Trial Outcomes & Findings for Study Evaluating Etanercept for the Treatment of Moderate to Severe Psoriasis (NCT NCT00663052)

Last Updated: 2012-04-23

Results Overview

PASI: Combined assessment of lesion severity and area affected into single score; range: 0(no disease) to 72(maximal disease). Body was divided into 4 sections (head, arms, trunk, legs); each area was scored by itself and scores were combined for final PASI. For each section percent area of skin involved was estimated: 0 (0%) to 6 (90 - 100%), and severity was estimated by clinical signs: erythema, induration, and desquamation; scale: 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each section \* area score \* weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

273 participants

Primary outcome timeframe

Week 24

Results posted on

2012-04-23

Participant Flow

Participant milestones

Participant milestones
Measure	ETN 50 mg BW/QW Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).	ETN 50 mg QW/QW ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
Overall Study STARTED	136	137
Overall Study COMPLETED	124	127
Overall Study NOT COMPLETED	12	10

Reasons for withdrawal

Reasons for withdrawal
Measure	ETN 50 mg BW/QW Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).	ETN 50 mg QW/QW ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
Overall Study Adverse Event	6	3
Overall Study Discontinuation of Study by Sponsor	2	0
Overall Study Protocol Violation	1	0
Overall Study Withdrawal by Subject	2	5
Overall Study Unsatisfactory Response - Efficacy	1	1
Overall Study Other	0	1

Baseline Characteristics

Study Evaluating Etanercept for the Treatment of Moderate to Severe Psoriasis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ETN 50 mg BW/QW n=136 Participants Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).	ETN 50 mg QW/QW n=137 Participants ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).	Total n=273 Participants Total of all reporting groups
Age Continuous	43.95 Years STANDARD_DEVIATION 12.68 • n=5 Participants	43.85 Years STANDARD_DEVIATION 12.69 • n=7 Participants	43.90 Years STANDARD_DEVIATION 12.66 • n=5 Participants
Sex: Female, Male Female	47 Participants n=5 Participants	36 Participants n=7 Participants	83 Participants n=5 Participants
Sex: Female, Male Male	89 Participants n=5 Participants	101 Participants n=7 Participants	190 Participants n=5 Participants
Mean Psoriasis Area and Severity Index (PASI) Score	21.4 Units on scale STANDARD_DEVIATION 9.4 • n=5 Participants	20.9 Units on scale STANDARD_DEVIATION 9.4 • n=7 Participants	21.2 Units on scale STANDARD_DEVIATION 9.4 • n=5 Participants
Number of Participants Achieving the Physician Global Assessment (PGA) of Psoriasis Reponses PGA Clear (0)	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Number of Participants Achieving the Physician Global Assessment (PGA) of Psoriasis Reponses PGA Clear/Almost Clear (0,1)	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Number of Participants Achieving the Physician Global Assessment (PGA) of Psoriasis Reponses PGA Clear/Almost Clear/Mild (0,1,2)	13 Participants n=5 Participants	17 Participants n=7 Participants	30 Participants n=5 Participants
Percent Body Surface Area (BSA) of Involvement	33.0 Percentage of BSA STANDARD_DEVIATION 19.4 • n=5 Participants	32.9 Percentage of BSA STANDARD_DEVIATION 21.0 • n=7 Participants	33.0 Percentage of BSA STANDARD_DEVIATION 20.2 • n=5 Participants
Number of Participants Not Using Topical Preparations	120 Participants n=5 Participants	124 Participants n=7 Participants	244 Participants n=5 Participants
Number of Participants Evaluated Using Psoriasis Physician Satisfaction Questionnaire (PPSQ) Consider patient's condition satisfactory	16 Participants n=5 Participants	16 Participants n=7 Participants	32 Participants n=5 Participants
Number of Participants Evaluated Using Psoriasis Physician Satisfaction Questionnaire (PPSQ) Consider primary psoriasis therapy satisfactory	15 Participants n=5 Participants	17 Participants n=7 Participants	32 Participants n=5 Participants
Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores Overall appearance of your skin	0.9 Units on scale STANDARD_DEVIATION 0.8 • n=5 Participants	0.9 Units on scale STANDARD_DEVIATION 0.9 • n=7 Participants	0.9 Units on scale STANDARD_DEVIATION 0.9 • n=5 Participants
Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores Flaking skin	1.0 Units on scale STANDARD_DEVIATION 0.9 • n=5 Participants	1.0 Units on scale STANDARD_DEVIATION 0.9 • n=7 Participants	1.0 Units on scale STANDARD_DEVIATION 0.9 • n=5 Participants
Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores Skin redness	1.1 Units on scale STANDARD_DEVIATION 0.9 • n=5 Participants	1.0 Units on scale STANDARD_DEVIATION 0.9 • n=7 Participants	1.0 Units on scale STANDARD_DEVIATION 0.9 • n=5 Participants
Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores Skin tightness	1.2 Units on scale STANDARD_DEVIATION 0.9 • n=5 Participants	1.2 Units on scale STANDARD_DEVIATION 1.0 • n=7 Participants	1.2 Units on scale STANDARD_DEVIATION 1.0 • n=5 Participants
Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores Skin bleeding	1.7 Units on scale STANDARD_DEVIATION 1.0 • n=5 Participants	1.8 Units on scale STANDARD_DEVIATION 1.2 • n=7 Participants	1.7 Units on scale STANDARD_DEVIATION 1.1 • n=5 Participants
Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores Burning sensation in the skin	1.5 Units on scale STANDARD_DEVIATION 1.1 • n=5 Participants	1.5 Units on scale STANDARD_DEVIATION 1.1 • n=7 Participants	1.5 Units on scale STANDARD_DEVIATION 1.1 • n=5 Participants
Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores Skin pain	1.5 Units on scale STANDARD_DEVIATION 1.2 • n=5 Participants	1.5 Units on scale STANDARD_DEVIATION 1.1 • n=7 Participants	1.5 Units on scale STANDARD_DEVIATION 1.1 • n=5 Participants
Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores Joint pain	1.8 Units on scale STANDARD_DEVIATION 1.3 • n=5 Participants	1.8 Units on scale STANDARD_DEVIATION 1.4 • n=7 Participants	1.8 Units on scale STANDARD_DEVIATION 1.3 • n=5 Participants
Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores Comfort level with your appearance	1.3 Units on scale STANDARD_DEVIATION 1.1 • n=5 Participants	1.2 Units on scale STANDARD_DEVIATION 1.0 • n=7 Participants	1.3 Units on scale STANDARD_DEVIATION 1.0 • n=5 Participants
Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores Anxiety	1.8 Units on scale STANDARD_DEVIATION 1.1 • n=5 Participants	1.7 Units on scale STANDARD_DEVIATION 1.1 • n=7 Participants	1.7 Units on scale STANDARD_DEVIATION 1.1 • n=5 Participants
Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores Depression	2.0 Units on scale STANDARD_DEVIATION 1.1 • n=5 Participants	1.9 Units on scale STANDARD_DEVIATION 1.1 • n=7 Participants	1.9 Units on scale STANDARD_DEVIATION 1.1 • n=5 Participants
Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores Fatigue	2.0 Units on scale STANDARD_DEVIATION 1.0 • n=5 Participants	1.8 Units on scale STANDARD_DEVIATION 1.0 • n=7 Participants	1.9 Units on scale STANDARD_DEVIATION 1.0 • n=5 Participants
Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores How others respond to your appearance	1.6 Units on scale STANDARD_DEVIATION 1.0 • n=5 Participants	1.8 Units on scale STANDARD_DEVIATION 1.0 • n=7 Participants	1.7 Units on scale STANDARD_DEVIATION 1.0 • n=5 Participants
Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores How your skin affects social, leisure activities	1.5 Units on scale STANDARD_DEVIATION 1.2 • n=5 Participants	1.3 Units on scale STANDARD_DEVIATION 1.0 • n=7 Participants	1.4 Units on scale STANDARD_DEVIATION 1.1 • n=5 Participants
Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores Satisfaction with psoriasis treatment in general	1.4 Units on scale STANDARD_DEVIATION 1.2 • n=5 Participants	1.4 Units on scale STANDARD_DEVIATION 1.1 • n=7 Participants	1.4 Units on scale STANDARD_DEVIATION 1.1 • n=5 Participants
Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores Would like to continue with my current treatment	2.0 Units on scale STANDARD_DEVIATION 1.6 • n=5 Participants	2.2 Units on scale STANDARD_DEVIATION 1.6 • n=7 Participants	2.1 Units on scale STANDARD_DEVIATION 1.6 • n=5 Participants
Number of Participants Who were Considered Satisfied According to Psoriasis Subject Satisfaction Satisfaction with health state	25 Participants n=5 Participants	28 Participants n=7 Participants	53 Participants n=5 Participants
Number of Participants Who were Considered Satisfied According to Psoriasis Subject Satisfaction Satisfaction with primary psoriasis treatment	31 Participants n=5 Participants	28 Participants n=7 Participants	59 Participants n=5 Participants
Mean Dermatology Life Quality Index (DLQI) Total Score	14.1 Units on scale STANDARD_DEVIATION 7.3 • n=5 Participants	15.0 Units on scale STANDARD_DEVIATION 8.0 • n=7 Participants	14.6 Units on scale STANDARD_DEVIATION 7.7 • n=5 Participants
Mean Euro Quality of Life 5 Dimension (EQ-5D) Utility Index Scores	0.65 Units on scale STANDARD_DEVIATION 0.30 • n=5 Participants	0.66 Units on scale STANDARD_DEVIATION 0.31 • n=7 Participants	0.65 Units on scale STANDARD_DEVIATION 0.31 • n=5 Participants
Mean Hospital Anxiety and Depression Scale (HADS) Anxiety and Depression Scores HADS Anxiety Score	7.2 Units on scale STANDARD_DEVIATION 4.4 • n=5 Participants	6.9 Units on scale STANDARD_DEVIATION 4.1 • n=7 Participants	7.0 Units on scale STANDARD_DEVIATION 4.3 • n=5 Participants
Mean Hospital Anxiety and Depression Scale (HADS) Anxiety and Depression Scores HADS Depression Score	6.0 Units on scale STANDARD_DEVIATION 4.1 • n=5 Participants	6.5 Units on scale STANDARD_DEVIATION 4.1 • n=7 Participants	6.2 Units on scale STANDARD_DEVIATION 4.1 • n=5 Participants
Work Productivity and Activity Impairment: Psoriasis (WPAI:PSO) Percent Activity Impairment Due to Problem	39.77 Percentage of indicated parameter STANDARD_DEVIATION 28.96 • n=5 Participants	40.15 Percentage of indicated parameter STANDARD_DEVIATION 30.94 • n=7 Participants	39.96 Percentage of indicated parameter STANDARD_DEVIATION 29.93 • n=5 Participants
Work Productivity and Activity Impairment: Psoriasis (WPAI:PSO) Percent Impairment While Working Due to Problem	24.36 Percentage of indicated parameter STANDARD_DEVIATION 23.28 • n=5 Participants	26.09 Percentage of indicated parameter STANDARD_DEVIATION 27.08 • n=7 Participants	25.27 Percentage of indicated parameter STANDARD_DEVIATION 25.29 • n=5 Participants
Work Productivity and Activity Impairment: Psoriasis (WPAI:PSO) Percent Overall Work Impairment Due to Problem	25.45 Percentage of indicated parameter STANDARD_DEVIATION 23.53 • n=5 Participants	29.51 Percentage of indicated parameter STANDARD_DEVIATION 28.66 • n=7 Participants	27.54 Percentage of indicated parameter STANDARD_DEVIATION 26.30 • n=5 Participants
Work Productivity and Activity Impairment: Psoriasis (WPAI:PSO) Percent Work Time Missed	3.60 Percentage of indicated parameter STANDARD_DEVIATION 16.14 • n=5 Participants	7.19 Percentage of indicated parameter STANDARD_DEVIATION 18.92 • n=7 Participants	5.45 Percentage of indicated parameter STANDARD_DEVIATION 17.67 • n=5 Participants
Mean Medical Outcomes Study (MOS) Sleep Scale Scores Sleep Snoring	37.9 Units on scale STANDARD_DEVIATION 29.6 • n=5 Participants	45.7 Units on scale STANDARD_DEVIATION 31.0 • n=7 Participants	41.9 Units on scale STANDARD_DEVIATION 30.5 • n=5 Participants
Mean Medical Outcomes Study (MOS) Sleep Scale Scores Sleep Somnolence	29.9 Units on scale STANDARD_DEVIATION 19.9 • n=5 Participants	30.9 Units on scale STANDARD_DEVIATION 19.3 • n=7 Participants	30.4 Units on scale STANDARD_DEVIATION 19.5 • n=5 Participants
Mean Medical Outcomes Study (MOS) Sleep Scale Scores Sleep Short of Breath or Headache	13.2 Units on scale STANDARD_DEVIATION 20.4 • n=5 Participants	14.3 Units on scale STANDARD_DEVIATION 20.7 • n=7 Participants	13.8 Units on scale STANDARD_DEVIATION 20.5 • n=5 Participants
Mean Medical Outcomes Study (MOS) Sleep Scale Scores Sleep Adequacy	54.6 Units on scale STANDARD_DEVIATION 25.9 • n=5 Participants	54.0 Units on scale STANDARD_DEVIATION 27.3 • n=7 Participants	54.3 Units on scale STANDARD_DEVIATION 26.6 • n=5 Participants
Mean Medical Outcomes Study (MOS) Sleep Scale Scores Sleep Disturbance	35.0 Units on scale STANDARD_DEVIATION 23.6 • n=5 Participants	34.4 Units on scale STANDARD_DEVIATION 23.8 • n=7 Participants	34.7 Units on scale STANDARD_DEVIATION 23.6 • n=5 Participants
Mean Medical Outcomes Study (MOS) Sleep Scale Scores Sleep Quantity	6.9 Units on scale STANDARD_DEVIATION 1.4 • n=5 Participants	6.9 Units on scale STANDARD_DEVIATION 1.4 • n=7 Participants	6.9 Units on scale STANDARD_DEVIATION 1.4 • n=5 Participants
Mean Medical Outcomes Study (MOS) Sleep Scale Scores Sleep Problem Index I	32.5 Units on scale STANDARD_DEVIATION 18.7 • n=5 Participants	32.9 Units on scale STANDARD_DEVIATION 19.1 • n=7 Participants	32.7 Units on scale STANDARD_DEVIATION 18.9 • n=5 Participants
Mean Medical Outcomes Study (MOS) Sleep Scale Scores Sleep Problem Index II	33.9 Units on scale STANDARD_DEVIATION 18.2 • n=5 Participants	34.2 Units on scale STANDARD_DEVIATION 19.6 • n=7 Participants	34.0 Units on scale STANDARD_DEVIATION 18.9 • n=5 Participants
Mean Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Questionnaire Total Scores	37.9 Units on scale STANDARD_DEVIATION 10.0 • n=5 Participants	36.7 Units on scale STANDARD_DEVIATION 10.8 • n=7 Participants	37.3 Units on scale STANDARD_DEVIATION 10.4 • n=5 Participants
Number of Participants With Emergency Room Visits	6 Participants n=5 Participants	8 Participants n=7 Participants	14 Participants n=5 Participants
Mean Number of Emergency Room Days	7.8 Days STANDARD_DEVIATION 5.64 • n=5 Participants	9.4 Days STANDARD_DEVIATION 7.31 • n=7 Participants	8.7 Days STANDARD_DEVIATION 6.45 • n=5 Participants
Number of Participants With Doctor Visits	58 Participants n=5 Participants	61 Participants n=7 Participants	119 Participants n=5 Participants
Mean Number of Doctor Visits	2.9 Visits STANDARD_DEVIATION 3.36 • n=5 Participants	3.0 Visits STANDARD_DEVIATION 3.68 • n=7 Participants	3.0 Visits STANDARD_DEVIATION 3.51 • n=5 Participants

