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A Long Term Study To Evaluate The Safety, Tolerability And Efficacy Of CP-690,550 In Patients With Moderate To Severe Plaque Psoriasis And/Or Psoriatic Arthritis

Primary Purpose

Psoriasis

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
CP-690,550
CP-690, 550
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis focused on measuring chronic, severe, moderate, treatment, safety, efficacy, CP-690, 550, Plaque psoriasis, Psoriasis Vulgaris, Psoriatic Arthritis, tofacitinib, Xeljanz

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Are 20 years or older and considered to be candidates for systemic or phototherapy.

[Moderate to Severe Plaque Psoriasis]

  • Diagnosed for at least 12 months.
  • Have Psoriasis Area and Severity Index (PASI) score of 12 and plaque type psoriasis covering at least 10% of body surface area (BSA).

[Psoriatic Arthritis]

  • Diagnosed for at least 6 months.
  • Meet the CASPAR (classification criteria for Psoriatic Arthritis) criteria at screening;
  • Have active arthritis (≥3 tender/painful joints on motion and ≥3 swollen joints), and active plaque psoriasis with at least 2 cm in diameter.

Exclusion Criteria:

  • Non-plaque or drug induced forms of psoriasis
  • Cannot discontinue current oral, injectable or topical therapy for psoriasis/psoriatic arthritis or cannot discontinue phototherapy (PUVA or UVB)
  • any uncontrolled significant medical condition

Sites / Locations

  • JR Sapporo hospital
  • Kobe University Hospital
  • Kanazawa Medical University Hospital
  • National Hospital Organization Sagamihara National Hospital
  • University of Miyazaki Hospital
  • Jichi Medical University Hospital
  • Tokyo Teishin Hospital
  • Tokyo medical university Hachioji medical center
  • Kanto Medical Center NTT East Corporation
  • Tokyo Medical University Hospital
  • Tonami General Hospital
  • Yamanashi Prefectural Central Hospital
  • Fukuoka University Hospital
  • Fukushima Medical University Hospital
  • Nissay Hospital
  • Jikei University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

CP-690,550 10 mg BID

CP690,550 5 mg BID

Arm Description

Outcomes

Primary Outcome Measures

Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response at Week 16
The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of body surface area (BSA)" affected. PASI is a composite scoring assessed by the investigator, of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI75 response was defined as at least a 75 percent (%) reduction in PASI at Week 16 relative to Baseline.
Percentage of Participants With a Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' at Week 16
The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear).
Proportion of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 16
ACR20 response: greater than or equal to (>=) 20 percent (%) improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).
Number of Participants With Adjudicated Cardiovacular Events
Adjudicated cardiovascular events were assessed by investigators 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; specific requirements vary with the event requiring adjudication.
Number of Participants With Malignancy Events _Week 0 Through Follow-up
For all biopsies of potentially malignant tumors, suspicious lymphadenopathy, or possible extranodal LPD, the study site requested the pathologist to send the original slides used to make the definitive diagnosis, ancillary study reports, and the pathologist's report to the central laboratory for a blinded review by a central pathologist.

