Rheumatoid Arthritis Clinical Trial
Official title:
Special Investigation (Working Productivity and Activity Impairment / WPAI in Japanese Patients With Rheumatoid Arthritis / RA)
| Verified date | January 2016 |
| Source | AbbVie |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Japan: Ministry of Health, Labor and Welfare |
| Study type | Observational |
Study Objectives
As special investigation (PMOS/non-mandatory) of HUMIRA® subcutaneous injection 40 mg
syringe 0.8 mL (generic name: Adalimumab) will be performed to examine the following (1) and
(2) for correlation between baseline and follow-up by clinical observation 48 weeks (planned
visit time; before the start of treatment, and at 12, 24, 36, and 48 weeks, 4 data
collection points) in Japanese rheumatoid arthritis patients who are engaged in paid work
and home work.
1. The primary objective; Situation of work productivity using the Work Productivity and
Activity Impairment/General Health questionnaire and functional impairment (daily life
activity) using the Modified Health Assessment Questionnaire when HUMIRA® treatment.
2. The secondary objective; Clinical observation and rate of improvement of the Disease
Activity Score 28 when HUMIRA® treatment. Situation of the occurrence of adverse events
definition during the course of the observation period while HUMIRA® treatment, other
factors considered to affect the safety and effectiveness.
| Status | Completed |
| Enrollment | 2085 |
| Est. completion date | January 2016 |
| Est. primary completion date | January 2016 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 16 Years to 99 Years |
| Eligibility |
Inclusion Criteria: - The subject of Non-interventional study are Rheumatoid arthritis patients (only those with insufficient response to the existing treatment) and to whom HUMIRA® is administered. Exclusion Criteria: - Rheumatoid arthritis patients showing lowered basic activities of daily life, such as hospitalization and being bedridden - Rheumatoid arthritis patients who are pregnant or may be pregnant (only when the physician can ascertain it) - Rheumatoid arthritis patients who are participating in another clinical trial of a drug of the same type and effectiveness - Other cases that the physician in charge judges to be unfavorable as the subject of this study |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Japan | Site Reference ID/Investigator# 65002 | Aichi | |
| Japan | Site Reference ID/Investigator# 65014 | Aichi | |
| Japan | Site Reference ID/Investigator# 65396 | Aichi | |
| Japan | Site Reference ID/Investigator# 67197 | Aichi | |
| Japan | Site Reference ID/Investigator# 71488 | Aichi | |
| Japan | Site Reference ID/Investigator# 121219 | Akita | |
| Japan | Site Reference ID/Investigator# 110061 | Akita-shi | |
| Japan | Site Reference ID/Investigator# 89794 | Amagasaki | |
| Japan | Site Reference ID/Investigator# 62241 | Ami-machi | |
| Japan | Site Reference ID/Investigator# 67222 | Anan | |
| Japan | Site Reference ID/Investigator# 64947 | Aomori | |
| Japan | Site Reference ID/Investigator# 64924 | Asahi-shi | |
| Japan | Site Reference ID/Investigator# 65318 | Asahikawa-shi | |
| Japan | Site Reference ID/Investigator# 65323 | Asahikawa-shi | |
| Japan | Site Reference ID/Investigator# 71491 | Ashiya | |
| Japan | Site Reference ID/Investigator# 80629 | Awara-shi | |
| Japan | Site Reference ID/Investigator# 80557 | Beppu-shi | |
| Japan | Site Reference ID/Investigator# 62441 | Chiba | |
| Japan | Site Reference ID/Investigator# 65393 | Chiba | |
| Japan | Site Reference ID/Investigator# 67200 | Chiba-shi | |
| Japan | Site Reference ID/Investigator# 80604 | Chiba-shi | |
| Japan | Site Reference ID/Investigator# 62429 | Chigasaki | |
| Japan | Site Reference ID/Investigator# 64981 | Chikushi | |
| Japan | Site Reference ID/Investigator# 89795 | Chikushino-shi | |
| Japan | Site Reference ID/Investigator# 84041 | Chofu | |
| Japan | Site Reference ID/Investigator# 80533 | Date | |
| Japan | Site Reference ID/Investigator# 71490 | Ehime | |
| Japan | Site Reference ID/Investigator# 89802 | Eiheiji-cho | |
