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利用者名:
UMIN ID:

試験進捗状況 開始前/Preinitiation
UMIN試験ID UMIN000044257
受付番号 R000050547
科学的試験名 Treatment effects of apremilast for Behcet's disease: a systematic review and meta-analysis
一般公開日(本登録希望日) 2021/05/19
最終更新日 2021/05/19

※ 本ページ収載の情報は、臨床試験に関する情報公開を目的として、UMINが開設しているUMIN臨床試験登録システムに提供された臨床試験情報です。
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基本情報/Basic information
一般向け試験名/Public title Treatment effects of apremilast for Behcet's disease: a systematic review and meta-analysis Treatment effects of apremilast for Behcet's disease: a systematic review and meta-analysis
一般向け試験名略称/Acronym Treatment effects of apremilast for Behcet's disease: a systematic review and meta-analysis Treatment effects of apremilast for Behcet's disease: a systematic review and meta-analysis
科学的試験名/Scientific Title Treatment effects of apremilast for Behcet's disease: a systematic review and meta-analysis Treatment effects of apremilast for Behcet's disease: a systematic review and meta-analysis
科学的試験名略称/Scientific Title:Acronym Treatment effects of apremilast for Behcet's disease: a systematic review and meta-analysis Treatment effects of apremilast for Behcet's disease: a systematic review and meta-analysis
試験実施地域/Region
日本/Japan

対象疾患/Condition
対象疾患名/Condition Behcet's disease Behcet's disease
疾患区分1/Classification by specialty
膠原病・アレルギー内科学/Clinical immunology
疾患区分2/Classification by malignancy 悪性腫瘍以外/Others
ゲノム情報の取扱い/Genomic information いいえ/NO

目的/Objectives
目的1/Narrative objectives1 Apremilast, an oral phosphodiesterase (PDE)-4 inhibitor, has been shown to be efficacious in controlling oral ulcers of Behcet disease, after successful phase 3 RELIEF trial, in which apremilast 30mg twice daily significantly reduced the area under the curve in the number of oral ulcers for12 weeks compared to placebo (PMID 31722152). However, in this trial, the effects of apremilast for other major organs were not evaluated. Recently, real world data shows that apremilast is effective for genital ulcers and also reduced disease activity scores of Behcet disease. We therefore aimed to perform the systematic literature review and meta-analysis whether apremilast really has an effect on the treatment outcomes of major organ involvements and disease activity scores. Apremilast, an oral phosphodiesterase (PDE)-4 inhibitor, has been shown to be efficacious in controlling oral ulcers of Behcet disease, after successful phase 3 RELIEF trial, in which apremilast 30mg twice daily significantly reduced the area under the curve in the number of oral ulcers for12 weeks compared to placebo (PMID 31722152). However, in this trial, the effects of apremilast for other major organs were not evaluated. Recently, real world data shows that apremilast is effective for genital ulcers and also reduced disease activity scores of Behcet disease. We therefore aimed to perform the systematic literature review and meta-analysis whether apremilast really has an effect on the treatment outcomes of major organ involvements and disease activity scores.
目的2/Basic objectives2 安全性・有効性/Safety,Efficacy
目的2 -その他詳細/Basic objectives -Others

試験の性質1/Trial characteristics_1
試験の性質2/Trial characteristics_2
試験のフェーズ/Developmental phase

評価/Assessment
主要アウトカム評価項目/Primary outcomes 投与開始から12週後のBDCAF、口腔潰瘍以外のベーチェット病病変の有無 BDCAF and presence of BD-related symptoms after 12 weeks of apremilast treatment
副次アウトカム評価項目/Key secondary outcomes


基本事項/Base
試験の種類/Study type その他・メタアナリシス等/Others,meta-analysis etc

試験デザイン/Study design
基本デザイン/Basic design
ランダム化/Randomization
ランダム化の単位/Randomization unit
ブラインド化/Blinding
コントロール/Control
層別化/Stratification
動的割付/Dynamic allocation
試験実施施設の考慮/Institution consideration
ブロック化/Blocking
割付コードを知る方法/Concealment

