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

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01519089
• Collaborator: (none)
• Enrollment: 95
• Locations: 16
• Arms: 2
• Duration (Months): 22
• Patients Per Site: 5.9
• Patients Per Site Per Month: 0.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Psoriasis	Drug: CP-690,550; Drug: CP-690, 550	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 95 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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 Start Date: Mar 1, 2012
• Actual Primary Completion Date: Jan 1, 2014
• Actual Study Completion Date: Jan 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CP-690,550 10 mg BID	Drug: CP-690,550; 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.
Experimental: CP690,550 5 mg BID	Drug: CP-690, 550; 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.

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response at Week 16 [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.

2. Percentage of Participants With a Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' at Week 16 [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).

3. Proportion of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 16 [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).

4. Number of Participants With Adjudicated Cardiovacular Events [Baseline to Follow-up]

   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.

5. Number of Participants With Malignancy Events _Week 0 Through Follow-up [Baseline to 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

1. Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response [Week 2, 4, 8, 12, 20, 28, 40, 52]

   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.

2. Percentage of Participants With a Psoriasis Area and Severity Index 50 (PASI50) Response [Week 2, 4, 8, 12, 16, 20, 28, 40, 52]

   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.

3. Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response [Week 2, 4, 8, 12, 16, 20, 28, 40, 52]

   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.

4. Time to Achieve a Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' [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). 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%.

5. Time to Achieve a Psoriasis Area and Severity Index 75 (PASI75) Response [Week 16]

   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%.

6. Time to Achieve a Psoriasis Area and Severity Index 50 (PASI50) Response [Week 16]

   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%.

7. Time to Achieve a Psoriasis Area and Severity Index 90 (PASI90) Response [Week 16]

   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%.

8. Percentage of Participants With a Psoriasis Area and Severity Index (PASI) Score >= 125 Percent of the Baseline PASI Score [Week 2, 4, 8, 12, 16, 20, 28, 40, 52]

   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.

9. Change From Baseline in Psoriasis Area and Severity Index (PASI) Score [Week 2, 4, 8, 12, 16, 20, 28, 40, 52]

   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.

10. Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score [Week 2, 4, 8, 12, 16, 20, 28, 40, 52]

    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.

11. Percentage of Participants With a Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' [Week 2, 4, 8, 12, 20, 28, 40, 52]

    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).

12. Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category [Week 2, 4, 8, 12, 16, 20, 28, 40, 52]

    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).

13. Percentage of Participants Maintaining Psoriasis Area and Severity Index 75 (PASI75) Response After Week 16 [Week 20, 28, 40, 52]

    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.

14. Percentage of Participants Maintaining Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' [Week 20, 28, 40, 52]

    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.

15. Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score [Week 8, 16, 20, 28, 40, 52]

    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.

16. Number of Affected Nails [Baseline, Week 8, 16, 20, 28, 40, 52]

    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.

17. Itch Severity Item (ISI) Score [Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52]

    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.

18. Dermatology Life Quality Index (DLQI) Score [Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52]

    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.

19. Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Domain Score [Week (W) 16, 28, 52]

    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).

20. Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Component Summary Score [Week 16, 28, 52]

    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).

21. Work Limitation Questionnaire (WLQ) [Baseline (BL), Week (W) 4, 16, 28, 52]

    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]).

22. Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category [Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52]

    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).

23. Joint Pain Assessment (JPA) [Baseline, Week 4, 16, 28, 52]

    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."

24. Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response [Week 2, 4, 8, 12, 20, 28, 40, 52]

    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).

25. Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response [Week 2, 4, 8, 12, 16, 20, 28, 40, 52]

    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).

26. Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response [Week 2, 4, 8, 12, 16, 20, 28, 40, 52]

    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).

27. Change From Baseline in American College of Rheumatology (ACR) Component_ Tender/Painful Joint Count [Week 2, 4, 8, 12, 16, 20, 28, 40, 52]

    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).

28. Change From Baseline in American College of Rheumatology (ACR) Component_ Swollen Joint Count [Week 2, 4, 8, 12, 16, 20, 28, 40, 52]

    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).

29. Change From Baseline in American College of Rheumatology (ACR) Component_ Patient Assessment of Arthritis Pain [Week 2, 4, 8, 12, 16, 20, 28, 40, 52]

    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.

30. Change From Baseline in American College of Rheumatology (ACR) Component_ Patient Global Assessment of Arthritis [Week 2, 4, 8, 12, 16, 20, 28, 40, 52]

    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.

31. Change From Baseline in American College of Rheumatology (ACR) Component_ Physician Global Assessment of Arthritis [Week 2, 4, 8, 12, 16, 20, 28, 40, 52]

    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.

32. Change From Baseline in American College of Rheumatology (ACR) Component_ C-Reactive Protein (CRP) [Week 2, 4, 8, 12, 16, 20, 28, 40, 52]

    The blood samples were collected at each visit for analysis of CRP with an assay analyzed by the central laboratory.

33. Change From Baseline in American College of Rheumatology (ACR) Component_ Health Assessment Questionnaire - Disability Index (HAQ-DI) [Week 2, 4, 8, 12, 16, 20, 28, 40, 52]

    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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	JR Sapporo hospital	Sapporo	Hokkaido	Japan	060-0033
2	Kobe University Hospital	Chuo-ku, Kobe	Hyogo	Japan	650-0017
3	Kanazawa Medical University Hospital	Kahoku-gun	Ishikawa	Japan	920-0293
4	National Hospital Organization Sagamihara National Hospital	Sagamihara	Kanagawa	Japan	252-0392
5	University of Miyazaki Hospital	Miyazaki-shi	Miyazaki	Japan	889-1692
6	Jichi Medical University Hospital	Shimotsuke	Tochigi	Japan	324-0498
7	Tokyo Teishin Hospital	Chiyoda-ku	Tokyo	Japan	102-8798
8	Tokyo medical university Hachioji medical center	Hachioji	Tokyo	Japan	193-0998
9	Kanto Medical Center NTT East Corporation	Shinagawa-ku	Tokyo	Japan	141-8625
10	Tokyo Medical University Hospital	Shinjyuku-ku	Tokyo	Japan	160-0023
11	Tonami General Hospital	Tonami	Toyama	Japan	939-1395
12	Yamanashi Prefectural Central Hospital	Kofu	Yamanashi	Japan	400-8506
13	Fukuoka University Hospital	Fukuoka		Japan	814-0180
14	Fukushima Medical University Hospital	Fukushima		Japan	960-1295
15	Nissay Hospital	Osaka		Japan	550-0012
16	Jikei University Hospital	Tokyo		Japan	105-8471

Sponsors and Collaborators

• Pfizer

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT01519089
• Other Study ID Numbers: A3921137
• First Posted: Jan 26, 2012
• Last Update Posted: Aug 13, 2015
• Last Verified: Aug 1, 2015

• Keywords provided by Pfizer: chronic; severe; moderate; treatment; safety; efficacy; CP-690; 550; Plaque psoriasis; Psoriasis Vulgaris; Psoriatic Arthritis; tofacitinib; Xeljanz
• Additional relevant MeSH terms: Arthritis; Arthritis, Psoriatic; Psoriasis; Tofacitinib

Study Results

Participant Flow

Arm/Group Title	CP-690,550 5 mg BID	CP-690,550 10 mg BID
Arm/Group Description	CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.	CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
Period Title: Overall Study
STARTED	47	48
Received Treatment	47	47
COMPLETED	40	33
NOT COMPLETED	7	15

Baseline Characteristics

Arm/Group Title	CP-690,550 5 mg BID	CP-690,550 10 mg BID	Total
Arm/Group Description	CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.	CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.	Total of all reporting groups
Overall Participants	47	47	94
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	50.9 (11.8)	46.4 (10.8)	48.7 (11.5)
Sex: Female, Male (Count of Participants)
Female	8 17%	8 17%	16 17%
Male	39 83%	39 83%	78 83%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs. Missing data was imputed as non-responder.

Arm/Group Title	CP-690,550 5 mg BID	CP-690,550 10 mg BID	Total
Arm/Group Description	CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.	CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.	(=sum across Arm/Groups)
Measure Participants	43	44	87
Number [Percentage of participants]	62.8 133.6%	72.7 154.7%	67.8 72.1%

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs. Missing data was imputed as non-responder.

Arm/Group Title	CP-690,550 5 mg BID	CP-690,550 10 mg BID	Total
Arm/Group Description	CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.	CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.	(=sum across Arm/Groups)
Measure Participants	43	44	87
Number [Percentage of participants]	67.4 143.4%	68.2 145.1%	67.8 72.1%

3. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Psoriatic Arthritis Population: Participants who met the inclusion criteria for the psoriatic arthritis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs. Missing data was imputed as non-responder.

Arm/Group Title	CP-690,550 5 mg BID	CP-690,550 10 mg BID	Total
Arm/Group Description	CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.	CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.	(=sum across Arm/Groups)
Measure Participants	4	8	12
Number [Percentage of participants]	100 212.8%	100 212.8%	100 106.4%

4. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Participants treated with at least 1 dose of study drugs.

Arm/Group Title	CP-690,550 5 mg BID	CP-690,550 10 mg BID	Total
Arm/Group Description	CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.	CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.	(=sum across Arm/Groups)
Measure Participants	47	47	94
Number [Participants]	0 0%	0 0%	0 0%

5. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Participants treated with at least 1 dose of study drugs.

Arm/Group Title	CP-690,550 5 mg BID	CP-690,550 10 mg BID	Total
Arm/Group Description	CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.	CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.	(=sum across Arm/Groups)
Measure Participants	47	47	94
Number of participants with any malignancy events	0 0%	0 0%	0 0%
Malignancy excluding non-melanoma skin cancer	0 0%	0 0%	0 0%
Lymphoma/Lymphoproliferative disorders (LPD)	0 0%	0 0%	0 0%
Melanoma	0 0%	0 0%	0 0%
Non-melanoma skin cancer	0 0%	0 0%	0 0%

6. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs. Missing data was imputed as non-responder.

