| Primary | Percentage of Participants Achieving a 75 Percent (%) Improvement in Psoriasis Area and Severity Index (PASI 75) Score at Week 24 | 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 combined for final PASI. For each section, area of skin involved was estimated: 0 (0%) to 6 (90 - 100%), and severity estimated by clinical signs: erythema, induration, and desquamation; scale: 0 (none) to 4 (exceptionally striking). 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: randomized participants who took at least 1 dose of test article and had both baseline and on-therapy PASI evaluations; Last Observation Carried Forward (LOCF) | Posted | | Number | 95% Confidence Interval | percentage of participants | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept | Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks | | OG001 | Etanercept and Acitretin | Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks. | | OG002 | Acitretin | Acitretin 10 mg subcutaneous injection BID for 24 weeks |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG00052.38(29.78 to 74.29)
- OG00157.89(33.50 to 79.75)
- OG00222.22(6.41 to 47.64)
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| Overall treatment difference | Fisher Exact | | 0.0672 | | | | | | 2-Sided | | | | | | | No | Superiority or Other | | |
|
| Secondary | Percentage of Participants Achieving a 50% Improvement in Psoriasis Area and Severity Index (PASI 50) Score | 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 combined for final PASI. For each section, area of skin involved was estimated: 0 (0%) to 6 (90 - 100%), and severity estimated by clinical signs: erythema, induration, and desquamation; scale: 0 (none) to 4 (exceptionally striking). 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). | | Posted | | Number | 95% Confidence Interval | percentage of participants | | Weeks 2, 4, 8, 12, 18, and 24 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept | Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks | | OG001 | Etanercept and Acitretin | Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks. | | OG002 | Acitretin | Acitretin 10 mg subcutaneous injection BID for 24 weeks |
|
| Secondary | Percentage of Participants Achieving a Status on the Physician Global Assessment (PGA) of Psoriasis of Clear | 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. Assessment of clear = PGA score of 0 (no evidence). | | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Baseline, Weeks 2, 4, 8, 12, 18 and 24 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept | Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks | | OG001 | Etanercept and Acitretin | Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks. | | OG002 | Acitretin | Acitretin 10 mg subcutaneous injection BID for 24 weeks |
| |
| Secondary | Percentage of Participants Achieving a Status on the PGA of Psoriasis of Clear or Almost Clear | 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. Assessment of clear or almost clear = PGA score of 0 (no evidence), or 1 (minimal/faint). | | Posted | | Number | 95% Confidence Interval | percentage of participants | | Baseline, Weeks 2, 4, 8, 12, 18 and 24 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept | Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks | | OG001 | Etanercept and Acitretin | Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks. | | OG002 | Acitretin | Acitretin 10 mg subcutaneous injection BID for 24 weeks |
| |
| Secondary | Percentage of Participants Achieving a Status on the PGA of Psoriasis of Clear or Almost Clear or Mild | 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. Assessment of clear or almost clear or mild = PGA score of 0 (no evidence), 1 (minimal/faint), 2 (mild). | | Posted | | Number | 95% Confidence Interval | percentage of participants | | Baseline, Weeks 2, 4, 8, 12, 18 and 24 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept | Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks | | OG001 | Etanercept and Acitretin | Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks. | | OG002 | Acitretin | Acitretin 10 mg subcutaneous injection BID for 24 weeks |
| |
| Secondary | Time to Achieve a PASI 50 Score | PASI 50 defined as a 50% or greater improvement in PASI score from Baseline | | Posted | | Median | 95% Confidence Interval | days | | Baseline up to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept | Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks | | OG001 | Etanercept and Acitretin | Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks. | | OG002 | Acitretin | Acitretin 10 mg subcutaneous injection BID for 24 weeks |
| |
| Secondary | Time to Achieve a PASI 75 Score | PASI 75 defined as a 75% or greater improvement in PASI score from Baseline | | Posted | | Median | 95% Confidence Interval | days | | Baseline up to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept | Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks | | OG001 | Etanercept and Acitretin | Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks. | | OG002 | Acitretin | Acitretin 10 mg subcutaneous injection BID for 24 weeks |
| |
| Secondary | Time to Achieve a Status on the PGA of Psoriasis of Clear or Almost Clear or Mild | 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. Assessment of clear or almost clear or mild = PGA score of 0 (no evidence), 1 (minimal/faint), or 2 (mild). | | Posted | | Median | 95% Confidence Interval | days | | Baseline up to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept | Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks | | OG001 | Etanercept and Acitretin | Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks. | | OG002 | Acitretin | Acitretin 10 mg subcutaneous injection BID for 24 weeks |
| |
