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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000044257
Receipt No. R000050547
Scientific Title Treatment effects of apremilast for Behcet's disease: a systematic review and meta-analysis
Date of disclosure of the study information 2021/05/19
Last modified on 2021/05/19

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Basic information
Public title Treatment effects of apremilast for Behcet's disease: a systematic review and meta-analysis
Acronym Treatment effects of apremilast for Behcet's disease: a systematic review and meta-analysis
Scientific Title Treatment effects of apremilast for Behcet's disease: a systematic review and meta-analysis
Scientific Title:Acronym Treatment effects of apremilast for Behcet's disease: a systematic review and meta-analysis
Region
Japan

Condition
Condition Behcet's disease
Classification by specialty
Clinical immunology
Classification by malignancy Others
Genomic information NO

Objectives
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.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes BDCAF and presence of BD-related symptoms after 12 weeks of apremilast treatment
Key secondary outcomes

Base
Study type Others,meta-analysis etc

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Behcet's disease patients treated with apremilast
Key exclusion criteria Patients not fulfilled Behcet's disease diagnostic criteria
Target sample size

Research contact person
Name of lead principal investigator
1st name Kaoru
Middle name
Last name Minegishi
Organization Yokohama City University School of Medicine
Division name Department of Stem Cell and Immune Regulation
Zip code 236-0004
Address 3-9 Fukuura Kanazawaku Yokohama
TEL 0457872800
Email kaoru-t@yokohama-cu.ac.jp

Public contact
Name of contact person
1st name Kaoru
Middle name
Last name Minegishi
Organization Yokohama City University School of Medicine
Division name Department of Stem Cell and Immune Regulation
Zip code 236-0004
Address 3-9 Fukuura Kanazawaku Yokohama
TEL 0457872800
Homepage URL
Email kaoru-t@yokohama-cu.ac.jp

Sponsor
Institute Yokohama City University School of Medicine
Institute
Department

Funding Source
Organization Yokohama City University
Organization
Division
Category of Funding Organization Local Government
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization not applicable
Address not applicable
Tel not applicable
Email not applicable

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

Other administrative information
Date of disclosure of the study information
2021 Year 05 Month 19 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Preinitiation
Date of protocol fixation
2021 Year 05 Month 19 Day
Date of IRB
Anticipated trial start date
2021 Year 05 Month 19 Day
Last follow-up date
2021 Year 05 Month 19 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
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.

Management information
Registered date
2021 Year 05 Month 19 Day
Last modified on
2021 Year 05 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050547

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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