Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study was to investigate the efficacy, safety, and pharmacokinetics of adalimumab in Japanese participants with generalized pustular psoriasis (GPP) who did not have an adequate response to their currently approved treatment.
This was a Phase 3, multicenter, open-label, single-arm study of adalimumab in Japanese participants with generalized pustular psoriasis (GPP). The study included a 30-day screening period, a 52-week treatment period, and a 70-day follow-up period. The dose regimen of adalimumab used in this study was 80 mg at Week 0 by subcutaneous (SC) injection, followed by 40 mg every other week (eow) on and after Week 2 until Week 50. Dose escalation to 80 mg eow was allowed for participants who did not have adequate response on or after Week 8.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants receiving adalimumab | Experimental | 80 mg at Week 0 by subcutaneous (SC) injection, followed by 40 mg every other week (eow) on and after Week 2 until Week 50. Dose escalation to 80 mg eow was allowed for participants who did not have adequate response on or after Week 8. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adalimumab | Drug | Adalimumab pre-filled syringe, administered by subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants Achieving Clinical Response at 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. | Baseline and Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Achieving Clinical Response Over Time | 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Anne Robinson, PharmD | AbbVie | Study Director |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The Full Analysis Set (FAS) included all participants who received at least 1 dose of study drug and had at least 1 post-treatment efficacy assessment.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Participants Receiving Adalimumab | 80 mg at Week 0 by subcutaneous (SC) injection, followed by 40 mg every other week (eow) on and after Week 2 until Week 50. Dose escalation to 80 mg eow was allowed for participants who did not have adequate response on or after Week 8. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Full Analysis Set (FAS): all participants who received at least 1 dose of study drug and had at least 1 post-treatment efficacy assessment.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Participants Receiving Adalimumab | 80 mg at Week 0 by subcutaneous (SC) injection, followed by 40 mg every other week (eow) on and after Week 2 until Week 50. Dose escalation to 80 mg eow was allowed for participants who did not have adequate response on or after Week 8. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Proportion of Participants Achieving Clinical Response at 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. | Full Analysis Set (FAS): all participants who received at least 1 dose of study drug and had at least 1 post-treatment efficacy assessment; non-responder imputation was used for participants with missing data | Posted | Count of Participants | Participants | Baseline and Week 16 |
|
Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 62 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Participants Receiving Adalimumab | 80 mg at Week 0 by subcutaneous (SC) injection, followed by 40 mg every other week (eow) on and after Week 2 until Week 50. Dose escalation to 80 mg eow was allowed for participants who did not have adequate response on or after Week 8. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac failure | Cardiac disorders | MedDRA (19.1) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eosinophilia | Blood and lymphatic system disorders | MedDRA (19.1) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie | 800-633-9110 | abbvieclinicaltrials@abbvie.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 25, 2017 | Jun 11, 2018 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Jun 8, 2015 | Jun 11, 2018 | Prot_001.pdf |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068879 | Adalimumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Baseline, Week 2, Week 4, Week 8, Week 12, Week 24, Week 36, Week 52 |
| Number of Participants Achieving Clinical Remission Over Time | 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. | Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52 |
| Mean Change From Baseline in the Total GPP Score Over Time | 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. | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52 |
| Mean Change From Baseline in JDA Severity Index of GPP Over Time | 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. | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52 |
| Mean Change From Baseline in Total Skin Score Over Time | 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. | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52 |
| Mean Percent Change From Baseline in Total Skin Score Over Time | 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. | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52 |
| Mean Change From Baseline in Total Systemic/Laboratory Test Score Over Time | 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. | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52 |
| Mean Change From Baseline in Total Erythema Area Over Time | 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. | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52 |
| Mean Change From Baseline in Total Erythema Area With Pustules Over Time | 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. | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52 |
