| Primary | Number of Subjects With Physician's Global Assessment of Psoriasis (PGA) of Clear or Almost Clear at Week 16 | Number of subjects achieving a PGA of clear (representing no signs of plaque psoriasis) or almost clear (representing just perceptible erythema and scaling) at Week 16. The PGA is a 5-point scale used to measure the severity of disease at the time of the physician's evaluation of the subject. The degree of overall severity is rated as follows: 0-Clear, 1-Almost clear, 2-Mild, 3-Moderate, and 4-Severe. | Analysis was based on the intention to treat (ITT) subject population. Subjects who did not achieve PGA assessments at Week 16 were imputed as non-responders. | Posted | | Number | | subjects | | Week 16 | | | | ID | Title | Description |
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| OG000 | Placebo/Adalimumab | Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27. | | OG001 | Adalimumab | 80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind. |
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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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| The primary null hypothesis for this study was that there was no difference in the proportion of subjects that achieved PGA clear or almost clear at Week 16 between the adalimumab and placebo groups. Analysis was done using a two-sided Fisher's exact test at alpha level=0.05. | Fisher Exact | | 0.014 | | | | | | | 95 | | | | | | No | Superiority or Other | | |
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| Secondary | Mean Change From Baseline in Erythema, Scaling, Induration, and Fissuring (ESIF) | Severity of each sign of ESIF was assessed using a 4-point scale (0 = clear, 1 = mild, 2 = moderate, and 3 = severe). The ESIF was calculated by adding the scores for the 4 signs for the two soles and two palms, for a total range from 0 (no disease) to 48 points (most severe condition). A decrease from Baseline in ESIF indicates improvement. | Analysis was based on the ITT subject population and performed using last observation carried forward (LOCF) method. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 28 | | | | ID | Title | Description |
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| OG000 | Placebo/Adalimumab | Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27. | | OG001 | Adalimumab | 80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind. |
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| Secondary | Mean Change From Baseline in ESIF for Palms | Severity of each sign of ESIF was assessed using a 4-point scale (0 = clear, 1 = mild, 2 = moderate, and 3 = severe). The ESIF was calculated by adding the scores for the 4 signs for the palms of the hands, yielding a total range from 0 (no disease) to 24 points (most severe condition) for the palms. A decrease from Baseline in ESIF indicates improvement. | Analysis was based on the ITT subject population and performed using the LOCF method. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline and Weeks 2, 4, 12, 16, 20, 24, and 28 | | | | ID | Title | Description |
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| OG000 | Placebo/Adalimumab | Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27. | | OG001 | Adalimumab | 80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind. |
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| Secondary | Mean Change From Baseline in ESIF for Soles | Severity of each sign of ESIF was assessed using a 4-point scale (0 = clear, 1 = mild, 2 = moderate, and 3 = severe). The ESIF was calculated by adding the scores for the 4 signs for the soles of the feet, yielding a total range from 0 (no disease) to 24 points (most severe condition) for the soles. A decrease from Baseline in ESIF indicates improvement. | Analysis was based on the ITT subject population and performed using the LOCF method. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 28 | | | | ID | Title | Description |
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| OG000 | Placebo/Adalimumab | Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27. | | OG001 | Adalimumab | 80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind. |
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| Secondary | Number of Subjects With Moderate Improvement in ESIF From Baseline | Number of subjects that achieved > 50% reduction from Baseline in ESIF. | Analysis was based on the ITT subject population and performed using non-responder imputation (NRI). | Posted | | Number | | subjects | | Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 28 | | | | ID | Title | Description |
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| OG000 | Placebo/Adalimumab | Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27. | | OG001 | Adalimumab | 80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind. |
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| Secondary | Number of Subjects With Marked Improvement in ESIF From Baseline | Number of subjects that achieved > 75% reduction from Baseline in ESIF | Analysis was based on the ITT subject population and performed using non-responder imputation (NRI). | Posted | | Number | | subjects | | Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 28 | | | | ID | Title | Description |
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| OG000 | Placebo/Adalimumab | Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27. | | OG001 | Adalimumab | 80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind. |
