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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01163253
Recruitment Status : Terminated
First Posted : July 15, 2010
Results First Posted : June 26, 2017
Last Update Posted : June 26, 2017
Sponsor:
Information provided by (Responsible Party):
Pfizer

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.

Condition or disease Intervention/treatment Phase
Psoriasis Drug: CP-690,550 Phase 3

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2867 participants
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
Study Start Date : September 2010
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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).

  4. Change From Baseline in Hemoglobin Level at Month 1 [ Time Frame: Baseline, Month 1 ]
  5. Change From Baseline in Hemoglobin Level at Month 3 [ Time Frame: Baseline, Month 3 ]
  6. Change From Baseline in Hemoglobin Level at Month 6 [ Time Frame: Baseline, Month 6 ]
  7. Change From Baseline in Hemoglobin Level at Month 12 [ Time Frame: Baseline, Month 12 ]
  8. Change From Baseline in Hemoglobin Level at Month 24 [ Time Frame: Baseline, Month 24 ]
  9. Change From Baseline in Hemoglobin Level at Month 36 [ Time Frame: Baseline, Month 36 ]
  10. Change From Baseline in Hemoglobin Level at Month 48 [ Time Frame: Baseline, Month 48 ]
  11. Change From Baseline in Lymphocyte and Neutrophil Count at Month 1 [ Time Frame: Baseline, Month 1 ]
  12. Change From Baseline in Lymphocyte and Neutrophil Count at Month 3 [ Time Frame: Baseline, Month 3 ]
  13. Change From Baseline in Lymphocyte and Neutrophil Count at Month 6 [ Time Frame: Baseline, Month 6 ]
  14. Change From Baseline in Lymphocyte and Neutrophil Count at Month 12 [ Time Frame: Baseline, Month 12 ]
  15. Change From Baseline in Lymphocyte and Neutrophil Count at Month 24 [ Time Frame: Baseline, Month 24 ]
  16. Change From Baseline in Lymphocyte and Neutrophil Count at Month 36 [ Time Frame: Baseline, Month 36 ]
  17. Change From Baseline in Lymphocyte and Neutrophil Count at Month 48 [ Time Frame: Baseline, Month 48 ]
  18. 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 ]
  19. 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 ]
  20. 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 ]
  21. 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 ]
  22. 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 ]
  23. 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 ]
  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 48 [ Time Frame: Baseline, Month 48 ]
  25. Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 1 [ Time Frame: Baseline, Month 1 ]
  26. Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 3 [ Time Frame: Baseline, Month 3 ]
  27. Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 6 [ Time Frame: Baseline, Month 6 ]
  28. Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 12 [ Time Frame: Baseline, Month 12 ]
  29. Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 24 [ Time Frame: Baseline, Month 24 ]
  30. Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 36 [ Time Frame: Baseline, Month 36 ]
  31. Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 48 [ Time Frame: Baseline, Month 48 ]
  32. 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.

  33. 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.

  34. Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 1 [ Time Frame: Baseline, Month 1 ]
  35. Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 3 [ Time Frame: Baseline, Month 3 ]
  36. Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 6 [ Time Frame: Baseline, Month 6 ]
  37. Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 12 [ Time Frame: Baseline, Month 12 ]
  38. Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 24 [ Time Frame: Baseline, Month 24 ]
  39. Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 36 [ Time Frame: Baseline, Month 36 ]
  40. Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 48 [ Time Frame: Baseline, Month 48 ]
  41. Change From Baseline in Heart Rate at Month 1 [ Time Frame: Baseline, Month 1 ]
  42. Change From Baseline in Heart Rate at Month 3 [ Time Frame: Baseline, Month 3 ]
  43. Change From Baseline in Heart Rate at Month 6 [ Time Frame: Baseline, Month 6 ]
  44. Change From Baseline in Heart Rate at Month 12 [ Time Frame: Baseline, Month 12 ]
  45. Change From Baseline in Heart Rate at Month 24 [ Time Frame: Baseline, Month 24 ]
  46. Change From Baseline in Heart Rate at Month 36 [ Time Frame: Baseline, Month 36 ]
  47. Change From Baseline in Heart Rate at Month 48 [ Time Frame: Baseline, Month 48 ]
  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.