| Japan | Site Reference ID/Investigator# 65395 | Fukuchiyama-shi | |
| Japan | Site Reference ID/Investigator# 62147 | Fukui | |
| Japan | Site Reference ID/Investigator# 62442 | Fukui | |
| Japan | Site Reference ID/Investigator# 62458 | Fukuoka | |
| Japan | Site Reference ID/Investigator# 64984 | Fukuoka | |
| Japan | Site Reference ID/Investigator# 65022 | Fukuoka | |
| Japan | Site Reference ID/Investigator# 67183 | Fukuoka | |
| Japan | Site Reference ID/Investigator# 67193 | Fukuoka | |
| Japan | Site Reference ID/Investigator# 62228 | Fukuoka-shi | |
| Japan | Site Reference ID/Investigator# 62231 | Fukuoka-shi | |
| Japan | Site Reference ID/Investigator# 65390 | Fukuoka-shi | |
| Japan | Site Reference ID/Investigator# 80627 | Fukuoka-shi | |
| Japan | Site Reference ID/Investigator# 81055 | Fukuoka-shi | |
| Japan | Site Reference ID/Investigator# 62142 | Fukushima | |
| Japan | Site Reference ID/Investigator# 64926 | Fukushima | |
| Japan | Site Reference ID/Investigator# 64927 | Fukushima | |
| Japan | Site Reference ID/Investigator# 65307 | Fukushima | |
| Japan | Site Reference ID/Investigator# 67176 | Fukushima | |
| Japan | Site Reference ID/Investigator# 65306 | Fukushima-shi | |
| Japan | Site Reference ID/Investigator# 65370 | Fukushima-shi | |
| Japan | Site Reference ID/Investigator# 124541 | Fukuyama | |
| Japan | Site Reference ID/Investigator# 62137 | Fukuyama | |
| Japan | Site Reference ID/Investigator# 67184 | Gifu | |
| Japan | Site Reference ID/Investigator# 67227 | Gifu | |
| Japan | Site Reference ID/Investigator# 67267 | Gifu | |
| Japan | Site Reference ID/Investigator# 71481 | Gifu | |
| Japan | Site Reference ID/Investigator# 67218 | Gifu-shi | |
| Japan | Site Reference ID/Investigator# 67219 | Gifu-shi | |
| Japan | Site Reference ID/Investigator# 80997 | Gifu-shi | |
| Japan | Site Reference ID/Investigator# 64980 | Gunma | |
| Japan | Site Reference ID/Investigator# 64949 | Gyoda | |
| Japan | Site Reference ID/Investigator# 62237 | Hakodate-shi | |
| Japan | Site Reference ID/Investigator# 65338 | Hamamatsu | |
| Japan | Site Reference ID/Investigator# 80599 | Hamamatsu | |
| Japan | Site Reference ID/Investigator# 80617 | Hamamatsu | |
| Japan | Site Reference ID/Investigator# 67191 | Hashima | |
| Japan | Site Reference ID/Investigator# 80623 | Higashimatsushima | |
| Japan | Site Reference ID/Investigator# 64979 | Higashiosaka-shi | |
| Japan | Site Reference ID/Investigator# 64993 | Higashiosaka-shi | |
| Japan | Site Reference ID/Investigator# 114256 | Higashiyamato | |
| Japan | Site Reference ID/Investigator# 64902 | Himeji | |
| Japan | Site Reference ID/Investigator# 84055 | Himeji | |
| Japan | Site Reference ID/Investigator# 65352 | Hirakata-shi | |
| Japan | Site Reference ID/Investigator# 65369 | Hirakata-shi | |
| Japan | Site Reference ID/Investigator# 64946 | Hiroshima | |
| Japan | Site Reference ID/Investigator# 65319 | Hiroshima | |
| Japan | Site Reference ID/Investigator# 64958 | Hiroshima-shi | |
| Japan | Site Reference ID/Investigator# 67181 | Hiroshima-shi | |
| Japan | Site Reference ID/Investigator# 67211 | Hiroshima-shi | |
| Japan | Site Reference ID/Investigator# 84196 | Hiroshima-shi | |
| Japan | Site Reference ID/Investigator# 81035 | Hitachi | |
| Japan | Site Reference ID/Investigator# 65315 | Hitachinaka-shi | |
| Japan | Site Reference ID/Investigator# 62449 | Hokkaido | |
| Japan | Site Reference ID/Investigator# 64964 | Hokkaido | |
| Japan | Site Reference ID/Investigator# 65335 | Hokkaido | |
| Japan | Site Reference ID/Investigator# 67189 | Hokkaido | |
| Japan | Site Reference ID/Investigator# 67192 | Hokkaido | |
| Japan | Site Reference ID/Investigator# 62239 | Hyogo | |
| Japan | Site Reference ID/Investigator# 62240 | Hyogo | |
| Japan | Site Reference ID/Investigator# 65333 | Hyogo | |
| Japan | Site Reference ID/Investigator# 65359 | Hyogo | |
| Japan | Site Reference ID/Investigator# 68709 | Hyogo | |
| Japan | Site Reference ID/Investigator# 62125 | Ibaraki | |
| Japan | Site Reference ID/Investigator# 62130 | Ibaraki | |
