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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01163253
First received: July 14, 2010
Last updated: May 30, 2017
Last verified: May 2017
  Purpose
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.

Condition Intervention Phase
Psoriasis Drug: CP-690,550 Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3, Multi-Site, Open-Label Study Of The Long Term Safety And Tolerability Of 2 Oral Doses Of CP-690,550 In Subjects With Moderate To Severe Chronic Plaque Psoriasis

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months) ]
    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 4 weeks after last dose (up to 67 months) that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events.

  • Number of Adverse Events (AEs) by Severity [ Time Frame: Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months) ]
    An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs were classified according to the severity in 3 categories: a) mild: AEs did not interfere with participant's usual function; b) moderate: AEs interfered to some extent with participant's usual function; c) severe: AEs interfered significantly with participant's usual function.

  • Number of Participants With Laboratory Abnormalities [ Time Frame: Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months) ]
    Abnormality criteria: hematology (hemoglobin, hematocrit, red blood cell <0.8*lower limit of normal [LLN]; reticulocyte<0.5*LLN,>1.5*ULN; platelets<0.5*LLN,>1.75* upper limit of normal [ULN]; WBC<0.6*LLN, >1.5*ULN; lymphocytes, neutrophils, basophils, eosinophils, monocytes<0.8*LLN; >1.2*ULN; coagulation (prothrombin [PT], PT ratio>1.1*ULN) liver function (bilirubin>1.5*ULN, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, gamma GT>0.3*ULN, protein, albumin<0.8*LLN; >1.2*ULN, globulin<0.5*LLN; >1.5*ULN); renal function (blood urea nitrogen, creatinine>1.3*ULN); electrolytes(sodium<0.95* LLN; >1.05* ULN, potassium, chloride, calcium, bicarbonate<0.9*LLN; >1.1*ULN), chemistry (glucose<0.6*LLN; >1.5* ULN), urinalysis (pH <4.5;>8, glucose, ketones, protein, blood, urobilinogen, nitrite, bilirubin, leukocyte esterase>=1; RBC, WBC>=20); lipids (cholesterol [C], LDL-C >1.3*ULN, HDL-C<0.8*LLN, triglycerides>1.3* ULN), hormones(T4, T3, T4, TSH<0.8* LLN; >1.2* ULN).

  • Change From Baseline in Hemoglobin Level at Month 1 [ Time Frame: Baseline, Month 1 ]
  • Change From Baseline in Hemoglobin Level at Month 3 [ Time Frame: Baseline, Month 3 ]
  • Change From Baseline in Hemoglobin Level at Month 6 [ Time Frame: Baseline, Month 6 ]
  • Change From Baseline in Hemoglobin Level at Month 12 [ Time Frame: Baseline, Month 12 ]
  • Change From Baseline in Hemoglobin Level at Month 24 [ Time Frame: Baseline, Month 24 ]
  • Change From Baseline in Hemoglobin Level at Month 36 [ Time Frame: Baseline, Month 36 ]
  • Change From Baseline in Hemoglobin Level at Month 48 [ Time Frame: Baseline, Month 48 ]
  • Change From Baseline in Lymphocyte and Neutrophil Count at Month 1 [ Time Frame: Baseline, Month 1 ]
  • Change From Baseline in Lymphocyte and Neutrophil Count at Month 3 [ Time Frame: Baseline, Month 3 ]
  • Change From Baseline in Lymphocyte and Neutrophil Count at Month 6 [ Time Frame: Baseline, Month 6 ]
  • Change From Baseline in Lymphocyte and Neutrophil Count at Month 12 [ Time Frame: Baseline, Month 12 ]
  • Change From Baseline in Lymphocyte and Neutrophil Count at Month 24 [ Time Frame: Baseline, Month 24 ]
  • Change From Baseline in Lymphocyte and Neutrophil Count at Month 36 [ Time Frame: Baseline, Month 36 ]
  • Change From Baseline in Lymphocyte and Neutrophil Count at Month 48 [ Time Frame: Baseline, Month 48 ]
  • Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 1 [ Time Frame: Baseline, Month 1 ]
  • Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 3 [ Time Frame: Baseline, Month 3 ]
  • Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 6 [ Time Frame: Baseline, Month 6 ]
  • Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 12 [ Time Frame: Baseline, Month 12 ]
  • Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 24 [ Time Frame: Baseline, Month 24 ]
  • Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 36 [ Time Frame: Baseline, Month 36 ]
  • Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 48 [ Time Frame: Baseline, Month 48 ]
  • Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 1 [ Time Frame: Baseline, Month 1 ]
  • Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 3 [ Time Frame: Baseline, Month 3 ]
  • Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 6 [ Time Frame: Baseline, Month 6 ]
  • Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 12 [ Time Frame: Baseline, Month 12 ]
  • Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 24 [ Time Frame: Baseline, Month 24 ]
  • Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 36 [ Time Frame: Baseline, Month 36 ]
  • Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 48 [ Time Frame: Baseline, Month 48 ]
  • Number of Participants With Clinically Significant Change From Baseline in Physical Examination [ Time Frame: Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months) ]
    Physical examinations included: general appearance; skin, head, eyes, ears, nose and throat; heart; lungs; abdomen; lower extremities (for the presence of peripheral edema) and lymph nodes. Clinical significance of change from baseline values in physical examination was based on investigator's discretion.