  49. Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 6 [ Time Frame: Baseline, Month 6 ]
  50. Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 12 [ Time Frame: Baseline, Month 12 ]
  51. Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 24 [ Time Frame: Baseline, Month 24 ]
  52. Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 36 [ Time Frame: Baseline, Month 36 ]
  53. Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 48 [ Time Frame: Baseline, Month 48 ]
  54. 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.

  55. 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 :
  1. 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.

  2. 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.

  3. 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.

  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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. 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.

  21. 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.

  22. 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.

  23. 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.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01163253


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Locations
Layout table for location information
United States, Alabama
Radiant Research, Inc.
Birmingham, Alabama, United States, 35209
UAB Dermatology
Birmingham, Alabama, United States, 35233
Horizon Research Group, Inc.
Mobile, Alabama, United States, 36608
United States, Arizona
Radiant Research, Inc.
Tucson, Arizona, United States, 85712
United States, Arkansas
Burke Pharmaceutical Research
Hot Springs, Arkansas, United States, 71913
United States, California
Bakersfield Dermatology and Skin Cancer Medical Group
Bakersfield, California, United States, 93309
Associates In Research, Inc.
Fresno, California, United States, 93720
University of California Irvine
Irvine, California, United States, 92697
Dermatology Research Associates
Los Angeles, California, United States, 90045
Dermatology Specialists, Inc.
Oceanside, California, United States, 92056
MedDerm Associates
San Diego, California, United States, 92103
UCSD Dermatology
San Diego, California, United States, 92122
University of California San Diego
San Diego, California, United States, 92122
University of California San Francisco
San Francisco, California, United States, 94118
Clinical Science Institute
Santa Monica, California, United States, 90404
Healthcare Partners Medical Group
Torrance, California, United States, 90503
United States, Colorado
Cherry Creek Research, Inc.
Denver, Colorado, United States, 80209
United States, Connecticut
The Savin Center, P.C.
New Haven, Connecticut, United States, 06511
New England Research Associates, LLC
Trumbull, Connecticut, United States, 06611
United States, Florida
Florida Academic Dermatology Center
Coral Gables, Florida, United States, 33134
North Florida Dermatology Associates, PA
Jacksonville, Florida, United States, 32204
International Dermatology Research, Inc.
Miami, Florida, United States, 33144
Renstar Medical Research
Ocala, Florida, United States, 34471
Park Avenue Dermatology, PA
Orange Park, Florida, United States, 32073
Leavitt Medical Associates of Florida dba Ameriderm Research
Ormond Beach, Florida, United States, 32174
Miami Research Associates, Inc.
South Miami, Florida, United States, 33143
Olympian Clinical Research
Tampa, Florida, United States, 33609
United States, Georgia
Atlanta Dermatology, Vein & Research Center, P.C.
Alpharetta, Georgia, United States, 30022
Advanced Medical Research, Inc.
Atlanta, Georgia, United States, 30342
MedaPhase Inc.
Newnan, Georgia, United States, 30263
United States, Illinois
Altman Dermatology Associates
