Trial Outcomes & Findings for A Phase 3, Multi Site, Randomized, Double Blind, Placebo Controlled Study Of The Efficacy And Safety Comparing CP- 690,550 And Etanercept In Subjects With Moderate To Severe Chronic Plaque Psoriasis (NCT NCT01241591)

Last Updated: 2018-12-26

Results Overview

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 to 4). The severity scores are summed and averaged after which the total average is 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).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1101 participants

Primary outcome timeframe

Week 12

Results posted on

2018-12-26

Participant Flow

Participant milestones

Participant milestones
Measure	CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.	CP-690,550 10 mg BID + Placebo BIW Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.	Placebo BID + Etanercept 50 mg BIW Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.	Placebo BID + Placebo BIW Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
Overall Study STARTED	329	330	335	107
Overall Study COMPLETED	306	306	313	95
Overall Study NOT COMPLETED	23	24	22	12

Reasons for withdrawal

Reasons for withdrawal
Measure	CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.	CP-690,550 10 mg BID + Placebo BIW Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.	Placebo BID + Etanercept 50 mg BIW Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.	Placebo BID + Placebo BIW Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
Overall Study Lack of Efficacy	5	2	2	3
Overall Study Protocol Violation	5	2	3	0
Overall Study Lost to Follow-up	1	2	2	2
Overall Study Screen Failure	3	2	1	0
Overall Study Withdrawal by Subject	6	4	2	2
Overall Study Other	0	1	0	1
Overall Study Adverse Event	3	11	12	4

Baseline Characteristics

A Phase 3, Multi Site, Randomized, Double Blind, Placebo Controlled Study Of The Efficacy And Safety Comparing CP- 690,550 And Etanercept In Subjects With Moderate To Severe Chronic Plaque Psoriasis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) n=329 Participants Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.	CP-690,550 10 mg BID + Placebo BIW n=330 Participants Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.	Placebo BID + Etanercept 50 mg BIW n=335 Participants Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.	Placebo BID + Placebo BIW n=107 Participants Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.	Total n=1101 Participants Total of all reporting groups
Age, Continuous	44.4 years STANDARD_DEVIATION 12.1 • n=5 Participants	43.6 years STANDARD_DEVIATION 12.6 • n=7 Participants	43.3 years STANDARD_DEVIATION 12.2 • n=5 Participants	46.1 years STANDARD_DEVIATION 13.4 • n=4 Participants	44.0 years STANDARD_DEVIATION 12.4 • n=21 Participants
Sex: Female, Male Female	93 Participants n=5 Participants	92 Participants n=7 Participants	102 Participants n=5 Participants	36 Participants n=4 Participants	323 Participants n=21 Participants
Sex: Female, Male Male	236 Participants n=5 Participants	238 Participants n=7 Participants	233 Participants n=5 Participants	71 Participants n=4 Participants	778 Participants n=21 Participants

PRIMARY outcome

Timeframe: Week 12

Population: Full Analysis Set (FAS): all participants who were randomized to the study and received at least 1 dose of the randomized investigational drug (CP-690,550, etanercept, or placebo); Non-Responder Imputation (NRI) method: participants with missing values were considered to be non-responders.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) n=329 Participants Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.	CP-690,550 10 mg BID + Placebo BIW n=330 Participants Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.	Placebo BID + Etanercept 50 mg BIW n=335 Participants Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.	Placebo BID + Placebo BIW n=107 Participants Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
Percentage of Participants With a Physician's Global Assessment (PGA) Response of "Clear" or "Almost Clear" at Week 12	47.11 percentage of participants	68.18 percentage of participants	66.27 percentage of participants	14.95 percentage of participants

PRIMARY outcome

Timeframe: Week 12

Population: FAS; NRI

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/Day 1.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) n=329 Participants Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.	CP-690,550 10 mg BID + Placebo BIW n=330 Participants Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.	Placebo BID + Etanercept 50 mg BIW n=335 Participants Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.	Placebo BID + Placebo BIW n=107 Participants Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response at Week 12	39.51 percentage of participants	63.64 percentage of participants	58.81 percentage of participants	5.61 percentage of participants

SECONDARY outcome

Timeframe: Weeks 2, 4, and 8

Population: FAS; Observed Case (OC): no imputation

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) n=325 Participants Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.	CP-690,550 10 mg BID + Placebo BIW n=326 Participants Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.	Placebo BID + Etanercept 50 mg BIW n=331 Participants Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.	Placebo BID + Placebo BIW n=107 Participants Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
Percentage of Participants With a PGA Response of "Clear" or "Almost Clear" During the 12-Week Double-Blind Treatment Week 4 (n=320,323,328,102)	21.25 percentage of participants	35.91 percentage of participants	28.35 percentage of participants	3.92 percentage of participants
Percentage of Participants With a PGA Response of "Clear" or "Almost Clear" During the 12-Week Double-Blind Treatment Week 8 (n=314,316,322,100)	40.45 percentage of participants	63.61 percentage of participants	60.87 percentage of participants	13.00 percentage of participants
Percentage of Participants With a PGA Response of "Clear" or "Almost Clear" During the 12-Week Double-Blind Treatment Week 2 (n=325,326,331,107)	6.77 percentage of participants	10.74 percentage of participants	7.85 percentage of participants	1.87 percentage of participants

SECONDARY outcome

Timeframe: Baseline and Weeks 2, 4, 8, and 12

Population: FAS; OC

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) n=329 Participants Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.	CP-690,550 10 mg BID + Placebo BIW n=330 Participants Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.	Placebo BID + Etanercept 50 mg BIW n=335 Participants Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.	Placebo BID + Placebo BIW n=107 Participants Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment Baseline, Clear (n=329,330,335,107)	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants
Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment Baseline, Almost Clear (n=329,330,335,107)	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants
Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment Week 12, Clear (n=314,316,322,100)	11.8 percentage of participants	27.0 percentage of participants	21.0 percentage of participants	2.1 percentage of participants
Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment Week 12, Mild (n=313,311,309,95)	33.5 percentage of participants	19.3 percentage of participants	21.4 percentage of participants	36.8 percentage of participants
Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment Baseline, Mild (n=329,330,335,107)	1.8 percentage of participants	1.2 percentage of participants	1.2 percentage of participants	2.8 percentage of participants
Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment Baseline, Moderate (n=329,330,335,107)	80.2 percentage of participants	83.3 percentage of participants	80.9 percentage of participants	82.2 percentage of participants
Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment Baseline, Severe (n=329,330,335,107)	17.9 percentage of participants	15.5 percentage of participants	17.9 percentage of participants	15.0 percentage of participants
Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment Week 2, Clear (n=325,326,331,107)	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants
Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment Week 2, Almost Clear (n=325,326,331,107)	6.8 percentage of participants	10.7 percentage of participants	7.9 percentage of participants	1.9 percentage of participants
Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment Week 2, Mild (n=325,326,331,107)	38.5 percentage of participants	47.9 percentage of participants	42.6 percentage of participants	25.2 percentage of participants
Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment Week 2, Moderate (n=325,326,331,107)	48.9 percentage of participants	38.3 percentage of participants	45.6 percentage of participants	64.5 percentage of participants
Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment Week 2, Severe (n=325,326,331,107)	5.8 percentage of participants	3.1 percentage of participants	3.9 percentage of participants	8.4 percentage of participants
Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment Week 4, Clear (n=320,323,328,102)	1.9 percentage of participants	2.5 percentage of participants	0.6 percentage of participants	0.0 percentage of participants
Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment Week 4, Almost Clear (n=320,323,328,102)	19.4 percentage of participants	33.4 percentage of participants	27.7 percentage of participants	3.9 percentage of participants
Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment Week 4, Mild (n=320,323,328,102)	46.3 percentage of participants	44.3 percentage of participants	51.5 percentage of participants	34.3 percentage of participants
Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment Week 4, Moderate (n=320,323,328,102)	30.0 percentage of participants	17.6 percentage of participants	19.5 percentage of participants	55.9 percentage of participants
Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment Week 4, Severe (n=320,323,328,102)	2.5 percentage of participants	2.2 percentage of participants	0.6 percentage of participants	5.9 percentage of participants
Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment Week 8, Clear (n=314,316,322,100)	5.4 percentage of participants	14.2 percentage of participants	9.0 percentage of participants	0.0 percentage of participants
Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment Week 8, Almost Clear (n=314,316,322,100)	35.0 percentage of participants	49.4 percentage of participants	51.9 percentage of participants	13.0 percentage of participants
Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment Week 8, Mild (n=314,316,322,100)	41.4 percentage of participants	25.0 percentage of participants	30.1 percentage of participants	35.0 percentage of participants
Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment Week 8, Moderate (n=314,316,322,100)	15.9 percentage of participants	10.8 percentage of participants	8.1 percentage of participants	49.0 percentage of participants
Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment Week 8, Severe (n=314,316,322,100)	2.2 percentage of participants	0.6 percentage of participants	0.9 percentage of participants	3.0 percentage of participants
Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment Week 12, Almost Clear (n=313,311,309,95)	37.7 percentage of participants	45.3 percentage of participants	50.8 percentage of participants	14.7 percentage of participants
Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment Week 12, Moderate (n=313,311,309,95)	15.7 percentage of participants	7.4 percentage of participants	5.5 percentage of participants	42.1 percentage of participants
Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment Week 12, Severe (n=313,311,309,95)	1.3 percentage of participants	1.0 percentage of participants	1.3 percentage of participants	4.2 percentage of participants

SECONDARY outcome

Timeframe: Weeks 2, 4, and 8

Population: FAS; OC

The PASI quantifies the severity of a participant's psoriasis based on both lesion severity and the 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 a 75% reduction in PASI relative to baseline/Day 1.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) n=326 Participants Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.	CP-690,550 10 mg BID + Placebo BIW n=327 Participants Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.	Placebo BID + Etanercept 50 mg BIW n=331 Participants Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.	Placebo BID + Placebo BIW n=106 Participants Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
Percentage of Participants With a PASI75 Response During the 12-Week Double-Blind Treatment Week 2 (n=326,327,331,106)	1.53 percentage of participants	2.75 percentage of participants	0.91 percentage of participants	0.00 percentage of participants
Percentage of Participants With a PASI75 Response During the 12-Week Double-Blind Treatment Week 4 (n=319,323,328,102)	10.34 percentage of participants	19.81 percentage of participants	8.23 percentage of participants	0.00 percentage of participants
Percentage of Participants With a PASI75 Response During the 12-Week Double-Blind Treatment Week 8 (n=315,319,323,99)	28.57 percentage of participants	52.35 percentage of participants	42.72 percentage of participants	3.03 percentage of participants

SECONDARY outcome

Timeframe: Baseline and Weeks 2, 4, 8, and 12

Population: FAS; OC

Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section\*area score\*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) n=329 Participants Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.	CP-690,550 10 mg BID + Placebo BIW n=330 Participants Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.	Placebo BID + Etanercept 50 mg BIW n=335 Participants Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.	Placebo BID + Placebo BIW n=107 Participants Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
Mean PASI Score During the 12-Week Double-Blind Treatment Baseline (n=329,330,335,107)	23.13 score on a scale Standard Error 0.48	23.29 score on a scale Standard Error 0.53	22.73 score on a scale Standard Error 0.53	22.78 score on a scale Standard Error 0.88
Mean PASI Score During the 12-Week Double-Blind Treatment Week 12 (n=313,311,309,95)	8.80 score on a scale Standard Error 0.43	5.77 score on a scale Standard Error 0.45	5.42 score on a scale Standard Error 0.36	17.39 score on a scale Standard Error 1.06
Mean PASI Score During the 12-Week Double-Blind Treatment Week 2 (n=326,327,328,102)	18.16 score on a scale Standard Error 0.47	16.81 score on a scale Standard Error 0.53	17.29 score on a scale Standard Error 0.49	21.26 score on a scale Standard Error 0.95
Mean PASI Score During the 12-Week Double-Blind Treatment Week 4 (n=319,323,328,102)	14.46 score on a scale Standard Error 0.46	12.13 score on a scale Standard Error 0.52	12.73 score on a scale Standard Error 0.44	20.06 score on a scale Standard Error 0.94
Mean PASI Score During the 12-Week Double-Blind Treatment Week 8 (n=315,319,323,99)	10.63 score on a scale Standard Error 0.44	7.59 score on a scale Standard Error 0.48	7.70 score on a scale Standard Error 0.38	17.91 score on a scale Standard Error 0.99

SECONDARY outcome

Timeframe: Weeks 2, 4, 8, and 12

Population: FAS; OC

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) n=326 Participants Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.	CP-690,550 10 mg BID + Placebo BIW n=327 Participants Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.	Placebo BID + Etanercept 50 mg BIW n=331 Participants Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.	Placebo BID + Placebo BIW n=106 Participants Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
Mean Change From Baseline in PASI Score During the 12-Week Double-Blind Treatment Week 8 (n=315,319,323,99)	-12.62 scores on a scale Standard Error 0.52	-15.81 scores on a scale Standard Error 0.51	-15.20 scores on a scale Standard Error 0.51	-4.82 scores on a scale Standard Error 0.81
Mean Change From Baseline in PASI Score During the 12-Week Double-Blind Treatment Week 2 (n=326,327,331,106)	-5.03 scores on a scale Standard Error 0.31	-6.47 scores on a scale Standard Error 0.31	-5.48 scores on a scale Standard Error 0.29	-1.58 scores on a scale Standard Error 0.46
Mean Change From Baseline in PASI Score During the 12-Week Double-Blind Treatment Week 4 (n=319,323,328,102)	-8.83 scores on a scale Standard Error 0.42	-11.30 scores on a scale Standard Error 0.43	-10.14 scores on a scale Standard Error 0.39	-2.58 scores on a scale Standard Error 0.62
Mean Change From Baseline in PASI Score During the 12-Week Double-Blind Treatment Week 12 (n=313,311,309,95)	-14.55 scores on a scale Standard Error 0.60	-17.54 scores on a scale Standard Error 0.54	-17.55 scores on a scale Standard Error 0.57	-5.33 scores on a scale Standard Error 0.97