介入/Intervention
群数/No. of arms
介入の目的/Purpose of intervention
介入の種類/Type of intervention
介入1/Interventions/Control_1

介入2/Interventions/Control_2

介入3/Interventions/Control_3

介入4/Interventions/Control_4

介入5/Interventions/Control_5

介入6/Interventions/Control_6

介入7/Interventions/Control_7

介入8/Interventions/Control_8

介入9/Interventions/Control_9

介入10/Interventions/Control_10


適格性/Eligibility
年齢(下限)/Age-lower limit

適用なし/Not applicable
年齢(上限)/Age-upper limit

適用なし/Not applicable
性別/Gender 男女両方/Male and Female
選択基準/Key inclusion criteria Behcet's disease patients treated with apremilast Behcet's disease patients treated with apremilast
除外基準/Key exclusion criteria Patients not fulfilled Behcet's disease diagnostic criteria Patients not fulfilled Behcet's disease diagnostic criteria
目標参加者数/Target sample size

責任研究者/Research contact person
責任研究者/Name of lead principal investigator
Kaoru
ミドルネーム
Minegishi
Kaoru
ミドルネーム
Minegishi
所属組織/Organization Yokohama City University School of Medicine Yokohama City University School of Medicine
所属部署/Division name Department of Stem Cell and Immune Regulation Department of Stem Cell and Immune Regulation
郵便番号/Zip code 236-0004
住所/Address 3-9 Fukuura Kanazawaku Yokohama 3-9 Fukuura Kanazawaku Yokohama
電話/TEL 0457872800
Email/Email kaoru-t@yokohama-cu.ac.jp

試験問い合わせ窓口/Public contact
試験問い合わせ窓口担当者/Name of contact person
Kaoru
ミドルネーム
Minegishi
Kaoru
ミドルネーム
Minegishi
組織名/Organization Yokohama City University School of Medicine Yokohama City University School of Medicine
部署名/Division name Department of Stem Cell and Immune Regulation Department of Stem Cell and Immune Regulation
郵便番号/Zip code 236-0004
住所/Address 3-9 Fukuura Kanazawaku Yokohama 3-9 Fukuura Kanazawaku Yokohama
電話/TEL 0457872800
試験のホームページURL/Homepage URL
Email/Email kaoru-t@yokohama-cu.ac.jp

実施責任組織/Sponsor
機関名/Institute 横浜市立大学 Yokohama City University School of Medicine
機関名/Institute
(機関選択不可の場合)
Yokohama City University School of Medicine
部署名/Department

研究費提供組織/Funding Source
機関名/Organization 横浜市立大学 Yokohama City University
機関名/Organization
(機関選択不可の場合)

組織名/Division
組織の区分/Category of Funding Organization 地方自治体/Local Government
研究費拠出国/Nationality of Funding Organization


その他の関連組織/Other related organizations
共同実施組織/Co-sponsor

その他の研究費提供組織/Name of secondary funder(s)


IRB等連絡先(公開)/IRB Contact (For public release)
組織名/Organization not applicable not applicable
住所/Address not applicable not applicable
電話/Tel not applicable
Email/Email not applicable

他機関から発行された試験ID/Secondary IDs
他機関から発行された試験ID/Secondary IDs いいえ/NO
試験ID1/Study ID_1
ID発行機関1/Org. issuing International ID_1

試験ID2/Study ID_2
ID発行機関2/Org. issuing International ID_2

治験届/IND to MHLW

試験実施施設/Institutions
試験実施施設名称/Institutions

その他の管理情報/Other administrative information
一般公開日(本登録希望日)/Date of disclosure of the study information
2021 05 19

関連情報/Related information
プロトコル掲載URL/URL releasing protocol
試験結果の公開状況/Publication of results 未公表/Unpublished