Arlington Heights, Illinois, United States, 60005
Schaumburg Dermatology
Schaumburg, Illinois, United States, 60173
NorthShore University Health System - Division of Dermatology
Skokie, Illinois, United States, 60077
Springfield Clinic
Springfield, Illinois, United States, 62703
Dundee Dermatology
West Dundee, Illinois, United States, 60118
United States, Indiana
Deaconess Clinic Downtown Research Institute
Evansville, Indiana, United States, 47713
Hudson Dermatology
Evansville, Indiana, United States, 47714
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, United States, 46256
United States, Kentucky
DermResearch, PLLC
Louisville, Kentucky, United States, 40217
United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111-1552
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Massachusetts General Hospital - Clinical Unit for Research Trials and Outcomes in Skin
Boston, Massachusetts, United States, 02114
United States, Michigan
Michigan Center for Research Corporation dba Michigan Center for Skin Care Research
Clinton, Michigan, United States, 48038
Hamzavi Dermatology
Fort Gratiot, Michigan, United States, 48059
Somerset Skin Centre - Dermcenter
Troy, Michigan, United States, 48084
United States, Minnesota
Minnesota Clinical Study Center
Fridley, Minnesota, United States, 55432
United States, Missouri
Saint Louis University - Department of Dermatology
Saint Louis, Missouri, United States, 63104
United States, Nebraska
Skin Specialists, P.C
Omaha, Nebraska, United States, 68144
United States, Nevada
Bettencourt Skin Center
Henderson, Nevada, United States, 89074
United States, New Hampshire
Dartmouth-Hitchcock Medical Center-Norris Cotton Cancer Center
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
Centennial Center-Comprehensive Clinical Research
Berlin, New Jersey, United States, 08009
United States, New York
New York University (NYU) School of Medicine - Investigational Pharmacy (IP Shipment, Pharmacy)
New York, New York, United States, 10016
NYU Langone Medical Center, Ambulatory Care Center, Department of Dermatology, Clinical Studies Unit
New York, New York, United States, 10016
The Rockefeller University
New York, New York, United States, 10065 6307
United States, North Carolina
University of North Carolina at Chapel Hill- Hospital
Chapel Hill, North Carolina, United States, 27514
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27516
Duke University Medical Center
Durham, North Carolina, United States, 27710
Dermatology Consulting Services
High Point, North Carolina, United States, 27262
Wake Dermatology Associates, LLC
Raleigh, North Carolina, United States, 27607
Wake Research Associates
Raleigh, North Carolina, United States, 27612
Dermatology Associates
Wilmington, North Carolina, United States, 28401
PMG Research of Wilmington, LLC
Wilmington, North Carolina, United States, 28401
Piedmont Imaging
Winston-Salem, North Carolina, United States, 27103
PMG Research of Winston-Salem
Winston-Salem, North Carolina, United States, 27103
Triad Dermatology, PA
Winston-Salem, North Carolina, United States, 27103
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27104
United States, Ohio
Jewish Hospital
Cincinnati, Ohio, United States, 45236
Radiant Research, Inc.
Cincinnati, Ohio, United States, 45249
IP ONLY: University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44106
University Hospitals Case Medical Center/Dept. of Dermatology
Cleveland, Ohio, United States, 44106
University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44106
United States, Oklahoma
Central Sooner Research
Norman, Oklahoma, United States, 73071
United States, Oregon
Baker Allergy Asthma and Dermatology Research Center, LLC
Lake Oswego, Oregon, United States, 97035
Oregon Dermatology and Research Center