Arm/Group Title	CP-690,550 5 mg BID	CP-690,550 10 mg BID	Total
Arm/Group Description	CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.	CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.	(=sum across Arm/Groups)
Measure Participants	43	44	87
Week 2	2.3 4.9%	4.5 9.6%	3.4 3.6%
Week 4	7.0 14.9%	22.7 48.3%	14.9 15.9%
Week 8	41.9 89.1%	54.5 116%	48.3 51.4%
Week 12	60.5 128.7%	70.5 150%	65.5 69.7%
Week 20	67.4 143.4%	63.6 135.3%	65.5 69.7%
Week 28	69.8 148.5%	65.9 140.2%	67.8 72.1%
Week 40	69.8 148.5%	63.6 135.3%	66.7 71%
Week 52	62.8 133.6%	63.6 135.3%	63.2 67.2%

7. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs. Missing data was imputed as non-responder.

Arm/Group Title	CP-690,550 5 mg BID	CP-690,550 10 mg BID	Total
Arm/Group Description	CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.	CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.	(=sum across Arm/Groups)
Measure Participants	43	44	87
Week 2	9.3 19.8%	22.7 48.3%	16.1 17.1%
Week 4	34.9 74.3%	56.8 120.9%	46.0 48.9%
Week 8	60.5 128.7%	81.8 174%	71.3 75.9%
Week 12	81.4 173.2%	84.1 178.9%	82.8 88.1%
Week 16	76.7 163.2%	79.5 169.1%	78.2 83.2%
Week 20	79.1 168.3%	75.0 159.6%	77.0 81.9%
Week 28	90.7 193%	72.7 154.7%	81.6 86.8%
Week 40	88.4 188.1%	79.5 169.1%	83.9 89.3%
Week 52	90.7 193%	68.2 145.1%	79.3 84.4%

8. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs. Missing data was imputed as non-responder.

Arm/Group Title	CP-690,550 5 mg BID	CP-690,550 10 mg BID	Total
Arm/Group Description	CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.	CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.	(=sum across Arm/Groups)
Measure Participants	43	44	87
Week 2	0.0 0%	0.0 0%	0.0 0%
Week 4	4.7 10%	13.6 28.9%	9.2 9.8%
Week 8	16.3 34.7%	29.5 62.8%	23.0 24.5%
Week 12	37.2 79.1%	45.5 96.8%	41.4 44%
Week 16	37.2 79.1%	54.5 116%	46.0 48.9%
Week 20	58.1 123.6%	56.8 120.9%	57.5 61.2%
Week 28	55.8 118.7%	45.5 96.8%	50.6 53.8%
Week 40	58.1 123.6%	47.7 101.5%	52.9 56.3%
Week 52	51.2 108.9%	47.7 101.5%	49.4 52.6%

9. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.

Arm/Group Title	CP-690,550 5 mg BID	CP-690,550 10 mg BID	Total
Arm/Group Description	CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.	CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.	(=sum across Arm/Groups)
Measure Participants	43	44	87
Median (95% Confidence Interval) [Week]	8.0	8.0	8.0

10. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.

Arm/Group Title	CP-690,550 5 mg BID	CP-690,550 10 mg BID	Total
Arm/Group Description	CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.	CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.	(=sum across Arm/Groups)
Measure Participants	43	44	87
Median (95% Confidence Interval) [Week]	12.0	8.0	12.0

11. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.

Arm/Group Title	CP-690,550 5 mg BID	CP-690,550 10 mg BID	Total
Arm/Group Description	CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.	CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.	(=sum across Arm/Groups)
Measure Participants	43	44	87
Median (95% Confidence Interval) [Week]	8.0	4.0	8.0

12. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.

Arm/Group Title	CP-690,550 5 mg BID	CP-690,550 10 mg BID	Total
Arm/Group Description	CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.	CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.	(=sum across Arm/Groups)
Measure Participants	43	44	87
Median (95% Confidence Interval) [Week]	NA	12.0	16.0

13. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.

Arm/Group Title	CP-690,550 5 mg BID	CP-690,550 10 mg BID	Total
Arm/Group Description	CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.	CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.	(=sum across Arm/Groups)
Measure Participants	43	44	87
Week 2	2.3 4.9%	0.0 0%	1.1 1.2%
Week 4	0.0 0%	2.3 4.9%	1.1 1.2%
Week 8 (n=43, 41, 84)	0.0 0%	0.0 0%	0.0 0%
Week 12 (n=43, 41, 84)	0.0 0%	2.4 5.1%	1.2 1.3%
Week 16 (n=43, 40, 83)	0.0 0%	2.5 5.3%	1.2 1.3%
Week 20 (n=43, 39, 82)	0.0 0%	0.0 0%	0.0 0%
Week 28 (n=43, 39, 82)	0.0 0%	0.0 0%	0.0 0%
Week 40 (n=41, 38, 79)	0.0 0%	0.0 0%	0.0 0%
Week 52 (n=39, 32, 71)	0.0 0%	0.0 0%	0.0 0%

14. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.

Arm/Group Title	CP-690,550 5 mg BID	CP-690,550 10 mg BID	Total
Arm/Group Description	CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.	CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.	(=sum across Arm/Groups)
Measure Participants	43	44	87
Week 2	-5.18 (5.898)	-7.36 (6.428)	-6.28 (6.232)
Week 4	-10.40 (7.518)	-13.16 (8.739)	-11.79 (8.229)
Week 8 (n=43, 41, 84)	-15.95 (8.392)	-19.90 (10.741)	-17.88 (9.756)
Week 12 (n=43, 41, 84)	-18.91 (8.918)	-21.68 (11.598)	-20.26 (10.344)
Week 16 (n=43, 40, 83)	-19.53 (9.094)	-22.06 (12.606)	-20.75 (10.935)
Week 20 (n=43, 39, 82)	-20.95 (9.239)	-22.18 (12.045)	-21.53 (10.617)
Week 28 (n=43, 39, 82)	-21.77 (10.196)	-21.46 (10.503)	-21.62 (10.280)
Week 40 (n=41, 38, 79)	-22.20 (10.181)	-21.18 (10.229)	-21.71 (10.151)
Week 52 (n=39, 32, 71)	-21.96 (9.621)	-22.11 (10.598)	-22.03 (10.000)

15. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.

