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

• 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: Pfizer
• Information provided by (Responsible Party): Pfizer

Study Description

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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.

Eligibility Criteria

• 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.

Contacts and Locations

  Hide Study Locations

Locations

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

• Study Director: Pfizer CT.gov Call Center; Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• 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
• 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:

Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Tofacitinib; Protein Kinase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action