| Mean Change From Baseline in Total Edema Area Over Time | 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. | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52 |
| Mean Change From Baseline in Body Temperature Over Time | Body temperature (oral) was obtained at each visit prior to blood sampling. | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52 |
| Mean Change From Baseline in White Blood Cell (WBC) Concentration Over Time | Blood was drawn at each study visit, and white blood cell concentration was determined. | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52 |
| Mean Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP) Over Time | Blood was drawn at each study visit, and high-sensitivity C-reactive protein (hs-CRP) concentration was determined. | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52 |
| Mean Change From Baseline in Serum Albumin Over Time | Blood was drawn at each study visit, and serum albumin concentration was determined. | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52 |
| 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 | 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. | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52 |
| Proportion of Participants Achieving Treatment Success in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Over Time | 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. | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52 |
| Change From Baseline in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade Over Time | 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. | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52 |
| 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 | 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. | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52 |
| Proportion of Participants Achieving Psoriasis Area and Severity Index 90 (PASI 90) Over Time | 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. | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52 |
| Proportion of Participants Achieving Psoriasis Area and Severity Index 75 (PASI 75) Over Time | The proportion of participants with a ≥ 75% 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. | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52 |
| Proportion of Participants Achieving Psoriasis Area and Severity Index 50 (PASI 50) Over Time | The proportion of participants with a ≥ 50% 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. | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52 |
| Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score Over Time | The mean change 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. Negative values indicate improvement from baseline. | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52 |
| Mean Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score Over Time | The percent change 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. Negative values indicate improvement from baseline. | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52 |
| Proportion of Participants Achieving Dermatology Life Quality Index (DLQI) Score of 0 Over Time | The DLQI questionnaire asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week, and includes the following parameters: symptoms and feelings, daily activities, leisure activities, work or school activities, personal relationships and treatment- related feelings. Participants respond to 10 questions on a scale from 0 (not at all) to 3 (very much); the range of the total score is 0 to 30. A score of 21 to 30 means that psoriasis has an extremely large effect on the participant's life whereas 0-1 means that the disease has no effect at all. | Week 8, Week 16, Week 24, Week 36, Week 52 |
| Mean Change From Baseline in Dermatology Life Quality Index (DLQI) Score Over Time | The DLQI questionnaire asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week, and includes the following parameters: symptoms and feelings, daily activities, leisure activities, work or school activities, personal relationships and treatment- related feelings. Participants respond to 10 questions on a scale from 0 (not at all) to 3 (very much); the range of the total score is 0 to 30. A score of 21 to 30 means that psoriasis has an extremely large effect on the participant's life whereas 0-1 means that the disease has no effect at all. Negative values indicate improvement from baseline. | Baseline, Week 8, Week 16, Week 24, Week 36, Week 52 |
| Mean Change From Baseline in Short Form-36 Health Status Survey Version 2 (SF-36 V2) Score Over Time | The Short Form-36 Health Status Survey Version 2 (SF-36 V2) is a 36-item generic health-related quality of life questionnaire to assess the participant's view of their health consisting of 2 components: physical and mental. For each component, a transformed summary score is calculated using 8 sub-domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Scores range from 0 to 100. Higher scores indicate a better health state. | Baseline, Week 8, Week 16, Week 24, Week 36, Week 52 |
| Proportion of Participants Taking Systemic Co-medication for Generalized Pustular Psoriasis (GPP) at Any Time During the Study | GPP-specific co-medications were documented at each scheduled study visit. | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44, Week 48, Week 52 |