SECONDARY outcome

Timeframe: Baseline and Weeks 2, 4, 8, and 12

Population: FAS; OC

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) n=329 Participants Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.	CP-690,550 10 mg BID + Placebo BIW n=329 Participants Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.	Placebo BID + Etanercept 50 mg BIW n=335 Participants Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.	Placebo BID + Placebo BIW n=107 Participants Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment Head/Neck Scaling, Baseline (n=329,329,335,107)	2.29 score on a scale Standard Error 0.06	2.38 score on a scale Standard Error 0.06	2.28 score on a scale Standard Error 0.06	2.33 score on a scale Standard Error 0.10
Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment Head/Neck Scaling, Week 4 (n=320,323,328,102)	1.38 score on a scale Standard Error 0.06	1.07 score on a scale Standard Error 0.06	1.16 score on a scale Standard Error 0.05	1.80 score on a scale Standard Error 0.11
Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment Head/Neck Scaling, Week 12 (n=313,311,309,95)	0.98 score on a scale Standard Error 0.06	0.60 score on a scale Standard Error 0.05	0.46 score on a scale Standard Error 0.05	1.51 score on a scale Standard Error 0.11
Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment Upper Limbs Induration, Week 4 (n=320,323,328,102)	1.76 score on a scale Standard Error 0.05	1.54 score on a scale Standard Error 0.05	1.59 score on a scale Standard Error 0.05	2.36 score on a scale Standard Error 0.08
Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment Upper Limbs Induration, Week 8 (n=315,319,323,99)	1.43 score on a scale Standard Error 0.06	1.13 score on a scale Standard Error 0.05	1.18 score on a scale Standard Error 0.05	2.12 score on a scale Standard Error 0.09
Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment Trunk Erythema, Baseline (n=329,329,335,107)	2.95 score on a scale Standard Error 0.04	2.88 score on a scale Standard Error 0.04	2.91 score on a scale Standard Error 0.04	2.97 score on a scale Standard Error 0.06
Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment Lower Limbs Induration Baseline(n=329,329,335,107)	2.94 score on a scale Standard Error 0.04	2.97 score on a scale Standard Error 0.04	3.00 score on a scale Standard Error 0.04	2.92 score on a scale Standard Error 0.07
Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment Head/Neck Erythema, Baseline (n=329,329,335,107)	2.28 score on a scale Standard Error 0.05	2.36 score on a scale Standard Error 0.05	2.32 score on a scale Standard Error 0.05	2.40 score on a scale Standard Error 0.09
Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment Head/Neck Erythema, Week 2 (n=326,326,331,106)	1.82 score on a scale Standard Error 0.05	1.65 score on a scale Standard Error 0.05	1.76 score on a scale Standard Error 0.06	2.27 score on a scale Standard Error 0.09
Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment Head/Neck Erythema, Week 4 (n=320,323,328,102)	1.48 score on a scale Standard Error 0.05	1.18 score on a scale Standard Error 0.05	1.23 score on a scale Standard Error 0.05	2.03 score on a scale Standard Error 0.09
Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment Head/Neck Erythema, Week 8 (n=315,319,323,99)	1.19 score on a scale Standard Error 0.06	0.78 score on a scale Standard Error 0.05	0.69 score on a scale Standard Error 0.05	1.89 score on a scale Standard Error 0.10
Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment Head/Neck Erythema, Week 12 (n=313,311,309,95)	1.04 score on a scale Standard Error 0.06	0.65 score on a scale Standard Error 0.05	0.48 score on a scale Standard Error 0.04	1.74 score on a scale Standard Error 0.11
Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment Head/Neck Induration, Baseline (n=329,329,335,107)	2.04 score on a scale Standard Error 0.05	2.08 score on a scale Standard Error 0.05	1.96 score on a scale Standard Error 0.06	2.12 score on a scale Standard Error 0.10
Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment Head/Neck Induration, Week 2 (n=326,326,331,106)	1.60 score on a scale Standard Error 0.05	1.44 score on a scale Standard Error 0.05	1.46 score on a scale Standard Error 0.06	1.97 score on a scale Standard Error 0.10
Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment Head/Neck Induration, Week 4 (n=320,323,328,102)	1.21 score on a scale Standard Error 0.05	0.94 score on a scale Standard Error 0.05	1.01 score on a scale Standard Error 0.05	1.69 score on a scale Standard Error 0.10
Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment Head/Neck Induration, Week 8 (n=315,319,323,99)	0.96 score on a scale Standard Error 0.05	0.59 score on a scale Standard Error 0.05	0.54 score on a scale Standard Error 0.05	1.57 score on a scale Standard Error 0.10
Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment Trunk Scaling, Week 2 (n=326,326,331,106)	2.12 score on a scale Standard Error 0.05	1.92 score on a scale Standard Error 0.06	1.93 score on a scale Standard Error 0.05	2.36 score on a scale Standard Error 0.09
Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment Head/Neck Induration, Week 12 (n=313,311,309,95)	0.87 score on a scale Standard Error 0.05	0.49 score on a scale Standard Error 0.04	0.37 score on a scale Standard Error 0.04	1.41 score on a scale Standard Error 0.11
Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment Head/Neck Scaling, Week 2 (n=326,326,331,106)	1.75 score on a scale Standard Error 0.06	1.63 score on a scale Standard Error 0.06	1.60 score on a scale Standard Error 0.06	2.15 score on a scale Standard Error 0.10
Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment Head/Neck Scaling, Week 8 (n=315,319,323,99)	1.12 score on a scale Standard Error 0.06	0.70 score on a scale Standard Error 0.05	0.65 score on a scale Standard Error 0.05	1.66 score on a scale Standard Error 0.11
Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment Upper Limbs Erythema, Baseline (n=329,329,335,107)	2.87 score on a scale Standard Error 0.04	2.87 score on a scale Standard Error 0.04	2.88 score on a scale Standard Error 0.04	2.92 score on a scale Standard Error 0.07
Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment Upper Limbs Erythema, Week 2 (n=326,326,331,106)	2.35 score on a scale Standard Error 0.04	2.18 score on a scale Standard Error 0.05	2.27 score on a scale Standard Error 0.05	2.75 score on a scale Standard Error 0.07
Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment Upper Limbs Erythema, Week 4 (n=320,323,328,102)	1.92 score on a scale Standard Error 0.05	1.73 score on a scale Standard Error 0.05	1.77 score on a scale Standard Error 0.05	2.61 score on a scale Standard Error 0.07
Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment Upper Limbs Erythema, Week 8 (n=315,319,323,99)	1.55 score on a scale Standard Error 0.05	1.27 score on a scale Standard Error 0.05	1.25 score on a scale Standard Error 0.05	2.42 score on a scale Standard Error 0.08
Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment Upper Limbs Erythema, Week 12 (n=313,311,309,95)	1.45 score on a scale Standard Error 0.06	1.07 score on a scale Standard Error 0.05	0.94 score on a scale Standard Error 0.05	2.32 score on a scale Standard Error 0.08
Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment Upper Limbs Induration Baseline(n=329,329,335,107)	2.69 score on a scale Standard Error 0.04	2.76 score on a scale Standard Error 0.04	2.72 score on a scale Standard Error 0.04	2.79 score on a scale Standard Error 0.07
Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment Upper Limbs Induration, Week 2 (n=326,326,331,106)	2.17 score on a scale Standard Error 0.05	2.03 score on a scale Standard Error 0.05	2.13 score on a scale Standard Error 0.05	2.54 score on a scale Standard Error 0.07
Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment Upper Limbs Induration, Week 12 (n=313,311,309,95)	1.31 score on a scale Standard Error 0.06	1.01 score on a scale Standard Error 0.05	0.81 score on a scale Standard Error 0.05	2.08 score on a scale Standard Error 0.09
Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment Upper Limbs Scaling, Baseline (n=329,329,335,107)	2.66 score on a scale Standard Error 0.04	2.72 score on a scale Standard Error 0.04	2.73 score on a scale Standard Error 0.04	2.63 score on a scale Standard Error 0.08
Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment Upper Limbs Scaling, Week 2 (n=326,326,331,106)	2.11 score on a scale Standard Error 0.05	2.00 score on a scale Standard Error 0.05	2.03 score on a scale Standard Error 0.05	2.35 score on a scale Standard Error 0.09
Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment Upper Limbs Scaling, Week 4 (n=320,323,328,102)	1.71 score on a scale Standard Error 0.05	1.50 score on a scale Standard Error 0.05	1.54 score on a scale Standard Error 0.05	2.22 score on a scale Standard Error 0.10
Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment Upper Limbs Scaling, Week 8 (n=315,319,323,99)	1.39 score on a scale Standard Error 0.06	1.11 score on a scale Standard Error 0.05	1.07 score on a scale Standard Error 0.05	1.98 score on a scale Standard Error 0.09
Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment Upper Limbs Scaling, Week 12 (n=313,311,309,95)	1.30 score on a scale Standard Error 0.06	1.00 score on a scale Standard Error 0.05	0.82 score on a scale Standard Error 0.05	1.95 score on a scale Standard Error 0.10
Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment Trunk Erythema, Week 2 (n=326,326,331,106)	2.40 score on a scale Standard Error 0.05	2.20 score on a scale Standard Error 0.05	2.27 score on a scale Standard Error 0.05	2.75 score on a scale Standard Error 0.07
Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment Trunk Erythema, Week 4 (n=320,323,328,102)	2.03 score on a scale Standard Error 0.05	1.75 score on a scale Standard Error 0.05	1.76 score on a scale Standard Error 0.05	2.59 score on a scale Standard Error 0.07
Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment Trunk Erythema, Week 8 (n=315,319,323,99)	1.71 score on a scale Standard Error 0.06	1.23 score on a scale Standard Error 0.05	1.24 score on a scale Standard Error 0.05	2.41 score on a scale Standard Error 0.09
Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment Trunk Erythema, Week 12 (n=313,311,309,95)	1.53 score on a scale Standard Error 0.06	0.97 score on a scale Standard Error 0.06	0.89 score on a scale Standard Error 0.05	2.33 score on a scale Standard Error 0.10
Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment Trunk Induration, Baseline (n=329,329,335,107)	2.75 score on a scale Standard Error 0.04	2.70 score on a scale Standard Error 0.05	2.66 score on a scale Standard Error 0.05	2.66 score on a scale Standard Error 0.07
Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment Trunk Induration, Week 2 (n=326,326,331,106)	2.26 score on a scale Standard Error 0.05	2.01 score on a scale Standard Error 0.05	2.05 score on a scale Standard Error 0.05	2.40 score on a scale Standard Error 0.07
Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment Trunk Induration, Week 4 (n=320,323,328,102)	1.83 score on a scale Standard Error 0.05	1.50 score on a scale Standard Error 0.05	1.50 score on a scale Standard Error 0.05	2.26 score on a scale Standard Error 0.07
Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment Trunk Induration, Week 8 (n=315,319,323,99)	1.50 score on a scale Standard Error 0.06	0.97 score on a scale Standard Error 0.05	0.98 score on a scale Standard Error 0.05	2.06 score on a scale Standard Error 0.09
Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment Trunk Induration, Week 12 (n=313,311,309,95)	1.33 score on a scale Standard Error 0.06	0.80 score on a scale Standard Error 0.05	0.66 score on a scale Standard Error 0.05	2.03 score on a scale Standard Error 0.09
Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment Trunk Scaling, Baseline (n=329,329,335,107)	2.64 score on a scale Standard Error 0.04	2.66 score on a scale Standard Error 0.05	2.57 score on a scale Standard Error 0.05	2.61 score on a scale Standard Error 0.07
Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment Trunk Scaling, Week 4 (n=320,323,328,102)	1.73 score on a scale Standard Error 0.05	1.39 score on a scale Standard Error 0.05	1.44 score on a scale Standard Error 0.05	2.12 score on a scale Standard Error 0.09
Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment Trunk Scaling, Week 8 (n=315,319,323,99)	1.47 score on a scale Standard Error 0.06	0.94 score on a scale Standard Error 0.05	0.90 score on a scale Standard Error 0.05	1.86 score on a scale Standard Error 0.08
Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment Trunk Scaling, Week 12 (n=313,311,309,95)	1.28 score on a scale Standard Error 0.06	0.74 score on a scale Standard Error 0.05	0.62 score on a scale Standard Error 0.05	1.91 score on a scale Standard Error 0.10
Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment Lower Limbs Erythema, Baseline (n=329,329,335,107)	3.12 score on a scale Standard Error 0.03	3.13 score on a scale Standard Error 0.04	3.14 score on a scale Standard Error 0.03	3.10 score on a scale Standard Error 0.06
Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment Lower Limbs Erythema, Week 2 (n=326,326,331,106)	2.60 score on a scale Standard Error 0.04	2.44 score on a scale Standard Error 0.05	2.61 score on a scale Standard Error 0.05	2.92 score on a scale Standard Error 0.07
Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment Lower Limbs Erythema, Week 4 (n=320,323,328,102)	2.17 score on a scale Standard Error 0.05	1.98 score on a scale Standard Error 0.05	2.15 score on a scale Standard Error 0.05	2.75 score on a scale Standard Error 0.07
Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment Lower Limbs Erythema, Week 8 (n=315,319,323,99)	1.77 score on a scale Standard Error 0.06	1.50 score on a scale Standard Error 0.05	1.62 score on a scale Standard Error 0.05	2.55 score on a scale Standard Error 0.08
Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment Lower Limbs Erythema, Week 12 (n=313,311,309,95)	1.56 score on a scale Standard Error 0.06	1.21 score on a scale Standard Error 0.06	1.35 score on a scale Standard Error 0.05	2.45 score on a scale Standard Error 0.09
Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment Lower Limbs Induration, Week 2 (n=326,326,331,106)	2.47 score on a scale Standard Error 0.04	2.26 score on a scale Standard Error 0.05	2.45 score on a scale Standard Error 0.04	2.69 score on a scale Standard Error 0.07
Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment Lower Limbs Induration, Week 4 (n=320,323,328,102)	2.03 score on a scale Standard Error 0.05	1.72 score on a scale Standard Error 0.05	1.92 score on a scale Standard Error 0.05	2.54 score on a scale Standard Error 0.07
Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment Lower Limbs Induration, Week 8 (n=315,319,323,99)	1.58 score on a scale Standard Error 0.06	1.18 score on a scale Standard Error 0.05	1.38 score on a scale Standard Error 0.05	2.25 score on a scale Standard Error 0.08
Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment Lower Limbs Induration, Week 12 (n=313,311,309,95)	1.40 score on a scale Standard Error 0.06	0.97 score on a scale Standard Error 0.05	1.10 score on a scale Standard Error 0.06	2.21 score on a scale Standard Error 0.08
Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment Lower Limbs Scaling, Baseline (n=329,329,335,107)	2.91 score on a scale Standard Error 0.04	2.95 score on a scale Standard Error 0.04	2.98 score on a scale Standard Error 0.04	2.89 score on a scale Standard Error 0.07
Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment Lower Limbs Scaling, Week 2 (n=326,326,331,106)	2.36 score on a scale Standard Error 0.05	2.25 score on a scale Standard Error 0.05	2.31 score on a scale Standard Error 0.05	2.62 score on a scale Standard Error 0.09
Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment Lower Limbs Scaling, Week 4 (n=320,323,328,102)	1.98 score on a scale Standard Error 0.05	1.69 score on a scale Standard Error 0.06	1.81 score on a scale Standard Error 0.05	2.44 score on a scale Standard Error 0.09
Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment Lower Limbs Scaling, Week 8 (n=315,319,323,99)	1.60 score on a scale Standard Error 0.06	1.21 score on a scale Standard Error 0.06	1.32 score on a scale Standard Error 0.05	2.11 score on a scale Standard Error 0.10
Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment Lower Limbs Scaling, Week 12 (n=313,311,309,95)	1.39 score on a scale Standard Error 0.06	0.96 score on a scale Standard Error 0.06	1.08 score on a scale Standard Error 0.06	2.09 score on a scale Standard Error 0.10