Secondary Outcome Measures

Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response
The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of body surface area (BSA)" affected. PASI is a composite scoring assessed by the investigator, of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI75 response was defined as at least a 75 percent (%) reduction in PASI at the each visit relative to Baseline.
Percentage of Participants With a Psoriasis Area and Severity Index 50 (PASI50) Response
The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of body surface area (BSA)" affected. PASI is a composite scoring assessed by the investigator, of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI50 response was defined as at least a 50 percent (%) reduction in PASI at the each visit relative to Baseline.
Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response
The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of body surface area (BSA)" affected. PASI is a composite scoring assessed by the investigator, of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI90 response was defined as at least a 90 percent (%) reduction in PASI at the each visit relative to Baseline.
Time to Achieve a Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear'
The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear). Median time to achieve a PGA response up to week 16 is reported. The median time to event is estimated based on Kaplan-Meier product-limit method. Median time to event is not estimable if the estimated probability of response by Week 16 is less than 50%.
Time to Achieve a Psoriasis Area and Severity Index 75 (PASI75) Response
The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and "percent of BSA" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI75 response was defined as at least 75% reduction in PASI relative to Baseline. The median time to event is estimated based on Kaplan-Meier product-limit method. Median time to event is not estimable if the estimated probability of response by Week 16 is less than 50%.
Time to Achieve a Psoriasis Area and Severity Index 50 (PASI50) Response
The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and "percent of BSA" affected. PASI is a composite scoring assessed by the investigator, of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI50 response was defined as at least 50% reduction in PASI relative to Baseline. The median time to event is estimated based on Kaplan-Meier product-limit method. Median time to event is not estimable if the estimated probability of response by Week 16 is less than 50%.
Time to Achieve a Psoriasis Area and Severity Index 90 (PASI90) Response
The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and "percent of BSA" affected. PASI is a composite scoring assessed by the investigator, of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI90 response was defined as at least 90% reduction in PASI relative to Baseline. The median time to event is estimated based on Kaplan-Meier product-limit method. Median time to event is not estimable if the estimated probability of response by Week 16 is less than 50%.
Percentage of Participants With a Psoriasis Area and Severity Index (PASI) Score >= 125 Percent of the Baseline PASI Score
The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of body surface area (BSA)" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis.
Change From Baseline in Psoriasis Area and Severity Index (PASI) Score
The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of body surface area (BSA)" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis.
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score
The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of body surface area (BSA)" affected. Basic characteristics of psoriatic lesions: erythema, induration, and scaling (PASI components) are scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]) according to a 5-point scale: 0 (no involvement); 1 (slight); 2 (moderate); 3 (marked); 4 (very marked). PASI component score range from 0 to 4, where higher scores indicate greater severity of psoriatic lesions.
Percentage of Participants With a Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear'
The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear).
Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category
The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe).
Percentage of Participants Maintaining Psoriasis Area and Severity Index 75 (PASI75) Response After Week 16
The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of body surface area (BSA)" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI75 response was defined as at least a 75 percent (%) reduction in PASI relative to Baseline. Maintenance of PASI75 response at Week 52 among participants achieving PASI75 response at Week 16 is reported.
Percentage of Participants Maintaining Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear'
The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear). Maintenance of PGA response at Week 52 among participants achieving PGA response at Week 16 is reported.
Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score
The NAPSI quantifies severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Each finger nail divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 [absence of psoriasis] to 4 [presence of psoriasis in all 4 quadrants]). The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 to 80. Higher scores = more severe psoriasis.
Number of Affected Nails
Nail psoriasis is evaluated by the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Total number psoriasis affected nails (presence of psoriatic manifestations on the nail matrix/nail bed) were assessed and reported.