PRIMARY outcome

Timeframe: Week 24

Population: Modified intent-to-treat (mITT) population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the last observation carried forward (LOCF) method of imputation was used.

Outcome measures

Outcome measures
Measure	ETN 50 mg BW/QW n=133 Participants Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).	ETN 50 mg QW/QW n=137 Participants ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
Percentage of Participants Achieving a 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 24	78.2 Percentage of participants	59.9 Percentage of participants

SECONDARY outcome

Timeframe: Baseline to Week 24

Population: mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.

Outcome measures

Outcome measures
Measure	ETN 50 mg BW/QW n=133 Participants Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).	ETN 50 mg QW/QW n=137 Participants ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
Percentage of Participants Achieving a 50% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 Week 20	93.2 Percentage of participants	82.5 Percentage of participants
Percentage of Participants Achieving a 50% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 Week 2	9.0 Percentage of participants	5.9 Percentage of participants
Percentage of Participants Achieving a 50% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 Week 8	71.4 Percentage of participants	51.8 Percentage of participants
Percentage of Participants Achieving a 50% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 Week 16	92.5 Percentage of participants	78.1 Percentage of participants
Percentage of Participants Achieving a 50% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 Week 24	92.5 Percentage of participants	81.0 Percentage of participants
Percentage of Participants Achieving a 50% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 Week 4	38.3 Percentage of participants	20.4 Percentage of participants
Percentage of Participants Achieving a 50% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 Week 12	88.0 Percentage of participants	67.9 Percentage of participants

SECONDARY outcome

Timeframe: Baseline to Week 24

Outcome measures

Outcome measures
Measure	ETN 50 mg BW/QW n=133 Participants Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).	ETN 50 mg QW/QW n=137 Participants ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
Percentage of Participants Achieving a 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 Week 2	1.5 Percentage of participants	0.0 Percentage of participants
Percentage of Participants Achieving a 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 Week 4	6.0 Percentage of participants	4.4 Percentage of participants
Percentage of Participants Achieving a 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 Week 8	35.3 Percentage of participants	21.9 Percentage of participants
Percentage of Participants Achieving a 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 Week 12	62.4 Percentage of participants	37.2 Percentage of participants
Percentage of Participants Achieving a 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 Week 16	72.9 Percentage of participants	51.1 Percentage of participants
Percentage of Participants Achieving a 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 Week 20	78.2 Percentage of participants	58.4 Percentage of participants
Percentage of Participants Achieving a 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 Week 24	78.2 Percentage of participants	59.9 Percentage of participants

