Unique ID issued by UMIN | UMIN000032390 |
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Receipt number | R000036939 |
Scientific Title | Multicenter, retrospective, observational study to explore treatment pattern of systemic corticosteroids for relapse of non-infectious intermediate and posterior uveitis, and pan-uveitis accompanying with VKH disease or sarcoidosis in daily routine practice. |
Date of disclosure of the study information | 2018/04/26 |
Last modified on | 2022/01/21 16:12:21 |
Multicenter, retrospective, observational study to explore treatment pattern of systemic corticosteroids for relapse of non-infectious intermediate and posterior uveitis, and pan-uveitis accompanying with VKH disease or sarcoidosis in daily routine practice.
Multicenter, retrospective, observational study to explore treatment pattern of systemic corticosteroids for relapse of non-infectious intermediate and posterior uveitis, and pan-uveitis accompanying with VKH disease or sarcoidosis in daily routine practice.
Multicenter, retrospective, observational study to explore treatment pattern of systemic corticosteroids for relapse of non-infectious intermediate and posterior uveitis, and pan-uveitis accompanying with VKH disease or sarcoidosis in daily routine practice.
Multicenter, retrospective, observational study to explore treatment pattern of systemic corticosteroids for relapse of non-infectious intermediate and posterior uveitis, and pan-uveitis accompanying with VKH disease or sarcoidosis in daily routine practice.
Japan |
non-infectious intermediate and posterior uveitis, and pan-uveitis
Ophthalmology |
Others
NO
To estimate the total dose of systemic corticosteroids during 12 months in the treatment of relapses of non-infectious, intermediate, posterior uveitis, or panuveitis associated with VKH disease or sarcoidosis .
Others
Total dose of systemic corticosteroids.
Others
Others
Not applicable
Total dose of systemic corticosteroids in the treatment of relapses of non-infectious, intermediate, posterior uveitis, or panuveitis associated with VKH disease or sarcoidosis during 12 months after the target relapse.
1) To assess the total days of systemic corticosteroid treatment during 12 months in the treatment of relapses of non-infectious, intermediate, posterior uveitis, or
panuveitis associated with VKH disease or sarcoidosis.
2) To assess the total dose of systemic corticosteroids per month at 1, 3, 6, 9 and 12-month in the treatment of relapses of non-infectious, intermediate, posterior uveitis, or panuveitis associated with VKH disease or sarcoidosis.
3) To evaluate the relationship between the total dose of systemic corticosteroids and the rate of re-relapse during 12 months after the target relapse by calculating
the coefficient estimate from logistic analysis.
4) To summarize concomitant medications used together with systemic corticosteroids in the treatment of relapses of non-infectious, intermediate, posterior uveitis, or panuveitis associated with VKH disease or sarcoidosis.
5) To calculate the rates and their 95% confidence intervals of steroid-free patients at 1, 3, 6, 9 and 12-month after the target relapse.
6) To assess the total days of high dose systemic corticosteroid treatment (10mg/day) during 12 months in the treatment of relapses of non-infectious, intermediate, posterior uveitis, or panuveitis associated with VKH disease or sarcoidosis.
7) To assess the total days of high dose systemic corticosteroid treatment at 1, 3, 6, 9 and 12-month after the target relapse.
8) To investigate the total dose of systemic corticosteroids by demographic factors (age, gender, comorbidities, systemic
corticosteroid treatment history, primary disease).
9) To evaluate the change of each clinical evaluation item from the best point before the target relapse and to the best point after the target relapse.
10) To describe the number of times of another relapse after the target relapse.
11) To assess the rate of adverse drug reactions (ADRs) associated with systemic corticosteroids after the target relapse.
Observational
15 | years-old | <= |
75 | years-old | >= |
Male and Female
Patients who meet all of the following criteria
1.Aged =>15 years and =<75 years as of the date of treatment given for the target relapse
2.Patients with a diagnosis of non-infectious intermediate and posterior uveitis, and pan-uveitis accompanying VKH disease or sarcoidosis
3.Patients with a target relapse meeting the criteria specified for this study
4.Patients whose medical record at the study sites during a 6-month period before and 12-month period after the start date of treatment of target relapse is available for the investigation.
5.Patients in whom systemic corticosteroid therapy is resumed or the dose of ongoing systemic corticosteroids is increased on the day on which treatment of target relapse starts
Patients who meet either of the following criteria
1.Patients undergoing an ophthalmic operation during the 12-month assessment period from the day on which treatment of target relapse starts.
