee
city: Knoxville
country: United States
facility: Dermatology Associates of Knoxville PC
state: Tennessee
city: Nashville
country: United States
facility: Dermatology Research Associates
state: Tennessee
city: Arlington
country: United States
facility: Arlington Research Center, Inc.
state: Texas
city: Dallas
country: United States
facility: Dermatology Treatment & Research Center
state: Texas
city: Dallas
country: United States
facility: Modern Research Associates, PLLC
state: Texas
city: Dallas
country: United States
facility: Menter Dermatology Research Institute
state: Texas
city: Houston
country: United States
facility: Center for Clinical Studies
state: Texas
city: Houston
country: United States
facility: Suzanne Bruce and Associates, PA
state: Texas
city: San Antonio
country: United States
facility: Office of Mark Lee, MD
state: Texas
city: San Antonio
country: United States
facility: Progressive Clinical research, P.A.
state: Texas
city: San Antonio
country: United States
facility: Stephen Miller, MD, PA
state: Texas
city: Webster
country: United States
facility: Center for Clinical Studies
state: Texas
city: Norfolk
country: United States
facility: Virginia Clinical Research, Inc.
state: Virginia
city: Norfolk
country: United States
facility: Virginia Clinical Research, Inc.
state: Virginia
city: Spokane
country: United States
facility: Rockwood Research Center
state: Washington
city: Wenatchee
country: United States
facility: Wenatchee Valley Hospital & Clinics
state: Washington
city: Bridgeport
country: United States
facility: Mountain State Clinical Research
state: West Virginia
city: Madison
country: United States
facility: Madison Skin and Research, Inc.
state: Wisconsin
city: Caba
country: Argentina
facility: Centro De Investigaciones Dermatologicas
city: Caba
country: Argentina
facility: CENIT Centro de Neurociencias Investigacion y Tratamiento
city: Kogarah
country: Australia
facility: Dr. Glenn and Partners
state: New South Wales
city: Kogarah
country: Australia
facility: Premier Dermatology
state: New South Wales
city: Malvern East
country: Australia
facility: Emeritus Research
state: Victoria
city: Malvern
country: Australia
facility: Malvern Diagnostic Imaging
state: Victoria
city: Melbourne
country: Australia
facility: Skin And Cancer Foundation
state: Victoria
city: Feldkirch
country: Austria
facility: LKH Feldkirch
city: Salzburg
country: Austria
facility: LKH Salzburg, Landesklinik fuer Dermatologie
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint-Luc
city: Sarajevo
country: Bosnia and Herzegovina
facility: UHC Sarajevo
city: Sao Paulo
country: Brazil
facility: Hospital da Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
state: SP
city: Rio De Janeiro
country: Brazil
facility: Instituto de Dermatologia e Estetica do Brasil LTDA - IDERJ
city: Sao Paulo
country: Brazil
facility: Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
city: Pleven
country: Bulgaria
facility: UMHAT "Dr Georgi Stranski"
city: Pleven
country: Bulgaria
facility: UMHAT "Dr. Georgi Stranski" - II clinical base
city: Sofia
country: Bulgaria
facility: Tsentar za kozhno venericheski zaboliavania EOOD
city: Sofia
country: Bulgaria
facility: Mnogoprofilna Bolnitsa Za Aktivno Lechenie- Tokuda Bolnitsa
city: Sofia
country: Bulgaria
facility: UMBAL-Alexandrovska- Sofia Klinika po dermatologia i venerologia
city: Sofia
country: Bulgaria
facility: MBAL na Voennomeditsinska Akademia
city: Calgary
country: Canada
facility: Kirk Barber Research
state: Alberta
city: Calgary
country: Canada
facility: Northwest Dermatology & Laser Centre
state: Alberta
city: Edmonton
country: Canada
facility: Stratica Medical
state: Alberta
city: Surrey
country: Canada
facility: Enverus Medical Research
state: British Columbia
city: Vancouver
country: Canada
facility: Derm Research @888 Inc
state: British Columbia
city: Vancouver
country: Canada
facility: The Skin Centre
state: British Columbia
city: Victoria
country: Canada
facility: Percuro Clinical Research Limited
state: British Columbia
city: Winnipeg
country: Canada
facility: Dermadvances Research
state: Manitoba
city: Winnipeg
country: Canada
facility: Wiseman Dermatology Research Inc.
