A Long Term Study To Evaluate The Safety And Tolerability Of CP-690,550 For Patients With Moderate To Severe Chronic Plaque Psoriasis
A Phase 3, Multi-Site, Open-Label Study Of The Long Term Safety And Tolerability Of 2 Oral Doses Of CP-690,550 In Subjects With Moderate To Severe Chronic Plaque Psoriasis
2 other identifiers
interventional
2,867
34 countries
312
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2010
Longer than P75 for phase_3
312 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 14, 2010
CompletedFirst Posted
Study publicly available on registry
July 15, 2010
CompletedStudy Start
First participant enrolled
September 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedResults Posted
Study results publicly available
June 26, 2017
CompletedJune 26, 2017
May 1, 2017
5.8 years
July 14, 2010
May 30, 2017
May 30, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (55)
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.
Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)
Number of Adverse Events (AEs) by Severity
An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs were classified according to the severity in 3 categories: a) mild: AEs did not interfere with participant's usual function; b) moderate: AEs interfered to some extent with participant's usual function; c) severe: AEs interfered significantly with participant's usual function.
Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)
Number of Participants With Laboratory Abnormalities
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).
Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)
Change From Baseline in Hemoglobin Level at Month 1
Baseline, Month 1
Change From Baseline in Hemoglobin Level at Month 3
Baseline, Month 3
Change From Baseline in Hemoglobin Level at Month 6
Baseline, Month 6
Change From Baseline in Hemoglobin Level at Month 12
Baseline, Month 12
Change From Baseline in Hemoglobin Level at Month 24
Baseline, Month 24
Change From Baseline in Hemoglobin Level at Month 36
Baseline, Month 36
Change From Baseline in Hemoglobin Level at Month 48
Baseline, Month 48
Change From Baseline in Lymphocyte and Neutrophil Count at Month 1
Baseline, Month 1
Change From Baseline in Lymphocyte and Neutrophil Count at Month 3
Baseline, Month 3
Change From Baseline in Lymphocyte and Neutrophil Count at Month 6
Baseline, Month 6
Change From Baseline in Lymphocyte and Neutrophil Count at Month 12
Baseline, Month 12
Change From Baseline in Lymphocyte and Neutrophil Count at Month 24
Baseline, Month 24
Change From Baseline in Lymphocyte and Neutrophil Count at Month 36
Baseline, Month 36
Change From Baseline in Lymphocyte and Neutrophil Count at Month 48
Baseline, Month 48
Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 1
Baseline, Month 1
Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 3
Baseline, Month 3
Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 6
Baseline, Month 6
Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 12
Baseline, Month 12
Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 24
Baseline, Month 24
Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 36
Baseline, Month 36
Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 48
Baseline, Month 48
Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 1
Baseline, Month 1
Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 3
Baseline, Month 3
Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 6
Baseline, Month 6
Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 12
Baseline, Month 12
Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 24
Baseline, Month 24
Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 36
Baseline, Month 36
Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 48
Baseline, 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.
Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)
Number of Participants With Vital Sign Abnormalities
Criteria for abnormalities in vital signs included: Systolic blood pressure (SBP): less than (\<) 90 millimeter of mercury (mmHg) and maximum increase from baseline (IFB) of greater than or equal to (\>=) 30 mmHg; diastolic blood pressure (DBP): \<50 and greater than (\>) 120 mmHg and maximum IFB of \>=20 mmHg; heart rate: \<40 and \>120 beats per minute.
Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)
Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 1
Baseline, Month 1
Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 3
Baseline, Month 3
Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 6
Baseline, Month 6
Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 12
Baseline, Month 12
Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 24
Baseline, Month 24
Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 36
Baseline, Month 36
Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 48
Baseline, Month 48
Change From Baseline in Heart Rate at Month 1
Baseline, Month 1
Change From Baseline in Heart Rate at Month 3
Baseline, Month 3
Change From Baseline in Heart Rate at Month 6
Baseline, Month 6
Change From Baseline in Heart Rate at Month 12
Baseline, Month 12
Change From Baseline in Heart Rate at Month 24
Baseline, Month 24
Change From Baseline in Heart Rate at Month 36
Baseline, Month 36
Change From Baseline in Heart Rate at Month 48
Baseline, 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.
Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)
Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 6
Baseline, Month 6
Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 12
Baseline, Month 12
Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 24
Baseline, Month 24
Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 36
Baseline, Month 36
Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 48
Baseline, 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.
Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)
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.
Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)
Secondary Outcomes (23)
Percentage of Participants Achieving Physician Global Assessment (PGA) Response of 'Clear' or 'Almost Clear'
Month 1, 3, 6, 12, 24, 36, 48
Percentage of Participants Achieving Greater Than or Equal to (>=) 75 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores
Baseline, Month 1, 3, 6, 12, 24, 36, 48
Psoriasis Area and Severity Index (PASI) Scores
Baseline, Month 1, 3, 6, 12, 24, 36, 48
Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores at Month 1, 3, 6, 12, 24, 36 and 48
Baseline, Month 1, 3, 6, 12, 24, 36, 48
Psoriasis Area and Severity Index (PASI) Component Scores: Erythema
Baseline, Month 1, 3, 6, 12, 24, 36, 48
- +18 more secondary outcomes
Study Arms (1)
Active Treatment
EXPERIMENTALThe 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
Interventions
Eligibility Criteria
You may qualify if:
- Have participated in qualifying study with CP-690,550 and are 18 years or older with diagnosis of plaque-type psoriasis (psoriasis vulgaris).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (323)
Radiant Research, Inc.
Birmingham, Alabama, 35209, United States
UAB Dermatology
Birmingham, Alabama, 35233, United States
Horizon Research Group, Inc.
Mobile, Alabama, 36608, United States
Radiant Research, Inc.
Tucson, Arizona, 85712, United States
Burke Pharmaceutical Research
Hot Springs, Arkansas, 71913, United States
Bakersfield Dermatology and Skin Cancer Medical Group
Bakersfield, California, 93309, United States
Associates In Research, Inc.
Fresno, California, 93720, United States
University of California Irvine
Irvine, California, 92697, United States
Dermatology Research Associates
Los Angeles, California, 90045, United States
Dermatology Specialists, Inc.
Oceanside, California, 92056, United States
MedDerm Associates
San Diego, California, 92103, United States
UCSD Dermatology
San Diego, California, 92122, United States
University of California San Diego
San Diego, California, 92122, United States
University of California San Francisco
San Francisco, California, 94118, United States
Clinical Science Institute
Santa Monica, California, 90404, United States
Healthcare Partners Medical Group
Torrance, California, 90503, United States
Cherry Creek Research, Inc.
Denver, Colorado, 80209, United States
The Savin Center, P.C.
New Haven, Connecticut, 06511, United States
New England Research Associates, LLC
Trumbull, Connecticut, 06611, United States
Florida Academic Dermatology Center
Coral Gables, Florida, 33134, United States
North Florida Dermatology Associates, PA
Jacksonville, Florida, 32204, United States
International Dermatology Research, Inc.
Miami, Florida, 33144, United States
Renstar Medical Research
Ocala, Florida, 34471, United States
Park Avenue Dermatology, PA
Orange Park, Florida, 32073, United States
Leavitt Medical Associates of Florida dba Ameriderm Research
Ormond Beach, Florida, 32174, United States
Miami Research Associates, Inc.
South Miami, Florida, 33143, United States
Olympian Clinical Research
Tampa, Florida, 33609, United States
Atlanta Dermatology, Vein & Research Center, P.C.
Alpharetta, Georgia, 30022, United States
Advanced Medical Research, Inc.
Atlanta, Georgia, 30342, United States
MedaPhase Inc.
Newnan, Georgia, 30263, United States
Altman Dermatology Associates
Arlington Heights, Illinois, 60005, United States
Schaumburg Dermatology
Schaumburg, Illinois, 60173, United States
NorthShore University Health System - Division of Dermatology
Skokie, Illinois, 60077, United States
Springfield Clinic
Springfield, Illinois, 62703, United States
Dundee Dermatology
West Dundee, Illinois, 60118, United States
Deaconess Clinic Downtown Research Institute
Evansville, Indiana, 47713, United States
Hudson Dermatology
Evansville, Indiana, 47714, United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, 46256, United States
DermResearch, PLLC
Louisville, Kentucky, 40217, United States
Tufts Medical Center
Boston, Massachusetts, 02111-1552, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Massachusetts General Hospital - Clinical Unit for Research Trials and Outcomes in Skin
Boston, Massachusetts, 02114, United States
Michigan Center for Research Corporation dba Michigan Center for Skin Care Research
Clinton, Michigan, 48038, United States
Hamzavi Dermatology
Fort Gratiot, Michigan, 48059, United States
Somerset Skin Centre - Dermcenter
Troy, Michigan, 48084, United States
Minnesota Clinical Study Center
Fridley, Minnesota, 55432, United States
Saint Louis University - Department of Dermatology
St Louis, Missouri, 63104, United States
Skin Specialists, P.C
Omaha, Nebraska, 68144, United States
Bettencourt Skin Center
Henderson, Nevada, 89074, United States
Dartmouth-Hitchcock Medical Center-Norris Cotton Cancer Center
Lebanon, New Hampshire, 03756, United States
Centennial Center-Comprehensive Clinical Research
Berlin, New Jersey, 08009, United States
New York University (NYU) School of Medicine - Investigational Pharmacy (IP Shipment, Pharmacy)
New York, New York, 10016, United States
NYU Langone Medical Center, Ambulatory Care Center, Department of Dermatology, Clinical Studies Unit
New York, New York, 10016, United States
The Rockefeller University
New York, New York, 10065 6307, United States
University of North Carolina at Chapel Hill- Hospital
Chapel Hill, North Carolina, 27514, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27516, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Dermatology Consulting Services
High Point, North Carolina, 27262, United States
Wake Dermatology Associates, LLC
Raleigh, North Carolina, 27607, United States
Wake Research Associates
Raleigh, North Carolina, 27612, United States
Dermatology Associates
Wilmington, North Carolina, 28401, United States
PMG Research of Wilmington, LLC
Wilmington, North Carolina, 28401, United States
Piedmont Imaging
Winston-Salem, North Carolina, 27103, United States
PMG Research of Winston-Salem
Winston-Salem, North Carolina, 27103, United States
Triad Dermatology, PA
Winston-Salem, North Carolina, 27103, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27104, United States
Jewish Hospital
Cincinnati, Ohio, 45236, United States
Radiant Research, Inc.
Cincinnati, Ohio, 45249, United States
IP ONLY: University Hospitals Case Medical Center
Cleveland, Ohio, 44106, United States
University Hospitals Case Medical Center/Dept. of Dermatology
Cleveland, Ohio, 44106, United States
University Hospitals Case Medical Center
Cleveland, Ohio, 44106, United States
Central Sooner Research
Norman, Oklahoma, 73071, United States
Baker Allergy Asthma and Dermatology Research Center, LLC
Lake Oswego, Oregon, 97035, United States
Oregon Dermatology and Research Center
Portland, Oregon, 97210, United States
Oregon Health & Science University
Portland, Oregon, 97239, United States
University of Pittsburgh Medical Center - Department of Dermatology
Pittsburgh, Pennsylvania, 15213, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
Clinical Partners, LLC
Johnston, Rhode Island, 02919, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
Office of John Michael Humeniuk, MD
Greer, South Carolina, 29650, United States
Radiant Research, Inc.
Greer, South Carolina, 29650, United States
Health Concepts
Rapid City, South Dakota, 57702, United States
Rivergate Dermatology Clinical Research Center, PLLC
Goodlettsville, Tennessee, 37072, United States
Dermatology Associates of Knoxville PC
Knoxville, Tennessee, 37917, United States
Dermatology Research Associates
Nashville, Tennessee, 37203, United States
Arlington Research Center, Inc.
Arlington, Texas, 76011, United States
Dermatology Treatment & Research Center
Dallas, Texas, 75230, United States
Modern Research Associates, PLLC
Dallas, Texas, 75231, United States
Menter Dermatology Research Institute
Dallas, Texas, 75246, United States
Center for Clinical Studies
Houston, Texas, 77004, United States
Suzanne Bruce and Associates, PA
Houston, Texas, 77056, United States
Office of Mark Lee, MD
San Antonio, Texas, 78229, United States
Progressive Clinical research, P.A.
San Antonio, Texas, 78229, United States
Stephen Miller, MD, PA
San Antonio, Texas, 78249, United States
Center for Clinical Studies
Webster, Texas, 77598, United States
Virginia Clinical Research, Inc.
Norfolk, Virginia, 23502, United States
Virginia Clinical Research, Inc.
Norfolk, Virginia, 23507, United States
Rockwood Research Center
Spokane, Washington, 99202, United States
Wenatchee Valley Hospital & Clinics
Wenatchee, Washington, 98801, United States
Mountain State Clinical Research
Bridgeport, West Virginia, 26330, United States
Madison Skin and Research, Inc.
Madison, Wisconsin, 53719, United States
Centro De Investigaciones Dermatologicas
Caba, C1114AAP, Argentina
CENIT Centro de Neurociencias Investigacion y Tratamiento
CABA, C1125ABD, Argentina
Dr. Glenn and Partners
Kogarah, New South Wales, 02217, Australia
Premier Dermatology
Kogarah, New South Wales, 02217, Australia
Malvern Diagnostic Imaging
Malvern, Victoria, 3144, Australia
Emeritus Research
Malvern East, Victoria, 3145, Australia
Skin And Cancer Foundation
Melbourne, Victoria, 3053, Australia
LKH Feldkirch
Feldkirch, 6807, Austria
LKH Salzburg, Landesklinik fuer Dermatologie
Salzburg, 5020, Austria
Cliniques Universitaires Saint-Luc
Brussels, 1200, Belgium
UHC Sarajevo
Sarajevo, 71000, Bosnia and Herzegovina
Hospital da Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
São Paulo, São Paulo, 05403-900, Brazil
Instituto de Dermatologia e Estetica do Brasil LTDA - IDERJ
Rio de Janeiro, 22470-220, Brazil
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
São Paulo, 05403-000, Brazil
UMHAT "Dr Georgi Stranski"
Pleven, 5800, Bulgaria
UMHAT "Dr. Georgi Stranski" - II clinical base
Pleven, 5800, Bulgaria
Tsentar za kozhno venericheski zaboliavania EOOD
Sofia, 1404, Bulgaria
Mnogoprofilna Bolnitsa Za Aktivno Lechenie- Tokuda Bolnitsa
Sofia, 1407, Bulgaria
UMBAL-Alexandrovska- Sofia Klinika po dermatologia i venerologia
Sofia, 1431, Bulgaria
MBAL na Voennomeditsinska Akademia
Sofia, 1606, Bulgaria
Kirk Barber Research
Calgary, Alberta, T2G 1B1, Canada
Northwest Dermatology & Laser Centre
Calgary, Alberta, T3G 0B4, Canada
Stratica Medical
Edmonton, Alberta, T5K 1X3, Canada
Enverus Medical Research
Surrey, British Columbia, V3V 0C6, Canada
Derm Research @888 Inc
Vancouver, British Columbia, V5Z 3Y1, Canada
The Skin Centre
Vancouver, British Columbia, V5Z 4E8, Canada
Percuro Clinical Research Limited
Victoria, British Columbia, V8V 3P9, Canada
Dermadvances Research
Winnipeg, Manitoba, R3C 1R4, Canada
Wiseman Dermatology Research Inc.
Winnipeg, Manitoba, R3M 3Z4, Canada
Nexus Clinical Research
St. John's, Newfoundland and Labrador, A1A 5E8, Canada
Dr. Zohair Tomi PMC Inc. Paton Medical Centre
St. John's, Newfoundland and Labrador, A1B 4S8, Canada
NewLab Clinical Research Inc.
St. John's, Newfoundland and Labrador, A1C 2H5, Canada
Eastern Canada Cutaneous Research Associates Ltd.
Halifax, Nova Scotia, B3H 1Z2, Canada
CCA Medical Research
Ajax, Ontario, L1S 7K8, Canada
The Waterside Clinic
Barrie, Ontario, L4M 6L2, Canada
Ultranova Skincare
Barrie, Ontario, L4M 6L2, Canada
Co-Medica Research Network Inc.
Courtice, Ontario, L1E 3C3, Canada
Dermatrials Research, Inc.
Hamilton, Ontario, L8N 1V6, Canada
The Guenther Dermatology Research Centre
London, Ontario, N6A 3H7, Canada
Lynderm Research Inc.
Markham, Ontario, L3P 1X2, Canada
North Bay Dermatology Centre
North Bay, Ontario, P1B 3Z7, Canada
Oakville Dermatology Laser Centre
Oakville, Ontario, L6J 7W5, Canada
Dr. Tuppal's Privat Practice, Oshawa Clinic
Oshawa, Ontario, L1H 1B9, Canada
Office of Dr. Michael Robern
Ottawa, Ontario, K2G 6E2, Canada
SKiN Centre for Dermatology
Peterborough, Ontario, K9J 5K2, Canada
Office of Dr. Paul Adam (back-up location)
Scarborough Village, Ontario, MlB 4Z8, Canada
K. Papp Clinical Research
Waterloo, Ontario, N2J 1C4, Canada
XLR8 Medical Research
Windsor, Ontario, N8W 1E6, Canada
Windsor Clinical Research
Windsor, Ontario, N8W 5L7, Canada
Innovaderm Research Inc
Montreal, Quebec, H2K 4L5, Canada
Siena Medical Research
Montreal, Quebec, H3Z 2S6, Canada
CRCMRGilbert Inc., Centre de Dermatologie Maizerets
Québec, Quebec, G1J 1X7, Canada
Centre de Recherche Dermatologique du Québec Métropolitain
Québec, Quebec, G1V 4X7, Canada
Diex Research Sherbrooke Inc.
Sherbrooke, Quebec, J1H 1Z1, Canada
Clinica Dermacross S.A.
Santiago, Santiago Metropolitan, 7640881, Chile
Hospital Clinico Universidad de Chile
Santiago, Santiago Metropolitan, 8380456, Chile
Centro Internacional de Estudios Clinicos, CIEC
Santiago, Santiago Metropolitan, 8420383, Chile
Reumalab S.A.S.
Medellín, Antioquia, 0, Colombia
Hospital Pablo Tobon Uribe
Medellín, Antioquia, Colombia
Centro Integral de Reumatologia del Caribe Cicaribe S.A.S
Barranquilla, Atlántico, 08001000, Colombia
Riesgo De Fractura S.A
Bogota, Cundinamarca, 0000, Colombia
Riesgo De Fractura S.A
Bogota, Cundinamarca, Colombia
Colegio Mayor de Nuestra Señora del Rosario
Bogotá, Cundinamarca, 110221, Colombia
Medicity S.A.S
Bucaramanga, Santander Department, 680003, Colombia
University Hospital Center Osijek
Osijek, 31000, Croatia
University hospital center "Sestre milosrdnice" clinic for dermatology and venerology disease
Zagreb, 10000, Croatia
University hospital center zagreb
Zagreb, 10000, Croatia
Nemocnice Ceske Budejovice, a.s. Ustavni lekarna
České Budějovice, Czech Republic, 370 01, Czechia
Ustanvi lekarna
Hradec Králové, Czech Republic, 50005, Czechia
Nemocnice Ceske Budejovice,a.s.
České Budějovice, 37001, Czechia
Klinika nemoci koznich a pohlavnich
Hradec Králové, 500 05, Czechia
Fakultni nemocnice Plzen
Plzen-Bory, 30599, Czechia
Kozni ordinace
Prague, 11000, Czechia
Lekarna U sv. Ignace
Prague, 120 00, Czechia
Krajska zdravotni a.s.,Masarykovy nemocnice o.z.
Ústí nad Labem, 40113, Czechia
Aarhus University Hospital
Aarhus C, 8000, Denmark
Bispebjerg Hospital, University of Copenhagen
Copenhagen NV, 2400, Denmark
Gentofte Hospital
Hellerup, 2900, Denmark
Hudklinikken Herning
Herning, 7400, Denmark
Hudklinikken
Svendborg, 5700, Denmark
Tampere Univeristy Hospital, Department of Dermatology and Venereology
Tampere, 33521, Finland
Chu Morvan
Brest, Cedex, 29609, France
CHU Limoges - Hôpital Dupuytren - Pharmacie
Limoges, Cedex, 87042, France
Hopital Saint Louis
Paris, Lle-de-france, 75010, France
Hôpital Jean Minjoz
Besançon, 25000, France
CHU Jean-Minjoz
Besançon, 25030, France
CHG Le Mans
Le Mans, 72037, France
Hopital Dupuytren
Limoges, 87042, France
CHU de Nantes - Hotel Dieu
Nantes, 44035, France
CHU De Nice Hopital De L'Archet II
Nice, 06202, France
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69310, France
Centre Hospitalier Lyon Sud - Pharmacie
Pierre-Bénite, 69495, France
C.H.U. de Poitiers la Miletrie
Poitiers, 86000, France
C.H.U de Reims
Reims, 51092, France
Hôpital Robert Debre
Reims, 51100, France
Hopital Nord
Saint-Priest-en-Jarez, 42270, France
Hopital Larrey Departement de Dermatologie
Toulouse, 31000, France
Hopital de Brabois / Batiment Philippe Canton
Vandœuvre-lès-Nancy, 54511, France
Universitaets-Hautklinik Eberhard-Karls-Universitaet Tuebingen
Tübingen, Baden-Wurttemberg, 72076, Germany
Universitatsklinikum Schleswig-Holstein
Kiel, Schleswig-Holstein, 24105, Germany
Charité Universitätsmedizin Berlin
Berlin, 10117, Germany
Klinische Forschung Berlin-Mitte GmbH
Berlin, 10117, Germany
Facharzt fuer Dermatologie und Allergologie
Berlin, 10435, Germany
MVZ Reichenberger Str., Aerztehaus "Rudolf Virchow"
Berlin, 13055, Germany
Hautarztpraxis Tegel
Berlin, 13507, Germany
Klinik and Poliklinik fur Dermatologie and Allergologie der Universitaet Bonn
Bonn, 53105, Germany
Klinik und Poliklinik fur Dermatologie und Allergologie der Universitaet Bonn
Bonn, 53105, Germany
Dres. Kirsten Prepeneit und Volker Streit
Buchholz, 21244, Germany
Universitaetsklinikum Koeln
Cologne, 50937, Germany
Universitaetsklinik Carl Gustav Carus
Dresden, 01307, Germany
Universitaetsklinikum Erlangen Hautklinik im Internistischen Zentrum
Erlangen, 91054, Germany
Klinikum der Johann Wolfgang Goethe Universitaet
Frankfurt am Main, 60590, Germany
Universitaetsklinik und Poliklinik fuer Dermatologie und Venerologie
Halle, 06120, Germany
Universitaetsklinikum Hamburg-Eppendorf
Hamburg, 20246, Germany
Klinische Forschung Hamburg GmbH
Hamburg, 20253, Germany
Gemeinschaftspraxis Dres.Michael Ockenfels und Christoph Sauter
Hanau, 63450, Germany
Universitaetsklinikum Heidelberg
Heidelberg, 69120, Germany
Universitaetsklinikum Schleswig-Holstein, Campus Kiel
Kiel, 24105, Germany
Universitaetsklinikum Schleswig-Holstein Campus Luebeck
Lübeck, 23538, Germany
Hautarztpraxis Dres. Scholz, Sebastian, Schilling
Mahlow, 15831, Germany
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KoeR
Mainz, 55131, Germany
Technischen Universitaet Muenchen
München, 80802, Germany
Universitaetsklinikum Muenster
Münster, 48149, Germany
Klinische Forschung Schwerin GmbH
Schwerin, 19055, Germany
Eberhard-Karls-Universitaet Tuebingen Universitaetshautklinik
Tübingen, 72076, Germany
HSK, Dr. Horst Schmidt Kliniken GmbH
Wiesbaden, 65199, Germany
Hautarztpraxis Centrovital
Witten, 58453, Germany
University Dermatology Clinic "Andreas Syggros" Hospital
Athens, Attica, 16121, Greece
University General Hospital of Ioannina / Dermatology and Venereology Department
Ioannina, 45500, Greece
"Papageorgiou" General Hospital/B' Dermatology and Venereology Clinic of University of Thessaloniki
Thessaloniki, 56403, Greece
The University of Hong Kong (HKU)-Queen Mary Hospital (QMH)
Hong Kong, Hong Kong
Synexus Magyarorszag Kft.
Budapest, 1036, Hungary
Debreceni Egyetem Klinikai Kozpont, Borgyogyaszati Klinika
Debrecen, 4032, Hungary
Bacs-Kiskun Megyei Korhaz Szegedi Tudomanyegyetem AOK Oktato Korhaza, Borgyogyaszati Osztaly
Kecskemét, 6000, Hungary
Miskolci Semmelweis Korhaz es Egyetemi Oktatokorhaz, Borgyogyaszati Osztaly
Miskolc, 3529, Hungary
Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz, Klinikai Kutatasi Osztaly
Nyíregyháza, 4400, Hungary
Szabolcs-Szatmar-Bereg Megyei Korjazak es Egyetemi Okatokorhaz, Borgyogyaszati Szakrendeles
Nyíregyháza, 4400, Hungary
Pecsi Tudomanyegyetem Aok Bor- Nemikortani Es Onkodermatologiai Klinika
Pécs, H-7632, Hungary
SZTE Szentgyorgyi Albert Klinikai Kozpont/Borgyogyaszati es Allergologiai Klinika
Szeged, 6720, Hungary
Tolna Megyei Balassa Janos Korhaz, Borgyogyaszati Osztaly
Szekszárd, 7100, Hungary
ALLERGO-DERM BAKOS Kft.
Szolnok, 5000, Hungary
Vas Megyei Markusovszky Korhaz/Borgyogyaszati Osztaly
Szombathely, H-9700, Hungary
Veszprem Megyei Csolnoky Ferenc Korhaz Borgyogyaszat
Veszprém, H-8200, Hungary
Gunma University Hospital
Maebashi, Gunma, 3718511, Japan
JR Sapporo hospital
Sapporo, Hokkaido, 060-0033, Japan
Kobe University
Kobe, Hyōgo, 6500017, Japan
Kumamoto University Hospital
Kumamoto, Kumamoto, 860-8556, Japan
Tokyo Yamate Medical Center
Shinjuku-ku, Tokyo, 169-0073, Japan
Instituto Dermatologico De Jalisco "Dr Jose Barba Rubio"
Zapopan, Jalisco, 45190, Mexico
Mexico Centre for Clinical Research S.A. de C.V.
Mexico City, Mexico City, 03100, Mexico
Centro de Dermatologia de Monterrey
Monterrey, Nuevo León, 64460, Mexico
Centro Medico San Lucas
Monterrey, Nuevo León, 64710, Mexico
Academisch Medisch Centrum Universiteit van Amsterdam
Amsterdam, North Holland, 1105 AZ, Netherlands
PT&R
Beek, 6191 JW, Netherlands
Uniwersyteckie Centrum Kliniczne
Gdansk, Pomeranian Voivodeship, 80-952, Poland
NZOZ Zdrowie Osteo-Medic
Bialystok, 15-351, Poland
Klinika Dermatologii, Wenerologii i Alergologii Uniwersyteckiego Centrum Klinicznego
Gdansk, 80-402, Poland
Krakowskie Centrum Medyczne NZOZ
Krakow, 31-501, Poland
Specjalistyczne Gabinety Lekarskie "Dermed"
Lodz, 90-265, Poland
Novum Instytut Dermatologii Leczniczej i Estetycznej
Opole, 45-080, Poland
Solumed Centrum Medyczne
Poznan, 60-529, Poland
Centrum Badan Klinicznych s.c. Wieslawa Porawska, Lukasz Porawski
Poznan, 60773, Poland
Katedra i Klinika Chorob Skornych i Wenerycznych, Pomorski Uniwersytet Medyczny
Szczecin, 70-111, Poland
Spolka Cywilna Andrzej Krolicki, Tomasz Kochanowski "Laser Clinic"
Szczecin, 70-332, Poland
MTZ Clinical Research Sp. z o.o.
Warsaw, 02-106, Poland
Klinika Dermatologii
Warsaw, 04-141, Poland
Zaklad Radiologii Lekarskiej
Warsaw, 04-141, Poland
Katedra i Klinika Dermatologii, Wenerologii i Alergologii Akademii Medycznej we Wroclawiu
Wroclaw, 50-368, Poland
Oddzial Dermatologiczny
Wroclaw, 51-124, Poland
Poradnia Dermatologiczna
Wroclaw, 51-124, Poland
Grupo Dermatologico De Carolina (Office of Dr. Alma Cruz MD)
Carolina, 00985, Puerto Rico
State Research Center of Dermatovenerology,
Moscow, 107076, Russia
State Research Center of Dermatovenerology
Moscow, 107076, Russia
Dermatovenerological dispensary #7
Moscow, 121614, Russia
Rostov-on-Don regional dermatovenerologic dispensary
Rostov-on-Don, 344007, Russia
Ryazan regional clinical dermatovenerologic dispensary
Ryazan, 390046, Russia
Dermatovenerologic dispensary #10 of Vyborg region
Saint Petersburg, 194021, Russia
Military Medical Academy N.A. S.M.Kirov
Saint Petersburg, 194044, Russia
North-Western State Medical University I.I. Mechnikov
Saint Petersburg, 195067, Russia
Smolensk State Medical Academy
Smolensk, 214019, Russia
Clinical hospital of emergency care N.V. Soloviev
Yaroslavl, 150003, Russia
Clinical Hospital Center Zvezdara
Belgrade, 11000, Serbia
Military Medical Academy
Belgrade, 11000, Serbia
National Skin Centre
Singapore, 308205, Singapore
Changi General Hospital
Singapore, 529889, Singapore
Dermatovenerologicka klinika SZU, Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica
Banská Bystrica, 975 17, Slovakia
Oddelenie biologickej liecby, Narodny ustav reumatickych chorob
Piešťany, 921 12, Slovakia
DOST-Dermatovenerologicke oddelenie sanatorneho typu, SANARE, spol. s r.o.
Svidník, 089 01, Slovakia
Seoul National University Hospital
Seoul, 03080, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
Yonsei University College of Medicine, Severance Hospital
Seoul, 120-752, South Korea
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, 28222, Spain
Hospital General Universitario de Alicante
Alicante, 03010, Spain
Hospital Universitario La Princesa
Madrid, 28006, Spain
Hospital 12 de Octubre
Madrid, 28041, Spain
Hospital Universitario Fundacion Alcorcon
Madrid, 28922, Spain
Consorcio Hospital General Universitario de Valencia
Valencia, 46014, Spain
Hud kliniken- Skanes Universitetssjukhus i Malmo
Malmo, Sverige, 205 02, Sweden
Hudkliniken
Falun, 791 82, Sweden
Hermelinen Forskning AB
Luleå, 972 33, Sweden
Pharmacy: Sjukhusapoteket Lund
Lund, 222 42, Sweden
Hudkliniken
Stockholm, 118 83, Sweden
Karolinska University Hospital- Solna
Stockholm, 171 76, Sweden
Kantonsspital St. Gallen
Sankt Gallen, 9007, Switzerland
Chung Shan Medical University Hospital
Taichung, Taiwan Roc, 40201, Taiwan
Chang Gung Medical Foundation Kaohsiung Branch
Kaohsiung City, 833, Taiwan
National Cheng Kung University Hospital
Tainan, 704, Taiwan
National Taiwan University Hospital
Taipei, 100, Taiwan
Taipei Medical University-Shuang Ho Hospital
Taipei, 235, Taiwan
Chang Gung Medical Foundation Linkou Branch
Taoyuan District, 333, Taiwan
Dept of Dermatology and Venerology of SI "Crimean State Medical University n.a. S.I.Georgiyevskyy"
Simferopol, Autonomous Republic of Crimea, 95006, Ukraine
Municipal Institution of health Care
Kharkiv, 61038, Ukraine
SI 'Institute for Dermatology and Venerology of AMS of Ukraine'
Kharkiv, 61057, Ukraine
Kyiv Oleksandrivska Clin. Hosp., Dermatology department, NMU n.a. O.O. Bogomolets,
Kyiv, 01601, Ukraine
Dept of Dermatology and Venerology of Lugansk State Medical University,
Luhansk, 91047, Ukraine
Regional Municipal Dermatovenerologic Dispensary
Lviv, 79013, Ukraine
Dept of Dermatology and Venerology of ONMU
Odesa, 65006, Ukraine
Ternopil Regional Municipal Clinical Dermatovenerologic Dispensary
Ternopil, 46006, Ukraine
Salford Royal NHS Foundation Trust
Salford, Manchester, M6 8HD, United Kingdom
Department of Dermatology
Nuneaton, Warwickshire, CV10 7DJ, United Kingdom
Whipps Cross University Hospital
London, E11 1NR, United Kingdom
eRT
Peterborough, PE 2 6UP, United Kingdom
Related Publications (4)
Kristensen LE, Deodhar A, Leung YY, Vranic I, Mortezavi M, Fallon L, Yndestad A, Kinch CD, Gladman DD. Risk Stratification of Patients with Psoriatic Arthritis and Ankylosing Spondylitis for Treatment with Tofacitinib: A Review of Current Clinical Data. Rheumatol Ther. 2024 Jun;11(3):487-499. doi: 10.1007/s40744-024-00662-5. Epub 2024 May 2.
PMID: 38696034DERIVEDKristensen LE, Strober B, Poddubnyy D, Leung YY, Jo H, Kwok K, Vranic I, Fleishaker DL, Fallon L, Yndestad A, Gladman DD. Association between baseline cardiovascular risk and incidence rates of major adverse cardiovascular events and malignancies in patients with psoriatic arthritis and psoriasis receiving tofacitinib. Ther Adv Musculoskelet Dis. 2023 Feb 7;15:1759720X221149965. doi: 10.1177/1759720X221149965. eCollection 2023.
PMID: 36777695DERIVEDPanaccione 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.
PMID: 32816215DERIVEDValenzuela 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.
PMID: 29782642DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 14, 2010
First Posted
July 15, 2010
Study Start
September 1, 2010
Primary Completion
June 1, 2016
Study Completion
June 1, 2016
Last Updated
June 26, 2017
Results First Posted
June 26, 2017
Record last verified: 2017-05
Data Sharing
- IPD Sharing
- Will share
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