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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
Date last updated
26/06/2017

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
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
Secondary ID [1] 0 0
2010-020002-15
Secondary ID [2] 0 0
A3921061
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psoriasis 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timepoint [1] 0 0
Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)
Primary outcome [2] 0 0
Number of Adverse Events (AEs) by Severity
Timepoint [2] 0 0
Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)
Primary outcome [3] 0 0
Number of Participants With Laboratory Abnormalities
Timepoint [3] 0 0
Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)
Primary outcome [4] 0 0
Change From Baseline in Hemoglobin Level at Month 1
Timepoint [4] 0 0
Baseline, Month 1
Primary outcome [5] 0 0
Change From Baseline in Hemoglobin Level at Month 3
Timepoint [5] 0 0
Baseline, Month 3
Primary outcome [6] 0 0
Change From Baseline in Hemoglobin Level at Month 6
Timepoint [6] 0 0
Baseline, Month 6
Primary outcome [7] 0 0
Change From Baseline in Hemoglobin Level at Month 12
Timepoint [7] 0 0
Baseline, Month 12
Primary outcome [8] 0 0
Change From Baseline in Hemoglobin Level at Month 24
Timepoint [8] 0 0
Baseline, Month 24
Primary outcome [9] 0 0
Change From Baseline in Hemoglobin Level at Month 36
Timepoint [9] 0 0
Baseline, Month 36
Primary outcome [10] 0 0
Change From Baseline in Hemoglobin Level at Month 48
Timepoint [10] 0 0
Baseline, Month 48
Primary outcome [11] 0 0
Change From Baseline in Lymphocyte and Neutrophil Count at Month 1
Timepoint [11] 0 0
Baseline, Month 1
Primary outcome [12] 0 0
Change From Baseline in Lymphocyte and Neutrophil Count at Month 3
Timepoint [12] 0 0
Baseline, Month 3
Primary outcome [13] 0 0
Change From Baseline in Lymphocyte and Neutrophil Count at Month 6
Timepoint [13] 0 0
Baseline, Month 6
Primary outcome [14] 0 0
Change From Baseline in Lymphocyte and Neutrophil Count at Month 12
Timepoint [14] 0 0
Baseline, Month 12
Primary outcome [15] 0 0
Change From Baseline in Lymphocyte and Neutrophil Count at Month 24
Timepoint [15] 0 0
Baseline, Month 24
Primary outcome [16] 0 0
Change From Baseline in Lymphocyte and Neutrophil Count at Month 36
Timepoint [16] 0 0
Baseline, Month 36
Primary outcome [17] 0 0
Change From Baseline in Lymphocyte and Neutrophil Count at Month 48
Timepoint [17] 0 0
Baseline, Month 48
Primary outcome [18] 0 0
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
Timepoint [18] 0 0
Baseline, Month 1
Primary outcome [19] 0 0
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
Timepoint [19] 0 0
Baseline, Month 3
Primary outcome [20] 0 0
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
Timepoint [20] 0 0
Baseline, Month 6
Primary outcome [21] 0 0
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
Timepoint [21] 0 0
Baseline, Month 12
Primary outcome [22] 0 0
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
Timepoint [22] 0 0
Baseline, Month 24
Primary outcome [23] 0 0
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
Timepoint [23] 0 0
Baseline, Month 36
Primary outcome [24] 0 0
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
Timepoint [24] 0 0
Baseline, Month 48
Primary outcome [25] 0 0
Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 1
Timepoint [25] 0 0
Baseline, Month 1
Primary outcome [26] 0 0
Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 3
Timepoint [26] 0 0
Baseline, Month 3
Primary outcome [27] 0 0
Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 6
Timepoint [27] 0 0
Baseline, Month 6
Primary outcome [28] 0 0
Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 12
Timepoint [28] 0 0
Baseline, Month 12
Primary outcome [29] 0 0
Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 24
Timepoint [29] 0 0
Baseline, Month 24
Primary outcome [30] 0 0
Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 36
Timepoint [30] 0 0
Baseline, Month 36
Primary outcome [31] 0 0
Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 48
Timepoint [31] 0 0
Baseline, Month 48
Primary outcome [32] 0 0
Number of Participants With Clinically Significant Change From Baseline in Physical Examination
Timepoint [32] 0 0
Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)
Primary outcome [33] 0 0
Number of Participants With Vital Sign Abnormalities
Timepoint [33] 0 0
Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)
Primary outcome [34] 0 0
Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 1
Timepoint [34] 0 0
Baseline, Month 1
Primary outcome [35] 0 0
Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 3
Timepoint [35] 0 0
Baseline, Month 3
Primary outcome [36] 0 0
Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 6
Timepoint [36] 0 0
Baseline, Month 6
Primary outcome [37] 0 0
Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 12
Timepoint [37] 0 0
Baseline, Month 12
Primary outcome [38] 0 0
Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 24
Timepoint [38] 0 0
Baseline, Month 24
Primary outcome [39] 0 0
Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 36
Timepoint [39] 0 0
Baseline, Month 36
Primary outcome [40] 0 0
Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 48
Timepoint [40] 0 0
Baseline, Month 48
Primary outcome [41] 0 0
Change From Baseline in Heart Rate at Month 1
Timepoint [41] 0 0
Baseline, Month 1
Primary outcome [42] 0 0
Change From Baseline in Heart Rate at Month 3
Timepoint [42] 0 0
Baseline, Month 3
Primary outcome [43] 0 0
Change From Baseline in Heart Rate at Month 6
Timepoint [43] 0 0
Baseline, Month 6
Primary outcome [44] 0 0
Change From Baseline in Heart Rate at Month 12
Timepoint [44] 0 0
Baseline, Month 12
Primary outcome [45] 0 0
Change From Baseline in Heart Rate at Month 24
Timepoint [45] 0 0
Baseline, Month 24
Primary outcome [46] 0 0
Change From Baseline in Heart Rate at Month 36
Timepoint [46] 0 0
Baseline, Month 36
Primary outcome [47] 0 0
Change From Baseline in Heart Rate at Month 48
Timepoint [47] 0 0
Baseline, Month 48
Primary outcome [48] 0 0
Number of Participants With Electrocardiogram (ECG) Abnormalities
Timepoint [48] 0 0
Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)
Primary outcome [49] 0 0
Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 6
Timepoint [49] 0 0
Baseline, Month 6
Primary outcome [50] 0 0
Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 12
Timepoint [50] 0 0
Baseline, Month 12
Primary outcome [51] 0 0
Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 24
Timepoint [51] 0 0
Baseline, Month 24
Primary outcome [52] 0 0
Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 36
Timepoint [52] 0 0
Baseline, Month 36
Primary outcome [53] 0 0
Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 48
Timepoint [53] 0 0
Baseline, Month 48
Primary outcome [54] 0 0
