Trial · NCT02533375
Registered outcomes29
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 29
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of Participants Achieving Clinical Response at Week 16 | Baseline and Week 16 | Clinical Response was defined as reduction of the Generalized Pustular Psoriasis (GPP) total skin score (range 0-9, with 9 representing severe symptoms) relative to baseline (Day 1), according to Japan Dermatology Association (JDA) severity index in GPP medical care guideline 2014. The total skin score is the combined skin scores for area of erythema (redness), area of erythema with pustules (small pockets of pus), and area of edema (swelling). Clinical Response was defined as the improvement (reduction) of total skin score of at least 1 point (if the participant's baseline total skin score was 3); improvement (reduction) at least 2 points (if the participant's baseline total skin score was 4-9); or remission if the total skin score was 0. |
| Secondary | Number of Participants Achieving Clinical Response Over Time | Baseline, Week 2, Week 4, Week 8, Week 12, Week 24, Week 36, Week 52 | Clinical Response was defined as reduction of the Generalized Pustular Psoriasis (GPP) total skin score (range 0-9, with 9 representing severe symptoms) relative to baseline (Day 1), according to Japan Dermatology Association (JDA) severity index in GPP medical care guideline 2014. The total skin score is the combined skin scores for area of erythema (redness), area of erythema with pustules (small pockets of pus), and area of edema (swelling). Clinical Response was defined as the improvement (reduction) of total skin score of at least 1 point (if the participant's baseline total skin score was 3); improvement (reduction) at least 2 points (if the participant's baseline total skin score was 4-9); or remission if the total skin score was 0. |
| Secondary | Number of Participants Achieving Clinical Remission Over Time | Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52 | The Generalized Pustular Psoriasis (GPP) total skin score (range 0-9, with 9 representing severe symptoms) was calculated according to Japan Dermatology Association (JDA) severity index in GPP medical care guideline 2014. The total skin score is the combined skin scores for area of erythema (redness), area of erythema with pustules (small pockets of pus), and area of edema (swelling). Clinical remission was defined as a total skin score of 0. |
| Secondary | Mean Change From Baseline in the Total GPP Score Over Time | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52 | The Generalized Pustular Psoriasis (GPP) total score (range 0-17, with 17 representing severe disease) was calculated according to Japan Dermatology Association (JDA) severity index in GPP medical care guideline 2014. The total skin score (range 0-9, with 9 representing severe symptoms) is the combined skin scores for area of erythema (redness), area of erythema with pustules (small pockets of pus), and area of edema (swelling). The systemic and laboratory results score (\[range 0-8, with 8 representing severe disease\] assesses body temperature, white blood cell \[WBC\] count, high-sensitivity C-reactive protein \[hs-CRP\], and serum albumin). Negative values indicate improvement from baseline. |
| Secondary | Mean Change From Baseline in JDA Severity Index of GPP Over Time | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52 | The Generalized Pustular Psoriasis (GPP) total score (range 0-17, with 17 representing severe disease) was calculated according to Japan Dermatology Association (JDA) severity index in GPP medical care guideline 2014. The total skin score (range 0-9, with 9 representing severe symptoms) is the combined skin scores for area of erythema (redness), area of erythema with pustules (small pockets of pus), and area of edema (swelling). The systemic and laboratory results score (\[range 0-8, with 8 representing severe disease\] assesses body temperature, white blood cell \[WBC\] count, high-sensitivity C-reactive protein \[hs-CRP\], and serum albumin). A total score on the JDA severity index of 0-6 is categorized as "Mild", "Moderate" is 7-10, and "Severe" is 11-17. |
| Secondary | Mean Change From Baseline in Total Skin Score Over Time | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52 | The Generalized Pustular Psoriasis (GPP) total skin score (range 0-9, with 9 representing severe symptoms) was calculated according to Japan Dermatology Association (JDA) severity index in GPP medical care guideline 2014. The total skin score is the combined skin scores for area of erythema (redness), area of erythema with pustules (small pockets of pus), and area of edema (swelling). Negative values indicate improvement from baseline. |
| Secondary | Mean Percent Change From Baseline in Total Skin Score Over Time | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52 | The Generalized Pustular Psoriasis (GPP) total skin score (range 0-9, with 9 representing severe symptoms) was calculated according to Japan Dermatology Association (JDA) severity index in GPP medical care guideline 2014. The total skin score is the combined skin scores for area of erythema (redness), area of erythema with pustules (small pockets of pus), and area of edema (swelling). Negative values indicate improvement from baseline. |
| Secondary | Mean Change From Baseline in Total Systemic/Laboratory Test Score Over Time | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52 | The Generalized Pustular Psoriasis (GPP) total systemic/laboratory test score (\[range 0-8, with 8 representing severe disease\] assesses body temperature, white blood cell \[WBC\] count, high-sensitivity C-reactive protein \[hs-CRP\], and serum albumin). Negative values indicate improvement from baseline. |
| Secondary | Mean Change From Baseline in Total Erythema Area Over Time | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52 | The Generalized Pustular Psoriasis (GPP) skin score scores for the total area of erythema (redness) were calculated according to Japan Dermatology Association (JDA) severity index in GPP medical care guideline 2014. The total erythema area is evaluated on a scale of 0 (none) to 3 (severe), with the percentage of body surface area involvement defined as follows: severe ≥ 75%; moderate, ≥ 25% and \< 75%; mild, \< 25%); and none (0%). Negative values indicate improvement from baseline. |