SECONDARY outcome

Timeframe: Weeks 2, 4, 8, and 12

Population: FAS; OC

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) n=326 Participants Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.	CP-690,550 10 mg BID + Placebo BIW n=326 Participants Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.	Placebo BID + Etanercept 50 mg BIW n=331 Participants Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.	Placebo BID + Placebo BIW n=106 Participants Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment Upper Limbs Induration, Week 4 (n=320,323,328,102)	-0.94 scores on a scale Standard Error 0.06	-1.23 scores on a scale Standard Error 0.05	-1.13 scores on a scale Standard Error 0.05	-0.39 scores on a scale Standard Error 0.07
Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment Upper Limbs Scaling, Week 8 (n=315,319,323,99)	-1.28 scores on a scale Standard Error 0.06	-1.62 scores on a scale Standard Error 0.06	-1.66 scores on a scale Standard Error 0.06	-0.64 scores on a scale Standard Error 0.08
Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment Trunk Erythema, Week 2 (n=326,326,331,106)	-0.54 scores on a scale Standard Error 0.04	-0.67 scores on a scale Standard Error 0.04	-0.63 scores on a scale Standard Error 0.04	-0.23 scores on a scale Standard Error 0.06
Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment Trunk Erythema, Week 4 (n=320,323,328,102)	-0.91 scores on a scale Standard Error 0.05	-1.13 scores on a scale Standard Error 0.05	-1.16 scores on a scale Standard Error 0.05	-0.35 scores on a scale Standard Error 0.06
Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment Upper Limbs Scaling, Week 12 (n=313,311,309,95)	-1.36 scores on a scale Standard Error 0.07	-1.73 scores on a scale Standard Error 0.06	-1.92 scores on a scale Standard Error 0.06	-0.65 scores on a scale Standard Error 0.10
Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment Trunk Erythema, Week 8 (n=315,319,323,99)	-1.23 scores on a scale Standard Error 0.06	-1.66 scores on a scale Standard Error 0.06	-1.67 scores on a scale Standard Error 0.06	-0.59 scores on a scale Standard Error 0.08
Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment Trunk Erythema, Week 12 (n=313,311,309,95)	-1.41 scores on a scale Standard Error 0.07	-1.90 scores on a scale Standard Error 0.07	-2.03 scores on a scale Standard Error 0.06	-0.67 scores on a scale Standard Error 0.10
Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment Trunk Induration, Week 2 (n=326,326,331,106)	-0.49 scores on a scale Standard Error 0.04	-0.69 scores on a scale Standard Error 0.04	-0.61 scores on a scale Standard Error 0.04	-0.27 scores on a scale Standard Error 0.06
Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment Trunk Induration, Week 4 (n=320,323,328,102)	-0.93 scores on a scale Standard Error 0.06	-1.20 scores on a scale Standard Error 0.06	-1.17 scores on a scale Standard Error 0.05	-0.37 scores on a scale Standard Error 0.07
Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment Trunk Induration, Week 8 (n=315,319,323,99)	-1.26 scores on a scale Standard Error 0.06	-1.74 scores on a scale Standard Error 0.06	-1.68 scores on a scale Standard Error 0.06	-0.62 scores on a scale Standard Error 0.10
Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment Trunk Induration, Week 12 (n=313,311,309,95)	-1.43 scores on a scale Standard Error 0.07	-1.91 scores on a scale Standard Error 0.07	-1.99 scores on a scale Standard Error 0.06	-0.64 scores on a scale Standard Error 0.11
Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment Trunk Scaling, Week 2 (n=326,326,331,106)	-0.52 scores on a scale Standard Error 0.05	-0.74 scores on a scale Standard Error 0.05	-0.64 scores on a scale Standard Error 0.05	-0.25 scores on a scale Standard Error 0.07
Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment Trunk Scaling, Week 4 (n=320,323,328,102)	-0.92 scores on a scale Standard Error 0.06	-1.27 scores on a scale Standard Error 0.06	-1.15 scores on a scale Standard Error 0.05	-0.47 scores on a scale Standard Error 0.08
Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment Trunk Scaling, Week 8 (n=315,319,323,99)	-1.19 scores on a scale Standard Error 0.06	-1.71 scores on a scale Standard Error 0.06	-1.67 scores on a scale Standard Error 0.06	-0.75 scores on a scale Standard Error 0.09
Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment Trunk Scaling, Week 12 (n=313,311,309,95)	-1.38 scores on a scale Standard Error 0.07	-1.92 scores on a scale Standard Error 0.06	-1.94 scores on a scale Standard Error 0.06	-0.71 scores on a scale Standard Error 0.10
Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment Lower Limbs Erythema, Week 2 (n=326,326,331,106)	-0.52 scores on a scale Standard Error 0.04	-0.69 scores on a scale Standard Error 0.04	-0.53 scores on a scale Standard Error 0.04	-0.20 scores on a scale Standard Error 0.05
Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment Lower Limbs Erythema, Week 4 (n=320,323,328,102)	-0.95 scores on a scale Standard Error 0.05	-1.15 scores on a scale Standard Error 0.05	-1.00 scores on a scale Standard Error 0.04	-0.32 scores on a scale Standard Error 0.06
Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment Lower Limbs Erythema, Week 8 (n=315,319,323,99)	-1.34 scores on a scale Standard Error 0.06	-1.63 scores on a scale Standard Error 0.05	-1.51 scores on a scale Standard Error 0.05	-0.55 scores on a scale Standard Error 0.08
Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment Lower Limbs Erythema, Week 12 (n=313,311,309,95)	-1.55 scores on a scale Standard Error 0.07	-1.92 scores on a scale Standard Error 0.07	-1.80 scores on a scale Standard Error 0.06	-0.61 scores on a scale Standard Error 0.09
Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment Lower Limbs Induration, Week 2 (n=326,326,331,106)	-0.47 scores on a scale Standard Error 0.04	-0.71 scores on a scale Standard Error 0.04	-0.56 scores on a scale Standard Error 0.04	-0.24 scores on a scale Standard Error 0.05
Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment Lower Limbs Induration, Week 4 (n=320,323,328,102)	-0.92 scores on a scale Standard Error 0.05	-1.25 scores on a scale Standard Error 0.05	-1.08 scores on a scale Standard Error 0.05	-0.35 scores on a scale Standard Error 0.07
Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment Lower Limbs Induration, Week 8 (n=315,319,323,99)	-1.37 scores on a scale Standard Error 0.06	-1.80 scores on a scale Standard Error 0.06	-1.62 scores on a scale Standard Error 0.06	-0.66 scores on a scale Standard Error 0.08
Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment Lower Limbs Induration, Week 12 (n=313,311,309,95)	-1.56 scores on a scale Standard Error 0.07	-2.01 scores on a scale Standard Error 0.06	-1.91 scores on a scale Standard Error 0.06	-0.67 scores on a scale Standard Error 0.09
Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment Lower Limbs Scaling, Week 2 (n=326,326,331,106)	-0.55 scores on a scale Standard Error 0.04	-0.69 scores on a scale Standard Error 0.05	-0.67 scores on a scale Standard Error 0.04	-0.27 scores on a scale Standard Error 0.06
Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment Lower Limbs Scaling, Week 4 (n=320,323,328,102)	-0.94 scores on a scale Standard Error 0.05	-1.26 scores on a scale Standard Error 0.06	-1.18 scores on a scale Standard Error 0.05	-0.43 scores on a scale Standard Error 0.09
Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment Lower Limbs Scaling, Week 8 (n=315,319,323,99)	-1.31 scores on a scale Standard Error 0.06	-1.74 scores on a scale Standard Error 0.06	-1.67 scores on a scale Standard Error 0.06	-0.75 scores on a scale Standard Error 0.09
Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment Lower Limbs Scaling, Week 12 (n=313,311,309,95)	-1.53 scores on a scale Standard Error 0.07	-1.99 scores on a scale Standard Error 0.06	-1.92 scores on a scale Standard Error 0.07	-0.76 scores on a scale Standard Error 0.10
Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment Head/Neck Scaling, Week 4 (n=320,323,328,102)	-0.91 scores on a scale Standard Error 0.06	-1.30 scores on a scale Standard Error 0.07	-1.13 scores on a scale Standard Error 0.06	-0.48 scores on a scale Standard Error 0.08
Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment Head/Neck Erythema, Week 2 (n=326,326,331,106)	-0.46 scores on a scale Standard Error 0.04	-0.72 scores on a scale Standard Error 0.05	-0.56 scores on a scale Standard Error 0.04	-0.15 scores on a scale Standard Error 0.06
Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment Head/Neck Erythema, Week 4 (n=320,323,328,102)	-0.80 scores on a scale Standard Error 0.06	-1.19 scores on a scale Standard Error 0.06	-1.10 scores on a scale Standard Error 0.05	-0.32 scores on a scale Standard Error 0.07
Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment Head/Neck Erythema, Week 8 (n=315,319,323,99)	-1.09 scores on a scale Standard Error 0.06	-1.59 scores on a scale Standard Error 0.06	-1.63 scores on a scale Standard Error 0.06	-0.54 scores on a scale Standard Error 0.10
Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment Head/Neck Erythema, Week 12 (n=313,311,309,95)	-1.25 scores on a scale Standard Error 0.07	-1.73 scores on a scale Standard Error 0.07	-1.83 scores on a scale Standard Error 0.06	-0.64 scores on a scale Standard Error 0.12
Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment Head/Neck Induration, Week 2 (n=326,326,331,106)	-0.44 scores on a scale Standard Error 0.04	-0.65 scores on a scale Standard Error 0.05	-0.49 scores on a scale Standard Error 0.04	-0.17 scores on a scale Standard Error 0.06
Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment Head/Neck Induration, Week 4 (n=320,323,328,102)	-0.83 scores on a scale Standard Error 0.06	-1.15 scores on a scale Standard Error 0.06	-0.95 scores on a scale Standard Error 0.05	-0.39 scores on a scale Standard Error 0.08
Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment Head/Neck Induration, Week 8 (n=315,319,323,99)	-1.08 scores on a scale Standard Error 0.06	-1.50 scores on a scale Standard Error 0.06	-1.41 scores on a scale Standard Error 0.06	-0.58 scores on a scale Standard Error 0.10
Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment Head/Neck Induration, Week 12 (n=313,311,309,95)	-1.19 scores on a scale Standard Error 0.06	-1.61 scores on a scale Standard Error 0.06	-1.57 scores on a scale Standard Error 0.06	-0.71 scores on a scale Standard Error 0.11
Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment Head/Neck Scaling, Week 2 (n=326,326,331,106)	-0.53 scores on a scale Standard Error 0.04	-0.76 scores on a scale Standard Error 0.05	-0.67 scores on a scale Standard Error 0.05	-0.20 scores on a scale Standard Error 0.07
Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment Head/Neck Scaling, Week 8 (n=315,319,323,99)	-1.16 scores on a scale Standard Error 0.07	-1.70 scores on a scale Standard Error 0.06	-1.62 scores on a scale Standard Error 0.06	-0.69 scores on a scale Standard Error 0.10
Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment Head/Neck Scaling, Week 12 (n=313,311,309,95)	-1.31 scores on a scale Standard Error 0.07	-1.78 scores on a scale Standard Error 0.07	-1.81 scores on a scale Standard Error 0.07	-0.80 scores on a scale Standard Error 0.11
Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment Upper Limbs Erythema, Week 2 (n=326,326,331,106)	-0.52 scores on a scale Standard Error 0.04	-0.68 scores on a scale Standard Error 0.04	-0.61 scores on a scale Standard Error 0.04	-0.18 scores on a scale Standard Error 0.06
Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment Upper Limbs Erythema, Week 4 (n=320,323,328,102)	-0.94 scores on a scale Standard Error 0.05	-1.13 scores on a scale Standard Error 0.05	-1.11 scores on a scale Standard Error 0.04	-0.26 scores on a scale Standard Error 0.07
Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment Upper Limbs Erythema, Week 8 (n=315,319,323,99)	-1.31 scores on a scale Standard Error 0.06	-1.60 scores on a scale Standard Error 0.06	-1.62 scores on a scale Standard Error 0.05	-0.49 scores on a scale Standard Error 0.08
Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment Upper Limbs Erythema, Week 12 (n=313,311,309,95)	-1.42 scores on a scale Standard Error 0.07	-1.79 scores on a scale Standard Error 0.06	-1.95 scores on a scale Standard Error 0.06	-0.58 scores on a scale Standard Error 0.09
Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment Upper Limbs Induration, Week 2 (n=326,326,331,106)	-0.52 scores on a scale Standard Error 0.04	-0.73 scores on a scale Standard Error 0.04	-0.59 scores on a scale Standard Error 0.04	-0.25 scores on a scale Standard Error 0.05
Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment Upper Limbs Induration, Week 8 (n=315,319,323,99)	-1.26 scores on a scale Standard Error 0.06	-1.65 scores on a scale Standard Error 0.06	-1.54 scores on a scale Standard Error 0.05	-0.67 scores on a scale Standard Error 0.08
Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment Upper Limbs Induration, Week 12 (n=313,311,309,95)	-1.39 scores on a scale Standard Error 0.07	-1.77 scores on a scale Standard Error 0.06	-1.92 scores on a scale Standard Error 0.06	-0.68 scores on a scale Standard Error 0.10
Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment Upper Limbs Scaling, Week 2 (n=326,326,331,106)	-0.56 scores on a scale Standard Error 0.04	-0.72 scores on a scale Standard Error 0.05	-0.69 scores on a scale Standard Error 0.04	-0.28 scores on a scale Standard Error 0.07
Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment Upper Limbs Scaling, Week 4 (n=320,323,328,102)	-0.96 scores on a scale Standard Error 0.05	-1.23 scores on a scale Standard Error 0.06	-1.19 scores on a scale Standard Error 0.05	-0.38 scores on a scale Standard Error 0.08

