| Primary | Percentage of Participants Who Achieve a PASI75 Response at Week 16 Compared With Baseline (Week 0) | PASI75 is defined as at least a 75% reduction in PASI (Psoriasis Area and Severity Index) score compared with the Baseline PASI score. PASI scores range from 0.0 (best) to 72.0 (worst), with the highest score representing complete erythroderma of the severest degree. The percent decrease in score is calculated as (Week 0 PASI score minus Week 16 PASI score) divided by Week 0 PASI score. Positive percent decreases indicate improvement, with best improvement being 100%. The outcome measure is the percentage of participants who had at least a 75% PASI score decrease. | ITT analysis; participants with a missing PASI assessment at Week 16 were imputed as nonresponders. | Posted | | Number | | percentage of participants | | Week 0 and Week 16 | | | | ID | Title | Description |
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| OG000 | Adalimumab + Placebo | adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15 | | OG001 | Adalimumab + Calcipotriol/Betamethasone | adalimumab + calcipotriol/betamethasone ointment |
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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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| Comparison of the proportion of participants in the adalimumab + calcipotriol/betamethasone group vs. the adalimumab + placebo group. | Cochran-Mantel-Haenszel | Two-sided CMH test stratified by country at the alpha level 0.05. Centers were pooled by country (Sweden and Finland pooled due to few participants). | 0.086 | Level of significance 5%; no adjustment for multiple comparisons necessary. | | | | | | | | | | | | No | Superiority or Other | | |
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| Secondary | Percentage of Participants With a PASI50 Response at Week 16 Compared With Baseline (Week 0) | PASI50 is defined as at least a 50% reduction in PASI (Psoriasis Area and Severity Index) score compared with the Baseline PASI score. PASI scores range from 0.0 (best) to 72.0 (worst), with the highest score representing complete erythroderma of the severest degree. The percent decrease in score is calculated as (Week 0 PASI score minus Week 16 PASI score) divided by Week 0 PASI score. Positive percent decreases indicate improvement, with best improvement 100%. The outcome measure is the percentage of participants who had at least a 50% PASI score decrease. | ITT analysis; participants with a missing PASI assessment at Week 16 were imputed as nonresponders. | Posted | | Number | | percentage of participants | | Week 0 and Week 16 | | | | ID | Title | Description |
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| OG000 | Adalimumab + Placebo | adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15 | | OG001 | Adalimumab + Calcipotriol/Betamethasone | adalimumab + calcipotriol/betamethasone ointment |
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| Secondary | Percentage of Participants With a PASI90 Response at Week 16 Compared With Baseline (Week 0) | PASI90 is defined as at least a 90% reduction in PASI (Psoriasis Area and Severity Index) score compared with the Baseline PASI score. PASI scores range from 0.0 (best) to 72.0 (worst), with the highest score representing complete erythroderma of the severest degree. The percent decrease in score is calculated as (Week 0 PASI score minus Week 16 PASI score) divided by Week 0 PASI score. Positive percent decreases indicate improvement, with best improvement 100%. The outcome measure is the percentage of participants who had at least a 90% PASI score decrease. | ITT analysis; participants with a missing PASI assessment at Week 16 were imputed as nonresponders. | Posted | | Number | | percentage of participants | | Week 0 and Week 16 | | | | ID | Title | Description |
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| OG000 | Adalimumab + Placebo | adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15 | | OG001 | Adalimumab + Calcipotriol/Betamethasone | adalimumab + calcipotriol/betamethasone ointment |
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| Secondary | Percentage of Participants With a PASI100 Response at Week 16 Compared With Baseline (Week 0) | PASI100 is defined as at least a 100% reduction in PASI (Psoriasis Area and Severity Index) score compared with the Baseline PASI score. PASI scores range from 0.0 (best) to 72.0 (worst) with the highest score representing complete erythroderma of the severest degree. The percent decrease in score is calculated as (Week 0 PASI score minus Week 16 PASI score) divided by Week 0 PASI score. Positive percent decreases indicate improvement, with best improvement 100%. The outcome measure is the percentage of participants who had at least a 100% PASI score decrease. | ITT analysis; participants with a missing PASI assessment at Week 16 were imputed as nonresponders. | Posted | | Number | | percentage of participants | | Week 0 and Week 16 | | | | ID | Title | Description |
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| OG000 | Adalimumab + Placebo | adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15 | | OG001 | Adalimumab + Calcipotriol/Betamethasone | adalimumab + calcipotriol/betamethasone ointment |