state: Manitoba
city: St. John's
country: Canada
facility: Nexus Clinical Research
state: Newfoundland and Labrador
city: St. John's
country: Canada
facility: Dr. Zohair Tomi PMC Inc. Paton Medical Centre
state: Newfoundland and Labrador
city: St. John's
country: Canada
facility: NewLab Clinical Research Inc.
state: Newfoundland and Labrador
city: Halifax
country: Canada
facility: Eastern Canada Cutaneous Research Associates Ltd.
state: Nova Scotia
city: Ajax
country: Canada
facility: CCA Medical Research
state: Ontario
city: Barrie
country: Canada
facility: The Waterside Clinic
state: Ontario
city: Barrie
country: Canada
facility: Ultranova Skincare
state: Ontario
city: Courtice
country: Canada
facility: Co-Medica Research Network Inc.
state: Ontario
city: Hamilton
country: Canada
facility: Dermatrials Research, Inc.
state: Ontario
city: London
country: Canada
facility: The Guenther Dermatology Research Centre
state: Ontario
city: Markham
country: Canada
facility: Lynderm Research Inc.
state: Ontario
city: North Bay
country: Canada
facility: North Bay Dermatology Centre
state: Ontario
city: Oakville
country: Canada
facility: Oakville Dermatology Laser Centre
state: Ontario
city: Oshawa
country: Canada
facility: Dr. Tuppal's Privat Practice, Oshawa Clinic
state: Ontario
city: Ottawa
country: Canada
facility: Office of Dr. Michael Robern
state: Ontario
city: Peterborough
country: Canada
facility: SKiN Centre for Dermatology
state: Ontario
city: Scarborough
country: Canada
facility: Office of Dr. Paul Adam (back-up location)
state: Ontario
city: Waterloo
country: Canada
facility: K. Papp Clinical Research
state: Ontario
city: Windsor
country: Canada
facility: XLR8 Medical Research
state: Ontario
city: Windsor
country: Canada
facility: Windsor Clinical Research
state: Ontario
city: Montreal
country: Canada
facility: Innovaderm Research Inc
state: Quebec
city: Montreal
country: Canada
facility: Siena Medical Research
state: Quebec
city: Québec
country: Canada
facility: Centre de Recherche Dermatologique du Québec Métropolitain
state: Quebec
city: Sherbrooke
country: Canada
facility: Diex Research Sherbrooke Inc.
state: Quebec
city: Quebec
country: Canada
facility: CRCMRGilbert Inc., Centre de Dermatologie Maizerets
city: Santiago
country: Chile
facility: Clinica Dermacross S.A.
state: Region Metropolitana
city: Santiago
country: Chile
facility: Hospital Clinico Universidad de Chile
state: Region Metropolitana
city: Santiago
country: Chile
facility: Centro Internacional de Estudios Clinicos, CIEC
state: Region Metropolitana
city: Medellin
country: Colombia
facility: Reumalab S.A.S.