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| Secondary | Mean Change From Baseline in Nail Psoriasis Severity Index (NAPSI) | For subjects with psoriasis nail involvement at Baseline, the target fingernail (most severely involved fingernail at Baseline) was assessed for NAPSI throughout the study. NAPSI ranges from 0 (no nail psoriasis) to 8 (most severe nail psoriasis). | Analysis was performed in the ITT subject population for subjects with nail involvement at baseline only and is based on LOCF. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline and Weeks 8, 16, and 28 | | | | ID | Title | Description |
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| OG000 | Placebo/Adalimumab | Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27. | | OG001 | Adalimumab | 80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind. |
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| Secondary | Number of Subjects With Physicians Global Assessment of Psoriasis (PGA) of Clear, Almost Clear, or Mild | Number of subjects achieving a PGA of clear (representing no signs of plaque psoriasis), almost clear (representing just perceptible erythema and scaling), or mild (representing light pink erythema with minimal scaling and with or without pustules). The PGA is a 5-point scale used to measure the severity of disease at the time of the physician's evaluation of the subject. The degree of overall severity is rated as follows: 0-Clear, 1-Almost clear, 2-Mild, 3-Moderate, and 4-Severe. | Analysis was based on the ITT subject population and performed using non-responder imputation (NRI). | Posted | | Number | | subjects | | Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, and 28 | | | | ID | Title | Description |
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| OG000 | Placebo/Adalimumab | Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27. | | OG001 | Adalimumab | 80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind. |
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| Secondary | Number of Subjects With PGA of Clear or Almost Clear | Number of subjects achieving a PGA of clear (representing no signs of plaque psoriasis) or almost clear (representing just perceptible erythema and scaling). The PGA is a 5-point scale used to measure the severity of disease at the time of the physician's evaluation of the subject. The degree of overall severity is rated as follows: 0-Clear, 1-Almost clear, 2-Mild, 3-Moderate, and 4-Severe. | Analysis was based on the ITT subject population and performed using non-responder imputation (NRI). | Posted | | Number | | subjects | | Baseline and Weeks 2, 4, 8, 12, 20, 24, and 28 | | | | ID | Title | Description |
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| OG000 | Placebo/Adalimumab | Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27. | | OG001 | Adalimumab | 80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind. |
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| Secondary | Number of Subjects With PGA of Clear | Number of subjects achieving a PGA of clear (representing no signs of plaque psoriasis). The PGA is a 5-point scale used to measure the severity of disease at the time of the physician's evaluation of the subject. The degree of overall severity is rated as follows: 0-Clear, 1-Almost clear, 2-Mild, 3-Moderate, and 4-Severe. | Analysis was based on the ITT subject population and performed using NRI. | Posted | | Number | | subjects | | Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, and 28 | | | | ID | Title | Description |
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| OG000 | Placebo/Adalimumab | Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27. | | OG001 | Adalimumab | 80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind. |
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| Secondary | Number of Subjects With Psoriasis Area and Severity Index (PASI) 50 | Number of subjects who achieved 50% or greater improvement from baseline PASI. The PASI scale is from 0 (no psoriasis) to 72 (complete erythroderma of the severest possible degree). | Analysis was based on the ITT subject population and performed using NRI. | Posted | | Number | | subjects | | Baseline and Weeks 16 and 28 | | | | ID | Title | Description |
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| OG000 | Placebo/Adalimumab | Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27. | | OG001 | Adalimumab | 80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind. |
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| Secondary | Number of Subjects With PASI 75 | Number of subjects who achieved 75% or greater improvement from baseline PASI. The PASI scale is from 0 (no psoriasis) to 72 (complete erythroderma of the severest possible degree). | Analysis was based on the ITT subject population and performed using NRI. | Posted | | Number | | subjects | | Baseline and Weeks 16 and 28 | | | | ID | Title | Description |
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| OG000 | Placebo/Adalimumab | Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27. | | OG001 | Adalimumab | 80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind. |
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| Secondary | Number of Subjects With PASI 90 | Number of subjects who achieved 90% or greater improvement from baseline PASI. The PASI scale is from 0 (no psoriasis) to 72 (complete erythroderma of the severest possible degree). | Analysis was based on the ITT subject population and performed using NRI. | Posted | | Number | | subjects | | Baseline and Weeks 16 and 28 | | | | ID | Title | Description |
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| OG000 | Placebo/Adalimumab | Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27. | | OG001 | Adalimumab | 80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind. |