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| Secondary | Percentage of Participants Achieving a Physician's Global Assessment (PGA) of Clear or Minimal at Week 2 | PGA is a physician's assessment of severity of disease (grading lesion severity). PGA scores range from 0 (best) to 6 (worst): on the 6-point scale, a score of 0 = Clear and a score of 6 = Very Severe for the lesion severity. PGA Clear (0) is no plaque elevation over normal skin and no scale with or without erythema. Minimal (1) is possible plaque elevation but difficult to ascertain a slight elevation above normal skin. Percentage of participants: 0% to 100% (best). | ITT analysis. Imputation of missing values at Week 2 as not achieving PGA of Clear or Minimal. | Posted | | Number | | percentage of participants | | Week 2 | | | | ID | Title | Description |
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| OG000 | Adalimumab + Placebo | adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15 | | OG001 | Adalimumab + Calcipotriol/Betamethasone | adalimumab + calcipotriol/betamethasone ointment |
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| Secondary | Percentage of Participants Achieving a Physician's Global Assessment (PGA) of Clear or Minimal at Week 4 | PGA is a physician's assessment of severity of disease (grading lesion severity). PGA scores range from 0 (best) to 6 (worst): on the 6-point scale, a score of 0 = Clear and a score of 6 = Very Severe for the lesion severity. PGA Clear (0) is no plaque elevation over normal skin and no scale with or without erythema. Minimal (1) is possible plaque elevation but difficult to ascertain a slight elevation above normal skin. Percentage of participants: 0% to 100% (best). | ITT analysis. Imputation of missing values at Week 4 as not achieving PGA of Clear or Minimal. | Posted | | Number | | percentage of participants | | Week 4 | | | | ID | Title | Description |
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| OG000 | Adalimumab + Placebo | adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15 | | OG001 | Adalimumab + Calcipotriol/Betamethasone | adalimumab + calcipotriol/betamethasone ointment |
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| Other Pre-specified | Percent Change in Psoriasis Scalp Severity Index (PSSI) From Baseline to Week 16. | PSSI is a physician assessment of clinical symptoms of scalp psoriasis. Computed as the sum of scores for erythema, induration, and desquamation (1 = absent; 4 = severest possible) multiplied by involved area (0 = 0%; 6 = 90-100%). Total score range: 0 (best) to 72 (worst). Negative change and percent change from Baseline indicate improvement. | Of the ITT analysis set, participants with a PSSI score at both Baseline and Week 16. Imputation of missing values using LOCF. Subjects with a zero score at Baseline were not included in analysis of percent change. | Posted | | Median | Inter-Quartile Range | percent change in score | | Week 0 and Week 16 | | | | ID | Title | Description |
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| OG000 | Adalimumab + Placebo | adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15 | | OG001 | Adalimumab + Calcipotriol/Betamethasone | adalimumab + calcipotriol/betamethasone ointment |
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| Other Pre-specified | Percent Change in Nail Psoriasis Severity Index (NAPSI) at Week 16. | NAPSI is a sum of 2 scores that grade nail matrix psoriasis (based on presence/absence of pitting, leukonychia, red spots in the lunula, and nail plate crumbling) and nail bed psoriasis (based on presence/absence of onycholysis splinter hemorrhages, oil drop [salmon patch] discoloration, and nail bed hyperkeratosis). Each fingernail is given a single score based on presence of psoriasis in quadrant of nail: 0 (none) to 4 (present in 4/4 nail quadrants). Score range: 0 (best) to 80 (worst). Negative change and percent change from Baseline indicate improvement. | Of the ITT analysis set, participants with a NAPSI score at both Baseline and Week 16. Imputation of missing values using LOCF. Subjects with a zero score at Baseline were not included in analysis of percent change. | Posted | | Median | Inter-Quartile Range | percent change in score | | Week 0 and Week 16 | | | | ID | Title | Description |
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| OG000 | Adalimumab + Placebo | adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15 | | OG001 | Adalimumab + Calcipotriol/Betamethasone | adalimumab + calcipotriol/betamethasone ointment |
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| Secondary | Percentage of Participants Achieving a Physician's Global Assessment (PGA) of Clear or Minimal at Week 8 | PGA is a physician's assessment of severity of disease (grading lesion severity). PGA scores range from 0 (best) to 6 (worst): on the 6-point scale, a score of 0 = Clear and a score of 6 = Very Severe for the lesion severity. PGA Clear (0) is no plaque elevation over normal skin and no scale with or without erythema. Minimal (1) is possible plaque elevation but difficult to ascertain a slight elevation above normal skin. Percentage of participants: 0% to 100% (best). | ITT analysis. Imputation of missing values at Week 8 as not achieving PGA of Clear or Minimal. | Posted | | Number | | percentage of participants | | Week 8 | | | | ID | Title | Description |