  • Number of Participants With Vital Sign Abnormalities [ Time Frame: Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months) ]
    Criteria for abnormalities in vital signs included: Systolic blood pressure (SBP): less than (<) 90 millimeter of mercury (mmHg) and maximum increase from baseline (IFB) of greater than or equal to (>=) 30 mmHg; diastolic blood pressure (DBP): <50 and greater than (>) 120 mmHg and maximum IFB of >=20 mmHg; heart rate: <40 and >120 beats per minute.

  • Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 1 [ Time Frame: Baseline, Month 1 ]
  • Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 3 [ Time Frame: Baseline, Month 3 ]
  • Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 6 [ Time Frame: Baseline, Month 6 ]
  • Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 12 [ Time Frame: Baseline, Month 12 ]
  • Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 24 [ Time Frame: Baseline, Month 24 ]
  • Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 36 [ Time Frame: Baseline, Month 36 ]
  • Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 48 [ Time Frame: Baseline, Month 48 ]
  • Change From Baseline in Heart Rate at Month 1 [ Time Frame: Baseline, Month 1 ]
  • Change From Baseline in Heart Rate at Month 3 [ Time Frame: Baseline, Month 3 ]
  • Change From Baseline in Heart Rate at Month 6 [ Time Frame: Baseline, Month 6 ]
  • Change From Baseline in Heart Rate at Month 12 [ Time Frame: Baseline, Month 12 ]
  • Change From Baseline in Heart Rate at Month 24 [ Time Frame: Baseline, Month 24 ]
  • Change From Baseline in Heart Rate at Month 36 [ Time Frame: Baseline, Month 36 ]
  • Change From Baseline in Heart Rate at Month 48 [ Time Frame: Baseline, Month 48 ]
  • Number of Participants With Electrocardiogram (ECG) Abnormalities [ Time Frame: Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months) ]
    Criteria for ECG abnormality: PR interval >=300 milliseconds (msec); QT interval >=500 msec; QTcB (Bazett's Correction) and QTcF (Fridericia's Correction) 450 to <480 msec, 480 to <500 msec and >=500 msec.

  • Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 6 [ Time Frame: Baseline, Month 6 ]
  • Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 12 [ Time Frame: Baseline, Month 12 ]
  • Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 24 [ Time Frame: Baseline, Month 24 ]
  • Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 36 [ Time Frame: Baseline, Month 36 ]
  • Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 48 [ Time Frame: Baseline, Month 48 ]
  • Number of Participants With Adjudicated Cardiovascular Events [ Time Frame: Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months) ]
    Adjudicated cardiovascular events were assessed by adjudication committee as independent reviewers based on event documentation including: hospital discharge summaries, operative reports, clinic notes, ECGs, diagnostic enzymes, results of other diagnostic tests, autopsy reports and death certificate information; as applicable.

  • Number of Participants With Malignancy Events [ Time Frame: Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months) ]
    Malignancy events included lymphoma, and demyelinating neurologic events. Biopsies collected for malignancy events were submitted to the central laboratory for pathologist over-read.


