UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032390
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

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Basic information

Public 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.

Acronym

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.

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.

Scientific Title:Acronym

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.

Region

Japan


Condition

Condition

non-infectious intermediate and posterior uveitis, and pan-uveitis

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

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 .

Basic objectives2

Others

Basic objectives -Others

Total dose of systemic corticosteroids.

Trial characteristics_1

Others

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

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.

Key secondary outcomes

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.


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

15 years-old <=

Age-upper limit

75 years-old >=

Gender

Male and Female

Key inclusion criteria

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

Key exclusion criteria

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

Target sample size

200


Research contact person

Name of lead principal investigator

1st name Hidekazu
Middle name
Last name Tsuruga

Organization

AbbVie GK

Division name

Medical Affairs

Zip code

108-0023

Address

3-1-21 Shibaura, Minato-ku, Tokyo , Japan

TEL

03-4577-1111

Email

motohiro.okayasu@abbvie.com


Public contact

Name of contact person

1st name Atsuo
Middle name
Last name Otsuka

Organization

EP CRSU Co., Ltd.

Division name

Clinical Study Division

Zip code

162-0814

Address

6-29 Shin-ogawa-cho, Shinjuku-ku, Tokyo, Japan

TEL

03-5946-8264

Homepage URL


Email

otsuka177@eps.co.jp


Sponsor or person

Institute

AbbVie GK

Institute

Department

Personal name



Funding Source

Organization

AbbVie GK

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

NA

Address

NA

Tel

NA

Email

NA


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

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)


Other administrative information

Date of disclosure of the study information

2018 Year 04 Month 26 Day


Related information

URL releasing protocol

https://doi.org/10.1007/s10384-021-00897-7

Publication of results

Published


Result

URL related to results and publications

https://doi.org/10.1007/s10384-021-00897-7

Number of participants that the trial has enrolled

157

Results

published

Results date posted

2022 Year 01 Month 21 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Non-infectious uveitis associated with Vogt-Koyanagi-Harada (VKH) disease or sarcoidosis treated with systemic corticosteroids.

Participant flow

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).

Adverse events

Subsequent relapse was experienced by 39.5% of patients, and 13.4% had a steroid-related ADR.

Outcome measures

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.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2018 Year 04 Month 11 Day

Date of IRB

2018 Year 05 Month 24 Day

Anticipated trial start date

2018 Year 06 Month 01 Day

Last follow-up date

2019 Year 06 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

-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.


Management information

Registered date

2018 Year 04 Month 26 Day

Last modified on

2022 Year 01 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036939


Research Plan
Registered date File name
2022/01/21 Protocol_3.0版_FIX Version.docx

Research case data specifications
Registered date File name
2022/01/21 H18-922_図表出力計画書.xlsx

Research case data
Registered date File name
2022/01/21 H18-922_Results_v1.0_20190920.xlsx