| Proportion of Participants Taking Topical Co-medication for Generalized Pustular Psoriasis (GPP) at Any Time During the Study | Participants using topical co-medications for GPP were documented at each scheduled study visit. | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44, Week 48, Week 52 |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Generalized Pustular Psoriasis (GPP) Duration | Mean | Standard Deviation | years |
|
| Prior GPP Therapy | Count of Participants | Participants |
|
| Prior Infliximab Use | Count of Participants | Participants |
|
| OG000 | Participants Receiving Adalimumab | 80 mg at Week 0 by subcutaneous (SC) injection, followed by 40 mg every other week (eow) on and after Week 2 until Week 50. Dose escalation to 80 mg eow was allowed for participants who did not have adequate response on or after Week 8. |
|
|
| Secondary | Number of Participants Achieving Clinical Response Over Time | 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. | Full Analysis Set (FAS): all participants who received at least 1 dose of study drug and had at least 1 post-treatment efficacy assessment; non-responder imputation was used for participants with missing data | Posted | Number | participants | Baseline, Week 2, Week 4, Week 8, Week 12, Week 24, Week 36, Week 52 |
|
|
|
| Secondary | Number of Participants Achieving Clinical Remission Over Time | 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. | Full Analysis Set (FAS): all participants who received at least 1 dose of study drug and had at least 1 post-treatment efficacy assessment; non-responder imputation was used for participants with missing data | Posted | Number | participants | Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52 |
|
|
|
| Secondary | Mean Change From Baseline in the Total GPP Score Over Time | 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. | Participants with available data | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52 |
|
|
|
| Secondary | Mean Change From Baseline in JDA Severity Index of GPP Over Time | 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. | Full Analysis Set (FAS): all participants who received at least 1 dose of study drug and had at least 1 post-treatment efficacy assessment | Posted | Count of Participants | Participants | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52 |
|
|
|
| Secondary | Mean Change From Baseline in Total Skin Score Over Time | 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. | Participants with available data | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52 |
|
|
|
| Secondary | Mean Percent Change From Baseline in Total Skin Score Over Time | 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. | Participants with available data | Posted | Mean | Standard Deviation | percentage change from baseline | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52 |
|
|
|
| Secondary | Mean Change From Baseline in Total Systemic/Laboratory Test Score Over Time | 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. | Participants with available data | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52 |
|
|
|
| Secondary | Mean Change From Baseline in Total Erythema Area Over Time | 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. | Participants with available data | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52 |
|
|
|
| Secondary | Mean Change From Baseline in Total Erythema Area With Pustules Over Time | 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. | Participants with available data | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52 |
|
|
|
| Secondary | Mean Change From Baseline in Total Edema Area Over Time | 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. | Participants with available data | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52 |
|
|
|
| Secondary | Mean Change From Baseline in Body Temperature Over Time | Body temperature (oral) was obtained at each visit prior to blood sampling. | Participants with available data | Posted | Mean | Standard Deviation | degrees Celsius | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52 |
|
|
|
| Secondary | Mean Change From Baseline in White Blood Cell (WBC) Concentration Over Time | Blood was drawn at each study visit, and white blood cell concentration was determined. | Participants with available data | Posted | Mean | Standard Deviation | cells/µL | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52 |
|
|
|
| Secondary | Mean Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP) Over Time | Blood was drawn at each study visit, and high-sensitivity C-reactive protein (hs-CRP) concentration was determined. | Participants with available data | Posted | Mean | Standard Deviation | mg/dL | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52 |
|
|
|
| Secondary | Mean Change From Baseline in Serum Albumin Over Time | Blood was drawn at each study visit, and serum albumin concentration was determined. | Participants with available data | Posted | Mean | Standard Deviation | g/dL | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52 |
|
|
|
| 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 | 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. | Participants with available data | Posted | Count of Participants | Participants | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52 |
|
|
|
| Secondary | Proportion of Participants Achieving Treatment Success in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Over Time | 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. | Participants with available data | Posted | Count of Participants | Participants | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52 |
|
|
|