Itch Severity Item (ISI) Score
ISI assessed severity of itch (pruritus) due to psoriasis. ISI is a single item, horizontal numeric rating scale. Participants were asked to rate "your worst itching due to psoriasis over the past 24 hours" on a numeric rating scale anchored by the terms "No itching" (0) and "Worst possible itching" (10) at the ends for post baseline time points. Baseline ISI is average of scores on 7 days prior to start of study treatment.
Dermatology Life Quality Index (DLQI) Score
The DLQI is a 10 item general dermatology questionnaire that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI item response options are rated by the participant from 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life.
Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Domain Score
36-Item Short-Form Health Survey (SF-36) is a standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects are summarized as physical and mental health summary scores. The score range for the physical and mental health scores is 0-100 (100=highest level of functioning).
Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Component Summary Score
36-Item Short-Form Health Survey (SF-36) is a standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects are summarized as physical and mental health summary scores. The score range for the physical and mental health scores is 0-100 (100=highest level of functioning).
Work Limitation Questionnaire (WLQ)
WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: Time Management scale (5 items); Physical Demands scale (6 items); Mental-Interpersonal Demands Scale (9 items); Output Demands Scale (5 items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). The WLQ Index score is the weighted sum of the scores from the 4 WLQ scales (total score: 0 [no loss] to 100 [complete loss of work]).
Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category
The PtGA asks the participant to evaluate the overall cutaneous disease at that point in time on a single item, 5-point scale (0=clear [no psoriasis]; 1=almost clear; 2=mild; 3=moderate; 4=severe).
Joint Pain Assessment (JPA)
The JPA assesses severity of joint pain. The JPA is a horizontal numeric rating scale. Participants were asked to "select the number that best describes any joint pain that participant may have experienced over the past 24 hours" with response options ranging from "0-no joint pain" to "10-worst possible joint pain."
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response
ACR20 response: greater than or equal to (>=) 20 percent (%) improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).
Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response
ACR50 response: greater than or equal to (>=) 50 percent (%) improvement in tender joint count; >=50% improvement in swollen joint count; and >=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).
Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response
ACR70 response: greater than or equal to (>=) 70 percent (%) improvement in tender joint count; >=70% improvement in swollen joint count; and >=70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).
Change From Baseline in American College of Rheumatology (ACR) Component_ Tender/Painful Joint Count
Sixty eight (68) joints were assessed by a rheumatologist investigator to determine the number of joints that were considered tender or painful. The response to pressure/motion on each joint was assessed with the following scale: Present/Absent/Not Done/Not Applicable (for Artificial or missing joints).
Change From Baseline in American College of Rheumatology (ACR) Component_ Swollen Joint Count
Sixty six (66) joints were assessed for swelling by a rheumatologist investigator to determine the number of joints that were considered swelling. The response to pressure/motion on each joint was assessed with the following scale: Present/Absent/Not Done/Not Applicable (for Artificial or missing joints).
Change From Baseline in American College of Rheumatology (ACR) Component_ Patient Assessment of Arthritis Pain
Subjects assessed the severity of their arthritis pain with a 100 mm visual analog scale (VAS) by placing a mark on the scale between 0 (no pain) and 100 (the most severe pain), which corresponded to the magnitude of their pain.
Change From Baseline in American College of Rheumatology (ACR) Component_ Patient Global Assessment of Arthritis
Subjects answered the following question, "Considering the possible effects of the arthritis, how are you feeling today?" The subject's response was recorded with a 100 mm visual analog scale (VAS), where 0 = very well and 100 = very poorly.
Change From Baseline in American College of Rheumatology (ACR) Component_ Physician Global Assessment of Arthritis
The rheumatologist investigator assessed how the subject's overall arthritis appeared at the time of the visit. This was an evaluation based on the subject's disease signs, functional capacity and physical examination, and was independent of the PGA of arthritis. The rheumatologist investigator's response was recorded a 100 mm visual analog scale (VAS), where 0 = very good and 100 = very poor.
Change From Baseline in American College of Rheumatology (ACR) Component_ C-Reactive Protein (CRP)
The blood samples were collected at each visit for analysis of CRP with an assay analyzed by the central laboratory.
Change From Baseline in American College of Rheumatology (ACR) Component_ Health Assessment Questionnaire - Disability Index (HAQ-DI)
HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0=least difficulty and 3=extreme difficulty.