| Secondary | Time to Achieve a Status on the PGA of Psoriasis of Clear or Almost Clear | 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. Assessment of clear or almost clear = PGA score of 0 (no evidence), or 1 (minimal/faint). | | Posted | | Median | 95% Confidence Interval | days | | Baseline up to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept | Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks | | OG001 | Etanercept and Acitretin | Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks. | | OG002 | Acitretin | Acitretin 10 mg subcutaneous injection BID for 24 weeks |
| |
| Secondary | Change From Baseline in the PGA of Psoriasis | 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. Assessment of clear = PGA score of 0 (no evidence). Change = Week x, minus Baseline, where smaller scores indicate improvement. | | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Weeks 2, 4, 8, 12, 18, and 24 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept | Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks | | OG001 | Etanercept and Acitretin | Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks. | | OG002 | Acitretin | Acitretin 10 mg subcutaneous injection BID for 24 weeks |
| |
| Secondary | Change From Baseline in the PASI Score | Combined assessment of lesion severity, area affected into single score; range:0(no disease) to 72(maximal disease).Body divided into 4 sections (head, arms, trunk, legs); each area scored by itself and scores combined for final PASI. For each section, area of skin involved was estimated:0(0%) to 6(90-100%), severity estimated by clinical signs: erythema, induration, desquamation; scale: 0(none) to 4(maximum). Final PASI = sum of severity parameters for each section * area score * weight of section(head:0.1,arm:0.2,body: 0.3, leg:0.4). Change=Week X-Baseline, smaller scores show improvement. | | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Weeks 2, 4, 8, 12, 18 and 24 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept | Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks | | OG001 | Etanercept and Acitretin | Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks. | | OG002 | Acitretin | Acitretin 10 mg subcutaneous injection BID for 24 weeks |
| |
| Secondary | Change From Baseline in Percent Body Surface Area (BSA) Involvement of Psoriasis at Weeks 2, 4, 8, 12, 18 and 24 | Change from Baseline in the percentage of the surface area of the body affected by psoriasis. Change = Week x minus Baseline, where smaller scores indicate improvement. | | Posted | | Mean | Standard Deviation | percentage of BSA | | Baseline, Weeks 2, 4, 8, 12, 18 and 24 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept | Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks | | OG001 | Etanercept and Acitretin | Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks. | | OG002 | Acitretin | Acitretin 10 mg subcutaneous injection BID for 24 weeks |
| |
| Secondary | Change From Baseline in Subject Global Assessment (SGA) of Joint Pain at Weeks 2, 4, 8, 12 ,18 and 24 | Participants were asked to rate the severity of their joint pain on a 6-point scale, where 0=good and 5=severe. Change = Week X minus Baseline, where smaller scores indicate improvement. | mITT; LOCF; Number of participants analyzed (N)= participants with evaluable data | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Weeks 2, 4, 8, 12, 18 and 24 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept | Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks | | OG001 | Etanercept and Acitretin | Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks. | | OG002 | Acitretin | Acitretin 10 mg subcutaneous injection BID for 24 weeks |
| |
| Secondary | Change From Baseline in SGA of Psoriasis at Weeks 2, 4, 8, 12 ,18 and 24 | Participants were asked to rate the severity of their psoriasis disease activity on a 6-point scale, where 0=good and 5=severe. Change = Week X minus Baseline, where smaller scores indicate improvement. | mITT; LOCF; Number of participants analyzed (N)= participants with evaluable data | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Weeks 2, 4, 8, 12 ,18 and 24 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept | Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks | | OG001 | Etanercept and Acitretin | Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks. | | OG002 | Acitretin | Acitretin 10 mg subcutaneous injection BID for 24 weeks |
| |
| Secondary | Change From Baseline in SGA of Itching at Each Visit | Participants were asked to rate the severity of their psoriasis itching on a 6-point scale, where 0=good and 5=severe. Change = Week X minus Baseline, where smaller scores indicate improvement. | mITT; LOCF; Number of participants analyzed (N)= participants with evaluable data | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Weeks 2, 4, 8, 12 ,18 and 24 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept | Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks | | OG001 | Etanercept and Acitretin | Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks. | | OG002 | Acitretin | Acitretin 10 mg subcutaneous injection BID for 24 weeks |
| |
| Secondary | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 1, at Weeks 2, 4, 8, 12, 18 and 24 | Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the overall appearance of their skin. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement. | | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline, Weeks 2, 4, 8, 12, 18 and 24 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept | Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks | | OG001 | Etanercept and Acitretin | Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks. | | OG002 | Acitretin | Acitretin 10 mg subcutaneous injection BID for 24 weeks |
| |
| Secondary | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 2, at Weeks 2, 4, 8, 12, 18 and 24 | Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on the flaking of their skin. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement. | | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline, Weeks 2, 4, 8, 12, 18 and 24 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept | Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks | | OG001 | Etanercept and Acitretin | Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks. | | OG002 | Acitretin | Acitretin 10 mg subcutaneous injection BID for 24 weeks |
