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The survey will be conducted with regard to the following aspects of treatment with Humira (adalimumab) in patients with psoriasis vulgaris and psoriatic arthritis receiving this drug:
This study was non-interventional, open-labeled, all-cases, central registration method, post marketing observational study in which Humira was prescribed for patients with psoriasis vulgaris and/or psoriatic arthritis in routine medical practice.
When investigators prescribed Humira to an eligible patient who provided informed consent, they filled out a registration form and send it to the registration center via postal mail. At the end of the 24-week observation period, an investigator filled out a case report form for each patient to describe the findings during the study period, and provided the completed form to medical representatives. Even if Humira treatment was for any reason discontinued, the investigators followed each such participant for 24 weeks after the first administration of Humira, and filled out a case report form for the participant at the end of the 24-week period.
Some participants entered this study from study NCT00647400 (M04-702), a Phase III extension study of Humira (adalimumab) in Japan.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Humira | Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs), Serious Adverse Drug Reactions (SADRs), Deaths, and Discontinuations Due to AEs | This study was mandated by the Japanese government as an approval condition for Humira in Japan; therefore, definitions of adverse events and seriousness criteria were applicable as specified in the Japanese local standard operating procedures, based on local Japanese regulations. ADRs were defined as adverse events for which the causal relationship with Humira was other than "not related" (ie, "probable," "possible," or "unclear"). The count of participants with AEs presented in this table includes serious and nonserious AEs. The count of participants with discontinuations due to AEs includes those who discontinued due to an AE plus other reasons. Please see Safety section for further details regarding adverse events. | From study registration through Week 24 |
| Physician's Global Assessment at Week 4 | The Physician's Global Assessment (PGA) is a 6-point scale used to measure the severity of disease at the time of the physician's evaluation of the participant. The degree of overall lesion severity was evaluated using the following categories:
| Week 4 |
| Physician's Global Assessment At Week 8 | The Physician's Global Assessment (PGA) is a 6-point scale used to measure the severity of disease at the time of the physician's evaluation of the participant. The degree of overall lesion severity was evaluated using the following categories:
|
| Measure | Description | Time Frame |
|---|---|---|
| Physician's Overall Response Rating At Week 24 | Overall response rating, according to investigator's subjective clinical opinion. The level of overall improvement rating was categorized as "markedly improved," "improved," "not changed," or "not assessable," comparing clinical conditions at Week 24 or at discontinuation with Baseline conditions. | Baseline and Week 24 |
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Inclusion Criteria:
All patients who receive Humira for the treatment of psoriasis vulgaris or psoriatic arthritis not responding to conventional treatment will be evaluated. Eligible patients should be
Exclusion Criteria:
Contraindications according to the Package Insert include patients who have any of the following:
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All patients who receive Humira for the treatment of psoriasis vulgaris or psoriatic arthritis
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| Name | Affiliation | Role |
|---|---|---|
| Yuji Yamaguchi, MD | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 41606 | Aichi | Japan | ||||
| Site Reference ID/Investigator# 41769 |
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| Label | URL |
|---|---|
| Related Info | View source |
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Of the 752 participants registered, 4 participants did not have case report forms retrieved (2 whose registration was duplicated and 2 who did not receive Humira). Of the remaining 748 participants, 14 were excluded from analysis (7 changed hospital after registration, 7 didn't visit clinic after the first Humira administration).
Ninety-four participants entered this study from study NCT00647400 (M04-702), a Phase III extension study of Humira (adalimumab) in Japan.
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| ID | Title | Description |
|---|---|---|
| FG000 | Humira | Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Week 8 |
| Physician's Global Assessment at Week 16 | The Physician's Global Assessment (PGA) is a 6-point scale used to measure the severity of disease at the time of the physician's evaluation of the participant. The degree of overall lesion severity was evaluated using the following categories:
| Week 16 |
| Physician's Global Assessment at Week 24 | The Physician's Global Assessment (PGA) is a 6-point scale used to measure the severity of disease at the time of the physician's evaluation of the participant. The degree of overall lesion severity was evaluated using the following categories:
| Week 24 |
| Psoriasis Area and Severity Index (PASI) at Week 16 | PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). | Week 16 |
| Psoriasis Area and Severity Index (PASI) at Week 24 | PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). | Week 24 |
| Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response at Week 16 | PASI75 is defined as at least a 75% reduction in PASI (Psoriasis Area and Severity Index) score compared with the Baseline PASI score. PASI scores range from 0 (best) to 72 (worst), with the highest score representing complete erythroderma of the severest degree. The percent decrease in score is calculated as (Week 0 PASI score minus Week 16 PASI score) divided by Week 0 PASI score. | Baseline and Week 16 |
| Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response at Week 24 | PASI75 is defined as at least a 75% reduction in PASI (Psoriasis Area and Severity Index) score compared with the Baseline PASI score. PASI scores range from 0 (best) to 72 (worst), with the highest score representing complete erythroderma of the severest degree. The percent decrease in score is calculated as (Week 0 PASI score minus Week 24 PASI score) divided by Week 0 PASI score. | Baseline and Week 24 |
| Percentage of Participants With Psoriasis Area and Severity Index 90 (PASI90) Response at Week 16 | PASI90 is defined as at least a 90% reduction in PASI (Psoriasis Area and Severity Index) score compared with the Baseline PASI score. PASI scores range from 0 (best) to 72 (worst), with the highest score representing complete erythroderma of the severest degree. The percent decrease in score is calculated as (Week 0 PASI score minus Week 16 PASI score) divided by Week 0 PASI score. | Baseline and Week 16 |
| Percentage of Participants With Psoriasis Area and Severity Index 90 (PASI90) Response at Week 24 | PASI90 is defined as at least a 90% reduction in PASI (Psoriasis Area and Severity Index) score compared with the Baseline PASI score. PASI scores range from 0 (best) to 72 (worst), with the highest score representing complete erythroderma of the severest degree. The percent decrease in score is calculated as (Week 0 PASI score minus Week 24 PASI score) divided by Week 0 PASI score. | Baseline and Week 24 |
| Dermatology Life Quality Index at Week 16 | Dermatology Life Quality Index (DLQI) score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot (score of 2), a little (score of 1), or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired. | Week 16 |
| Dermatology Life Quality Index at Week 24 | Dermatology Life Quality Index (DLQI) score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot (score of 2), a little (score of 1), or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired. | Week 24 |
| Pain Visual Analog Scale (VAS) at Week 4 | Participants assessed their pain due to psoriatic arthritis in the past week, on a single-line Visual Analog Scale (VAS) from 0 (no pain) to 100 (pain as bad as it could be). | Week 4 |
| Pain Visual Analog Scale (VAS) at Week 16 | Participants assessed their pain due to psoriatic arthritis in the past week, on a single-line Visual Analog Scale (VAS) from 0 (no pain) to 100 (pain as bad as it could be). | Week 16 |
| Pain Visual Analog Scale (VAS) at Week 24 | Participants assessed their pain due to psoriatic arthritis in the past week, on a single-line Visual Analog Scale (VAS) from 0 (no pain) to 100 (pain as bad as it could be). | Week 24 |
