| Primary | Time-Normalized Area Under Curve (AUC) of Physician Global Assessment (PGA) of Psoriasis Score at Week 52 | PGA psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration and scaling across all psoriatic lesions. PGA of Psoriasis scale ranges from 0 (no psoriasis) to 5 (severe disease). 'Clear' and "Almost clear' includes all participants who were scored as a 0 or 1. For participants who discontinued the study before week 52, the final PGA score was carried forward to the remaining time points before calculating the 52-week AUC. The AUC was calculated on the PGA score profile with the method of trapeziums from baseline visit to visit 52. The time-normalized AUC is defined as the ratio between AUC and the expected treatment period (days): AUC/ 52 weeks*7days + 1. | The modified intent-to-treat (mITT) population was the primary efficacy population and corresponded to all randomized subjects who had a baseline PGA and at least one postbaseline PGA. Last Observation Carried Forward (LOCF). | Posted | | Mean | Standard Deviation | Units on a scale | | Week 52 | | | | ID | Title | Description |
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| OG000 | Stop Arm | Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator | | OG001 | Maintenance Arm | Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG0001.64± 0.75
- OG0011.33± 0.76
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| Secondary | Time-Normalized Area Under Curve (AUC) of Dermatology Life Quality Index (DLQI) at Week 52 | 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). | The modified intent-to-treat (mITT) population was the primary efficacy population and corresponded to all randomized subjects who had a baseline PGA and at least one postbaseline PGA. | Posted | | Mean | Standard Deviation | Units on a scale | | Week 52 | | | | ID | Title | Description |
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| OG000 | Stop Arm | Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator | | OG001 | Maintenance Arm | Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator |
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| Secondary | Patient Psoriasis Satisfaction Questionnaire (PSSQ): The Overall Appearance of Skin, at Baseline, Before Retreatment, and at the End of Retreatment | 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) to very satisfied (4), and never had this problem (5). | mITT population was the primary efficacy population and corresponded to all randomized subjects who had a baseline PGA and at least one postbaseline PGA. | Posted | | Number | | Number of participants | | Baseline to Week 52 | | | | ID | Title | Description |
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| OG000 | Stop Arm | Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator | | OG001 | Maintenance Arm | Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator |
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| Secondary | Patient Psoriasis Satisfaction Questionnaire (PSSQ): Flaking Skin, at Baseline, Before Retreatment, and at the End of Retreatment | 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) to very satisfied (4), and never had this problem (5). | mITT population was the primary efficacy population and corresponded to all randomized subjects who had a baseline PGA and at least one postbaseline PGA. | Posted | | Number | | Number of Participants | | Baseline to Week 52 | | | | ID | Title | Description |
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| OG000 | Stop Arm | Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator | | OG001 | Maintenance Arm | Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator |
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| Secondary | Patient Psoriasis Satisfaction Questionnaire (PSSQ): Redness of the Skin, at Baseline, Before Retreatment, and at the End of Retreatment | 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) to very satisfied (4), and never had this problem (5). | mITT population was the primary efficacy population and corresponded to all randomized subjects who had a baseline PGA and at least one postbaseline PGA. | Posted | | Number | | Number of Participants | | Baseline to Week 52 | | | | ID | Title | Description |
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| OG000 | Stop Arm | Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator | | OG001 | Maintenance Arm | Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator |
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| Secondary | Patient Psoriasis Satisfaction Questionnaire (PSSQ): Tightness of the Skin, at Baseline, Before Retreatment, and at the End of Retreatment | 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) to very satisfied (4), and never had this problem (5). | mITT population was the primary efficacy population and corresponded to all randomized subjects who had a baseline PGA and at least one postbaseline PGA. | Posted | | Number | | Number of Participants | | Baseline to Week 52 | | | | ID | Title | Description |
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| OG000 | Stop Arm | Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator | | OG001 | Maintenance Arm | Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator |
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| Secondary | Patient Psoriasis Satisfaction Questionnaire (PSSQ): Bleeding of the Skin, at Baseline, Before Retreatment, and at the End of Retreatment | 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) to very satisfied (4), and never had this problem (5). | mITT population was the primary efficacy population and corresponded to all randomized subjects who had a baseline PGA and at least one postbaseline PGA. | Posted | | Number | | Number of Participants | | Baseline to Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Stop Arm | Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator | | OG001 | Maintenance Arm | Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator |
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| Secondary | Patient Psoriasis Satisfaction Questionnaire (PSSQ): Burning Sensation in the Skin, at Baseline, Before Retreatment, and at the End of Retreatment | 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) to very satisfied (4), and never had this problem (5). | mITT population was the primary efficacy population and corresponded to all randomized subjects who had a baseline PGA and at least one postbaseline PGA. | Posted | | Number | | Number of Participants | | Baseline to Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Stop Arm | Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator | | OG001 | Maintenance Arm | Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator |
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| Secondary | Patient Psoriasis Satisfaction Questionnaire (PSSQ): Skin Pain, at Baseline, Before Retreatment, and at the End of Retreatment | 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) to very satisfied (4), and never had this problem (5). | mITT population was the primary efficacy population and corresponded to all randomized subjects who had a baseline PGA and at least one postbaseline PGA. | Posted | | Number | | Number of Participants | | Baseline to Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Stop Arm | Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator | | OG001 | Maintenance Arm | Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator |
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| Secondary | Patient Psoriasis Satisfaction Questionnaire (PSSQ): Joint Pain, at Baseline, Before Retreatment, and at the End of Retreatment | 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) to very satisfied (4), and never had this problem (5). | mITT population was the primary efficacy population and corresponded to all randomized subjects who had a baseline PGA and at least one postbaseline PGA. | Posted | | Number | | Number of Participants | | Baseline to Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Stop Arm | Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator | | OG001 | Maintenance Arm | Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator |
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| Secondary | Patient Psoriasis Satisfaction Questionnaire (PSSQ): Your Comfort Level With Your Personal Appearance, at Baseline, Before Retreatment, and at the End of Retreatment | 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) to very satisfied (4), and never had this problem (5). | mITT population was the primary efficacy population and corresponded to all randomized subjects who had a baseline PGA and at least one postbaseline PGA. | Posted | | Number | | Number of Participants | | Baseline to Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Stop Arm | Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator | | OG001 | Maintenance Arm | Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator |
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| Secondary | Patient Psoriasis Satisfaction Questionnaire (PSSQ): Anxiety, at Baseline, Before Retreatment, and at the End of Retreatment | 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) to very satisfied (4), and never had this problem (5). | mITT population was the primary efficacy population and corresponded to all randomized subjects who had a baseline PGA and at least one postbaseline PGA. | Posted | | Number | | Number of Participants | | Baseline to Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Stop Arm | Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator | | OG001 | Maintenance Arm | Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator |
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| Secondary | Patient Psoriasis Satisfaction Questionnaire (PSSQ): Depression, at Baseline, Before Retreatment, and at the End of Retreatment | 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) to very satisfied (4), and never had this problem (5). | mITT population was the primary efficacy population and corresponded to all randomized subjects who had a baseline PGA and at least one postbaseline PGA. | Posted | | Number | | Number of Participants | | Baseline to Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Stop Arm | Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator | | OG001 | Maintenance Arm | Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator |
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| Secondary | Patient Psoriasis Satisfaction Questionnaire (PSSQ): Fatigue, at Baseline, Before Retreatment, and at the End of Retreatment | 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) to very satisfied (4), and never had this problem (5). | mITT population was the primary efficacy population and corresponded to all randomized subjects who has a baseline PGA and at least one postbaseline PGA. | Posted | | Number | | Number of Participants | | Baseline to Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Stop Arm | Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator | | OG001 | Maintenance Arm | Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator |
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| Secondary | Patient Psoriasis Satisfaction Questionnaire (PSSQ): How Others Respond to Your Personal Appearance at Work/School, at Baseline, Before Retreatment, and at the End of Retreatment | 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) to very satisfied (4), and never had this problem (5). | mITT) population was the primary efficacy population and corresponded to all randomized subjects who had a baseline PGA and at least one postbaseline PGA. | Posted | | Number | | Number of Participants | | Baseline to Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Stop Arm | Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator | | OG001 | Maintenance Arm | Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator |
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| Secondary | Patient Psoriasis Satisfaction Questionnaire (PSSQ): How Your Skin Affects Your Social and Leisure Activities, at Baseline, Before Retreatment, and at the End of Retreatment | 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) to very satisfied (4), and never had this problem (5). | mITT population was the primary efficacy population and corresponded to all randomized subjects who had a baseline PGA and at least one postbaseline PGA. | Posted | | Number | | Number of Participants | | Baseline to Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Stop Arm | Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator | | OG001 | Maintenance Arm | Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator |
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| Secondary | Patient Psoriasis Satisfaction Questionnaire (PSSQ): How Satisfied Were You With Your Psoriasis Treatment in General? at Baseline, Before Retreatment, and at the End of Retreatment | 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) to very satisfied (4), and never had this problem (5). | mITT population was the primary efficacy population and corresponded to all randomized subjects who has a baseline PGA and at least one postbaseline PGA. | Posted | | Number | | Number of Participants | | Baseline to Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Stop Arm | Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator | | OG001 | Maintenance Arm | Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator |
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| Secondary | Patient Psoriasis Satisfaction Questionnaire (PSSQ): I Would Like to Continue With my Current Psoriasis Treatment, at Baseline, Before Retreatment, and at the End of Retreatment | 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) to very satisfied (4), and never had this problem (5). | mITT population was the primary efficacy population and corresponded to all randomized subjects who has a baseline PGA and at least one postbaseline PGA. | Posted | | Number | | Number of Participants | | Baseline to Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Stop Arm | Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator | | OG001 | Maintenance Arm | Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator |
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| Secondary | Physician Global Assessment (PGA) of Disease Activity at Week 52 | 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) to very satisfied (4), and never had this problem (5). | The modified intent-to-treat (mITT) population will be the primary efficacy population and will correspond to all randomized subjects who have a baseline PGA and at least one postbaseline PGA. | Posted | | Mean | Standard Deviation | Units on a scale | | Week 52 | | | | ID | Title | Description |
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| OG000 | Stop Arm | Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator | | OG001 | Maintenance Arm | Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator |
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