SECONDARY outcome

Timeframe: Baseline to week 24

Outcome measures

Outcome measures
Measure	ETN 50 mg BW/QW n=133 Participants Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).	ETN 50 mg QW/QW n=137 Participants ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
Percentage of Participants Achieving a 90% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 Week 2	0.0 Percentage of participants	0.0 Percentage of participants
Percentage of Participants Achieving a 90% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 Week 4	0.8 Percentage of participants	0.7 Percentage of participants
Percentage of Participants Achieving a 90% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 Week 8	9.8 Percentage of participants	5.8 Percentage of participants
Percentage of Participants Achieving a 90% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 Week 12	29.3 Percentage of participants	10.9 Percentage of participants
Percentage of Participants Achieving a 90% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 Week 16	42.9 Percentage of participants	25.5 Percentage of participants
Percentage of Participants Achieving a 90% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 Week 20	45.1 Percentage of participants	29.2 Percentage of participants
Percentage of Participants Achieving a 90% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 Week 24	49.6 Percentage of participants	32.8 Percentage of participants

SECONDARY outcome

Timeframe: Baseline to Week 24

Outcome measures

Outcome measures
Measure	ETN 50 mg BW/QW n=133 Participants Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).	ETN 50 mg QW/QW n=137 Participants ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
Percentage of Participants Achieving a 100% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 Week 4	0.0 Percentage of participants Interval 0.0 to 2.7	0.7 Percentage of participants Interval 0.0 to 4.0
Percentage of Participants Achieving a 100% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 Week 2	0.0 Percentage of participants Interval 0.0 to 2.7	0.0 Percentage of participants Interval 0.0 to 2.7
Percentage of Participants Achieving a 100% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 Week 8	0.0 Percentage of participants Interval 0.0 to 2.7	1.5 Percentage of participants Interval 0.2 to 5.2
Percentage of Participants Achieving a 100% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 Week 12	3.8 Percentage of participants Interval 1.2 to 8.6	2.2 Percentage of participants Interval 0.5 to 6.3
Percentage of Participants Achieving a 100% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 Week 16	7.5 Percentage of participants Interval 3.7 to 13.4	4.4 Percentage of participants Interval 1.6 to 9.3
Percentage of Participants Achieving a 100% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 Week 20	14.3 Percentage of participants Interval 8.8 to 21.4	7.3 Percentage of participants Interval 3.6 to 13.0
Percentage of Participants Achieving a 100% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 Week 24	14.3 Percentage of participants Interval 8.8 to 21.4	8.8 Percentage of participants Interval 4.6 to 14.8

SECONDARY outcome

Timeframe: Baseline to Week 24

PASI: Combined assessment of lesion severity and area affected into single score; range: 0(no disease) to 72(maximal disease). Body was divided into 4 sections (head, arms, trunk, legs); each area scored by itself and scores were combined for final PASI. For each section, percent area of skin involved estimated: 0 (0%) to 6 (90 - 100%), and severity was estimated by clinical signs: erythema, induration, and desquamation; scale: 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each section \* area score \* weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).

Outcome measures

Outcome measures
Measure	ETN 50 mg BW/QW n=133 Participants Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).	ETN 50 mg QW/QW n=137 Participants ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 Week 2	-4.5 Units on scale Standard Error 0.4	-3.2 Units on scale Standard Error 0.4
Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 Week 4	-8.7 Units on scale Standard Error 0.5	-6.8 Units on scale Standard Error 0.4
Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 Week 8	-13.6 Units on scale Standard Error 0.5	-10.6 Units on scale Standard Error 0.5
Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 Week 12	-16.2 Units on scale Standard Error 0.5	-12.6 Units on scale Standard Error 0.5
Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 Week 16	-17.4 Units on scale Standard Error 0.5	-14.6 Units on scale Standard Error 0.5
Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 Week 20	-17.5 Units on scale Standard Error 0.5	-15.5 Units on scale Standard Error 0.5
Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 Week 24	-17.4 Units on scale Standard Error 0.5	-15.4 Units on scale Standard Error 0.5

SECONDARY outcome

Timeframe: Baseline to Week 24

Population: mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. Observed cases (OC) analyses were performed including only those participants who were evaluated at the specified visits.

Time taken to achieve first PASI was calculated using Kaplan-Meier estimate and presented as median. PASI 50=50% improvement from baseline in PASI; PASI 75=75% improvement from baseline in PASI; PASI 90=90% improvement from baseline in PASI; PASI 100=100% improvement from baseline in PASI. PASI score percent improvement =100\*(baseline score - visit score)/baseline score.

Outcome measures

Outcome measures
Measure	ETN 50 mg BW/QW n=133 Participants Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).	ETN 50 mg QW/QW n=137 Participants ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
Time to Achieve Psoriasis Area and Severity Index (PASI) 50, PASI 75 and PASI 100 Over 24 Weeks PASI 50	57 Days Interval 56.0 to 57.0	57 Days Interval 57.0 to 85.0
Time to Achieve Psoriasis Area and Severity Index (PASI) 50, PASI 75 and PASI 100 Over 24 Weeks PASI 75	85 Days Interval 84.0 to 85.0	113 Days Interval 110.0 to 141.0
Time to Achieve Psoriasis Area and Severity Index (PASI) 50, PASI 75 and PASI 100 Over 24 Weeks PASI 90	141 Days Interval 113.0 to 170.0	171 Days Interval 169.0 to Not estimable
Time to Achieve Psoriasis Area and Severity Index (PASI) 50, PASI 75 and PASI 100 Over 24 Weeks PASI 100	NA Days Not estimable	NA Days Not estimable

SECONDARY outcome

Timeframe: Baseline to Week 24

PGA of Psoriasis: score based on dermatologist's assessment of head, scalp, and neck psoriasis (averaged over all lesions). The PGA of Psoriasis scale ranges from 0 (no psoriasis) to 5 (severe disease). PGA score of 0 = Status of Clear.

Outcome measures

Outcome measures
Measure	ETN 50 mg BW/QW n=133 Participants Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).	ETN 50 mg QW/QW n=137 Participants ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
Percentage of Participants Achieving the Physician Global Assessment (PGA) of Psoriasis Responses of Clear (0) at Each Visit Through Week 24 Week 2	0.0 Percentage of participants Interval 0.0 to 2.7	0.0 Percentage of participants Interval 0.0 to 2.7
Percentage of Participants Achieving the Physician Global Assessment (PGA) of Psoriasis Responses of Clear (0) at Each Visit Through Week 24 Week 4	0.0 Percentage of participants Interval 0.0 to 2.7	0.7 Percentage of participants Interval 0.0 to 4.0
Percentage of Participants Achieving the Physician Global Assessment (PGA) of Psoriasis Responses of Clear (0) at Each Visit Through Week 24 Week 8	1.5 Percentage of participants Interval 0.2 to 5.3	1.5 Percentage of participants Interval 0.2 to 5.2
Percentage of Participants Achieving the Physician Global Assessment (PGA) of Psoriasis Responses of Clear (0) at Each Visit Through Week 24 Week 12	9.0 Percentage of participants Interval 4.7 to 15.2	2.9 Percentage of participants Interval 0.8 to 7.3
Percentage of Participants Achieving the Physician Global Assessment (PGA) of Psoriasis Responses of Clear (0) at Each Visit Through Week 24 Week 16	12.8 Percentage of participants Interval 7.6 to 19.7	9.5 Percentage of participants Interval 5.1 to 15.7
Percentage of Participants Achieving the Physician Global Assessment (PGA) of Psoriasis Responses of Clear (0) at Each Visit Through Week 24 Week 20	19.5 Percentage of participants Interval 13.2 to 27.3	10.9 Percentage of participants Interval 6.3 to 17.4
Percentage of Participants Achieving the Physician Global Assessment (PGA) of Psoriasis Responses of Clear (0) at Each Visit Through Week 24 Week 24	21.1 Percentage of participants Interval 14.5 to 29.0	12.4 Percentage of participants Interval 7.4 to 19.1

SECONDARY outcome

Timeframe: Baseline to Week 24

Outcome measures

Outcome measures
Measure	ETN 50 mg BW/QW n=133 Participants Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).	ETN 50 mg QW/QW n=137 Participants ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
Percentage of Participants Achieving the Physician Global Assessment (PGA) of Psoriasis Responses Clear/Almost Clear (0, 1) at Each Visit Through Week 24 Week 2	0.8 Percentage of participants Interval 0.0 to 4.1	2.2 Percentage of participants Interval 0.5 to 6.3
Percentage of Participants Achieving the Physician Global Assessment (PGA) of Psoriasis Responses Clear/Almost Clear (0, 1) at Each Visit Through Week 24 Week 4	12.8 Percentage of participants Interval 7.6 to 19.7	6.6 Percentage of participants Interval 3.0 to 12.1
Percentage of Participants Achieving the Physician Global Assessment (PGA) of Psoriasis Responses Clear/Almost Clear (0, 1) at Each Visit Through Week 24 Week 8	33.8 Percentage of participants Interval 25.9 to 42.5	18.2 Percentage of participants Interval 12.2 to 25.7
Percentage of Participants Achieving the Physician Global Assessment (PGA) of Psoriasis Responses Clear/Almost Clear (0, 1) at Each Visit Through Week 24 Week 12	54.9 Percentage of participants Interval 46.0 to 63.5	32.8 Percentage of participants Interval 25.1 to 41.4
Percentage of Participants Achieving the Physician Global Assessment (PGA) of Psoriasis Responses Clear/Almost Clear (0, 1) at Each Visit Through Week 24 Week 16	60.9 Percentage of participants Interval 52.1 to 69.2	47.4 Percentage of participants Interval 38.9 to 56.1
Percentage of Participants Achieving the Physician Global Assessment (PGA) of Psoriasis Responses Clear/Almost Clear (0, 1) at Each Visit Through Week 24 Week 20	65.4 Percentage of participants Interval 56.7 to 73.4	50.4 Percentage of participants Interval 41.7 to 59.0
Percentage of Participants Achieving the Physician Global Assessment (PGA) of Psoriasis Responses Clear/Almost Clear (0, 1) at Each Visit Through Week 24 Week 24	69.9 Percentage of participants Interval 61.4 to 77.6	50.4 Percentage of participants Interval 41.7 to 59.0

