| Primary | Achievement of Psoriasis Activity and Severity Index (PASI75) Response at Week 12 | Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities. PASI75 response at Week 12 is defined as a decrease in PASI score at Week 12 from Baseline of at least 75 %. | Intention-To-Treat (ITT) population consisting of all randomized subjects. | Posted | | Number | | percentage of subjects | | Week 12 | | | | ID | Title | Description |
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| OG000 | Placebo (ITT) | Subcutaneous injections of Placebo every 2 weeks | | OG001 | Certolizumab Pegol 200 mg (ITT) | Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter | | OG002 | Certolizumab Pegol 400 mg (ITT) | Subcutaneous injections of 400 mg every 2 weeks |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG0006.8
- OG00174.6
- OG00282.8
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| | 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 |
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| | Regression, Logistic | Logistic regression with treatment and baseline severity of psoriasis as factors. | <0.001 | | Odds Ratio (OR) | 40.2 | | | 2-Sided | 95 | 13.7 | 150.3 | | | Confidence limits are based on likelihood ratio statistics. | | Superiority | | | | |
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| Primary | Achievement of a Physician's Global Assessment (PGA) of Clear or Almost Clear at Week 12 | The overall severity of the disease was evaluated using the following 6-point scale: 5 = Severe: Very marked plaque elevation, scaling, and/or erythema. 4 = Moderate to severe: Marked plaque elevation, scaling, and/or erythema. 3 = Moderate: Moderate plaque elevation, scaling, and/or erythema. 2 = Mild: Slight plaque elevation, scaling, and/or erythema 1 = Almost clear: Intermediate between mild and clear 0 = Clear: No signs of psoriasis (post-inflammatory hyperpigmentation may be present) | Intention-To-Treat (ITT) population consisting of all randomized subjects. | Posted | | Number | | percentage of subjects | | Week 12 | | | | ID | Title | Description |
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| OG000 | Placebo (ITT) | Subcutaneous injections of Placebo every 2 weeks | | OG001 | Certolizumab Pegol 200 mg (ITT) | Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter | | OG002 | Certolizumab Pegol 400 mg (ITT) | Subcutaneous injections of 400 mg every 2 weeks |
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| Secondary | Time to Psoriasis Activity and Severity Index 50 (PASI50) | Time to PASI50 is defined as the time elapsed between the start of the Treatment Period (Week 0) and the first occurrence of PASI50 during the Treatment Period. This variable is defined only for those patients who have achieved PASI75 at the end of the Treatment Period (Week 12). | Only those subjects from the Intention-To-Treat (ITT) population who are PASI75 responder at Week 12 are included in the analysis of this variable. | Posted | | Median | 95% Confidence Interval | days | | During the 12-weeks Treatment Period | | | | ID | Title | Description |
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| OG000 | Placebo (ITT) | Subcutaneous injections of Placebo every 2 weeks | | OG001 | Certolizumab Pegol 200 mg (ITT) | Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter | | OG002 | Certolizumab Pegol 400 mg (ITT) | Subcutaneous injections of 400 mg every 2 weeks |
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| Secondary | Time to Psoriasis Activity and Severity Index 75 (PASI75) | Time to PASI75 is defined as the time elapsed between the start of the Treatment Period (Week 0) and the first occurrence of PASI75 during the Treatment Period. This variable is defined only for those patients who have achieved PASI75 at the end of the Treatment Period (Week 12). | Only those subjects from the Intention-To-Treat (ITT) population who are PASI75 responder at Week 12 are included in the analysis of this variable. | Posted | | Median | 95% Confidence Interval | days | | During the 12-weeks Treatment Period | | | | ID | Title | Description |
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| OG000 | Placebo (ITT) | Subcutaneous injections of Placebo every 2 weeks | | OG001 | Certolizumab Pegol 200 mg (ITT) | Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter | | OG002 | Certolizumab Pegol 400 mg (ITT) | Subcutaneous injections of 400 mg every 2 weeks |
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| Secondary | Time to Relapse | Time to relapse is defined as the time elapsed between the last dose and when maximal improvement in PASI from Baseline was reduced by > 50 %. This variable is defined only for those patients who have achieved PASI75 at the end of the Treatment Period (Week 12). | Only those subjects from the Intention-To-Treat (ITT) population who are PASI75 responder at Week 12 are included in the analysis of this variable. | Posted | | Median | 95% Confidence Interval | weeks | | During the 12-weeks Treatment Period | | | | ID | Title | Description |
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| OG000 | Placebo (ITT) | Subcutaneous injections of Placebo every 2 weeks | | OG001 | Certolizumab Pegol 200 mg (ITT) | Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter | | OG002 | Certolizumab Pegol 400 mg (ITT) | Subcutaneous injections of 400 mg every 2 weeks |
