Psoriasis Clinical Trial
Official title:
Special Investigation (All Cases Investigation in Patients With Psoriasis Vulgaris and Psoriatic Arthritis)
| Verified date | September 2013 |
| Source | AbbVie |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Japan: Ministry of Health, Labor and Welfare |
| Study type | Observational |
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:
- unknown adverse drug reactions, especially clinically significant adverse reactions
- incidence and conditions of occurrence of adverse reactions in the clinical setting
- factors that may affect the safety and effectiveness of Humira.
| Status | Completed |
| Enrollment | 752 |
| Est. completion date | July 2012 |
| Est. primary completion date | July 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 - those not responding to at least one type of conventional systemic treatment (including ultraviolet therapy) who have skin lesions involving 10% of body surface area or - patients with intractable eruptions of joint signs/symptoms. Exclusion Criteria: Contraindications according to the Package Insert include patients who have any of the following: - serious infections - tuberculosis - a history of hypersensitivity to any ingredient of Humira - demyelinating disease or a history of demyelinating disease - congestive cardiac failure. |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Japan | Site Reference ID/Investigator# 41606 | Aichi | |
| Japan | Site Reference ID/Investigator# 41769 | 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 | Aizuwakamatsu | |
| 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 | Chuo | |
| 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# 41696 | Eiheiji | |
| 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 | Hyogo | |
| Japan | Site Reference ID/Investigator# 41683 | Hyogo | |
| Japan | Site Reference ID/Investigator# 41687 | Hyogo | |
| Japan | Site Reference ID/Investigator# 41691 | Hyogo | |
| Japan | Site Reference ID/Investigator# 41750 | Hyogo | |
| Japan | Site Reference ID/Investigator# 41771 | Hyogo | |
| Japan | Site Reference ID/Investigator# 41846 | Hyogo | |
| Japan | Site Reference ID/Investigator# 56142 | Hyogo | |
| Japan | Site Reference ID/Investigator# 56143 | Hyogo | |
| Japan | Site Reference ID/Investigator# 56144 | Hyogo | |
| Japan | Site Reference ID/Investigator# 56146 | Hyogo | |
| Japan | Site Reference ID/Investigator# 56342 | Hyogo | |
| Japan | Site Reference ID/Investigator# 56343 | Hyogo | |
| Japan | Site Reference ID/Investigator# 60015 | Hyogo | |
| Japan | Site Reference ID/Investigator# 67149 | Hyogo | |
| 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# 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# 41914 | Iwate | |
| Japan | Site Reference ID/Investigator# 59998 | Iwate | |
| 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 | Joetsu | |
| 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# 41817 | Konan | |
| Japan | Site Reference ID/Investigator# 41798 | Koriyama | |
| Japan | Site Reference ID/Investigator# 41819 | Koriyama | |
| Japan | Site Reference ID/Investigator# 41262 | Koshigaya | |
| 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# 64808 | Nagaokakyo | |
| 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 | |
| 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# 41841 | Obihiro | |
| Japan | Site Reference ID/Investigator# 41843 | Obihiro | |
| Japan | Site Reference ID/Investigator# 41857 | Odawara | |
| Japan | Site Reference ID/Investigator# 41766 | Ogaki | |
| Japan | Site Reference ID/Investigator# 41906 | Oita | |
| Japan | Site Reference ID/Investigator# 56203 | Oita | |
| Japan | Site Reference ID/Investigator# 80876 | Okawa | |
| 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# 41457 | Osakasayama | |
| Japan | Site Reference ID/Investigator# 41469 | Osakasayama | |
| Japan | Site Reference ID/Investigator# 41840 | Osaki | |
| Japan | Site Reference ID/Investigator# 41867 | Osaki | |
| Japan | Site Reference ID/Investigator# 41869 | Osaki | |
| Japan | Site Reference ID/Investigator# 56113 | Osaki | |
| Japan | Site Reference ID/Investigator# 41708 | Otsu | |
| Japan | Site Reference ID/Investigator# 56345 | Otsu | |
| 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# 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 | Shunan | |
| Japan | Site Reference ID/Investigator# 80886 | Soka | |
| 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 |
| Lead Sponsor | Collaborator |
|---|---|
| AbbVie (prior sponsor, Abbott) |
Japan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| 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. | From study registration through Week 24 | Yes |
| 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: 0 / Clear (plaque elevation=none, scaling=none, erythema=hyperpigmentation, pigmented macules, diffuse faint pink or red coloration); 1 / Minimal (plaque elevation=possible but difficult to ascertain whether there is a slight elevation above normal skin, scaling=surface dryness with some white coloration, erythema=up to moderate); 2 / Mild (plaque elevation=slight, scaling=fine, erythema=up to moderate); 3 / Moderate (plaque elevation=moderate, scaling=coarser, erythema=moderate); 4 / Severe (plaque elevation=marked, scaling=coarse, erythema=severe); 5 / Very Severe (plaque elevation=very marked, scaling=very coarse, erythema=very severe). |
Week 4 | No |
| 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: 0 / Clear (plaque elevation=none, scaling=none, erythema=hyperpigmentation, pigmented macules, diffuse faint pink or red coloration); 1 / Minimal (plaque elevation=possible but difficult to ascertain whether there is a slight elevation above normal skin, scaling=surface dryness with some white coloration, erythema=up to moderate); 2 / Mild (plaque elevation=slight, scaling=fine, erythema=up to moderate); 3 / Moderate (plaque elevation=moderate, scaling=coarser, erythema=moderate); 4 / Severe (plaque elevation=marked, scaling=coarse, erythema=severe); 5 / Very Severe (plaque elevation=very marked, scaling=very coarse, erythema=very severe). |
Week 8 | No |