SECONDARY outcome

Timeframe: Baseline to Week 24

Outcome measures

Outcome measures
Measure	ETN 50 mg BW/QW n=133 Participants Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).	ETN 50 mg QW/QW n=137 Participants ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
Percentage of Participants Achieving the Physician Global Assessment (PGA) of Psoriasis Responses of Clear/Almost Clear/Mild (0, 1, 2) at Each Visit Through Week 24 Week 2	27.1 Percentage of participants Interval 19.7 to 35.5	22.1 Percentage of participants Interval 15.4 to 30.0
Percentage of Participants Achieving the Physician Global Assessment (PGA) of Psoriasis Responses of Clear/Almost Clear/Mild (0, 1, 2) at Each Visit Through Week 24 Week 4	46.6 Percentage of participants Interval 37.9 to 55.5	38.0 Percentage of participants Interval 29.8 to 46.6
Percentage of Participants Achieving the Physician Global Assessment (PGA) of Psoriasis Responses of Clear/Almost Clear/Mild (0, 1, 2) at Each Visit Through Week 24 Week 8	72.9 Percentage of participants Interval 64.5 to 80.3	59.1 Percentage of participants Interval 50.4 to 67.4
Percentage of Participants Achieving the Physician Global Assessment (PGA) of Psoriasis Responses of Clear/Almost Clear/Mild (0, 1, 2) at Each Visit Through Week 24 Week 12	88.7 Percentage of participants Interval 82.1 to 93.5	69.3 Percentage of participants Interval 60.9 to 76.9
Percentage of Participants Achieving the Physician Global Assessment (PGA) of Psoriasis Responses of Clear/Almost Clear/Mild (0, 1, 2) at Each Visit Through Week 24 Week 16	88.7 Percentage of participants Interval 82.1 to 93.5	75.2 Percentage of participants Interval 67.1 to 82.2
Percentage of Participants Achieving the Physician Global Assessment (PGA) of Psoriasis Responses of Clear/Almost Clear/Mild (0, 1, 2) at Each Visit Through Week 24 Week 20	88.7 Percentage of participants Interval 82.1 to 93.5	78.1 Percentage of participants Interval 70.2 to 84.7
Percentage of Participants Achieving the Physician Global Assessment (PGA) of Psoriasis Responses of Clear/Almost Clear/Mild (0, 1, 2) at Each Visit Through Week 24 Week 24	89.5 Percentage of participants Interval 83.0 to 94.1	78.1 Percentage of participants Interval 70.2 to 84.7

SECONDARY outcome

Timeframe: Baseline to Week 24

Population: mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. OC analyses were performed including only those participants who were evaluated at the specified visits.

Time taken to achieve PGA was calculated using Kaplan-Meier estimate and presented as median. Assessment of clear or almost clear or Mild = PGA score of 0 (no evidence) or 1 (minimal/faint) or 2 (mild plaque elevation, mild fine scales predominates or light red coloration).

Outcome measures

Outcome measures
Measure	ETN 50 mg BW/QW n=133 Participants Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).	ETN 50 mg QW/QW n=137 Participants ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
Time to First Physician Global Assessment (PGA) of Psoriasis of Clear/Almost Clear (0, 1), or Clear/Almost Clear/Mild (0, 1, 2) Over 24 Weeks PGA Clear / Almost Clear (0, 1)	85 Days Interval 85.0 to 89.0	114 Days Interval 112.0 to 167.0
Time to First Physician Global Assessment (PGA) of Psoriasis of Clear/Almost Clear (0, 1), or Clear/Almost Clear/Mild (0, 1, 2) Over 24 Weeks PGA Clear / Almost Clear / Mild (0, 1, 2)	53 Days Interval 29.0 to 57.0	57 Days Interval 56.0 to 57.0

SECONDARY outcome

Timeframe: Baseline to Week 24

PGA of Psoriasis: score based on dermatologist's assessment of disease averaged over all lesions of head, scalp, and neck. Overall lesions were graded for induration, erythema, and scaling; range: 0 (no evidence) to 5 (severe). The sum of the 3 scores was divided by 3 to obtain a final PGA score. Higher scores indicate greater severity of disease.

Outcome measures

Outcome measures
Measure	ETN 50 mg BW/QW n=133 Participants Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).	ETN 50 mg QW/QW n=137 Participants ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
Change From Baseline in Physician Global Assessment (PGA) of Psoriasis at Each Visit Through Week 24 Week 2	-0.4 Units on scale Standard Error 0.0	-0.3 Units on scale Standard Error 0.0
Change From Baseline in Physician Global Assessment (PGA) of Psoriasis at Each Visit Through Week 24 Week 4	-0.9 Units on scale Standard Error 0.1	-0.7 Units on scale Standard Error 0.1
Change From Baseline in Physician Global Assessment (PGA) of Psoriasis at Each Visit Through Week 24 Week 8	-1.4 Units on scale Standard Error 0.1	-1.1 Units on scale Standard Error 0.1
Change From Baseline in Physician Global Assessment (PGA) of Psoriasis at Each Visit Through Week 24 Week 12	-1.9 Units on scale Standard Error 0.1	-1.4 Units on scale Standard Error 0.1
Change From Baseline in Physician Global Assessment (PGA) of Psoriasis at Each Visit Through Week 24 Week 16	-2.0 Units on scale Standard Error 0.1	-1.7 Units on scale Standard Error 0.1
Change From Baseline in Physician Global Assessment (PGA) of Psoriasis at Each Visit Through Week 24 Week 20	-2.1 Units on scale Standard Error 0.1	-1.7 Units on scale Standard Error 0.1
Change From Baseline in Physician Global Assessment (PGA) of Psoriasis at Each Visit Through Week 24 Week 24	-2.1 Units on scale Standard Error 0.1	-1.8 Units on scale Standard Error 0.1

SECONDARY outcome

Timeframe: Baseline to Week 24

Outcome measures

Outcome measures
Measure	ETN 50 mg BW/QW n=133 Participants Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).	ETN 50 mg QW/QW n=137 Participants ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
Change From Baseline in Percent Body Surface Area (BSA) Involvement of Psoriasis at Each Visit Through Week 24 Week 24	-25.9 Percentage of BSA Standard Deviation 19.2	-19.0 Percentage of BSA Standard Deviation 17.2
Change From Baseline in Percent Body Surface Area (BSA) Involvement of Psoriasis at Each Visit Through Week 24 Week 2	-1.8 Percentage of BSA Standard Deviation 7.0	-0.3 Percentage of BSA Standard Deviation 6.7
Change From Baseline in Percent Body Surface Area (BSA) Involvement of Psoriasis at Each Visit Through Week 24 Week 4	-5.3 Percentage of BSA Standard Deviation 10.1	-3.1 Percentage of BSA Standard Deviation 7.7
Change From Baseline in Percent Body Surface Area (BSA) Involvement of Psoriasis at Each Visit Through Week 24 Week 8	-13.4 Percentage of BSA Standard Deviation 15.2	-8.4 Percentage of BSA Standard Deviation 11.8
Change From Baseline in Percent Body Surface Area (BSA) Involvement of Psoriasis at Each Visit Through Week 24 Week 12	-20.0 Percentage of BSA Standard Deviation 19.2	-12.7 Percentage of BSA Standard Deviation 15.7
Change From Baseline in Percent Body Surface Area (BSA) Involvement of Psoriasis at Each Visit Through Week 24 Week 16	-23.8 Percentage of BSA Standard Deviation 19.7	-15.9 Percentage of BSA Standard Deviation 15.9
Change From Baseline in Percent Body Surface Area (BSA) Involvement of Psoriasis at Each Visit Through Week 24 Week 20	-25.4 Percentage of BSA Standard Deviation 18.8	-18.2 Percentage of BSA Standard Deviation 16.3

SECONDARY outcome

Timeframe: Baseline to Week 24

Population: The data was not collected as planned.

Compare the before and after photographs with the clinical assessments (Psoriasis Area and Severity Index, Physician's Global Assessment) taken at the same time for illustration purposes. Measured as yes or no for change.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From Week 12 to Week 24

Moderate topical steroids to very potent topical steroids, topical vitamin D analogs, topical steroids in combination with vitamin D analogs, and anthralin compounds were prohibited for 14 days before the baseline visit until week 12.

Outcome measures

Outcome measures
Measure	ETN 50 mg BW/QW n=133 Participants Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).	ETN 50 mg QW/QW n=137 Participants ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
Percentage of Participants Not Using Topical Preparations at Each Visit From Week 12 Through Week 24 Week 12	89.5 Percentage of participants	89.1 Percentage of participants
Percentage of Participants Not Using Topical Preparations at Each Visit From Week 12 Through Week 24 Week 16	85.0 Percentage of participants	81.0 Percentage of participants
Percentage of Participants Not Using Topical Preparations at Each Visit From Week 12 Through Week 24 Week 20	86.5 Percentage of participants	82.5 Percentage of participants
Percentage of Participants Not Using Topical Preparations at Each Visit From Week 12 Through Week 24 Week 24	85.7 Percentage of participants	83.2 Percentage of participants

SECONDARY outcome

Timeframe: Week 12

PSSQ: participant's assessment that includes 18 items, 16 items (1-16) scored using Likert score with scores from 0 (very dissatisfied) to 4 (very satisfied) and 5 ( never had this problem). Only those participants who do not have score of 5 at baseline included in the item 1-16 analyses. Two items (17, 18) are with Yes/No answers. The scores of items 1-16 for change from baseline are summarized here.