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| Secondary | Number of Subjects With PASI 100 | Number of subjects who achieved 100% improvement from baseline PASI. The PASI scale is from 0 (no psoriasis) to 72 (complete erythroderma of the severest possible degree). | Analysis was based on the ITT subject population and performed using NRI. | Posted | | Number | | subjects | | Baseline and Weeks 16 and 28 | | | | ID | Title | Description |
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| OG000 | Placebo/Adalimumab | Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27. | | OG001 | Adalimumab | 80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind. |
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| Secondary | Mean Change From Baseline in Dermatology Life Quality Index (DLQI) | The DLQI consists of 10 questions and is scored from 0 (total lack of impairment) to 30 (life is very much impaired). A decrease in DLQI indicates improvement. | Analysis was based on the ITT subject population and performed using LOCF. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline and Weeks 2, 8, 16, and 28 | | | | ID | Title | Description |
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| OG000 | Placebo/Adalimumab | Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27. | | OG001 | Adalimumab | 80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind. |
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| Secondary | Number of Subjects Achieving a DLQI of 0 | Number of subjects achieving a DLQI score of 0, indicating total lack of impairment. The DLQI consists of 10 questions and is scored from 0 to 30 (life is very much impaired). A decrease in DLQI indicates improvement. | Analysis was based on the ITT subject population and performed using NRI. | Posted | | Number | | subjects | | Baseline and Weeks 2, 8, 16, and 28 | | | | ID | Title | Description |
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| OG000 | Placebo/Adalimumab | Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27. | | OG001 | Adalimumab | 80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind. |
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| Secondary | Mean Change From Baseline in Visual Analog Scale (VAS) for Psoriasis and Psoriatic Arthritis Pain | On one single VAS, subjects assessed their pain due to psoriasis (and psoriatic arthritis, if applicable). Mean change in psoriasis and psoriatic arthritis pain from Baseline as measured by a VAS from 0 (no pain) to 100 (pain as bad as it could be). | Analysis was based on the ITT subject population and performed using LOCF. | Posted | | Mean | Standard Deviation | mm on scale | | Baseline and Weeks 16 and 28 | | | | ID | Title | Description |
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| OG000 | Placebo/Adalimumab | Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27. | | OG001 | Adalimumab | 80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind. |
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| Secondary | Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Psoriasis (WPAI:PSO) | WPAI:PSO assesses the effect on the subject's ability to work and perform regular activities in 4 areas: % work time (in hours) missed due to psoriasis, % impairment while working (on a scale from 0 [psoriasis having no effect] to 10 [psoriasis completely prevented subject from working]), % overall work impairment (on a scale from 0 [psoriasis having no effect] to 10 [psoriasis completely prevented subject from working]), and % activity impairment (on a scale from 0 [psoriasis having no effect on daily activities] to 10 [psoriasis completely prevented subject from doing daily activities]). | Analysis was based on the ITT subject population and performed using LOCF. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline and Weeks 8, 16, and 28 | | | | ID | Title | Description |
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| OG000 | Placebo/Adalimumab | Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27. | | OG001 | Adalimumab | 80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind. |
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| Secondary | Mean Change From Baseline in Patient Health Questionnaire (PHQ-9) | The PHQ-9 consists of 9 questions that assess how often over the past 2 weeks subjects had signs or symptoms of depression (0=not at all, 1=several days, 2=more than half days, and 3=nearly every day). The PHQ-9 is the sum of the scores from the 9 questions for a total range from 0 (not depressed at all) to 27 (depressed nearly every day). | Analysis was based on the ITT subject population and performed using LOCF. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline and Weeks 2, 8, 16, and 28 | | | | ID | Title | Description |
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| OG000 | Placebo/Adalimumab | Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27. | | OG001 | Adalimumab | 80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind. |
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| Secondary | Number of Subjects With Difficulties According to PHQ-9 | Based on the 9 questions of the PHQ-9, if subjects indicated any problems (PHQ-9 score > 0), the difficulty to do work, take care of things at home, and get along with people (question 10 of the PHQ) were assessed (not difficult at all, somewhat difficult, very difficult, and extremely difficult). | Analysis was based on the ITT subject population. Missing values were imputed as "extremely difficult." | Posted | | Number | | subjects | | Baseline and Weeks 2, 8, 16, and 28 | | | | ID | Title | Description |
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| OG000 | Placebo/Adalimumab | Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27. | | OG001 | Adalimumab | 80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind. |
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