Full Information

First Posted
December 22, 2011
Last Updated
August 6, 2015
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT01519089
Brief Title
A Long Term Study To Evaluate The Safety, Tolerability And Efficacy Of CP-690,550 In Patients With Moderate To Severe Plaque Psoriasis And/Or Psoriatic Arthritis
Official Title
A Phase 3, Multi Site, Randomized, Double Blind Study Of The Long-term Safety, Tolerability And Efficacy Of 2 Oral Doses Of Cp 690,550 In Subjects With Moderate To Severe Plaque Psoriasis And/or Psoriatic Arthritis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
Yes

5. 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 plaque psoriasis and/or psoriatic arthritis. This study will also to compare the efficacy of two oral doses of CP-690,550 (5 mg BID and 10 mg BID) after 16 weeks of treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
Keywords
chronic, severe, moderate, treatment, safety, efficacy, CP-690, 550, Plaque psoriasis, Psoriasis Vulgaris, Psoriatic Arthritis, tofacitinib, Xeljanz

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
95 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CP-690,550 10 mg BID
Arm Type
Experimental
Arm Title
CP690,550 5 mg BID
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
CP-690,550
Intervention Description
10 mg BID, continuous treatment for 16 weeks under blinding, 10 mg BID, continuous treatment for 4 weeks and variable dose (5 mg or 10 mg), continuous treatment for 32 weeks.
Intervention Type
Drug
Intervention Name(s)
CP-690, 550
Intervention Description
5 mg BID, continuous treatment for 16 weeks under blinding, 10 mg BID, continuous treatment for 4 weeks and variable dose (5 mg or 10 mg), continuous treatment for 32 weeks.
Primary Outcome Measure Information:
Title
Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response at Week 16
Description
The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of body surface area (BSA)" affected. PASI is a composite scoring assessed by the investigator, of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI75 response was defined as at least a 75 percent (%) reduction in PASI at Week 16 relative to Baseline.
Time Frame
Week 16
Title
Percentage of Participants With a Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' at Week 16
Description
The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear).
Time Frame
Week 16
Title
Proportion of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 16
Description
ACR20 response: greater than or equal to (>=) 20 percent (%) improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).
Time Frame
Week 16
Title
Number of Participants With Adjudicated Cardiovacular Events
Description
Adjudicated cardiovascular events were assessed by investigators 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; specific requirements vary with the event requiring adjudication.
Time Frame
Baseline to Follow-up
Title
Number of Participants With Malignancy Events _Week 0 Through Follow-up
Description
For all biopsies of potentially malignant tumors, suspicious lymphadenopathy, or possible extranodal LPD, the study site requested the pathologist to send the original slides used to make the definitive diagnosis, ancillary study reports, and the pathologist's report to the central laboratory for a blinded review by a central pathologist.
Time Frame
Baseline to Follow-up
Secondary Outcome Measure Information:
Title
Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response
Description
The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of body surface area (BSA)" affected. PASI is a composite scoring assessed by the investigator, of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI75 response was defined as at least a 75 percent (%) reduction in PASI at the each visit relative to Baseline.
Time Frame
Week 2, 4, 8, 12, 20, 28, 40, 52
Title
Percentage of Participants With a Psoriasis Area and Severity Index 50 (PASI50) Response
Description
The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of body surface area (BSA)" affected. PASI is a composite scoring assessed by the investigator, of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI50 response was defined as at least a 50 percent (%) reduction in PASI at the each visit relative to Baseline.
Time Frame
Week 2, 4, 8, 12, 16, 20, 28, 40, 52
Title
Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response
Description
The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of body surface area (BSA)" affected. PASI is a composite scoring assessed by the investigator, of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI90 response was defined as at least a 90 percent (%) reduction in PASI at the each visit relative to Baseline.
Time Frame
Week 2, 4, 8, 12, 16, 20, 28, 40, 52
Title
Time to Achieve a Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear'
Description