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| OG000 | Adalimumab + Placebo | adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15 | | OG001 | Adalimumab + Calcipotriol/Betamethasone | adalimumab + calcipotriol/betamethasone ointment |
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| Secondary | Percentage of Participants Achieving a Physician's Global Assessment (PGA) of Clear or Minimal at Week 12 | PGA is a physician's assessment of severity of disease (grading lesion severity). PGA scores range from 0 (best) to 6 (worst): on the 6-point scale, a score of 0 = Clear and a score of 6 = Very Severe for the lesion severity. PGA Clear (0) is no plaque elevation over normal skin and no scale with or without erythema. Minimal (1) is possible plaque elevation but difficult to ascertain a slight elevation above normal skin. Percentage of participants: 0% to 100% (best). | ITT analysis. Imputation of missing values at Week 12 as not achieving PGA of Clear or Minimal. | Posted | | Number | | percentage of participants | | Week 12 | | | | ID | Title | Description |
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| OG000 | Adalimumab + Placebo | adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15 | | OG001 | Adalimumab + Calcipotriol/Betamethasone | adalimumab + calcipotriol/betamethasone ointment |
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| Secondary | Percentage of Participants Achieving a Physicians Global Assessment (PGA) Response of Clear or Minimal at Week 16 | PGA is a physician's assessment of severity of disease (grading lesion severity). PGA scores range from 0 (best) to 6 (worst): on the 6-point scale, a score of 0 = Clear and a score of 6 = Very Severe for the lesion severity. PGA Clear (0) is no plaque elevation over normal skin and no scale with or without erythema. Minimal (1) is possible plaque elevation but difficult to ascertain a slight elevation above normal skin. Percentage of participants: 0% to 100% (best). | ITT analysis. Imputation of missing values at Week 16 as not achieving PGA of Clear or Minimal. | Posted | | Number | | percentage of participants | | Week 16 | | | | ID | Title | Description |
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| OG000 | Adalimumab + Placebo | adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15 | | OG001 | Adalimumab + Calcipotriol/Betamethasone | adalimumab + calcipotriol/betamethasone ointment |
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| Secondary | Percent Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 16 Compared With Baseline (Week 0) | DLQI is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which (i.e., how much) the subject's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much, a lot, a little, or not at all. Total score range: 0 (best) to 30 (worst). Negative change and percent change from Baseline indicate improvement, with best improvement -100%. | Of the ITT analysis set, participants with DLQI scores both at Baseline and Week 16. Imputation of missing values using last observation carried forward (LOCF). Participants with a zero score at Baseline were not included in analysis of percent change. | Posted | | Mean | Standard Deviation | percent change in score | | Week 0 and Week 16 | | | | ID | Title | Description |
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| OG000 | Adalimumab + Placebo | adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15 | | OG001 | Adalimumab + Calcipotriol/Betamethasone | adalimumab + calcipotriol/betamethasone ointment |
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| Secondary | Percent Change in the Dermatology Life Quality Index (DLQI) Total Score at Week 2 Compared With Baseline (Week 0) | DLQI is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which (i.e., how much) the subject's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much, a lot, a little, or not at all. Total score range: 0 (best) to 30 (worst). Negative change and percent change from Baseline indicate improvement, with best improvement -100%. | Of the ITT analysis set, participants with DLQI scores at both Baseline and Week 2. Imputation of missing values using LOCF. Participants with a zero score at Baseline were not included in analysis of percent change. | Posted | | Mean | Standard Deviation | percent change in score | | Week 0 and Week 2 | | | | ID | Title | Description |
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| OG000 | Adalimumab + Placebo | adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15 | | OG001 | Adalimumab + Calcipotriol/Betamethasone | adalimumab + calcipotriol/betamethasone ointment |