state: Antioquia
city: Medellin
country: Colombia
facility: Hospital Pablo Tobon Uribe
state: Antioquia
city: Barranquilla
country: Colombia
facility: Centro Integral de Reumatologia del Caribe Cicaribe S.A.S
state: Atlantico
city: Bogota
country: Colombia
facility: Riesgo De Fractura S.A
state: Cundinamarca
city: Bogota
country: Colombia
facility: Riesgo De Fractura S.A
state: Cundinamarca
city: Bogotá
country: Colombia
facility: Colegio Mayor de Nuestra Señora del Rosario
state: Cundinamarca
city: Bucaramanga
country: Colombia
facility: Medicity S.A.S
state: Santander
city: Osijek
country: Croatia
facility: University Hospital Center Osijek
city: Zagreb
country: Croatia
facility: University hospital center "Sestre milosrdnice" clinic for dermatology and venerology disease
city: Zagreb
country: Croatia
facility: University hospital center zagreb
city: Ceske Budejovice
country: Czechia
facility: Nemocnice Ceske Budejovice, a.s. Ustavni lekarna
state: Czech Republic
city: Hradec Kralove
country: Czechia
facility: Ustanvi lekarna
state: Czech Republic
city: Ceske Budejovice
country: Czechia
facility: Nemocnice Ceske Budejovice,a.s.
city: Hradec Kralove
country: Czechia
facility: Klinika nemoci koznich a pohlavnich
city: Plzen-Bory
country: Czechia
facility: Fakultni nemocnice Plzen
city: Praha 1
country: Czechia
facility: Kozni ordinace
city: Praha 2
country: Czechia
facility: Lekarna U sv. Ignace
city: Usti nad Labem
country: Czechia
facility: Krajska zdravotni a.s.,Masarykovy nemocnice o.z.
city: Aarhus C
country: Denmark
facility: Aarhus University Hospital
city: Copenhagen NV
country: Denmark
facility: Bispebjerg Hospital, University of Copenhagen
city: Hellerup
country: Denmark
facility: Gentofte Hospital
city: Herning
country: Denmark
facility: Hudklinikken Herning
city: Svendborg
country: Denmark
facility: Hudklinikken
city: Tampere
country: Finland
facility: Tampere Univeristy Hospital, Department of Dermatology and Venereology
city: Brest
country: France
facility: Chu Morvan
state: Cedex
city: Limoges
country: France
facility: CHU Limoges - Hôpital Dupuytren - Pharmacie
state: Cedex
city: Paris
country: France
facility: Hopital Saint Louis
state: Lle-de-france
city: Besancon
country: France
facility: Hôpital Jean Minjoz
city: Besancon
country: France
facility: CHU Jean-Minjoz
city: Le Mans, Cedex 09
country: France
facility: CHG Le Mans
city: Limoges
country: France
facility: Hopital Dupuytren
city: Nantes Cedex 01
country: France
facility: CHU de Nantes - Hotel Dieu
city: Nice
country: France
facility: CHU De Nice Hopital De L'Archet II
city: Pierre Benite
country: France
facility: Centre Hospitalier Lyon Sud - Pharmacie
city: Pierre-Benite
country: France
facility: Centre Hospitalier Lyon Sud
city: Poitiers
country: France
facility: C.H.U. de Poitiers la Miletrie
city: Reims
country: France
facility: C.H.U de Reims
city: Reims
country: France
facility: Hôpital Robert Debre
city: Saint Priest En Jarez
country: France
facility: Hopital Nord
city: Toulouse
country: France
facility: Hopital Larrey Departement de Dermatologie
city: Vandoeuvre les Nancy
country: France
facility: Hopital de Brabois / Batiment Philippe Canton
city: Tuebingen
country: Germany
facility: Universitaets-Hautklinik Eberhard-Karls-Universitaet Tuebingen
state: Baden-wuerttemberg
city: Kiel
country: Germany
facility: Universitatsklinikum Schleswig-Holstein
state: Schleswig-holstein
city: Berlin
country: Germany
facility: Charité Universitätsmedizin Berlin
city: Berlin
country: Germany
facility: Klinische Forschung Berlin-Mitte GmbH
city: Berlin
country: Germany
facility: Facharzt fuer Dermatologie und Allergologie