The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear). Median time to achieve a PGA response up to week 16 is reported. The median time to event is estimated based on Kaplan-Meier product-limit method. Median time to event is not estimable if the estimated probability of response by Week 16 is less than 50%.
Time Frame
Week 16
Title
Time to Achieve a Psoriasis Area and Severity Index 75 (PASI75) Response
Description
The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and "percent of BSA" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI75 response was defined as at least 75% reduction in PASI relative to Baseline. The median time to event is estimated based on Kaplan-Meier product-limit method. Median time to event is not estimable if the estimated probability of response by Week 16 is less than 50%.
Time Frame
Week 16
Title
Time to Achieve a Psoriasis Area and Severity Index 50 (PASI50) Response
Description
The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and "percent of BSA" affected. PASI is a composite scoring assessed by the investigator, of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI50 response was defined as at least 50% reduction in PASI relative to Baseline. The median time to event is estimated based on Kaplan-Meier product-limit method. Median time to event is not estimable if the estimated probability of response by Week 16 is less than 50%.
Time Frame
Week 16
Title
Time to Achieve a Psoriasis Area and Severity Index 90 (PASI90) Response
Description
The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and "percent of BSA" affected. PASI is a composite scoring assessed by the investigator, of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI90 response was defined as at least 90% reduction in PASI relative to Baseline. The median time to event is estimated based on Kaplan-Meier product-limit method. Median time to event is not estimable if the estimated probability of response by Week 16 is less than 50%.
Time Frame
Week 16
Title
Percentage of Participants With a Psoriasis Area and Severity Index (PASI) Score >= 125 Percent of the Baseline PASI Score
Description
The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of body surface area (BSA)" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis.
Time Frame
Week 2, 4, 8, 12, 16, 20, 28, 40, 52
Title
Change From Baseline in Psoriasis Area and Severity Index (PASI) Score
Description
The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of body surface area (BSA)" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis.
Time Frame
Week 2, 4, 8, 12, 16, 20, 28, 40, 52
Title
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score
Description
The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of body surface area (BSA)" affected. Basic characteristics of psoriatic lesions: erythema, induration, and scaling (PASI components) are scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]) according to a 5-point scale: 0 (no involvement); 1 (slight); 2 (moderate); 3 (marked); 4 (very marked). PASI component score range from 0 to 4, where higher scores indicate greater severity of psoriatic lesions.
Time Frame
Week 2, 4, 8, 12, 16, 20, 28, 40, 52
Title
Percentage of Participants With a Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear'
Description
The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear).
Time Frame
Week 2, 4, 8, 12, 20, 28, 40, 52
Title
Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category
Description
The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe).
Time Frame
Week 2, 4, 8, 12, 16, 20, 28, 40, 52
Title
Percentage of Participants Maintaining Psoriasis Area and Severity Index 75 (PASI75) Response After Week 16
Description
The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of body surface area (BSA)" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI75 response was defined as at least a 75 percent (%) reduction in PASI relative to Baseline. Maintenance of PASI75 response at Week 52 among participants achieving PASI75 response at Week 16 is reported.
Time Frame
Week 20, 28, 40, 52
Title
Percentage of Participants Maintaining Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear'
Description
The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear). Maintenance of PGA response at Week 52 among participants achieving PGA response at Week 16 is reported.
Time Frame
Week 20, 28, 40, 52
Title
Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score
Description
The NAPSI quantifies severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Each finger nail divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 [absence of psoriasis] to 4 [presence of psoriasis in all 4 quadrants]). The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 to 80. Higher scores = more severe psoriasis.
Time Frame
Week 8, 16, 20, 28, 40, 52
Title
Number of Affected Nails
Description
Nail psoriasis is evaluated by the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Total number psoriasis affected nails (presence of psoriatic manifestations on the nail matrix/nail bed) were assessed and reported.
Time Frame
Baseline, Week 8, 16, 20, 28, 40, 52
Title
