Study Evaluating Etanercept for the Treatment of Moderate to Severe Psoriasis (PRISTINE)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Pfizer

ClinicalTrials.gov Identifier:

NCT00663052

First received: April 17, 2008

Last updated: March 29, 2012

Last verified: March 2012

History of Changes

Results First Received: January 18, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Conditions:	Plaque Psoriasis Psoriasis
Intervention:	Drug: Etanercept

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
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).

Participant Flow: Overall Study

	ETN 50 mg BW/QW	ETN 50 mg QW/QW
STARTED	136	137
COMPLETED	124	127
NOT COMPLETED	12	10
Adverse Event	6	3
Discontinuation of Study by Sponsor	2	0
Protocol Violation	1	0
Withdrawal by Subject	2	5
Unsatisfactory Response - Efficacy	1	1
Unspecified	0	1

Baseline Characteristics

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Reporting Groups

	Description
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).
Total	Total of all reporting groups

Baseline Measures

	ETN 50 mg BW/QW	ETN 50 mg QW/QW	Total
Number of Participants [units: participants]	136	137	273
Age [units: Years] Mean ± Standard Deviation	43.95 ± 12.68	43.85 ± 12.69	43.90 ± 12.66
Gender [units: Participants]
Female	47	36	83
Male	89	101	190
Mean Psoriasis Area and Severity Index (PASI) Score ^[1] [units: Units on scale] Mean ± Standard Deviation	21.4 ± 9.4	20.9 ± 9.4	21.2 ± 9.4
Number of Participants Achieving the Physician Global Assessment (PGA) of Psoriasis Reponses ^[2] [units: Participants]
PGA Clear (0)	0	0	0
PGA Clear/Almost Clear (0,1)	0	1	1
PGA Clear/Almost Clear/Mild (0,1,2)	13	17	30
Percent Body Surface Area (BSA) of Involvement [units: Percentage of BSA] Mean ± Standard Deviation	33.0 ± 19.4	32.9 ± 21.0	33.0 ± 20.2
Number of Participants Not Using Topical Preparations ^[3] [units: Participants]	120	124	244
Number of Participants Evaluated Using Psoriasis Physician Satisfaction Questionnaire (PPSQ) ^[4] [units: Participants]
Consider patient's condition satisfactory	16	16	32
Consider primary psoriasis therapy satisfactory	15	17	32
Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores ^[5] [units: Units on scale] Mean ± Standard Deviation
Overall appearance of your skin	0.9 ± 0.8	0.9 ± 0.9	0.9 ± 0.9
Flaking skin	1.0 ± 0.9	1.0 ± 0.9	1.0 ± 0.9
Skin redness	1.1 ± 0.9	1.0 ± 0.9	1.0 ± 0.9
Skin tightness	1.2 ± 0.9	1.2 ± 1.0	1.2 ± 1.0
Skin bleeding	1.7 ± 1.0	1.8 ± 1.2	1.7 ± 1.1
Burning sensation in the skin	1.5 ± 1.1	1.5 ± 1.1	1.5 ± 1.1
Skin pain	1.5 ± 1.2	1.5 ± 1.1	1.5 ± 1.1
Joint pain	1.8 ± 1.3	1.8 ± 1.4	1.8 ± 1.3
Comfort level with your appearance	1.3 ± 1.1	1.2 ± 1.0	1.3 ± 1.0
Anxiety	1.8 ± 1.1	1.7 ± 1.1	1.7 ± 1.1
Depression	2.0 ± 1.1	1.9 ± 1.1	1.9 ± 1.1
Fatigue	2.0 ± 1.0	1.8 ± 1.0	1.9 ± 1.0
How others respond to your appearance	1.6 ± 1.0	1.8 ± 1.0	1.7 ± 1.0
How your skin affects social, leisure activities	1.5 ± 1.2	1.3 ± 1.0	1.4 ± 1.1
Satisfaction with psoriasis treatment in general	1.4 ± 1.2	1.4 ± 1.1	1.4 ± 1.1
Would like to continue with my current treatment	2.0 ± 1.6	2.2 ± 1.6	2.1 ± 1.6
Number of Participants Who were Considered Satisfied According to Psoriasis Subject Satisfaction ^[5] [units: Participants]
Satisfaction with health state	25	28	53
Satisfaction with primary psoriasis treatment	31	28	59
Mean Dermatology Life Quality Index (DLQI) Total Score ^[6] [units: Units on scale] Mean ± Standard Deviation	14.1 ± 7.3	15.0 ± 8.0	14.6 ± 7.7
Mean Euro Quality of Life 5 Dimension (EQ-5D) Utility Index Scores ^[7] [units: Units on scale] Mean ± Standard Deviation	0.65 ± 0.30	0.66 ± 0.31	0.65 ± 0.31
Mean Hospital Anxiety and Depression Scale (HADS) Anxiety and Depression Scores ^[8] [units: Units on scale] Mean ± Standard Deviation
HADS Anxiety Score	7.2 ± 4.4	6.9 ± 4.1	7.0 ± 4.3
HADS Depression Score	6.0 ± 4.1	6.5 ± 4.1	6.2 ± 4.1
Work Productivity and Activity Impairment: Psoriasis (WPAI:PSO) ^[9] [units: Percentage of indicated parameter] Mean ± Standard Deviation
Percent Activity Impairment Due to Problem	39.77 ± 28.96	40.15 ± 30.94	39.96 ± 29.93
Percent Impairment While Working Due to Problem	24.36 ± 23.28	26.09 ± 27.08	25.27 ± 25.29
Percent Overall Work Impairment Due to Problem	25.45 ± 23.53	29.51 ± 28.66	27.54 ± 26.30
Percent Work Time Missed	3.60 ± 16.14	7.19 ± 18.92	5.45 ± 17.67
Mean Medical Outcomes Study (MOS) Sleep Scale Scores ^[10] [units: Units on scale] Mean ± Standard Deviation
Sleep Snoring	37.9 ± 29.6	45.7 ± 31.0	41.9 ± 30.5
Sleep Somnolence	29.9 ± 19.9	30.9 ± 19.3	30.4 ± 19.5
Sleep Short of Breath or Headache	13.2 ± 20.4	14.3 ± 20.7	13.8 ± 20.5
Sleep Adequacy	54.6 ± 25.9	54.0 ± 27.3	54.3 ± 26.6
Sleep Disturbance	35.0 ± 23.6	34.4 ± 23.8	34.7 ± 23.6
Sleep Quantity	6.9 ± 1.4	6.9 ± 1.4	6.9 ± 1.4
Sleep Problem Index I	32.5 ± 18.7	32.9 ± 19.1	32.7 ± 18.9
Sleep Problem Index II	33.9 ± 18.2	34.2 ± 19.6	34.0 ± 18.9
Mean Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Questionnaire Total Scores ^[11] [units: Units on scale] Mean ± Standard Deviation	37.9 ± 10.0	36.7 ± 10.8	37.3 ± 10.4
Number of Participants With Emergency Room Visits [units: Participants]	6	8	14
Mean Number of Emergency Room Days [units: Days] Mean ± Standard Deviation	7.8 ± 5.64	9.4 ± 7.31	8.7 ± 6.45
Number of Participants With Doctor Visits [units: Participants]	58	61	119
Mean Number of Doctor Visits [units: Visits] Mean ± Standard Deviation	2.9 ± 3.36	3.0 ± 3.68	3.0 ± 3.51