Secondary Outcome Measures:
  • Percentage of Participants Achieving Physician Global Assessment (PGA) Response of 'Clear' or 'Almost Clear' [ Time Frame: Month 1, 3, 6, 12, 24, 36, 48 ]
    The PGA of psoriasis was scored on a 5-point scale, reflecting a global consideration of the erythema (E), induration (I), and scaling (S) across all psoriatic lesions in participants. The severity rating scores (Erythema: 0= no evidence of erythema to 4= dark, deep red; Induration: 0= no evidence of plaque elevation to 4= marked plaque elevation, hard/sharp borders; Scaling: 0= no evidence of scaling to 4= thick, coarse scale predominates) were summed (E + I + S = total) and the average (total/3) was taken. The total average was rounded to the nearest whole number score to determine the PGA. The 5-point scale for PGA was: 0= clear; 1= almost clear; 2= mild; 3= moderate; 4= severe, where higher score indicated more severity of psoriasis. Percentage of participants with response of 'clear' (score of '0') and 'almost clear' (score of '1') were reported.

  • Percentage of Participants Achieving Greater Than or Equal to (>=) 75 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores [ Time Frame: Baseline, Month 1, 3, 6, 12, 24, 36, 48 ]
    PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Each component of severity, that is, erythema, induration and scaling was assessed separately for four body areas (head and neck [h], upper limbs [u], trunk [t] and lower limbs [l]) on a 5-point scale ranging from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity. Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head and neck: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4. Percentage of participants with >=75 percent (%) reduction from baseline in PASI scores were reported.

  • Psoriasis Area and Severity Index (PASI) Scores [ Time Frame: Baseline, Month 1, 3, 6, 12, 24, 36, 48 ]
    PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Each component of severity, that is, erythema, induration and scaling was assessed separately for four body areas (head and neck [h], upper limbs [u], trunk [t] and lower limbs [l]) on a 5-point scale ranging from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity. Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head and neck: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4.

  • Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores at Month 1, 3, 6, 12, 24, 36 and 48 [ Time Frame: Baseline, Month 1, 3, 6, 12, 24, 36, 48 ]
    PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Each component of severity, that is, erythema, induration and scaling was assessed separately for four body areas (head and neck [h], upper limbs [u], trunk [t] and lower limbs [l]) on a 5-point scale ranging from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity. Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head and neck: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4.

  • Psoriasis Area and Severity Index (PASI) Component Scores: Erythema [ Time Frame: Baseline, Month 1, 3, 6, 12, 24, 36, 48 ]
    PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Erythema was assessed separately for four body areas (head and neck, upper limbs, trunk and lower limbs) on a 5-point scale ranges from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity.

  • Psoriasis Area and Severity Index (PASI) Component Scores: Induration [ Time Frame: Baseline, Month 1, 3, 6, 12, 24, 36, 48 ]
    PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Induration was assessed separately for four body areas (head and neck, upper limbs, trunk and lower limbs) on a 5-point scale ranges from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity.

  • Psoriasis Area and Severity Index (PASI) Component Scores: Scaling [ Time Frame: Baseline, Month 1, 3, 6, 12, 24, 36, 48 ]
    PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Scaling was assessed separately for four body areas (head and neck, upper limbs, trunk and lower limbs) on a 5-point scale ranges from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity.

  • Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Erythema at Month 1, 3, 6, 12, 24, 36 and 48 [ Time Frame: Baseline, Month 1, 3, 6, 12, 24, 36, 48 ]
    PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Erythema was assessed separately for four body areas (head and neck, upper limbs, trunk and lower limbs) on a 5-point scale ranges from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity.

  • Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Induration at Month 1, 3, 6, 12, 24, 36 and 48 [ Time Frame: Baseline, Month 1, 3, 6, 12, 24, 36, 48 ]
    PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Induration was assessed separately for four body areas (head and neck, upper limbs, trunk and lower limbs) on a 5-point scale ranges from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity.

  • Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Scaling at Month 1, 3, 6, 12, 24, 36 and 48 [ Time Frame: Baseline, Month 1, 3, 6, 12, 24, 36, 48 ]
    PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Scaling was assessed separately for four body areas (head and neck, upper limbs, trunk and lower limbs) on a 5-point scale ranges from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity.