Outcome measures

Outcome measures
Measure	ETN 50 mg BW/QW n=133 Participants Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).	ETN 50 mg QW/QW n=137 Participants ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 12 How your skin affects social, leisure activities	3.1 Units on scale Standard Deviation 1.2	2.7 Units on scale Standard Deviation 1.4
Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 12 Flaking skin	3.3 Units on scale Standard Deviation 1.0	2.7 Units on scale Standard Deviation 1.2
Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 12 Skin pain	3.8 Units on scale Standard Deviation 1.1	3.1 Units on scale Standard Deviation 1.4
Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 12 Depression	3.5 Units on scale Standard Deviation 1.3	3.2 Units on scale Standard Deviation 1.4
Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 12 How others respond to your appearance	3.5 Units on scale Standard Deviation 1.1	2.9 Units on scale Standard Deviation 1.3
Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 12 Satisfaction with psoriasis treatment in general	3.3 Units on scale Standard Deviation 0.8	2.9 Units on scale Standard Deviation 1.0
Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 12 Would like to continue with my current treatment	3.7 Units on scale Standard Deviation 0.6	3.5 Units on scale Standard Deviation 0.9
Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 12 Skin redness	3.2 Units on scale Standard Deviation 1.0	2.5 Units on scale Standard Deviation 1.2
Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 12 Skin tightness	3.4 Units on scale Standard Deviation 1.1	3.0 Units on scale Standard Deviation 1.2
Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 12 Skin bleeding	3.8 Units on scale Standard Deviation 1.0	3.2 Units on scale Standard Deviation 1.3
Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 12 Burning sensation in the skin	3.8 Units on scale Standard Deviation 1.1	3.0 Units on scale Standard Deviation 1.4
Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 12 Joint pain	3.1 Units on scale Standard Deviation 1.3	2.9 Units on scale Standard Deviation 1.4
Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 12 Comfort level with your appearance	3.2 Units on scale Standard Deviation 1.0	2.7 Units on scale Standard Deviation 1.2
Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 12 Anxiety	3.2 Units on scale Standard Deviation 1.3	3.1 Units on scale Standard Deviation 1.3
Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 12 Fatigue	3.0 Units on scale Standard Deviation 1.1	2.9 Units on scale Standard Deviation 1.2
Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 12 Overall appearance of your skin	3.2 Units on scale Standard Deviation 0.9	2.6 Units on scale Standard Deviation 1.2

SECONDARY outcome

Timeframe: Week 24

PSSQ: participant's assessment that includes 18 items, 16 items (1-16) scored using Likert score with scores from 0 (very dissatisfied) to 4 (very satisfied) and 5 (never had this problem). Only those participants who do not have score of 5 at baseline included in the item 1-16 analyses. Two items (17, 18) are with Yes/No answers. The scores of items 1-16 for change from baseline are summarized here.

Outcome measures

Outcome measures
Measure	ETN 50 mg BW/QW n=133 Participants Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).	ETN 50 mg QW/QW n=137 Participants ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 24 Would like to continue with my current treatment	3.5 Units on scale Standard Deviation 1.0	3.4 Units on scale Standard Deviation 1.0
Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 24 Overall appearance of your skin	3.2 Units on scale Standard Deviation 1.0	2.8 Units on scale Standard Deviation 1.2
Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 24 Flaking skin	3.4 Units on scale Standard Deviation 1.1	3.0 Units on scale Standard Deviation 1.3
Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 24 Skin redness	3.3 Units on scale Standard Deviation 1.1	2.9 Units on scale Standard Deviation 1.3
Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 24 Skin tightness	3.5 Units on scale Standard Deviation 1.1	3.2 Units on scale Standard Deviation 1.3
Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 24 Skin bleeding	3.8 Units on scale Standard Deviation 1.1	3.3 Units on scale Standard Deviation 1.4
Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 24 Burning sensation in the skin	3.7 Units on scale Standard Deviation 1.1	3.3 Units on scale Standard Deviation 1.4
Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 24 Skin pain	3.7 Units on scale Standard Deviation 1.1	3.3 Units on scale Standard Deviation 1.4
Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 24 Joint pain	3.3 Units on scale Standard Deviation 1.2	3.1 Units on scale Standard Deviation 1.5
Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 24 Comfort level with your appearance	3.2 Units on scale Standard Deviation 1.0	2.9 Units on scale Standard Deviation 1.2
Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 24 Anxiety	3.4 Units on scale Standard Deviation 1.2	3.2 Units on scale Standard Deviation 1.5
Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 24 Depression	3.3 Units on scale Standard Deviation 1.3	3.4 Units on scale Standard Deviation 1.4
Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 24 Fatigue	3.1 Units on scale Standard Deviation 1.1	3.0 Units on scale Standard Deviation 1.3
Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 24 How others respond to your appearance	3.4 Units on scale Standard Deviation 1.0	3.2 Units on scale Standard Deviation 1.2
Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 24 How your skin affects social, leisure activities	3.4 Units on scale Standard Deviation 1.0	3.2 Units on scale Standard Deviation 1.4
Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 24 Satisfaction with psoriasis treatment in general	3.2 Units on scale Standard Deviation 1.0	3.1 Units on scale Standard Deviation 1.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to Week 24

SGA of Psoriasis: score based on participant's assessment of itching at a scale of 0 to 5; where 0 = no itching and 5 = severe itching.

Outcome measures

Outcome measures
Measure	ETN 50 mg BW/QW n=133 Participants Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).	ETN 50 mg QW/QW n=137 Participants ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
Change From Baseline in Subject Global Assessment (SGA) of Itching at Each Visit Through Week 24 Week 2	-0.8 Units on scale Standard Error 0.1	-0.7 Units on scale Standard Error 0.1
Change From Baseline in Subject Global Assessment (SGA) of Itching at Each Visit Through Week 24 Week 4	-1.5 Units on scale Standard Error 0.1	-1.1 Units on scale Standard Error 0.1
Change From Baseline in Subject Global Assessment (SGA) of Itching at Each Visit Through Week 24 Week 8	-2.0 Units on scale Standard Error 0.1	-1.4 Units on scale Standard Error 0.1
Change From Baseline in Subject Global Assessment (SGA) of Itching at Each Visit Through Week 24 Week 12	-2.4 Units on scale Standard Error 0.1	-1.6 Units on scale Standard Error 0.1
Change From Baseline in Subject Global Assessment (SGA) of Itching at Each Visit Through Week 24 Week 16	-2.2 Units on scale Standard Error 0.1	-1.8 Units on scale Standard Error 0.1
Change From Baseline in Subject Global Assessment (SGA) of Itching at Each Visit Through Week 24 Week 20	-2.3 Units on scale Standard Error 0.1	-1.8 Units on scale Standard Error 0.1
Change From Baseline in Subject Global Assessment (SGA) of Itching at Each Visit Through Week 24 Week 24	-2.2 Units on scale Standard Error 0.1	-2.0 Units on scale Standard Error 0.1

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to Week 24

SGA of Joint Pain: score based on participant's assessment of joint pain at a scale of 0 to 5; where 0 = no pain and 5 = severe pain.

Outcome measures

Outcome measures
Measure	ETN 50 mg BW/QW n=133 Participants Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).	ETN 50 mg QW/QW n=137 Participants ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
Change From Baseline in Subject Global Assessment (SGA) of Joint Pain at Each Visit Through Week 24 Week 2	-0.4 Units on scale Standard Error 0.1	-0.5 Units on scale Standard Error 0.1
Change From Baseline in Subject Global Assessment (SGA) of Joint Pain at Each Visit Through Week 24 Week 4	-0.7 Units on scale Standard Error 0.1	-0.5 Units on scale Standard Error 0.1
Change From Baseline in Subject Global Assessment (SGA) of Joint Pain at Each Visit Through Week 24 Week 8	-0.7 Units on scale Standard Error 0.1	-0.6 Units on scale Standard Error 0.1
Change From Baseline in Subject Global Assessment (SGA) of Joint Pain at Each Visit Through Week 24 Week 12	-0.8 Units on scale Standard Error 0.1	-0.6 Units on scale Standard Error 0.1
Change From Baseline in Subject Global Assessment (SGA) of Joint Pain at Each Visit Through Week 24 Week 16	-0.8 Units on scale Standard Error 0.1	-0.6 Units on scale Standard Error 0.1
Change From Baseline in Subject Global Assessment (SGA) of Joint Pain at Each Visit Through Week 24 Week 20	-0.9 Units on scale Standard Error 0.1	-0.6 Units on scale Standard Error 0.1
Change From Baseline in Subject Global Assessment (SGA) of Joint Pain at Each Visit Through Week 24 Week 24	-0.8 Units on scale Standard Error 0.1	-0.8 Units on scale Standard Error 0.1

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to Week 24

SGA of Psoriasis: score based on participant's assessment of psoriasis disease activity at a scale of 0 to 5; where 0 = good and 5 = severe.