SECONDARY outcome

Timeframe: Baseline and Weeks 2, 4, 8, and 12

Population: FAS; OC

Assessment of BSA with psoriasis performed separately for 4 body regions: head and neck, upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). The % surface area with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (fully extended palm, fingers and thumb together) represented approximately 1% of the total BSA. The number of handprints of psoriatic skin in a body region was used to determine the extent (%) to which a body region was involved with psoriasis.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) n=329 Participants Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.	CP-690,550 10 mg BID + Placebo BIW n=329 Participants Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.	Placebo BID + Etanercept 50 mg BIW n=335 Participants Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.	Placebo BID + Placebo BIW n=107 Participants Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
Mean Percentage of Total Psoriatic BSA During the 12-Week Double-Blind Treatment Week 2 (n=326,326,331,106)	29.53 percent psoriatic BSA Standard Error 0.96	28.12 percent psoriatic BSA Standard Error 0.94	28.29 percent psoriatic BSA Standard Error 0.97	32.03 percent psoriatic BSA Standard Error 1.76
Mean Percentage of Total Psoriatic BSA During the 12-Week Double-Blind Treatment Week 4 (n=320,323,328,102)	25.98 percent psoriatic BSA Standard Error 0.96	22.88 percent psoriatic BSA Standard Error 0.93	24.82 percent psoriatic BSA Standard Error 0.95	32.47 percent psoriatic BSA Standard Error 1.89
Mean Percentage of Total Psoriatic BSA During the 12-Week Double-Blind Treatment Week 8 (n=315,319,323,99)	19.74 percent psoriatic BSA Standard Error 0.98	14.76 percent psoriatic BSA Standard Error 0.89	15.42 percent psoriatic BSA Standard Error 0.81	31.00 percent psoriatic BSA Standard Error 1.98
Mean Percentage of Total Psoriatic BSA During the 12-Week Double-Blind Treatment Baseline (n=329,329,335,107)	32.15 percent psoriatic BSA Standard Error 0.98	31.74 percent psoriatic BSA Standard Error 0.95	30.63 percent psoriatic BSA Standard Error 1.00	31.88 percent psoriatic BSA Standard Error 1.62
Mean Percentage of Total Psoriatic BSA During the 12-Week Double-Blind Treatment Week 12 (n=313,311,309,95)	16.04 percent psoriatic BSA Standard Error 0.94	10.55 percent psoriatic BSA Standard Error 0.77	10.60 percent psoriatic BSA Standard Error 0.76	29.77 percent psoriatic BSA Standard Error 2.12

SECONDARY outcome

Timeframe: Weeks 2, 4, 8, and 12

Population: FAS; OC

Assessment of BSA with psoriasis performed separately for 4 body regions: head and neck, upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). The %surface area with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant(fully extended palm, fingers and thumb together) represented approximately 1% of the total BSA. The number of handprints of psoriatic skin in a body region was used to determine the extent (%) to which a body region was involved with psoriasis.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) n=326 Participants Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.	CP-690,550 10 mg BID + Placebo BIW n=326 Participants Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.	Placebo BID + Etanercept 50 mg BIW n=331 Participants Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.	Placebo BID + Placebo BIW n=106 Participants Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
Mean Percent Change From Baseline in Total Psoriatic BSA During the 12-Week Double-Blind Treatment Week 2 (n=326,326,331,106)	-7.54 percent change from baseline Standard Error 1.23	-11.71 percent change from baseline Standard Error 1.12	-7.54 percent change from baseline Standard Error 0.96	0.23 percent change from baseline Standard Error 1.89
Mean Percent Change From Baseline in Total Psoriatic BSA During the 12-Week Double-Blind Treatment Week 4 (n=320,323,328,102)	-19.90 percent change from baseline Standard Error 1.66	-29.17 percent change from baseline Standard Error 1.69	-19.60 percent change from baseline Standard Error 1.46	1.58 percent change from baseline Standard Error 2.84
Mean Percent Change From Baseline in Total Psoriatic BSA During the 12-Week Double-Blind Treatment Week 8 (n=315,319,323,99)	-37.81 percent change from baseline Standard Error 2.81	-55.02 percent change from baseline Standard Error 1.93	-48.65 percent change from baseline Standard Error 1.91	-1.33 percent change from baseline Standard Error 3.57
Mean Percent Change From Baseline in Total Psoriatic BSA During the 12-Week Double-Blind Treatment Week 12 (n=313,311,309,95)	-47.66 percent change from baseline Standard Error 3.35	-67.51 percent change from baseline Standard Error 1.86	-64.91 percent change from baseline Standard Error 1.91	-6.68 percent change from baseline Standard Error 4.06

SECONDARY outcome

Timeframe: Weeks 2, 4, 8, and 12

Population: FAS; OC

PASI quantifies severity of psoriasis based on both lesion severity and percent of BSA affected. PASI is a composite score by the investigator of degree of erythema, induration, and scaling (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; higher scores represent greater severity of psoriasis.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) n=326 Participants Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.	CP-690,550 10 mg BID + Placebo BIW n=327 Participants Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.	Placebo BID + Etanercept 50 mg BIW n=331 Participants Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.	Placebo BID + Placebo BIW n=106 Participants Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
Percentage of Participants Who Achieved a 50% Reduction in PASI Relative to Baseline (PASI50) During the 12-Week Double-Blind Treatment Week 2 (n=326,327,331,106)	10.74 percentage of participatns	18.35 percentage of participatns	11.18 percentage of participatns	0.94 percentage of participatns
Percentage of Participants Who Achieved a 50% Reduction in PASI Relative to Baseline (PASI50) During the 12-Week Double-Blind Treatment Week 4 (n=319,323,328,102)	33.23 percentage of participatns	50.46 percentage of participatns	48.78 percentage of participatns	6.86 percentage of participatns
Percentage of Participants Who Achieved a 50% Reduction in PASI Relative to Baseline (PASI50) During the 12-Week Double-Blind Treatment Week 8 (n=315,319, 323,99)	59.05 percentage of participatns	78.06 percentage of participatns	77.09 percentage of participatns	20.20 percentage of participatns
Percentage of Participants Who Achieved a 50% Reduction in PASI Relative to Baseline (PASI50) During the 12-Week Double-Blind Treatment Week 12 (n=313,311,309,95)	69.01 percentage of participatns	85.53 percentage of participatns	87.06 percentage of participatns	23.16 percentage of participatns

SECONDARY outcome

Timeframe: Baseline up to Week 12

Population: FAS; OC

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) n=329 Participants Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.	CP-690,550 10 mg BID + Placebo BIW n=330 Participants Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.	Placebo BID + Etanercept 50 mg BIW n=335 Participants Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.	Placebo BID + Placebo BIW n=107 Participants Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
Median Time to PASI50 Response During the 12-Week Double-Blind Treatment	8.1 weeks The lower (upper) bound of the 95% confidence interval (CI) was not estimable because the lower (upper) bound of the survival function using LogLog transformation was not below the median.	5.0 weeks Interval 4.1 to 8.0	7.9 weeks Interval 4.4 to 8.0	NA weeks Median and 95% CI were not estimable due to less than (\<)50% of events occurring.

SECONDARY outcome

Timeframe: Weeks 2, 4, 8, and 12

Population: FAS; OC

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) n=326 Participants Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.	CP-690,550 10 mg BID + Placebo BIW n=327 Participants Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.	Placebo BID + Etanercept 50 mg BIW n=331 Participants Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.	Placebo BID + Placebo BIW n=106 Participants Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
Percentage of Participants Who Achieved a 90% Reduction in PASI Relative to Baseline (PASI90) During the 12-Week Double-Blind Treatment Week 2 (n=326,327,331,106)	0.00 percentage of participants	0.61 percentage of participants	0.30 percentage of participants	0.00 percentage of participants
Percentage of Participants Who Achieved a 90% Reduction in PASI Relative to Baseline (PASI90) During the 12-Week Double-Blind Treatment Week 4 (n=319,323,328,102)	1.57 percentage of participants	4.64 percentage of participants	1.83 percentage of participants	0.00 percentage of participants
Percentage of Participants Who Achieved a 90% Reduction in PASI Relative to Baseline (PASI90) During the 12-Week Double-Blind Treatment Week 8 (n=315,319,323,99)	12.06 percentage of participants	26.02 percentage of participants	15.79 percentage of participants	0.00 percentage of participants
Percentage of Participants Who Achieved a 90% Reduction in PASI Relative to Baseline (PASI90) During the 12-Week Double-Blind Treatment Week 12 (n=313,311,309,95)	22.04 percentage of participants	38.26 percentage of participants	34.95 percentage of participants	1.05 percentage of participants

SECONDARY outcome

Timeframe: Baseline up to Week 12

Population: FAS; OC

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) n=329 Participants Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.	CP-690,550 10 mg BID + Placebo BIW n=330 Participants Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.	Placebo BID + Etanercept 50 mg BIW n=335 Participants Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.	Placebo BID + Placebo BIW n=107 Participants Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
Median Time to Achieve PASI75 Response During the 12-Week Double-Blind Treatment	12.6 weeks Interval 12.4 to 13.1	8.6 weeks Interval 8.1 to 12.1	12.1 weeks Interval 11.1 to 12.1	NA weeks Median and 95% CI were not estimable due to \<50% of events occurring.

SECONDARY outcome

Timeframe: Weeks 2, 4, 8, and 12

Population: FAS; OC

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) n=326 Participants Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.	CP-690,550 10 mg BID + Placebo BIW n=327 Participants Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.	Placebo BID + Etanercept 50 mg BIW n=331 Participants Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.	Placebo BID + Placebo BIW n=106 Participants Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
Percentage of Participants With a PASI Score Greater Than or Equal to (≥)125% of the Baseline PASI Score During the 12-Week Double-Blind Treatment Week 12 (n=313,311,309,95)	2.88 percentage of participants	0.32 percentage of participants	0.97 percentage of participants	7.37 percentage of participants
Percentage of Participants With a PASI Score Greater Than or Equal to (≥)125% of the Baseline PASI Score During the 12-Week Double-Blind Treatment Week 2 (n=326,327,331,106)	0.92 percentage of participants	0.61 percentage of participants	0.30 percentage of participants	4.72 percentage of participants
Percentage of Participants With a PASI Score Greater Than or Equal to (≥)125% of the Baseline PASI Score During the 12-Week Double-Blind Treatment Week 4 (n=319,323,328,102)	2.19 percentage of participants	0.93 percentage of participants	0.91 percentage of participants	8.82 percentage of participants
Percentage of Participants With a PASI Score Greater Than or Equal to (≥)125% of the Baseline PASI Score During the 12-Week Double-Blind Treatment Week 8 (n=315,319,323,99)	2.54 percentage of participants	0.31 percentage of participants	0.31 percentage of participants	7.07 percentage of participants
Percentage of Participants With a PASI Score Greater Than or Equal to (≥)125% of the Baseline PASI Score During the 12-Week Double-Blind Treatment Overall (n=327,329,334,107)	4.59 percentage of participants	1.82 percentage of participants	1.80 percentage of participants	15.89 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, and 12

Population: FAS; OC

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.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) n=305 Participants Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.	CP-690,550 10 mg BID + Placebo BIW n=308 Participants Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.	Placebo BID + Etanercept 50 mg BIW n=305 Participants Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.	Placebo BID + Placebo BIW n=107 Participants Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
Mean Itch Severity Item (ISI) Score During the 12-Week Double-Blind Treatment Baseline (n=305,308,305,107)	5.19 score on a scale Standard Error 0.16	5.26 score on a scale Standard Error 0.16	5.23 score on a scale Standard Error 0.15	5.15 score on a scale Standard Error 0.27
Mean Itch Severity Item (ISI) Score During the 12-Week Double-Blind Treatment Week 2 (n=325,322,330,105)	3.47 score on a scale Standard Error 0.15	2.87 score on a scale Standard Error 0.14	3.90 score on a scale Standard Error 0.15	4.90 score on a scale Standard Error 0.30
Mean Itch Severity Item (ISI) Score During the 12-Week Double-Blind Treatment Week 4 (n=318,323,328,101)	2.92 score on a scale Standard Error 0.15	1.86 score on a scale Standard Error 0.13	2.97 score on a scale Standard Error 0.13	4.65 score on a scale Standard Error 0.31
Mean Itch Severity Item (ISI) Score During the 12-Week Double-Blind Treatment Week 8 (n=313,315,320,100)	2.11 score on a scale Standard Error 0.14	1.22 score on a scale Standard Error 0.11	2.06 score on a scale Standard Error 0.13	4.74 score on a scale Standard Error 0.32
Mean Itch Severity Item (ISI) Score During the 12-Week Double-Blind Treatment Week 12 (n=312,309,311,95)	1.98 score on a scale Standard Error 0.14	1.25 score on a scale Standard Error 0.12	1.72 score on a scale Standard Error 0.13	4.75 score on a scale Standard Error 0.32

SECONDARY outcome

Timeframe: Weeks 2, 4, 8, and 12

Population: FAS; OC

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) n=303 Participants Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.	CP-690,550 10 mg BID + Placebo BIW n=300 Participants Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.	Placebo BID + Etanercept 50 mg BIW n=301 Participants Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.	Placebo BID + Placebo BIW n=105 Participants Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
Mean Change From Baseline in ISI Score During the 12-Week Double-Blind Treatment Week 2	-1.73 score on a scale Standard Error 0.15	-2.39 score on a scale Standard Error 0.14	-1.22 score on a scale Standard Error 0.15	-0.26 score on a scale Standard Error 0.22
Mean Change From Baseline in ISI Score During the 12-Week Double-Blind Treatment Week 4	-2.24 score on a scale Standard Error 0.18	-3.43 score on a scale Standard Error 0.17	-2.20 score on a scale Standard Error 0.15	-0.44 score on a scale Standard Error 0.24
Mean Change From Baseline in ISI Score During the 12-Week Double-Blind Treatment Week 8	-3.01 score on a scale Standard Error 0.18	-4.02 score on a scale Standard Error 0.17	-3.13 score on a scale Standard Error 0.17	-0.46 score on a scale Standard Error 0.26
Mean Change From Baseline in ISI Score During the 12-Week Double-Blind Treatment Week 12	-3.18 score on a scale Standard Error 0.18	-3.96 score on a scale Standard Error 0.18	-3.46 score on a scale Standard Error 0.19	-0.43 score on a scale Standard Error 0.28