Portland, Oregon, United States, 97210
Oregon Health & Science University
Portland, Oregon, United States, 97239
United States, Pennsylvania
University of Pittsburgh Medical Center - Department of Dermatology
Pittsburgh, Pennsylvania, United States, 15213
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
United States, Rhode Island
Clinical Partners, LLC
Johnston, Rhode Island, United States, 02919
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
United States, South Carolina
Office of John Michael Humeniuk, MD
Greer, South Carolina, United States, 29650
Radiant Research, Inc.
Greer, South Carolina, United States, 29650
United States, South Dakota
Health Concepts
Rapid City, South Dakota, United States, 57702
United States, Tennessee
Rivergate Dermatology Clinical Research Center, PLLC
Goodlettsville, Tennessee, United States, 37072
Dermatology Associates of Knoxville PC
Knoxville, Tennessee, United States, 37917
Dermatology Research Associates
Nashville, Tennessee, United States, 37203
United States, Texas
Arlington Research Center, Inc.
Arlington, Texas, United States, 76011
Dermatology Treatment & Research Center
Dallas, Texas, United States, 75230
Modern Research Associates, PLLC
Dallas, Texas, United States, 75231
Menter Dermatology Research Institute
Dallas, Texas, United States, 75246
Center for Clinical Studies
Houston, Texas, United States, 77004
Suzanne Bruce and Associates, PA
Houston, Texas, United States, 77056
Office of Mark Lee, MD
San Antonio, Texas, United States, 78229
Progressive Clinical research, P.A.
San Antonio, Texas, United States, 78229
Stephen Miller, MD, PA
San Antonio, Texas, United States, 78249
Center for Clinical Studies
Webster, Texas, United States, 77598
United States, Virginia
Virginia Clinical Research, Inc.
Norfolk, Virginia, United States, 23502
Virginia Clinical Research, Inc.
Norfolk, Virginia, United States, 23507
United States, Washington
Rockwood Research Center
Spokane, Washington, United States, 99202
Wenatchee Valley Hospital & Clinics
Wenatchee, Washington, United States, 98801
United States, West Virginia
Mountain State Clinical Research
Bridgeport, West Virginia, United States, 26330
United States, Wisconsin
Madison Skin and Research, Inc.
Madison, Wisconsin, United States, 53719
Argentina
Centro De Investigaciones Dermatologicas
Caba, Argentina, C1114AAP
CENIT Centro de Neurociencias Investigacion y Tratamiento
Caba, Argentina, C1125ABD
Australia, New South Wales
Dr. Glenn and Partners
Kogarah, New South Wales, Australia, 02217
Premier Dermatology
Kogarah, New South Wales, Australia, 02217
Australia, Victoria
Emeritus Research
Malvern East, Victoria, Australia, 3145
Malvern Diagnostic Imaging
Malvern, Victoria, Australia, 3144
Skin And Cancer Foundation
Melbourne, Victoria, Australia, 3053
Austria
LKH Feldkirch
Feldkirch, Austria, 6807
LKH Salzburg, Landesklinik fuer Dermatologie
Salzburg, Austria, 5020
Belgium
Cliniques Universitaires Saint-Luc
Brussels, Belgium, 1200
Bosnia and Herzegovina
UHC Sarajevo
Sarajevo, Bosnia and Herzegovina, 71000
Brazil
Hospital da Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
Sao Paulo, SP, Brazil, 05403-900
Instituto de Dermatologia e Estetica do Brasil LTDA - IDERJ
Rio De Janeiro, Brazil, 22470-220
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
Sao Paulo, Brazil, 05403-000
Bulgaria
UMHAT "Dr Georgi Stranski"
Pleven, Bulgaria, 5800
UMHAT "Dr. Georgi Stranski" - II clinical base
Pleven, Bulgaria, 5800
Tsentar za kozhno venericheski zaboliavania EOOD
Sofia, Bulgaria, 1404
Mnogoprofilna Bolnitsa Za Aktivno Lechenie- Tokuda Bolnitsa
Sofia, Bulgaria, 1407
UMBAL-Alexandrovska- Sofia Klinika po dermatologia i venerologia
Sofia, Bulgaria, 1431
MBAL na Voennomeditsinska Akademia
Sofia, Bulgaria, 1606