| Japan | Site Reference ID/Investigator# 62242 | Ibaraki | |
| Japan | Site Reference ID/Investigator# 64992 | Ibaraki | |
| Japan | Site Reference ID/Investigator# 65360 | Ibaraki | |
| Japan | Site Reference ID/Investigator# 64960 | Ibaraki, Inashiki-gun | |
| Japan | Site Reference ID/Investigator# 65012 | Ichihara-shi | |
| Japan | Site Reference ID/Investigator# 62155 | Ichikawa-shi | |
| Japan | Site Reference ID/Investigator# 62453 | Ichinomiya | |
| Japan | Site Reference ID/Investigator# 62454 | Ichinomiya-machi | |
| Japan | Site Reference ID/Investigator# 62230 | Iizuka-shi | |
| Japan | Site Reference ID/Investigator# 80998 | Ikoma | |
| Japan | Site Reference ID/Investigator# 65343 | Ina-shi | |
| Japan | Site Reference ID/Investigator# 80564 | Inabe | |
| Japan | Site Reference ID/Investigator# 62124 | Iruma-shi | |
| Japan | Site Reference ID/Investigator# 65366 | Isahaya | |
| Japan | Site Reference ID/Investigator# 67187 | Isehara-shi | |
| Japan | Site Reference ID/Investigator# 64929 | Isesaki | |
| Japan | Site Reference ID/Investigator# 62123 | Ishikawa | |
| Japan | Site Reference ID/Investigator# 62244 | Ishikawa | |
| Japan | Site Reference ID/Investigator# 62246 | Ishikawa | |
| Japan | Site Reference ID/Investigator# 62234 | Iwaki | |
| Japan | Site Reference ID/Investigator# 67268 | Izumo | |
| Japan | Site Reference ID/Investigator# 62427 | Izumo-shi | |
| Japan | Site Reference ID/Investigator# 68711 | Izumo-shi | |
| Japan | Site Reference ID/Investigator# 65371 | Izunokuni-shi | |
| Japan | Site Reference ID/Investigator# 84074 | Kagamigahara | |
| Japan | Site Reference ID/Investigator# 64961 | Kagawa | |
| Japan | Site Reference ID/Investigator# 62132 | Kagoshima | |
| Japan | Site Reference ID/Investigator# 62138 | Kagoshima | |
| Japan | Site Reference ID/Investigator# 62247 | Kagoshima | |
| Japan | Site Reference ID/Investigator# 65347 | Kagoshima | |
| Japan | Site Reference ID/Investigator# 62150 | Kagoshima-shi | |
| Japan | Site Reference ID/Investigator# 65394 | Kamagaya | |
| Japan | Site Reference ID/Investigator# 62457 | Kamakura-shi | |
| Japan | Site Reference ID/Investigator# 62149 | Kanagawa | |
| Japan | Site Reference ID/Investigator# 62252 | Kanagawa | |
| Japan | Site Reference ID/Investigator# 71492 | Kanagawa | |
| Japan | Site Reference ID/Investigator# 64940 | Kanazawa-shi | |
| Japan | Site Reference ID/Investigator# 64943 | Kanazawa-shi | |
| Japan | Site Reference ID/Investigator# 65368 | Kanazawa-shi | |
| Japan | Site Reference ID/Investigator# 65386 | Kanazawa-shi | |
| Japan | Site Reference ID/Investigator# 64923 | Kariya | |
| Japan | Site Reference ID/Investigator# 62135 | Kasama | |
| Japan | Site Reference ID/Investigator# 64985 | Kashiba | |
| Japan | Site Reference ID/Investigator# 68696 | Kashiba-shi | |
| Japan | Site Reference ID/Investigator# 64904 | Kashihara-shi | |
| Japan | Site Reference ID/Investigator# 65005 | Kashihara-shi | |
| Japan | Site Reference ID/Investigator# 64977 | Kashiwa | |
| Japan | Site Reference ID/Investigator# 80568 | Kasugai | |
| Japan | Site Reference ID/Investigator# 65334 | Kawachinagano | |
| Japan | Site Reference ID/Investigator# 62272 | Kawagoe | |
| Japan | Site Reference ID/Investigator# 65304 | Kawagoe-shi | |
| Japan | Site Reference ID/Investigator# 64975 | Kawagow | |
| Japan | Site Reference ID/Investigator# 62154 | Kawaguchi | |
| Japan | Site Reference ID/Investigator# 80624 | Kawanishi | |
| Japan | Site Reference ID/Investigator# 81053 | Kawanishi | |
| Japan | Site Reference ID/Investigator# 62251 | Kawasaki | |
| Japan | Site Reference ID/Investigator# 62253 | Kawasaki | |
| Japan | Site Reference ID/Investigator# 62259 | Kawasaki | |
| Japan | Site Reference ID/Investigator# 98356 | Kawasaki | |
| Japan | Site Reference ID/Investigator# 62260 | Kawasaki-shi | |
| Japan | Site Reference ID/Investigator# 62456 | Kirishima | |
| Japan | Site Reference ID/Investigator# 89804 | Kirishima | |
| Japan | Site Reference ID/Investigator# 71499 | Kitakami | |
| Japan | Site Reference ID/Investigator# 62232 | Kitakyushu | |
| Japan | Site Reference ID/Investigator# 62233 | Kitakyushu | |