結果/Result
結果掲載URL/URL related to results and publications
組み入れ参加者数/Number of participants that the trial has enrolled
主な結果/Results

主な結果入力日/Results date posted
結果掲載遅延/Results Delayed
結果遅延理由/Results Delay Reason

最初の試験結果の出版日/Date of the first journal publication of results
参加者背景/Baseline Characteristics

参加者の流れ/Participant flow

有害事象/Adverse events

評価項目/Outcome measures

個別症例データ共有計画/Plan to share IPD

個別症例データ共有計画の詳細/IPD sharing Plan description


試験進捗状況/Progress
試験進捗状況/Recruitment status 開始前/Preinitiation
プロトコル確定日/Date of protocol fixation
2021 05 19
倫理委員会による承認日/Date of IRB
登録・組入れ開始(予定)日/Anticipated trial start date
2021 05 19
フォロー終了(予定)日/Last follow-up date
2021 05 19
入力終了(予定)日/Date of closure to data entry
データ固定(予定)日/Date trial data considered complete
解析終了(予定)日/Date analysis concluded

その他/Other
その他関連情報/Other related information Study search
We will search for candidate articles using PubMed, Cochrane, EMBASE, and Web of Science Core Collection on May 20th, 2021.

Publication type
Case-control studies, cohort studies, and randomized controlled trials will be included when each study provided data of treatment effects of apremilast for Behcet's disease.
Studies that offered information concerning only the secondary endpoints will be also included.
Non-English language article and conference abstract will be allowed.

Treatment
Apremilast with any type of concomitant medications will be allowed.

Primary outcome
The primary outcome will be relative efficacy for major organ involvements on apremilast in the form of an unadjusted odds ratio (OR) in Behcet's disease patients.

Secondary outcome.
The secondary outcomes includes (i) oral ulcers pain visual analogue scale (VAS) change from the baseline, difference (MD), (ii) Behcet's Disease Current Activity Form (BDCAF) score change from the baseline, difference (MD), and (iii) relative efficacy for arthritis/arthralgia in the form of an unadjusted odds ratio (OR) in Behcet's disease patients.

Quality assessment
The risk of bias of each study will be assessed by Cochrane risk of bias (RoB) tool for randomized trials and Newcastle-Ottawa Scale (NOS) for non-randomized studies.

Subgroup analysis
Subgroup analysis based on study designs will be conducted.
Study search
We will search for candidate articles using PubMed, Cochrane, EMBASE, and Web of Science Core Collection on May 20th, 2021.

Publication type
Case-control studies, cohort studies, and randomized controlled trials will be included when each study provided data of treatment effects of apremilast for Behcet's disease.
Studies that offered information concerning only the secondary endpoints will be also included.
Non-English language article and conference abstract will be allowed.

Treatment
Apremilast with any type of concomitant medications will be allowed.

Primary outcome
The primary outcome will be relative efficacy for major organ involvements on apremilast in the form of an unadjusted odds ratio (OR) in Behcet's disease patients.

Secondary outcome.
The secondary outcomes includes (i) oral ulcers pain visual analogue scale (VAS) change from the baseline, difference (MD), (ii) Behcet's Disease Current Activity Form (BDCAF) score change from the baseline, difference (MD), and (iii) relative efficacy for arthritis/arthralgia in the form of an unadjusted odds ratio (OR) in Behcet's disease patients.

Quality assessment
The risk of bias of each study will be assessed by Cochrane risk of bias (RoB) tool for randomized trials and Newcastle-Ottawa Scale (NOS) for non-randomized studies.

Subgroup analysis
Subgroup analysis based on study designs will be conducted.

管理情報/Management information
登録日時/Registered date
2021 05 19
最終更新日/Last modified on
2021 05 19


閲覧ページへのリンク/Link to view the page
URL(日本語) https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000050547
URL(英語) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050547

研究計画書
登録日時 ファイル名

研究症例データ仕様書
登録日時 ファイル名

研究症例データ
登録日時 ファイル名


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