Itch Severity Item (ISI) Score
Description
ISI assessed severity of itch (pruritus) due to psoriasis. ISI is a single item, horizontal numeric rating scale. Participants were asked to rate "your worst itching due to psoriasis over the past 24 hours" on a numeric rating scale anchored by the terms "No itching" (0) and "Worst possible itching" (10) at the ends for post baseline time points. Baseline ISI is average of scores on 7 days prior to start of study treatment.
Time Frame
Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52
Title
Dermatology Life Quality Index (DLQI) Score
Description
The DLQI is a 10 item general dermatology questionnaire that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI item response options are rated by the participant from 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life.
Time Frame
Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52
Title
Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Domain Score
Description
36-Item Short-Form Health Survey (SF-36) is a standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects are summarized as physical and mental health summary scores. The score range for the physical and mental health scores is 0-100 (100=highest level of functioning).
Time Frame
Week (W) 16, 28, 52
Title
Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Component Summary Score
Description
36-Item Short-Form Health Survey (SF-36) is a standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects are summarized as physical and mental health summary scores. The score range for the physical and mental health scores is 0-100 (100=highest level of functioning).
Time Frame
Week 16, 28, 52
Title
Work Limitation Questionnaire (WLQ)
Description
WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: Time Management scale (5 items); Physical Demands scale (6 items); Mental-Interpersonal Demands Scale (9 items); Output Demands Scale (5 items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). The WLQ Index score is the weighted sum of the scores from the 4 WLQ scales (total score: 0 [no loss] to 100 [complete loss of work]).
Time Frame
Baseline (BL), Week (W) 4, 16, 28, 52
Title
Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category
Description
The PtGA asks the participant to evaluate the overall cutaneous disease at that point in time on a single item, 5-point scale (0=clear [no psoriasis]; 1=almost clear; 2=mild; 3=moderate; 4=severe).
Time Frame
Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52
Title
Joint Pain Assessment (JPA)
Description
The JPA assesses severity of joint pain. The JPA is a horizontal numeric rating scale. Participants were asked to "select the number that best describes any joint pain that participant may have experienced over the past 24 hours" with response options ranging from "0-no joint pain" to "10-worst possible joint pain."
Time Frame
Baseline, Week 4, 16, 28, 52
Title
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response
Description
ACR20 response: greater than or equal to (>=) 20 percent (%) improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).
Time Frame
Week 2, 4, 8, 12, 20, 28, 40, 52
Title
Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response
Description
ACR50 response: greater than or equal to (>=) 50 percent (%) improvement in tender joint count; >=50% improvement in swollen joint count; and >=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).
Time Frame
Week 2, 4, 8, 12, 16, 20, 28, 40, 52
Title
Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response
Description
ACR70 response: greater than or equal to (>=) 70 percent (%) improvement in tender joint count; >=70% improvement in swollen joint count; and >=70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).
Time Frame
Week 2, 4, 8, 12, 16, 20, 28, 40, 52
Title
Change From Baseline in American College of Rheumatology (ACR) Component_ Tender/Painful Joint Count
Description
Sixty eight (68) joints were assessed by a rheumatologist investigator to determine the number of joints that were considered tender or painful. The response to pressure/motion on each joint was assessed with the following scale: Present/Absent/Not Done/Not Applicable (for Artificial or missing joints).
Time Frame
Week 2, 4, 8, 12, 16, 20, 28, 40, 52
Title
Change From Baseline in American College of Rheumatology (ACR) Component_ Swollen Joint Count
Description
Sixty six (66) joints were assessed for swelling by a rheumatologist investigator to determine the number of joints that were considered swelling. The response to pressure/motion on each joint was assessed with the following scale: Present/Absent/Not Done/Not Applicable (for Artificial or missing joints).
Time Frame
Week 2, 4, 8, 12, 16, 20, 28, 40, 52
Title
Change From Baseline in American College of Rheumatology (ACR) Component_ Patient Assessment of Arthritis Pain
Description
Subjects assessed the severity of their arthritis pain with a 100 mm visual analog scale (VAS) by placing a mark on the scale between 0 (no pain) and 100 (the most severe pain), which corresponded to the magnitude of their pain.