2.Patients in whom dose reduction or discontinuation of systemic corticosteroids cannot be allowed due to the underlying disease (e.g., treatment of pulmonary lesion associated with sarcoidosis), an immunologic disease, interstitial pneumonia, or other relevant condition during the 12-month assessment period from the day on which treatment of target relapse starts.
3.Patients who received the study drug during the 12-month assessment period from the day on which treatment of target relapse starts
200
1st name | Hidekazu |
Middle name | |
Last name | Tsuruga |
AbbVie GK
Medical Affairs
108-0023
3-1-21 Shibaura, Minato-ku, Tokyo , Japan
03-4577-1111
motohiro.okayasu@abbvie.com
1st name | Atsuo |
Middle name | |
Last name | Otsuka |
EP CRSU Co., Ltd.
Clinical Study Division
162-0814
6-29 Shin-ogawa-cho, Shinjuku-ku, Tokyo, Japan
03-5946-8264
otsuka177@eps.co.jp
AbbVie GK
AbbVie GK
Profit organization
Japan
NA
NA
NA
NA
NO
北海道大学病院(北海道)/ Hokkaido University Hospital (Hokkaido)
東北大学病院(宮城県)/ Tohoku University Hospital (Miyagi-ken)
山形大学医学部附属病院(山形県)、/ Yamagata University Hospital (Yamagata-ken)
東京大学医学部附属病院(東京都)/ The University of Tokyo Hospital (Tokyo-to)
東京医科歯科大学医学部附属病院(東京都)/ Tokyo Medical And Dental University, Medical Hospital (Tokyo-to)
東京医科大学病院(東京都)/ Tokyo Medical University Hospital (Tokyo-to)
横浜市立大学附属病院(神奈川県)/ Yokohama City University Hospital (Kanagawa-ken)
大阪大学医学部附属病院(大阪府)/ Osaka University Hospital(Osaka-fu)
淀川キリスト教病院(大阪府)/ Yodogawa Christian Hospital (Osaka-fu)
神戸大学医学部附属病院(兵庫県)/ Kobe University Hospital (Hyogo-ken)
山口大学医学部附属病院(山口県)/ Yamaguchi University Hospital (Yamaguchi-ken)
九州大学病院(福岡県)/ Kyushu University Hospital (Fukuoka-ken)
神戸海星病院(兵庫県)/ Kobe Kaisei Hospital (Hyogo-ken)
2018 | Year | 04 | Month | 26 | Day |
https://doi.org/10.1007/s10384-021-00897-7
Published
https://doi.org/10.1007/s10384-021-00897-7
157
published
2022 | Year | 01 | Month | 21 | Day |
Non-infectious uveitis associated with Vogt-Koyanagi-Harada (VKH) disease or sarcoidosis treated with systemic corticosteroids.
One hundred fifty-seven patients (15-75 years; 103 VKH disease, 54 sarcoidosis) given systemic corticosteroids to treat a relapse of non-infectious intermediate, posterior, or panuveitis accompanying VKH disease or sarcoidosis were studied (August 2011-December 2018).
Subsequent relapse was experienced by 39.5% of patients, and 13.4% had a steroid-related ADR.
Mean (plus minus SD) total systemic corticosteroids dose over 12 months after target relapse treatment was 3874 plus minus 2775 mg, and was higher in patients with immunosuppressants than in those without (4575 mg vs 3496 mg). Immunosuppressant use was the only factor significantly associated with higher total systemic corticosteroids dose (p=0.0196). Mean duration of systemic corticosteroids treatment for relapse was 318.7 plus minus 89.3 days. 29.3% of patients were steroid-free after 12 months.
Completed
2018 | Year | 04 | Month | 11 | Day |
2018 | Year | 05 | Month | 24 | Day |
2018 | Year | 06 | Month | 01 | Day |
2019 | Year | 06 | Month | 30 | Day |
-Study Design:
Multicenter,retrospective, observational study
-Sampling of the subject candidate:
Patients who visited the institutions from February 2012 to January 2017, and meet all of the inclusion criteria.
2018 | Year | 04 | Month | 26 | Day |
2022 | Year | 01 | Month | 21 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036939
Research Plan | |
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Registered date | File name |
2022/01/21 | Protocol_3.0版_FIX Version.docx |
Research case data specifications | |
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Registered date | File name |
2022/01/21 | H18-922_図表出力計画書.xlsx |
Research case data | |
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Registered date | File name |
2022/01/21 | H18-922_Results_v1.0_20190920.xlsx |