  • Percentage of Participants Achieving Greater Than or Equal to (>=) 50 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores [ Time Frame: Baseline, Month 1, 3, 6, 12, 24, 36, 48 ]
    PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Each component of severity, that is, erythema, induration and scaling was assessed separately for four body areas (head and neck [h], upper limbs [u], trunk [t] and lower limbs [l]) on a 5-point scale ranging from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity. Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head and neck: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4. Percentage of participants with >=50% reduction from baseline in PASI scores were reported.

  • Percentage of Participants Achieving Greater Than or Equal to (>=) 90 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores [ Time Frame: Baseline, Month 1, 3, 6, 12, 24, 36, 48 ]
    PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Each component of severity, that is, erythema, induration and scaling was assessed separately for four body areas (head and neck [h], upper limbs [u], trunk [t] and lower limbs [l]) on a 5-point scale ranging from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity. Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head and neck: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4. Percentage of participants with >=90% reduction from baseline in PASI scores were reported.

  • Percentage of Participants Achieving Greater Than or Equal to (>=) 125 Percent Increase From Baseline in Psoriasis Area and Severity Index (PASI) Scores [ Time Frame: Baseline, Month 1, 3, 6, 12, 24, 36, 48 ]
    PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Each component of severity, that is, erythema, induration and scaling was assessed separately for four body areas (head and neck [h], upper limbs [u], trunk [t] and lower limbs [l]) on a 5-point scale ranging from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity. Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head and neck: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4. Percentage of participants with >=125% increase from baseline in PASI scores were reported.

  • Itch Severity Item (ISI) Scores [ Time Frame: Baseline, Month 1, 3, 6, 12, 24, 36, 48 ]
    ISI assessed severity of itching due to psoriasis. ISI was a single item, horizontal numeric rating scale. Participants were asked to rate their 'severity of itching' due to psoriasis over the past 24 hours on a numeric rating scale anchored by the terms '0=no itching' and '10=worst possible itching' at the ends. Higher scores indicated greater severity of itching.

  • Change From Baseline in Itch Severity Item (ISI) Scores at Month 1, 3, 6, 12, 24, 36 and 48 [ Time Frame: Baseline, Month 1, 3, 6, 12, 24, 36, 48 ]
    ISI assessed severity of itching due to psoriasis. ISI was a single item, horizontal numeric rating scale. Participants were asked to rate their 'severity of itching' due to psoriasis over the past 24 hours on a numeric rating scale anchored by the terms '0=no itching' and '10=worst possible itching' at the ends. Higher scores indicated greater severity of itching.

  • Dermatology Life Quality Index (DLQI) Scores [ Time Frame: Baseline, Month 1, 6, 12, 24, 36, 48 ]
    The DLQI was a validated, self-administered, 10-item quality-of-life questionnaire that consisted of 10 items that assessed the impact of skin disease on quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). Each question was scored on a scale of 0=not at all/not relevant to 3=very much. Response from all of the 10 questions were added to derive the DLQI total scores. Total DLQI scores ranges from 0=not at all to 30=very much, with higher scores indicating greater impairment in quality of life.

  • Change From Baseline in Dermatology Life Quality Index (DLQI) Scores at Month 1, 6, 12, 24, 36 and 48 [ Time Frame: Baseline, Month 1, 6, 12, 24, 36, 48 ]
    The DLQI was a validated, self-administered, 10-item quality-of-life questionnaire that consisted of 10 items that assessed the impact of skin disease on quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). Each question was scored on a scale of 0=not at all/not relevant to 3=very much. Response from all of the 10 questions were added to derive the DLQI total scores. Total DLQI scores ranges from 0=not at all to 30=very much, with higher scores indicating greater impairment in quality of life.

  • 36-Item Short-Form (SF-36) Health Survey Version 2, Acute: Physical Component Summary Scores [ Time Frame: Baseline, Month 6, 12, 24, 36, 48 ]
    The SF-36 questionnaire, version 2, acute was a 36-item generic health status measure. SF-36 evaluated 8 health-related aspects of an individual: physical functioning, role-physical, bodily pain, social functioning, mental health, role emotional, vitality, and general health. The score range for each of the 8 health aspects ranged from 0 (worst) to 100 (best), with higher scores indicating good health condition. Two summary scale scores were computed from the 8 health aspect scores: physical component summary score and mental component summary score. Score range for both summary scales ranged from 0 (worst) to 100 (best), with higher scores indicating good health condition.

