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

Phase 3

Terminated

Conditions: Psoriasis

Interventions: Drug: CP-690,550

Registration Number: NCT01163253

Lead Sponsor: 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.

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 2867

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Active Treatment	CP-690,550	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

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Hemoglobin Level at Month 1	Baseline, Month 1
Change From Baseline in Lymphocyte and Neutrophil Count at Month 12	Baseline, Month 12
Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 3	Baseline, Month 3
Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 12	Baseline, Month 12
Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 3	Baseline, Month 3
Number of Adverse Events (AEs) by Severity	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.
Change From Baseline in Lymphocyte and Neutrophil Count at Month 1	Baseline, Month 1
Change From Baseline in Hemoglobin Level at Month 6	Baseline, Month 6
Change From Baseline in Hemoglobin Level at Month 36	Baseline, Month 36
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)	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.
Change From Baseline in Lymphocyte and Neutrophil Count at Month 6	Baseline, Month 6
Change From Baseline in Lymphocyte and Neutrophil Count at Month 36	Baseline, Month 36
Change From Baseline in Lymphocyte and Neutrophil Count at Month 48	Baseline, Month 48
Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 48	Baseline, Month 48
Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 6	Baseline, Month 6
Number of Participants With Laboratory Abnormalities	Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)	Abnormality criteria: hematology (hemoglobin, hematocrit, red blood cell \<0.8\lower limit of normal \[LLN\]; reticulocyte\<0.5\LLN,\>1.5\ULN; platelets\<0.5\LLN,\>1.75\* upper limit of normal \[ULN\]; WBC\<0.6\LLN, \>1.5\ULN; lymphocytes, neutrophils, basophils, eosinophils, monocytes\<0.8\LLN; \>1.2\ULN; coagulation (prothrombin \[PT\], PT ratio\>1.1\ULN) liver function (bilirubin\>1.5\ULN, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, gamma GT\>0.3\ULN, protein, albumin\<0.8\LLN; \>1.2\ULN, globulin\<0.5\LLN; \>1.5\ULN); renal function (blood urea nitrogen, creatinine\>1.3\ULN); electrolytes(sodium\<0.95\* LLN; \>1.05\* ULN, potassium, chloride, calcium, bicarbonate\<0.9\LLN; \>1.1\ULN), chemistry (glucose\<0.6\LLN; \>1.5\ ULN), urinalysis (pH \<4.5;\>8, glucose, ketones, protein, blood, urobilinogen, nitrite, bilirubin, leukocyte esterase\>=1; RBC, WBC\>=20); lipids (cholesterol \[C\], LDL-C \>1.3\ULN, HDL-C\<0.8\LLN, triglycerides\>1.3\* ULN), hormones(T4, T3, T4, TSH\<0.8\* LLN; \>1.2\* ULN).
Change From Baseline in Hemoglobin Level at Month 3	Baseline, Month 3
Change From Baseline in Hemoglobin Level at Month 12	Baseline, Month 12
Change From Baseline in Hemoglobin Level at Month 24	Baseline, Month 24
Change From Baseline in Hemoglobin Level at Month 48	Baseline, Month 48
Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 1	Baseline, Month 1
Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 3	Baseline, Month 3
Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 6	Baseline, Month 6
Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 36	Baseline, Month 36
Number of Participants With Clinically Significant Change From Baseline in Physical Examination	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.
Change From Baseline in Lymphocyte and Neutrophil Count at Month 24	Baseline, Month 24
Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 24	Baseline, Month 24
Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 36	Baseline, Month 36
Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 1	Baseline, Month 1
Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 24	Baseline, Month 24
Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 6	Baseline, Month 6
Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 12	Baseline, Month 12
Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 48	Baseline, Month 48
Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 1	Baseline, Month 1
Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 24	Baseline, Month 24
Change From Baseline in Heart Rate at Month 1	Baseline, Month 1
Change From Baseline in Heart Rate at Month 24	Baseline, Month 24
Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 12	Baseline, Month 12
Number of Participants With Adjudicated Cardiovascular Events	Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)	Adjudicated cardiovascular events were assessed by adjudication committee as independent reviewers based on event documentation including: hospital discharge summaries, operative reports, clinic notes, ECGs, diagnostic enzymes, results of other diagnostic tests, autopsy reports and death certificate information; as applicable.
Number of Participants With Vital Sign Abnormalities	Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)	Criteria for abnormalities in vital signs included: Systolic blood pressure (SBP): less than (\<) 90 millimeter of mercury (mmHg) and maximum increase from baseline (IFB) of greater than or equal to (\>=) 30 mmHg; diastolic blood pressure (DBP): \<50 and greater than (\>) 120 mmHg and maximum IFB of \>=20 mmHg; heart rate: \<40 and \>120 beats per minute.
Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 36	Baseline, Month 36
Change From Baseline in Heart Rate at Month 36	Baseline, Month 36
Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 24	Baseline, Month 24
Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 36	Baseline, Month 36
Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 12	Baseline, Month 12
Change From Baseline in Heart Rate at Month 12	Baseline, Month 12
Number of Participants With Electrocardiogram (ECG) Abnormalities	Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)	Criteria for ECG abnormality: PR interval \>=300 milliseconds (msec); QT interval \>=500 msec; QTcB (Bazett's Correction) and QTcF (Fridericia's Correction) 450 to \<480 msec, 480 to \<500 msec and \>=500 msec.
Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 48	Baseline, Month 48
Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 48	Baseline, Month 48
Change From Baseline in Heart Rate at Month 3	Baseline, Month 3
Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 6	Baseline, Month 6
Number of Participants With Malignancy Events	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.
Change From Baseline in Lymphocyte and Neutrophil Count at Month 3	Baseline, Month 3
Change From Baseline in Heart Rate at Month 48	Baseline, Month 48
Change From Baseline in Heart Rate at Month 6	Baseline, Month 6