Canada, Alberta
Kirk Barber Research
Calgary, Alberta, Canada, T2G 1B1
Northwest Dermatology & Laser Centre
Calgary, Alberta, Canada, T3G 0B4
Stratica Medical
Edmonton, Alberta, Canada, T5K 1X3
Canada, British Columbia
Enverus Medical Research
Surrey, British Columbia, Canada, V3V 0C6
Derm Research @888 Inc
Vancouver, British Columbia, Canada, V5Z 3Y1
The Skin Centre
Vancouver, British Columbia, Canada, V5Z 4E8
Percuro Clinical Research Limited
Victoria, British Columbia, Canada, V8V 3P9
Canada, Manitoba
Dermadvances Research
Winnipeg, Manitoba, Canada, R3C 1R4
Wiseman Dermatology Research Inc.
Winnipeg, Manitoba, Canada, R3M 3Z4
Canada, Newfoundland and Labrador
Nexus Clinical Research
St. John's, Newfoundland and Labrador, Canada, A1A 5E8
Dr. Zohair Tomi PMC Inc. Paton Medical Centre
St. John's, Newfoundland and Labrador, Canada, A1B 4S8
NewLab Clinical Research Inc.
St. John's, Newfoundland and Labrador, Canada, A1C 2H5
Canada, Nova Scotia
Eastern Canada Cutaneous Research Associates Ltd.
Halifax, Nova Scotia, Canada, B3H 1Z2
Canada, Ontario
CCA Medical Research
Ajax, Ontario, Canada, L1S 7K8
The Waterside Clinic
Barrie, Ontario, Canada, L4M 6L2
Ultranova Skincare
Barrie, Ontario, Canada, L4M 6L2
Co-Medica Research Network Inc.
Courtice, Ontario, Canada, L1E 3C3
Dermatrials Research, Inc.
Hamilton, Ontario, Canada, L8N 1V6
The Guenther Dermatology Research Centre
London, Ontario, Canada, N6A 3H7
Lynderm Research Inc.
Markham, Ontario, Canada, L3P 1X2
North Bay Dermatology Centre
North Bay, Ontario, Canada, P1B 3Z7
Oakville Dermatology Laser Centre
Oakville, Ontario, Canada, L6J 7W5
Dr. Tuppal's Privat Practice, Oshawa Clinic
Oshawa, Ontario, Canada, L1H 1B9
Office of Dr. Michael Robern
Ottawa, Ontario, Canada, K2G 6E2
SKiN Centre for Dermatology
Peterborough, Ontario, Canada, K9J 5K2
Office of Dr. Paul Adam (back-up location)
Scarborough, Ontario, Canada, MlB 4Z8
K. Papp Clinical Research
Waterloo, Ontario, Canada, N2J 1C4
XLR8 Medical Research
Windsor, Ontario, Canada, N8W 1E6
Windsor Clinical Research
Windsor, Ontario, Canada, N8W 5L7
Canada, Quebec
Innovaderm Research Inc
Montreal, Quebec, Canada, H2K 4L5
Siena Medical Research
Montreal, Quebec, Canada, H3Z 2S6
Centre de Recherche Dermatologique du Québec Métropolitain
Québec, Quebec, Canada, G1V 4X7
Diex Research Sherbrooke Inc.
Sherbrooke, Quebec, Canada, J1H 1Z1
Canada
CRCMRGilbert Inc., Centre de Dermatologie Maizerets
Quebec, Canada, G1J 1X7
Chile
Clinica Dermacross S.A.
Santiago, Region Metropolitana, Chile, 7640881
Hospital Clinico Universidad de Chile
Santiago, Region Metropolitana, Chile, 8380456
Centro Internacional de Estudios Clinicos, CIEC
Santiago, Region Metropolitana, Chile, 8420383
Colombia
Reumalab S.A.S.
Medellin, Antioquia, Colombia, 0
Hospital Pablo Tobon Uribe
Medellin, Antioquia, Colombia
Centro Integral de Reumatologia del Caribe Cicaribe S.A.S
Barranquilla, Atlantico, Colombia, 08001000
Riesgo De Fractura S.A
Bogota, Cundinamarca, Colombia, 0000
Riesgo De Fractura S.A
Bogota, Cundinamarca, Colombia
Colegio Mayor de Nuestra Señora del Rosario
Bogotá, Cundinamarca, Colombia, 110221
Medicity S.A.S
Bucaramanga, Santander, Colombia, 680003
Croatia
University Hospital Center Osijek
Osijek, Croatia, 31000
University hospital center "Sestre milosrdnice" clinic for dermatology and venerology disease
Zagreb, Croatia, 10000
University hospital center zagreb
Zagreb, Croatia, 10000
Czechia
Nemocnice Ceske Budejovice, a.s. Ustavni lekarna
Ceske Budejovice, Czech Republic, Czechia, 370 01
Ustanvi lekarna
Hradec Kralove, Czech Republic, Czechia, 50005
Nemocnice Ceske Budejovice,a.s.
Ceske Budejovice, Czechia, 37001
Klinika nemoci koznich a pohlavnich
Hradec Kralove, Czechia, 500 05
Fakultni nemocnice Plzen
Plzen-Bory, Czechia, 30599