| Disease Activity Score 28-4, Erythrocyte Sedimentation Rate (DAS28-4 [ESR]) at Week 4 | DAS28-4 (ESR) is calculated using the number of tender and swollen joints (out of 28 counted), erythrocyte sedimentation rate (ESR), and the patient's global assessment of disease activity via the visual analog scale (VAS). The calculated range of DAS28-4 is 0 to 10. A score less than 2.6 indicates clinical remission, a score of 2.6 to 3.2 indicates low disease activity, a score of 3.2 to less than 5.1 indicates moderate disease activity, and a score of 5.1 or greater indicates high disease activity. | Week 4 |
| Disease Activity Score 28-4, Erythrocyte Sedimentation Rate (DAS28-4 [ESR]) at Week 16 | DAS28-4 (ESR) is calculated using the number of tender and swollen joints (out of 28 counted), erythrocyte sedimentation rate (ESR), and the patient's global assessment of disease activity via the visual analog scale (VAS). The calculated range of DAS28-4 is 0 to 10. A score less than 2.6 indicates clinical remission, a score of 2.6 to 3.2 indicates low disease activity, a score of 3.2 to less than 5.1 indicates moderate disease activity, and a score of 5.1 or greater indicates high disease activity. | Week 16 |
| Disease Activity Score 28-4, Erythrocyte Sedimentation Rate (DAS28-4 [ESR]) at Week 24 | DAS28-4 (ESR) is calculated using the number of tender and swollen joints (out of 28 counted), erythrocyte sedimentation rate (ESR), and the patient's global assessment of disease activity via the visual analog scale (VAS). The calculated range of DAS28-4 is 0 to 10. A score less than 2.6 indicates clinical remission, a score of 2.6 to 3.2 indicates low disease activity, a score of 3.2 to less than 5.1 indicates moderate disease activity, and a score of 5.1 or greater indicates high disease activity. | Week 24 |
| Disease Activity Score 28-4, C-reactive Protein (DAS28-4 [CRP]) at Week 4 | DAS28-4 (CRP) is calculated using the number of tender and swollen joints (out of 28 counted), C-reactive protein (CRP) level, and the patient's global assessment of disease activity via the visual analog scale (VAS). The calculated range of DAS28-4 is 0 to 10. A score less than 2.6 indicates clinical remission, a score of 2.6 to 3.2 indicates low disease activity, a score of 3.2 to less than 5.1 indicates moderate disease activity, and a score of 5.1 or greater indicates high disease activity. | Week 4 |
| Disease Activity Score 28-4, C-reactive Protein (DAS28-4 [CRP]) at Week 16 | DAS28-4 (CRP) is calculated using the number of tender and swollen joints (out of 28 counted), C-reactive protein (CRP) level, and the patient's global assessment of disease activity via the visual analog scale (VAS). The calculated range of DAS28-4 is 0 to 10. A score less than 2.6 indicates clinical remission, a score of 2.6 to 3.2 indicates low disease activity, a score of 3.2 to less than 5.1 indicates moderate disease activity, and a score of 5.1 or greater indicates high disease activity. | Week 16 |
| Disease Activity Score 28-4, C-reactive Protein (DAS28-4 [CRP]) at Week 24 | DAS28-4 (CRP) is calculated using the number of tender and swollen joints (out of 28 counted), C-reactive protein (CRP) level, and the patient's global assessment of disease activity via the visual analog scale (VAS). The calculated range of DAS28-4 is 0 to 10. A score less than 2.6 indicates clinical remission, a score of 2.6 to 3.2 indicates low disease activity, a score of 3.2 to less than 5.1 indicates moderate disease activity, and a score of 5.1 or greater indicates high disease activity. | Week 24 |
| Aichi |
| Japan |
| Site Reference ID/Investigator# 41810 | Aichi | Japan |
| Site Reference ID/Investigator# 56131 | Aichi | Japan |
| Site Reference ID/Investigator# 56251 | Aichi | Japan |
| Site Reference ID/Investigator# 56252 | Aichi | Japan |
| Site Reference ID/Investigator# 56254 | Aichi | Japan |
| Site Reference ID/Investigator# 56340 | Aichi | Japan |
| Site Reference ID/Investigator# 60016 | Aichi | Japan |
| Site Reference ID/Investigator# 67150 | Aichi | Japan |
| Site Reference ID/Investigator# 68627 | Aichi | Japan |
| Site Reference ID/Investigator# 41327 | Aizu-Wakamatsu | Japan |
| Site Reference ID/Investigator# 41820 | Akita | Japan |
| Site Reference ID/Investigator# 41823 | Akita | Japan |
| Site Reference ID/Investigator# 41684 | Amagasaki | Japan |
| Site Reference ID/Investigator# 41851 | Amagasaki | Japan |
| Site Reference ID/Investigator# 41305 | Anjo | Japan |
| Site Reference ID/Investigator# 41822 | Aomori | Japan |
| Site Reference ID/Investigator# 60012 | Aomori | Japan |
| Site Reference ID/Investigator# 64811 | Aomori | Japan |
| Site Reference ID/Investigator# 41800 | Asahikawa | Japan |
| Site Reference ID/Investigator# 80887 | Ashikaga | Japan |
| Site Reference ID/Investigator# 80879 | Ayabe | Japan |
| Site Reference ID/Investigator# 41207 | Bunkyo-ku, Tokyo | Japan |
| Site Reference ID/Investigator# 41247 | Chiba | Japan |
| Site Reference ID/Investigator# 41258 | Chiba | Japan |
| Site Reference ID/Investigator# 41260 | Chiba | Japan |
| Site Reference ID/Investigator# 41263 | Chiba | Japan |
| Site Reference ID/Investigator# 41485 | Chiba | Japan |
| Site Reference ID/Investigator# 41821 | Chiba | Japan |
| Site Reference ID/Investigator# 41927 | Chiba | Japan |
| Site Reference ID/Investigator# 56127 | Chiba | Japan |
| Site Reference ID/Investigator# 56224 | Chiba | Japan |
| Site Reference ID/Investigator# 59995 | Chiba | Japan |
| Site Reference ID/Investigator# 41893 | Chūō | Japan |
| Site Reference ID/Investigator# 41721 | Ehime | Japan |
| Site Reference ID/Investigator# 41724 | Ehime | Japan |
| Site Reference ID/Investigator# 41727 | Ehime | Japan |
| Site Reference ID/Investigator# 80873 | Fujieda | Japan |
| Site Reference ID/Investigator# 41287 | Fujisawa | Japan |
| Site Reference ID/Investigator# 41550 | Fukui | Japan |
| Site Reference ID/Investigator# 41693 | Fukui | Japan |
| Site Reference ID/Investigator# 41694 | Fukui | Japan |
| Site Reference ID/Investigator# 41697 | Fukui | Japan |
| Site Reference ID/Investigator# 41746 | Fukui | Japan |
| Site Reference ID/Investigator# 41805 | Fukui | Japan |
| Site Reference ID/Investigator# 41326 | Fukuoka | Japan |
| Site Reference ID/Investigator# 41476 | Fukuoka | Japan |
| Site Reference ID/Investigator# 41604 | Fukuoka | Japan |
| Site Reference ID/Investigator# 41607 | Fukuoka | Japan |
| Site Reference ID/Investigator# 41731 | Fukuoka | Japan |
| Site Reference ID/Investigator# 41734 | Fukuoka | Japan |
| Site Reference ID/Investigator# 41747 | Fukuoka | Japan |
| Site Reference ID/Investigator# 41796 | Fukuoka | Japan |
| Site Reference ID/Investigator# 41812 | Fukuoka | Japan |
| Site Reference ID/Investigator# 56349 | Fukuoka | Japan |
| Site Reference ID/Investigator# 56350 | Fukuoka | Japan |
| Site Reference ID/Investigator# 59987 | Fukuoka | Japan |
| Site Reference ID/Investigator# 59991 | Fukuoka | Japan |
| Site Reference ID/Investigator# 41745 | Fukushima | Japan |
| Site Reference ID/Investigator# 41757 | Fukushima | Japan |
| Site Reference ID/Investigator# 41758 | Fukushima | Japan |
| Site Reference ID/Investigator# 41818 | Fukushima | Japan |
| Site Reference ID/Investigator# 41824 | Fukushima | Japan |
| Site Reference ID/Investigator# 41825 | Fukushima | Japan |
| Site Reference ID/Investigator# 56095 | Fukushima | Japan |
| Site Reference ID/Investigator# 56242 | Fukushima | Japan |
| Site Reference ID/Investigator# 56330 | Fukushima | Japan |
| Site Reference ID/Investigator# 41301 | Gifu | Japan |
| Site Reference ID/Investigator# 41302 | Gifu | Japan |
| Site Reference ID/Investigator# 41306 | Gifu | Japan |
| Site Reference ID/Investigator# 41309 | Gifu | Japan |
| Site Reference ID/Investigator# 41322 | Gifu | Japan |
| Site Reference ID/Investigator# 41774 | Gifu | Japan |
| Site Reference ID/Investigator# 56103 | Gifu | Japan |
| Site Reference ID/Investigator# 59989 | Gifu | Japan |
| Site Reference ID/Investigator# 41830 | Gunma | Japan |
| Site Reference ID/Investigator# 56122 | Gunma | Japan |
| Site Reference ID/Investigator# 56123 | Gunma | Japan |
| Site Reference ID/Investigator# 56207 | Gunma | Japan |
| Site Reference ID/Investigator# 59986 | Gunma | Japan |
| Site Reference ID/Investigator# 59997 | Gunma | Japan |
| Site Reference ID/Investigator# 41828 | Hakodate | Japan |
| Site Reference ID/Investigator# 41303 | Hamamatsu | Japan |
| Site Reference ID/Investigator# 41304 | Hamamatsu | Japan |
| Site Reference ID/Investigator# 59992 | Hamamatsu | Japan |
| Site Reference ID/Investigator# 80895 | Hamamatsu | Japan |
| Site Reference ID/Investigator# 56135 | Hannan | Japan |
| Site Reference ID/Investigator# 56198 | Higashihiroshima | Japan |
| Site Reference ID/Investigator# 41748 | Himeji | Japan |
| Site Reference ID/Investigator# 41917 | Himeji | Japan |
| Site Reference ID/Investigator# 41668 | Hirakata | Japan |
| Site Reference ID/Investigator# 41915 | Hirosaki | Japan |
| Site Reference ID/Investigator# 41712 | Hiroshima | Japan |
| Site Reference ID/Investigator# 41713 | Hiroshima | Japan |