SECONDARY outcome

Timeframe: Weeks 2, 4, 8, and 12

Population: FAS; OC

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) n=288 Participants Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.	CP-690,550 10 mg BID + Placebo BIW n=281 Participants Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.	Placebo BID + Etanercept 50 mg BIW n=294 Participants Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.	Placebo BID + Placebo BIW n=98 Participants Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
Percentage of Participants Achieving an ISI Score of 0 During the 12-Week Double-Blind Treatment Week 2	10.42 percentage of participants	13.88 percentage of participants	10.54 percentage of participants	1.02 percentage of participants
Percentage of Participants Achieving an ISI Score of 0 During the 12-Week Double-Blind Treatment Week 4	15.66 percentage of participants	34.28 percentage of participants	14.09 percentage of participants	2.13 percentage of participants
Percentage of Participants Achieving an ISI Score of 0 During the 12-Week Double-Blind Treatment Week 8	29.45 percentage of participants	47.83 percentage of participants	28.67 percentage of participants	6.38 percentage of participants
Percentage of Participants Achieving an ISI Score of 0 During the 12-Week Double-Blind Treatment Week 12	31.64 percentage of participants	51.85 percentage of participants	40.07 percentage of participants	6.74 percentage of participants

SECONDARY outcome

Timeframe: Baseline and Weeks 4 and 12

Population: FAS; OC

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) n=328 Participants Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.	CP-690,550 10 mg BID + Placebo BIW n=326 Participants Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.	Placebo BID + Etanercept 50 mg BIW n=332 Participants Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.	Placebo BID + Placebo BIW n=106 Participants Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
Mean Dermatology Life Quality Index (DLQI) Score During the 12-Week Double-Blind Treatment Baseline (n=328,326,332,106)	12.98 score on a scale Standard Error 0.39	13.32 score on a scale Standard Error 0.38	12.73 score on a scale Standard Error 0.38	12.27 score on a scale Standard Error 0.69
Mean Dermatology Life Quality Index (DLQI) Score During the 12-Week Double-Blind Treatment Week 4 (n=318,323,325,100)	7.82 score on a scale Standard Error 0.36	5.95 score on a scale Standard Error 0.32	6.90 score on a scale Standard Error 0.35	10.51 score on a scale Standard Error 0.77
Mean Dermatology Life Quality Index (DLQI) Score During the 12-Week Double-Blind Treatment Week 12 (n=306,305,307,93)	5.61 score on a scale Standard Error 0.36	3.47 score on a scale Standard Error 0.27	3.84 score on a scale Standard Error 0.30	10.33 score on a scale Standard Error 0.81

SECONDARY outcome

Timeframe: Weeks 4 and 12

Population: FAS; OC

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) n=317 Participants Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.	CP-690,550 10 mg BID + Placebo BIW n=319 Participants Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.	Placebo BID + Etanercept 50 mg BIW n=322 Participants Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.	Placebo BID + Placebo BIW n=99 Participants Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
Mean Change From Baseline in DLQI Score During the 12-Week Double-Blind Treatment Week 4 (n=317,319,322,99)	-5.28 score on a scale Standard Error 0.35	-7.43 score on a scale Standard Error 0.36	-5.80 score on a scale Standard Error 0.33	-1.64 score on a scale Standard Error 0.55
Mean Change From Baseline in DLQI Score During the 12-Week Double-Blind Treatment Week 12 (n=305,301,305,93)	-7.33 score on a scale Standard Error 0.43	-9.72 score on a scale Standard Error 0.40	-8.97 score on a scale Standard Error 0.40	-1.85 score on a scale Standard Error 0.66

SECONDARY outcome

Timeframe: Baseline and Weeks 4 and 12

Population: FAS; OC

The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much); higher scores indicate poor quality of life. The DLQI can be analyzed under 6 subscales by combining questions and is categorized as follows: symptoms and feelings (maximum score=6); daily activities (maximum score=6); leisure (maximum score=6); work and school (maximum score=3); personal relationships (maximum score=6); and treatment (maximum score=3).

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) n=328 Participants Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.	CP-690,550 10 mg BID + Placebo BIW n=327 Participants Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.	Placebo BID + Etanercept 50 mg BIW n=332 Participants Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.	Placebo BID + Placebo BIW n=106 Participants Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
Mean DLQI Subscale Scores During the 12-Week Double-Blind Treatment Daily Activities, Week 12 (n=306,305,306,93)	1.19 score on a scale Standard Error 0.08	0.70 score on a scale Standard Error 0.07	0.79 score on a scale Standard Error 0.07	2.17 score on a scale Standard Error 0.19
Mean DLQI Subscale Scores During the 12-Week Double-Blind Treatment Symptoms and Feelings,Baseline (n=328,327,332,106)	3.44 score on a scale Standard Error 0.09	3.49 score on a scale Standard Error 0.08	3.47 score on a scale Standard Error 0.08	3.46 score on a scale Standard Error 0.16
Mean DLQI Subscale Scores During the 12-Week Double-Blind Treatment Symptoms and Feelings, Week 4 (n=318,323,324,100)	2.11 score on a scale Standard Error 0.08	1.63 score on a scale Standard Error 0.07	1.94 score on a scale Standard Error 0.07	2.92 score on a scale Standard Error 0.15
Mean DLQI Subscale Scores During the 12-Week Double-Blind Treatment Symptoms and Feelings, Week 12 (n=306,304,307,93)	1.60 score on a scale Standard Error 0.09	1.04 score on a scale Standard Error 0.07	1.16 score on a scale Standard Error 0.07	2.85 score on a scale Standard Error 0.17
Mean DLQI Subscale Scores During the 12-Week Double-Blind Treatment Daily Activities,Baseline (n=327,327,332,106)	2.76 score on a scale Standard Error 0.10	2.85 score on a scale Standard Error 0.09	2.76 score on a scale Standard Error 0.09	2.52 score on a scale Standard Error 0.16
Mean DLQI Subscale Scores During the 12-Week Double-Blind Treatment Daily Activities, Week 4 (n=318,322,324,100)	1.68 score on a scale Standard Error 0.08	1.30 score on a scale Standard Error 0.08	1.53 score on a scale Standard Error 0.08	2.28 score on a scale Standard Error 0.18
Mean DLQI Subscale Scores During the 12-Week Double-Blind Treatment Leisure, Baseline (n=326,326,330,106)	2.52 score on a scale Standard Error 0.11	2.67 score on a scale Standard Error 0.11	2.57 score on a scale Standard Error 0.11	2.25 score on a scale Standard Error 0.17
Mean DLQI Subscale Scores During the 12-Week Double-Blind Treatment Leisure, Week 4 (n=318,322,325,100)	1.50 score on a scale Standard Error 0.09	1.14 score on a scale Standard Error 0.08	1.33 score on a scale Standard Error 0.09	1.84 score on a scale Standard Error 0.18
Mean DLQI Subscale Scores During the 12-Week Double-Blind Treatment Leisure, Week 12 (n=306,305,307,93)	1.09 score on a scale Standard Error 0.09	0.70 score on a scale Standard Error 0.07	0.71 score on a scale Standard Error 0.07	1.90 score on a scale Standard Error 0.19
Mean DLQI Subscale Scores During the 12-Week Double-Blind Treatment Work and School,Baseline (n=328,327,331,106)	1.12 score on a scale Standard Error 0.06	1.08 score on a scale Standard Error 0.06	1.06 score on a scale Standard Error 0.06	0.97 score on a scale Standard Error 0.11
Mean DLQI Subscale Scores During the 12-Week Double-Blind Treatment Work and School, Week 4 (n=318,323,325,100)	0.56 score on a scale Standard Error 0.05	0.46 score on a scale Standard Error 0.05	0.54 score on a scale Standard Error 0.05	0.81 score on a scale Standard Error 0.11
Mean DLQI Subscale Scores During the 12-Week Double-Blind Treatment Work and School, Week 12 (n=306,304,307,92)	0.41 score on a scale Standard Error 0.04	0.24 score on a scale Standard Error 0.04	0.32 score on a scale Standard Error 0.04	0.83 score on a scale Standard Error 0.12
Mean DLQI Subscale Scores During the 12-Week Double-Blind Treatment Personal Relationships,Baseline(n=328,326,332,106)	1.95 score on a scale Standard Error 0.11	1.98 score on a scale Standard Error 0.10	1.67 score on a scale Standard Error 0.10	1.89 score on a scale Standard Error 0.18
Mean DLQI Subscale Scores During the 12-Week Double-Blind Treatment Personal Relationships, Week 4 (n=318,323,325,100)	1.21 score on a scale Standard Error 0.09	0.90 score on a scale Standard Error 0.08	0.93 score on a scale Standard Error 0.08	1.64 score on a scale Standard Error 0.20
Mean DLQI Subscale Scores During the 12-Week Double-Blind Treatment Personal Relationships, Week 12 (n=306,305,307,93)	0.85 score on a scale Standard Error 0.09	0.48 score on a scale Standard Error 0.06	0.52 score on a scale Standard Error 0.07	1.65 score on a scale Standard Error 0.20
Mean DLQI Subscale Scores During the 12-Week Double-Blind Treatment Treatment, Baseline(n=328,327,332,106)	1.22 score on a scale Standard Error 0.06	1.24 score on a scale Standard Error 0.06	1.23 score on a scale Standard Error 0.06	1.18 score on a scale Standard Error 0.10
Mean DLQI Subscale Scores During the 12-Week Double-Blind Treatment Treatment, Week 4 (n=318,323,325,100)	0.76 score on a scale Standard Error 0.05	0.52 score on a scale Standard Error 0.04	0.65 score on a scale Standard Error 0.04	1.02 score on a scale Standard Error 0.11
Mean DLQI Subscale Scores During the 12-Week Double-Blind Treatment Treatment, Week 12 (n=306,305,307,93)	0.45 score on a scale Standard Error 0.04	0.31 score on a scale Standard Error 0.03	0.33 score on a scale Standard Error 0.04	0.95 score on a scale Standard Error 0.11

SECONDARY outcome

Timeframe: Weeks 4 and 12

Population: FAS; OC

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) n=317 Participants Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.	CP-690,550 10 mg BID + Placebo BIW n=320 Participants Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.	Placebo BID + Etanercept 50 mg BIW n=321 Participants Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.	Placebo BID + Placebo BIW n=99 Participants Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
Mean Change From Baseline in DLQI Subscale Scores During the 12-Week Double-Blind Treatment Symptoms and Feelings, Week 12 (n=305,301,305,93)	-1.81 scores on a scale Standard Error 0.10	-2.41 scores on a scale Standard Error 0.10	-2.30 scores on a scale Standard Error 0.10	-0.62 scores on a scale Standard Error 0.18
Mean Change From Baseline in DLQI Subscale Scores During the 12-Week Double-Blind Treatment Symptoms and Feelings, Week 4 (n=317,320,321,99)	-1.34 scores on a scale Standard Error 0.09	-1.87 scores on a scale Standard Error 0.08	-1.53 scores on a scale Standard Error 0.08	-0.53 scores on a scale Standard Error 0.15
Mean Change From Baseline in DLQI Subscale Scores During the 12-Week Double-Blind Treatment Daily Activities, Week 4 (n=316,319,321,99)	-1.13 scores on a scale Standard Error 0.09	-1.57 scores on a scale Standard Error 0.09	-1.21 scores on a scale Standard Error 0.09	-0.28 scores on a scale Standard Error 0.15
Mean Change From Baseline in DLQI Subscale Scores During the 12-Week Double-Blind Treatment Daily Activities, Week 12 (n=304,302,304,93)	-1.58 scores on a scale Standard Error 0.10	-2.14 scores on a scale Standard Error 0.10	-1.96 scores on a scale Standard Error 0.10	-0.34 scores on a scale Standard Error 0.19
Mean Change From Baseline in DLQI Subscale Scores During the 12-Week Double-Blind Treatment Leisure, Week 4 (n=316,318,320,99)	-1.03 scores on a scale Standard Error 0.10	-1.54 scores on a scale Standard Error 0.10	-1.24 scores on a scale Standard Error 0.10	-0.39 scores on a scale Standard Error 0.15
Mean Change From Baseline in DLQI Subscale Scores During the 12-Week Double-Blind Treatment Leisure, Week 12 (n=303,301,303,93)	-1.41 scores on a scale Standard Error 0.11	-1.95 scores on a scale Standard Error 0.11	-1.90 scores on a scale Standard Error 0.11	-0.31 scores on a scale Standard Error 0.18
Mean Change From Baseline in DLQI Subscale Scores During the 12-Week Double-Blind Treatment Work and School, Week 4 (n=317,320,321,99)	-0.56 scores on a scale Standard Error 0.06	-0.63 scores on a scale Standard Error 0.06	-0.52 scores on a scale Standard Error 0.06	-0.13 scores on a scale Standard Error 0.10
Mean Change From Baseline in DLQI Subscale Scores During the 12-Week Double-Blind Treatment Work and School, Week 12 (n=305,301,304,92)	-0.69 scores on a scale Standard Error 0.07	-0.86 scores on a scale Standard Error 0.06	-0.77 scores on a scale Standard Error 0.07	-0.12 scores on a scale Standard Error 0.10
Mean Change From Baseline in DLQI Subscale Scores During the 12-Week Double-Blind Treatment Personal Relationships, Week 4 (n=317,319,322,99)	-0.76 scores on a scale Standard Error 0.09	-1.09 scores on a scale Standard Error 0.09	-0.73 scores on a scale Standard Error 0.08	-0.18 scores on a scale Standard Error 0.14
Mean Change From Baseline in DLQI Subscale Scores During the 12-Week Double-Blind Treatment Personal Relationships, Week 12 (n=305,301,305,93)	-1.10 scores on a scale Standard Error 0.11	-1.46 scores on a scale Standard Error 0.10	-1.17 scores on a scale Standard Error 0.09	-0.20 scores on a scale Standard Error 0.15
Mean Change From Baseline in DLQI Subscale Scores During the 12-Week Double-Blind Treatment Treatment, Week 4 (n=317,320,322,99)	-0.47 scores on a scale Standard Error 0.06	-0.72 scores on a scale Standard Error 0.06	-0.58 scores on a scale Standard Error 0.06	-0.12 scores on a scale Standard Error 0.10
Mean Change From Baseline in DLQI Subscale Scores During the 12-Week Double-Blind Treatment Treatment, Week 12 (n=305,302,305,93)	-0.75 scores on a scale Standard Error 0.06	-0.91 scores on a scale Standard Error 0.06	-0.91 scores on a scale Standard Error 0.06	-0.24 scores on a scale Standard Error 0.10