| Secondary | Change From Baseline in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade Over Time | 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. | Participants with available data | Posted | Count of Participants | Participants | No | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52 |
|
|
|
| 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 | 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. | Participants with available data | Posted | Count of Participants | Participants | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52 |
|
|
|
| Secondary | Proportion of Participants Achieving Psoriasis Area and Severity Index 90 (PASI 90) Over Time | 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. | Participants with available data | Posted | Count of Participants | Participants | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52 |
|
|
|
| Secondary | Proportion of Participants Achieving Psoriasis Area and Severity Index 75 (PASI 75) Over Time | The proportion of participants with a ≥ 75% 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. | Participants with available data | Posted | Count of Participants | Participants | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52 |
|
|
|
| Secondary | Proportion of Participants Achieving Psoriasis Area and Severity Index 50 (PASI 50) Over Time | The proportion of participants with a ≥ 50% 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. | Participants with available data | Posted | Count of Participants | Participants | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52 |
|
|
|
| Secondary | Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score Over Time | The mean change 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. Negative values indicate improvement from baseline. | Participants with available data | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52 |
|
|
|
| Secondary | Mean Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score Over Time | The percent change 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. Negative values indicate improvement from baseline. | Participants with available data | Posted | Mean | Standard Deviation | percentage change from baseline | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52 |
|
|
|
| Secondary | Proportion of Participants Achieving Dermatology Life Quality Index (DLQI) Score of 0 Over Time | The DLQI questionnaire asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week, and includes the following parameters: symptoms and feelings, daily activities, leisure activities, work or school activities, personal relationships and treatment- related feelings. Participants respond to 10 questions on a scale from 0 (not at all) to 3 (very much); the range of the total score is 0 to 30. A score of 21 to 30 means that psoriasis has an extremely large effect on the participant's life whereas 0-1 means that the disease has no effect at all. | Participants with available data | Posted | Count of Participants | Participants | Week 8, Week 16, Week 24, Week 36, Week 52 |
|
|
|
| Secondary | Mean Change From Baseline in Dermatology Life Quality Index (DLQI) Score Over Time | The DLQI questionnaire asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week, and includes the following parameters: symptoms and feelings, daily activities, leisure activities, work or school activities, personal relationships and treatment- related feelings. Participants respond to 10 questions on a scale from 0 (not at all) to 3 (very much); the range of the total score is 0 to 30. A score of 21 to 30 means that psoriasis has an extremely large effect on the participant's life whereas 0-1 means that the disease has no effect at all. Negative values indicate improvement from baseline. | Participants with available data | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 8, Week 16, Week 24, Week 36, Week 52 |
|
|
|
| Secondary | Mean Change From Baseline in Short Form-36 Health Status Survey Version 2 (SF-36 V2) Score Over Time | The Short Form-36 Health Status Survey Version 2 (SF-36 V2) is a 36-item generic health-related quality of life questionnaire to assess the participant's view of their health consisting of 2 components: physical and mental. For each component, a transformed summary score is calculated using 8 sub-domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Scores range from 0 to 100. Higher scores indicate a better health state. | Participants with available data | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 8, Week 16, Week 24, Week 36, Week 52 |
|
|
|
| Secondary | Proportion of Participants Taking Systemic Co-medication for Generalized Pustular Psoriasis (GPP) at Any Time During the Study | GPP-specific co-medications were documented at each scheduled study visit. | Full Analysis Set (FAS): all participants who received at least 1 dose of study drug and had at least 1 post-treatment efficacy assessment | Posted | Count of Participants | Participants | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44, Week 48, Week 52 |
|
|
|
| Secondary | Proportion of Participants Taking Topical Co-medication for Generalized Pustular Psoriasis (GPP) at Any Time During the Study | Participants using topical co-medications for GPP were documented at each scheduled study visit. | Full Analysis Set (FAS): all participants who received at least 1 dose of study drug and had at least 1 post-treatment efficacy assessment | Posted | Count of Participants | Participants | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44, Week 48, Week 52 |
|
|
|
| 0 |