| Site Reference ID/Investigator# 41714 | Hiroshima | Japan |
| Site Reference ID/Investigator# 41715 | Hiroshima | Japan |
| Site Reference ID/Investigator# 41716 | Hiroshima | Japan |
| Site Reference ID/Investigator# 41717 | Hiroshima | Japan |
| Site Reference ID/Investigator# 41753 | Hiroshima | Japan |
| Site Reference ID/Investigator# 41773 | Hiroshima | Japan |
| Site Reference ID/Investigator# 41833 | Hiroshima | Japan |
| Site Reference ID/Investigator# 41835 | Hiroshima | Japan |
| Site Reference ID/Investigator# 56196 | Hiroshima | Japan |
| Site Reference ID/Investigator# 56197 | Hiroshima | Japan |
| Site Reference ID/Investigator# 56346 | Hiroshima | Japan |
| Site Reference ID/Investigator# 56347 | Hiroshima | Japan |
| Site Reference ID/Investigator# 59988 | Hiroshima | Japan |
| Site Reference ID/Investigator# 59999 | Hiroshima | Japan |
| Site Reference ID/Investigator# 60013 | Hiroshima | Japan |
| Site Reference ID/Investigator# 60017 | Hiroshima | Japan |
| Site Reference ID/Investigator# 60018 | Hiroshima | Japan |
| Site Reference ID/Investigator# 41827 | Hokkaido | Japan |
| Site Reference ID/Investigator# 41829 | Hokkaido | Japan |
| Site Reference ID/Investigator# 41832 | Hokkaido | Japan |
| Site Reference ID/Investigator# 41837 | Hokkaido | Japan |
| Site Reference ID/Investigator# 41838 | Hokkaido | Japan |
| Site Reference ID/Investigator# 41842 | Hokkaido | Japan |
| Site Reference ID/Investigator# 41844 | Hokkaido | Japan |
| Site Reference ID/Investigator# 41847 | Hokkaido | Japan |
| Site Reference ID/Investigator# 41852 | Hokkaido | Japan |
| Site Reference ID/Investigator# 41929 | Hokkaido | Japan |
| Site Reference ID/Investigator# 56109 | Hokkaido | Japan |
| Site Reference ID/Investigator# 56206 | Hokkaido | Japan |
| Site Reference ID/Investigator# 56327 | Hokkaido | Japan |
| Site Reference ID/Investigator# 60014 | Hokkaido | Japan |
| Site Reference ID/Investigator# 64802 | Hokkaido | Japan |
| Site Reference ID/Investigator# 64813 | Hokkaido | Japan |
| Site Reference ID/Investigator# 67144 | Hokkaido | Japan |
| Site Reference ID/Investigator# 71456 | Hokkaido | Japan |
| Site Reference ID/Investigator# 41481 | Hyōgo | Japan |
| Site Reference ID/Investigator# 41683 | Hyōgo | Japan |
| Site Reference ID/Investigator# 41687 | Hyōgo | Japan |
| Site Reference ID/Investigator# 41691 | Hyōgo | Japan |
| Site Reference ID/Investigator# 41750 | Hyōgo | Japan |
| Site Reference ID/Investigator# 41771 | Hyōgo | Japan |
| Site Reference ID/Investigator# 41846 | Hyōgo | Japan |
| Site Reference ID/Investigator# 56142 | Hyōgo | Japan |
| Site Reference ID/Investigator# 56143 | Hyōgo | Japan |
| Site Reference ID/Investigator# 56144 | Hyōgo | Japan |
| Site Reference ID/Investigator# 56146 | Hyōgo | Japan |
| Site Reference ID/Investigator# 56342 | Hyōgo | Japan |
| Site Reference ID/Investigator# 56343 | Hyōgo | Japan |
| Site Reference ID/Investigator# 60015 | Hyōgo | Japan |
| Site Reference ID/Investigator# 67149 | Hyōgo | Japan |
| Site Reference ID/Investigator# 41848 | Ibaraki | Japan |
| Site Reference ID/Investigator# 41849 | Ibaraki | Japan |
| Site Reference ID/Investigator# 41858 | Ibaraki | Japan |
| Site Reference ID/Investigator# 41908 | Ichikawa | Japan |
| Site Reference ID/Investigator# 41293 | Ichinomiya | Japan |
| Site Reference ID/Investigator# 56229 | Ichinomiya | Japan |
| Site Reference ID/Investigator# 56333 | Ichinomiya | Japan |
| Site Reference ID/Investigator# 41696 | Iijima | Japan |
| Site Reference ID/Investigator# 56137 | Ikoma | Japan |
| Site Reference ID/Investigator# 56226 | Inabe | Japan |
| Site Reference ID/Investigator# 56120 | Inashiki | Japan |
| Site Reference ID/Investigator# 80893 | Inzai | Japan |
| Site Reference ID/Investigator# 41740 | Isahaya | Japan |
| Site Reference ID/Investigator# 56230 | Isesaki | Japan |
| Site Reference ID/Investigator# 41330 | Ishikawa | Japan |
| Site Reference ID/Investigator# 41543 | Ishikawa | Japan |
| Site Reference ID/Investigator# 41695 | Ishikawa | Japan |
| Site Reference ID/Investigator# 41920 | Ishikawa | Japan |
| Site Reference ID/Investigator# 41889 | Iwafune | Japan |
| Site Reference ID/Investigator# 56348 | Iwakuni | Japan |
| Site Reference ID/Investigator# 80916 | Iwakuni | Japan |
| Site Reference ID/Investigator# 41704 | Izumo | Japan |
| Site Reference ID/Investigator# 41719 | Izumo | Japan |
| Site Reference ID/Investigator# 56195 | Izumo | Japan |
| Site Reference ID/Investigator# 41294 | Izunokuni | Japan |
| Site Reference ID/Investigator# 41299 | Izunokuni | Japan |
| Site Reference ID/Investigator# 41300 | Izunokuni | Japan |
| Site Reference ID/Investigator# 60006 | Jōetsu | Japan |
| Site Reference ID/Investigator# 41720 | Kagawa | Japan |
| Site Reference ID/Investigator# 41725 | Kagawa | Japan |
| Site Reference ID/Investigator# 56200 | Kagawa | Japan |
| Site Reference ID/Investigator# 56201 | Kagawa | Japan |
| Site Reference ID/Investigator# 41737 | Kagoshima | Japan |
| Site Reference ID/Investigator# 67145 | Kagoshima | Japan |
| Site Reference ID/Investigator# 41283 | Kanagawa | Japan |
| Site Reference ID/Investigator# 41284 | Kanagawa | Japan |
| Site Reference ID/Investigator# 41451 | Kanagawa | Japan |
| Site Reference ID/Investigator# 41452 | Kanagawa | Japan |
| Site Reference ID/Investigator# 41815 | Kanagawa | Japan |
| Site Reference ID/Investigator# 41854 | Kanagawa | Japan |
| Site Reference ID/Investigator# 41856 | Kanagawa | Japan |
| Site Reference ID/Investigator# 41862 | Kanagawa | Japan |
| Site Reference ID/Investigator# 56098 | Kanagawa | Japan |
| Site Reference ID/Investigator# 56250 | Kanagawa | Japan |
| Site Reference ID/Investigator# 60011 | Kanagawa | Japan |
| Site Reference ID/Investigator# 64805 | Kanagawa | Japan |
| Site Reference ID/Investigator# 68629 | Kanagawa | Japan |
| Site Reference ID/Investigator# 41699 | Kanazawa | Japan |
| Site Reference ID/Investigator# 41762 | Kariya | Japan |
| Site Reference ID/Investigator# 41461 | Kashihara | Japan |
| Site Reference ID/Investigator# 41486 | Kashiwa | Japan |
| Site Reference ID/Investigator# 41482 | Kawagoe | Japan |
| Site Reference ID/Investigator# 41484 | Kawagoe | Japan |
| Site Reference ID/Investigator# 41784 | Kawagoe | Japan |
| Site Reference ID/Investigator# 41279 | Kawasaki | Japan |
| Site Reference ID/Investigator# 41280 | Kawasaki | Japan |
| Site Reference ID/Investigator# 41281 | Kawasaki | Japan |
| Site Reference ID/Investigator# 41282 | Kawasaki | Japan |
| Site Reference ID/Investigator# 71453 | Kawasaki | Japan |
| Site Reference ID/Investigator# 80880 | Kawasaki | Japan |
| Site Reference ID/Investigator# 41269 | Kisarazu | Japan |
| Site Reference ID/Investigator# 41733 | Kitakyushu | Japan |
| Site Reference ID/Investigator# 41735 | Kitakyushu | Japan |
| Site Reference ID/Investigator# 68626 | Kitakyushu | Japan |
| Site Reference ID/Investigator# 71454 | Kitakyushu | Japan |
| Site Reference ID/Investigator# 80892 | Kitakyushu | Japan |
| Site Reference ID/Investigator# 41471 | Kobe | Japan |
| Site Reference ID/Investigator# 41472 | Kobe | Japan |
| Site Reference ID/Investigator# 41544 | Kobe | Japan |
| Site Reference ID/Investigator# 41686 | Kobe | Japan |
| Site Reference ID/Investigator# 56090 | Kobe | Japan |
| Site Reference ID/Investigator# 56145 | Kobe | Japan |
| Site Reference ID/Investigator# 56264 | Kobe | Japan |
| Site Reference ID/Investigator# 80874 | Kobe | Japan |
| Site Reference ID/Investigator# 80883 | Kobe | Japan |
| Site Reference ID/Investigator# 80914 | Kobe | Japan |
| Site Reference ID/Investigator# 41480 | Kochi | Japan |
| Site Reference ID/Investigator# 41548 | Kochi | Japan |
| Site Reference ID/Investigator# 89493 | Kofu | Japan |
| Site Reference ID/Investigator# 60003 | Komaki | Japan |
| Site Reference ID/Investigator# 67153 | Komoro | Japan |
| Site Reference ID/Investigator# 41262 | Koshigaya | Japan |
| Site Reference ID/Investigator# 41817 | Kōnan | Japan |
| Site Reference ID/Investigator# 41798 | Kōriyama | Japan |
| Site Reference ID/Investigator# 41819 | Kōriyama | Japan |
| Site Reference ID/Investigator# 64808 | Kōtari | Japan |
| Site Reference ID/Investigator# 56263 | Kudamatsu | Japan |
| Site Reference ID/Investigator# 56087 | Kumamoto | Japan |
| Site Reference ID/Investigator# 56351 | Kumamoto | Japan |
| Site Reference ID/Investigator# 41467 | Kurashiki | Japan |
| Site Reference ID/Investigator# 41903 | Kurashiki | Japan |
| Site Reference ID/Investigator# 41904 | Kurashiki | Japan |
| Site Reference ID/Investigator# 41926 | Kurashiki | Japan |
| Site Reference ID/Investigator# 60001 | Kurashiki | Japan |
| Site Reference ID/Investigator# 41718 | Kure | Japan |
| Site Reference ID/Investigator# 41689 | Kurobe | Japan |
| Site Reference ID/Investigator# 41460 | Kurume | Japan |
| Site Reference ID/Investigator# 56202 | Kurume | Japan |
| Site Reference ID/Investigator# 41839 | Kushiro | Japan |
