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| ID | Type | Description | Link |
|---|---|---|---|
| B1801013 |
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The purpose of this study is to compare the safety and efficacy of different doses of etanercept for the treatment of moderate to severe psoriasis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | A |
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| Group B | Experimental | B |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etanercept | Drug | ETN 50 mg QW + PBO QW for 12 weeks followed by ETN 50 mg QW for 12 weeks. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving a 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at 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 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). | Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving a 50% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through 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 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Subject Global Assessment (SGA) of Itching at Each Visit Through 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. | Baseline to Week 24 |
| Change From Baseline in Subject Global Assessment (SGA) of Joint Pain at Each Visit Through Week 24 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Capital Federal | Buenos Aires | 01114 | Argentina | ||
| Pfizer Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25994179 | Derived | Kemeny L, Amaya M, Cetkovska P, Rajatanavin N, Lee WR, Szumski A, Marshall L, Mahgoub EY, Aldinc E. Effect of etanercept therapy on psoriasis symptoms in patients from Latin America, Central Europe, and Asia: a subset analysis of the PRISTINE trial. BMC Dermatol. 2015 May 21;15:9. doi: 10.1186/s12895-015-0028-8. | |
| 25913550 | Derived |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| FG001 | ETN 50 mg QW/QW |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Etanercept |
| Drug |
ETN 50 mg BIW for 12 weeks folowed ETN 50 mg QW for 12 weeks. |
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| Baseline to Week 24 |
| Percentage of Participants Achieving a 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through 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 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). | Baseline to Week 24 |
| Percentage of Participants Achieving a 90% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through 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 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). | Baseline to week 24 |
| Percentage of Participants Achieving a 100% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through 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 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). | Baseline to Week 24 |
| Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through 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). | Baseline to Week 24 |
| Time to Achieve Psoriasis Area and Severity Index (PASI) 50, PASI 75 and PASI 100 Over 24 Weeks | 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. | Baseline to Week 24 |
| Percentage of Participants Achieving the Physician Global Assessment (PGA) of Psoriasis Responses of Clear (0) at Each Visit Through 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. | Baseline to Week 24 |
| Percentage of Participants Achieving the Physician Global Assessment (PGA) of Psoriasis Responses Clear/Almost Clear (0, 1) at Each Visit Through 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; 1 = Almost Clear. | Baseline to Week 24 |
| 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 | 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; 1 = Almost Clear and 2 = Mild. | Baseline to Week 24 |
| 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 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). | Baseline to Week 24 |
| Change From Baseline in Physician Global Assessment (PGA) of Psoriasis at Each Visit Through 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. | Baseline to Week 24 |
| Change From Baseline in Percent Body Surface Area (BSA) Involvement of Psoriasis at Each Visit Through Week 24 | Baseline to Week 24 |
| Change From Baseline in the Photographed Image of Lesions in Selected Participants | 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. | Baseline to Week 24 |
| Percentage of Participants Not Using Topical Preparations at Each Visit From Week 12 Through 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. | From Week 12 to Week 24 |
| Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at 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. | Week 12 |
| Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at 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. | 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. |
| Baseline to Week 24 |
| Change From Baseline in Subject Global Assessment (SGA) of Psoriasis at Each Visit Through 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. | Baseline to Week 24 |
| Change From Baseline in Psoriatic Arthritis Screening and Evaluation (PASE) Total Score at 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. | Baseline, Week 12 |
| Percentage of Participants Evaluated Using Psoriasis Physician Satisfaction Questionnaire (PPSQ): Consider Patient's Condition Satisfactory From Baseline at Each Visit Through 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. | Baseline to Week 24 |