| Japan | Site Reference ID/Investigator# 62461 | Kitakyushu | |
| Japan | Site Reference ID/Investigator# 71509 | Kitakyushu | |
| Japan | Site Reference ID/Investigator# 84054 | Kitakyushu | |
| Japan | Site Reference ID/Investigator# 94810 | Kitakyushu-shi | |
| Japan | Site Reference ID/Investigator# 114836 | Kitanagoya | |
| Japan | Site Reference ID/Investigator# 62445 | Kizugawa | |
| Japan | Site Reference ID/Investigator# 62440 | Kobe | |
| Japan | Site Reference ID/Investigator# 71479 | Kobe | |
| Japan | Site Reference ID/Investigator# 71495 | Kobe | |
| Japan | Site Reference ID/Investigator# 71502 | Kobe | |
| Japan | Site Reference ID/Investigator# 64907 | Kobe-shi | |
| Japan | Site Reference ID/Investigator# 64908 | Kobe-shi | |
| Japan | Site Reference ID/Investigator# 62163 | Kochi | |
| Japan | Site Reference ID/Investigator# 68724 | Kochi | |
| Japan | Site Reference ID/Investigator# 94896 | Kochi-shi | |
| Japan | Site Reference ID/Investigator# 62282 | Kofu | |
| Japan | Site Reference ID/Investigator# 67196 | Komae | |
| Japan | Site Reference ID/Investigator# 84076 | Komaki | |
| Japan | Site Reference ID/Investigator# 62245 | Komatsu | |
| Japan | Site Reference ID/Investigator# 62157 | Koriyama-shi | |
| Japan | Site Reference ID/Investigator# 65328 | Koshigaya | |
| Japan | Site Reference ID/Investigator# 62443 | Kumamoto | |
| Japan | Site Reference ID/Investigator# 65019 | Kumamoto | |
| Japan | Site Reference ID/Investigator# 65332 | Kumamoto-shi | |
| Japan | Site Reference ID/Investigator# 65387 | Kumamoto-shi | |
| Japan | Site Reference ID/Investigator# 80518 | Kumamoto-shi | |
| Japan | Site Reference ID/Investigator# 81034 | Kumamoto-shi | |
| Japan | Site Reference ID/Investigator# 80614 | Kurobe | |
| Japan | Site Reference ID/Investigator# 65311 | Kurume | |
| Japan | Site Reference ID/Investigator# 62143 | Kurume-shi | |
| Japan | Site Reference ID/Investigator# 64962 | Kurume-shi | |
| Japan | Site Reference ID/Investigator# 65326 | Kushiro-shi | |
| Japan | Site Reference ID/Investigator# 62153 | Kyoto | |
| Japan | Site Reference ID/Investigator# 65350 | Kyoto | |
| Japan | Site Reference ID/Investigator# 65385 | Kyoto | |
| Japan | Site Reference ID/Investigator# 67186 | Kyoto | |
| Japan | Site Reference ID/Investigator# 71483 | Kyoto | |
| Japan | Site Reference ID/Investigator# 80555 | Kyoto | |
| Japan | Site Reference ID/Investigator# 80597 | Kyoto | |
| Japan | Site Reference ID/Investigator# 80619 | Kyoto | |
| Japan | Site Reference ID/Investigator# 64952 | Kyoto-shi | |
| Japan | Site Reference ID/Investigator# 65310 | Kyoto-shi | |
| Japan | Site Reference ID/Investigator# 65373 | Kyoto-shi | |
| Japan | Site Reference ID/Investigator# 67199 | Kyoto-shi | |
| Japan | Site Reference ID/Investigator# 64955 | Kyoto-shi, Kyoto | |
| Japan | Site Reference ID/Investigator# 67178 | Kyoto-shi, Kyoto | |
| Japan | Site Reference ID/Investigator# 68699 | Machida | |
| Japan | Site Reference ID/Investigator# 80626 | Maebashi | |
| Japan | Site Reference ID/Investigator# 81013 | Maebashi | |
| Japan | Site Reference ID/Investigator# 65384 | Maebashi-shi | |
| Japan | Site Reference ID/Investigator# 65392 | Maebashi-shi | |
| Japan | Site Reference ID/Investigator# 64930 | Matsudo | |
| Japan | Site Reference ID/Investigator# 62450 | Matsumoto | |
| Japan | Site Reference ID/Investigator# 64953 | Matsumoto-shi | |
| Japan | Site Reference ID/Investigator# 89799 | Matsusaka | |
| Japan | Site Reference ID/Investigator# 62435 | Matsuyama | |
| Japan | Site Reference ID/Investigator# 71503 | Matsuyama | |
| Japan | Site Reference ID/Investigator# 64945 | Matsuyama-shi | |
| Japan | Site Reference ID/Investigator# 65356 | Mie | |
| Japan | Site Reference ID/Investigator# 64903 | Mitaka | |
| Japan | Site Reference ID/Investigator# 67223 | Mito | |
| Japan | Site Reference ID/Investigator# 62151 | Miyagi | |
| Japan | Site Reference ID/Investigator# 62152 | Miyazaki | |
| Japan | Site Reference ID/Investigator# 62262 | Miyazaki | |
| Japan | Site Reference ID/Investigator# 65316 | Miyazaki | |