city: Berlin
country: Germany
facility: MVZ Reichenberger Str., Aerztehaus "Rudolf Virchow"
city: Berlin
country: Germany
facility: Hautarztpraxis Tegel
city: Bonn
country: Germany
facility: Klinik and Poliklinik fur Dermatologie and Allergologie der Universitaet Bonn
city: Bonn
country: Germany
facility: Klinik und Poliklinik fur Dermatologie und Allergologie der Universitaet Bonn
city: Buchholz
country: Germany
facility: Dres. Kirsten Prepeneit und Volker Streit
city: Dresden
country: Germany
facility: Universitaetsklinik Carl Gustav Carus
city: Erlangen
country: Germany
facility: Universitaetsklinikum Erlangen Hautklinik im Internistischen Zentrum
city: Frankfurt/Main
country: Germany
facility: Klinikum der Johann Wolfgang Goethe Universitaet
city: Halle
country: Germany
facility: Universitaetsklinik und Poliklinik fuer Dermatologie und Venerologie
city: Hamburg
country: Germany
facility: Universitaetsklinikum Hamburg-Eppendorf
city: Hamburg
country: Germany
facility: Klinische Forschung Hamburg GmbH
city: Hanau
country: Germany
facility: Gemeinschaftspraxis Dres.Michael Ockenfels und Christoph Sauter
city: Heidelberg
country: Germany
facility: Universitaetsklinikum Heidelberg
city: Kiel
country: Germany
facility: Universitaetsklinikum Schleswig-Holstein, Campus Kiel
city: Koeln
country: Germany
facility: Universitaetsklinikum Koeln
city: Luebeck
country: Germany
facility: Universitaetsklinikum Schleswig-Holstein Campus Luebeck
city: Mahlow
country: Germany
facility: Hautarztpraxis Dres. Scholz, Sebastian, Schilling
city: Mainz
country: Germany
facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KoeR
city: Muenchen
country: Germany
facility: Technischen Universitaet Muenchen
city: Muenster
country: Germany
facility: Universitaetsklinikum Muenster
city: Schwerin
country: Germany
facility: Klinische Forschung Schwerin GmbH
city: Tuebingen
country: Germany
facility: Eberhard-Karls-Universitaet Tuebingen Universitaetshautklinik
city: Wiesbaden
country: Germany
facility: HSK, Dr. Horst Schmidt Kliniken GmbH
city: Witten
country: Germany
facility: Hautarztpraxis Centrovital
city: Athens
country: Greece
facility: University Dermatology Clinic "Andreas Syggros" Hospital
state: Attiki
city: Ioannina
country: Greece
facility: University General Hospital of Ioannina / Dermatology and Venereology Department
city: Thessaloniki
country: Greece
facility: "Papageorgiou" General Hospital/B' Dermatology and Venereology Clinic of University of Thessaloniki
city: Hong Kong
country: Hong Kong
facility: The University of Hong Kong (HKU)-Queen Mary Hospital (QMH)
city: Budapest
country: Hungary
facility: Synexus Magyarorszag Kft.
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont, Borgyogyaszati Klinika
city: Kecskemet
country: Hungary
facility: Bacs-Kiskun Megyei Korhaz Szegedi Tudomanyegyetem AOK Oktato Korhaza, Borgyogyaszati Osztaly
city: Miskolc
country: Hungary
facility: Miskolci Semmelweis Korhaz es Egyetemi Oktatokorhaz, Borgyogyaszati Osztaly
city: Nyiregyhaza
country: Hungary
facility: Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz, Klinikai Kutatasi Osztaly
city: Nyiregyhaza
country: Hungary
facility: Szabolcs-Szatmar-Bereg Megyei Korjazak es Egyetemi Okatokorhaz, Borgyogyaszati Szakrendeles
city: Pecs
country: Hungary
facility: Pecsi Tudomanyegyetem Aok Bor- Nemikortani Es Onkodermatologiai Klinika
city: Szeged
country: Hungary
facility: SZTE Szentgyorgyi Albert Klinikai Kozpont/Borgyogyaszati es Allergologiai Klinika
city: Szekszard
country: Hungary
facility: Tolna Megyei Balassa Janos Korhaz, Borgyogyaszati Osztaly
city: Szolnok
country: Hungary
facility: ALLERGO-DERM BAKOS Kft.