| Site Reference ID/Investigator# 41454 | Kyoto | Japan |
| Site Reference ID/Investigator# 41698 | Kyoto | Japan |
| Site Reference ID/Investigator# 41700 | Kyoto | Japan |
| Site Reference ID/Investigator# 41705 | Kyoto | Japan |
| Site Reference ID/Investigator# 41768 | Kyoto | Japan |
| Site Reference ID/Investigator# 41801 | Kyoto | Japan |
| Site Reference ID/Investigator# 41806 | Kyoto | Japan |
| Site Reference ID/Investigator# 41905 | Kyoto | Japan |
| Site Reference ID/Investigator# 41921 | Kyoto | Japan |
| Site Reference ID/Investigator# 56193 | Kyoto | Japan |
| Site Reference ID/Investigator# 56194 | Kyoto | Japan |
| Site Reference ID/Investigator# 56259 | Kyoto | Japan |
| Site Reference ID/Investigator# 56344 | Kyoto | Japan |
| Site Reference ID/Investigator# 60005 | Kyoto | Japan |
| Site Reference ID/Investigator# 64807 | Kyoto | Japan |
| Site Reference ID/Investigator# 41831 | Maebashi | Japan |
| Site Reference ID/Investigator# 41834 | Maebashi | Japan |
| Site Reference ID/Investigator# 56121 | Maebashi | Japan |
| Site Reference ID/Investigator# 67263 | Maebashi | Japan |
| Site Reference ID/Investigator# 59994 | Maizuru | Japan |
| Site Reference ID/Investigator# 41900 | Matsumoto | Japan |
| Site Reference ID/Investigator# 41901 | Matsumoto | Japan |
| Site Reference ID/Investigator# 41324 | Matsuyama | Japan |
| Site Reference ID/Investigator# 41723 | Matsuyama | Japan |
| Site Reference ID/Investigator# 41902 | Matsuyama | Japan |
| Site Reference ID/Investigator# 41308 | Mie | Japan |
| Site Reference ID/Investigator# 41749 | Mie | Japan |
| Site Reference ID/Investigator# 56208 | Mie | Japan |
| Site Reference ID/Investigator# 56255 | Mie | Japan |
| Site Reference ID/Investigator# 59996 | Mie | Japan |
| Site Reference ID/Investigator# 41608 | Minato | Japan |
| Site Reference ID/Investigator# 41794 | Minato | Japan |
| Site Reference ID/Investigator# 41760 | Mito | Japan |
| Site Reference ID/Investigator# 41855 | Miyagi | Japan |
| Site Reference ID/Investigator# 41859 | Miyagi | Japan |
| Site Reference ID/Investigator# 41861 | Miyagi | Japan |
| Site Reference ID/Investigator# 41865 | Miyagi | Japan |
| Site Reference ID/Investigator# 41871 | Miyagi | Japan |
| Site Reference ID/Investigator# 56111 | Miyagi | Japan |
| Site Reference ID/Investigator# 56112 | Miyagi | Japan |
| Site Reference ID/Investigator# 56329 | Miyagi | Japan |
| Site Reference ID/Investigator# 41475 | Miyazaki | Japan |
| Site Reference ID/Investigator# 41790 | Miyazaki | Japan |
| Site Reference ID/Investigator# 41791 | Miyazaki | Japan |
| Site Reference ID/Investigator# 41919 | Miyazaki | Japan |
| Site Reference ID/Investigator# 60021 | Miyazaki | Japan |
| Site Reference ID/Investigator# 41458 | Morioka | Japan |
| Site Reference ID/Investigator# 41462 | Nagakute | Japan |
| Site Reference ID/Investigator# 41545 | Nagakute | Japan |
| Site Reference ID/Investigator# 41797 | Nagano | Japan |
| Site Reference ID/Investigator# 41863 | Nagano | Japan |
| Site Reference ID/Investigator# 41866 | Nagano | Japan |
| Site Reference ID/Investigator# 41870 | Nagano | Japan |
| Site Reference ID/Investigator# 56124 | Nagano | Japan |
| Site Reference ID/Investigator# 41464 | Nagasaki | Japan |
| Site Reference ID/Investigator# 41728 | Nagasaki | Japan |
| Site Reference ID/Investigator# 41730 | Nagasaki | Japan |
| Site Reference ID/Investigator# 41736 | Nagasaki | Japan |
| Site Reference ID/Investigator# 41756 | Nagasaki | Japan |
| Site Reference ID/Investigator# 41789 | Nagasaki | Japan |
| Site Reference ID/Investigator# 41864 | Nagasaki | Japan |
| Site Reference ID/Investigator# 41877 | Nagasaki | Japan |
| Site Reference ID/Investigator# 41289 | Nagoya | Japan |
| Site Reference ID/Investigator# 41290 | Nagoya | Japan |
| Site Reference ID/Investigator# 41549 | Nagoya | Japan |
| Site Reference ID/Investigator# 41744 | Nagoya | Japan |
| Site Reference ID/Investigator# 41802 | Nagoya | Japan |
| Site Reference ID/Investigator# 41909 | Nagoya | Japan |
| Site Reference ID/Investigator# 41910 | Nagoya | Japan |
| Site Reference ID/Investigator# 56130 | Nagoya | Japan |
| Site Reference ID/Investigator# 41804 | Nanao | Japan |
| Site Reference ID/Investigator# 41478 | Nankoku | Japan |
| Site Reference ID/Investigator# 41710 | Nara | Japan |
| Site Reference ID/Investigator# 56091 | Nara | Japan |
| Site Reference ID/Investigator# 56227 | Nara | Japan |
| Site Reference ID/Investigator# 59985 | Nara | Japan |
| Site Reference ID/Investigator# 80896 | Nayori | Japan |
| Site Reference ID/Investigator# 67152 | Nigata-honmachi | Japan |
| Site Reference ID/Investigator# 41793 | Niigata | Japan |
| Site Reference ID/Investigator# 41873 | Niigata | Japan |
| Site Reference ID/Investigator# 41879 | Niigata | Japan |
| Site Reference ID/Investigator# 56326 | Niigata | Japan |
| Site Reference ID/Investigator# 64812 | Niigata | Japan |
| Site Reference ID/Investigator# 41741 | Nishihara | Japan |
| Site Reference ID/Investigator# 41682 | Nishinomiya | Japan |
| Site Reference ID/Investigator# 41690 | Nishinomiya | Japan |
| Site Reference ID/Investigator# 80877 | Nishio | Japan |
| Site Reference ID/Investigator# 67264 | Nisshin | Japan |
| Site Reference ID/Investigator# 41914 | Numakunai | Japan |
| Site Reference ID/Investigator# 59998 | Numakunai | Japan |
| Site Reference ID/Investigator# 41841 | Obihiro | Japan |
| Site Reference ID/Investigator# 41843 | Obihiro | Japan |
| Site Reference ID/Investigator# 41857 | Odawara | Japan |
| Site Reference ID/Investigator# 41701 | Okayama | Japan |
| Site Reference ID/Investigator# 41702 | Okayama | Japan |
| Site Reference ID/Investigator# 41703 | Okayama | Japan |
| Site Reference ID/Investigator# 41709 | Okayama | Japan |
| Site Reference ID/Investigator# 41918 | Okayama | Japan |
| Site Reference ID/Investigator# 60019 | Okayama | Japan |
| Site Reference ID/Investigator# 64809 | Okayama | Japan |
| Site Reference ID/Investigator# 41310 | Osaka | Japan |
| Site Reference ID/Investigator# 41455 | Osaka | Japan |
| Site Reference ID/Investigator# 41456 | Osaka | Japan |
| Site Reference ID/Investigator# 41466 | Osaka | Japan |
| Site Reference ID/Investigator# 41477 | Osaka | Japan |
| Site Reference ID/Investigator# 41662 | Osaka | Japan |
| Site Reference ID/Investigator# 41663 | Osaka | Japan |
| Site Reference ID/Investigator# 41664 | Osaka | Japan |
| Site Reference ID/Investigator# 41667 | Osaka | Japan |
| Site Reference ID/Investigator# 41669 | Osaka | Japan |
| Site Reference ID/Investigator# 41670 | Osaka | Japan |
| Site Reference ID/Investigator# 41671 | Osaka | Japan |
| Site Reference ID/Investigator# 41672 | Osaka | Japan |
| Site Reference ID/Investigator# 41673 | Osaka | Japan |
| Site Reference ID/Investigator# 41674 | Osaka | Japan |
| Site Reference ID/Investigator# 41675 | Osaka | Japan |
| Site Reference ID/Investigator# 41676 | Osaka | Japan |
| Site Reference ID/Investigator# 41678 | Osaka | Japan |
| Site Reference ID/Investigator# 41679 | Osaka | Japan |
| Site Reference ID/Investigator# 41680 | Osaka | Japan |
| Site Reference ID/Investigator# 41743 | Osaka | Japan |
| Site Reference ID/Investigator# 41786 | Osaka | Japan |
| Site Reference ID/Investigator# 41799 | Osaka | Japan |
| Site Reference ID/Investigator# 41809 | Osaka | Japan |
| Site Reference ID/Investigator# 41811 | Osaka | Japan |
| Site Reference ID/Investigator# 41874 | Osaka | Japan |
| Site Reference ID/Investigator# 41875 | Osaka | Japan |
| Site Reference ID/Investigator# 41878 | Osaka | Japan |
| Site Reference ID/Investigator# 56088 | Osaka | Japan |
| Site Reference ID/Investigator# 56134 | Osaka | Japan |
| Site Reference ID/Investigator# 56205 | Osaka | Japan |
| Site Reference ID/Investigator# 56256 | Osaka | Japan |
| Site Reference ID/Investigator# 56257 | Osaka | Japan |
| Site Reference ID/Investigator# 56325 | Osaka | Japan |
| Site Reference ID/Investigator# 56341 | Osaka | Japan |
| Site Reference ID/Investigator# 59990 | Osaka | Japan |
| Site Reference ID/Investigator# 67143 | Osaka | Japan |
| Site Reference ID/Investigator# 67148 | Osaka | Japan |
| Site Reference ID/Investigator# 67151 | Osaka | Japan |
| Site Reference ID/Investigator# 80878 | Osaka | Japan |
| Site Reference ID/Investigator# 80882 | Osaka | Japan |
| Site Reference ID/Investigator# 80915 | Osaka | Japan |
| Site Reference ID/Investigator# 41766 | Ōgaki | Japan |
| Site Reference ID/Investigator# 41906 | Ōita | Japan |
| Site Reference ID/Investigator# 56203 | Ōita | Japan |
| Site Reference ID/Investigator# 80876 | Ōkawa | Japan |
| Site Reference ID/Investigator# 41840 | Ōsaki | Japan |
| Site Reference ID/Investigator# 41867 | Ōsaki | Japan |
| Site Reference ID/Investigator# 41869 | Ōsaki | Japan |
| Site Reference ID/Investigator# 56113 | Ōsaki | Japan |
| Site Reference ID/Investigator# 41708 | Ōtsu | Japan |
| Site Reference ID/Investigator# 56345 | Ōtsu | Japan |
| Site Reference ID/Investigator# 80875 | Rifu | Japan |
| Site Reference ID/Investigator# 41729 | Saga | Japan |
| Site Reference ID/Investigator# 41732 | Saga | Japan |
| Site Reference ID/Investigator# 41876 | Saga | Japan |
| Site Reference ID/Investigator# 41323 | Sagamihara | Japan |
| Site Reference ID/Investigator# 41468 | Sagamihara, Kanagawa | Japan |
| Site Reference ID/Investigator# 41256 | Saitama | Japan |
| Site Reference ID/Investigator# 41257 | Saitama | Japan |
| Site Reference ID/Investigator# 41261 | Saitama | Japan |
| Site Reference ID/Investigator# 41264 | Saitama | Japan |
| Site Reference ID/Investigator# 41265 | Saitama | Japan |
| Site Reference ID/Investigator# 41266 | Saitama | Japan |
| Site Reference ID/Investigator# 41267 | Saitama | Japan |
| Site Reference ID/Investigator# 41270 | Saitama | Japan |
| Site Reference ID/Investigator# 41271 | Saitama | Japan |
| Site Reference ID/Investigator# 41272 | Saitama | Japan |
| Site Reference ID/Investigator# 41274 | Saitama | Japan |
| Site Reference ID/Investigator# 41278 | Saitama | Japan |
| Site Reference ID/Investigator# 41329 | Saitama | Japan |
| Site Reference ID/Investigator# 56094 | Saitama | Japan |
| Site Reference ID/Investigator# 56099 | Saitama | Japan |
| Site Reference ID/Investigator# 56100 | Saitama | Japan |
| Site Reference ID/Investigator# 56249 | Saitama | Japan |
| Site Reference ID/Investigator# 60009 | Saitama | Japan |
| Site Reference ID/Investigator# 64803 | Saitama | Japan |
| Site Reference ID/Investigator# 64804 | Saitama | Japan |
| Site Reference ID/Investigator# 64810 | Saitama | Japan |
| Site Reference ID/Investigator# 41603 | Sakai | Japan |
| Site Reference ID/Investigator# 56136 | Sakai | Japan |
| Site Reference ID/Investigator# 41868 | Saku | Japan |
| Site Reference ID/Investigator# 41826 | Sakura | Japan |
| Site Reference ID/Investigator# 41763 | Sapporo | Japan |
| Site Reference ID/Investigator# 41850 | Sapporo | Japan |
| Site Reference ID/Investigator# 41853 | Sapporo | Japan |
| Site Reference ID/Investigator# 56105 | Sapporo | Japan |
| Site Reference ID/Investigator# 56107 | Sapporo | Japan |
| Site Reference ID/Investigator# 56108 | Sapporo | Japan |
| Site Reference ID/Investigator# 56209 | Sapporo | Japan |
| Site Reference ID/Investigator# 80884 | Sapporo | Japan |
| Site Reference ID/Investigator# 41739 | Sasebo | Japan |
| Site Reference ID/Investigator# 41755 | Sasebo | Japan |
| Site Reference ID/Investigator# 41457 | Sayama | Japan |
| Site Reference ID/Investigator# 41469 | Sayama | Japan |
| Site Reference ID/Investigator# 41605 | Sendai | Japan |
| Site Reference ID/Investigator# 41813 | Sendai | Japan |
| Site Reference ID/Investigator# 41814 | Sendai | Japan |
| Site Reference ID/Investigator# 41930 | Sendai | Japan |
| Site Reference ID/Investigator# 80889 | Sendai | Japan |
| Site Reference ID/Investigator# 41546 | Seto | Japan |
| Site Reference ID/Investigator# 41553 | Shiga | Japan |
| Site Reference ID/Investigator# 41707 | Shiga | Japan |
| Site Reference ID/Investigator# 41754 | Shiga | Japan |
| Site Reference ID/Investigator# 41922 | Shiga | Japan |
| Site Reference ID/Investigator# 59993 | Shiga | Japan |
| Site Reference ID/Investigator# 60007 | Shimane | Japan |
| Site Reference ID/Investigator# 41884 | Shimotsuke | Japan |
| Site Reference ID/Investigator# 41885 | Shimotsuke | Japan |
| Site Reference ID/Investigator# 41292 | Shizuoka | Japan |
| Site Reference ID/Investigator# 41295 | Shizuoka | Japan |
| Site Reference ID/Investigator# 41296 | Shizuoka | Japan |
| Site Reference ID/Investigator# 41298 | Shizuoka | Japan |
| Site Reference ID/Investigator# 41328 | Shizuoka | Japan |
| Site Reference ID/Investigator# 41479 | Shizuoka | Japan |
| Site Reference ID/Investigator# 41772 | Shizuoka | Japan |
| Site Reference ID/Investigator# 41808 | Shizuoka | Japan |
| Site Reference ID/Investigator# 41872 | Shizuoka | Japan |
| Site Reference ID/Investigator# 41880 | Shizuoka | Japan |
| Site Reference ID/Investigator# 41881 | Shizuoka | Japan |
| Site Reference ID/Investigator# 56101 | Shizuoka | Japan |
| Site Reference ID/Investigator# 56132 | Shizuoka | Japan |
| Site Reference ID/Investigator# 56133 | Shizuoka | Japan |
| Site Reference ID/Investigator# 56253 | Shizuoka | Japan |
| Site Reference ID/Investigator# 56339 | Shizuoka | Japan |
| Site Reference ID/Investigator# 68628 | Shizuoka | Japan |
| Site Reference ID/Investigator# 41928 | Shūnan | Japan |
| Site Reference ID/Investigator# 80886 | Sōka | Japan |
| Site Reference ID/Investigator# 41551 | Takamatsu | Japan |
| Site Reference ID/Investigator# 41552 | Takamatsu | Japan |
| Site Reference ID/Investigator# 41761 | Takamatsu | Japan |
| Site Reference ID/Investigator# 41836 | Takasaki | Japan |
| Site Reference ID/Investigator# 41665 | Takatsuki | Japan |
| Site Reference ID/Investigator# 41666 | Takatsuki | Japan |
| Site Reference ID/Investigator# 41767 | Takatsuki | Japan |
| Site Reference ID/Investigator# 56138 | Tanabe | Japan |
| Site Reference ID/Investigator# 41465 | Tenri | Japan |
| Site Reference ID/Investigator# 41752 | Tenri | Japan |
| Site Reference ID/Investigator# 41803 | Tokushima | Japan |
| Site Reference ID/Investigator# 56222 | Tokushima | Japan |
| Site Reference ID/Investigator# 67146 | Tokushima | Japan |
| Site Reference ID/Investigator# 26162 | Tokyo | Japan |
| Site Reference ID/Investigator# 41206 | Tokyo | Japan |
| Site Reference ID/Investigator# 41208 | Tokyo | Japan |
| Site Reference ID/Investigator# 41209 | Tokyo | Japan |
| Site Reference ID/Investigator# 41210 | Tokyo | Japan |
| Site Reference ID/Investigator# 41211 | Tokyo | Japan |
| Site Reference ID/Investigator# 41212 | Tokyo | Japan |
| Site Reference ID/Investigator# 41213 | Tokyo | Japan |
| Site Reference ID/Investigator# 41214 | Tokyo | Japan |
| Site Reference ID/Investigator# 41222 | Tokyo | Japan |
| Site Reference ID/Investigator# 41223 | Tokyo | Japan |
| Site Reference ID/Investigator# 41224 | Tokyo | Japan |
| Site Reference ID/Investigator# 41225 | Tokyo | Japan |
| Site Reference ID/Investigator# 41226 | Tokyo | Japan |
| Site Reference ID/Investigator# 41227 | Tokyo | Japan |
| Site Reference ID/Investigator# 41228 | Tokyo | Japan |
| Site Reference ID/Investigator# 41229 | Tokyo | Japan |
| Site Reference ID/Investigator# 41230 | Tokyo | Japan |
| Site Reference ID/Investigator# 41239 | Tokyo | Japan |
| Site Reference ID/Investigator# 41240 | Tokyo | Japan |
| Site Reference ID/Investigator# 41241 | Tokyo | Japan |
| Site Reference ID/Investigator# 41242 | Tokyo | Japan |
| Site Reference ID/Investigator# 41243 | Tokyo | Japan |
| Site Reference ID/Investigator# 41244 | Tokyo | Japan |
| Site Reference ID/Investigator# 41245 | Tokyo | Japan |
| Site Reference ID/Investigator# 41246 | Tokyo | Japan |
| Site Reference ID/Investigator# 41259 | Tokyo | Japan |
| Site Reference ID/Investigator# 41268 | Tokyo | Japan |
| Site Reference ID/Investigator# 41273 | Tokyo | Japan |
| Site Reference ID/Investigator# 41443 | Tokyo | Japan |
| Site Reference ID/Investigator# 41444 | Tokyo | Japan |
| Site Reference ID/Investigator# 41445 | Tokyo | Japan |
| Site Reference ID/Investigator# 41446 | Tokyo | Japan |
| Site Reference ID/Investigator# 41447 | Tokyo | Japan |
| Site Reference ID/Investigator# 41448 | Tokyo | Japan |
| Site Reference ID/Investigator# 41449 | Tokyo | Japan |
| Site Reference ID/Investigator# 41459 | Tokyo | Japan |
| Site Reference ID/Investigator# 41470 | Tokyo | Japan |
| Site Reference ID/Investigator# 41474 | Tokyo | Japan |
| Site Reference ID/Investigator# 41547 | Tokyo | Japan |
| Site Reference ID/Investigator# 41602 | Tokyo | Japan |
| Site Reference ID/Investigator# 41610 | Tokyo | Japan |
| Site Reference ID/Investigator# 41742 | Tokyo | Japan |
| Site Reference ID/Investigator# 41764 | Tokyo | Japan |
| Site Reference ID/Investigator# 41765 | Tokyo | Japan |
| Site Reference ID/Investigator# 41792 | Tokyo | Japan |
| Site Reference ID/Investigator# 41795 | Tokyo | Japan |
| Site Reference ID/Investigator# 41882 | Tokyo | Japan |
| Site Reference ID/Investigator# 41883 | Tokyo | Japan |
| Site Reference ID/Investigator# 41886 | Tokyo | Japan |
| Site Reference ID/Investigator# 41887 | Tokyo | Japan |
| Site Reference ID/Investigator# 41888 | Tokyo | Japan |
| Site Reference ID/Investigator# 41890 | Tokyo | Japan |
| Site Reference ID/Investigator# 41891 | Tokyo | Japan |
| Site Reference ID/Investigator# 41892 | Tokyo | Japan |
| Site Reference ID/Investigator# 41896 | Tokyo | Japan |
| Site Reference ID/Investigator# 41897 | Tokyo | Japan |
| Site Reference ID/Investigator# 41907 | Tokyo | Japan |
| Site Reference ID/Investigator# 41911 | Tokyo | Japan |
| Site Reference ID/Investigator# 41912 | Tokyo | Japan |
| Site Reference ID/Investigator# 41913 | Tokyo | Japan |
| Site Reference ID/Investigator# 41924 | Tokyo | Japan |
| Site Reference ID/Investigator# 41925 | Tokyo | Japan |
| Site Reference ID/Investigator# 56092 | Tokyo | Japan |