Outcome measures

Outcome measures
Measure	ETN 50 mg BW/QW n=133 Participants Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).	ETN 50 mg QW/QW n=137 Participants ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
Change From Baseline in Subject Global Assessment (SGA) of Psoriasis at Each Visit Through Week 24 Week 2	-1.0 Units on scale Standard Error 0.1	-1.0 Units on scale Standard Error 0.1
Change From Baseline in Subject Global Assessment (SGA) of Psoriasis at Each Visit Through Week 24 Week 4	-1.8 Units on scale Standard Error 0.1	-1.4 Units on scale Standard Error 0.1
Change From Baseline in Subject Global Assessment (SGA) of Psoriasis at Each Visit Through Week 24 Week 8	-2.1 Units on scale Standard Error 0.1	-1.7 Units on scale Standard Error 0.1
Change From Baseline in Subject Global Assessment (SGA) of Psoriasis at Each Visit Through Week 24 Week 12	-2.5 Units on scale Standard Error 0.1	-1.9 Units on scale Standard Error 0.1
Change From Baseline in Subject Global Assessment (SGA) of Psoriasis at Each Visit Through Week 24 Week 16	-2.6 Units on scale Standard Error 0.1	-2.0 Units on scale Standard Error 0.1
Change From Baseline in Subject Global Assessment (SGA) of Psoriasis at Each Visit Through Week 24 Week 20	-2.6 Units on scale Standard Error 0.1	-2.1 Units on scale Standard Error 0.1
Change From Baseline in Subject Global Assessment (SGA) of Psoriasis at Each Visit Through Week 24 Week 24	-2.5 Units on scale Standard Error 0.1	-2.2 Units on scale Standard Error 0.1

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Week 12

PASE a participant-administered questionnaire and a simple scoring system to assist physicians in screening participants with psoriasis for evidence of psoriatic arthritis with two sub-scales: system sub-scale and function sub-scale. Total of 15 questions in both sub-scales (7 questions in system and 8 in function sub-scale) to score from 1 to 5; where 1 = strongly disagree and 5 = strongly agree. The total of system and function scores provides the total PASE score ranging from 15 to 75 where higher scores indicate greater severity.

Outcome measures

Outcome measures
Measure	ETN 50 mg BW/QW n=129 Participants Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).	ETN 50 mg QW/QW n=133 Participants ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
Change From Baseline in Psoriatic Arthritis Screening and Evaluation (PASE) Total Score at Week 12	-3.7 Units on scale Standard Error 1.0	-3.5 Units on scale Standard Error 0.9

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to Week 24

Physician Psoriasis Satisfaction Questionnaire (PPSQ) included two global satisfaction questions to which physicians respond either 'satisfactory' or 'not satisfactory.' These are: 1) whether the participant's current condition is satisfactory, considering psoriasis symptoms, skin appearance and all other problems that psoriasis causes; 2) whether the participant's current primary psoriasis therapy is satisfactory, considering psoriasis symptoms, skin appearance, therapy side effects and therapy ease/difficulty of use. Each of these questions was summarized for change from baseline.

Outcome measures

Outcome measures
Measure	ETN 50 mg BW/QW n=133 Participants Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).	ETN 50 mg QW/QW n=137 Participants ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
Percentage of Participants Evaluated Using Psoriasis Physician Satisfaction Questionnaire (PPSQ): Consider Patient's Condition Satisfactory From Baseline at Each Visit Through Week 24 Week 2	33.1 Percentage of participants Interval 25.2 to 41.8	27.4 Percentage of participants Interval 20.1 to 35.7
Percentage of Participants Evaluated Using Psoriasis Physician Satisfaction Questionnaire (PPSQ): Consider Patient's Condition Satisfactory From Baseline at Each Visit Through Week 24 Week 4	53.4 Percentage of participants Interval 44.5 to 62.1	38.7 Percentage of participants Interval 30.5 to 47.4
Percentage of Participants Evaluated Using Psoriasis Physician Satisfaction Questionnaire (PPSQ): Consider Patient's Condition Satisfactory From Baseline at Each Visit Through Week 24 Week 8	68.4 Percentage of participants Interval 59.8 to 76.2	54.0 Percentage of participants Interval 45.3 to 62.6
Percentage of Participants Evaluated Using Psoriasis Physician Satisfaction Questionnaire (PPSQ): Consider Patient's Condition Satisfactory From Baseline at Each Visit Through Week 24 Week 12	87.2 Percentage of participants Interval 80.3 to 92.4	65.7 Percentage of participants Interval 57.1 to 73.6
Percentage of Participants Evaluated Using Psoriasis Physician Satisfaction Questionnaire (PPSQ): Consider Patient's Condition Satisfactory From Baseline at Each Visit Through Week 24 Week 16	85.7 Percentage of participants Interval 78.6 to 91.2	75.2 Percentage of participants Interval 67.1 to 82.2
Percentage of Participants Evaluated Using Psoriasis Physician Satisfaction Questionnaire (PPSQ): Consider Patient's Condition Satisfactory From Baseline at Each Visit Through Week 24 Week 20	87.2 Percentage of participants Interval 80.3 to 92.4	75.2 Percentage of participants Interval 67.1 to 82.2
Percentage of Participants Evaluated Using Psoriasis Physician Satisfaction Questionnaire (PPSQ): Consider Patient's Condition Satisfactory From Baseline at Each Visit Through Week 24 Week 24	86.5 Percentage of participants Interval 79.5 to 91.8	75.2 Percentage of participants Interval 67.1 to 82.2

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to Week 24

Physician Psoriasis Satisfaction Questionnaire (PPSQ) includes two global satisfaction questions to which physicians respond either 'satisfactory' or 'not satisfactory.' These are: 1) whether the participant's current condition is satisfactory, considering psoriasis symptoms, skin appearance and all other problems that psoriasis causes; 2) whether the participant's current primary psoriasis therapy is satisfactory, considering psoriasis symptoms, skin appearance, therapy side effects and therapy ease/difficulty of use. Each of these questions was summarized for change from baseline.

Outcome measures

Outcome measures
Measure	ETN 50 mg BW/QW n=133 Participants Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).	ETN 50 mg QW/QW n=137 Participants ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
Percentage of Participants Evaluated by Physicians Using Psoriasis Physician Satisfaction Questionnaire (PPSQ): Consider Primary Psoriasis Therapy Satisfactory From Baseline at Each Visit Through Week 24 Week 2	66.9 Percentage of participants Interval 58.2 to 74.8	54.8 Percentage of participants Interval 46.0 to 63.4
Percentage of Participants Evaluated by Physicians Using Psoriasis Physician Satisfaction Questionnaire (PPSQ): Consider Primary Psoriasis Therapy Satisfactory From Baseline at Each Visit Through Week 24 Week 4	77.4 Percentage of participants Interval 69.4 to 84.2	68.6 Percentage of participants Interval 60.1 to 76.3
Percentage of Participants Evaluated by Physicians Using Psoriasis Physician Satisfaction Questionnaire (PPSQ): Consider Primary Psoriasis Therapy Satisfactory From Baseline at Each Visit Through Week 24 Week 8	83.5 Percentage of participants Interval 76.0 to 89.3	72.3 Percentage of participants Interval 64.0 to 79.6
Percentage of Participants Evaluated by Physicians Using Psoriasis Physician Satisfaction Questionnaire (PPSQ): Consider Primary Psoriasis Therapy Satisfactory From Baseline at Each Visit Through Week 24 Week 12	91.7 Percentage of participants Interval 85.7 to 95.8	83.2 Percentage of participants Interval 75.9 to 89.0
Percentage of Participants Evaluated by Physicians Using Psoriasis Physician Satisfaction Questionnaire (PPSQ): Consider Primary Psoriasis Therapy Satisfactory From Baseline at Each Visit Through Week 24 Week 16	91.7 Percentage of participants Interval 85.7 to 95.8	84.7 Percentage of participants Interval 77.5 to 90.3
Percentage of Participants Evaluated by Physicians Using Psoriasis Physician Satisfaction Questionnaire (PPSQ): Consider Primary Psoriasis Therapy Satisfactory From Baseline at Each Visit Through Week 24 Week 20	91.7 Percentage of participants Interval 85.7 to 95.8	83.9 Percentage of participants Interval 76.7 to 89.7
Percentage of Participants Evaluated by Physicians Using Psoriasis Physician Satisfaction Questionnaire (PPSQ): Consider Primary Psoriasis Therapy Satisfactory From Baseline at Each Visit Through Week 24 Week 24	88.7 Percentage of participants Interval 82.1 to 93.5	81.0 Percentage of participants Interval 73.4 to 87.2

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to Week 24

PSSQ: participant's assessment that includes 18 items, 16 items (1-16) scored using Likert score with scores from 0 (very dissatisfied) to 4 (very satisfied) and 5 (never had this problem). Only those participants who do not have score of 5 at baseline included in the item 1-16 analyses. Two items (17, 18) with Yes/No answers are summarized here.