| 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 | 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. | Baseline to Week 24 |
| Percentage of Participants Who Were Considered Satisfied With Health State According to Psoriasis Subject Satisfaction Questionnaire (PSSQ) | 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. | Baseline to Week 24 |
| Percentage of Participants Who Were Considered Satisfied With Primary Psoriasis Treatment According to Psoriasis Subject Satisfaction Questionnaire (PSSQ) | 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. | Baseline to Week 24 |
| Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score 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). | Baseline to Week 24 |
| Change From Baseline in the Euro Quality of Life 5 Dimension (EQ-5D) Utility Index | 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. | Baseline, Week 12 and Week 24 |
| Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) - Anxiety Score | 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. | Baseline, Week 12 and Week 24 |
| Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) - Depression Score | 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. | Baseline, Week 12 and Week 24 |
| Work Productivity and Activity Impairment: Psoriasis (WPAI:PSO) at Week 12 | 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]). | Week 12 |
| Work Productivity and Activity Impairment: Psoriasis (WPAI:PSO) at Week 24 | 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]). | Week 24 |
| Mean Medical Outcomes Study (MOS) Sleep Scale Scores at 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. | Week 12 |
| Mean Medical Outcomes Study (MOS) Sleep Scale Scores at 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. | Week 24 |
| Mean Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Questionnaire Total Scores | 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. | Week 12 and Week 24 |
| Percentage of Participants With Emergency Room Visits | As a part of pharmacoeconomic questionnaire, the visits to emergency room were evaluated and presented as Yes or No. | Week 12 and Week 24 |
| Mean Number of Emergency Room Days | As a part of pharmacoeconomic questionnaire, mean number of emergency room days were summarized. | Week 12 and Week 24 |
| Percentage of Participants With Doctor Visits | As a part of pharmacoeconomic questionnaire, the percentage of participants who had doctor visits were presented as Yes or No. | Week 12 and Week 24 |
| Mean Number of Doctor Visits | As a part of pharmacoeconomic questionnaire, the mean number of doctor visits were summarized. | Week 12 and Week 24 |
| Capital Federal |
| Buenos Aires |
| 01199 |
| Argentina |
| Pfizer Investigational Site | San Miguel | Buenos Aires | 1684 | Argentina |
| Pfizer Investigational Site | Feldkirch | Austria |
| Pfizer Investigational Site | Vienna | 1030 | Austria |
| Pfizer Investigational Site | Brussels | Belgium | B-1200 | Belgium |
| Pfizer Investigational Site | Ghent | 9000 | Belgium |
| Pfizer Investigational Site | Liège | 4020 | Belgium |
| Pfizer Investigational Site | Jihlava | 586 33 | Czechia |
| Pfizer Investigational Site | Ostrava- Poruba | 708 00 | Czechia |
| Pfizer Investigational Site | Plzen-Bory | 305 99 | Czechia |
| Pfizer Investigational Site | Bochum | 44791 | Germany |
| Pfizer Investigational Site | Erlangen | 91052 | Germany |
| Pfizer Investigational Site | Frankfurt am Main | 60590 | Germany |
| Pfizer Investigational Site | Hamburg | 20246 | Germany |
| Pfizer Investigational Site | Kiel | 24105 | Germany |
| Pfizer Investigational Site | München | 80802 | Germany |
| Pfizer Investigational Site | Osnabrück | 49078 | Germany |
| Pfizer Investigational Site | Athens | 124 62 | Greece |
| Pfizer Investigational Site | Athens | 16121 | Greece |
| Pfizer Investigational Site | Budapest | 1085 | Hungary |
| Pfizer Investigational Site | Debrecen | 4012 | Hungary |
| Pfizer Investigational Site | Miskolc | 3529 | Hungary |
| Pfizer Investigational Site | Szeged | 6720 | Hungary |
| Pfizer Investigational Site | Catanzaro | 88110 | Italy |
| Pfizer Investigational Site | L’Aquila | 67100 | Italy |
| Pfizer Investigational Site | Zapopan | Jalisco | 45190 | Mexico |
| Pfizer Investigational Site | Monterrey | Nuevo Leon / Mexico | 64020 | Mexico |
| Pfizer Investigational Site | Monterrey | Nuevo León | 64710 | Mexico |
| Pfizer Investigational Site | Gangnam-gu | 135-710 | South Korea |
| Pfizer Investigational Site | Seoul | 110-744 | South Korea |
| Pfizer Investigational Site | Barcelona | Barcelona | 08025 | Spain |
| Pfizer Investigational Site | Santiago de Compostela | La Coruña | 15706 | Spain |
| Pfizer Investigational Site | Fuenlabrada | Madrid | 28942 | Spain |
| Pfizer Investigational Site | Valencia | 46014 | Spain |
| Pfizer Investigational Site | Taipei | 110 | Taiwan |
| Pfizer Investigational Site | Taipei TOC | 100 | Taiwan |
| Pfizer Investigational Site | Bangkok | Thailand |
| Griffiths CE, Christophers E, Szumski A, Jones H, Mallbris L. Impact of early vs. late disease onset on treatment response to etanercept in patients with psoriasis. Br J Dermatol. 2015 Nov;173(5):1271-3. doi: 10.1111/bjd.13865. Epub 2015 Aug 17. No abstract available. |
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).