| |
| Secondary | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 3, at Weeks 2, 4, 8, 12, 18 and 24 | Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on the redness of their skin. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement. | | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline, Weeks 2, 4, 8, 12, 18 and 24 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept | Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks | | OG001 | Etanercept and Acitretin | Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks. | | OG002 | Acitretin | Acitretin 10 mg subcutaneous injection BID for 24 weeks |
| |
| Secondary | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 4, at Weeks 2, 4, 8, 12, 18 and 24 | Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on tightness in the skin. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement. | | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline, Weeks 2, 4, 8, 12, 18 and 24 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept | Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks | | OG001 | Etanercept and Acitretin | Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks. | | OG002 | Acitretin | Acitretin 10 mg subcutaneous injection BID for 24 weeks |
| |
| Secondary | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 5, at Weeks 2, 4, 8, 12, 18 and 24 | Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on bleeding of the skin. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement. | | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline, Weeks 2, 4, 8, 12, 18 and 24 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept | Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks | | OG001 | Etanercept and Acitretin | Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks. | | OG002 | Acitretin | Acitretin 10 mg subcutaneous injection BID for 24 weeks |
| |
| Secondary | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 6, at Weeks 2, 4, 8, 12, 18 and 24 | Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on burning sensation of the skin. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement. | | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline, Weeks 2, 4, 8, 12, 18 and 24 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept | Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks | | OG001 | Etanercept and Acitretin | Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks. | | OG002 | Acitretin | Acitretin 10 mg subcutaneous injection BID for 24 weeks |
| |
| Secondary | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 7, at Weeks 2, 4, 8, 12, 18 and 24 | Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on skin pain. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement. | | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline, Weeks 2, 4, 8, 12, 18 and 24 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept | Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks | | OG001 | Etanercept and Acitretin | Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks. | | OG002 | Acitretin | Acitretin 10 mg subcutaneous injection BID for 24 weeks |
| |
| Secondary | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 8, at Weeks 2, 4, 8, 12, 18 and 24 | Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on joint pain. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement. | | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline, Weeks 2, 4, 8, 12, 18 and 24 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept | Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks | | OG001 | Etanercept and Acitretin | Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks. | | OG002 | Acitretin | Acitretin 10 mg subcutaneous injection BID for 24 weeks |
| |
| Secondary | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 9, at Weeks 2, 4, 8, 12, 18 and 24 | Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on their comfort level with their personal appearance. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement. | | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline, Weeks 2, 4, 8, 12, 18 and 24 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept | Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks | | OG001 | Etanercept and Acitretin | Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks. | | OG002 | Acitretin | Acitretin 10 mg subcutaneous injection BID for 24 weeks |
|
| Secondary | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 10, at Weeks 2, 4, 8, 12, 18 and 24 | Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on their anxiety. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement. | | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline, Weeks 2, 4, 8, 12, 18 and 24 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept | Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks | | OG001 | Etanercept and Acitretin | Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks. | | OG002 | Acitretin | Acitretin 10 mg subcutaneous injection BID for 24 weeks |
| |
| Secondary | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 11, at Weeks 2, 4, 8, 12, 18 and 24 | Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on their depression. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement. | | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline, Weeks 2, 4, 8, 12, 18 and 24 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept | Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks | | OG001 | Etanercept and Acitretin | Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks. | | OG002 | Acitretin | Acitretin 10 mg subcutaneous injection BID for 24 weeks |
| |