| 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: 0 / Clear (plaque elevation=none, scaling=none, erythema=hyperpigmentation, pigmented macules, diffuse faint pink or red coloration); 1 / Minimal (plaque elevation=possible but difficult to ascertain whether there is a slight elevation above normal skin, scaling=surface dryness with some white coloration, erythema=up to moderate); 2 / Mild (plaque elevation=slight, scaling=fine, erythema=up to moderate); 3 / Moderate (plaque elevation=moderate, scaling=coarser, erythema=moderate); 4 / Severe (plaque elevation=marked, scaling=coarse, erythema=severe); 5 / Very Severe (plaque elevation=very marked, scaling=very coarse, erythema=very severe). |
Week 16 | No |
| 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: 0 / Clear (plaque elevation=none, scaling=none, erythema=hyperpigmentation, pigmented macules, diffuse faint pink or red coloration); 1 / Minimal (plaque elevation=possible but difficult to ascertain whether there is a slight elevation above normal skin, scaling=surface dryness with some white coloration, erythema=up to moderate); 2 / Mild (plaque elevation=slight, scaling=fine, erythema=up to moderate); 3 / Moderate (plaque elevation=moderate, scaling=coarser, erythema=moderate); 4 / Severe (plaque elevation=marked, scaling=coarse, erythema=severe); 5 / Very Severe (plaque elevation=very marked, scaling=very coarse, erythema=very severe). |
Week 24 | No |
| 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). | Week 16 | No |
| 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). | Week 24 | No |
| 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. | Baseline and Week 16 | No |
| 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. | Baseline and Week 24 | No |
| 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. | Baseline and Week 16 | No |
| 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. | Baseline and Week 24 | No |
| 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. | Week 16 | No |
| 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. | Week 24 | No |
| 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). | Week 4 | No |
| 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). | Week 16 | No |
| 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). | Week 24 | No |
| 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. | Week 4 | No |
| 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. | Week 16 | No |
| 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. | Week 24 | No |
| 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. | Week 4 | No |
| 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. | Week 16 | No |
| 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. | Week 24 | No |
| 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. | Baseline and Week 24 | No |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03236870 -
A Study to Evaluate the Effectiveness and Patient-Reported Outcome of Adalimumab in Patients With Moderate to Severe Plaque Psoriasis in China
|
||
| Completed |
NCT00078819 -
Etanercept (Enbrel®) in Psoriasis - Pediatrics
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Phase 3 | |
| Completed |
NCT04841187 -
Assessing the Long Term Effectiveness and Safety of Systemic Treatments in Cutaneous Psoriasis
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| Active, not recruiting |
NCT03927352 -
The Purpose of This Research Study is to Compare the Efficacy and Safety of SCT630 and Adalimumab (HUMIRA®) in Adults With Plaque Psoriasis
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Phase 3 | |
| Completed |
NCT03284879 -
Post-Marketing Surveillance Study of OTEZLA
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| Recruiting |
NCT06027034 -
Effectiveness of a Digital Health Application for Psoriasis
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N/A | |
| Not yet recruiting |
NCT06050330 -
CD4+ T Cells and S100A7 Epression in Normal and Psoriatic Skin: A Histological and Histochemical Study
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N/A | |
| Recruiting |
NCT05744466 -
A Real-world Observational Study to Compare Effectiveness of Deucravacitinib Vs Apremilast in Adults With Plaque Psoriasis
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| Completed |
NCT04149587 -
A Study of Brodalumab (SILIQ®) in Psoriasis Participants With Inadequate Response to Their Current Biologic Agent Regimen
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| Completed |
NCT01384630 -
Safety, Pharmacokinetics, and Efficacy of RA-18C3 in Subjects With Moderate to Severe Psoriasis
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Phase 2 | |
| Completed |
NCT03998683 -
A Study of Guselkumab for the Treatment of Palmoplantar-non-Pustular Psoriasis
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Phase 3 | |
| Terminated |
NCT03556202 -
A Long-term Study to Evaluate Safety and Maintenance of Treatment Effect of LY3074828 in Participants With Moderate-to-Severe Plaque Psoriasis (OASIS-3)
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Phase 3 | |
| Completed |
NCT05051943 -
A Study of the Real-world Use of an Adalimumab Biosimilar and Evaluation of Nutritional Status on the Therapeutic Response
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| Recruiting |
NCT06077331 -
A Study to Evaluate Efficacy and Safety of HS-10374 for Moderate to Severe Plaque Psoriasis
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Phase 2 | |
| Completed |
NCT04316585 -
A Study to Evaluate the Benefit and Safety of GSK2982772 in Moderate to Severe Psoriasis Participants
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Phase 1 | |
| Completed |
NCT04894890 -
A Prospective Multicenter Study for the Assessment of Treatment Patterns, Effectiveness and Safety of Secukinumab in Adult Patients With Moderate to Severe Plaque Psoriasis in a Real-world Setting in China
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| Completed |
NCT00358384 -
Chronic Plaque Psoriasis Study With Topical Formulation Of GW786034
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Phase 1 | |
| Completed |
NCT03757013 -
A Study to Assess Benefits of Apremilast in Patients With Moderate to Severe Chronic Plaque Psoriasis Followed by Dermatologists Under Real Life Settings in France
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| Completed |
NCT03265613 -
Safety and Efficacy of Expanded Allogeneic AD-MSCs in Patients With Moderate to Severe Psoriasis
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Phase 1/Phase 2 | |
| Completed |
NCT05003531 -
A Study to Evaluate IBI112 in the Treatment of Subjects With Moderate to Severe Plaque Psoriasis
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Phase 2 |