  • 36-Item Short-Form (SF-36) Health Survey Version 2, Acute: Mental Component Summary Scores [ Time Frame: Baseline, Month 6, 12, 24, 36, 48 ]
    The SF-36 questionnaire, version 2 was a 36-item generic health status measure. SF-36 evaluated 8 health-related aspects of an individual: physical functioning, role-physical, bodily pain, social functioning, mental health, role emotional, vitality, and general health. The score range for each of the 8 health aspects ranged from 0 (worst) to 100 (best), with higher scores indicating good health condition. Two summary scale scores were computed from the 8 health aspect scores: the Physical Component Summary and the Mental Component Summary. Score range for both summary scale ranged from 0 (worst) to 100 (best), with higher scores indicating good health condition.

  • Number of Participants With Patient Global Assessment (PtGA) Response of "Clear" or "Almost Clear" [ Time Frame: Baseline, Month 1, 3, 6, 12, 24, 36, 48 ]
    The PtGA evaluated the overall skin disease of participants at that point in time on a single-item. Participants provided their response on a 5-point scale ranges from: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe. Higher score indicated greater severity of disease. Participants who provided their response as "clear (score of 0)" or "almost clear (score of 1)" in PtGA at each specified visit were reported in this outcome measure.

  • Euro Quality of Life- 5-Dimensions (EQ-5D)-Utility Scores [ Time Frame: Baseline, Month 6, 12, 24, 36, 48 ]
    EQ-5D: participant rated 5-dimension (mobility, self-care, usual activities, pain and discomfort, and anxiety and depression) questionnaire to assess health-related quality of life in terms of a single utility score. Each dimension was assessed on a 3-point scale (1=no problems, 2=some problems, 3=extreme problems, where higher scores=worse health condition). The responses from the 5 dimensions were used to calculate a single utility index value. Scoring formula developed by EuroQol Group assigned a utility value for each dimension in the profile. Score was transformed and results in a total score range -0.594 to 1.000; higher score indicated a better health state.

  • Euro Quality of Life-5-Dimensions (EQ-5D)-Visual Analogue Scale Scores (VAS) [ Time Frame: Baseline, Month 6, 12, 24, 36, 48 ]
    EQ-5D VAS was a participant rated questionnaire to assess health-related quality of life in terms of a single index value. It was a visual analogue scale that ranged from 0 (minimum) to 100 (maximum), with higher scores indicating a better health condition.

  • Number of Participants Who Answered Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) [ Time Frame: Baseline, Month 1, 3, 6, 12, 24, 36, 48 ]
    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.


Enrollment: 2867
Study Start Date: September 2010
Study Completion Date: June 2016
Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Drug: CP-690,550
5 mg oral BID
Drug: CP-690,550
10 mg oral BID

Detailed Description:
The study terminated on 08MAR2016 as it met its objectives of characterizing long term safety and tolerability. The study did not terminate due to safety concerns.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have participated in qualifying study with CP-690,550 and are 18 years or older with diagnosis of plaque-type psoriasis (psoriasis vulgaris).

Exclusion Criteria:

  • Non-plaque or drug induced forms of psoriasis;
  • Cannot discontinue current oral, injectable or topical therapy for psoriasis or cannot discontinue phototherapy (PUVA or UVB).
  • Any uncontrolled significant medical condition.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01163253

  Show 323 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01163253     History of Changes
Other Study ID Numbers: A3921061
2010-020002-15 ( EudraCT Number )
Study First Received: July 14, 2010
Results First Received: May 30, 2017
Last Updated: May 30, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Information relating to our policy on data sharing and the process for requesting data can be found at the following link:

http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests


Keywords provided by Pfizer:
chronic
severe
treatment
safety
CP-690,55
Plaque Psoriasis
Psoriasis Vulgaris
Xeljanz
Tofacitinib

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Tofacitinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 22, 2017