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| BG001 | 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). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Mean Psoriasis Area and Severity Index (PASI) Score | 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. | Mean | Standard Deviation | Units on scale |
| ||||||||||||||
| Number of Participants Achieving the Physician Global Assessment (PGA) of Psoriasis Reponses | 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. | Number | Participants |
| |||||||||||||||
| Percent Body Surface Area (BSA) of Involvement | Mean | Standard Deviation | Percentage of BSA |
| |||||||||||||||
| Number of Participants Not Using Topical Preparations | 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. | Number | Participants |
| |||||||||||||||
| Number of Participants Evaluated Using Psoriasis Physician Satisfaction Questionnaire (PPSQ) | PPSQ includes two global satisfaction questions to which physicians respond either 'satisfactory' or 'not satisfactory'. | Number | Participants |
| |||||||||||||||
| Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores | 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. | Mean | Standard Deviation | Units on scale |
| ||||||||||||||
| Number of Participants Who were Considered Satisfied According to Psoriasis Subject Satisfaction | 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. | Number | Participants |
| |||||||||||||||
| Mean Dermatology Life Quality Index (DLQI) Total Score | 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). | Mean | Standard Deviation | Units on scale |
| ||||||||||||||
| Mean Euro Quality of Life 5 Dimension (EQ-5D) Utility Index Scores | 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"). | Mean | Standard Deviation | Units on scale |
| ||||||||||||||
| Mean Hospital Anxiety and Depression Scale (HADS) Anxiety and Depression Scores | 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. | Mean | Standard Deviation | Units on scale |
| ||||||||||||||
| Work Productivity and Activity Impairment: Psoriasis (WPAI:PSO) | 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]). | Mean | Standard Deviation | Percentage of indicated parameter |
| ||||||||||||||
| Mean Medical Outcomes Study (MOS) Sleep Scale Scores | 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. | Mean | Standard Deviation | Units on scale |
| ||||||||||||||
| Mean Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Questionnaire Total Scores | 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). | Mean | Standard Deviation | Units on scale |
| ||||||||||||||
| Number of Participants With Emergency Room Visits | Number | Participants |
| ||||||||||||||||
| Mean Number of Emergency Room Days | Mean | Standard Deviation | Days |
| |||||||||||||||
| Number of Participants With Doctor Visits | Number | Participants |
| ||||||||||||||||
| Mean Number of Doctor Visits | Mean | Standard Deviation | Visits |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Percentage of Participants Achieving a 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at 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 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). | 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. | Posted | Number | Percentage of participants | Week 24 |
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| Secondary | Percentage of Participants Achieving a 50% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through 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 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). | 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. | Posted | Number | Percentage of participants | Baseline to Week 24 |
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| Secondary | Percentage of Participants Achieving a 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through 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 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). | 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. | Posted | Number | Percentage of participants | Baseline to Week 24 |
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| Secondary | Percentage of Participants Achieving a 90% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through 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 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). | 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. | Posted | Number | Percentage of participants | Baseline to week 24 |
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| Secondary | Percentage of Participants Achieving a 100% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through 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 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). | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline to Week 24 |
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| Secondary | Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through 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). | 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. | Posted | Mean | Standard Error | Units on scale | Baseline to Week 24 |
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| Secondary | Time to Achieve Psoriasis Area and Severity Index (PASI) 50, PASI 75 and PASI 100 Over 24 Weeks | 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. | 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. | Posted | Median | 95% Confidence Interval | Days | Baseline to Week 24 |
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| Secondary | Percentage of Participants Achieving the Physician Global Assessment (PGA) of Psoriasis Responses of Clear (0) at Each Visit Through 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline to Week 24 |
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| Secondary | Percentage of Participants Achieving the Physician Global Assessment (PGA) of Psoriasis Responses Clear/Almost Clear (0, 1) at Each Visit Through 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; 1 = Almost Clear. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline to Week 24 |
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| 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 | 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; 1 = Almost Clear and 2 = Mild. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline to Week 24 |