SECONDARY outcome

Timeframe: Weeks 4 and 12

Population: FAS; OC

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) n=279 Participants Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.	CP-690,550 10 mg BID + Placebo BIW n=283 Participants Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.	Placebo BID + Etanercept 50 mg BIW n=282 Participants Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.	Placebo BID + Placebo BIW n=82 Participants Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
Percentage of Participants Achieving DLQI Response ≥5 During the 12-Week Double-Blind Treatment Week 4	60.93 percentage of participants	71.38 percentage of participants	61.35 percentage of participants	36.59 percentage of participants
Percentage of Participants Achieving DLQI Response ≥5 During the 12-Week Double-Blind Treatment Week 12	71.54 percentage of participants	85.28 percentage of participants	81.34 percentage of participants	35.90 percentage of participants

SECONDARY outcome

Timeframe: Weeks 4 and 12

Population: FAS; OC

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) n=306 Participants Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.	CP-690,550 10 mg BID + Placebo BIW n=312 Participants Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.	Placebo BID + Etanercept 50 mg BIW n=316 Participants Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.	Placebo BID + Placebo BIW n=95 Participants Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
Percentage of Participants Achieving DLQI Response ≤1 During the 12-Week Double-Blind Treatment Week 4	13.07 percentage of participants	21.79 percentage of participants	15.51 percentage of participants	7.37 percentage of participants
Percentage of Participants Achieving DLQI Response ≤1 During the 12-Week Double-Blind Treatment Week 12	33.22 percentage of participants	51.36 percentage of participants	47.18 percentage of participants	8.89 percentage of participants

SECONDARY outcome

Timeframe: Weeks 4 and 12

Population: Data were not analyzed as the endpoint of proportion of participants achieving a 5-point reduction from baseline in DLQI provided similar information.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: FAS; OC

The SF-36 is a general health status questionnaire that assesses 8 domains of functional health and well being: Physical Functioning, Role Limitations due to Physical Health Problems, Bodily Pain, Social Functioning, Mental Health, Role Limitations due to Emotional Problems, Vitality, and General Health Perceptions. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). A PCS score and MCS score are based on a normalized sum of the 8 scale scores; PCS/MCS summary concept score = (raw score\*10) plus 50. Higher scores indicate a better health related quality of life.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) n=327 Participants Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.	CP-690,550 10 mg BID + Placebo BIW n=327 Participants Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.	Placebo BID + Etanercept 50 mg BIW n=327 Participants Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.	Placebo BID + Placebo BIW n=105 Participants Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
Mean Short Form 36 (SF-36) Mental Component Summary (MCS) and Physical Component Summary (PCS) Scores at Baseline and Week 12 Baseline Physical Health Score (n=327,327,327,105)	47.4 score on a scale Standard Error 0.5	48.3 score on a scale Standard Error 0.5	47.5 score on a scale Standard Error 0.5	46.8 score on a scale Standard Error 1.0
Mean Short Form 36 (SF-36) Mental Component Summary (MCS) and Physical Component Summary (PCS) Scores at Baseline and Week 12 Week 12 Physical Health Score (n=303,304,307,95)	51.7 score on a scale Standard Error 0.5	53.6 score on a scale Standard Error 0.4	52.5 score on a scale Standard Error 0.5	47.8 score on a scale Standard Error 1.0
Mean Short Form 36 (SF-36) Mental Component Summary (MCS) and Physical Component Summary (PCS) Scores at Baseline and Week 12 Baseline Mental Health Score (n=327,327,327,105)	42.0 score on a scale Standard Error 0.6	41.2 score on a scale Standard Error 0.6	42.0 score on a scale Standard Error 0.7	39.8 score on a scale Standard Error 1.2
Mean Short Form 36 (SF-36) Mental Component Summary (MCS) and Physical Component Summary (PCS) Scores at Baseline and Week 12 Week 12 Mental Health Score (n=303,304,307,95)	47.0 score on a scale Standard Error 0.6	49.3 score on a scale Standard Error 0.5	47.8 score on a scale Standard Error 0.6	41.7 score on a scale Standard Error 1.3

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: FAS; OC

The SF-36 is a general health status questionnaire that assesses 8 domains of functional health and well being: Physical Functioning, Role Limitations due to Physical Health Problems, Bodily Pain, Social Functioning, Mental Health, Role Limitations due to Emotional Problems, Vitality, and General Health Perceptions. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Higher scores indicate a better health related quality of life.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) n=328 Participants Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.	CP-690,550 10 mg BID + Placebo BIW n=328 Participants Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.	Placebo BID + Etanercept 50 mg BIW n=330 Participants Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.	Placebo BID + Placebo BIW n=106 Participants Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
Mean SF-36 Domain Scores at Baseline and Week 12 Week 12 Role-Emotional (n=306,305,307,95)	48.6 score on a scale Standard Error 0.5	50.2 score on a scale Standard Error 0.5	48.6 score on a scale Standard Error 0.6	43.3 score on a scale Standard Error 1.4
Mean SF-36 Domain Scores at Baseline and Week 12 Baseline Physical Functioning (n=328,328,330,106)	48.3 score on a scale Standard Error 0.5	49.0 score on a scale Standard Error 0.5	48.6 score on a scale Standard Error 0.5	46.7 score on a scale Standard Error 1.1
Mean SF-36 Domain Scores at Baseline and Week 12 Week 12 Physical Functioning (n=306,305,308,95)	51.9 score on a scale Standard Error 0.5	53.1 score on a scale Standard Error 0.4	52.2 score on a scale Standard Error 0.4	48.1 score on a scale Standard Error 1.1
Mean SF-36 Domain Scores at Baseline and Week 12 Baseline Role Physical (n=328,328,330,106)	45.4 score on a scale Standard Error 0.6	45.9 score on a scale Standard Error 0.6	45.5 score on a scale Standard Error 0.6	44.4 score on a scale Standard Error 1.1
Mean SF-36 Domain Scores at Baseline and Week 12 Week 12 Role Physical (n=307,305,308,95)	50.5 score on a scale Standard Error 0.5	52.5 score on a scale Standard Error 0.4	51.2 score on a scale Standard Error 0.5	46.1 score on a scale Standard Error 1.1
Mean SF-36 Domain Scores at Baseline and Week 12 Baseline Bodily Pain (n=328,329,331,107)	44.5 score on a scale Standard Error 0.7	45.6 score on a scale Standard Error 0.7	44.0 score on a scale Standard Error 0.7	43.6 score on a scale Standard Error 1.2
Mean SF-36 Domain Scores at Baseline and Week 12 Week 12 Bodily Pain (n=306,305,307,95)	51.7 score on a scale Standard Error 0.6	54.6 score on a scale Standard Error 0.5	52.4 score on a scale Standard Error 0.6	45.7 score on a scale Standard Error 1.3
Mean SF-36 Domain Scores at Baseline and Week 12 Baseline General Health (n=328,328,330,106)	43.4 score on a scale Standard Error 0.5	42.8 score on a scale Standard Error 0.5	43.5 score on a scale Standard Error 0.6	42.4 score on a scale Standard Error 1.0
Mean SF-36 Domain Scores at Baseline and Week 12 Week 12 General Health (n=305,304,308,95)	46.2 score on a scale Standard Error 0.5	48.5 score on a scale Standard Error 0.5	47.9 score on a scale Standard Error 0.5	42.6 score on a scale Standard Error 1.0
Mean SF-36 Domain Scores at Baseline and Week 12 Baseline Vitality (n=328,329,331,107)	47.9 score on a scale Standard Error 0.5	48.5 score on a scale Standard Error 0.6	48.3 score on a scale Standard Error 0.5	46.5 score on a scale Standard Error 1.0
Mean SF-36 Domain Scores at Baseline and Week 12 Week 12 Vitality (n=306,305,307,95)	52.4 score on a scale Standard Error 0.5	54.4 score on a scale Standard Error 0.5	52.9 score on a scale Standard Error 0.5	47.9 score on a scale Standard Error 1.1
Mean SF-36 Domain Scores at Baseline and Week 12 Baseline Social Functioning (n=328,329,331,107)	41.6 score on a scale Standard Error 0.6	41.1 score on a scale Standard Error 0.6	42.3 score on a scale Standard Error 0.7	40.7 score on a scale Standard Error 1.2
Mean SF-36 Domain Scores at Baseline and Week 12 Week 12 Social Functioning (n=306,305,307,95)	47.8 score on a scale Standard Error 0.6	50.6 score on a scale Standard Error 0.5	49.3 score on a scale Standard Error 0.5	42.0 score on a scale Standard Error 1.2
Mean SF-36 Domain Scores at Baseline and Week 12 Baseline Role-Emotional (n=328,329,331,107)	43.2 score on a scale Standard Error 0.7	42.4 score on a scale Standard Error 0.7	43.1 score on a scale Standard Error 0.7	40.4 score on a scale Standard Error 1.3
Mean SF-36 Domain Scores at Baseline and Week 12 Baseline Mental Health (n=328,329,331,107)	42.0 score on a scale Standard Error 0.6	41.5 score on a scale Standard Error 0.6	41.7 score on a scale Standard Error 0.7	39.5 score on a scale Standard Error 1.2
Mean SF-36 Domain Scores at Baseline and Week 12 Week 12 Mental Health (n=306,305,307,95)	46.6 score on a scale Standard Error 0.6	48.9 score on a scale Standard Error 0.5	47.5 score on a scale Standard Error 0.6	41.4 score on a scale Standard Error 1.2
Mean SF-36 Domain Scores at Baseline and Week 12 Baseline Health Transition (n=328,329,331,107)	3.2 score on a scale Standard Error 0.0	3.2 score on a scale Standard Error 0.0	3.1 score on a scale Standard Error 0.0	3.2 score on a scale Standard Error 0.1
Mean SF-36 Domain Scores at Baseline and Week 12 Week 12 Health Transition (n=306,305,307,95)	2.6 score on a scale Standard Error 0.0	2.6 score on a scale Standard Error 0.0	2.5 score on a scale Standard Error 0.0	3.0 score on a scale Standard Error 0.1

SECONDARY outcome

Timeframe: Week 12

Population: FAS; OC

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) n=301 Participants Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.	CP-690,550 10 mg BID + Placebo BIW n=302 Participants Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.	Placebo BID + Etanercept 50 mg BIW n=301 Participants Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.	Placebo BID + Placebo BIW n=93 Participants Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
Mean Change From Baseline in SF-36 MCS and PCS Scores Mental Health Score	5.0 score on a scale Standard Error 0.6	7.6 score on a scale Standard Error 0.6	5.8 score on a scale Standard Error 0.6	1.5 score on a scale Standard Error 1.1
Mean Change From Baseline in SF-36 MCS and PCS Scores Physical Health Score	4.1 score on a scale Standard Error 0.4	5.0 score on a scale Standard Error 0.5	5.2 score on a scale Standard Error 0.5	0.8 score on a scale Standard Error 0.7

SECONDARY outcome

Timeframe: Week 12

Population: FAS; OC

The SF-36 is a general health status questionnaire that assesses 8 domains of functional health and well being: Physical Functioning, Role Limitations due to Physical Health Problems, Bodily Pain, Social Functioning, Mental Health, Role Limitations due to Emotional Problems, Vitality, and General Health Perceptions. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Higher scores indicate a better health related quality of life.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) n=305 Participants Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.	CP-690,550 10 mg BID + Placebo BIW n=304 Participants Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.	Placebo BID + Etanercept 50 mg BIW n=304 Participants Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.	Placebo BID + Placebo BIW n=94 Participants Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
Mean Change From Baseline in SF-36 Domain Scores Physical Functioning	3.5 score on a scale Standard Error 0.4	3.7 score on a scale Standard Error 0.4	3.7 score on a scale Standard Error 0.5	1.1 score on a scale Standard Error 0.8
Mean Change From Baseline in SF-36 Domain Scores Role Physical	5.1 score on a scale Standard Error 0.5	6.3 score on a scale Standard Error 0.6	6.1 score on a scale Standard Error 0.5	1.3 score on a scale Standard Error 0.9
Mean Change From Baseline in SF-36 Domain Scores Bodily Pain	7.0 score on a scale Standard Error 0.7	8.5 score on a scale Standard Error 0.6	8.6 score on a scale Standard Error 0.7	1.6 score on a scale Standard Error 1.0
Mean Change From Baseline in SF-36 Domain Scores General Health	2.5 score on a scale Standard Error 0.5	5.5 score on a scale Standard Error 0.5	4.4 score on a scale Standard Error 0.5	0.2 score on a scale Standard Error 0.8
Mean Change From Baseline in SF-36 Domain Scores Vitality	4.2 score on a scale Standard Error 0.5	5.4 score on a scale Standard Error 0.5	4.6 score on a scale Standard Error 0.5	1.3 score on a scale Standard Error 0.9
Mean Change From Baseline in SF-36 Domain Scores Social Functioning	6.0 score on a scale Standard Error 0.7	9.2 score on a scale Standard Error 0.6	7.3 score on a scale Standard Error 0.6	0.7 score on a scale Standard Error 1.1
Mean Change From Baseline in SF-36 Domain Scores Role - Emotional	5.4 score on a scale Standard Error 0.6	7.2 score on a scale Standard Error 0.6	5.8 score on a scale Standard Error 0.7	2.3 score on a scale Standard Error 1.2
Mean Change From Baseline in SF-36 Domain Scores Mental Health	4.5 score on a scale Standard Error 0.6	7.0 score on a scale Standard Error 0.6	5.9 score on a scale Standard Error 0.6	1.4 score on a scale Standard Error 1.1
Mean Change From Baseline in SF-36 Domain Scores Health Transition	-0.5 score on a scale Standard Error 0.1	-0.6 score on a scale Standard Error 0.1	-0.6 score on a scale Standard Error 0.1	-0.2 score on a scale Standard Error 0.1

SECONDARY outcome

Timeframe: Baseline and Weeks 2, 4, and 8

Population: FAS; OC

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; 1=almost clear; 2=mild; 3=moderate; 4=severe).