Arm/Group Title	CP-690,550 5 mg BID	CP-690,550 10 mg BID	Total
Arm/Group Description	CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.	CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.	(=sum across Arm/Groups)
Measure Participants	43	44	87
Week 2: Erythema (Head/Neck)	-0.5 (0.83)	-0.9 (0.82)	-0.7 (0.84)
Week 2: Erythema (Upper Limbs)	-0.5 (0.67)	-0.8 (0.72)	-0.6 (0.70)
Week 2: Erythema (Trunk)	-0.6 (0.67)	-0.8 (0.69)	-0.7 (0.69)
Week 2: Erythema (Lower Limbs)	-0.7 (0.69)	-0.8 (0.71)	-0.7 (0.70)
Week 2: Induration (Head/Neck)	-0.4 (0.70)	-0.8 (0.89)	-0.6 (0.82)
Week 2: Induration (Upper Limbs)	-0.5 (0.63)	-0.6 (0.75)	-0.6 (0.69)
Week 2: Induration (Trunk)	-0.5 (0.63)	-0.7 (0.59)	-0.6 (0.62)
Week 2: Induration (Lower Limbs)	-0.5 (0.67)	-0.7 (0.71)	-0.6 (0.69)
Week 2: Scaling (Head/Neck)	-0.4 (0.66)	-0.9 (0.91)	-0.7 (0.83)
Week 2: Scaling (Upper Limbs)	-0.4 (0.59)	-0.8 (0.74)	-0.6 (0.69)
Week 2: Scaling (Trunk)	-0.3 (0.57)	-0.8 (0.76)	-0.6 (0.71)
Week 2: Scaling (Lower Limbs)	-0.4 (0.70)	-0.7 (0.73)	-0.6 (0.73)
Week 4: Erythema (Head/Neck)	-0.8 (1.02)	-1.3 (0.99)	-1.0 (1.02)
Week 4: Erythema (Upper Limbs)	-1.1 (0.81)	-1.2 (0.94)	-1.1 (0.87)
Week 4: Erythema (Trunk)	-1.0 (0.64)	-1.3 (0.79)	-1.1 (0.72)
Week 4: Erythema (Lower Limbs)	-1.1 (0.91)	-1.2 (0.79)	-1.2 (0.85)
Week 4: Induration (Head/Neck)	-0.7 (0.89)	-1.2 (1.09)	-1.0 (1.02)
Week 4: Induration (Upper Limbs)	-1.1 (0.86)	-1.0 (0.85)	-1.0 (0.85)
Week 4: Induration (Trunk)	-0.9 (0.80)	-1.3 (0.82)	-1.1 (0.83)
Week 4: Induration (Lower Limbs)	-1.0 (0.90)	-1.2 (0.98)	-1.1 (0.94)
Week 4: Scaling (Head/Neck)	-0.8 (0.86)	-1.2 (0.99)	-1.0 (0.95)
Week 4: Scaling (Upper Limbs)	-0.9 (0.70)	-1.2 (0.86)	-1.0 (0.79)
Week 4: Scaling (Trunk)	-0.9 (0.71)	-1.3 (0.95)	-1.1 (0.87)
Week 4: Scaling (Lower Limbs)	-0.8 (0.72)	-1.3 (0.96)	-1.1 (0.89)
Week 8: Erythema (Head/Neck) (n=43, 41, 84)	-1.4 (1.13)	-1.6 (1.03)	-1.5 (1.08)
Week 8: Erythema (Upper Limbs) (n=43, 41, 84)	-1.5 (0.93)	-1.6 (0.98)	-1.5 (0.95)
Week 8: Erythema (Trunk) (n=43, 41, 84)	-1.7 (0.91)	-1.9 (0.93)	-1.8 (0.92)
Week 8: Erythema (Lower Limbs) (n=43, 41, 84)	-1.5 (0.91)	-1.7 (0.91)	-1.6 (0.91)
Week 8: Induration (Head/Neck) (n=43, 41, 84)	-1.3 (0.91)	-1.6 (1.10)	-1.4 (1.01)
Week 8: Induration (Upper Limbs) (n=43, 41, 84)	-1.6 (0.93)	-1.6 (0.89)	-1.6 (0.91)
Week 8: Induration (Trunk) (n=43, 41, 84)	-1.6 (0.98)	-1.7 (1.03)	-1.7 (1.00)
Week 8: Induration (Lower Limbs) (n=43, 41, 84)	-1.6 (0.91)	-1.7 (0.98)	-1.7 (0.94)
Week 8: Scaling (Head/Neck) (n=43, 41, 84)	-1.3 (0.90)	-1.5 (1.03)	-1.4 (0.96)
Week 8: Scaling (Upper Limbs) (n=43, 41, 84)	-1.3 (0.80)	-1.6 (0.86)	-1.5 (0.84)
Week 8: Scaling (Trunk) (n=43, 41, 84)	-1.4 (0.82)	-1.8 (1.00)	-1.6 (0.93)
Week 8: Scaling (Lower Limbs) (n=43, 41, 84)	-1.3 (0.82)	-1.8 (0.88)	-1.5 (0.88)
Week 12: Erythema (Head/Neck) (n=43, 41, 84)	-1.7 (1.10)	-1.7 (0.98)	-1.7 (1.04)
Week 12: Erythema (Upper Limbs) (n=43, 41, 84)	-1.9 (0.99)	-1.8 (1.13)	-1.8 (1.05)
Week 12: Erythema (Trunk) (n=43, 41, 84)	-2.1 (1.08)	-2.0 (0.95)	-2.0 (1.01)
Week 12: Erythema (Lower Limbs) (n=43, 41, 84)	-1.9 (0.92)	-1.9 (0.94)	-1.9 (0.92)
Week 12: Induration (Head/Neck) (n=43, 41, 84)	-1.5 (0.94)	-1.6 (1.12)	-1.6 (1.02)
Week 12: Induration (Upper Limbs) (n=43, 41, 84)	-1.7 (0.94)	-1.8 (0.99)	-1.7 (0.96)
Week 12: Induration (Trunk) (n=43, 41, 84)	-2.0 (1.01)	-2.0 (1.00)	-2.0 (1.00)
Week 12: Induration (Lower Limbs) (n=43, 41, 84)	-1.9 (0.91)	-1.9 (1.06)	-1.9 (0.98)
Week 12: Scaling (Head/Neck) (n=43, 41, 84)	-1.7 (0.92)	-1.6 (1.02)	-1.6 (0.96)
Week 12: Scaling (Upper Limbs) (n=43, 41, 84)	-1.4 (0.91)	-1.7 (0.95)	-1.6 (0.94)
Week 12: Scaling (Trunk) (n=43, 41, 84)	-1.6 (1.05)	-1.9 (1.00)	-1.7 (1.03)
Week 12: Scaling (Lower Limbs) (n=43, 41, 84)	-1.5 (0.85)	-1.9 (1.00)	-1.7 (0.95)
Week 16: Erythema (Head/Neck) (n=43, 40, 83)	-1.7 (1.14)	-1.7 (1.07)	-1.7 (1.10)
Week 16: Erythema (Upper Limbs) (n=43, 40, 83)	-1.9 (1.13)	-1.9 (1.12)	-1.9 (1.12)
Week 16: Erythema (Trunk) (n=43, 40, 83)	-2.1 (1.10)	-2.0 (1.07)	-2.0 (1.08)
Week 16: Erythema (Lower Limbs) (n=43, 40, 83)	-2.0 (1.03)	-1.9 (0.94)	-2.0 (0.99)
Week 16: Induration (Head/Neck) (n=43, 40, 83)	-1.5 (0.96)	-1.6 (1.17)	-1.6 (1.06)
Week 16: Induration (Upper Limbs) (n=43, 40, 83)	-1.8 (0.96)	-1.8 (1.01)	-1.8 (0.98)
Week 16: Induration (Trunk) (n=43, 40, 83)	-2.1 (1.01)	-2.0 (1.01)	-2.0 (1.01)
Week 16: Induration (Lower Limbs) (n=43, 40, 83)	-2.1 (0.95)	-2.0 (1.08)	-2.0 (1.01)
Week 16: Scaling (Head/Neck) (n=43, 40, 83)	-1.6 (0.95)	-1.6 (1.08)	-1.6 (1.01)
Week 16: Scaling (Upper Limbs) (n=43, 40, 83)	-1.5 (0.93)	-1.7 (1.05)	-1.6 (0.99)
Week 16: Scaling (Trunk) (n=43, 40, 83)	-1.6 (0.96)	-1.8 (1.09)	-1.7 (1.02)
Week 16: Scaling (Lower Limbs) (n=43, 40, 83)	-1.6 (0.93)	-1.8 (1.06)	-1.7 (1.00)
Week 20: Erythema (Head/Neck) (n=43, 39, 82)	-1.8 (1.15)	-1.6 (0.96)	-1.7 (1.07)
Week 20: Erythema (Upper Limbs) (n=43, 39, 82)	-1.9 (0.97)	-1.9 (1.26)	-1.9 (1.11)
Week 20: Erythema (Trunk) (n=43, 39, 82)	-2.2 (1.04)	-2.1 (1.04)	-2.1 (1.04)
Week 20: Erythema (Lower Limbs) (n=43, 39, 82)	-2.1 (1.04)	-2.1 (1.09)	-2.1 (1.05)
Week 20: Induration (Head/Neck) (n=43, 39, 82)	-1.6 (1.00)	-1.5 (1.12)	-1.6 (1.06)
Week 20: Induration (Upper Limbs) (n=43, 39, 82)	-1.9 (0.97)	-1.7 (1.14)	-1.8 (1.05)
Week 20: Induration (Trunk) (n=43, 39, 82)	-2.1 (1.01)	-1.9 (1.07)	-2.0 (1.04)
Week 20: Induration (Lower Limbs) (n=43, 39, 82)	-2.2 (0.95)	-2.0 (1.06)	-2.1 (1.00)
Week 20: Scaling (Head/Neck) (n=43, 39, 82)	-1.7 (0.94)	-1.5 (1.05)	-1.6 (0.99)
Week 20: Scaling (Upper Limbs) (n=43, 39, 82)	-1.5 (0.96)	-1.6 (1.14)	-1.5 (1.04)
Week 20: Scaling (Trunk) (n=43, 39, 82)	-1.7 (0.93)	-1.8 (1.05)	-1.8 (0.99)
Week 20: Scaling (Lower Limbs) (n=43, 39, 82)	-1.7 (0.92)	-1.8 (1.16)	-1.8 (1.04)
Week 28: Erythema (Head/Neck) (n=43, 39, 82)	-1.8 (1.11)	-1.6 (0.81)	-1.7 (0.98)
Week 28: Erythema (Upper Limbs) (n=43, 39, 82)	-2.1 (1.09)	-1.8 (1.07)	-2.0 (1.08)
Week 28: Erythema (Trunk) (n=43, 39, 82)	-2.1 (1.13)	-2.0 (0.99)	-2.1 (1.06)
Week 28: Erythema (Lower Limbs) (n=43, 39, 82)	-2.3 (1.05)	-1.9 (0.99)	-2.1 (1.03)
Week 28: Induration (Head/Neck) (n=43, 39, 82)	-1.7 (0.97)	-1.6 (0.99)	-1.6 (0.98)
Week 28: Induration (Upper Limbs) (n=43, 39, 82)	-2.0 (1.12)	-1.7 (1.10)	-1.9 (1.12)
Week 28: Induration (Trunk) (n=43, 39, 82)	-2.0 (1.12)	-1.8 (1.16)	-1.9 (1.14)
Week 28: Induration (Lower Limbs) (n=43, 39, 82)	-2.2 (1.03)	-1.8 (1.14)	-2.0 (1.09)
Week 28: Scaling (Head/Neck) (n=43, 39, 82)	-1.7 (1.01)	-1.4 (1.07)	-1.6 (1.04)
Week 28: Scaling (Upper Limbs) (n=43, 39, 82)	-1.8 (1.05)	-1.6 (1.02)	-1.7 (1.03)
Week 28: Scaling (Trunk) (n=43, 39, 82)	-1.7 (0.99)	-1.8 (1.11)	-1.7 (1.05)
Week 28: Scaling (Lower Limbs) (n=43, 39, 82)	-1.8 (1.09)	-1.7 (1.02)	-1.7 (1.05)
Week 40: Erythema (Head/Neck) (n=41, 38, 79)	-1.9 (1.10)	-1.7 (0.90)	-1.8 (1.01)
Week 40: Erythema (Upper Limbs) (n=41, 38, 79)	-2.1 (1.05)	-1.9 (1.06)	-2.0 (1.06)
Week 40: Erythema (Trunk) (n=41, 38, 79)	-2.1 (1.04)	-2.2 (0.87)	-2.2 (0.95)
Week 40: Erythema (Lower Limbs) (n=41, 38, 79)	-2.4 (1.05)	-2.0 (1.03)	-2.2 (1.05)
Week 40: Induration (Head/Neck) (n=41, 38, 79)	-1.7 (1.05)	-1.5 (1.08)	-1.6 (1.07)
Week 40: Induration (Upper Limbs) (n=41, 38, 79)	-2.0 (1.18)	-1.8 (0.98)	-1.9 (1.09)
Week 40: Induration (Trunk) (n=41, 38, 79)	-1.9 (1.26)	-2.1 (0.93)	-2.1 (1.11)
Week 40: Induration (Lower Limbs) (n=41, 38, 79)	-2.2 (1.14)	-1.9 (1.03)	-2.1 (1.10)
Week 40: Scaling (Head/Neck) (n=41, 38, 79)	-1.8 (0.97)	-1.4 (1.00)	-1.6 (0.99)
Week 40: Scaling (Upper Limbs) (n=41, 38, 79)	-1.7 (1.10)	-1.8 (0.94)	-1.7 (1.02)
Week 40: Scaling (Trunk) (n=41, 38, 79)	-1.7 (0.93)	-1.9 (1.03)	-1.8 (0.98)
Week 40: Scaling (Lower Limbs) (n=41, 38, 79)	-1.9 (1.11)	-1.8 (1.06)	-1.8 (1.08)
Week 52: Erythema (Head/Neck) (n=39, 32, 71)	-1.9 (1.17)	-1.6 (1.24)	-1.8 (1.20)
Week 52: Erythema (Upper Limbs) (n=39, 32, 71)	-2.0 (1.15)	-2.0 (0.90)	-2.0 (1.04)
Week 52: Erythema (Trunk) (n=39, 32, 71)	-2.2 (1.01)	-2.2 (0.93)	-2.2 (0.97)
Week 52: Erythema (Lower Limbs) (n=39, 32, 71)	-2.1 (1.11)	-2.2 (0.94)	-2.1 (1.03)
Week 52: Induration (Head/Neck) (n=39, 32, 71)	-1.7 (1.06)	-1.5 (1.22)	-1.6 (1.13)
Week 52: Induration (Upper Limbs) (n=39, 32, 71)	-1.9 (1.21)	-2.0 (0.97)	-1.9 (1.10)
Week 52: Induration (Trunk) (n=39, 32, 71)	-1.8 (1.39)	-2.1 (1.03)	-2.0 (1.24)
Week 52: Induration (Lower Limbs) (n=39, 32, 71)	-2.0 (1.29)	-2.2 (0.97)	-2.1 (1.15)
Week 52: Scaling (Head/Neck) (n=39, 32, 71)	-1.8 (0.98)	-1.6 (1.08)	-1.7 (1.02)
Week 52: Scaling (Upper Limbs) (n=39, 32, 71)	-1.6 (1.02)	-1.9 (0.98)	-1.7 (1.01)
Week 52: Scaling (Trunk) (n=39, 32, 71)	-1.6 (0.96)	-1.9 (1.01)	-1.7 (0.98)
Week 52: Scaling (Lower Limbs) (n=39, 32, 71)	-1.7 (1.15)	-2.0 (1.03)	-1.8 (1.10)

16. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs. Missing data was imputed as non-responder.

Arm/Group Title	CP-690,550 5 mg BID	CP-690,550 10 mg BID	Total
Arm/Group Description	CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.	CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.	(=sum across Arm/Groups)
Measure Participants	43	44	87
Week 2	7.0 14.9%	15.9 33.8%	11.5 12.2%
Week 4	30.2 64.3%	38.6 82.1%	34.5 36.7%
Week 8	58.1 123.6%	61.4 130.6%	59.8 63.6%
Week 12	72.1 153.4%	75.0 159.6%	73.6 78.3%
Week 20	72.1 153.4%	59.1 125.7%	65.5 69.7%
Week 28	67.4 143.4%	54.5 116%	60.9 64.8%
Week 40	67.4 143.4%	54.5 116%	60.9 64.8%
Week 52	58.1 123.6%	56.8 120.9%	57.5 61.2%

17. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.

Arm/Group Title	CP-690,550 5 mg BID	CP-690,550 10 mg BID	Total
Arm/Group Description	CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.	CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.	(=sum across Arm/Groups)
Measure Participants	43	44	87
Week 2: Clear	0 0%	0 0%	0 0%
Week 2: Almost Clear	7.0 14.9%	15.9 33.8%	11.5 12.2%
Week 2: Mild	39.5 84%	43.2 91.9%	41.4 44%
Week 2: Moderate	46.5 98.9%	34.1 72.6%	40.2 42.8%
Week 2: Severe	7.0 14.9%	6.8 14.5%	6.9 7.3%
Week 4: Clear	0 0%	11.4 24.3%	5.7 6.1%
Week 4: Almost Clear	30.2 64.3%	27.3 58.1%	28.7 30.5%
Week 4: Mild	44.2 94%	40.9 87%	42.5 45.2%
Week 4: Moderate	18.6 39.6%	20.5 43.6%	19.5 20.7%
Week 4: Severe	7.0 14.9%	0 0%	3.4 3.6%
Week 8: Clear (n=43, 41, 84)	7.0 14.9%	26.8 57%	16.7 17.8%
Week 8: Almost Clear (n=43, 41, 84)	51.2 108.9%	39.0 83%	45.2 48.1%
Week 8: Mild (n=43, 41, 84)	27.9 59.4%	24.4 51.9%	26.2 27.9%
Week 8: Moderate (n=43, 41, 84)	14.0 29.8%	9.8 20.9%	11.9 12.7%
Week 8: Severe (n=43, 41, 84)	0 0%	0 0%	0 0%
Week 12: Clear (n=43, 41, 84)	14.0 29.8%	36.6 77.9%	25.0 26.6%
Week 12: Almost Clear (n=43, 41, 84)	58.1 123.6%	43.9 93.4%	51.2 54.5%
Week 12: Mild (n=43, 41, 84)	20.9 44.5%	9.8 20.9%	15.5 16.5%
Week 12: Moderate (n=43, 41, 84)	7.0 14.9%	9.8 20.9%	8.3 8.8%
Week 12: Severe (n=43, 41, 84)	0 0%	0 0%	0 0%
Week 16: Clear (n=43, 40, 83)	27.9 59.4%	40.0 85.1%	33.7 35.9%
Week 16: Almost Clear (n=43, 40, 83)	39.5 84%	35.0 74.5%	37.3 39.7%
Week 16: Mild (n=43, 40, 83)	25.6 54.5%	17.5 37.2%	21.7 23.1%
Week 16: Moderate (n=43, 40, 83)	7.0 14.9%	5.0 10.6%	6.0 6.4%
Week 16: Severe (n=43, 40, 83)	0 0%	2.5 5.3%	1.2 1.3%
Week 20: Clear (n=43, 39, 82)	27.9 59.4%	38.5 81.9%	32.9 35%
Week 20: Almost Clear (n=43, 39, 82)	44.2 94%	28.2 60%	36.6 38.9%
Week 20: Mild (n=43, 39, 82)	18.6 39.6%	25.6 54.5%	22.0 23.4%
Week 20: Moderate (n=43, 39, 82)	9.3 19.8%	7.7 16.4%	8.5 9%
Week 20: Severe(n=43, 39, 82)	0 0%	0 0%	0 0%
Week 28: Clear (n=43, 39, 82)	37.2 79.1%	33.3 70.9%	35.4 37.7%
Week 28: Almost Clear (n=43, 39, 82)	30.2 64.3%	28.2 60%	29.3 31.2%
Week 28: Mild (n=43, 39, 82)	27.9 59.4%	30.8 65.5%	29.3 31.2%
Week 28: Moderate (n=43, 39, 82)	4.7 10%	7.7 16.4%	6.1 6.5%
Week 28: Severe (n=43, 39, 82)	0 0%	0 0%	0 0%
Week 40: Clear (n=41, 38, 79)	43.9 93.4%	34.2 72.8%	39.2 41.7%
Week 40: Almost Clear (n=41, 38, 79)	26.8 57%	28.9 61.5%	27.8 29.6%
Week 40: Mild (n=41, 38, 79)	24.4 51.9%	28.9 61.5%	26.6 28.3%
Week 40: Moderate (n=41, 38, 79)	4.9 10.4%	7.9 16.8%	6.3 6.7%
Week 40: Severe (n=41, 38, 79)	0 0%	0 0%	0 0%
Week 52: Clear (n=39, 32, 71)	41.0 87.2%	43.8 93.2%	42.3 45%
Week 52: Almost Clear (n=39, 32, 71)	23.1 49.1%	34.4 73.2%	28.2 30%
Week 52: Mild (n=39, 32, 71)	30.8 65.5%	18.8 40%	25.4 27%
Week 52: Moderate (n=39, 32, 71)	5.1 10.9%	3.1 6.6%	4.2 4.5%
Week 52: Severe (n=39, 32, 71)	0 0%	0 0%	0 0%

18. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs. Missing data was imputed as non-responder.

Arm/Group Title	CP-690,550 5 mg BID	CP-690,550 10 mg BID	Total
Arm/Group Description	CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.	CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.	(=sum across Arm/Groups)
Measure Participants	28	35	63
Week 20	96.3 204.9%	87.5 186.2%	91.5 97.3%
Week 28	92.6 197%	78.1 166.2%	84.7 90.1%
Week 40	81.5 173.4%	71.9 153%	76.3 81.2%
Week 52	70.4 149.8%	62.5 133%	66.1 70.3%

19. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs. Missing data was imputed as non-responder.

Arm/Group Title	CP-690,550 5 mg BID	CP-690,550 10 mg BID	Total
Arm/Group Description	CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.	CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.	(=sum across Arm/Groups)
Measure Participants	30	31	61
Week 20	100 212.8%	83.3 177.2%	91.5 97.3%
Week 28	93.1 198.1%	73.3 156%	83.1 88.4%
Week 40	82.8 176.2%	66.7 141.9%	74.6 79.4%
Week 52	65.5 139.4%	60.0 127.7%	62.7 66.7%

20. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.

Arm/Group Title	CP-690,550 5 mg BID	CP-690,550 10 mg BID	Total
Arm/Group Description	CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.	CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.	(=sum across Arm/Groups)
Measure Participants	32	30	62
Week 8 (n=32, 28, 60)	-3.3 (9.63)	-1.8 (7.72)	-2.6 (8.75)
Week 16 (n=32, 28, 60)	-11.2 (15.27)	-9.4 (12.66)	-10.4 (14.02)
Week 20 (n=32, 27, 59)	-15.0 (15.29)	-14.1 (13.03)	-14.6 (14.18)
Week 28 (n=32, 27, 59)	-21.1 (15.83)	-16.4 (15.27)	-18.9 (15.62)
Week 40 (n=31, 26, 57)	-22.2 (16.18)	-16.2 (14.13)	-19.5 (15.45)
Week 52 (n=30, 22, 52)	-20.6 (15.16)	-16.2 (15.62)	-18.7 (15.36)

21. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.

Arm/Group Title	CP-690,550 5 mg BID	CP-690,550 10 mg BID	Total
Arm/Group Description	CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.	CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.	(=sum across Arm/Groups)
Measure Participants	32	30	62
Baseline	7.94 (2.82)	7.13 (3.07)	7.55 (2.95)
Week 8 (n=32, 28, 60)	7.66 (3.17)	7.11 (3.02)	7.40 (3.09)
Week 16 (n=32, 28, 60)	6.91 (3.43)	5.75 (3.56)	6.37 (3.51)
Week 20 (n=32, 27, 59)	6.16 (3.60)	4.59 (4.02)	5.44 (3.85)
Week 28 (n=32, 27, 59)	4.53 (3.87)	3.59 (3.96)	4.10 (3.91)
Week 40 (n=31, 26, 57)	3.32 (3.94)	3.77 (3.81)	3.53 (3.85)
Week 52 (n=30, 22, 52)	3.73 (4.25)	2.50 (3.07)	3.21 (3.81)

22. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.

Arm/Group Title	CP-690,550 5 mg BID	CP-690,550 10 mg BID	Total
Arm/Group Description	CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.	CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.	(=sum across Arm/Groups)
Measure Participants	43	44	87
Baseline	6.16 (2.669)	5.32 (2.967)	5.74 (2.839)
Week 2	5.19 (2.797)	3.30 (2.530)	4.23 (2.815)
Week 4	3.65 (2.379)	2.27 (2.472)	2.95 (2.510)
Week 8 (n=43, 41, 84)	2.26 (2.381)	1.22 (1.739)	1.75 (2.145)
Week 12 (n=43, 41, 84)	1.77 (2.379)	1.20 (1.833)	1.49 (2.137)
Week 16 (n=43, 40, 83)	1.67 (2.378)	0.90 (1.257)	1.30 (1.949)
Week 20 (n=43, 39, 82)	0.95 (1.618)	1.28 (1.589)	1.11 (1.603)
Week 28 (n=43, 39, 82)	1.12 (1.651)	1.62 (2.196)	1.35 (1.933)
Week 40 (n=41, 38, 79)	0.90 (1.814)	1.13 (1.848)	1.01 (1.822)
Week 52 (n=39, 32, 71)	1.15 (2.084)	0.91 (1.329)	1.04 (1.776)

23. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.

Arm/Group Title	CP-690,550 5 mg BID	CP-690,550 10 mg BID	Total
Arm/Group Description	CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.	CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.	(=sum across Arm/Groups)
Measure Participants	43	44	87
Baseline	11.3 (6.25)	8.6 (5.91)	9.9 (6.19)
Week 2	7.8 (5.20)	5.8 (5.32)	6.8 (5.32)
Week 4 (n=43, 43, 86)	5.9 (5.07)	4.2 (4.63)	5.1 (4.90)
Week 8 (n=43, 41, 84)	4.0 (3.95)	2.8 (3.30)	3.4 (3.67)
Week 12 (n=43, 41, 84)	2.6 (2.86)	1.8 (2.68)	2.2 (2.79)
Week 16 (n=43, 40, 83)	2.2 (3.04)	1.9 (2.73)	2.1 (2.88)
Week 20 (n=43, 39, 82)	1.9 (3.13)	1.8 (2.54)	1.9 (2.84)
Week 28 (n=43, 39, 82)	1.7 (2.66)	2.9 (3.68)	2.3 (3.23)
Week 40 (n=41, 38, 79)	1.8 (2.81)	2.3 (4.11)	2.0 (3.48)
Week 52 (n=39, 32, 71)	1.6 (2.42)	2.2 (4.00)	1.9 (3.22)

24. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.

Arm/Group Title	CP-690,550 5 mg BID	CP-690,550 10 mg BID	Total
Arm/Group Description	CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.	CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.	(=sum across Arm/Groups)
Measure Participants	43	44	87
W16: Physical Functioning Domain (n=43, 40, 83)	1.951 (5.1880)	4.809 (9.1822)	3.329 (7.4800)
W16: Role-Physical Domain (n=43, 40, 83)	6.160 (9.3615)	5.130 (11.1600)	5.664 (10.2172)
W16: Bodily Pain Domain (n=43, 40, 83)	11.808 (13.8431)	10.663 (12.2936)	11.256 (13.0524)
W16: General Health Domain (n=43, 40, 83)	2.392 (7.0933)	4.333 (7.0145)	3.328 (7.0799)
W16: Vitality Domain (n=43, 40, 83)	4.664 (9.5406)	3.517 (11.4421)	4.112 (10.4509)
W16: Social Function Domain (n=43, 40, 83)	7.629 (9.9734)	7.932 (8.8645)	7.775 (9.3992)
W16: Role-Emotional Domain (n=43, 40, 83)	7.219 (11.5898)	5.584 (11.5654)	6.431 (11.5365)
W16: Mental Health Domain (n=43, 40, 83)	5.928 (12.8757)	5.125 (13.3613)	5.541 (13.0378)
W28: Physical Functioning Domain (n=43, 39, 82)	1.571 (6.3446)	4.303 (10.3695)	2.870 (8.5558)
W28: Role-Physical Domain (n=43, 39, 82)	5.882 (10.6375)	5.017 (11.4671)	5.471 (10.9795)
W28: Bodily Pain Domain (n=43, 39, 82)	10.113 (15.9485)	8.394 (12.5405)	9.295 (14.3670)
W28: General Health Domain (n=43, 39, 82)	2.644 (5.9230)	3.517 (7.1375)	3.059 (6.5025)
W28: Vitality Domain (n=43, 39, 82)	4.038 (10.0116)	3.608 (10.0742)	3.833 (9.9815)
W28: Social Function Domain (n=43, 39, 82)	6.628 (11.3068)	6.205 (10.4347)	6.427 (10.8358)
W28: Role-Emotional Domain (n=43, 39, 82)	7.395 (11.8846)	6.310 (12.9504)	6.879 (12.3375)
W28: Mental Health Domain (n=43, 39, 82)	6.701 (12.4375)	5.328 (12.8129)	6.048 (12.5580)
W52: Physical Functioning Domain (n=39,32,71)	2.151 (5.6134)	3.773 (7.3533)	2.882 (6.4585)
W52: Role-Physical Domain (n=39, 32, 71)	6.669 (10.0520)	4.623 (9.7340)	5.747 (9.8926)
W52: Bodily Pain Domain (n=39, 32, 71)	12.335 (12.1413)	10.673 (9.7128)	11.586 (11.0678)
W52: General Health Domain (n=39, 32, 71)	2.758 (6.0866)	4.888 (6.8235)	3.718 (6.4707)
W52: Vitality Domain (n=39, 32, 71)	4.068 (10.5612)	5.052 (8.5160)	4.511 (9.6390)
W52: Social Function Domain (n=39, 32, 71)	8.411 (9.4598)	8.402 (9.2577)	8.407 (9.3024)
W52: Role-Emotional Domain (n=39, 32, 71)	8.445 (11.0018)	5.915 (10.3091)	7.305 (10.6949)
W52: Mental Health Domain (n=39, 32, 71)	7.317 (11.6243)	6.926 (12.6861)	7.141 (12.0276)

25. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.

Arm/Group Title	CP-690,550 5 mg BID	CP-690,550 10 mg BID	Total
Arm/Group Description	CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.	CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.	(=sum across Arm/Groups)
Measure Participants	43	44	87
Week 16: Physical Health Score (n=43, 40, 83)	4.719 (6.6806)	6.146 (8.5192)	5.407 (7.6087)
Week 16: Mental Health Score (n=43, 40, 83)	6.767 (11.0945)	5.029 (11.4967)	5.929 (11.2548)
Week 28: Physical Health Score (n=43, 39, 82)	3.770 (7.7829)	4.799 (8.8893)	4.259 (8.2914)
Week 28: Mental Health Score (n=43, 39, 82)	7.085 (11.3660)	5.364 (10.9089)	6.266 (11.1159)
Week 52: Physical Health Score (n=39, 32, 71)	4.676 (5.7405)	5.250 (5.7614)	4.935 (5.7159)
Week 52: Mental Health Score (n=39, 32, 71)	7.878 (10.1983)	6.826 (10.5988)	7.404 (10.3192)

26. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.

Arm/Group Title	CP-690,550 5 mg BID	CP-690,550 10 mg BID	Total
Arm/Group Description	CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.	CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.	(=sum across Arm/Groups)
Measure Participants	43	44	87
BL: Time Management scale (n=34, 37, 71)	44.49 (37.783)	42.36 (33.716)	43.38 (35.479)
BL: Physical Demands scale (n=33, 35, 68)	66.67 (33.522)	78.40 (31.122)	72.71 (32.606)
BL: Mental/Interpersonal Demands Scale(n=34,38,72)	28.61 (29.012)	31.52 (30.930)	30.15 (29.865)
BL: Output Demands scale (n=33, 37, 70)	22.61 (26.832)	30.27 (35.295)	26.66 (31.602)
BL: WLQ Index Score (n=34, 38, 72)	9.55 (6.716)	10.74 (8.045)	10.18 (7.420)
W4: Time Management scale (n=31, 36, 67)	35.32 (42.425)	31.39 (36.715)	33.21 (39.203)
W4: Physical Demands scale (n=29, 36, 65)	77.16 (33.013)	83.59 (29.593)	80.72 (31.083)
W4:Mental/Interpersonal Demands Scale(n=32,36,68)	17.94 (26.979)	23.39 (32.878)	20.82 (30.149)
W4: Output Demands scale (n=30, 36, 66)	13.50 (21.978)	20.14 (33.306)	17.12 (28.704)
W4: WLQ Index Score (n=32, 37, 69)	7.23 (5.591)	8.66 (7.754)	8.00 (6.827)
W16: Time Management scale (n=31, 35, 66)	35.07 (38.894)	33.29 (39.182)	34.12 (38.756)
W16: Physical Demands scale (n=30, 32, 62)	81.60 (26.982)	86.52 (25.548)	84.14 (26.153)
W16:Mental/Interpersonal Demands Scale(n=31,35,66)	13.33 (21.038)	20.28 (33.419)	17.01 (28.296)
W16: Output Demands scale (n=32, 33, 65)	11.88 (20.111)	19.55 (32.485)	15.77 (27.175)
W16: WLQ Index Score (n=32, 35, 67)	6.88 (4.715)	8.35 (7.425)	7.65 (6.276)
W28: Time Management scale (n=34, 34, 68)	38.68 (40.100)	29.78 (39.092)	34.23 (39.557)
W28: Physical Demands scale (n=32, 34, 66)	76.02 (31.041)	85.42 (24.730)	80.86 (28.151)
W28:Mental/Interpersonal Demands Scale(n=33,35,68)	16.84 (28.242)	16.39 (27.736)	16.61 (27.774)
W28: Output Demands scale (n=33, 34, 67)	13.94 (27.408)	14.71 (28.761)	14.33 (27.892)
W28: WLQ Index Score (n=34, 36, 70)	7.43 (6.493)	7.26 (6.829)	7.34 (6.620)
W52: Time Management scale (n=31, 31, 62)	50.32 (43.683)	31.88 (40.686)	41.10 (42.883)
W52: Physical Demands scale (n=29, 29, 58)	78.16 (30.205)	89.74 (24.410)	83.95 (27.838)
W52:Mental/Interpersonal Demands Scale(n=30,30,60)	25.56 (36.007)	16.89 (27.293)	21.22 (31.977)
W52: Output Demands scale (n=30, 29, 59)	22.63 (33.750)	12.24 (24.589)	17.52 (29.813)
W52: WLQ Index Score (n=32, 31, 63)	9.44 (8.127)	7.34 (6.429)	8.41 (7.358)

27. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.

Arm/Group Title	CP-690,550 5 mg BID	CP-690,550 10 mg BID	Total
Arm/Group Description	CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.	CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.	(=sum across Arm/Groups)
Measure Participants	43	44	87
Baseline: Clear	0 0%	0 0%	0 0%
Baseline: Almost Clear	0 0%	0 0%	0 0%
Baseline: Mild	0 0%	2.3 4.9%	1.1 1.2%
Baseline: Moderate	41.9 89.1%	43.2 91.9%	42.5 45.2%
Baseline: Severe	58.1 123.6%	54.5 116%	56.3 59.9%
Week 2: Clear	0 0%	0 0%	0 0%
Week 2: Almost Clear	2.3 4.9%	0 0%	1.1 1.2%
Week 2: Mild	2.3 4.9%	29.5 62.8%	16.1 17.1%
Week 2: Moderate	60.5 128.7%	36.4 77.4%	48.3 51.4%
Week 2: Severe	34.9 74.3%	34.1 72.6%	34.5 36.7%
Week 4: Clear (n=43, 43, 86)	0 0%	2.3 4.9%	1.2 1.3%
Week 4: Almost Clear (n=43, 43, 86)	4.7 10%	9.3 19.8%	7.0 7.4%
Week 4: Mild (n=43, 43, 86)	18.6 39.6%	25.6 54.5%	22.1 23.5%
Week 4: Moderate (n=43, 43, 86)	53.5 113.8%	48.8 103.8%	51.2 54.5%
Week 4: Severe (n=43, 43, 86)	23.3 49.6%	14.0 29.8%	18.6 19.8%
Week 8: Clear (n=43, 41, 84)	4.7 10%	7.3 15.5%	6.0 6.4%
Week 8: Almost Clear (n=43, 41, 84)	14.0 29.8%	17.1 36.4%	15.5 16.5%
Week 8: Mild (n=43, 41, 84)	32.6 69.4%	34.1 72.6%	33.3 35.4%
Week 8: Moderate (n=43, 41, 84)	39.5 84%	34.1 72.6%	36.9 39.3%
Week 8: Severe (n=43, 41, 84)	9.3 19.8%	7.3 15.5%	8.3 8.8%
Week 12: Clear (n=43, 41, 84)	2.3 4.9%	7.3 15.5%	4.8 5.1%
Week 12: Almost Clear (n=43, 41, 84)	20.9 44.5%	26.8 57%	23.8 25.3%
Week 12: Mild (n=43, 41, 84)	34.9 74.3%	41.5 88.3%	38.1 40.5%
Week 12: Moderate (n=43, 41, 84)	34.9 74.3%	17.1 36.4%	26.2 27.9%
Week 12: Severe (n=43, 41, 84)	7.0 14.9%	7.3 15.5%	7.1 7.6%
Week 16: Clear (n=43, 40, 83)	4.7 10%	10.0 21.3%	7.2 7.7%
Week 16: Almost Clear (n=43, 40, 83)	32.6 69.4%	22.5 47.9%	27.7 29.5%
Week 16: Mild (n=43, 40, 83)	23.3 49.6%	35.0 74.5%	28.9 30.7%
Week 16: Moderate (n=43, 40, 83)	32.6 69.4%	22.5 47.9%	27.7 29.5%
Week 16: Severe (n=43, 40, 83)	7.0 14.9%	10.0 21.3%	8.4 8.9%
Week 20: Clear (n=43, 39, 82)	7.0 14.9%	12.8 27.2%	9.8 10.4%
Week 20: Almost Clear (n=43, 39, 82)	37.2 79.1%	23.1 49.1%	30.5 32.4%
Week 20: Mild (n=43, 39, 82)	25.6 54.5%	33.3 70.9%	29.3 31.2%
Week 20: Moderate (n=43, 39, 82)	23.3 49.6%	25.6 54.5%	24.4 26%
Week 20: Severe (n=43, 39, 82)	7.0 14.9%	5.1 10.9%	6.1 6.5%
Week 28: Clear (n=43, 39, 82)	11.6 24.7%	5.1 10.9%	8.5 9%
Week 28: Almost Clear (n=43, 39, 82)	37.2 79.1%	35.9 76.4%	36.6 38.9%
Week 28: Mild (n=43, 39, 82)	23.3 49.6%	20.5 43.6%	22.0 23.4%
Week 28: Moderate (n=43, 39, 82)	20.9 44.5%	33.3 70.9%	26.8 28.5%
Week 28: Severe (n=43, 39, 82)	7.0 14.9%	5.1 10.9%	6.1 6.5%
Week 40: Clear (n=41, 38, 79)	7.3 15.5%	18.4 39.1%	12.7 13.5%
Week 40: Almost Clear (n=41, 38, 79)	46.3 98.5%	31.6 67.2%	39.2 41.7%
Week 40: Mild (n=41, 38, 79)	19.5 41.5%	18.4 39.1%	19.0 20.2%
Week 40: Moderate (n=41, 38, 79)	22.0 46.8%	26.3 56%	24.1 25.6%
Week 40: Severe (n=41, 38, 79)	4.9 10.4%	5.3 11.3%	5.1 5.4%
Week 52: Clear (n=39, 32, 71)	20.5 43.6%	18.8 40%	19.7 21%
Week 52: Almost Clear (n=39, 32, 71)	20.5 43.6%	31.3 66.6%	25.4 27%
Week 52: Mild (n=39, 32, 71)	28.2 60%	25.0 53.2%	26.8 28.5%
Week 52: Moderate (n=39, 32, 71)	15.4 32.8%	21.9 46.6%	18.3 19.5%
Week 52: Severe (n=39, 32, 71)	15.4 32.8%	3.1 6.6%	9.9 10.5%

28. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

The subjects with a medical history of ongoing psoriatic arthritis (that was defined as the MedDRA preferred term for psoriatic arthropathy regardless of meeting the inclusion criteria for the psoriatic arthritis) in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.

Arm/Group Title	CP-690,550 5 mg BID	CP-690,550 10 mg BID	Total
Arm/Group Description	CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.	CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.	(=sum across Arm/Groups)
Measure Participants	8	15	23
Baseline	5.25 (3.327)	4.60 (2.558)	4.83 (2.790)
Week 4 (n=8, 14, 22)	4.00 (2.726)	1.36 (1.008)	2.32 (2.191)
Week 16 (n=8, 15, 23)	1.88 (2.295)	0.60 (0.737)	1.04 (1.551)
Week 28 (n=8, 14, 22)	1.75 (1.753)	0.86 (0.949)	1.18 (1.332)
Week 52 (n=4, 13, 17)	0.50 (0.577)	0.54 (0.660)	0.53 (0.624)

29. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Psoriatic Arthritis Population: Participants who met the inclusion criteria for the psoriatic arthritis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs. Missing data was imputed as non-responder.

Arm/Group Title	CP-690,550 5 mg BID	CP-690,550 10 mg BID	Total
Arm/Group Description	CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.	CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.	(=sum across Arm/Groups)
Measure Participants	4	8	12
Week 2	0.0 0%	62.5 133%	41.7 44.4%
Week 4	50.0 106.4%	75.0 159.6%	66.7 71%
Week 8	75.0 159.6%	100 212.8%	91.7 97.6%
Week 12	100 212.8%	87.5 186.2%	91.7 97.6%
Week 20	100 212.8%	87.5 186.2%	91.7 97.6%
Week 28	100 212.8%	100 212.8%	100 106.4%
Week 40	75.0 159.6%	100 212.8%	91.7 97.6%
Week 52	50.0 106.4%	100 212.8%	83.3 88.6%

30. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Psoriatic Arthritis Population: Participants who met the inclusion criteria for the psoriatic arthritis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs. Missing data was imputed as non-responder.

Arm/Group Title	CP-690,550 5 mg BID	CP-690,550 10 mg BID	Total
Arm/Group Description	CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.	CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.	(=sum across Arm/Groups)
Measure Participants	4	8	12
Week 2	0.0 0%	25.0 53.2%	16.7 17.8%
Week 4	25.0 53.2%	50.0 106.4%	41.7 44.4%
Week 8	50.0 106.4%	62.5 133%	58.3 62%
Week 12	75.0 159.6%	75.0 159.6%	75.0 79.8%
Week 16	75.0 159.6%	87.5 186.2%	83.3 88.6%
Week 20	100 212.8%	87.5 186.2%	91.7 97.6%
Week 28	100 212.8%	75.0 159.6%	83.3 88.6%
Week 40	75.0 159.6%	87.5 186.2%	83.3 88.6%
Week 52	50.0 106.4%	87.5 186.2%	75.0 79.8%

31. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Psoriatic Arthritis Population: Participants who met the inclusion criteria for the psoriatic arthritis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs. Missing data was imputed as non-responder.

Arm/Group Title	CP-690,550 5 mg BID	CP-690,550 10 mg BID	Total
Arm/Group Description	CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.	CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.	(=sum across Arm/Groups)
Measure Participants	4	8	12
Week 2	0.0 0%	0.0 0%	0.0 0%
Week 4	0.0 0%	37.5 79.8%	25.0 26.6%
Week 8	25.0 53.2%	62.5 133%	50.0 53.2%
Week 12	50.0 106.4%	62.5 133%	58.3 62%
Week 16	50.0 106.4%	62.5 133%	58.3 62%
Week 20	75.0 159.6%	75.0 159.6%	75.0 79.8%
Week 28	75.0 159.6%	50.0 106.4%	58.3 62%
Week 40	50.0 106.4%	75.0 159.6%	66.7 71%
Week 52	50.0 106.4%	75.0 159.6%	66.7 71%

32. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Psoriatic Arthritis Population: Participants who met the inclusion criteria for the psoriatic arthritis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.

Arm/Group Title	CP-690,550 5 mg BID	CP-690,550 10 mg BID	Total
Arm/Group Description	CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.	CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.	(=sum across Arm/Groups)
Measure Participants	4	8	12
Week 2	-1.8 (1.50)	-3.5 (2.78)	-2.9 (2.50)
Week 4	-6.3 (6.70)	-9.3 (11.37)	-8.3 (9.84)
Week 8	-11.5 (10.08)	-11.6 (10.24)	-11.6 (9.72)
Week 12	-13.8 (10.78)	-12.5 (11.95)	-12.9 (11.09)
Week 16	-13.0 (9.59)	-13.0 (12.17)	-13.0 (10.92)
Week 20	-14.3 (9.11)	-12.4 (12.87)	-13.0 (11.35)
Week 28	-14.0 (9.38)	-12.4 (12.52)	-12.9 (11.16)
Week 40	-14.3 (10.14)	-13.4 (12.09)	-13.7 (11.02)
Week 52 (n=3, 8, 11)	-11.3 (9.24)	-13.5 (12.08)	-12.9 (10.97)

33. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Psoriatic Arthritis Population: Participants who met the inclusion criteria for the psoriatic arthritis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.

Arm/Group Title	CP-690,550 5 mg BID	CP-690,550 10 mg BID	Total
Arm/Group Description	CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.	CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.	(=sum across Arm/Groups)
Measure Participants	4	8	12
Week 2	-1.8 (2.22)	-3.8 (5.55)	-3.1 (4.68)
Week 4	-5.0 (4.69)	-5.3 (5.80)	-5.2 (5.24)
Week 8	-6.0 (7.35)	-6.4 (4.37)	-6.3 (5.19)
Week 12	-6.5 (6.35)	-7.0 (4.44)	-6.8 (4.86)
Week 16	-7.3 (7.85)	-7.8 (3.85)	-7.6 (5.12)
Week 20	-7.0 (8.00)	-8.9 (4.42)	-8.3 (5.55)
Week 28	-7.3 (7.85)	-7.6 (4.03)	-7.5 (5.21)
Week 40	-7.3 (7.85)	-8.8 (4.20)	-8.3 (5.34)
Week 52 (n=3, 8, 11)	-3.0 (0.00)	-8.8 (4.13)	-7.2 (4.38)

34. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Psoriatic Arthritis Population: Participants who met the inclusion criteria for the psoriatic arthritis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.

Arm/Group Title	CP-690,550 5 mg BID	CP-690,550 10 mg BID	Total
Arm/Group Description	CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.	CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.	(=sum across Arm/Groups)
Measure Participants	4	8	12
Week 2	-13.3 (8.30)	-29.5 (23.40)	-24.1 (20.77)
Week 4	-13.0 (23.41)	-41.4 (25.29)	-31.9 (27.42)
Week 8	-16.0 (19.78)	-43.6 (22.68)	-34.4 (24.88)
Week 12	-34.5 (19.71)	-46.0 (23.42)	-42.2 (22.07)
Week 16	-27.3 (15.22)	-46.0 (22.44)	-39.8 (21.65)
Week 20	-44.0 (22.82)	-45.3 (21.53)	-44.8 (20.91)
Week 28	-45.8 (23.26)	-45.8 (20.46)	-45.8 (20.34)
Week 40	-20.0 (54.86)	-46.9 (22.66)	-37.9 (36.37)
Week 52 (n=3, 8, 11)	-33.0 (31.19)	-48.4 (22.14)	-44.2 (24.28)

35. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Psoriatic Arthritis Population: Participants who met the inclusion criteria for the psoriatic arthritis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.

Arm/Group Title	CP-690,550 5 mg BID	CP-690,550 10 mg BID	Total
Arm/Group Description	CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.	CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.	(=sum across Arm/Groups)
Measure Participants	4	8	12
Week 2	-8.0 (8.87)	-32.6 (27.55)	-24.4 (25.53)
Week 4	-20.5 (11.27)	-43.4 (27.47)	-35.8 (25.33)
Week 8	-23.3 (19.69)	-51.3 (20.53)	-41.9 (23.75)
Week 12	-45.0 (8.83)	-52.1 (21.35)	-49.8 (17.99)
Week 16	-40.0 (13.64)	-53.0 (20.96)	-48.7 (19.27)
Week 20	-49.5 (20.09)	-49.6 (20.26)	-49.6 (19.27)
Week 28	-52.3 (11.18)	-46.3 (26.67)	-48.3 (22.26)
Week 40	-20.8 (30.24)	-50.8 (20.78)	-40.8 (27.24)
Week 52 (n=3, 8, 11)	-40.7 (16.80)	-55.3 (20.51)	-51.3 (19.94)

36. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Psoriatic Arthritis Population: Participants who met the inclusion criteria for the psoriatic arthritis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.

Arm/Group Title	CP-690,550 5 mg BID	CP-690,550 10 mg BID	Total
Arm/Group Description	CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.	CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.	(=sum across Arm/Groups)
Measure Participants	4	8	12
Week 2	-15.3 (18.01)	-28.5 (18.60)	-24.1 (18.74)
Week 4	-32.5 (22.28)	-34.6 (19.39)	-33.9 (19.38)
Week 8	-29.5 (30.01)	-41.8 (21.87)	-37.7 (24.21)
Week 12	-39.8 (21.00)	-45.8 (22.76)	-43.8 (21.42)
Week 16	-49.8 (23.34)	-47.9 (20.09)	-48.5 (20.16)
Week 20	-50.8 (25.29)	-45.3 (26.81)	-47.1 (25.28)
Week 28	-49.5 (25.96)	-42.8 (22.79)	-45.0 (22.92)
Week 40	-38.5 (39.03)	-49.5 (18.54)	-45.8 (25.76)
Week 52 (n=3, 8, 11)	-29.0 (20.30)	-46.8 (25.08)	-41.9 (24.32)

37. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Psoriatic Arthritis Population: Participants who met the inclusion criteria for the psoriatic arthritis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.

Arm/Group Title	CP-690,550 5 mg BID	CP-690,550 10 mg BID	Total
Arm/Group Description	CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.	CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.	(=sum across Arm/Groups)
Measure Participants	4	8	12
Week 2	-1.20 (2.137)	-1.68 (2.231)	-1.52 (2.114)
Week 4	-1.20 (2.267)	-1.69 (2.272)	-1.53 (2.178)
Week 8	-1.28 (2.354)	-1.70 (2.222)	-1.56 (2.167)
Week 12	-1.28 (2.351)	-1.68 (2.235)	-1.54 (2.174)
Week 16	-1.30 (2.337)	-1.69 (2.189)	-1.56 (2.139)
Week 20	-1.33 (2.387)	-1.59 (2.336)	-1.50 (2.246)
Week 28	-1.30 (2.337)	-1.15 (2.770)	-1.20 (2.526)
Week 40 (n=4, 7, 11)	-1.15 (2.037)	-1.84 (2.461)	-1.59 (2.236)
Week 52 (n=3, 8, 11)	-0.03 (0.058)	-1.65 (2.295)	-1.21 (2.064)

38. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Psoriatic Arthritis Population: Participants who met the inclusion criteria for the psoriatic arthritis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.

Arm/Group Title	CP-690,550 5 mg BID	CP-690,550 10 mg BID	Total
Arm/Group Description	CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.	CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.	(=sum across Arm/Groups)
Measure Participants	4	8	12
Week 2	-0.19 (0.239)	-0.28 (0.376)	-0.25 (0.329)
Week 4	-0.28 (0.329)	-0.36 (0.381)	-0.33 (0.351)
Week 8	-0.28 (0.359)	-0.42 (0.433)	-0.38 (0.399)
Week 12	-0.28 (0.359)	-0.42 (0.433)	-0.38 (0.399)
Week 16	-0.31 (0.375)	-0.42 (0.433)	-0.39 (0.400)
Week 20	-0.28 (0.359)	-0.42 (0.433)	-0.38 (0.399)
Week 28	-0.34 (0.400)	-0.42 (0.433)	-0.40 (0.405)
Week 40	-0.09 (0.640)	-0.42 (0.433)	-0.31 (0.507)
Week 52 (n=3, 8, 11)	-0.13 (0.573)	-0.42 (0.433)	-0.34 (0.465)