| Japan | Site Reference ID/Investigator# 124538 | Miyazaki-shi | |
| Japan | Site Reference ID/Investigator# 81038 | Miyoshi | |
| Japan | Site Reference ID/Investigator# 65367 | Moriguchi-shi | |
| Japan | Site Reference ID/Investigator# 65375 | Morioka | |
| Japan | Site Reference ID/Investigator# 67202 | Morioka | |
| Japan | Site Reference ID/Investigator# 68700 | Moriyama-shi | |
| Japan | Site Reference ID/Investigator# 80534 | Munakata-shi | |
| Japan | Site Reference ID/Investigator# 64944 | Nagakute-shi | |
| Japan | Site Reference ID/Investigator# 65013 | Nagakute-shi | |
| Japan | Site Reference ID/Investigator# 62128 | Nagano | |
| Japan | Site Reference ID/Investigator# 65322 | Nagano | |
| Japan | Site Reference ID/Investigator# 65361 | Nagano | |
| Japan | Site Reference ID/Investigator# 68723 | Nagano | |
| Japan | Site Reference ID/Investigator# 80567 | Nagano | |
| Japan | Site Reference ID/Investigator# 62131 | Nagasaki | |
| Japan | Site Reference ID/Investigator# 67214 | Nagasaki | |
| Japan | Site Reference ID/Investigator# 62160 | Nagasaki-shi | |
| Japan | Site Reference ID/Investigator# 62281 | Nagato | |
| Japan | Site Reference ID/Investigator# 62460 | Nagoya | |
| Japan | Site Reference ID/Investigator# 68716 | Nagoya | |
| Japan | Site Reference ID/Investigator# 80609 | Nagoya | |
| Japan | Site Reference ID/Investigator# 64905 | Nagoya-shi | |
| Japan | Site Reference ID/Investigator# 64925 | Nagoya-shi | |
| Japan | Site Reference ID/Investigator# 64989 | Nagoya-shi | |
| Japan | Site Reference ID/Investigator# 65009 | Nagoya-shi | |
| Japan | Site Reference ID/Investigator# 65382 | Nagoya-shi | |
| Japan | Site Reference ID/Investigator# 68693 | Nagoya-shi | |
| Japan | Site Reference ID/Investigator# 80554 | Nanao | |
| Japan | Site Reference ID/Investigator# 65317 | Nara | |
| Japan | Site Reference ID/Investigator# 71485 | Nara | |
| Japan | Site Reference ID/Investigator# 65007 | Narashino-shi | |
| Japan | Site Reference ID/Investigator# 94806 | Naruto | |
| Japan | Site Reference ID/Investigator# 80595 | Niigata-shi | |
| Japan | Site Reference ID/Investigator# 65003 | Nishihara | |
| Japan | Site Reference ID/Investigator# 71508 | Nishinomiya | |
| Japan | Site Reference ID/Investigator# 80571 | Nishinomiya | |
| Japan | Site Reference ID/Investigator# 80611 | Nishinomiya | |
| Japan | Site Reference ID/Investigator# 80996 | Nishinomiya | |
| Japan | Site Reference ID/Investigator# 80535 | Nishinomiya-shi | |
| Japan | Site Reference ID/Investigator# 121217 | Nishitokyo | |
| Japan | Site Reference ID/Investigator# 110060 | Nogata-shi | |
| Japan | Site Reference ID/Investigator# 62436 | Obihiro-shi | |
| Japan | Site Reference ID/Investigator# 80536 | Ogawa-shi | |
| Japan | Site Reference ID/Investigator# 62265 | Oita | |
| Japan | Site Reference ID/Investigator# 62266 | Oita | |
| Japan | Site Reference ID/Investigator# 67221 | Oita-shi | |
| Japan | Site Reference ID/Investigator# 67180 | Okawa-shi | |
| Japan | Site Reference ID/Investigator# 62267 | Okayama | |
| Japan | Site Reference ID/Investigator# 62268 | Okayama | |
| Japan | Site Reference ID/Investigator# 62459 | Okayama | |
| Japan | Site Reference ID/Investigator# 62462 | Okayama | |
| Japan | Site Reference ID/Investigator# 62463 | Okayama | |
| Japan | Site Reference ID/Investigator# 65308 | Okayama | |
| Japan | Site Reference ID/Investigator# 80570 | Okayama-Shi | |
| Japan | Site Reference ID/Investigator# 62159 | Okazaki | |
| Japan | Site Reference ID/Investigator# 80634 | Okazaki | |
| Japan | Site Reference ID/Investigator# 65346 | Omaezaki | |
| Japan | Site Reference ID/Investigator# 68686 | Ome-shi | |
| Japan | Site Reference ID/Investigator# 124539 | Omura-shi | |
| Japan | Site Reference ID/Investigator# 62264 | Omura-shi | |
| Japan | Site Reference ID/Investigator# 62156 | Omuta | |
| Japan | Site Reference ID/Investigator# 62271 | Osaka | |
| Japan | Site Reference ID/Investigator# 62452 | Osaka | |
| Japan | Site Reference ID/Investigator# 64922 | Osaka | |
| Japan | Site Reference ID/Investigator# 65312 | Osaka | |