| 10 |
| 3 |
| 10 |
| 9 |
| 10 |
| Chronic sinusitis | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
|
| Enterocolitis bacterial | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA (19.1) | Systematic Assessment |
|
| Pustular psoriasis | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA (19.1) | Systematic Assessment |
|
| Autoimmune Thyroiditis | Endocrine disorders | MedDRA (19.1) | Systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA (19.1) | Systematic Assessment |
|
| Episcleritis | Eye disorders | MedDRA (19.1) | Systematic Assessment |
|
| Glaucoma | Eye disorders | MedDRA (19.1) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
|
| Oedema | General disorders | MedDRA (19.1) | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA (19.1) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (19.1) | Systematic Assessment |
|
| Hepatic Function Abnormal | Hepatobiliary disorders | MedDRA (19.1) | Systematic Assessment |
|
| Hepatic Steatosis | Hepatobiliary disorders | MedDRA (19.1) | Systematic Assessment |
|
| Liver disorder | Hepatobiliary disorders | MedDRA (19.1) | Systematic Assessment |
|
| Bacterial infection | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
|
| Body tinea | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
|
| Chronic sinusitis | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
|
| Enterocolitis bacterial | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
|
| Enterocolitis infectious | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
|
| Folliculitis | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA (19.1) | Systematic Assessment |
|
| Eye contusion | Injury, poisoning and procedural complications | MedDRA (19.1) | Systematic Assessment |
|
| Patella fracture | Injury, poisoning and procedural complications | MedDRA (19.1) | Systematic Assessment |
|
| Tooth fracture | Injury, poisoning and procedural complications | MedDRA (19.1) | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
|
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
|
| Malnutrition | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
|
| Periarthritis | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
|
| Spondylolisthesis | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
|
| Skin papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.1) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (19.1) | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA (19.1) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
|
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
|
| Pustular psoriasis | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
|
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| Title | Measurements |
|---|
|
| Week 12 |
|
| Week 24 |
|
| Week 36 |
|
| Week 52 |
|
| Title | Measurements |
|---|
|
| Week 12 |
|
| Week 16 |
|
| Week 24 |
|
| Week 36 |
|
| Week 52 |
|
|
| Week 8 |
|
|
| Week 12 |
|
|
| Week 16 |
|
|
| Week 24 |
|
|
| Week 36 |
|
|
| Week 52 |
|
|
| Missing |
|
| Week 2 |
|
| Week 4 |
|
| Week 8 |
|
| Week 12 |
|
| Week 16 |
|
| Week 24 |
|
| Week 36 |
|
| Week 52 |
|
|
| Week 8 |
|
|
| Week 12 |
|
|
| Week 16 |
|
|
| Week 24 |
|
|
| Week 36 |
|
|
| Week 52 |
|
|
|
| Week 8 |
|
|
| Week 12 |
|
|
| Week 16 |
|
|
| Week 24 |
|
|
| Week 36 |
|
|
| Week 52 |
|
|
|
| Week 8 |
|
|
| Week 12 |
|
|
| Week 16 |
|
|
| Week 24 |
|
|
| Week 36 |
|
|
| Week 52 |
|
|
|
| Week 8 |
|
|
| Week 12 |
|
|
| Week 16 |
|
|
| Week 24 |
|
|
| Week 36 |
|
|
| Week 52 |
|
|
|
| Week 8 |
|
|
| Week 12 |
|
|
| Week 16 |
|
|
| Week 24 |
|
|
| Week 36 |
|
|
| Week 52 |
|
|
|
| Week 8 |
|
|
| Week 12 |
|
|
| Week 16 |
|
|
| Week 24 |
|
|
| Week 36 |
|
|
| Week 52 |
|
|
|
| Week 8 |
|
|
| Week 12 |
|
|
| Week 16 |
|
|
| Week 24 |
|
|
| Week 36 |
|
|
| Week 52 |
|
|
|
| Week 8 |
|
|
| Week 12 |
|
|
| Week 16 |
|
|
| Week 24 |
|
|
| Week 36 |
|
|
| Week 52 |
|
|
|
| Week 8 |
|
|
| Week 12 |
|
|
| Week 16 |
|
|
| Week 24 |
|
|
| Week 36 |
|
|
| Week 52 |
|
|
|
| Week 8 |
|
|
| Week 12 |
|
|
| Week 16 |
|
|
| Week 24 |
|
|
| Week 36 |
|
|
| Week 52 |
|
|
|
| Week 8 |
|
|
| Week 12 |
|
|
| Week 16 |
|
|
| Week 24 |
|
|
| Week 36 |
|
|
| Week 52 |
|
|
|
| Week 8 |
|
|
| Week 12 |
|
|
| Week 16 |
|
|
| Week 24 |
|
|
| Week 36 |
|
|
| Week 52 |
|
|
| PGA Grade 2 |
|
| PGA Grade 3 |
|
| PGA Grade 4 |
|
| PGA Grade 5 |
|
| Week 2 |
|
|
| Week 4 |
|
|
| Week 8 |
|
|
| Week 12 |
|
|
| Week 16 |
|
|
| Week 24 |
|
|
| Week 36 |
|
|
| Week 52 |
|
|
|
| Week 8 |
|
|
| Week 12 |
|
|
| Week 16 |
|
|
| Week 24 |
|
|
| Week 36 |
|
|
| Week 52 |
|
|
|
| Week 8 |
|
|
| Week 12 |
|
|
| Week 16 |
|
|
| Week 24 |
|
|
| Week 36 |
|
|
| Week 52 |
|
|
|
| Week 8 |
|
|
| Week 12 |
|
|
| Week 16 |
|
|
| Week 24 |
|
|
| Week 36 |
|
|
| Week 52 |
|
|
|
| Week 8 |
|
|
| Week 12 |
|
|
| Week 16 |
|
|
| Week 24 |
|
|
| Week 36 |
|
|
| Week 52 |
|
|
|
| Week 8 |
|
|
| Week 12 |
|
|
| Week 16 |
|
|
| Week 24 |
|
|
| Week 36 |
|
|
| Week 52 |
|
|
|
| Week 8 |
|
|
| Week 12 |
|
|
| Week 16 |
|
|
| Week 24 |
|
|
| Week 36 |
|
|
| Week 52 |
|
|
|
| Week 24 |
|
|
| Week 36 |
|
|
| Week 52 |
|
|
|
| Week 24 |
|
|
| Week 36 |
|
|
| Week 52 |
|
|
|
| Physical Component Summary- Week 24 |
|
|
| Physical Component Summary- Week 36 |
|
|
| Physical Component Summary- Week 52 |
|
|
| Mental Component Summary- Week 8 |
|
|
| Mental Component Summary- Week 16 |
|
|
| Mental Component Summary- Week 24 |
|
|
| Mental Component Summary- Week 36 |
|
|
| Mental Component Summary- Week 52 |
|
|
| Title | Measurements |
|---|---|
|
| Cyclosporine |
|
| Title | Measurements |
|---|---|
|