Outcome measures

Outcome measures
Measure	ETN 50 mg BW/QW n=133 Participants Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).	ETN 50 mg QW/QW n=137 Participants ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
Percentage of Participants Who Were Considered Satisfied With Health State According to Psoriasis Subject Satisfaction Questionnaire (PSSQ) Week 2	47.4 Percentage of participants Interval 38.7 to 56.2	44.1 Percentage of participants Interval 35.6 to 52.9
Percentage of Participants Who Were Considered Satisfied With Health State According to Psoriasis Subject Satisfaction Questionnaire (PSSQ) Week 4	68.4 Percentage of participants Interval 59.8 to 76.2	59.1 Percentage of participants Interval 50.4 to 67.4
Percentage of Participants Who Were Considered Satisfied With Health State According to Psoriasis Subject Satisfaction Questionnaire (PSSQ) Week 8	81.2 Percentage of participants Interval 73.5 to 87.5	69.3 Percentage of participants Interval 60.9 to 76.9
Percentage of Participants Who Were Considered Satisfied With Health State According to Psoriasis Subject Satisfaction Questionnaire (PSSQ) Week 12	85.0 Percentage of participants Interval 77.7 to 90.6	70.8 Percentage of participants Interval 62.4 to 78.3
Percentage of Participants Who Were Considered Satisfied With Health State According to Psoriasis Subject Satisfaction Questionnaire (PSSQ) Week 16	85.7 Percentage of participants Interval 78.6 to 91.2	73.7 Percentage of participants Interval 65.5 to 80.9
Percentage of Participants Who Were Considered Satisfied With Health State According to Psoriasis Subject Satisfaction Questionnaire (PSSQ) Week 20	85.0 Percentage of participants Interval 77.7 to 90.6	75.9 Percentage of participants Interval 67.9 to 82.8
Percentage of Participants Who Were Considered Satisfied With Health State According to Psoriasis Subject Satisfaction Questionnaire (PSSQ) Week 24	85.0 Percentage of participants Interval 77.7 to 90.6	74.5 Percentage of participants Interval 66.3 to 81.5

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to Week 24

PSSQ: participant's assessment that includes 18 items, 16 items (1-16) scored using Likert score with scores from 0 (very dissatisfied) to 4 (very satisfied) and 5 (never had this problem). Only those participants who do not have score of 5 at baseline included in the item 1-16 analyses. Two items (17, 18) with Yes/No answers are summarized here.

Outcome measures

Outcome measures
Measure	ETN 50 mg BW/QW n=133 Participants Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).	ETN 50 mg QW/QW n=137 Participants ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
Percentage of Participants Who Were Considered Satisfied With Primary Psoriasis Treatment According to Psoriasis Subject Satisfaction Questionnaire (PSSQ) Week 2	82.7 Percentage of participants	76.5 Percentage of participants
Percentage of Participants Who Were Considered Satisfied With Primary Psoriasis Treatment According to Psoriasis Subject Satisfaction Questionnaire (PSSQ) Week 4	88.0 Percentage of participants	82.5 Percentage of participants
Percentage of Participants Who Were Considered Satisfied With Primary Psoriasis Treatment According to Psoriasis Subject Satisfaction Questionnaire (PSSQ) Week 8	92.5 Percentage of participants	82.5 Percentage of participants
Percentage of Participants Who Were Considered Satisfied With Primary Psoriasis Treatment According to Psoriasis Subject Satisfaction Questionnaire (PSSQ) Week 12	92.5 Percentage of participants	82.5 Percentage of participants
Percentage of Participants Who Were Considered Satisfied With Primary Psoriasis Treatment According to Psoriasis Subject Satisfaction Questionnaire (PSSQ) Week 16	91.0 Percentage of participants	86.1 Percentage of participants
Percentage of Participants Who Were Considered Satisfied With Primary Psoriasis Treatment According to Psoriasis Subject Satisfaction Questionnaire (PSSQ) Week 20	91.7 Percentage of participants	86.1 Percentage of participants
Percentage of Participants Who Were Considered Satisfied With Primary Psoriasis Treatment According to Psoriasis Subject Satisfaction Questionnaire (PSSQ) Week 24	87.2 Percentage of participants	83.2 Percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to Week 24

DLQI is the dermatology-specific quality of life measure used for psoriatic population. The 10-item questionnaire has a score range of 0 to 30 with higher scores indicating poor quality of life. An estimate of the minimal clinically important difference of the DLQI total score is a 5 point improvement. Total score range: 0 (best) to 30 (worst).

Outcome measures

Outcome measures
Measure	ETN 50 mg BW/QW n=133 Participants Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).	ETN 50 mg QW/QW n=137 Participants ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score to Week 24 Week 2	-4.6 Units on scale Standard Error 0.4	-4.3 Units on scale Standard Error 0.4
Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score to Week 24 Week 4	-7.1 Units on scale Standard Error 0.5	-5.9 Units on scale Standard Error 0.4
Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score to Week 24 Week 8	-9.0 Units on scale Standard Error 0.5	-7.0 Units on scale Standard Error 0.5
Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score to Week 24 Week 12	-10.2 Units on scale Standard Error 0.5	-8.1 Units on scale Standard Error 0.5
Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score to Week 24 Week 16	-10.7 Units on scale Standard Error 0.4	-8.8 Units on scale Standard Error 0.4
Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score to Week 24 Week 20	-10.5 Units on scale Standard Error 0.5	-9.0 Units on scale Standard Error 0.5
Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score to Week 24 Week 24	-10.5 Units on scale Standard Error 0.5	-9.2 Units on scale Standard Error 0.5

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Week 12 and Week 24

EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of 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 (example "confined to bed"). Scoring formula developed by EuroQol Group assigns utility value for each domain in the profile. Score is transformed and results in total score range -0.594 to 1.000; higher score indicates better health state.

Outcome measures

Outcome measures
Measure	ETN 50 mg BW/QW n=130 Participants Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).	ETN 50 mg QW/QW n=134 Participants ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
Change From Baseline in the Euro Quality of Life 5 Dimension (EQ-5D) Utility Index Week 12	0.21 Units on scale Standard Error 0.02	0.17 Units on scale Standard Error 0.02
Change From Baseline in the Euro Quality of Life 5 Dimension (EQ-5D) Utility Index Week 24	0.21 Units on scale Standard Error 0.02	0.15 Units on scale Standard Error 0.02

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Week 12 and Week 24

HADS: participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.

Outcome measures

Outcome measures
Measure	ETN 50 mg BW/QW n=131 Participants Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).	ETN 50 mg QW/QW n=135 Participants ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) - Anxiety Score Week 12	-1.6 Units on scale Standard Error 0.3	-1.6 Units on scale Standard Error 0.3
Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) - Anxiety Score Week 24	-1.9 Units on scale Standard Error 0.3	-1.8 Units on scale Standard Error 0.3

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Week 12 and Week 24

Outcome measures

Outcome measures
Measure	ETN 50 mg BW/QW n=131 Participants Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).	ETN 50 mg QW/QW n=135 Participants ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) - Depression Score Week 12	-1.9 Units on scale Standard Error 0.3	-1.3 Units on scale Standard Error 0.3
Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) - Depression Score Week 24	-2.2 Units on scale Standard Error 0.3	-1.7 Units on scale Standard Error 0.3

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 12

Population: mITT population: all randomized participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had missing values at any time point, LOCF method of imputation used. 'n' signifies participants evaluated for this measure at each timepoint, for each group respectively.

WPAI:PSO - participant rated questionnaire to assess effect of psoriasis on ability to work and perform regular activities in 4 areas: percent activity impairment (0 \[no effect on daily activities\] to 100 \[psoriasis completely prevented from doing daily activities\]), percent impairment while working (0 \[no effect\] to 100 \[completely prevented from working\]); percent work time missed due to psoriasis, and percent overall work impairment (0 \[no effect\] to 100 \[completely prevented from working\]).

Outcome measures

Outcome measures
Measure	ETN 50 mg BW/QW n=131 Participants Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).	ETN 50 mg QW/QW n=135 Participants ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
Work Productivity and Activity Impairment: Psoriasis (WPAI:PSO) at Week 12 Percent Activity Impairment (n=131, 135)	16.87 Percentage of indicated parameter Standard Deviation 21.49	21.78 Percentage of indicated parameter Standard Deviation 25.65
Work Productivity and Activity Impairment: Psoriasis (WPAI:PSO) at Week 12 Percent Impairment While Working (n=66, 78)	10.25 Percentage of indicated parameter Standard Deviation 14.41	13.19 Percentage of indicated parameter Standard Deviation 20.43
Work Productivity and Activity Impairment: Psoriasis (WPAI:PSO) at Week 12 Percent Overall Work Impairment (n=64, 71))	14.30 Percentage of indicated parameter Standard Deviation 21.49	16.88 Percentage of indicated parameter Standard Deviation 25.24
Work Productivity and Activity Impairment: Psoriasis (WPAI:PSO) at Week 12 Percent Work Time Missed (n=66, 73)	4.35 Percentage of indicated parameter Standard Deviation 16.86	4.85 Percentage of indicated parameter Standard Deviation 19.11

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 24

Outcome measures

Outcome measures
Measure	ETN 50 mg BW/QW n=131 Participants Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).	ETN 50 mg QW/QW n=135 Participants ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
Work Productivity and Activity Impairment: Psoriasis (WPAI:PSO) at Week 24 Percent Activity Impairment (n=131, 135))	13.28 Percentage of indicated parameter Standard Deviation 18.99	18.85 Percentage of indicated parameter Standard Deviation 24.58
Work Productivity and Activity Impairment: Psoriasis (WPAI:PSO) at Week 24 Percent Impairment While Working (n=72, 81)	8.00 Percentage of indicated parameter Standard Deviation 11.34	13.43 Percentage of indicated parameter Standard Deviation 19.57
Work Productivity and Activity Impairment: Psoriasis (WPAI:PSO) at Week 24 Percent Overall Work Impairment (n=70, 76)	12.78 Percentage of indicated parameter Standard Deviation 20.27	15.96 Percentage of indicated parameter Standard Deviation 23.05
Work Productivity and Activity Impairment: Psoriasis (WPAI:PSO) at Week 24 Percent Work Time Missed (n=72, 78)	5.03 Percentage of indicated parameter Standard Deviation 17.57	3.10 Percentage of indicated parameter Standard Deviation 13.91

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 12

MOS scale has 12 questions to assess sleep quality \& quantity: 1)time to fall asleep, 2)hours of sleep/night in past 4 weeks,3)sleep not peaceful, 4)got enough sleep to feel rested in morning,5)awaken short of breath/headache 6)feel drowsy in day,7)trouble going to sleep, 8)wake up during sleep; trouble going back to sleep,9)trouble staying awake in day, 10)Snoring,11)take naps in day,12)get amount of sleep needed. Sleep problem index(SPI) I:mean of 4,5,7,8,9,12; SPI II:mean of 1,3,4,5,6,7,8,9,12. All reported responses are on scale:0-100, higher scores indicate greater intensity of attribute.