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) n=328 Participants Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.	CP-690,550 10 mg BID + Placebo BIW n=328 Participants Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.	Placebo BID + Etanercept 50 mg BIW n=330 Participants Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.	Placebo BID + Placebo BIW n=107 Participants Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
Percentage of Participants in Each Patient Global Assessment of Psoriasis (PtGA) Category During the 12-Week Double-Blind Treatment Almost Clear, Week 8 (n=313,317,315,97)	16.9 percentage of participants	38.2 percentage of participants	29.8 percentage of participants	4.1 percentage of participants
Percentage of Participants in Each Patient Global Assessment of Psoriasis (PtGA) Category During the 12-Week Double-Blind Treatment Clear, Baseline (n=328,328,330,107)	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants
Percentage of Participants in Each Patient Global Assessment of Psoriasis (PtGA) Category During the 12-Week Double-Blind Treatment Almost Clear, Baseline (n=328,328,330,107)	0.0 percentage of participants	0.3 percentage of participants	0.3 percentage of participants	0.0 percentage of participants
Percentage of Participants in Each Patient Global Assessment of Psoriasis (PtGA) Category During the 12-Week Double-Blind Treatment Mild, Baseline (n=328,328,330,107)	3.4 percentage of participants	1.5 percentage of participants	4.2 percentage of participants	3.7 percentage of participants
Percentage of Participants in Each Patient Global Assessment of Psoriasis (PtGA) Category During the 12-Week Double-Blind Treatment Moderate, Baseline (n=328,328,330,107)	32.3 percentage of participants	30.2 percentage of participants	28.5 percentage of participants	23.4 percentage of participants
Percentage of Participants in Each Patient Global Assessment of Psoriasis (PtGA) Category During the 12-Week Double-Blind Treatment Severe, Baseline (n=328,328,330,107)	64.3 percentage of participants	68.0 percentage of participants	67.0 percentage of participants	72.9 percentage of participants
Percentage of Participants in Each Patient Global Assessment of Psoriasis (PtGA) Category During the 12-Week Double-Blind Treatment Clear, Week 2 (n=324,322,331,106)	0.3 percentage of participants	0.0 percentage of participants	0.3 percentage of participants	0.0 percentage of participants
Percentage of Participants in Each Patient Global Assessment of Psoriasis (PtGA) Category During the 12-Week Double-Blind Treatment Almost Clear, Week 2 (n=324,322,331,106)	1.2 percentage of participants	4.3 percentage of participants	1.2 percentage of participants	0.9 percentage of participants
Percentage of Participants in Each Patient Global Assessment of Psoriasis (PtGA) Category During the 12-Week Double-Blind Treatment Mild, Week 2 (n=324,322,331,106)	13.3 percentage of participants	14.9 percentage of participants	11.8 percentage of participants	2.8 percentage of participants
Percentage of Participants in Each Patient Global Assessment of Psoriasis (PtGA) Category During the 12-Week Double-Blind Treatment Moderate, Week 2 (n=324,322,331,106)	49.4 percentage of participants	54.3 percentage of participants	52.0 percentage of participants	38.7 percentage of participants
Percentage of Participants in Each Patient Global Assessment of Psoriasis (PtGA) Category During the 12-Week Double-Blind Treatment Severe, Week 2 (n=324,322,331,106)	35.8 percentage of participants	26.4 percentage of participants	34.7 percentage of participants	57.5 percentage of participants
Percentage of Participants in Each Patient Global Assessment of Psoriasis (PtGA) Category During the 12-Week Double-Blind Treatment Clear, Week 4 (n=319,323,324,100)	0.3 percentage of participants	0.6 percentage of participants	0.3 percentage of participants	0.0 percentage of participants
Percentage of Participants in Each Patient Global Assessment of Psoriasis (PtGA) Category During the 12-Week Double-Blind Treatment Almost Clear, Week 4 (n=319,323,324,100)	6.9 percentage of participants	17.0 percentage of participants	9.3 percentage of participants	0.0 percentage of participants
Percentage of Participants in Each Patient Global Assessment of Psoriasis (PtGA) Category During the 12-Week Double-Blind Treatment Mild, Week 4 (n=319,323,324,100)	21.6 percentage of participants	30.7 percentage of participants	26.5 percentage of participants	5.0 percentage of participants
Percentage of Participants in Each Patient Global Assessment of Psoriasis (PtGA) Category During the 12-Week Double-Blind Treatment Moderate, Week 4 (n=319,323,324,100)	46.7 percentage of participants	36.8 percentage of participants	43.5 percentage of participants	35.0 percentage of participants
Percentage of Participants in Each Patient Global Assessment of Psoriasis (PtGA) Category During the 12-Week Double-Blind Treatment Severe, Week 4 (n=319,323,324,100)	24.5 percentage of participants	14.9 percentage of participants	20.4 percentage of participants	60.0 percentage of participants
Percentage of Participants in Each Patient Global Assessment of Psoriasis (PtGA) Category During the 12-Week Double-Blind Treatment Clear, Week 8 (n=313,317,315,97)	2.9 percentage of participants	4.7 percentage of participants	3.5 percentage of participants	0.0 percentage of participants
Percentage of Participants in Each Patient Global Assessment of Psoriasis (PtGA) Category During the 12-Week Double-Blind Treatment Mild, Week 8 (n=313,317,315,97)	33.5 percentage of participants	27.1 percentage of participants	33.0 percentage of participants	7.2 percentage of participants
Percentage of Participants in Each Patient Global Assessment of Psoriasis (PtGA) Category During the 12-Week Double-Blind Treatment Moderate, Week 8 (n=313,317,315,97)	31.3 percentage of participants	22.1 percentage of participants	24.8 percentage of participants	38.1 percentage of participants
Percentage of Participants in Each Patient Global Assessment of Psoriasis (PtGA) Category During the 12-Week Double-Blind Treatment Severe, Week 8 (n=313,317,315,97)	15.3 percentage of participants	7.9 percentage of participants	8.9 percentage of participants	50.5 percentage of participants

SECONDARY outcome

Timeframe: Weeks 2, 4, 8, and 12

Population: FAS; OC

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; 1=almost clear; 2=mild; 3=moderate; 4=severe). Response defined as score of 0 or 1.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) n=324 Participants Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.	CP-690,550 10 mg BID + Placebo BIW n=322 Participants Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.	Placebo BID + Etanercept 50 mg BIW n=331 Participants Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.	Placebo BID + Placebo BIW n=106 Participants Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
Percentage of Participants With a PtGA Response During the 12-Week Double-Blind Treatment Week 2 (n=324,322,331,106)	1.54 percentage of participants	4.35 percentage of participants	1.51 percentage of participants	0.94 percentage of participants
Percentage of Participants With a PtGA Response During the 12-Week Double-Blind Treatment Week 4 (n=319,323,324,100)	7.21 percentage of participants	17.65 percentage of participants	9.57 percentage of participants	0.00 percentage of participants
Percentage of Participants With a PtGA Response During the 12-Week Double-Blind Treatment Week 8 (n=313,317,315,97)	19.81 percentage of participants	42.90 percentage of participants	33.33 percentage of participants	4.12 percentage of participants
Percentage of Participants With a PtGA Response During the 12-Week Double-Blind Treatment Week 12 (n=306,304,309,95)	32.68 percentage of participants	56.25 percentage of participants	53.07 percentage of participants	1.05 percentage of participants

SECONDARY outcome

Timeframe: Week 12

Population: FAS; OC

The PSSM is a single, 7 point item that evaluates overall participant satisfaction with the study treatment. Response options range from "very dissatisfied" to "very satisfied" with the study medication.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) n=307 Participants Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.	CP-690,550 10 mg BID + Placebo BIW n=305 Participants Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.	Placebo BID + Etanercept 50 mg BIW n=306 Participants Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.	Placebo BID + Placebo BIW n=95 Participants Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
Percentage of Participants in Each Patient Satisfaction With Study Medication (PSSM) Category During the 12-Week Double-Blind Treatment Very satisfied	44.0 percentage of participants	68.5 percentage of participants	62.4 percentage of participants	15.8 percentage of participants
Percentage of Participants in Each Patient Satisfaction With Study Medication (PSSM) Category During the 12-Week Double-Blind Treatment Somewhat satisfied	27.0 percentage of participants	17.4 percentage of participants	23.5 percentage of participants	15.8 percentage of participants
Percentage of Participants in Each Patient Satisfaction With Study Medication (PSSM) Category During the 12-Week Double-Blind Treatment Slightly satisfied	11.7 percentage of participants	5.2 percentage of participants	7.2 percentage of participants	11.6 percentage of participants
Percentage of Participants in Each Patient Satisfaction With Study Medication (PSSM) Category During the 12-Week Double-Blind Treatment Neither satisfied nor dissatisfied	4.6 percentage of participants	2.3 percentage of participants	2.0 percentage of participants	11.6 percentage of participants
Percentage of Participants in Each Patient Satisfaction With Study Medication (PSSM) Category During the 12-Week Double-Blind Treatment Slightly dissatisfied	2.6 percentage of participants	1.6 percentage of participants	2.0 percentage of participants	4.2 percentage of participants
Percentage of Participants in Each Patient Satisfaction With Study Medication (PSSM) Category During the 12-Week Double-Blind Treatment Somewhat dissatisfied	4.6 percentage of participants	3.0 percentage of participants	2.0 percentage of participants	12.6 percentage of participants
Percentage of Participants in Each Patient Satisfaction With Study Medication (PSSM) Category During the 12-Week Double-Blind Treatment Very dissatisfied	5.5 percentage of participants	2.0 percentage of participants	1.0 percentage of participants	28.4 percentage of participants

SECONDARY outcome

Timeframe: Week 12

Population: FAS; OC

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) n=307 Participants Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.	CP-690,550 10 mg BID + Placebo BIW n=305 Participants Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.	Placebo BID + Etanercept 50 mg BIW n=306 Participants Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.	Placebo BID + Placebo BIW n=95 Participants Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
Percentage of Participants Achieving PSSM Response of 'Very Satisfied' or 'Somewhat Satisfied' at Week 12	71.01 percentage of participants	85.90 percentage of participants	85.95 percentage of participants	31.58 percentage of participants

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: FAS; OC

EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) n=325 Participants Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.	CP-690,550 10 mg BID + Placebo BIW n=326 Participants Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.	Placebo BID + Etanercept 50 mg BIW n=330 Participants Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.	Placebo BID + Placebo BIW n=104 Participants Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
Mean European Quality of Life 5 Dimension (EQ-5D) Health State Utility Score During the 12-Week Double-Blind Treatment Baseline	0.7 score on a scale Standard Error 0.0	0.7 score on a scale Standard Error 0.0	0.7 score on a scale Standard Error 0.0	0.6 score on a scale Standard Error 0.0
Mean European Quality of Life 5 Dimension (EQ-5D) Health State Utility Score During the 12-Week Double-Blind Treatment Week 12	0.8 score on a scale Standard Error 0.0	0.9 score on a scale Standard Error 0.0	0.9 score on a scale Standard Error 0.0	0.7 score on a scale Standard Error 0.0

SECONDARY outcome

Timeframe: Week 12

Population: FAS; OC

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) n=301 Participants Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.	CP-690,550 10 mg BID + Placebo BIW n=300 Participants Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.	Placebo BID + Etanercept 50 mg BIW n=303 Participants Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.	Placebo BID + Placebo BIW n=92 Participants Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
Least Squares (LS) Mean Change From Baseline in EQ-5D Health State Utility Score During the 12-Week Double-Blind Treatment	0.14 scores on a scale Standard Error 0.011	0.21 scores on a scale Standard Error 0.011	0.19 scores on a scale Standard Error 0.011	0.03 scores on a scale Standard Error 0.021

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: FAS; OC

EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) n=315 Participants Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.	CP-690,550 10 mg BID + Placebo BIW n=318 Participants Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.	Placebo BID + Etanercept 50 mg BIW n=312 Participants Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.	Placebo BID + Placebo BIW n=100 Participants Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
Mean EQ-5D Visual Analog Score (VAS) During the 12-Week Double-Blind Treatment Baseline (n=315,318,312,100)	63.3 mm Standard Error 1.3	63.3 mm Standard Error 1.3	64.2 mm Standard Error 1.3	60.5 mm Standard Error 2.7
Mean EQ-5D Visual Analog Score (VAS) During the 12-Week Double-Blind Treatment Week 12 (n=298,294,297,91)	75.3 mm Standard Error 1.1	81.1 mm Standard Error 1.0	80.0 mm Standard Error 1.0	65.1 mm Standard Error 2.6

SECONDARY outcome

Timeframe: Week 12

Population: FAS; OC

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) n=289 Participants Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.	CP-690,550 10 mg BID + Placebo BIW n=288 Participants Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.	Placebo BID + Etanercept 50 mg BIW n=285 Participants Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.	Placebo BID + Placebo BIW n=88 Participants Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
Mean Change From Baseline in EQ-5D VAS at Week 12	11.6 mm Standard Error 1.4	16.6 mm Standard Error 1.5	15.7 mm Standard Error 1.4	3.0 mm Standard Error 2.4

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: FAS; OC

EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. The score for each of the 5 dimensions can range from 1 to 3; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed").

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) n=326 Participants Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.	CP-690,550 10 mg BID + Placebo BIW n=327 Participants Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.	Placebo BID + Etanercept 50 mg BIW n=330 Participants Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.	Placebo BID + Placebo BIW n=104 Participants Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
Dimension Health State EQ-5D Score During the 12-Week Double-Blind Treatment Mobility, Baseline (n=326,327,330,104)	1.3 Units on a scale Standard Error 0.0	1.3 Units on a scale Standard Error 0.0	1.3 Units on a scale Standard Error 0.0	1.3 Units on a scale Standard Error 0.0
Dimension Health State EQ-5D Score During the 12-Week Double-Blind Treatment Mobility, Week 12 (n=306,304,307,95)	1.2 Units on a scale Standard Error 0.0	1.1 Units on a scale Standard Error 0.0	1.2 Units on a scale Standard Error 0.0	1.3 Units on a scale Standard Error 0.1
Dimension Health State EQ-5D Score During the 12-Week Double-Blind Treatment Self Care, Baseline (n=327,327,330,104)	1.2 Units on a scale Standard Error 0.0	1.1 Units on a scale Standard Error 0.0	1.1 Units on a scale Standard Error 0.0	1.2 Units on a scale Standard Error 0.0
Dimension Health State EQ-5D Score During the 12-Week Double-Blind Treatment Self Care, Week 12 (n=306,304,307,95)	1.1 Units on a scale Standard Error 0.0	1.0 Units on a scale Standard Error 0.0	1.1 Units on a scale Standard Error 0.0	1.2 Units on a scale Standard Error 0.0
Dimension Health State EQ-5D Score During the 12-Week Double-Blind Treatment Usual Activities, Baseline (n=327,327,330,104)	1.4 Units on a scale Standard Error 0.0	1.4 Units on a scale Standard Error 0.0	1.4 Units on a scale Standard Error 0.0	1.5 Units on a scale Standard Error 0.1
Dimension Health State EQ-5D Score During the 12-Week Double-Blind Treatment Usual Activities, Week 12 (n=307,304,307,95)	1.2 Units on a scale Standard Error 0.0	1.1 Units on a scale Standard Error 0.0	1.2 Units on a scale Standard Error 0.0	1.3 Units on a scale Standard Error 0.1
Dimension Health State EQ-5D Score During the 12-Week Double-Blind Treatment Pain/Discomfort, Baseline (n=327,328,330,104)	1.8 Units on a scale Standard Error 0.0	1.8 Units on a scale Standard Error 0.0	1.9 Units on a scale Standard Error 0.0	1.8 Units on a scale Standard Error 0.1
Dimension Health State EQ-5D Score During the 12-Week Double-Blind Treatment Pain/Discomfort, Week 12 (n=307,304,307,95)	1.5 Units on a scale Standard Error 0.0	1.3 Units on a scale Standard Error 0.0	1.4 Units on a scale Standard Error 0.0	1.7 Units on a scale Standard Error 0.1
Dimension Health State EQ-5D Score During the 12-Week Double-Blind Treatment Anxiety/Depression, Baseline (n=326,327,330,104)	1.6 Units on a scale Standard Error 0.0	1.7 Units on a scale Standard Error 0.0	1.6 Units on a scale Standard Error 0.0	1.7 Units on a scale Standard Error 0.1
Dimension Health State EQ-5D Score During the 12-Week Double-Blind Treatment Anxiety/Depression, Week 12 (n=305,304,307,95)	1.4 Units on a scale Standard Error 0.0	1.3 Units on a scale Standard Error 0.0	1.3 Units on a scale Standard Error 0.0	1.5 Units on a scale Standard Error 0.1

SECONDARY outcome

Timeframe: Week 12

Population: FAS; OC

EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. The score for each of the 5 dimensions can range from 1 to 3; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed").