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| Secondary | Percent Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 4 Compared With Baseline (Week 0) | DLQI is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which (i.e., how much) the subject's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much, a lot, a little, or not at all. Total score range: 0 (best) to 30 (worst). Negative change and percent change from Baseline indicate improvement, with best improvement -100%. | Of the ITT analysis set, participants with DLQI scores at both Baseline and Week 4. Imputation of missing values using LOCF. Participants with a zero score at Baseline were not included in the analysis of percent change. | Posted | | Mean | Standard Deviation | percent change in score | | Week 0 and Week 4 | | | | ID | Title | Description |
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| OG000 | Adalimumab + Placebo | adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15 | | OG001 | Adalimumab + Calcipotriol/Betamethasone | adalimumab + calcipotriol/betamethasone ointment |
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| Secondary | Percent Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 8 Compared With Baseline (Week 0) | DLQI is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which (i.e., how much) the subject's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much, a lot, a little, or not at all. Total score range: 0 (best) to 30 (worst). Negative change and percent change from Baseline indicate improvement, with best improvement -100%. | Of the ITT analysis set, participants with DLQI scores at both Baseline and Week 8. Imputation of missing values using LOCF. Participants with a zero score at Baseline were not included in analysis of percent change. | Posted | | Mean | Standard Deviation | percent change in score | | Week 0 and Week 8 | | | | ID | Title | Description |
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| OG000 | Adalimumab + Placebo | adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15 | | OG001 | Adalimumab + Calcipotriol/Betamethasone | adalimumab + calcipotriol/betamethasone ointment |
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| Secondary | Percent Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 12 Compared With Baseline (Week 0) | DLQI is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which (i.e., how much) the subject's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much, a lot, a little, or not at all. Total score range: 0 (best) to 30 (worst). Negative change and percent change from Baseline indicate improvement, with best improvement -100%. | Of the ITT analysis set, participants with DLQI scores at both Baseline and Week 12. Imputation of missing values using LOCF. Participants with a zero score at Baseline were not included in analysis of percent change. | Posted | | Mean | Standard Deviation | percent change in score | | Week 0 and Week 12 | | | | ID | Title | Description |
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| OG000 | Adalimumab + Placebo | adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15 | | OG001 | Adalimumab + Calcipotriol/Betamethasone | adalimumab + calcipotriol/betamethasone ointment |
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| Secondary | Percent Change in Short Form 36 Health Survey (SF-36) Physical Component Score (PCS) at Week 16 Compared With Baseline (Week 0) | Short Form 36 Health Survey (SF-36) Physical Component Score (PCS) is a participant-reported outcome that employs a questionnaire that asks for the participant's views about their health. Percent change at Week 16 is calculated as (Week 16 SF-36 PCS minus Week 0 SF-36 PCS) divided by Week 0 SF-36 PCS. Positive percent change in score indicates improvement, with best improvement 100%. | Of the ITT analysis set, participants with an SF-36 score at both Baseline and Week 16. Imputation of missing values using LOCF. Participants with a zero score at Baseline were not included in the analysis of percent change. | Posted | | Mean | Standard Deviation | percent change in score | | Week 0 and Week 16 | | | | ID | Title | Description |
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| OG000 | Adalimumab + Placebo | adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15 | | OG001 | Adalimumab + Calcipotriol/Betamethasone | adalimumab + calcipotriol/betamethasone ointment |
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| Secondary | Percent Change in Short Form 36 Health Survey (SF-36) Physical Component Score (PCS) at Week 8 Compared With Baseline (Week 0) | Short Form 36 Health Survey (SF-36) Physical Component Score (PCS) is a participant-reported outcome that employs a questionnaire that asks for the participant's views about their health. Percent change at Week 8 is calculated as (Week 8 SF-36 PCS minus Week 0 SF-36 PCS) divided by Week 0 SF-36 PCS. Positive percent change in score indicates improvement, with best improvement 100%. | Of the ITT analysis set, participants with an SF-36 score both at Baseline and Week 8. Imputation of missing values using LOCF. Participants with a zero score at Baseline were not included in the analysis of percent change. | Posted | | Mean | Standard Deviation | percent change in score | | Week 0 and Week 8 | | | | ID | Title | Description |
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| OG000 | Adalimumab + Placebo | adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15 | | OG001 | Adalimumab + Calcipotriol/Betamethasone | adalimumab + calcipotriol/betamethasone ointment |
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