city: Szombathely
country: Hungary
facility: Vas Megyei Markusovszky Korhaz/Borgyogyaszati Osztaly
city: Veszprem
country: Hungary
facility: Veszprem Megyei Csolnoky Ferenc Korhaz Borgyogyaszat
city: Maebashi-shi
country: Japan
facility: Gunma University Hospital
state: Gunma
city: Sapporo-City
country: Japan
facility: JR Sapporo hospital
state: Hokkaido
city: Kobe
country: Japan
facility: Kobe University
state: Hyogo
city: Kumamoto-city
country: Japan
facility: Kumamoto University Hospital
state: Kumamoto
city: Shinjuku-ku
country: Japan
facility: Tokyo Yamate Medical Center
state: Tokyo
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Yonsei University College of Medicine, Severance Hospital
city: Mexico
country: Mexico
facility: Mexico Centre for Clinical Research S.A. de C.V.
state: Distrito Federal
city: Zapopan
country: Mexico
facility: Instituto Dermatologico De Jalisco "Dr Jose Barba Rubio"
state: Jalisco
city: Monterrey
country: Mexico
facility: Centro de Dermatologia de Monterrey
state: Nuevo Leon
city: Monterrey
country: Mexico
facility: Centro Medico San Lucas
state: Nuevo Leon
city: Amsterdam
country: Netherlands
facility: Academisch Medisch Centrum Universiteit van Amsterdam
state: Noord-holland
city: Beek
country: Netherlands
facility: PT&R
city: Gdansk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne
state: Pomorskie
city: Bialystok
country: Poland
facility: NZOZ Zdrowie Osteo-Medic
city: Gdansk
country: Poland
facility: Klinika Dermatologii, Wenerologii i Alergologii Uniwersyteckiego Centrum Klinicznego
city: Krakow
country: Poland
facility: Krakowskie Centrum Medyczne NZOZ
city: Lodz
country: Poland
facility: Specjalistyczne Gabinety Lekarskie "Dermed"
city: Opole
country: Poland
facility: Novum Instytut Dermatologii Leczniczej i Estetycznej
city: Poznan
country: Poland
facility: Solumed Centrum Medyczne
city: Poznan
country: Poland
facility: Centrum Badan Klinicznych s.c. Wieslawa Porawska, Lukasz Porawski
city: Szczecin
country: Poland
facility: Katedra i Klinika Chorob Skornych i Wenerycznych, Pomorski Uniwersytet Medyczny
city: Szczecin
country: Poland
facility: Spolka Cywilna Andrzej Krolicki, Tomasz Kochanowski "Laser Clinic"
city: Warszawa
country: Poland
facility: MTZ Clinical Research Sp. z o.o.