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) n=305 Participants Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.	CP-690,550 10 mg BID + Placebo BIW n=302 Participants Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.	Placebo BID + Etanercept 50 mg BIW n=303 Participants Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.	Placebo BID + Placebo BIW n=92 Participants Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
Mean Change From Baseline in EQ-5D Dimension Health State Score at Week 12 Mobility	-0.1 scores on a scale Standard Error 0.0	-0.1 scores on a scale Standard Error 0.0	-0.1 scores on a scale Standard Error 0.0	-0.0 scores on a scale Standard Error 0.0
Mean Change From Baseline in EQ-5D Dimension Health State Score at Week 12 Self-Care	-0.1 scores on a scale Standard Error 0.0	-0.1 scores on a scale Standard Error 0.0	-0.1 scores on a scale Standard Error 0.0	-0.1 scores on a scale Standard Error 0.0
Mean Change From Baseline in EQ-5D Dimension Health State Score at Week 12 Usual Activities	-0.3 scores on a scale Standard Error 0.0	-0.3 scores on a scale Standard Error 0.0	-0.2 scores on a scale Standard Error 0.0	-0.1 scores on a scale Standard Error 0.1
Mean Change From Baseline in EQ-5D Dimension Health State Score at Week 12 Pain/Discomfort	-0.4 scores on a scale Standard Error 0.0	-0.5 scores on a scale Standard Error 0.0	-0.5 scores on a scale Standard Error 0.0	-0.1 scores on a scale Standard Error 0.1
Mean Change From Baseline in EQ-5D Dimension Health State Score at Week 12 Anxiety/Depression	-0.2 scores on a scale Standard Error 0.0	-0.4 scores on a scale Standard Error 0.0	-0.3 scores on a scale Standard Error 0.0	-0.1 scores on a scale Standard Error 0.1

SECONDARY outcome

Timeframe: Baseline (BL) and Week 12

Population: FAS; OC

The Psoriasis Health Care Resource Utilization (Ps-HCRU) questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work. The first section assesses direct costs associated with healthcare resource use (interactions with healthcare providers such as general practitioners \[GPs\], primary care physicians \[PCPs\], or family medicine physicians \[FMP\], emergency room visits, and hospitalizations), and the second section assesses indirect costs associated with absenteeism due to psoriasis and the impact of psoriasis on productivity at work.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) n=255 Participants Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.	CP-690,550 10 mg BID + Placebo BIW n=251 Participants Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.	Placebo BID + Etanercept 50 mg BIW n=261 Participants Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.	Placebo BID + Placebo BIW n=79 Participants Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
Percentage of Participants Interacting With Healthcare Professionals During the 12-Week Double-Blind Treatment Baseline, GP/PCP/FMP (n=230,220,224,77)	0.8 percentage of participants	0.9 percentage of participants	1.3 percentage of participants	2.5 percentage of participants
Percentage of Participants Interacting With Healthcare Professionals During the 12-Week Double-Blind Treatment Baseline, Dermatologist (n=230,220,224,77)	6.9 percentage of participants	4.5 percentage of participants	7.5 percentage of participants	10.3 percentage of participants
Percentage of Participants Interacting With Healthcare Professionals During the 12-Week Double-Blind Treatment Baseline, Rheumatologist (n=230,220,224,77)	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants
Percentage of Participants Interacting With Healthcare Professionals During the 12-Week Double-Blind Treatment Baseline, Cardiologist (n=230,220,224,77)	0.4 percentage of participants	0.4 percentage of participants	0.4 percentage of participants	2.5 percentage of participants
Percentage of Participants Interacting With Healthcare Professionals During the 12-Week Double-Blind Treatment Baseline, Gastroenterologist (n=230,220,224,77)	0.4 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants
Percentage of Participants Interacting With Healthcare Professionals During the 12-Week Double-Blind Treatment Baseline, Psychiatrist (n=230,220,224,77)	0.0 percentage of participants	0.4 percentage of participants	0.0 percentage of participants	1.2 percentage of participants
Percentage of Participants Interacting With Healthcare Professionals During the 12-Week Double-Blind Treatment Baseline, Surgeon (n=230,220,224,77)	0.4 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants
Percentage of Participants Interacting With Healthcare Professionals During the 12-Week Double-Blind Treatment Baseline, Nurse (n=230,220,224,77)	1.3 percentage of participants	1.3 percentage of participants	0.8 percentage of participants	2.5 percentage of participants
Percentage of Participants Interacting With Healthcare Professionals During the 12-Week Double-Blind Treatment Baseline, Other (n=230,220,224,77)	2.1 percentage of participants	0.9 percentage of participants	0.0 percentage of participants	1.2 percentage of participants
Percentage of Participants Interacting With Healthcare Professionals During the 12-Week Double-Blind Treatment Week 12, GP/PCP/FMP (n=255,251,261,79)	10.1 percentage of participants	6.7 percentage of participants	8.4 percentage of participants	8.8 percentage of participants
Percentage of Participants Interacting With Healthcare Professionals During the 12-Week Double-Blind Treatment Week 12, Dermatologist (n=255,251,261,79)	8.2 percentage of participants	4.3 percentage of participants	5.7 percentage of participants	7.5 percentage of participants
Percentage of Participants Interacting With Healthcare Professionals During the 12-Week Double-Blind Treatment Week 12, Rheumatologist (n=255,251,261,79)	0.7 percentage of participants	1.1 percentage of participants	0.7 percentage of participants	0.0 percentage of participants
Percentage of Participants Interacting With Healthcare Professionals During the 12-Week Double-Blind Treatment Week 12, Cardiologist (n=255,251,261,79)	1.5 percentage of participants	1.9 percentage of participants	2.6 percentage of participants	1.2 percentage of participants
Percentage of Participants Interacting With Healthcare Professionals During the 12-Week Double-Blind Treatment Week 12, Gastroenterologist (n=255,251,261,79)	1.1 percentage of participants	1.5 percentage of participants	1.5 percentage of participants	0.0 percentage of participants
Percentage of Participants Interacting With Healthcare Professionals During the 12-Week Double-Blind Treatment Week 12, Psychiatrist (n=255,251,261,79)	0.0 percentage of participants	0.7 percentage of participants	1.5 percentage of participants	0.0 percentage of participants
Percentage of Participants Interacting With Healthcare Professionals During the 12-Week Double-Blind Treatment Week 12, Surgeon (n=255,251,261,79)	0.3 percentage of participants	0.3 percentage of participants	0.0 percentage of participants	0.0 percentage of participants
Percentage of Participants Interacting With Healthcare Professionals During the 12-Week Double-Blind Treatment Week 12, Nurse (n=255,251,261,79)	1.1 percentage of participants	1.9 percentage of participants	2.6 percentage of participants	0.0 percentage of participants
Percentage of Participants Interacting With Healthcare Professionals During the 12-Week Double-Blind Treatment Week 12, Other (n=255,251,261,79)	8.6 percentage of participants	5.1 percentage of participants	6.8 percentage of participants	2.5 percentage of participants

SECONDARY outcome

Timeframe: Week 12

Population: FAS; OC

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) n=230 Participants Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.	CP-690,550 10 mg BID + Placebo BIW n=225 Participants Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.	Placebo BID + Etanercept 50 mg BIW n=238 Participants Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.	Placebo BID + Placebo BIW n=71 Participants Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
Percentage of Participants Reporting Healthcare Resource Use Events During the 12-Week Double-Blind Treatment	10.43 percentage of participants	9.78 percentage of participants	10.08 percentage of participants	8.45 percentage of participants

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: FAS; OC

Psoriasis Health Care Resource Utilization Questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work. The questionnaire assesses employment status of participant (employed: yes or no) and if currently employed it asks the participant if they were absent or on sick leave from work due to psoriasis; if unemployed it asks the participant if the unemployment is due to psoriasis.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) n=230 Participants Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.	CP-690,550 10 mg BID + Placebo BIW n=219 Participants Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.	Placebo BID + Etanercept 50 mg BIW n=224 Participants Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.	Placebo BID + Placebo BIW n=77 Participants Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
Percentage of Participants Employed or Not Employed and the Impact of Psoriasis on Work Baseline, unemployed due to psoriasis	9.6 percentage of participants	7.3 percentage of participants	6.3 percentage of participants	2.6 percentage of participants
Percentage of Participants Employed or Not Employed and the Impact of Psoriasis on Work Week 12, employed	69.2 percentage of participants	73.8 percentage of participants	69.1 percentage of participants	68.1 percentage of participants
Percentage of Participants Employed or Not Employed and the Impact of Psoriasis on Work Week 12, absent/sick leave due to psoriasis	13.2 percentage of participants	14.7 percentage of participants	15.7 percentage of participants	17.4 percentage of participants
Percentage of Participants Employed or Not Employed and the Impact of Psoriasis on Work Week 12, not employed	30.8 percentage of participants	26.2 percentage of participants	30.9 percentage of participants	31.9 percentage of participants
Percentage of Participants Employed or Not Employed and the Impact of Psoriasis on Work Week 12, unemployed due to psoriasis	4.0 percentage of participants	4.9 percentage of participants	4.7 percentage of participants	4.3 percentage of participants
Percentage of Participants Employed or Not Employed and the Impact of Psoriasis on Work Baseline, employed	67.8 percentage of participants	71.2 percentage of participants	72.3 percentage of participants	71.4 percentage of participants
Percentage of Participants Employed or Not Employed and the Impact of Psoriasis on Work Baseline, absent/sick leave due to psoriasis	18.3 percentage of participants	21.0 percentage of participants	22.3 percentage of participants	23.4 percentage of participants
Percentage of Participants Employed or Not Employed and the Impact of Psoriasis on Work Baseline, not employed	32.2 percentage of participants	28.8 percentage of participants	27.7 percentage of participants	28.6 percentage of participants

SECONDARY outcome

Timeframe: Week 12

Population: FAS; OC

Psoriasis Health Care Resource Utilization Questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) n=158 Participants Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.	CP-690,550 10 mg BID + Placebo BIW n=164 Participants Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.	Placebo BID + Etanercept 50 mg BIW n=164 Participants Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.	Placebo BID + Placebo BIW n=48 Participants Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
Percentage of Participants Reporting Work-Impacted Events During the 12-Week Double-Blind Treatment	37.97 percentage of participants	30.49 percentage of participants	34.15 percentage of participants	56.25 percentage of participants

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: FAS; OC

The PQOL-12 is a 12-item questionnaire; 8 of the items on the Koo-Menter Psoriasis Index 12-item Quality of Life Questionnaire (PQOL-12) focus on emotional issues associated with psoriasis (self conscious, helpless, embarrassed, ability to enjoy life). The last 4 items deal with physical symptoms (pain or soreness, itch, physical irritation) and choice of clothing. The recall period is over the past month. The questions are answered on a scale from 0 to 10 with 0 being best and 10 being worst. Scores from each question are summed to give a total score (range 0 -120); higher scores indicate greater impairment to quality of life.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) n=323 Participants Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.	CP-690,550 10 mg BID + Placebo BIW n=326 Participants Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.	Placebo BID + Etanercept 50 mg BIW n=331 Participants Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.	Placebo BID + Placebo BIW n=105 Participants Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
Mean Psoriasis Quality of Life 12 (PQOL-12) Score During the 12-Week Double-Blind Treatment Baseline (n=323,326,331,105)	75.4 score on a scale Standard Error 1.5	77.0 score on a scale Standard Error 1.5	75.7 score on a scale Standard Error 1.5	74.9 score on a scale Standard Error 2.9
Mean Psoriasis Quality of Life 12 (PQOL-12) Score During the 12-Week Double-Blind Treatment Week 12 (n=303,303,306,92)	40.0 score on a scale Standard Error 1.8	29.2 score on a scale Standard Error 1.6	31.0 score on a scale Standard Error 1.7	65.5 score on a scale Standard Error 3.5

SECONDARY outcome

Timeframe: Week 12

Population: FAS; OC

The PQOL-12 is a 12-item questionnaire; 8 of the items on the PQOL-12) focus on emotional issues associated with psoriasis (self conscious, helpless, embarrassed, ability to enjoy life). The last 4 items deal with physical symptoms (pain or soreness, itch, physical irritation) and choice of clothing. The recall period is over the past month. The questions are answered on a scale from 0 to 10 with 0 being best and 10 being worst. Scores from each question are summed to give a total score (range 0 -120); higher scores indicate greater impairment to quality of life.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW) n=299 Participants Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.	CP-690,550 10 mg BID + Placebo BIW n=299 Participants Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.	Placebo BID + Etanercept 50 mg BIW n=303 Participants Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.	Placebo BID + Placebo BIW n=90 Participants Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
Mean Change From Baseline in PQOL-12 Score During the 12-Week Double-Blind Treatment	-35.2 scores on a scale Standard Error 1.9	-47.9 scores on a scale Standard Error 1.8	-44.3 scores on a scale Standard Error 1.8	-9.6 scores on a scale Standard Error 2.6

Adverse Events

CP-690,550 5 mg BID

Serious events: 7 serious events

Other events: 103 other events

Deaths: 0 deaths

CP-690,550 10 mg BID

Serious events: 5 serious events

Other events: 121 other events

Deaths: 0 deaths

Etanercept 50 mg BIW

Serious events: 7 serious events

Other events: 109 other events

Deaths: 0 deaths

Placebo

Serious events: 2 serious events

Other events: 34 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER