Rheumatoid Arthritis Clinical Trial
Official title:
Special Investigation in Japanese Rheumatoid Arthritis Patients Who Have no Previous Use of DMARDs and Biological Agents
| Verified date | October 2015 |
| Source | AbbVie |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Japan: Ministry of Health, Labor and Welfare |
| Study type | Observational |
This study will be conducted to examine the safety profile and the effectiveness in daily clinical practice of adalimumab in rheumatoid arthritis patients showing rapid progression of structural damage of the joints, who have no prior history of treatment with disease-modifying anti-rheumatic drugs or biological agents.
| Status | Completed |
| Enrollment | 166 |
| Est. completion date | September 2015 |
| Est. primary completion date | September 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 16 Years to 99 Years |
| Eligibility |
Inclusion Criteria: Rheumatoid Arthritis patients meeting all of the following
requirements will be the subjects of this study. 1. High disease activity, with poor prognostic factors 2. Combination of adalimumab and Methotrexate will be started 3. No prior history of treatment with disease-modifying anti-rheumatic drugs 4. No prior history of treatment with biological agents 5. Adalimumab is dosed according to the registered product label 6. Signed informed consent Exclusion Criteria: There are no specific exclusion criteria. |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Japan | Site Reference ID/Investigator# 115744 | Anan | |
| Japan | Site Reference ID/Investigator# 115745 | Aomori-shi | |
| Japan | Site Reference ID/Investigator# 112701 | Chiba-shi | |
| Japan | Site Reference ID/Investigator# 128945 | Fujimi-shi | |
| Japan | Site Reference ID/Investigator# 114537 | Fukushima-shi | |
| Japan | Site Reference ID/Investigator# 114536 | Gifu-shi | |
| Japan | Site Reference ID/Investigator# 133756 | Gyoda-shi | |
| Japan | Site Reference ID/Investigator# 115836 | Hamamatsu | |
| Japan | Site Reference ID/Investigator# 114516 | Hiroshima | |
| Japan | Site Reference ID/Investigator# 112629 | Hiroshima-shi | |
| Japan | Site Reference ID/Investigator# 114380 | Hiroshima-shi | |
| Japan | Site Reference ID/Investigator# 133740 | Hitachinaka-shi | |
| Japan | Site Reference ID/Investigator# 114376 | Iwaki | |
| Japan | Site Reference ID/Investigator# 133742 | Izumiotsu-shi | |
| Japan | Site Reference ID/Investigator# 98875 | Izumisano | |
| Japan | Site Reference ID/Investigator# 112798 | Izumo-shi | |
| Japan | Site Reference ID/Investigator# 133744 | Kagoshima-shi | |
| Japan | Site Reference ID/Investigator# 114378 | Kakogawa | |
| Japan | Site Reference ID/Investigator# 114515 | Kamagaya | |
| Japan | Site Reference ID/Investigator# 112638 | Kamakura-shi | |
| Japan | Site Reference ID/Investigator# 112630 | Kasuga-shi | |
| Japan | Site Reference ID/Investigator# 115837 | Kawagoe-shi | |
| Japan | Site Reference ID/Investigator# 115778 | Kawasaki | |
| Japan | Site Reference ID/Investigator# 112775 | Kitakyushu-shi | |
| Japan | Site Reference ID/Investigator# 114475 | Kitanagoya | |
| Japan | Site Reference ID/Investigator# 124660 | Kizugawa | |
| Japan | Site Reference ID/Investigator# 121259 | Kobe | |
| Japan | Site Reference ID/Investigator# 115840 | Kurashiki-shi | |
| Japan | Site Reference ID/Investigator# 112702 | Kurume | |
| Japan | Site Reference ID/Investigator# 112799 | Kyoto | |
| Japan | Site Reference ID/Investigator# 114375 | Kyoto-shi | |
| Japan | Site Reference ID/Investigator# 114495 | Kyoto-shi | |
| Japan | Site Reference ID/Investigator# 112675 | Matsuyama | |
| Japan | Site Reference ID/Investigator# 133753 | Matsuyama-shi | |
| Japan | Site Reference ID/Investigator# 112698 | Moriguchi-shi | |
| Japan | Site Reference ID/Investigator# 112597 | Morioka | |
| Japan | Site Reference ID/Investigator# 121275 | Nagakute-shi | |
| Japan | Site Reference ID/Investigator# 133751 | Nagaoka-shi | |
| Japan | Site Reference ID/Investigator# 124658 | Nagoya-shi | |
| Japan | Site Reference ID/Investigator# 115777 | Niigata | |