city: Warszawa
country: Poland
facility: Klinika Dermatologii
city: Warszawa
country: Poland
facility: Zaklad Radiologii Lekarskiej
city: Wroclaw
country: Poland
facility: Katedra i Klinika Dermatologii, Wenerologii i Alergologii Akademii Medycznej we Wroclawiu
city: Wroclaw
country: Poland
facility: Oddzial Dermatologiczny
city: Wroclaw
country: Poland
facility: Poradnia Dermatologiczna
city: Carolina
country: Puerto Rico
facility: Grupo Dermatologico De Carolina (Office of Dr. Alma Cruz MD)
city: Moscow
country: Russian Federation
facility: State Research Center of Dermatovenerology,
city: Moscow
country: Russian Federation
facility: State Research Center of Dermatovenerology
city: Moscow
country: Russian Federation
facility: Dermatovenerological dispensary #7
city: Rostov-on-Don
country: Russian Federation
facility: Rostov-on-Don regional dermatovenerologic dispensary
city: Ryazan
country: Russian Federation
facility: Ryazan regional clinical dermatovenerologic dispensary
city: Saint-Petersburg
country: Russian Federation
facility: Dermatovenerologic dispensary #10 of Vyborg region
city: Saint-Petersburg
country: Russian Federation
facility: Military Medical Academy N.A. S.M.Kirov
city: Saint-Petersburg
country: Russian Federation
facility: North-Western State Medical University I.I. Mechnikov
city: Smolensk
country: Russian Federation
facility: Smolensk State Medical Academy
city: Yaroslavl
country: Russian Federation
facility: Clinical hospital of emergency care N.V. Soloviev
city: Belgrade
country: Serbia
facility: Clinical Hospital Center Zvezdara
city: Belgrade
country: Serbia
facility: Military Medical Academy
city: Singapore
country: Singapore
facility: National Skin Centre
city: Singapore
country: Singapore
facility: Changi General Hospital
city: Banska Bystrica
country: Slovakia
facility: Dermatovenerologicka klinika SZU, Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica
city: Piestany
country: Slovakia
facility: Oddelenie biologickej liecby, Narodny ustav reumatickych chorob
city: Svidnik
country: Slovakia
facility: DOST-Dermatovenerologicke oddelenie sanatorneho typu, SANARE, spol. s r.o.
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro
state: Madrid
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante
city: Madrid
country: Spain
facility: Hospital Universitario La Princesa
city: Madrid
country: Spain
facility: Hospital 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario Fundacion Alcorcon
city: Valencia
country: Spain
facility: Consorcio Hospital General Universitario de Valencia
city: Malmo
country: Sweden
facility: Hud kliniken- Skanes Universitetssjukhus i Malmo
state: Sverige
city: Falun
country: Sweden
facility: Hudkliniken
city: Lulea
country: Sweden
facility: Hermelinen Forskning AB
city: Lund
country: Sweden
facility: Pharmacy: Sjukhusapoteket Lund
city: Stockholm
country: Sweden
facility: Hudkliniken
city: Stockholm
country: Sweden
facility: Karolinska University Hospital- Solna
city: St. Gallen
country: Switzerland
facility: Kantonsspital St. Gallen
city: Taichung
country: Taiwan
facility: Chung Shan Medical University Hospital
state: Taiwan Roc
city: Kaohsiung
country: Taiwan
facility: Chang Gung Medical Foundation Kaohsiung Branch
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Medical University-Shuang Ho Hospital
city: Taoyuan
country: Taiwan
facility: Chang Gung Medical Foundation Linkou Branch
city: Simferopol,
country: Ukraine
facility: Dept of Dermatology and Venerology of SI "Crimean State Medical University n.a. S.I.Georgiyevskyy"
state: Crimea
city: Kharkiv
country: Ukraine
facility: Municipal Institution of health Care
city: Kharkiv
country: Ukraine
facility: SI 'Institute for Dermatology and Venerology of AMS of Ukraine'
city: Kyiv
country: Ukraine
facility: Kyiv Oleksandrivska Clin. Hosp., Dermatology department, NMU n.a. O.O. Bogomolets,
city: Lugansk
country: Ukraine
facility: Dept of Dermatology and Venerology of Lugansk State Medical University,
city: Lviv
country: Ukraine
facility: Regional Municipal Dermatovenerologic Dispensary
city: Odessa
country: Ukraine
facility: Dept of Dermatology and Venerology of ONMU
city: Ternopil
country: Ukraine
facility: Ternopil Regional Municipal Clinical Dermatovenerologic Dispensary
city: Salford
country: United Kingdom
facility: Salford Royal NHS Foundation Trust
state: Manchester
city: Nuneaton
country: United Kingdom
facility: Department of Dermatology
state: Warwickshire
city: London
country: United Kingdom
facility: Whipps Cross University Hospital
city: Peterbrough
country: United Kingdom
facility: eRT
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
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.
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.