| Site Reference ID/Investigator# 56093 | Tokyo | Japan |
| Site Reference ID/Investigator# 56102 | Tokyo | Japan |
| Site Reference ID/Investigator# 56104 | Tokyo | Japan |
| Site Reference ID/Investigator# 56125 | Tokyo | Japan |
| Site Reference ID/Investigator# 56126 | Tokyo | Japan |
| Site Reference ID/Investigator# 56211 | Tokyo | Japan |
| Site Reference ID/Investigator# 56225 | Tokyo | Japan |
| Site Reference ID/Investigator# 56243 | Tokyo | Japan |
| Site Reference ID/Investigator# 56244 | Tokyo | Japan |
| Site Reference ID/Investigator# 56245 | Tokyo | Japan |
| Site Reference ID/Investigator# 56246 | Tokyo | Japan |
| Site Reference ID/Investigator# 56247 | Tokyo | Japan |
| Site Reference ID/Investigator# 56248 | Tokyo | Japan |
| Site Reference ID/Investigator# 56331 | Tokyo | Japan |
| Site Reference ID/Investigator# 60000 | Tokyo | Japan |
| Site Reference ID/Investigator# 60002 | Tokyo | Japan |
| Site Reference ID/Investigator# 60008 | Tokyo | Japan |
| Site Reference ID/Investigator# 60020 | Tokyo | Japan |
| Site Reference ID/Investigator# 80885 | Tokyo | Japan |
| Site Reference ID/Investigator# 80888 | Tokyo | Japan |
| Site Reference ID/Investigator# 41787 | Tonami | Japan |
| Site Reference ID/Investigator# 67142 | Toride | Japan |
| Site Reference ID/Investigator# 56262 | Tottori | Japan |
| Site Reference ID/Investigator# 41325 | Toyama | Japan |
| Site Reference ID/Investigator# 41609 | Toyama | Japan |
| Site Reference ID/Investigator# 41685 | Toyama | Japan |
| Site Reference ID/Investigator# 41688 | Toyama | Japan |
| Site Reference ID/Investigator# 41692 | Toyama | Japan |
| Site Reference ID/Investigator# 41783 | Toyama | Japan |
| Site Reference ID/Investigator# 56097 | Toyama | Japan |
| Site Reference ID/Investigator# 56192 | Toyama | Japan |
| Site Reference ID/Investigator# 56258 | Toyama | Japan |
| Site Reference ID/Investigator# 60004 | Toyama | Japan |
| Site Reference ID/Investigator# 64806 | Toyama | Japan |
| Site Reference ID/Investigator# 41288 | Toyoake | Japan |
| Site Reference ID/Investigator# 60010 | Toyoake | Japan |
| Site Reference ID/Investigator# 67147 | Toyoake | Japan |
| Site Reference ID/Investigator# 41307 | Toyohashi | Japan |
| Site Reference ID/Investigator# 41845 | Toyooka | Japan |
| Site Reference ID/Investigator# 56228 | Toyooka | Japan |
| Site Reference ID/Investigator# 56089 | Toyota | Japan |
| Site Reference ID/Investigator# 56114 | Tsukuba | Japan |
| Site Reference ID/Investigator# 56115 | Tsukuba | Japan |
| Site Reference ID/Investigator# 56204 | Tsuyama | Japan |
| Site Reference ID/Investigator# 56210 | Uji | Japan |
| Site Reference ID/Investigator# 41453 | Urayasu | Japan |
| Site Reference ID/Investigator# 41759 | Urayasu | Japan |
| Site Reference ID/Investigator# 41807 | Utazu | Japan |
| Site Reference ID/Investigator# 41923 | Utazu | Japan |
| Site Reference ID/Investigator# 80913 | Utsunomiya | Japan |
| Site Reference ID/Investigator# 41463 | Wakayama | Japan |
| Site Reference ID/Investigator# 41677 | Wakayama | Japan |
| Site Reference ID/Investigator# 41681 | Wakayama | Japan |
| Site Reference ID/Investigator# 41770 | Wakayama | Japan |
| Site Reference ID/Investigator# 80890 | Yachiyo | Japan |
| Site Reference ID/Investigator# 80891 | Yachiyo | Japan |
| Site Reference ID/Investigator# 80894 | Yachiyo | Japan |
| Site Reference ID/Investigator# 41894 | Yamagata | Japan |
| Site Reference ID/Investigator# 41895 | Yamagata | Japan |
| Site Reference ID/Investigator# 41898 | Yamagata | Japan |
| Site Reference ID/Investigator# 56110 | Yamagata | Japan |
| Site Reference ID/Investigator# 56328 | Yamagata | Japan |
| Site Reference ID/Investigator# 41711 | Yamaguchi | Japan |
| Site Reference ID/Investigator# 41722 | Yamaguchi | Japan |
| Site Reference ID/Investigator# 41726 | Yamaguchi | Japan |
| Site Reference ID/Investigator# 56199 | Yamaguchi | Japan |
| Site Reference ID/Investigator# 56223 | Yamaguchi | Japan |
| Site Reference ID/Investigator# 41899 | Yamanashi | Japan |
| Site Reference ID/Investigator# 41297 | Yatomi | Japan |
| Site Reference ID/Investigator# 41275 | Yokohama | Japan |
| Site Reference ID/Investigator# 41276 | Yokohama | Japan |
| Site Reference ID/Investigator# 41277 | Yokohama | Japan |
| Site Reference ID/Investigator# 41285 | Yokohama | Japan |
| Site Reference ID/Investigator# 41286 | Yokohama | Japan |
| Site Reference ID/Investigator# 41450 | Yokohama | Japan |
| Site Reference ID/Investigator# 41860 | Yokohama | Japan |
| Site Reference ID/Investigator# 41916 | Yokohama | Japan |
| Site Reference ID/Investigator# 56128 | Yokohama | Japan |
| Site Reference ID/Investigator# 56332 | Yokohama | Japan |
| Site Reference ID/Investigator# 71459 | Yokohama | Japan |
| Site Reference ID/Investigator# 80917 | Yokohama | Japan |
| Site Reference ID/Investigator# 41291 | Yokosuka | Japan |
| Site Reference ID/Investigator# 71458 | Yokosuka | Japan |
| Site Reference ID/Investigator# 41706 | Yonago | Japan |
| Site Reference ID/Investigator# 41738 | Yufu | Japan |
| Efficacy Analysis Population |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety Analysis Population
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Humira | Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Physician's Global Assessment (PGA) | The Physician's Global Assessment (PGA) is a 6-point scale used to measure the severity of disease at the time of the physician's evaluation of the participant. The degree of overall lesion severity was evaluated using the following categories: 0 (Clear); 1 (Minimal); 2 (Mild); 3 (Moderate); 4 (Severe); 5 (Very Severe). PGA was assessed at baseline in 644 participants. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||||
| Psoriasis Area and Severity Index (PASI) | Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions, and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). PASI was assessed at baseline in 625 participants. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||||
| Dermatology Life Quality Index (DLQI) | Dermatology Life Quality Index (DLQI) score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each question are: very much (score of 3), a lot, a little, or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired. DLQI was assessed at baseline in 280 participants. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||||
| Pain Visual Analog Scale (VAS) | Participants assessed their pain due to psoriatic arthritis in the last week, on a a single-line Visual Analogue Scale (VAS) from 0 (no pain) to 100 (pain as bad as it could be). VAS was assessed at baseline in 153 participants. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||||
| Disease Activity Score 28-4, Erythrocyte Sedimentation Rate (DAS28-4 [ESR]) | DAS28-4 (ESR) is calculated using the number of tender and swollen joints (out of 28 counted), erythrocyte sedimentation rate (ESR), and the patient's global assessment of disease activity via the visual analog scale (VAS). The calculated range of DAS28-4 is 0.49 to 9.07. A DAS28-4 score less than 2.6 indicates clinical remission, DAS28-4 2.6 to 3.2 indicates low disease activity, DAS28-4 3.2 to less than 5.1 indicates moderate disease activity, and DAS28-4 of 5.1 or greater indicates high disease activity. DAS28-4 (ESR) was assessed at baseline in 94 participants with psoriatic arthritis. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||||
| Disease Activity Score 28-4, C-reactive Protein (DAS28-4 [CRP]) | DAS28-4 (CRP) is calculated using the number of tender and swollen joints (out of 28 counted), C-reactive protein (CRP) level, and the patient's global assessment of disease activity via the visual analog scale (VAS). The calculated range of DAS28-4 is 0.49 to 9.07. A DAS28-4 score less than 2.6 indicates clinical remission, DAS28-4 2.6 to 3.2 indicates low disease activity, DAS28-4 3.2 to less than 5.1 indicates moderate disease activity, and DAS28-4 of 5.1 or greater indicates high disease activity. DAS28-4 (CRP) was assessed at baseline in 131 participants with psoriatic arthritis. | Mean | Standard Deviation | units on a scale |
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| 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 | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs), Serious Adverse Drug Reactions (SADRs), Deaths, and Discontinuations Due to AEs | This study was mandated by the Japanese government as an approval condition for Humira in Japan; therefore, definitions of adverse events and seriousness criteria were applicable as specified in the Japanese local standard operating procedures, based on local Japanese regulations. ADRs were defined as adverse events for which the causal relationship with Humira was other than "not related" (ie, "probable," "possible," or "unclear"). The count of participants with AEs presented in this table includes serious and nonserious AEs. The count of participants with discontinuations due to AEs includes those who discontinued due to an AE plus other reasons. Please see Safety section for further details regarding adverse events. | Safety Analysis Population | Posted | Number | participants | From study registration through Week 24 |