| Japan | Site Reference ID/Investigator# 65331 | Osaka | |
| Japan | Site Reference ID/Investigator# 65358 | Osaka | |
| Japan | Site Reference ID/Investigator# 67194 | Osaka | |
| Japan | Site Reference ID/Investigator# 67198 | Osaka | |
| Japan | Site Reference ID/Investigator# 67205 | Osaka | |
| Japan | Site Reference ID/Investigator# 68688 | Osaka | |
| Japan | Site Reference ID/Investigator# 68690 | Osaka | |
| Japan | Site Reference ID/Investigator# 68717 | Osaka | |
| Japan | Site Reference ID/Investigator# 68719 | Osaka | |
| Japan | Site Reference ID/Investigator# 71496 | Osaka | |
| Japan | Site Reference ID/Investigator# 71510 | Osaka | |
| Japan | Site Reference ID/Investigator# 62136 | Osaka-shi | |
| Japan | Site Reference ID/Investigator# 62269 | Osaka-shi | |
| Japan | Site Reference ID/Investigator# 62270 | Osaka-shi | |
| Japan | Site Reference ID/Investigator# 64978 | Osaka-shi | |
| Japan | Site Reference ID/Investigator# 65364 | Osaka-shi | |
| Japan | Site Reference ID/Investigator# 67217 | Osaka-shi | |
| Japan | Site Reference ID/Investigator# 68697 | Osaka-shi | |
| Japan | Site Reference ID/Investigator# 84195 | Osaka-shi | |
| Japan | Site Reference ID/Investigator# 89805 | Osaka-shi | |
| Japan | Site Reference ID/Investigator# 67179 | Osakasayama-shi | |
| Japan | Site Reference ID/Investigator# 80621 | Osakasayama-shi | |
| Japan | Site Reference ID/Investigator# 62433 | Osaki | |
| Japan | Site Reference ID/Investigator# 65018 | Otsu | |
| Japan | Site Reference ID/Investigator# 80576 | Otsu | |
| Japan | Site Reference ID/Investigator# 65004 | Otsu-shi | |
| Japan | Site Reference ID/Investigator# 62432 | Rifu | |
| Japan | Site Reference ID/Investigator# 65324 | Saga | |
| Japan | Site Reference ID/Investigator# 80606 | Saga | |
| Japan | Site Reference ID/Investigator# 65017 | Saga-shi | |
| Japan | Site Reference ID/Investigator# 65397 | Sagamihara-shi | |
| Japan | Site Reference ID/Investigator# 80514 | Sagamihara-shi | |
| Japan | Site Reference ID/Investigator# 110036 | Saitama | |
| Japan | Site Reference ID/Investigator# 62273 | Saitama | |
| Japan | Site Reference ID/Investigator# 65008 | Saitama | |
| Japan | Site Reference ID/Investigator# 65339 | Saitama | |
| Japan | Site Reference ID/Investigator# 64939 | Saitama-shi | |
| Japan | Site Reference ID/Investigator# 65006 | Saitama-shi | |
| Japan | Site Reference ID/Investigator# 65314 | Saitama-shi | |
| Japan | Site Reference ID/Investigator# 68714 | Sakai-shi | |
| Japan | Site Reference ID/Investigator# 80553 | Sakai-shi | |
| Japan | Site Reference ID/Investigator# 62455 | Sakaki | |
| Japan | Site Reference ID/Investigator# 68718 | Sakata-shi | |
| Japan | Site Reference ID/Investigator# 120078 | Sannohe | |
| Japan | Site Reference ID/Investigator# 62437 | Sano-shi | |
| Japan | Site Reference ID/Investigator# 62238 | Sapporo | |
| Japan | Site Reference ID/Investigator# 62438 | Sapporo | |
| Japan | Site Reference ID/Investigator# 81054 | Sapporo | |
| Japan | Site Reference ID/Investigator# 62439 | Sapporo-shi | |
| Japan | Site Reference ID/Investigator# 65340 | Sapporo-shi | |
| Japan | Site Reference ID/Investigator# 65363 | Sapporo-shi | |
| Japan | Site Reference ID/Investigator# 67203 | Sapporo-shi | |
| Japan | Site Reference ID/Investigator# 68689 | Sapporo-shi | |
| Japan | Site Reference ID/Investigator# 80613 | Sapporo-shi | |
| Japan | Site Reference ID/Investigator# 62444 | Sasebo-shi | |
| Japan | Site Reference ID/Investigator# 62126 | Sayama-shi | |
| Japan | Site Reference ID/Investigator# 62148 | Sendai-shi | |
| Japan | Site Reference ID/Investigator# 62261 | Sendai-shi | |
| Japan | Site Reference ID/Investigator# 62430 | Sendai-shi | |
| Japan | Site Reference ID/Investigator# 68683 | Sendai-shi | |
| Japan | Site Reference ID/Investigator# 80600 | Seto | |
| Japan | Site Reference ID/Investigator# 64954 | Shibata-shi | |
| Japan | Site Reference ID/Investigator# 62428 | Shiga | |
| Japan | Site Reference ID/Investigator# 64987 | Shikokuchuo | |
| Japan | Site Reference ID/Investigator# 62161 | Shimane | |