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| Secondary | Achievement of a Psoriasis Activity and Severity Index (PASI50) Response at Week 12 | Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities. PASI50 response at Week 12 is defined as a decrease in PASI score at Week 12 from Baseline of at least 50 %. | Intention-To-Treat (ITT) population consisting of all randomized subjects. | Posted | | Number | | percentage of subjects | | Week 12 | | | | ID | Title | Description |
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| OG000 | Placebo (ITT) | Subcutaneous injections of Placebo every 2 weeks | | OG001 | Certolizumab Pegol 200 mg (ITT) | Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter | | OG002 | Certolizumab Pegol 400 mg (ITT) | Subcutaneous injections of 400 mg every 2 weeks |
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| Secondary | Achievement of a Psoriasis Activity and Severity Index (PASI90) Response at Week 12 | Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities. PASI90 response at Week 12 is defined as a decrease in PASI score at Week 12 from Baseline of at least 90 %. | Intention-To-Treat (ITT) population consisting of all randomized subjects. | Posted | | Number | | percentage of subjects | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo (ITT) | Subcutaneous injections of Placebo every 2 weeks | | OG001 | Certolizumab Pegol 200 mg (ITT) | Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter | | OG002 | Certolizumab Pegol 400 mg (ITT) | Subcutaneous injections of 400 mg every 2 weeks |
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| Secondary | Experience of a Rebound Effect Within 2 Months After Stopping Therapy | Rebound is defined as worsening of psoriasis over baseline value with more than 125 % or new pustular, erythrodermic or more inflammatory psoriasis within 2 months of stopping therapy. | Intention-To-Treat (ITT) population consisting of all randomized subjects. | Posted | | Number | | percentage of subjects | | Within 2 months of stopping therapy | | | | ID | Title | Description |
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| OG000 | Placebo (ITT) | Subcutaneous injections of Placebo every 2 weeks | | OG001 | Certolizumab Pegol 200 mg (ITT) | Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter | | OG002 | Certolizumab Pegol 400 mg (ITT) | Subcutaneous injections of 400 mg every 2 weeks |
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| Secondary | Percent of Body Surface Area (BSA) Affected by Psoriasis at Week 12 | Two methods were used for the evaluation of BSA:
- The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis
- The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %)
| ITT population consisting of all randomized subjects. The analysis was performed for week 12 using observed case data (i.e., no imputation was performed for missing data). By week 12, there were 29 patients who had prematurely discontinued the study. | Posted | | Mean | Standard Deviation | percentage of affected Body Surface Area | | Week 12 | | | | ID | Title | Description |
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| OG000 | Placebo (ITT) | Subcutaneous injections of Placebo every 2 weeks | | OG001 | Certolizumab Pegol 200 mg (ITT) | Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter | | OG002 | Certolizumab Pegol 400 mg (ITT) | Subcutaneous injections of 400 mg every 2 weeks |
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| Secondary | Absolute Change From Baseline in the Body Surface Area (BSA) Affected by Psoriasis at Week 12 | Two methods were used for the evaluation of BSA:
- The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis
- The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %) A positive value in Change from Baseline indicates an improvement from Baseline. The higher the positive value, the higher the change.
| ITT population consisting of all randomized subjects. The analysis was performed for week 12 using observed case data (i.e., no imputation was performed for missing data). By week 12, there were 29 patients who had prematurely discontinued the study. | Posted | | Mean | Standard Deviation | Percent of total Body surface area | | Baseline up to Week 12 | | | | ID | Title | Description |
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| OG000 | Placebo (ITT) | Subcutaneous injections of Placebo every 2 weeks | | OG001 | Certolizumab Pegol 200 mg (ITT) | Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter | | OG002 | Certolizumab Pegol 400 mg (ITT) |
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| Secondary | Time to Discontinuation From the Treatment Period Due to Lack of Efficacy or Worsening of Psoriasis | | Intention-To-Treat (ITT) population consisting of all randomized subjects. | Posted | | Median | Full Range | days | | During the 12-week Treatment Period | | | | ID | Title | Description |
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| OG000 | Placebo (ITT) | Subcutaneous injections of Placebo every 2 weeks | | OG001 | Certolizumab Pegol 200 mg (ITT) | Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter | | OG002 | Certolizumab Pegol 400 mg (ITT) | Subcutaneous injections of 400 mg every 2 weeks |
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