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| Primary | Physician's Global Assessment at Week 4 | The Physician's Global Assessment (PGA) is a 6-point scale used to measure the severity of disease at the time of the physician's evaluation of the participant. The degree of overall lesion severity was evaluated using the following categories:
| Observed cases: participants in the Efficacy Analysis Population with an assessment at time point. | Posted | Mean | Standard Deviation | units on a scale | Week 4 |
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| Primary | Physician's Global Assessment At Week 8 | The Physician's Global Assessment (PGA) is a 6-point scale used to measure the severity of disease at the time of the physician's evaluation of the participant. The degree of overall lesion severity was evaluated using the following categories:
| Observed cases: participants in the Efficacy Analysis Population with an assessment at time point. | Posted | Mean | Standard Deviation | units on a scale | Week 8 |
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| Primary | Physician's Global Assessment at Week 16 | The Physician's Global Assessment (PGA) is a 6-point scale used to measure the severity of disease at the time of the physician's evaluation of the participant. The degree of overall lesion severity was evaluated using the following categories:
| Observed cases: participants in the Efficacy Analysis Population with an assessment at time point. | Posted | Mean | Standard Deviation | units on a scale | Week 16 |
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| Primary | Physician's Global Assessment at Week 24 | The Physician's Global Assessment (PGA) is a 6-point scale used to measure the severity of disease at the time of the physician's evaluation of the participant. The degree of overall lesion severity was evaluated using the following categories:
| Observed cases: participants in the Efficacy Analysis Population with an assessment at time point. | Posted | Mean | Standard Deviation | units on a scale | Week 24 |
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| Primary | Psoriasis Area and Severity Index (PASI) at Week 16 | PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). | Observed cases: participants in the Efficacy Analysis Population with an assessment at time point. | Posted | Mean | Standard Deviation | units on a scale | Week 16 |
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| Primary | Psoriasis Area and Severity Index (PASI) at Week 24 | PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). | Observed cases: participants in the Efficacy Analysis Population with an assessment at time point. | Posted | Mean | Standard Deviation | units on a scale | Week 24 |
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| Primary | Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response at Week 16 | PASI75 is defined as at least a 75% reduction in PASI (Psoriasis Area and Severity Index) score compared with the Baseline PASI score. PASI scores range from 0 (best) to 72 (worst), with the highest score representing complete erythroderma of the severest degree. The percent decrease in score is calculated as (Week 0 PASI score minus Week 16 PASI score) divided by Week 0 PASI score. | Observed cases: participants in the Efficacy Analysis Population with an assessment at time point. | Posted | Number | percentage of participants | Baseline and Week 16 |
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| Primary | Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response at Week 24 | PASI75 is defined as at least a 75% reduction in PASI (Psoriasis Area and Severity Index) score compared with the Baseline PASI score. PASI scores range from 0 (best) to 72 (worst), with the highest score representing complete erythroderma of the severest degree. The percent decrease in score is calculated as (Week 0 PASI score minus Week 24 PASI score) divided by Week 0 PASI score. | Observed cases: participants in the Efficacy Analysis Population with an assessment at time point. | Posted | Number | percentage of participants | Baseline and Week 24 |
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| Primary | Percentage of Participants With Psoriasis Area and Severity Index 90 (PASI90) Response at Week 16 | PASI90 is defined as at least a 90% reduction in PASI (Psoriasis Area and Severity Index) score compared with the Baseline PASI score. PASI scores range from 0 (best) to 72 (worst), with the highest score representing complete erythroderma of the severest degree. The percent decrease in score is calculated as (Week 0 PASI score minus Week 16 PASI score) divided by Week 0 PASI score. | Observed cases: participants in the Efficacy Analysis Population with an assessment at time point. | Posted | Number | percentage of participants | Baseline and Week 16 |
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| Primary | Percentage of Participants With Psoriasis Area and Severity Index 90 (PASI90) Response at Week 24 | PASI90 is defined as at least a 90% reduction in PASI (Psoriasis Area and Severity Index) score compared with the Baseline PASI score. PASI scores range from 0 (best) to 72 (worst), with the highest score representing complete erythroderma of the severest degree. The percent decrease in score is calculated as (Week 0 PASI score minus Week 24 PASI score) divided by Week 0 PASI score. | Observed cases: participants in the Efficacy Analysis Population with an assessment at time point. | Posted | Number | percentage of participants | Baseline and Week 24 |
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| Primary | Dermatology Life Quality Index at Week 16 | Dermatology Life Quality Index (DLQI) score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot (score of 2), a little (score of 1), or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired. | Observed cases: participants in the Efficacy Analysis Population with an assessment at time point. | Posted | Mean | Standard Deviation | units on a scale | Week 16 |
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| Primary | Dermatology Life Quality Index at Week 24 | Dermatology Life Quality Index (DLQI) score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot (score of 2), a little (score of 1), or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired. | Observed cases: participants in the Efficacy Analysis Population with an assessment at time point. | Posted | Mean | Standard Deviation | units on a scale | Week 24 |
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| Primary | Pain Visual Analog Scale (VAS) at Week 4 | Participants assessed their pain due to psoriatic arthritis in the past week, on a single-line Visual Analog Scale (VAS) from 0 (no pain) to 100 (pain as bad as it could be). | Observed cases: participants with psoriatic arthritis in the Efficacy Analysis Population with an assessment at time point. | Posted | Mean | Standard Deviation | units on a scale | Week 4 |
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| Primary | Pain Visual Analog Scale (VAS) at Week 16 | Participants assessed their pain due to psoriatic arthritis in the past week, on a single-line Visual Analog Scale (VAS) from 0 (no pain) to 100 (pain as bad as it could be). | Observed cases: participants with psoriatic arthritis in the Efficacy Analysis Population with an assessment at time point. | Posted | Mean | Standard Deviation | units on a scale | Week 16 |
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| Secondary | Physician's Overall Response Rating At Week 24 | Overall response rating, according to investigator's subjective clinical opinion. The level of overall improvement rating was categorized as "markedly improved," "improved," "not changed," or "not assessable," comparing clinical conditions at Week 24 or at discontinuation with Baseline conditions. | Participants in the Efficacy Analysis Population with assessment at Week 24. | Posted | Number | participants | Baseline and Week 24 |
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| Primary | Pain Visual Analog Scale (VAS) at Week 24 | Participants assessed their pain due to psoriatic arthritis in the past week, on a single-line Visual Analog Scale (VAS) from 0 (no pain) to 100 (pain as bad as it could be). | Observed cases: participants with psoriatic arthritis in the Efficacy Analysis Population with an assessment at time point. | Posted | Mean | Standard Deviation | units on a scale | Week 24 |