Kozni ordinace
Praha 1, Czechia, 11000
Lekarna U sv. Ignace
Praha 2, Czechia, 120 00
Krajska zdravotni a.s.,Masarykovy nemocnice o.z.
Usti nad Labem, Czechia, 40113
Denmark
Aarhus University Hospital
Aarhus C, Denmark, 8000
Bispebjerg Hospital, University of Copenhagen
Copenhagen NV, Denmark, 2400
Gentofte Hospital
Hellerup, Denmark, 2900
Hudklinikken Herning
Herning, Denmark, 7400
Hudklinikken
Svendborg, Denmark, 5700
Finland
Tampere Univeristy Hospital, Department of Dermatology and Venereology
Tampere, Finland, 33521
France
Chu Morvan
Brest, Cedex, France, 29609
CHU Limoges - Hôpital Dupuytren - Pharmacie
Limoges, Cedex, France, 87042
Hopital Saint Louis
Paris, Lle-de-france, France, 75010
Hôpital Jean Minjoz
Besancon, France, 25000
CHU Jean-Minjoz
Besancon, France, 25030
CHG Le Mans
Le Mans, Cedex 09, France, 72037
Hopital Dupuytren
Limoges, France, 87042
CHU de Nantes - Hotel Dieu
Nantes Cedex 01, France, 44035
CHU De Nice Hopital De L'Archet II
Nice, France, 06202
Centre Hospitalier Lyon Sud - Pharmacie
Pierre Benite, France, 69495
Centre Hospitalier Lyon Sud
Pierre-Benite, France, 69310
C.H.U. de Poitiers la Miletrie
Poitiers, France, 86000
C.H.U de Reims
Reims, France, 51092
Hôpital Robert Debre
Reims, France, 51100
Hopital Nord
Saint Priest En Jarez, France, 42270
Hopital Larrey Departement de Dermatologie
Toulouse, France, 31000
Hopital de Brabois / Batiment Philippe Canton
Vandoeuvre les Nancy, France, 54511
Germany
Universitaets-Hautklinik Eberhard-Karls-Universitaet Tuebingen
Tuebingen, Baden-wuerttemberg, Germany, 72076
Universitatsklinikum Schleswig-Holstein
Kiel, Schleswig-holstein, Germany, 24105
Charité Universitätsmedizin Berlin
Berlin, Germany, 10117
Klinische Forschung Berlin-Mitte GmbH
Berlin, Germany, 10117
Facharzt fuer Dermatologie und Allergologie
Berlin, Germany, 10435
MVZ Reichenberger Str., Aerztehaus "Rudolf Virchow"
Berlin, Germany, 13055
Hautarztpraxis Tegel
Berlin, Germany, 13507
Klinik and Poliklinik fur Dermatologie and Allergologie der Universitaet Bonn
Bonn, Germany, 53105
Klinik und Poliklinik fur Dermatologie und Allergologie der Universitaet Bonn
Bonn, Germany, 53105
Dres. Kirsten Prepeneit und Volker Streit
Buchholz, Germany, 21244
Universitaetsklinik Carl Gustav Carus
Dresden, Germany, 01307
Universitaetsklinikum Erlangen Hautklinik im Internistischen Zentrum
Erlangen, Germany, 91054
Klinikum der Johann Wolfgang Goethe Universitaet
Frankfurt/Main, Germany, 60590
Universitaetsklinik und Poliklinik fuer Dermatologie und Venerologie
Halle, Germany, 06120
Universitaetsklinikum Hamburg-Eppendorf
Hamburg, Germany, 20246
Klinische Forschung Hamburg GmbH
Hamburg, Germany, 20253
Gemeinschaftspraxis Dres.Michael Ockenfels und Christoph Sauter
Hanau, Germany, 63450
Universitaetsklinikum Heidelberg
Heidelberg, Germany, 69120
Universitaetsklinikum Schleswig-Holstein, Campus Kiel
Kiel, Germany, 24105
Universitaetsklinikum Koeln
Koeln, Germany, 50937
Universitaetsklinikum Schleswig-Holstein Campus Luebeck
Luebeck, Germany, 23538
Hautarztpraxis Dres. Scholz, Sebastian, Schilling
Mahlow, Germany, 15831
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KoeR
Mainz, Germany, 55131
Technischen Universitaet Muenchen
Muenchen, Germany, 80802
Universitaetsklinikum Muenster
Muenster, Germany, 48149
Klinische Forschung Schwerin GmbH
Schwerin, Germany, 19055
Eberhard-Karls-Universitaet Tuebingen Universitaetshautklinik
Tuebingen, Germany, 72076
HSK, Dr. Horst Schmidt Kliniken GmbH
Wiesbaden, Germany, 65199
Hautarztpraxis Centrovital
Witten, Germany, 58453
Greece
University Dermatology Clinic "Andreas Syggros" Hospital
Athens, Attiki, Greece, 16121
University General Hospital of Ioannina / Dermatology and Venereology Department
Ioannina, Greece, 45500