| Japan | Site Reference ID/Investigator# 124661 | Nishitokyo | |
| Japan | Site Reference ID/Investigator# 112620 | Obihiro-shi | |
| Japan | Site Reference ID/Investigator# 114576 | Okazaki | |
| Japan | Site Reference ID/Investigator# 114381 | Omaezaki | |
| Japan | Site Reference ID/Investigator# 112715 | Osaka | |
| Japan | Site Reference ID/Investigator# 112800 | Osaka | |
| Japan | Site Reference ID/Investigator# 112601 | Osaka-shi | |
| Japan | Site Reference ID/Investigator# 133726 | Osaka-shi | |
| Japan | Site Reference ID/Investigator# 133727 | Osaka-shi | |
| Japan | Site Reference ID/Investigator# 112736 | Osakasayama-shi | |
| Japan | Site Reference ID/Investigator# 112743 | Saitama-shi | |
| Japan | Site Reference ID/Investigator# 124659 | Sakado | |
| Japan | Site Reference ID/Investigator# 112635 | Sakaki | |
| Japan | Site Reference ID/Investigator# 112599 | Sapporo-shi | |
| Japan | Site Reference ID/Investigator# 112600 | Sasebo-shi | |
| Japan | Site Reference ID/Investigator# 112595 | Sayama-shi | |
| Japan | Site Reference ID/Investigator# 112656 | Sendai-shi | |
| Japan | Site Reference ID/Investigator# 121265 | Shibata-shi | |
| Japan | Site Reference ID/Investigator# 133741 | Shimonoseki-shi | |
| Japan | Site Reference ID/Investigator# 112627 | Shirahama | |
| Japan | Site Reference ID/Investigator# 112739 | Shizuoka | |
| Japan | Site Reference ID/Investigator# 133730 | Shizuoka-shi | |
| Japan | Site Reference ID/Investigator# 120091 | Suita-shi | |
| Japan | Site Reference ID/Investigator# 120093 | Suita-shi | |
| Japan | Site Reference ID/Investigator# 120089 | Tajimi | |
| Japan | Site Reference ID/Investigator# 114575 | Takamatsu | |
| Japan | Site Reference ID/Investigator# 112803 | Takarazuka | |
| Japan | Site Reference ID/Investigator# 115835 | Tochigi, Shimotsuga-gun | |
| Japan | Site Reference ID/Investigator# 112637 | Tokyo | |
| Japan | Site Reference ID/Investigator# 112741 | Tokyo | |
| Japan | Site Reference ID/Investigator# 114497 | Tokyo | |
| Japan | Site Reference ID/Investigator# 114538 | Tokyo | |
| Japan | Site Reference ID/Investigator# 115780 | Tokyo | |
| Japan | Site Reference ID/Investigator# 115781 | Tokyo | |
| Japan | Site Reference ID/Investigator# 115796 | Tokyo | |
| Japan | Site Reference ID/Investigator# 124656 | Tokyo | |
| Japan | Site Reference ID/Investigator# 124663 | Tokyo | |
| Japan | Site Reference ID/Investigator# 133755 | Tokyo | |
| Japan | Site Reference ID/Investigator# 112697 | Tomigusuku | |
| Japan | Site Reference ID/Investigator# 112742 | Toon-shi | |
| Japan | Site Reference ID/Investigator# 115775 | Tsukuba | |
| Japan | Site Reference ID/Investigator# 112636 | Tsuruga | |
| Japan | Site Reference ID/Investigator# 128948 | Tsuruga-shi | |
| Japan | Site Reference ID/Investigator# 112744 | Uji | |
| Japan | Site Reference ID/Investigator# 112624 | Utsunomiya | |
| Japan | Site Reference ID/Investigator# 112623 | Yokkaichi-shi | |
| Japan | Site Reference ID/Investigator# 121257 | Yokohama-shi | |
| Japan | Site Reference ID/Investigator# 126757 | Yokohama-shi | |
| Japan | Site Reference ID/Investigator# 115743 | Yufu-shi | |
| Japan | Site Reference ID/Investigator# 128425 | Zushi-shi |
| Lead Sponsor | Collaborator |
|---|---|
| AbbVie |
Japan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Disease Activity Score 28 | at week 4 | No | |
| Primary | Disease Activity Score 28 | at week 12 | No | |
| Primary | Disease Activity Score 28 | at week 24 | No | |
| Primary | 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 24 | Yes |
| Secondary | Clinical disease activity index | at week 4 | No | |
| Secondary | Clinical disease activity index | at week 12 | No | |
| Secondary | Clinical disease activity index | at week 24 | No | |
| Secondary | Simplified disease activity index | at week 4 | No | |
| Secondary | Simplified disease activity index | at week 12 | No | |
| Secondary | Simplified disease activity index | at week 24 | No |
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