Number of Participants With Adjudicated Cardiovascular Events
Timepoint [54] 0 0
Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)
Primary outcome [55] 0 0
Number of Participants With Malignancy Events
Timepoint [55] 0 0
Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)
Secondary outcome [1] 0 0
Percentage of Participants Achieving Physician Global Assessment (PGA) Response of 'Clear' or 'Almost Clear'
Timepoint [1] 0 0
Month 1, 3, 6, 12, 24, 36, 48
Secondary outcome [2] 0 0
Percentage of Participants Achieving Greater Than or Equal to (>=) 75 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores
Timepoint [2] 0 0
Baseline, Month 1, 3, 6, 12, 24, 36, 48
Secondary outcome [3] 0 0
Psoriasis Area and Severity Index (PASI) Scores
Timepoint [3] 0 0
Baseline, Month 1, 3, 6, 12, 24, 36, 48
Secondary outcome [4] 0 0
Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores at Month 1, 3, 6, 12, 24, 36 and 48
Timepoint [4] 0 0
Baseline, Month 1, 3, 6, 12, 24, 36, 48
Secondary outcome [5] 0 0
Psoriasis Area and Severity Index (PASI) Component Scores: Erythema
Timepoint [5] 0 0
Baseline, Month 1, 3, 6, 12, 24, 36, 48
Secondary outcome [6] 0 0
Psoriasis Area and Severity Index (PASI) Component Scores: Induration
Timepoint [6] 0 0
Baseline, Month 1, 3, 6, 12, 24, 36, 48
Secondary outcome [7] 0 0
Psoriasis Area and Severity Index (PASI) Component Scores: Scaling
Timepoint [7] 0 0
Baseline, Month 1, 3, 6, 12, 24, 36, 48
Secondary outcome [8] 0 0
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Erythema at Month 1, 3, 6, 12, 24, 36 and 48
Timepoint [8] 0 0
Baseline, Month 1, 3, 6, 12, 24, 36, 48
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
Timepoint [9] 0 0
Baseline, Month 1, 3, 6, 12, 24, 36, 48
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
Timepoint [10] 0 0
Baseline, Month 1, 3, 6, 12, 24, 36, 48
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
Timepoint [11] 0 0
Baseline, Month 1, 3, 6, 12, 24, 36, 48
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
Timepoint [12] 0 0
Baseline, Month 1, 3, 6, 12, 24, 36, 48
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
Timepoint [13] 0 0
Baseline, Month 1, 3, 6, 12, 24, 36, 48
Secondary outcome [14] 0 0
Itch Severity Item (ISI) Scores
Timepoint [14] 0 0
Baseline, Month 1, 3, 6, 12, 24, 36, 48
Secondary outcome [15] 0 0
Change From Baseline in Itch Severity Item (ISI) Scores at Month 1, 3, 6, 12, 24, 36 and 48
Timepoint [15] 0 0
Baseline, Month 1, 3, 6, 12, 24, 36, 48
Secondary outcome [16] 0 0
Dermatology Life Quality Index (DLQI) Scores
Timepoint [16] 0 0
Baseline, Month 1, 6, 12, 24, 36, 48
Secondary outcome [17] 0 0
Change From Baseline in Dermatology Life Quality Index (DLQI) Scores at Month 1, 6, 12, 24, 36 and 48
Timepoint [17] 0 0
Baseline, Month 1, 6, 12, 24, 36, 48
Secondary outcome [18] 0 0
36-Item Short-Form (SF-36) Health Survey Version 2, Acute: Physical Component Summary Scores
Timepoint [18] 0 0
Baseline, Month 6, 12, 24, 36, 48
Secondary outcome [19] 0 0
36-Item Short-Form (SF-36) Health Survey Version 2, Acute: Mental Component Summary Scores
Timepoint [19] 0 0
Baseline, Month 6, 12, 24, 36, 48
Secondary outcome [20] 0 0
Number of Participants With Patient Global Assessment (PtGA) Response of "Clear" or "Almost Clear"
Timepoint [20] 0 0
Baseline, Month 1, 3, 6, 12, 24, 36, 48
Secondary outcome [21] 0 0
Euro Quality of Life- 5-Dimensions (EQ-5D)-Utility Scores
Timepoint [21] 0 0
Baseline, Month 6, 12, 24, 36, 48
Secondary outcome [22] 0 0
Euro Quality of Life-5-Dimensions (EQ-5D)-Visual Analogue Scale Scores (VAS)
Timepoint [22] 0 0
Baseline, Month 6, 12, 24, 36, 48
Secondary outcome [23] 0 0
Number of Participants Who Answered Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU)
Timepoint [23] 0 0
Baseline, Month 1, 3, 6, 12, 24, 36, 48

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).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2016
Sample size
Target
Accrual to date
Final
2867
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Dr. Glenn and Partners - Kogarah
Recruitment hospital [2] 0 0
Premier Dermatology - Kogarah
Recruitment hospital [3] 0 0
Emeritus Research - Malvern East
Recruitment hospital [4] 0 0
Malvern Diagnostic Imaging - Malvern
Recruitment hospital [5] 0 0
Skin And Cancer Foundation - Melbourne
Recruitment postcode(s) [1] 0 0
02217 - Kogarah
Recruitment postcode(s) [2] 0 0
3145 - Malvern East
Recruitment postcode(s) [3] 0 0
3144 - Malvern
Recruitment postcode(s) [4] 0 0
3053 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Colorado
Country [6] 0 0
United States of America
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Connecticut
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United States of America
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Florida
Country [8] 0 0
United States of America
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Georgia
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United States of America
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Illinois
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Indiana
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Kentucky
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Massachusetts
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Michigan
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Minnesota
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Missouri
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Nebraska
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Nevada
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New Hampshire
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New Jersey
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New York
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North Carolina
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Ohio
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Oklahoma
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Oregon
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Pennsylvania
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Rhode Island
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South Carolina
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South Dakota
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Tennessee
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Texas
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United States of America
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Virginia
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Washington
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West Virginia
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United States of America
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Wisconsin
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Argentina
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Caba
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Austria
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Feldkirch
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Austria
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Salzburg
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Belgium
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Brussels
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Bosnia and Herzegovina
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Sarajevo
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Brazil
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SP
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Brazil
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Rio De Janeiro
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Brazil
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Sao Paulo
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Pleven
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Sofia
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Manitoba
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Newfoundland and Labrador
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Canada
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Nova Scotia
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Canada
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Ontario
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Canada
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Quebec
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Chile
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Region Metropolitana
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Colombia
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Antioquia
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Colombia
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Atlantico
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Colombia
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Cundinamarca
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Colombia
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Santander
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Croatia
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Osijek
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Zagreb
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Ceske Budejovice
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Hradec Kralove
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Czechia
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Plzen-Bory
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Czechia
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Praha 1
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Czechia
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Praha 2
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Czechia
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Usti nad Labem
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Denmark
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Aarhus C
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Denmark
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Copenhagen NV
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Denmark
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Hellerup
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Denmark
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Herning
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Svendborg
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Finland
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Tampere
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Cedex
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Lle-de-france
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Besancon
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Limoges
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Nice
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Pierre Benite
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Pierre-Benite
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Poitiers
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France
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Reims
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France
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Saint Priest En Jarez
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France
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Toulouse
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France
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Vandoeuvre les Nancy
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Germany
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Baden-wuerttemberg
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Germany
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Schleswig-holstein
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Germany
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Berlin
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Germany
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Bonn
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Germany
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Buchholz
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Germany
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Dresden
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Germany
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Erlangen
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Germany
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Frankfurt/Main
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Germany
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Halle
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Germany
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Hamburg
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Germany
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Hanau
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Germany
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Heidelberg
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Germany
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Kiel
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Germany
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Koeln
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Germany
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Luebeck
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Germany
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Mahlow
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Peterbrough

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT01163253
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.
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01163253