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| 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 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). | 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. | Posted | Median | 95% Confidence Interval | Days | Baseline to Week 24 |
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| Secondary | Change From Baseline in Physician Global Assessment (PGA) of Psoriasis at Each Visit Through 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. | 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. | Posted | Mean | Standard Error | Units on scale | Baseline to Week 24 |
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| Other Pre-specified | Change From Baseline in Subject Global Assessment (SGA) of Itching at Each Visit Through 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. | 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. | Posted | Mean | Standard Error | Units on scale | Baseline to Week 24 |
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| Other Pre-specified | Change From Baseline in Subject Global Assessment (SGA) of Joint Pain at Each Visit Through 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. | 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. | Posted | Mean | Standard Error | Units on scale | Baseline to Week 24 |
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| Other Pre-specified | Change From Baseline in Subject Global Assessment (SGA) of Psoriasis at Each Visit Through 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. | 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. | Posted | Mean | Standard Error | Units on scale | Baseline to Week 24 |
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| Secondary | Change From Baseline in Percent Body Surface Area (BSA) Involvement of Psoriasis at Each Visit Through Week 24 | 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. | Posted | Mean | Standard Deviation | Percentage of BSA | Baseline to Week 24 |
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| Secondary | Change From Baseline in the Photographed Image of Lesions in Selected Participants | 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. | The data was not collected as planned. | Posted | Number | Units on scale | Baseline to Week 24 |
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| Secondary | Percentage of Participants Not Using Topical Preparations at Each Visit From Week 12 Through 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. | 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. | Posted | Number | Percentage of participants | From Week 12 to Week 24 |
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| Other Pre-specified | Change From Baseline in Psoriatic Arthritis Screening and Evaluation (PASE) Total Score at 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. | 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. | Posted | Mean | Standard Error | Units on scale | Baseline, Week 12 |
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| 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 | 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline to Week 24 |
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| 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 | 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline to Week 24 |
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| Secondary | Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at 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. | 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. | Posted | Mean | Standard Deviation | Units on scale | Week 12 |
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| Secondary | Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at 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. | 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. | Posted | Mean | Standard Deviation | Units on scale | Week 24 |
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| Other Pre-specified | Percentage of Participants Who Were Considered Satisfied With Health State According to Psoriasis Subject Satisfaction Questionnaire (PSSQ) | 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline to Week 24 |
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| Other Pre-specified | Percentage of Participants Who Were Considered Satisfied With Primary Psoriasis Treatment According to Psoriasis Subject Satisfaction Questionnaire (PSSQ) | 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. | 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. | Posted | Number | Percentage of participants | Baseline to Week 24 |
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| Other Pre-specified | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score 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). | 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. | Posted | Mean | Standard Error | Units on scale | Baseline to Week 24 |
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| Other Pre-specified | Change From Baseline in the Euro Quality of Life 5 Dimension (EQ-5D) Utility Index | 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. | 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. | Posted | Mean | Standard Error | Units on scale | Baseline, Week 12 and Week 24 |
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| Other Pre-specified | Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) - Anxiety Score | 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. | 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. | Posted | Mean | Standard Error | Units on scale | Baseline, Week 12 and Week 24 |
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| Other Pre-specified | Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) - Depression Score | 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. | 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. | Posted | Mean | Standard Error | Units on scale | Baseline, Week 12 and Week 24 |
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| Other Pre-specified | Work Productivity and Activity Impairment: Psoriasis (WPAI:PSO) at Week 12 | 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]). | 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. | Posted | Mean | Standard Deviation | Percentage of indicated parameter | Week 12 |