"Papageorgiou" General Hospital/B' Dermatology and Venereology Clinic of University of Thessaloniki
Thessaloniki, Greece, 56403
Hong Kong
The University of Hong Kong (HKU)-Queen Mary Hospital (QMH)
Hong Kong, Hong Kong
Hungary
Synexus Magyarorszag Kft.
Budapest, Hungary, 1036
Debreceni Egyetem Klinikai Kozpont, Borgyogyaszati Klinika
Debrecen, Hungary, 4032
Bacs-Kiskun Megyei Korhaz Szegedi Tudomanyegyetem AOK Oktato Korhaza, Borgyogyaszati Osztaly
Kecskemet, Hungary, 6000
Miskolci Semmelweis Korhaz es Egyetemi Oktatokorhaz, Borgyogyaszati Osztaly
Miskolc, Hungary, 3529
Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz, Klinikai Kutatasi Osztaly
Nyiregyhaza, Hungary, 4400
Szabolcs-Szatmar-Bereg Megyei Korjazak es Egyetemi Okatokorhaz, Borgyogyaszati Szakrendeles
Nyiregyhaza, Hungary, 4400
Pecsi Tudomanyegyetem Aok Bor- Nemikortani Es Onkodermatologiai Klinika
Pecs, Hungary, H-7632
SZTE Szentgyorgyi Albert Klinikai Kozpont/Borgyogyaszati es Allergologiai Klinika
Szeged, Hungary, 6720
Tolna Megyei Balassa Janos Korhaz, Borgyogyaszati Osztaly
Szekszard, Hungary, 7100
ALLERGO-DERM BAKOS Kft.
Szolnok, Hungary, 5000
Vas Megyei Markusovszky Korhaz/Borgyogyaszati Osztaly
Szombathely, Hungary, H-9700
Veszprem Megyei Csolnoky Ferenc Korhaz Borgyogyaszat
Veszprem, Hungary, H-8200
Japan
Gunma University Hospital
Maebashi-shi, Gunma, Japan, 3718511
JR Sapporo hospital
Sapporo-City, Hokkaido, Japan, 060-0033
Kobe University
Kobe, Hyogo, Japan, 6500017
Kumamoto University Hospital
Kumamoto-city, Kumamoto, Japan, 860-8556
Tokyo Yamate Medical Center
Shinjuku-ku, Tokyo, Japan, 169-0073
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 03080
Samsung Medical Center
Seoul, Korea, Republic of, 06351
Yonsei University College of Medicine, Severance Hospital
Seoul, Korea, Republic of, 120-752
Mexico
Mexico Centre for Clinical Research S.A. de C.V.
Mexico, Distrito Federal, Mexico, 03100
Instituto Dermatologico De Jalisco "Dr Jose Barba Rubio"
Zapopan, Jalisco, Mexico, 45190
Centro de Dermatologia de Monterrey
Monterrey, Nuevo Leon, Mexico, 64460
Centro Medico San Lucas
Monterrey, Nuevo Leon, Mexico, 64710
Netherlands
Academisch Medisch Centrum Universiteit van Amsterdam
Amsterdam, Noord-holland, Netherlands, 1105 AZ
PT&R
Beek, Netherlands, 6191 JW
Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, Pomorskie, Poland, 80-952
NZOZ Zdrowie Osteo-Medic
Bialystok, Poland, 15-351
Klinika Dermatologii, Wenerologii i Alergologii Uniwersyteckiego Centrum Klinicznego
Gdansk, Poland, 80-402
Krakowskie Centrum Medyczne NZOZ
Krakow, Poland, 31-501
Specjalistyczne Gabinety Lekarskie "Dermed"
Lodz, Poland, 90-265
Novum Instytut Dermatologii Leczniczej i Estetycznej
Opole, Poland, 45-080
Solumed Centrum Medyczne
Poznan, Poland, 60-529
Centrum Badan Klinicznych s.c. Wieslawa Porawska, Lukasz Porawski
Poznan, Poland, 60773
Katedra i Klinika Chorob Skornych i Wenerycznych, Pomorski Uniwersytet Medyczny
Szczecin, Poland, 70-111
Spolka Cywilna Andrzej Krolicki, Tomasz Kochanowski "Laser Clinic"
Szczecin, Poland, 70-332
MTZ Clinical Research Sp. z o.o.
Warszawa, Poland, 02-106
Klinika Dermatologii
Warszawa, Poland, 04-141
Zaklad Radiologii Lekarskiej
Warszawa, Poland, 04-141
Katedra i Klinika Dermatologii, Wenerologii i Alergologii Akademii Medycznej we Wroclawiu
Wroclaw, Poland, 50-368
Oddzial Dermatologiczny
Wroclaw, Poland, 51-124
Poradnia Dermatologiczna
Wroclaw, Poland, 51-124
Puerto Rico
Grupo Dermatologico De Carolina (Office of Dr. Alma Cruz MD)
Carolina, Puerto Rico, 00985
Russian Federation
State Research Center of Dermatovenerology,
Moscow, Russian Federation, 107076
State Research Center of Dermatovenerology
Moscow, Russian Federation, 107076
Dermatovenerological dispensary #7
Moscow, Russian Federation, 121614
Rostov-on-Don regional dermatovenerologic dispensary