[1]	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.
[2]	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 psorasis) to 5 (severe disease). PGA score of 0 = Status of Clear; 1 = Almost Clear and 2 = Mild.
[3]	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.
[4]	PPSQ includes two global satisfaction questions to which physicians respond either ‘satisfactory’ or ‘not satisfactory'.
[5]	PSSQ: participant’s assessment which 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 were included in the item 1-16 analyses. Two items (17, 18) are with Yes/No answers.
[6]	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).
[7]	EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains; 1 indicates better health state (no problems); 3 indicates worst health state (example "confined to bed").
[8]	HADS: participant rated questionnaire with 2 subscales for anxiety and depression. 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.
[9]	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]).
[10]	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.
[11]	FACIT Fatigue questionnaire: Participant rated 13- item 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 (Total score range= 0 to 52).

Outcome Measures

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1. Primary:

Percentage of Participants Achieving a 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 24 [ Time Frame: Week 24 ]

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2. Secondary:

Percentage of Participants Achieving a 50% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 [ Time Frame: Baseline to Week 24 ]

Show Outcome Measure 2

3. Secondary:

Percentage of Participants Achieving a 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 [ Time Frame: Baseline to Week 24 ]

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4. Secondary:

Percentage of Participants Achieving a 90% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 [ Time Frame: Baseline to week 24 ]

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5. Secondary:

Percentage of Participants Achieving a 100% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 [ Time Frame: Baseline to Week 24 ]

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6. Secondary:

Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 [ Time Frame: Baseline to Week 24 ]

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7. Secondary:

Time to Achieve Psoriasis Area and Severity Index (PASI) 50, PASI 75 and PASI 100 Over 24 Weeks [ Time Frame: Baseline to Week 24 ]

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8. Secondary:

Percentage of Participants Achieving the Physician Global Assessment (PGA) of Psoriasis Responses of Clear (0) at Each Visit Through Week 24 [ Time Frame: Baseline to Week 24 ]

Show Outcome Measure 8

9. Secondary:

Percentage of Participants Achieving the Physician Global Assessment (PGA) of Psoriasis Responses Clear/Almost Clear (0, 1) at Each Visit Through Week 24 [ Time Frame: Baseline to Week 24 ]

Show Outcome Measure 9

10. Secondary:

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 [ Time Frame: Baseline to Week 24 ]

Show Outcome Measure 10

11. Secondary:

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 [ Time Frame: Baseline to Week 24 ]