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| Other Pre-specified | Work Productivity and Activity Impairment: Psoriasis (WPAI:PSO) at Week 24 | 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]). | 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. | Posted | Mean | Standard Deviation | Percentage of indicated parameter | Week 24 |
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| Other Pre-specified | Mean Medical Outcomes Study (MOS) Sleep Scale Scores at 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. | 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. | Posted | Mean | Standard Deviation | Units on scale | Week 12 |
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| Other Pre-specified | Mean Medical Outcomes Study (MOS) Sleep Scale Scores at 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. | 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. | Posted | Mean | Standard Deviation | Units on scale | Week 24 |
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| Other Pre-specified | Mean Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Questionnaire Total Scores | 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. | 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. | Posted | Mean | Standard Deviation | Units on scale | Week 12 and Week 24 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Percentage of Participants With Emergency Room Visits | As a part of pharmacoeconomic questionnaire, the visits to emergency room were evaluated and presented as Yes or No. | 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. | Posted | Number | Percentage of participants | Week 12 and Week 24 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Mean Number of Emergency Room Days | As a part of pharmacoeconomic questionnaire, mean number of emergency room days were summarized. | 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. | Posted | Mean | Standard Deviation | Days | Week 12 and Week 24 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Percentage of Participants With Doctor Visits | As a part of pharmacoeconomic questionnaire, the percentage of participants who had doctor visits were presented as Yes or No. | 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. | Posted | Number | Percentage of participants | Week 12 and Week 24 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Mean Number of Doctor Visits | As a part of pharmacoeconomic questionnaire, the mean number of doctor visits were summarized. | 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. | Posted | Mean | Standard Deviation | Visits | Week 12 and Week 24 |
|
|
Not provided
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). | 3 | 136 | 97 | 136 | ||
| EG001 | 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). | 4 | 137 | 91 | 137 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site erythema | General disorders | MedDRA | Non-systematic Assessment |
| |
| Injection site pruritus | General disorders | MedDRA | Non-systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | MedDRA | Non-systematic Assessment |
| |
| Dengue fever | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Demyelinating polyneuropathy | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Dysaesthesia | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Libido decreased | Psychiatric disorders | MedDRA | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
| |
| Lymphadenopathy mediastinal | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA | Non-systematic Assessment |
| |
| Arteriosclerosis coronary artery | Cardiac disorders | MedDRA | Non-systematic Assessment |
| |
| Deafness | Ear and labyrinth disorders | MedDRA | Non-systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA | Non-systematic Assessment |
| |
| Asthenopia | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Eye discharge | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Eye pruritus | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Anal inflammation | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Apical granuloma | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Chapped lips | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Dental caries | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Glossodynia | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Lip dry | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Periodontitis | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Cyst | General disorders | MedDRA | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA | Non-systematic Assessment |
| |
| Generalised oedema | General disorders | MedDRA | Non-systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA | Non-systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA | Non-systematic Assessment |
| |
| Injection site induration | General disorders | MedDRA | Non-systematic Assessment |
| |
| Injection site oedema | General disorders | MedDRA | Non-systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA | Non-systematic Assessment |
| |
| Injection site pruritus | General disorders | MedDRA | Non-systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA | Non-systematic Assessment |
| |
| Injection site swelling | General disorders | MedDRA | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA | Non-systematic Assessment |
| |
| Allergy to arthropod bite | Immune system disorders | MedDRA | Non-systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA | Non-systematic Assessment |
| |
| Acute tonsillitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Body tinea | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Fungal infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Furuncle | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Infection parasitic | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Mumps | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Nail infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Otitis externa | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Pharyngotonsillitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Soft tissue infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Tinea cruris | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Tinea pedis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Vaginitis bacterial | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Arthropod sting | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Epicondylitis | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Excoriation | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Face injury | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Joint injury | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Joint sprain | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Medical device pain | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Alanine aminotransferase abnormal | Investigations | MedDRA | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Albumin urine present | Investigations | MedDRA | Non-systematic Assessment |