Adverse Events

Adverse Event Reporting Description	The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Arm/Group Title	CP-690,550 5 mg BID		CP-690,550 10 mg BID		Total
Arm/Group Description	CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.		CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.		(=sum across Arm/Groups)
All Cause Mortality
	CP-690,550 5 mg BID		CP-690,550 10 mg BID		Total
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	CP-690,550 5 mg BID		CP-690,550 10 mg BID		Total
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/47 (6.4%)		3/47 (6.4%)		6/94 (6.4%)
Ear and labyrinth disorders
Vertigo	0/47 (0%)		1/47 (2.1%)		1/94 (1.1%)
Infections and infestations
Herpes zoster	3/47 (6.4%)		0/47 (0%)		3/94 (3.2%)
Impetigo	0/47 (0%)		1/47 (2.1%)		1/94 (1.1%)
Skin and subcutaneous tissue disorders
Erythrodermic psoriasis	0/47 (0%)		1/47 (2.1%)		1/94 (1.1%)
Psoriasis	0/47 (0%)		1/47 (2.1%)		1/94 (1.1%)
Other (Not Including Serious) Adverse Events
	CP-690,550 5 mg BID		CP-690,550 10 mg BID		Total
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	37/47 (78.7%)		40/47 (85.1%)		77/94 (81.9%)
Blood and lymphatic system disorders
Anaemia	0/47 (0%)		1/47 (2.1%)		1/94 (1.1%)
Lymphadenitis	0/47 (0%)		1/47 (2.1%)		1/94 (1.1%)
Lymphadenopathy	0/47 (0%)		1/47 (2.1%)		1/94 (1.1%)
Ear and labyrinth disorders
Vertigo	0/47 (0%)		2/47 (4.3%)		2/94 (2.1%)
Eye disorders
Asthenopia	1/47 (2.1%)		0/47 (0%)		1/94 (1.1%)
Cataract	0/47 (0%)		1/47 (2.1%)		1/94 (1.1%)
Conjunctival deposit	0/47 (0%)		1/47 (2.1%)		1/94 (1.1%)
Eyelid oedema	1/47 (2.1%)		0/47 (0%)		1/94 (1.1%)
Presbyopia	1/47 (2.1%)		0/47 (0%)		1/94 (1.1%)
Gastrointestinal disorders
Abdominal discomfort	0/47 (0%)		1/47 (2.1%)		1/94 (1.1%)
Abdominal pain upper	2/47 (4.3%)		1/47 (2.1%)		3/94 (3.2%)
Colitis	0/47 (0%)		1/47 (2.1%)		1/94 (1.1%)
Constipation	1/47 (2.1%)		1/47 (2.1%)		2/94 (2.1%)
Dental caries	3/47 (6.4%)		1/47 (2.1%)		4/94 (4.3%)
Diarrhoea	0/47 (0%)		2/47 (4.3%)		2/94 (2.1%)
Gastrooesophageal reflux disease	1/47 (2.1%)		0/47 (0%)		1/94 (1.1%)
Lip erosion	1/47 (2.1%)		0/47 (0%)		1/94 (1.1%)
Nausea	0/47 (0%)		1/47 (2.1%)		1/94 (1.1%)
Toothache	0/47 (0%)		1/47 (2.1%)		1/94 (1.1%)
General disorders
Fatigue	1/47 (2.1%)		1/47 (2.1%)		2/94 (2.1%)
Malaise	1/47 (2.1%)		0/47 (0%)		1/94 (1.1%)
Oedema	0/47 (0%)		1/47 (2.1%)		1/94 (1.1%)
Oedema peripheral	1/47 (2.1%)		2/47 (4.3%)		3/94 (3.2%)
Pyrexia	0/47 (0%)		3/47 (6.4%)		3/94 (3.2%)
Hepatobiliary disorders
Hepatic function abnormal	2/47 (4.3%)		2/47 (4.3%)		4/94 (4.3%)
Infections and infestations
Bronchitis	1/47 (2.1%)		0/47 (0%)		1/94 (1.1%)
Enteritis infectious	0/47 (0%)		1/47 (2.1%)		1/94 (1.1%)
Folliculitis	2/47 (4.3%)		2/47 (4.3%)		4/94 (4.3%)
Furuncle	1/47 (2.1%)		1/47 (2.1%)		2/94 (2.1%)
Gastroenteritis	3/47 (6.4%)		0/47 (0%)		3/94 (3.2%)
Gastroenteritis norovirus	0/47 (0%)		1/47 (2.1%)		1/94 (1.1%)
Gastroenteritis viral	0/47 (0%)		2/47 (4.3%)		2/94 (2.1%)
Herpes zoster	3/47 (6.4%)		10/47 (21.3%)		13/94 (13.8%)
Hordeolum	1/47 (2.1%)		0/47 (0%)		1/94 (1.1%)
Influenza	3/47 (6.4%)		3/47 (6.4%)		6/94 (6.4%)
Nasopharyngitis	14/47 (29.8%)		14/47 (29.8%)		28/94 (29.8%)
Oral herpes	0/47 (0%)		1/47 (2.1%)		1/94 (1.1%)
Otitis media acute	1/47 (2.1%)		1/47 (2.1%)		2/94 (2.1%)
Periodontitis	0/47 (0%)		1/47 (2.1%)		1/94 (1.1%)
Pertussis	0/47 (0%)		1/47 (2.1%)		1/94 (1.1%)
Pharyngitis	0/47 (0%)		2/47 (4.3%)		2/94 (2.1%)
Pneumonia	1/47 (2.1%)		1/47 (2.1%)		2/94 (2.1%)
Rhinitis	0/47 (0%)		1/47 (2.1%)		1/94 (1.1%)
Salpingitis	1/47 (2.1%)		0/47 (0%)		1/94 (1.1%)
Sinusitis	0/47 (0%)		1/47 (2.1%)		1/94 (1.1%)
Subcutaneous abscess	1/47 (2.1%)		0/47 (0%)		1/94 (1.1%)
Tinea infection	1/47 (2.1%)		1/47 (2.1%)		2/94 (2.1%)
Tinea pedis	4/47 (8.5%)		6/47 (12.8%)		10/94 (10.6%)
Tinea versicolour	0/47 (0%)		1/47 (2.1%)		1/94 (1.1%)
Upper respiratory tract infection	2/47 (4.3%)		0/47 (0%)		2/94 (2.1%)
Vaginitis gardnerella	1/47 (2.1%)		0/47 (0%)		1/94 (1.1%)
Injury, poisoning and procedural complications
Arthropod bite	0/47 (0%)		1/47 (2.1%)		1/94 (1.1%)
Arthropod sting	0/47 (0%)		1/47 (2.1%)		1/94 (1.1%)
Epicondylitis	1/47 (2.1%)		0/47 (0%)		1/94 (1.1%)
Excoriation	1/47 (2.1%)		0/47 (0%)		1/94 (1.1%)
Fall	0/47 (0%)		1/47 (2.1%)		1/94 (1.1%)
Hand fracture	0/47 (0%)		1/47 (2.1%)		1/94 (1.1%)
Muscle strain	1/47 (2.1%)		0/47 (0%)		1/94 (1.1%)
Rib fracture	0/47 (0%)		1/47 (2.1%)		1/94 (1.1%)
Thermal burn	0/47 (0%)		1/47 (2.1%)		1/94 (1.1%)
Traumatic haematoma	0/47 (0%)		1/47 (2.1%)		1/94 (1.1%)
Investigations
Alanine aminotransferase increased	1/47 (2.1%)		3/47 (6.4%)		4/94 (4.3%)
Aspartate aminotransferase increased	1/47 (2.1%)		2/47 (4.3%)		3/94 (3.2%)
Blood bilirubin increased	0/47 (0%)		1/47 (2.1%)		1/94 (1.1%)
Blood cholesterol increased	0/47 (0%)		1/47 (2.1%)		1/94 (1.1%)
Blood creatine phosphokinase increased	3/47 (6.4%)		2/47 (4.3%)		5/94 (5.3%)
Blood triglycerides increased	0/47 (0%)		1/47 (2.1%)		1/94 (1.1%)
Gamma-glutamyltransferase increased	0/47 (0%)		3/47 (6.4%)		3/94 (3.2%)
Haemoglobin decreased	1/47 (2.1%)		4/47 (8.5%)		5/94 (5.3%)
Liver function test abnormal	0/47 (0%)		2/47 (4.3%)		2/94 (2.1%)
Low density lipoprotein increased	0/47 (0%)		1/47 (2.1%)		1/94 (1.1%)
Occult blood positive	1/47 (2.1%)		0/47 (0%)		1/94 (1.1%)
Platelet count decreased	0/47 (0%)		1/47 (2.1%)		1/94 (1.1%)
Weight decreased	0/47 (0%)		1/47 (2.1%)		1/94 (1.1%)
Weight increased	0/47 (0%)		1/47 (2.1%)		1/94 (1.1%)
White blood cell count decreased	0/47 (0%)		1/47 (2.1%)		1/94 (1.1%)
Metabolism and nutrition disorders
Diabetes mellitus	2/47 (4.3%)		0/47 (0%)		2/94 (2.1%)
Dyslipidaemia	1/47 (2.1%)		1/47 (2.1%)		2/94 (2.1%)
Hypercholesterolaemia	1/47 (2.1%)		0/47 (0%)		1/94 (1.1%)
Hyperlipidaemia	0/47 (0%)		1/47 (2.1%)		1/94 (1.1%)
Musculoskeletal and connective tissue disorders
Arthralgia	1/47 (2.1%)		2/47 (4.3%)		3/94 (3.2%)
Back pain	2/47 (4.3%)		1/47 (2.1%)		3/94 (3.2%)
Joint swelling	0/47 (0%)		1/47 (2.1%)		1/94 (1.1%)
Musculoskeletal pain	0/47 (0%)		1/47 (2.1%)		1/94 (1.1%)
Myalgia	1/47 (2.1%)		0/47 (0%)		1/94 (1.1%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anogenital warts	0/47 (0%)		1/47 (2.1%)		1/94 (1.1%)
Seborrhoeic keratosis	0/47 (0%)		1/47 (2.1%)		1/94 (1.1%)
Skin papilloma	0/47 (0%)		1/47 (2.1%)		1/94 (1.1%)
Uterine leiomyoma	0/47 (0%)		1/47 (2.1%)		1/94 (1.1%)
Nervous system disorders
Cervicobrachial syndrome	1/47 (2.1%)		1/47 (2.1%)		2/94 (2.1%)
Headache	1/47 (2.1%)		3/47 (6.4%)		4/94 (4.3%)
Hypoaesthesia	1/47 (2.1%)		0/47 (0%)		1/94 (1.1%)
Neuropathy peripheral	0/47 (0%)		1/47 (2.1%)		1/94 (1.1%)
Post herpetic neuralgia	0/47 (0%)		3/47 (6.4%)		3/94 (3.2%)
Renal and urinary disorders
Calculus ureteric	0/47 (0%)		1/47 (2.1%)		1/94 (1.1%)
Nephrolithiasis	1/47 (2.1%)		0/47 (0%)		1/94 (1.1%)
Pollakiuria	1/47 (2.1%)		1/47 (2.1%)		2/94 (2.1%)
Reproductive system and breast disorders
Atrophic vulvovaginitis	0/47 (0%)		1/47 (2.1%)		1/94 (1.1%)
Cervical polyp	0/47 (0%)		1/47 (2.1%)		1/94 (1.1%)
Endometriosis	1/47 (2.1%)		0/47 (0%)		1/94 (1.1%)
Prostatitis	1/47 (2.1%)		0/47 (0%)		1/94 (1.1%)
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain	1/47 (2.1%)		0/47 (0%)		1/94 (1.1%)
Upper respiratory tract inflammation	0/47 (0%)		1/47 (2.1%)		1/94 (1.1%)
Skin and subcutaneous tissue disorders
Acne	0/47 (0%)		3/47 (6.4%)		3/94 (3.2%)
Alopecia	1/47 (2.1%)		0/47 (0%)		1/94 (1.1%)
Dermatitis contact	2/47 (4.3%)		1/47 (2.1%)		3/94 (3.2%)
Dyshidrotic eczema	0/47 (0%)		1/47 (2.1%)		1/94 (1.1%)
Eczema	1/47 (2.1%)		1/47 (2.1%)		2/94 (2.1%)
Hirsutism	1/47 (2.1%)		0/47 (0%)		1/94 (1.1%)
Psoriasis	4/47 (8.5%)		6/47 (12.8%)		10/94 (10.6%)
Purpura	1/47 (2.1%)		0/47 (0%)		1/94 (1.1%)
Seborrhoeic dermatitis	1/47 (2.1%)		0/47 (0%)		1/94 (1.1%)
Solar dermatitis	2/47 (4.3%)		0/47 (0%)		2/94 (2.1%)
Urticaria	1/47 (2.1%)		2/47 (4.3%)		3/94 (3.2%)
Vascular disorders
Hypertension	0/47 (0%)		2/47 (4.3%)		2/94 (2.1%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.