Secondary Outcome Measures

Name	Time	Method
Psoriasis Area and Severity Index (PASI) Scores	Baseline, Month 1, 3, 6, 12, 24, 36, 48	PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Each component of severity, that is, erythema, induration and scaling was assessed separately for four body areas (head and neck \[h\], upper limbs \[u\], trunk \[t\] and lower limbs \[l\]) on a 5-point scale ranging from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity. Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head and neck: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4.
Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores at Month 1, 3, 6, 12, 24, 36 and 48	Baseline, Month 1, 3, 6, 12, 24, 36, 48	PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Each component of severity, that is, erythema, induration and scaling was assessed separately for four body areas (head and neck \[h\], upper limbs \[u\], trunk \[t\] and lower limbs \[l\]) on a 5-point scale ranging from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity. Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head and neck: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4.
Psoriasis Area and Severity Index (PASI) Component Scores: Erythema	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.
Itch Severity Item (ISI) Scores	Baseline, Month 1, 3, 6, 12, 24, 36, 48	ISI assessed severity of itching due to psoriasis. ISI was a single item, horizontal numeric rating scale. Participants were asked to rate their 'severity of itching' due to psoriasis over the past 24 hours on a numeric rating scale anchored by the terms '0=no itching' and '10=worst possible itching' at the ends. Higher scores indicated greater severity of itching.
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Induration at Month 1, 3, 6, 12, 24, 36 and 48	Baseline, Month 1, 3, 6, 12, 24, 36, 48	PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Induration was assessed separately for four body areas (head and neck, upper limbs, trunk and lower limbs) on a 5-point scale ranges from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity.
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Scaling at Month 1, 3, 6, 12, 24, 36 and 48	Baseline, Month 1, 3, 6, 12, 24, 36, 48	PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Scaling was assessed separately for four body areas (head and neck, upper limbs, trunk and lower limbs) on a 5-point scale ranges from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity.
Percentage of Participants Achieving Greater Than or Equal to (>=) 90 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores	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.
Change From Baseline in Itch Severity Item (ISI) Scores at Month 1, 3, 6, 12, 24, 36 and 48	Baseline, Month 1, 3, 6, 12, 24, 36, 48	ISI assessed severity of itching due to psoriasis. ISI was a single item, horizontal numeric rating scale. Participants were asked to rate their 'severity of itching' due to psoriasis over the past 24 hours on a numeric rating scale anchored by the terms '0=no itching' and '10=worst possible itching' at the ends. Higher scores indicated greater severity of itching.
Change From Baseline in Dermatology Life Quality Index (DLQI) Scores at Month 1, 6, 12, 24, 36 and 48	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.
Percentage of Participants Achieving Physician Global Assessment (PGA) Response of 'Clear' or 'Almost Clear'	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.
Psoriasis Area and Severity Index (PASI) Component Scores: Scaling	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.
Dermatology Life Quality Index (DLQI) Scores	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.
Percentage of Participants Achieving Greater Than or Equal to (>=) 75 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores	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.
Percentage of Participants Achieving Greater Than or Equal to (>=) 125 Percent Increase From Baseline in Psoriasis Area and Severity Index (PASI) Scores	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.
Number of Participants Who Answered Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU)	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.