Show Outcome Measure 11

12. Secondary:

Change From Baseline in Physician Global Assessment (PGA) of Psoriasis at Each Visit Through Week 24 [ Time Frame: Baseline to Week 24 ]

Show Outcome Measure 12

13. Secondary:

Change From Baseline in Percent Body Surface Area (BSA) Involvement of Psoriasis at Each Visit Through Week 24 [ Time Frame: Baseline to Week 24 ]

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14. Secondary:

Change From Baseline in the Photographed Image of Lesions in Selected Participants [ Time Frame: Baseline to Week 24 ]

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15. Secondary:

Percentage of Participants Not Using Topical Preparations at Each Visit From Week 12 Through Week 24 [ Time Frame: From Week 12 to Week 24 ]

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16. Secondary:

Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 12 [ Time Frame: Week 12 ]

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17. Secondary:

Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 24 [ Time Frame: Week 24 ]

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18. Other Pre-specified:

Change From Baseline in Subject Global Assessment (SGA) of Itching at Each Visit Through Week 24 [ Time Frame: Baseline to Week 24 ]

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19. Other Pre-specified:

Change From Baseline in Subject Global Assessment (SGA) of Joint Pain at Each Visit Through Week 24 [ Time Frame: Baseline to Week 24 ]

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20. Other Pre-specified:

Change From Baseline in Subject Global Assessment (SGA) of Psoriasis at Each Visit Through Week 24 [ Time Frame: Baseline to Week 24 ]

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21. Other Pre-specified:

Change From Baseline in Psoriatic Arthritis Screening and Evaluation (PASE) Total Score at Week 12 [ Time Frame: Baseline, Week 12 ]

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22. Other Pre-specified:

Percentage of Participants Evaluated Using Psoriasis Physician Satisfaction Questionnaire (PPSQ): Consider Patient's Condition Satisfactory From Baseline at Each Visit Through Week 24 [ Time Frame: Baseline to Week 24 ]

Show Outcome Measure 22

23. Other Pre-specified:

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 [ Time Frame: Baseline to Week 24 ]

Show Outcome Measure 23

24. Other Pre-specified:

Percentage of Participants Who Were Considered Satisfied With Health State According to Psoriasis Subject Satisfaction Questionnaire (PSSQ) [ Time Frame: Baseline to Week 24 ]

Show Outcome Measure 24

25. Other Pre-specified:

Percentage of Participants Who Were Considered Satisfied With Primary Psoriasis Treatment According to Psoriasis Subject Satisfaction Questionnaire (PSSQ) [ Time Frame: Baseline to Week 24 ]

Show Outcome Measure 25

26. Other Pre-specified:

Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score to Week 24 [ Time Frame: Baseline to Week 24 ]

Show Outcome Measure 26

27. Other Pre-specified:

Change From Baseline in the Euro Quality of Life 5 Dimension (EQ-5D) Utility Index [ Time Frame: Baseline, Week 12 and Week 24 ]

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28. Other Pre-specified:

Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) - Anxiety Score [ Time Frame: Baseline, Week 12 and Week 24 ]

Show Outcome Measure 28

29. Other Pre-specified:

Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) - Depression Score [ Time Frame: Baseline, Week 12 and Week 24 ]

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30. Other Pre-specified:

Work Productivity and Activity Impairment: Psoriasis (WPAI:PSO) at Week 12 [ Time Frame: Week 12 ]

Show Outcome Measure 30

31. Other Pre-specified:

Work Productivity and Activity Impairment: Psoriasis (WPAI:PSO) at Week 24 [ Time Frame: Week 24 ]

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32. Other Pre-specified:

Mean Medical Outcomes Study (MOS) Sleep Scale Scores at Week 12 [ Time Frame: Week 12 ]

Show Outcome Measure 32

33. Other Pre-specified:

Mean Medical Outcomes Study (MOS) Sleep Scale Scores at Week 24 [ Time Frame: Week 24 ]

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34. Other Pre-specified:

Mean Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Questionnaire Total Scores [ Time Frame: Week 12 and Week 24 ]

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35. Other Pre-specified:

Percentage of Participants With Emergency Room Visits [ Time Frame: Week 12 and Week 24 ]

Show Outcome Measure 35

36. Other Pre-specified:

Mean Number of Emergency Room Days [ Time Frame: Week 12 and Week 24 ]

Show Outcome Measure 36

37. Other Pre-specified:

Percentage of Participants With Doctor Visits [ Time Frame: Week 12 and Week 24 ]

Show Outcome Measure 37

38. Other Pre-specified:

Mean Number of Doctor Visits [ Time Frame: Week 12 and Week 24 ]

Show Outcome Measure 38

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

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

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Wyeth, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com

No publications provided

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT00663052 History of Changes
Other Study ID Numbers:	0881A6-4425, B1801013
Study First Received:	April 17, 2008
Results First Received:	January 18, 2011
Last Updated:	March 29, 2012
Health Authority:	Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica Austria: Federal

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