| Secondary | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 12, at Weeks 2, 4, 8, 12, 18 and 24 | Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on their fatigue. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement. | | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline, Weeks 2, 4, 8, 12, 18 and 24 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept | Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks | | OG001 | Etanercept and Acitretin | Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks. | | OG002 | Acitretin | Acitretin 10 mg subcutaneous injection BID for 24 weeks |
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| Secondary | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 13, at Weeks 2, 4, 8, 12, 18 and 24 | Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on how others responded to their personal appearance at work/school. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement. | | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline, Weeks 2, 4, 8, 12, 18 and 24 | | | | ID | Title | Description |
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| OG000 | Etanercept | Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks | | OG001 | Etanercept and Acitretin | Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks. | | OG002 | Acitretin | Acitretin 10 mg subcutaneous injection BID for 24 weeks |
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| Secondary | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 14, at Weeks 2, 4, 8, 12, 18 and 24 | Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on how their skin affected social and leisure activities. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement. | | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline, Weeks 2, 4, 8, 12, 18 and 24 | | | | ID | Title | Description |
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| OG000 | Etanercept | Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks | | OG001 | Etanercept and Acitretin | Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks. | | OG002 | Acitretin | Acitretin 10 mg subcutaneous injection BID for 24 weeks |
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| Secondary | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 15, at Weeks 2, 4, 8, 12, 18 and 24 | Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: very dissatisfied (0), dissatisfied (1), neither satisfied nor dissatisfied (2), satisfied (3), very satisfied (4). Change = Week X minus Baseline, where larger scores indicate improvement. | | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline, Weeks 2, 4, 8, 12, 18 and 24 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept | Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks | | OG001 | Etanercept and Acitretin | Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks. | | OG002 | Acitretin | Acitretin 10 mg subcutaneous injection BID for 24 weeks |
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| Secondary | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 16, at Weeks 2, 4, 8, 12, 18 and 24 | Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to respond to the statement "I would like to continue with my current psoriasis treatment". Responses were based on a 5-point scale: strongly disagree (0), disagree(1), neither agree nor disagree (2), agree (3), strongly agree (4). Change = Week X minus Baseline, where larger scores indicate improvement. | | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline, Weeks 2, 4, 8, 12, 18 and 24 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept | Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks | | OG001 | Etanercept and Acitretin | Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks. | | OG002 | Acitretin | Acitretin 10 mg subcutaneous injection BID for 24 weeks |
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| Secondary | Change From Baseline in the Percentage of Participants Who Responded "Yes" to the Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 17, at Weeks 2, 4, 8, 12, 18 and 24 | Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to answer the following question with either a "yes" or "no", "Taking into account your psoriasis symptoms, the appearance of your skin and all other problems which psoriasis causes, do you consider that your current health state is satisfactory?" Percentage of participants who responded "yes" reported. | | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Baseline, Weeks 2, 4, 8, 12, 18 and 24 | | | | ID | Title | Description |
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| OG000 | Etanercept | Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks | | OG001 | Etanercept and Acitretin | Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks. | | OG002 | Acitretin | Acitretin 10 mg subcutaneous injection BID for 24 weeks |
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| Secondary | Change From Baseline in the Percentage of Participants Who Responded "Yes" to Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 18, at Weeks 2, 4, 8, 12, 18 and 24 | Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to answer the following question with either a "yes" or "no", "Taking into account your psoriasis symptoms, the appearance of your skin, medicine side effects and medicine ease/difficulty of use, do you consider that your current psoriasis treatment is satisfactory?" Percentage of participants who responded "yes" reported. | | Posted | | Number | 95% Confidence Interval | percentage of participants | | Baseline, Weeks 2, 4, 8, 12, 18 and 24 | | | | ID | Title | Description |
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| OG000 | Etanercept | Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks | | OG001 | Etanercept and Acitretin | Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks. | | OG002 | Acitretin | Acitretin 10 mg subcutaneous injection BID for 24 weeks |
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