| Japan | Site Reference ID/Investigator# 67195 | Shimizu-sho | |
| Japan | Site Reference ID/Investigator# 80618 | Shimonoseki | |
| Japan | Site Reference ID/Investigator# 62162 | Shimonoseki-shi | |
| Japan | Site Reference ID/Investigator# 65329 | Shimotsuga-gun | |
| Japan | Site Reference ID/Investigator# 62164 | Shizuoka | |
| Japan | Site Reference ID/Investigator# 62274 | Shizuoka | |
| Japan | Site Reference ID/Investigator# 68710 | Shizuoka | |
| Japan | Site Reference ID/Investigator# 80575 | Shizuoka | |
| Japan | Site Reference ID/Investigator# 80565 | Shizuoka-shi | |
| Japan | Site Reference ID/Investigator# 65020 | Soka | |
| Japan | Site Reference ID/Investigator# 65309 | Suita-shi | |
| Japan | Site Reference ID/Investigator# 80558 | Suita-shi | |
| Japan | Site Reference ID/Investigator# 80559 | Suita-shi | |
| Japan | Site Reference ID/Investigator# 98355 | Suita-shi | |
| Japan | Site Reference ID/Investigator# 80563 | Sukagawa | |
| Japan | Site Reference ID/Investigator# 80577 | Suzaka | |
| Japan | Site Reference ID/Investigator# 80537 | Takamatsu | |
| Japan | Site Reference ID/Investigator# 81002 | Takamatsu-shi | |
| Japan | Site Reference ID/Investigator# 62146 | Takasaki-shi | |
| Japan | Site Reference ID/Investigator# 65344 | Takatsuki-shi | |
| Japan | Site Reference ID/Investigator# 81040 | Takatsuki-shi | |
| Japan | Site Reference ID/Investigator# 110075 | Takikawa-shi | |
| Japan | Site Reference ID/Investigator# 114258 | Takikawa-shi | |
| Japan | Site Reference ID/Investigator# 67190 | Tenri-shi | |
| Japan | Site Reference ID/Investigator# 64910 | Tochigi | |
| Japan | Site Reference ID/Investigator# 65313 | Tochigi | |
| Japan | Site Reference ID/Investigator# 65353 | Tochigi | |
| Japan | Site Reference ID/Investigator# 80513 | Toki | |
| Japan | Site Reference ID/Investigator# 62139 | Tokorozawa | |
| Japan | Site Reference ID/Investigator# 68712 | Tokushima-shi | |
| Japan | Site Reference ID/Investigator# 114835 | Tokyo | |
| Japan | Site Reference ID/Investigator# 50022 | Tokyo | |
| Japan | Site Reference ID/Investigator# 62127 | Tokyo | |
| Japan | Site Reference ID/Investigator# 62275 | Tokyo | |
| Japan | Site Reference ID/Investigator# 62276 | Tokyo | |
| Japan | Site Reference ID/Investigator# 62277 | Tokyo | |
| Japan | Site Reference ID/Investigator# 62278 | Tokyo | |
| Japan | Site Reference ID/Investigator# 62446 | Tokyo | |
| Japan | Site Reference ID/Investigator# 64941 | Tokyo | |
| Japan | Site Reference ID/Investigator# 64942 | Tokyo | |
| Japan | Site Reference ID/Investigator# 64957 | Tokyo | |
| Japan | Site Reference ID/Investigator# 64965 | Tokyo | |
| Japan | Site Reference ID/Investigator# 64990 | Tokyo | |
| Japan | Site Reference ID/Investigator# 65327 | Tokyo | |
| Japan | Site Reference ID/Investigator# 65330 | Tokyo | |
| Japan | Site Reference ID/Investigator# 65342 | Tokyo | |
| Japan | Site Reference ID/Investigator# 65345 | Tokyo | |
| Japan | Site Reference ID/Investigator# 65348 | Tokyo | |
| Japan | Site Reference ID/Investigator# 65372 | Tokyo | |
| Japan | Site Reference ID/Investigator# 65388 | Tokyo | |
| Japan | Site Reference ID/Investigator# 65389 | Tokyo | |
| Japan | Site Reference ID/Investigator# 67177 | Tokyo | |
| Japan | Site Reference ID/Investigator# 68691 | Tokyo | |
| Japan | Site Reference ID/Investigator# 68695 | Tokyo | |
| Japan | Site Reference ID/Investigator# 71478 | Tokyo | |
| Japan | Site Reference ID/Investigator# 80540 | Tokyo | |
| Japan | Site Reference ID/Investigator# 80561 | Tokyo | |
| Japan | Site Reference ID/Investigator# 80593 | Tokyo | |
| Japan | Site Reference ID/Investigator# 80596 | Tokyo | |
| Japan | Site Reference ID/Investigator# 80602 | Tokyo | |
| Japan | Site Reference ID/Investigator# 81000 | Tokyo | |
| Japan | Site Reference ID/Investigator# 89793 | Tokyo | |
| Japan | Site Reference ID/Investigator# 96678 | Tokyo | |
| Japan | Site Reference ID/Investigator# 67213 | Tomakomai | |
| Japan | Site Reference ID/Investigator# 62426 | Tomigusuku | |
| Japan | Site Reference ID/Investigator# 94807 | Toon-shi | |