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| Primary | Disease Activity Score 28-4, Erythrocyte Sedimentation Rate (DAS28-4 [ESR]) at Week 4 | DAS28-4 (ESR) is calculated using the number of tender and swollen joints (out of 28 counted), erythrocyte sedimentation rate (ESR), and the patient's global assessment of disease activity via the visual analog scale (VAS). The calculated range of DAS28-4 is 0 to 10. A score less than 2.6 indicates clinical remission, a score of 2.6 to 3.2 indicates low disease activity, a score of 3.2 to less than 5.1 indicates moderate disease activity, and a score of 5.1 or greater indicates high disease activity. | Observed cases: participants with psoriatic arthritis in the Efficacy Analysis Population with an assessment at time point. | Posted | Mean | Standard Deviation | units on a scale | Week 4 |
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| Primary | Disease Activity Score 28-4, Erythrocyte Sedimentation Rate (DAS28-4 [ESR]) at Week 16 | DAS28-4 (ESR) is calculated using the number of tender and swollen joints (out of 28 counted), erythrocyte sedimentation rate (ESR), and the patient's global assessment of disease activity via the visual analog scale (VAS). The calculated range of DAS28-4 is 0 to 10. A score less than 2.6 indicates clinical remission, a score of 2.6 to 3.2 indicates low disease activity, a score of 3.2 to less than 5.1 indicates moderate disease activity, and a score of 5.1 or greater indicates high disease activity. | Observed cases: participants with psoriatic arthritis in the Efficacy Analysis Population with an assessment at time point. | Posted | Mean | Standard Deviation | units on a scale | Week 16 |
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| Primary | Disease Activity Score 28-4, Erythrocyte Sedimentation Rate (DAS28-4 [ESR]) at Week 24 | DAS28-4 (ESR) is calculated using the number of tender and swollen joints (out of 28 counted), erythrocyte sedimentation rate (ESR), and the patient's global assessment of disease activity via the visual analog scale (VAS). The calculated range of DAS28-4 is 0 to 10. A score less than 2.6 indicates clinical remission, a score of 2.6 to 3.2 indicates low disease activity, a score of 3.2 to less than 5.1 indicates moderate disease activity, and a score of 5.1 or greater indicates high disease activity. | Observed cases: participants with psoriatic arthritis in the Efficacy Analysis Population with an assessment at time point. | Posted | Mean | Standard Deviation | units on a scale | Week 24 |
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| Primary | Disease Activity Score 28-4, C-reactive Protein (DAS28-4 [CRP]) at Week 4 | DAS28-4 (CRP) is calculated using the number of tender and swollen joints (out of 28 counted), C-reactive protein (CRP) level, and the patient's global assessment of disease activity via the visual analog scale (VAS). The calculated range of DAS28-4 is 0 to 10. A score less than 2.6 indicates clinical remission, a score of 2.6 to 3.2 indicates low disease activity, a score of 3.2 to less than 5.1 indicates moderate disease activity, and a score of 5.1 or greater indicates high disease activity. | Observed cases: participants with psoriatic arthritis in the Efficacy Analysis Population with an assessment at time point. | Posted | Mean | Standard Deviation | units on a scale | Week 4 |
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| Primary | Disease Activity Score 28-4, C-reactive Protein (DAS28-4 [CRP]) at Week 16 | DAS28-4 (CRP) is calculated using the number of tender and swollen joints (out of 28 counted), C-reactive protein (CRP) level, and the patient's global assessment of disease activity via the visual analog scale (VAS). The calculated range of DAS28-4 is 0 to 10. A score less than 2.6 indicates clinical remission, a score of 2.6 to 3.2 indicates low disease activity, a score of 3.2 to less than 5.1 indicates moderate disease activity, and a score of 5.1 or greater indicates high disease activity. | Observed cases: participants with psoriatic arthritis in the Efficacy Analysis Population with an assessment at time point. | Posted | Mean | Standard Deviation | units on a scale | Week 16 |
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| Primary | Disease Activity Score 28-4, C-reactive Protein (DAS28-4 [CRP]) at Week 24 | DAS28-4 (CRP) is calculated using the number of tender and swollen joints (out of 28 counted), C-reactive protein (CRP) level, and the patient's global assessment of disease activity via the visual analog scale (VAS). The calculated range of DAS28-4 is 0 to 10. A score less than 2.6 indicates clinical remission, a score of 2.6 to 3.2 indicates low disease activity, a score of 3.2 to less than 5.1 indicates moderate disease activity, and a score of 5.1 or greater indicates high disease activity. | Observed cases: participants with psoriatic arthritis in the Efficacy Analysis Population with an assessment at time point. | Posted | Mean | Standard Deviation | units on a scale | Week 24 |
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From study registration through Week 24
Safety Analysis Population
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 | Humira | Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg. | 35 | 734 | 0 | 734 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diverticulitis | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
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| Encephalitis herpes | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
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| External ear cellulitis | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
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| Herpes zoster | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
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| Meningitis bacterial | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
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| Pneumonia pneumococcal | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
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| Pulmonary tuberculosis | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
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| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Non-systematic Assessment |
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| Gallbladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Non-systematic Assessment |
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| Esophageal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Non-systematic Assessment |
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| Gastric neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Non-systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Cerebral hemorrhage | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Cerebral infarction | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Angina pectoris | Cardiac disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Temporal arteritis | Vascular disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Bleeding gastric ulcer | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Pancreatic cyst | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Alcoholic pancreatitis | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Alcoholic liver disease | Hepatobiliary disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Cholecystitis | Hepatobiliary disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Cholelithiasis | Hepatobiliary disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Pustular psoriasis | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Dermatitis psoriasiform | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Tubulointerstitial nephritis | Renal and urinary disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Renal impairment | Renal and urinary disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Chest pain | General disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Malaise | General disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Edema | General disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA 15.0 | Non-systematic Assessment |
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| C-reactive protein increased | Investigations | MedDRA 15.0 | Non-systematic Assessment |
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| Liver function test abnormal | Investigations | MedDRA 15.0 | Non-systematic Assessment |
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| Splenic rupture | Injury, poisoning and procedural complications | MedDRA 15.0 | Non-systematic Assessment |
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| Brain contusion | Injury, poisoning and procedural complications | MedDRA 15.0 | Non-systematic Assessment |
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Not provided
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie (prior sponsor, Abbott) | 800-633-9110 |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
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| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
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