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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01163253
Registration number
NCT01163253
Ethics application status
Date submitted
14/07/2010
Date registered
15/07/2010
Titles & IDs
Public title
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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Scientific 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
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Secondary ID [1]
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2010-020002-15
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Secondary ID [2]
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A3921061
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Psoriasis
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Condition category
Condition code
Skin
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Dermatological conditions
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Skin
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Other skin conditions
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - CP-690,550
Treatment: Drugs - CP-690,550
Experimental: Active Treatment - The study is anticipated to continue for up to at least 2 years post First Market Approval (FMA) in a global, major market.
All subjects will receive 10 mg BID of CP-690,550 for first 3 months of trial. Study has the option for variable dosing with 5 mg or 10 mg BID after first 3-months of treatment based on PI discretion
Treatment: Drugs: CP-690,550
5 mg oral BID
Treatment: Drugs: CP-690,550
10 mg oral BID
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)
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Primary outcome [2]
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Number of Adverse Events (AEs) by Severity
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Assessment method [2]
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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.
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Timepoint [2]
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Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)
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Primary outcome [3]
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Number of Participants With Laboratory Abnormalities
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Assessment method [3]
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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).
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Timepoint [3]
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Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)
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Primary outcome [4]
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Change From Baseline in Hemoglobin Level at Month 1
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Assessment method [4]
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Timepoint [4]
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Baseline, Month 1
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Primary outcome [5]
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Change From Baseline in Hemoglobin Level at Month 3
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Assessment method [5]
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Timepoint [5]
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Baseline, Month 3
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Primary outcome [6]
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Change From Baseline in Hemoglobin Level at Month 6
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Assessment method [6]
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Timepoint [6]
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Baseline, Month 6
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Primary outcome [7]
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Change From Baseline in Hemoglobin Level at Month 12
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Assessment method [7]
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0
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Timepoint [7]
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Baseline, Month 12
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Primary outcome [8]
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Change From Baseline in Hemoglobin Level at Month 24
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Assessment method [8]
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0
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Timepoint [8]
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Baseline, Month 24
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Primary outcome [9]
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Change From Baseline in Hemoglobin Level at Month 36
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Assessment method [9]
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0
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Timepoint [9]
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Baseline, Month 36
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Primary outcome [10]
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Change From Baseline in Hemoglobin Level at Month 48
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Assessment method [10]
0
0
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Timepoint [10]
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Baseline, Month 48
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Primary outcome [11]
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Change From Baseline in Lymphocyte and Neutrophil Count at Month 1
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Assessment method [11]
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Timepoint [11]
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Baseline, Month 1
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Primary outcome [12]
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Change From Baseline in Lymphocyte and Neutrophil Count at Month 3
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Assessment method [12]
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Timepoint [12]
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Baseline, Month 3
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Primary outcome [13]
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Change From Baseline in Lymphocyte and Neutrophil Count at Month 6
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Assessment method [13]
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Timepoint [13]
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Baseline, Month 6
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Primary outcome [14]
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Change From Baseline in Lymphocyte and Neutrophil Count at Month 12
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Assessment method [14]
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Timepoint [14]
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Baseline, Month 12
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Primary outcome [15]
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Change From Baseline in Lymphocyte and Neutrophil Count at Month 24
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Assessment method [15]
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Timepoint [15]
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Baseline, Month 24
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Primary outcome [16]
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Change From Baseline in Lymphocyte and Neutrophil Count at Month 36
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Assessment method [16]
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Timepoint [16]
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Baseline, Month 36
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Primary outcome [17]
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Change From Baseline in Lymphocyte and Neutrophil Count at Month 48
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Assessment method [17]
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0
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Timepoint [17]
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Baseline, Month 48
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Primary outcome [18]
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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
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Assessment method [18]
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Timepoint [18]
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Baseline, Month 1
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Primary outcome [19]
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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
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Assessment method [19]
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Timepoint [19]
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Baseline, Month 3
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Primary outcome [20]
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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
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Assessment method [20]
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Timepoint [20]
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Baseline, Month 6
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Primary outcome [21]
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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
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Assessment method [21]
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Timepoint [21]
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Baseline, Month 12
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Primary outcome [22]
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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
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Assessment method [22]
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0
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Timepoint [22]
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Baseline, Month 24
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Primary outcome [23]
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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
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Assessment method [23]
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0
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Timepoint [23]
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Baseline, Month 36
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Primary outcome [24]
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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
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Assessment method [24]
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0
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Timepoint [24]
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Baseline, Month 48
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Primary outcome [25]
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Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 1
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Assessment method [25]
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0
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Timepoint [25]
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Baseline, Month 1
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Primary outcome [26]
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Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 3
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Assessment method [26]
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0
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Timepoint [26]
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Baseline, Month 3
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Primary outcome [27]
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Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 6
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Assessment method [27]
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0
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Timepoint [27]
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0
Baseline, Month 6
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Primary outcome [28]
0
0
Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 12
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Assessment method [28]
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0
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Timepoint [28]
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0
Baseline, Month 12
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Primary outcome [29]
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0
Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 24
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Assessment method [29]
0
0
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Timepoint [29]
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0
Baseline, Month 24
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Primary outcome [30]
0
0
Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 36
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Assessment method [30]
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0
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Timepoint [30]
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Baseline, Month 36
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Primary outcome [31]
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0
Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 48
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Assessment method [31]
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Timepoint [31]
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Baseline, Month 48
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Primary outcome [32]
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Number of Participants With Clinically Significant Change From Baseline in Physical Examination
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Assessment method [32]
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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.