| Japan | Site Reference ID/Investigator# 62448 | Tottori | |
| Japan | Site Reference ID/Investigator# 62279 | Toyama | |
| Japan | Site Reference ID/Investigator# 64959 | Toyama | |
| Japan | Site Reference ID/Investigator# 62431 | Toyama-shi | |
| Japan | Site Reference ID/Investigator# 80993 | Toyoake-shi | |
| Japan | Site Reference ID/Investigator# 80994 | Toyoake-shi | |
| Japan | Site Reference ID/Investigator# 114255 | Toyohashi | |
| Japan | Site Reference ID/Investigator# 64971 | Toyohashi | |
| Japan | Site Reference ID/Investigator# 65398 | Toyokawa-shi | |
| Japan | Site Reference ID/Investigator# 65341 | Toyooka | |
| Japan | Site Reference ID/Investigator# 71505 | Tsu | |
| Japan | Site Reference ID/Investigator# 84075 | Tsuchiura-shi | |
| Japan | Site Reference ID/Investigator# 80607 | Tsukuba-shi | |
| Japan | Site Reference ID/Investigator# 57603 | Tsuruga | |
| Japan | Site Reference ID/Investigator# 89803 | Uji | |
| Japan | Site Reference ID/Investigator# 62145 | Utazu | |
| Japan | Site Reference ID/Investigator# 62425 | Utsunomiya | |
| Japan | Site Reference ID/Investigator# 71494 | Utsunomiya | |
| Japan | Site Reference ID/Investigator# 67209 | Wakayama | |
| Japan | Site Reference ID/Investigator# 80541 | Wakayama-shi | |
| Japan | Site Reference ID/Investigator# 64928 | Yamagata-shi | |
| Japan | Site Reference ID/Investigator# 62134 | Yamaguchi | |
| Japan | Site Reference ID/Investigator# 65365 | Yamaguchi | |
| Japan | Site Reference ID/Investigator# 71500 | Yamaguchi-shi | |
| Japan | Site Reference ID/Investigator# 71501 | Yamaguchi-shi | |
| Japan | Site Reference ID/Investigator# 80608 | Yatomi-shi | |
| Japan | Site Reference ID/Investigator# 65354 | Yokkaichi-shi | |
| Japan | Site Reference ID/Investigator# 110059 | Yokohama | |
| Japan | Site Reference ID/Investigator# 110062 | Yokohama | |
| Japan | Site Reference ID/Investigator# 62140 | Yokohama | |
| Japan | Site Reference ID/Investigator# 64950 | Yokohama | |
| Japan | Site Reference ID/Investigator# 65325 | Yokohama | |
| Japan | Site Reference ID/Investigator# 67201 | Yokohama | |
| Japan | Site Reference ID/Investigator# 62258 | Yokohama-shi | |
| Japan | Site Reference ID/Investigator# 65320 | Yokohama-shi | |
| Japan | Site Reference ID/Investigator# 65336 | Yokohama-shi | |
| Japan | Site Reference ID/Investigator# 80520 | Yokohama-shi | |
| Japan | Site Reference ID/Investigator# 80601 | Yokohama-shi | |
| Japan | Site Reference ID/Investigator# 67188 | Yokohama-shi, Kanagawa | |
| Japan | Site Reference ID/Investigator# 64906 | Yokosuka | |
| Japan | Site Reference ID/Investigator# 67206 | Yonago-shi | |
| Japan | Site Reference ID/Investigator# 65010 | Yufu-shi | |
| Japan | Site Reference ID/Investigator# 68684 | Yufu-shi |
| Lead Sponsor | Collaborator |
|---|---|
| AbbVie (prior sponsor, Abbott) |
Japan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Work Productivity and Activity Impairment-Rheumatoid Arthritis | at week 12 | No | |
| Primary | Work Productivity and Activity Impairment-Rheumatoid Arthritis | at week 24 | No | |
| Primary | Work Productivity and Activity Impairment-Rheumatoid Arthritis | at week 36 | No | |
| Primary | Work Productivity and Activity Impairment-Rheumatoid Arthritis | at week 48 | No | |
| Primary | Health Assessment Questionnaire | at week 12 | No | |
| Primary | Health Assessment Questionnaire | at week 24 | No | |
| Primary | Health Assessment Questionnaire | at week 36 | No | |
| Primary | Health Assessment Questionnaire | at week 48 | No | |
| Secondary | Number of patients with adverse events | Occurrence of adverse event (yes or no), nature of adverse events, date of onset, seriousness,clinical course of adverse events, outcome, measures, causal relationship between the event and Humira | at week 48 | Yes |
| Secondary | Disease activity Score 28 | at week 12 | No | |
| Secondary | Disease activity Score 28 | at week 24 | No | |
| Secondary | Disease activity Score 28 | at week 36 | No | |
| Secondary | Disease activity Score 28 | at week 48 | No |
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