Time Frame
Week 2, 4, 8, 12, 16, 20, 28, 40, 52
Title
Change From Baseline in American College of Rheumatology (ACR) Component_ Patient Global Assessment of Arthritis
Description
Subjects answered the following question, "Considering the possible effects of the arthritis, how are you feeling today?" The subject's response was recorded with a 100 mm visual analog scale (VAS), where 0 = very well and 100 = very poorly.
Time Frame
Week 2, 4, 8, 12, 16, 20, 28, 40, 52
Title
Change From Baseline in American College of Rheumatology (ACR) Component_ Physician Global Assessment of Arthritis
Description
The rheumatologist investigator assessed how the subject's overall arthritis appeared at the time of the visit. This was an evaluation based on the subject's disease signs, functional capacity and physical examination, and was independent of the PGA of arthritis. The rheumatologist investigator's response was recorded a 100 mm visual analog scale (VAS), where 0 = very good and 100 = very poor.
Time Frame
Week 2, 4, 8, 12, 16, 20, 28, 40, 52
Title
Change From Baseline in American College of Rheumatology (ACR) Component_ C-Reactive Protein (CRP)
Description
The blood samples were collected at each visit for analysis of CRP with an assay analyzed by the central laboratory.
Time Frame
Week 2, 4, 8, 12, 16, 20, 28, 40, 52
Title
Change From Baseline in American College of Rheumatology (ACR) Component_ Health Assessment Questionnaire - Disability Index (HAQ-DI)
Description
HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0=least difficulty and 3=extreme difficulty.
Time Frame
Week 2, 4, 8, 12, 16, 20, 28, 40, 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Are 20 years or older and considered to be candidates for systemic or phototherapy. [Moderate to Severe Plaque Psoriasis] Diagnosed for at least 12 months. Have Psoriasis Area and Severity Index (PASI) score of 12 and plaque type psoriasis covering at least 10% of body surface area (BSA). [Psoriatic Arthritis] Diagnosed for at least 6 months. Meet the CASPAR (classification criteria for Psoriatic Arthritis) criteria at screening; Have active arthritis (≥3 tender/painful joints on motion and ≥3 swollen joints), and active plaque psoriasis with at least 2 cm in diameter. Exclusion Criteria: Non-plaque or drug induced forms of psoriasis Cannot discontinue current oral, injectable or topical therapy for psoriasis/psoriatic arthritis or cannot discontinue phototherapy (PUVA or UVB) any uncontrolled significant medical condition
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
JR Sapporo hospital
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-0033
Country
Japan
Facility Name
Kobe University Hospital
City
Chuo-ku, Kobe
State/Province
Hyogo
ZIP/Postal Code
650-0017
Country
Japan
Facility Name
Kanazawa Medical University Hospital
City
Kahoku-gun
State/Province
Ishikawa
ZIP/Postal Code
920-0293
Country
Japan
Facility Name
National Hospital Organization Sagamihara National Hospital
City
Sagamihara
State/Province
Kanagawa
ZIP/Postal Code
252-0392
Country
Japan
Facility Name
University of Miyazaki Hospital
City
Miyazaki-shi
State/Province
Miyazaki
ZIP/Postal Code
889-1692
Country
Japan
Facility Name
Jichi Medical University Hospital
City
Shimotsuke
State/Province
Tochigi
ZIP/Postal Code
324-0498
Country
Japan
Facility Name
Tokyo Teishin Hospital
City
Chiyoda-ku
State/Province
Tokyo
ZIP/Postal Code
102-8798
Country
Japan
Facility Name
Tokyo medical university Hachioji medical center
City
Hachioji
State/Province
Tokyo
ZIP/Postal Code
193-0998
Country
Japan
Facility Name
Kanto Medical Center NTT East Corporation
City
Shinagawa-ku
State/Province
Tokyo
ZIP/Postal Code
141-8625
Country
Japan
Facility Name
Tokyo Medical University Hospital
City
Shinjyuku-ku
State/Province
Tokyo
ZIP/Postal Code
160-0023
Country
Japan
Facility Name
Tonami General Hospital
City
Tonami
State/Province
Toyama
ZIP/Postal Code
939-1395
Country
Japan
Facility Name
Yamanashi Prefectural Central Hospital
City
Kofu
State/Province
Yamanashi
ZIP/Postal Code
400-8506
Country
Japan
Facility Name
Fukuoka University Hospital
City
Fukuoka
ZIP/Postal Code
814-0180
Country
Japan
Facility Name
Fukushima Medical University Hospital
City
Fukushima
ZIP/Postal Code
960-1295
Country
Japan
Facility Name
Nissay Hospital
City
Osaka
ZIP/Postal Code
550-0012
Country
Japan
Facility Name
Jikei University Hospital
City
Tokyo
ZIP/Postal Code
105-8471
Country
Japan

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3921137&StudyName=A%20Long%20Term%20Study%20To%20Evaluate%20The%20Safety%2C%20Tolerability%20And%20Efficacy%20Of%20CP-690%2C550%20In%20Patients%20With%20Moderate%20To%20Severe%20Plaque%20Psori
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

A Long Term Study To Evaluate The Safety, Tolerability And Efficacy Of CP-690,550 In Patients With Moderate To Severe Plaque Psoriasis And/Or Psoriatic Arthritis

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