| |
| Apolipoprotein B/Apolipoprotein A-1 ratio increased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Blood cholesterol increased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Blood insulin increased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Blood iron decreased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Blood pressure abnormal | Investigations | MedDRA | Non-systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Blood triglycerides increased | Investigations | MedDRA | Non-systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Glycosylated haemoglobin increased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Lipids increased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Liver function test abnormal | Investigations | MedDRA | Non-systematic Assessment |
| |
| Low density lipoprotein increased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Prostatic specific antigen increased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Urine albumin/creatinine ratio increased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Weight increased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Increased appetite | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Obesity | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Myofascial pain syndrome | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Myosclerosis | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Psoriatic arthropathy | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Keratoacanthoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
| |
| Oral neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
| |
| Skin papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
| |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
| |
| Burning sensation | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Dysaesthesia | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Hypersomnia | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Initial insomnia | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Libido decreased | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Panic attack | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
| |
| Breast pain | Reproductive system and breast disorders | MedDRA | Non-systematic Assessment |
| |
| Gynaecomastia | Reproductive system and breast disorders | MedDRA | Non-systematic Assessment |
| |
| Menstruation irregular | Reproductive system and breast disorders | MedDRA | Non-systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA | Non-systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Nasal inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Nasal mucosal disorder | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Erythema multiforme | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Pain of skin | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Rosacea | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Scar pain | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Skin chapped | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Skin fissures | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Skin nodule | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA | Non-systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA | Non-systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA | Non-systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Wyeth, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068800 | Etanercept |
| ID | Term |
|---|---|
| D007141 | Immunoglobulin Fc Fragments |
| D007128 | Immunoglobulin Fragments |
| D010446 | Peptide Fragments |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D007127 | Immunoglobulin Constant Regions |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D018124 | Receptors, Tumor Necrosis Factor |
| D018121 | Receptors, Cytokine |
| D011971 | Receptors, Immunologic |
| D011956 | Receptors, Cell Surface |
| D008565 | Membrane Proteins |
Not provided
Not provided
| Male |
|
| PGA Clear/Almost Clear (0,1) |
|
| PGA Clear/Almost Clear/Mild (0,1,2) |
|
| Consider primary psoriasis therapy satisfactory |
|
| Flaking skin |
|
| Skin redness |
|
| Skin tightness |
|
| Skin bleeding |
|
| Burning sensation in the skin |
|
| Skin pain |
|
| Joint pain |
|
| Comfort level with your appearance |
|
| Anxiety |
|
| Depression |
|
| Fatigue |
|
| How others respond to your appearance |
|
| How your skin affects social, leisure activities |
|
| Satisfaction with psoriasis treatment in general |
|
| Would like to continue with my current treatment |
|
| Satisfaction with primary psoriasis treatment |
|
| HADS Depression Score |
|
| Percent Impairment While Working Due to Problem |
|
| Percent Overall Work Impairment Due to Problem |
|
| Percent Work Time Missed |
|
| Sleep Somnolence |
|
| Sleep Short of Breath or Headache |
|
| Sleep Adequacy |
|
| Sleep Disturbance |
|
| Sleep Quantity |
|
| Sleep Problem Index I |
|
| Sleep Problem Index II |
|
| Superiority or Other |
|
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| Participants |
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| Units | Counts |
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| Participants |
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| Units | Counts |
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| Participants |
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| Units | Counts |
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| Participants |
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| Units | Counts |
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| Participants |
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| Units | Counts |
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| Participants |
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