Rostov-on-Don, Russian Federation, 344007
Ryazan regional clinical dermatovenerologic dispensary
Ryazan, Russian Federation, 390046
Dermatovenerologic dispensary #10 of Vyborg region
Saint-Petersburg, Russian Federation, 194021
Military Medical Academy N.A. S.M.Kirov
Saint-Petersburg, Russian Federation, 194044
North-Western State Medical University I.I. Mechnikov
Saint-Petersburg, Russian Federation, 195067
Smolensk State Medical Academy
Smolensk, Russian Federation, 214019
Clinical hospital of emergency care N.V. Soloviev
Yaroslavl, Russian Federation, 150003
Serbia
Clinical Hospital Center Zvezdara
Belgrade, Serbia, 11000
Military Medical Academy
Belgrade, Serbia, 11000
Singapore
National Skin Centre
Singapore, Singapore, 308205
Changi General Hospital
Singapore, Singapore, 529889
Slovakia
Dermatovenerologicka klinika SZU, Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica
Banska Bystrica, Slovakia, 975 17
Oddelenie biologickej liecby, Narodny ustav reumatickych chorob
Piestany, Slovakia, 921 12
DOST-Dermatovenerologicke oddelenie sanatorneho typu, SANARE, spol. s r.o.
Svidnik, Slovakia, 089 01
Spain
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, Spain, 28222
Hospital General Universitario de Alicante
Alicante, Spain, 03010
Hospital Universitario La Princesa
Madrid, Spain, 28006
Hospital 12 de Octubre
Madrid, Spain, 28041
Hospital Universitario Fundacion Alcorcon
Madrid, Spain, 28922
Consorcio Hospital General Universitario de Valencia
Valencia, Spain, 46014
Sweden
Hud kliniken- Skanes Universitetssjukhus i Malmo
Malmo, Sverige, Sweden, 205 02
Hudkliniken
Falun, Sweden, 791 82
Hermelinen Forskning AB
Lulea, Sweden, 972 33
Pharmacy: Sjukhusapoteket Lund
Lund, Sweden, 222 42
Hudkliniken
Stockholm, Sweden, 118 83
Karolinska University Hospital- Solna
Stockholm, Sweden, 171 76
Switzerland
Kantonsspital St. Gallen
St. Gallen, Switzerland, 9007
Taiwan
Chung Shan Medical University Hospital
Taichung, Taiwan Roc, Taiwan, 40201
Chang Gung Medical Foundation Kaohsiung Branch
Kaohsiung, Taiwan, 833
National Cheng Kung University Hospital
Tainan, Taiwan, 704
National Taiwan University Hospital
Taipei, Taiwan, 100
Taipei Medical University-Shuang Ho Hospital
Taipei, Taiwan, 235
Chang Gung Medical Foundation Linkou Branch
Taoyuan, Taiwan, 333
Ukraine
Dept of Dermatology and Venerology of SI "Crimean State Medical University n.a. S.I.Georgiyevskyy"
Simferopol,, Crimea, Ukraine, 95006
Municipal Institution of health Care
Kharkiv, Ukraine, 61038
SI 'Institute for Dermatology and Venerology of AMS of Ukraine'
Kharkiv, Ukraine, 61057
Kyiv Oleksandrivska Clin. Hosp., Dermatology department, NMU n.a. O.O. Bogomolets,
Kyiv, Ukraine, 01601
Dept of Dermatology and Venerology of Lugansk State Medical University,
Lugansk, Ukraine, 91047
Regional Municipal Dermatovenerologic Dispensary
Lviv, Ukraine, 79013
Dept of Dermatology and Venerology of ONMU
Odessa, Ukraine, 65006
Ternopil Regional Municipal Clinical Dermatovenerologic Dispensary
Ternopil, Ukraine, 46006
United Kingdom
Salford Royal NHS Foundation Trust
Salford, Manchester, United Kingdom, M6 8HD
Department of Dermatology
Nuneaton, Warwickshire, United Kingdom, CV10 7DJ
Whipps Cross University Hospital
London, United Kingdom, E11 1NR
eRT
Peterbrough, United Kingdom, PE 2 6UP
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01163253     History of Changes
Other Study ID Numbers: A3921061
2010-020002-15 ( EudraCT Number )
First Posted: July 15, 2010    Key Record Dates
Results First Posted: June 26, 2017
Last Update Posted: June 26, 2017
Last Verified: May 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:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Tofacitinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action