Psoriasis Area and Severity Index (PASI) Component Scores: Induration	Baseline, Month 1, 3, 6, 12, 24, 36, 48	PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Induration was assessed separately for four body areas (head and neck, upper limbs, trunk and lower limbs) on a 5-point scale ranges from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity.
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Erythema at Month 1, 3, 6, 12, 24, 36 and 48	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.
Percentage of Participants Achieving Greater Than or Equal to (>=) 50 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores	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.
36-Item Short-Form (SF-36) Health Survey Version 2, Acute: Physical Component Summary Scores	Baseline, Month 6, 12, 24, 36, 48	The SF-36 questionnaire, version 2, acute was a 36-item generic health status measure. SF-36 evaluated 8 health-related aspects of an individual: physical functioning, role-physical, bodily pain, social functioning, mental health, role emotional, vitality, and general health. The score range for each of the 8 health aspects ranged from 0 (worst) to 100 (best), with higher scores indicating good health condition. Two summary scale scores were computed from the 8 health aspect scores: physical component summary score and mental component summary score. Score range for both summary scales ranged from 0 (worst) to 100 (best), with higher scores indicating good health condition.
36-Item Short-Form (SF-36) Health Survey Version 2, Acute: Mental Component Summary Scores	Baseline, Month 6, 12, 24, 36, 48	The SF-36 questionnaire, version 2 was a 36-item generic health status measure. SF-36 evaluated 8 health-related aspects of an individual: physical functioning, role-physical, bodily pain, social functioning, mental health, role emotional, vitality, and general health. The score range for each of the 8 health aspects ranged from 0 (worst) to 100 (best), with higher scores indicating good health condition. Two summary scale scores were computed from the 8 health aspect scores: the Physical Component Summary and the Mental Component Summary. Score range for both summary scale ranged from 0 (worst) to 100 (best), with higher scores indicating good health condition.
Number of Participants With Patient Global Assessment (PtGA) Response of "Clear" or "Almost Clear"	Baseline, Month 1, 3, 6, 12, 24, 36, 48	The PtGA evaluated the overall skin disease of participants at that point in time on a single-item. Participants provided their response on a 5-point scale ranges from: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe. Higher score indicated greater severity of disease. Participants who provided their response as "clear (score of 0)" or "almost clear (score of 1)" in PtGA at each specified visit were reported in this outcome measure.
Euro Quality of Life- 5-Dimensions (EQ-5D)-Utility Scores	Baseline, Month 6, 12, 24, 36, 48	EQ-5D: participant rated 5-dimension (mobility, self-care, usual activities, pain and discomfort, and anxiety and depression) questionnaire to assess health-related quality of life in terms of a single utility score. Each dimension was assessed on a 3-point scale (1=no problems, 2=some problems, 3=extreme problems, where higher scores=worse health condition). The responses from the 5 dimensions were used to calculate a single utility index value. Scoring formula developed by EuroQol Group assigned a utility value for each dimension in the profile. Score was transformed and results in a total score range -0.594 to 1.000; higher score indicated a better health state.
Euro Quality of Life-5-Dimensions (EQ-5D)-Visual Analogue Scale Scores (VAS)	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.

Trial Locations

Locations (314): Radiant Research, Inc.
🇺🇸
Greer, South Carolina, United States
UAB Dermatology
🇺🇸
Birmingham, Alabama, United States
Horizon Research Group, Inc.
🇺🇸
Mobile, Alabama, United States
Burke Pharmaceutical Research
🇺🇸
Hot Springs, Arkansas, United States
Bakersfield Dermatology and Skin Cancer Medical Group
🇺🇸
Bakersfield, California, United States
Associates In Research, Inc.
🇺🇸
Fresno, California, United States
University of California Irvine
🇺🇸
Irvine, California, United States
Dermatology Research Associates
🇺🇸
Nashville, Tennessee, United States
Dermatology Specialists, Inc.
🇺🇸
Oceanside, California, United States
MedDerm Associates
🇺🇸
San Diego, California, United States
Scroll for more (304 remaining)
Radiant Research, Inc.
🇺🇸Greer, South Carolina, United States