Outcome measures

Outcome measures
Measure	ETN 50 mg BW/QW n=133 Participants Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).	ETN 50 mg QW/QW n=137 Participants ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
Mean Medical Outcomes Study (MOS) Sleep Scale Scores at Week 12 Sleep Snoring	35.7 Units on scale Standard Deviation 27.8	45.3 Units on scale Standard Deviation 30.3
Mean Medical Outcomes Study (MOS) Sleep Scale Scores at Week 12 Sleep Somnolence	27.3 Units on scale Standard Deviation 19.8	28.8 Units on scale Standard Deviation 20.3
Mean Medical Outcomes Study (MOS) Sleep Scale Scores at Week 12 Sleep Short of Breath or Headache	13.6 Units on scale Standard Deviation 20.8	15.3 Units on scale Standard Deviation 21.2
Mean Medical Outcomes Study (MOS) Sleep Scale Scores at Week 12 Sleep Adequacy	59.8 Units on scale Standard Deviation 26.4	55.6 Units on scale Standard Deviation 24.4
Mean Medical Outcomes Study (MOS) Sleep Scale Scores at Week 12 Sleep Disturbance	30.1 Units on scale Standard Deviation 21.3	28.4 Units on scale Standard Deviation 21.1
Mean Medical Outcomes Study (MOS) Sleep Scale Scores at Week 12 Sleep Quantity	7.2 Units on scale Standard Deviation 1.4	6.9 Units on scale Standard Deviation 1.2
Mean Medical Outcomes Study (MOS) Sleep Scale Scores at Week 12 Sleep Problem Index I	29.3 Units on scale Standard Deviation 17.8	30.4 Units on scale Standard Deviation 17.8
Mean Medical Outcomes Study (MOS) Sleep Scale Scores at Week 12 Sleep Problem Index II	30.1 Units on scale Standard Deviation 17.5	30.8 Units on scale Standard Deviation 17.7

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 24

MOS: participant rated questionnaire to assess sleep quality and quantity. Consists of a 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with headache, somnolence adequacy, and sleep quantity. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute.

Outcome measures

Outcome measures
Measure	ETN 50 mg BW/QW n=133 Participants Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).	ETN 50 mg QW/QW n=137 Participants ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
Mean Medical Outcomes Study (MOS) Sleep Scale Scores at Week 24 Sleep Snoring	38.2 Units on scale Standard Deviation 31.1	44.0 Units on scale Standard Deviation 31.3
Mean Medical Outcomes Study (MOS) Sleep Scale Scores at Week 24 Sleep Somnolence	27.0 Units on scale Standard Deviation 18.4	28.1 Units on scale Standard Deviation 20.3
Mean Medical Outcomes Study (MOS) Sleep Scale Scores at Week 24 Sleep Short of Breath or Headache	11.9 Units on scale Standard Deviation 17.3	13.9 Units on scale Standard Deviation 19.7
Mean Medical Outcomes Study (MOS) Sleep Scale Scores at Week 24 Sleep Adequacy	59.8 Units on scale Standard Deviation 25.4	60.9 Units on scale Standard Deviation 26.7
Mean Medical Outcomes Study (MOS) Sleep Scale Scores at Week 24 Sleep Disturbance	26.7 Units on scale Standard Deviation 19.8	26.6 Units on scale Standard Deviation 21.1
Mean Medical Outcomes Study (MOS) Sleep Scale Scores at Week 24 Sleep Quantity	7.2 Units on scale Standard Deviation 1.5	7.0 Units on scale Standard Deviation 1.3
Mean Medical Outcomes Study (MOS) Sleep Scale Scores at Week 24 Sleep Problem Index I	27.3 Units on scale Standard Deviation 15.9	27.7 Units on scale Standard Deviation 17.7
Mean Medical Outcomes Study (MOS) Sleep Scale Scores at Week 24 Sleep Problem Index II	28.2 Units on scale Standard Deviation 15.7	28.4 Units on scale Standard Deviation 17.5

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 12 and Week 24

FACIT Fatigue questionnaire: Participant rated 13 items questionnaire to assess fatigue. For each question, participant rates his / her condition for the past week on a 5-point Likert scale ranging from 0 (not at all) to 4 (very much). Higher scores always represent less fatigue. The total FACIT-Fatigue score ranges from 0 to 52 and is the sum of non-missing item scores; divided by the number of non-missing items, then multiplied by 13. If more than 6 items were missing, the total score was missing.

Outcome measures

Outcome measures
Measure	ETN 50 mg BW/QW n=133 Participants Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).	ETN 50 mg QW/QW n=137 Participants ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
Mean Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Questionnaire Total Scores Week 12	41.8 Units on scale Standard Deviation 8.1	40.1 Units on scale Standard Deviation 8.6
Mean Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Questionnaire Total Scores Week 24	41.9 Units on scale Standard Deviation 8.3	40.8 Units on scale Standard Deviation 9.1

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 12 and Week 24

As a part of pharmacoeconomic questionnaire, the visits to emergency room were evaluated and presented as Yes or No.

Outcome measures

Outcome measures
Measure	ETN 50 mg BW/QW n=133 Participants Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).	ETN 50 mg QW/QW n=137 Participants ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
Percentage of Participants With Emergency Room Visits Week 12	0.8 Percentage of participants	3.7 Percentage of participants
Percentage of Participants With Emergency Room Visits Week 24	1.6 Percentage of participants	0.8 Percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 12 and Week 24

As a part of pharmacoeconomic questionnaire, mean number of emergency room days were summarized.

Outcome measures

Outcome measures
Measure	ETN 50 mg BW/QW n=133 Participants Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).	ETN 50 mg QW/QW n=137 Participants ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
Mean Number of Emergency Room Days Week 24	1.0 Days Standard Deviation 0.00	1.0 Days Standard Deviation NA Not estimable due to small sample size.
Mean Number of Emergency Room Days Week 12	1.0 Days Standard Deviation NA Not estimable due to small sample size.	3.6 Days Standard Deviation 5.81

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 12 and Week 24

As a part of pharmacoeconomic questionnaire, the percentage of participants who had doctor visits were presented as Yes or No.

Outcome measures

Outcome measures
Measure	ETN 50 mg BW/QW n=133 Participants Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).	ETN 50 mg QW/QW n=137 Participants ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
Percentage of Participants With Doctor Visits Week 12	29.8 Percentage of participants	36.8 Percentage of participants
Percentage of Participants With Doctor Visits Week 24	31.7 Percentage of participants	31.7 Percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 12 and Week 24

As a part of pharmacoeconomic questionnaire, the mean number of doctor visits were summarized.

Outcome measures

Outcome measures
Measure	ETN 50 mg BW/QW n=133 Participants Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).	ETN 50 mg QW/QW n=137 Participants ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
Mean Number of Doctor Visits Week 12	2.2 Visits Standard Deviation 1.25	3.3 Visits Standard Deviation 3.89
Mean Number of Doctor Visits Week 24	2.4 Visits Standard Deviation 1.99	1.9 Visits Standard Deviation 1.28

Adverse Events

ETN 50 mg BW/QW

Serious events: 3 serious events

Other events: 97 other events

Deaths: 0 deaths

ETN 50 mg QW/QW

Serious events: 4 serious events

Other events: 91 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	ETN 50 mg BW/QW n=136 participants at risk Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).	ETN 50 mg QW/QW n=137 participants at risk ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
General disorders Injection site erythema	0.00% 0/136 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.73% 1/137 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
General disorders Injection site pruritus	0.00% 0/136 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.73% 1/137 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Hepatobiliary disorders Hepatitis	0.00% 0/136 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.73% 1/137 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Infections and infestations Dengue fever	0.00% 0/136 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.73% 1/137 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Infections and infestations Erysipelas	0.74% 1/136 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/137 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Investigations Transaminases increased	0.00% 0/136 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.73% 1/137 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Joint swelling	0.00% 0/136 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.73% 1/137 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Muscle spasms	0.74% 1/136 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/137 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Nervous system disorders Demyelinating polyneuropathy	0.74% 1/136 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/137 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Nervous system disorders Dysaesthesia	0.74% 1/136 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/137 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Nervous system disorders Paraesthesia	0.74% 1/136 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/137 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Libido decreased	0.74% 1/136 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/137 The same event may appear as both an Adverse Event and a Serious Adverse Event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.

Other adverse events

Additional Information

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Wyeth, Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Wyeth 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