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Timepoint [32]
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Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)
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Primary outcome [33]
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Number of Participants With Vital Sign Abnormalities
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Assessment method [33]
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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.
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Timepoint [33]
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Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)
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Primary outcome [34]
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Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 1
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Assessment method [34]
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Timepoint [34]
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Baseline, Month 1
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Primary outcome [35]
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Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 3
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Assessment method [35]
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Timepoint [35]
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Baseline, Month 3
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Primary outcome [36]
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Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 6
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Assessment method [36]
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Timepoint [36]
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Baseline, Month 6
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Primary outcome [37]
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Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 12
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Assessment method [37]
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Timepoint [37]
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Baseline, Month 12
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Primary outcome [38]
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Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 24
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Assessment method [38]
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Timepoint [38]
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Baseline, Month 24
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Primary outcome [39]
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Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 36
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Assessment method [39]
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Timepoint [39]
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Baseline, Month 36
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Primary outcome [40]
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Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 48
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Assessment method [40]
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Timepoint [40]
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Baseline, Month 48
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Primary outcome [41]
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Change From Baseline in Heart Rate at Month 1
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Assessment method [41]
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Timepoint [41]
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Baseline, Month 1
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Primary outcome [42]
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Change From Baseline in Heart Rate at Month 3
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Assessment method [42]
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Timepoint [42]
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Baseline, Month 3
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Primary outcome [43]
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Change From Baseline in Heart Rate at Month 6
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Assessment method [43]
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Timepoint [43]
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Baseline, Month 6
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Primary outcome [44]
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Change From Baseline in Heart Rate at Month 12
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Assessment method [44]
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Timepoint [44]
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Baseline, Month 12
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Primary outcome [45]
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Change From Baseline in Heart Rate at Month 24
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Assessment method [45]
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Timepoint [45]
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Baseline, Month 24
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Primary outcome [46]
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Change From Baseline in Heart Rate at Month 36
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Assessment method [46]
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Timepoint [46]
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Baseline, Month 36
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Primary outcome [47]
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Change From Baseline in Heart Rate at Month 48
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Assessment method [47]
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Timepoint [47]
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Baseline, Month 48
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Primary outcome [48]
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Number of Participants With Electrocardiogram (ECG) Abnormalities
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Assessment method [48]
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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.
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Timepoint [48]
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Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)
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Primary outcome [49]
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Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 6
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Assessment method [49]
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0
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Timepoint [49]
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Baseline, Month 6
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Primary outcome [50]
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Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 12
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Assessment method [50]
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Timepoint [50]
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Baseline, Month 12
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Primary outcome [51]
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Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 24
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Assessment method [51]
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0
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Timepoint [51]
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Baseline, Month 24
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Primary outcome [52]
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Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 36
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Assessment method [52]
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0
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Timepoint [52]
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Baseline, Month 36
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Primary outcome [53]
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Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 48
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Assessment method [53]
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0
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Timepoint [53]
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Baseline, Month 48
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Primary outcome [54]
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Number of Participants With Adjudicated Cardiovascular Events
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Assessment method [54]
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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.
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Timepoint [54]
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Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)
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Primary outcome [55]
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Number of Participants With Malignancy Events
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Assessment method [55]
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Malignancy events included lymphoma, and demyelinating neurologic events. Biopsies collected for malignancy events were submitted to the central laboratory for pathologist over-read.
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Timepoint [55]
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Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)
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Secondary outcome [1]
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Percentage of Participants Achieving Physician Global Assessment (PGA) Response of 'Clear' or 'Almost Clear'
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Assessment method [1]
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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.
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Timepoint [1]
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Month 1, 3, 6, 12, 24, 36, 48
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Secondary outcome [2]
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Percentage of Participants Achieving Greater Than or Equal to (>=) 75 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores
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Assessment method [2]
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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.
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Timepoint [2]
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Baseline, Month 1, 3, 6, 12, 24, 36, 48
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Secondary outcome [3]
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Psoriasis Area and Severity Index (PASI) Scores
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Assessment method [3]
0
0
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.
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Timepoint [3]
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0
Baseline, Month 1, 3, 6, 12, 24, 36, 48
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Secondary outcome [4]
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Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores at Month 1, 3, 6, 12, 24, 36 and 48
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Assessment method [4]
0
0
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.
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Timepoint [4]
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0
Baseline, Month 1, 3, 6, 12, 24, 36, 48
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Secondary outcome [5]
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0
Psoriasis Area and Severity Index (PASI) Component Scores: Erythema
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Assessment method [5]
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0
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.
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Timepoint [5]
0
0
Baseline, Month 1, 3, 6, 12, 24, 36, 48
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Secondary outcome [6]
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0
Psoriasis Area and Severity Index (PASI) Component Scores: Induration
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Assessment method [6]
0
0
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.
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Timepoint [6]
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0
Baseline, Month 1, 3, 6, 12, 24, 36, 48
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Secondary outcome [7]
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0
Psoriasis Area and Severity Index (PASI) Component Scores: Scaling
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Assessment method [7]
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0
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.
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Timepoint [7]
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0
Baseline, Month 1, 3, 6, 12, 24, 36, 48
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Secondary outcome [8]
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0
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Erythema at Month 1, 3, 6, 12, 24, 36 and 48
Query!
Assessment method [8]
0
0
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.
Query!
Timepoint [8]
0
0
Baseline, Month 1, 3, 6, 12, 24, 36, 48
Query!
Secondary outcome [9]
0
0
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Induration at Month 1, 3, 6, 12, 24, 36 and 48
Query!
Assessment method [9]
0
0
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.
Query!
Timepoint [9]
0
0
Baseline, Month 1, 3, 6, 12, 24, 36, 48
Query!
Secondary outcome [10]
0
0
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Scaling at Month 1, 3, 6, 12, 24, 36 and 48
Query!
Assessment method [10]
0
0
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.
Query!
Timepoint [10]
0
0
Baseline, Month 1, 3, 6, 12, 24, 36, 48
Query!
Secondary outcome [11]
0
0
Percentage of Participants Achieving Greater Than or Equal to (>=) 50 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores
Query!
Assessment method [11]
0
0
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.
Query!
Timepoint [11]
0
0
Baseline, Month 1, 3, 6, 12, 24, 36, 48
Query!
Secondary outcome [12]
0
0
Percentage of Participants Achieving Greater Than or Equal to (>=) 90 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores
Query!
Assessment method [12]
0
0
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.
Query!
Timepoint [12]
0
0
Baseline, Month 1, 3, 6, 12, 24, 36, 48
Query!
Secondary outcome [13]
0
0
Percentage of Participants Achieving Greater Than or Equal to (>=) 125 Percent Increase From Baseline in Psoriasis Area and Severity Index (PASI) Scores
Query!
Assessment method [13]
0
0
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.
Query!
Timepoint [13]
0
0
Baseline, Month 1, 3, 6, 12, 24, 36, 48
Query!
Secondary outcome [14]
0
0
Itch Severity Item (ISI) Scores
Query!
Assessment method [14]
0
0
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.
Query!
Timepoint [14]
0
0
Baseline, Month 1, 3, 6, 12, 24, 36, 48
Query!
Secondary outcome [15]
0
0
Change From Baseline in Itch Severity Item (ISI) Scores at Month 1, 3, 6, 12, 24, 36 and 48
Query!
Assessment method [15]
0
0
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.
Query!
Timepoint [15]
0
0
Baseline, Month 1, 3, 6, 12, 24, 36, 48
Query!
Secondary outcome [16]
0
0
Dermatology Life Quality Index (DLQI) Scores
Query!
Assessment method [16]
0
0
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.
Query!
Timepoint [16]
0
0
Baseline, Month 1, 6, 12, 24, 36, 48
Query!
Secondary outcome [17]
0
0
Change From Baseline in Dermatology Life Quality Index (DLQI) Scores at Month 1, 6, 12, 24, 36 and 48
Query!
Assessment method [17]
0
0
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.
Query!
Timepoint [17]
0
0
Baseline, Month 1, 6, 12, 24, 36, 48
Query!
Secondary outcome [18]
0
0
36-Item Short-Form (SF-36) Health Survey Version 2, Acute: Physical Component Summary Scores
Query!
Assessment method [18]
0
0
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.
Query!
Timepoint [18]
0
0
Baseline, Month 6, 12, 24, 36, 48
Query!
Secondary outcome [19]
0
0
36-Item Short-Form (SF-36) Health Survey Version 2, Acute: Mental Component Summary Scores
Query!
Assessment method [19]
0
0
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.
Query!
Timepoint [19]
0
0
Baseline, Month 6, 12, 24, 36, 48
Query!
Secondary outcome [20]
0
0
Number of Participants With Patient Global Assessment (PtGA) Response of "Clear" or "Almost Clear"
Query!
Assessment method [20]
0
0
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.
Query!
Timepoint [20]
0
0
Baseline, Month 1, 3, 6, 12, 24, 36, 48
Query!
Secondary outcome [21]
0
0
Euro Quality of Life- 5-Dimensions (EQ-5D)-Utility Scores
Query!
Assessment method [21]
0
0
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.
Query!
Timepoint [21]
0
0
Baseline, Month 6, 12, 24, 36, 48
Query!
Secondary outcome [22]
0
0
Euro Quality of Life-5-Dimensions (EQ-5D)-Visual Analogue Scale Scores (VAS)
Query!
Assessment method [22]
0
0
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.
Query!
Timepoint [22]
0
0
Baseline, Month 6, 12, 24, 36, 48
Query!
Secondary outcome [23]
0
0
Number of Participants Who Answered Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU)
Query!
Assessment method [23]
0
0
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.
Query!
Timepoint [23]
0
0
Baseline, Month 1, 3, 6, 12, 24, 36, 48
Query!
Eligibility
Key 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).
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key 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.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
NA
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Single group
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Stopped early
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/09/2010
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/06/2016
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
2867
Query!
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Query!
Recruitment hospital [1]
0
0
Dr. Glenn and Partners - Kogarah
Query!
Recruitment hospital [2]
0
0
Premier Dermatology - Kogarah
Query!
Recruitment hospital [3]
0
0
Emeritus Research - Malvern East
Query!
Recruitment hospital [4]
0
0
Malvern Diagnostic Imaging - Malvern
Query!
Recruitment hospital [5]
0
0
Skin And Cancer Foundation - Melbourne
Query!
Recruitment postcode(s) [1]
0
0
02217 - Kogarah
Query!
Recruitment postcode(s) [2]
0
0
3145 - Malvern East
Query!
Recruitment postcode(s) [3]
0
0
3144 - Malvern
Query!
Recruitment postcode(s) [4]
0
0
3053 - Melbourne
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arizona
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Arkansas
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
California
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Colorado
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Connecticut
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Florida
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Georgia
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Illinois
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Indiana
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Kentucky
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Massachusetts
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Michigan
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Minnesota
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Missouri
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Nebraska
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Nevada
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
New Hampshire
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
New Jersey
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
New York
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
North Carolina
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
Ohio
Query!
Country [23]
0
0
United States of America
Query!
State/province [23]
0
0
Oklahoma
Query!
Country [24]
0
0
United States of America
Query!
State/province [24]
0
0
Oregon
Query!
Country [25]
0
0
United States of America
Query!
State/province [25]
0
0
Pennsylvania
Query!
Country [26]
0
0
United States of America
Query!
State/province [26]
0
0
Rhode Island
Query!
Country [27]
0
0
United States of America
Query!
State/province [27]
0
0
South Carolina
Query!
Country [28]
0
0
United States of America
Query!
State/province [28]
0
0
South Dakota
Query!
Country [29]
0
0
United States of America
Query!
State/province [29]
0
0
Tennessee
Query!
Country [30]
0
0
United States of America
Query!
State/province [30]
0
0
Texas
Query!
Country [31]
0
0
United States of America
Query!
State/province [31]
0
0
Virginia
Query!
Country [32]
0
0
United States of America
Query!
State/province [32]
0
0
Washington
Query!
Country [33]
0
0
United States of America
Query!
State/province [33]
0
0
West Virginia
Query!
Country [34]
0
0
United States of America
Query!
State/province [34]
0
0
Wisconsin
Query!
Country [35]
0
0
Argentina
Query!
State/province [35]
0
0
Caba
Query!
Country [36]
0
0
Austria
Query!
State/province [36]
0
0
Feldkirch
Query!
Country [37]
0
0
Austria
Query!
State/province [37]
0
0
Salzburg
Query!
Country [38]
0
0
Belgium
Query!
State/province [38]
0
0
Brussels
Query!
Country [39]
0
0
Bosnia and Herzegovina
Query!
State/province [39]
0
0
Sarajevo
Query!
Country [40]
0
0
Brazil
Query!
State/province [40]
0
0
SP
Query!
Country [41]
0
0
Brazil
Query!
State/province [41]
0
0
Rio De Janeiro
Query!
Country [42]
0
0
Brazil
Query!
State/province [42]
0
0
Sao Paulo
Query!
Country [43]
0
0
Bulgaria
Query!
State/province [43]
0
0
Pleven
Query!
Country [44]
0
0
Bulgaria
Query!
State/province [44]
0
0
Sofia
Query!
Country [45]
0
0
Canada
Query!
State/province [45]
0
0
Alberta
Query!
Country [46]
0
0
Canada
Query!
State/province [46]
0
0
British Columbia
Query!
Country [47]
0
0
Canada
Query!
State/province [47]
0
0
Manitoba
Query!
Country [48]
0
0
Canada
Query!
State/province [48]
0
0
Newfoundland and Labrador
Query!
Country [49]
0
0
Canada
Query!
State/province [49]
0
0
Nova Scotia
Query!
Country [50]
0
0
Canada
Query!
State/province [50]
0
0
Ontario
Query!
Country [51]
0
0
Canada
Query!
State/province [51]
0
0
Quebec
Query!
Country [52]
0
0
Chile
Query!
State/province [52]
0
0
Region Metropolitana
Query!
Country [53]
0
0
Colombia
Query!
State/province [53]
0
0
Antioquia
Query!
Country [54]
0
0
Colombia
Query!
State/province [54]
0
0
Atlantico
Query!
Country [55]
0
0
Colombia
Query!
State/province [55]
0
0
Cundinamarca
Query!
Country [56]
0
0
Colombia
Query!
State/province [56]
0
0
Santander
Query!
Country [57]
0
0
Croatia
Query!
State/province [57]
0
0
Osijek
Query!
Country [58]
0
0
Croatia
Query!
State/province [58]
0
0
Zagreb
Query!
Country [59]
0
0
Czechia
Query!
State/province [59]
0
0
Czech Republic
Query!
Country [60]
0
0
Czechia
Query!
State/province [60]
0
0
Ceske Budejovice
Query!
Country [61]
0
0
Czechia
Query!
State/province [61]
0
0
Hradec Kralove
Query!
Country [62]
0
0
Czechia
Query!
State/province [62]
0
0
Plzen-Bory
Query!
Country [63]
0
0
Czechia
Query!
State/province [63]
0
0
Praha 1
Query!
Country [64]
0
0
Czechia
Query!
State/province [64]
0
0
Praha 2
Query!
Country [65]
0
0
Czechia
Query!
State/province [65]
0
0
Usti nad Labem
Query!
Country [66]
0
0
Denmark
Query!
State/province [66]
0
0
Aarhus C
Query!
Country [67]
0
0
Denmark
Query!
State/province [67]
0
0
Copenhagen NV
Query!
Country [68]
0
0
Denmark
Query!
State/province [68]
0
0
Hellerup
Query!
Country [69]
0
0
Denmark
Query!
State/province [69]
0
0
Herning
Query!
Country [70]
0
0
Denmark
Query!
State/province [70]
0
0
Svendborg
Query!
Country [71]
0
0
Finland
Query!
State/province [71]
0
0
Tampere
Query!
Country [72]
0
0
France
Query!
State/province [72]
0
0
Cedex
Query!
Country [73]
0
0
France
Query!
State/province [73]
0
0
Lle-de-france
Query!
Country [74]
0
0
France
Query!
State/province [74]
0
0
Besancon
Query!
Country [75]
0
0
France
Query!
State/province [75]
0
0
Le Mans, Cedex 09
Query!
Country [76]
0
0
France
Query!
State/province [76]
0
0
Limoges
Query!
Country [77]
0
0
France
Query!
State/province [77]
0
0
Nantes Cedex 01
Query!
Country [78]
0
0
France
Query!
State/province [78]
0
0
Nice
Query!
Country [79]
0
0
France
Query!
State/province [79]
0
0
Pierre Benite
Query!
Country [80]
0
0
France
Query!
State/province [80]
0
0
Pierre-Benite
Query!
Country [81]
0
0
France
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Poitiers
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Reims
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Vandoeuvre les Nancy
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United Kingdom
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Peterbrough
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Pfizer
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Address
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Ethics approval
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT01163253
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Trial related presentations / publications
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. 2021 Sep;66(9):3214-3215. doi: 10.1007/s10620-020-06638-z. 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.
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Public notes
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Contacts
Principal investigator
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Pfizer CT.gov Call Center
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Pfizer
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
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
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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT01163253