| Secondary | Mean Change From Baseline in Total Erythema Area With Pustules Over Time | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52 | The Generalized Pustular Psoriasis (GPP) skin score scores for the total area of erythema with pustules (small pockets of pus) were calculated according to Japan Dermatology Association (JDA) severity index in GPP medical care guideline 2014. The total erythema area with pustules is evaluated on a scale of 0 (none) to 3 (severe), with the percentage of body surface area involvement defined as follows: severe ≥ 50%; moderate, ≥ 10% and \< 50%; mild, \< 10%); and none (0%). Negative values indicate improvement from baseline. |
| Secondary | Mean Change From Baseline in Total Edema Area Over Time | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52 | The Generalized Pustular Psoriasis (GPP) skin score scores for the total area of edema (swelling) were calculated according to Japan Dermatology Association (JDA) severity index in GPP medical care guideline 2014. The total area of edema is evaluated on a scale of 0 (none) to 3 (severe), with the percentage of body surface area involvement defined as follows: severe ≥ 50%; moderate, ≥ 10% and \< 50%; mild, \< 10%); and none (0%). Negative values indicate improvement from baseline. |
| Secondary | Mean Change From Baseline in Body Temperature Over Time | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52 | Body temperature (oral) was obtained at each visit prior to blood sampling. |
| Secondary | Mean Change From Baseline in White Blood Cell (WBC) Concentration Over Time | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52 | Blood was drawn at each study visit, and white blood cell concentration was determined. |
| Secondary | Mean Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP) Over Time | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52 | Blood was drawn at each study visit, and high-sensitivity C-reactive protein (hs-CRP) concentration was determined. |
| Secondary | Mean Change From Baseline in Serum Albumin Over Time | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52 | Blood was drawn at each study visit, and serum albumin concentration was determined. |
| Secondary | Number of Participants Achieving "Mild" in the JDA Severity Index of Generalized Pustular Psoriasis (GPP) for Participants With "Moderate" or "Severe" at Baseline Over Time | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52 | The Generalized Pustular Psoriasis (GPP) total score (range 0-17, with 17 representing severe disease) was calculated according to Japan Dermatology Association (JDA) severity index in GPP medical care guideline 2014. The total skin score (range 0-9, with 9 representing severe symptoms) is the combined skin scores for area of erythema (redness), area of erythema with pustules (small pockets of pus), and area of edema (swelling). The systemic and laboratory results score (\[range 0-8, with 8 representing severe disease\] assesses body temperature, white blood cell \[WBC\] count, high-sensitivity C-reactive protein \[hs-CRP\], and serum albumin). A total score on the JDA severity index of 0-6 is categorized as "Mild", "Moderate" is 7-10, and "Severe" is 11-17. |
| Secondary | Proportion of Participants Achieving Treatment Success in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Over Time | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52 | The Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) is a 6-point scale used to measure the severity of skin disease at the time of the qualified investigator's evaluation of the participant. The degree of overall severity was evaluated using the following categories: erythema, pustulation, and edema, and graded as follows. Grade 0 = cleared, except for residual discoloration; Grade 1 = minimal; Grade 2 = mild; Grade 3 = moderate; Grade 4 = severe; and Grade 5 = very severe. The score is an arithmetic average of the grades for erythema, pustulation, and edema, rounded to the nearest whole number. Treatment Success was defined by at least a 2 grade improvement relative to baseline. |
| Secondary | Change From Baseline in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade Over Time | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52 | The Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) is a 6-point scale used to measure the severity of skin disease at the time of the qualified investigator's evaluation of the participant. The degree of overall severity was evaluated using the following categories: erythema, pustulation, and edema, and graded as follows. Grade 0 = cleared, except for residual discoloration; Grade 1 = minimal; Grade 2 = mild; Grade 3 = moderate; Grade 4 = severe; and Grade 5 = very severe. The score is an arithmetic average of the grades for erythema, pustulation, and edema, rounded to the nearest whole number. |
| Secondary | Proportion of Participants Achieving Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade 0 or 1 for Those With PGA Grade of at Least 2 at Baseline Over Time | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52 | The Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) is a 6-point scale used to measure the severity of skin disease at the time of the qualified investigator's evaluation of the participant. The degree of overall severity was evaluated using the following categories: erythema, pustulation, and edema, and graded as follows. Grade 0 = cleared, except for residual discoloration; Grade 1 = minimal; Grade 2 = mild; Grade 3 = moderate; Grade 4 = severe; and Grade 5 = very severe. The score is an arithmetic average of the grades for erythema, pustulation, and edema, rounded to the nearest whole number. |
| Secondary | Proportion of Participants Achieving Psoriasis Area and Severity Index 90 (PASI 90) Over Time | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52 | The proportion of participants with a ≥ 90% reduction (improvement) in the Psoriasis Area and Severity Index (PASI) score from baseline was calculated. PASI is a combination of the intensity of psoriasis, assessed for erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from no symptoms (0), slight (1), moderate (2), marked (3) or very marked (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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