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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000020926
Receipt No. R000019625
Scientific Title Prevalence of non-alchoholic steatohepatitis in patients with rheumatoid arthritis.
Date of disclosure of the study information 2016/02/08
Last modified on 2018/10/17

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Basic information
Public title Prevalence of non-alchoholic steatohepatitis in patients with rheumatoid arthritis.
Acronym Impact of Non alchoholic steatohepatitis in rheumatoid arthrtis
Scientific Title Prevalence of non-alchoholic steatohepatitis in patients with rheumatoid arthritis.
Scientific Title:Acronym Impact of Non alchoholic steatohepatitis in rheumatoid arthrtis
Region
Japan

Condition
Condition Rheumatoid arthritis
Classification by specialty
Medicine in general Hepato-biliary-pancreatic medicine Clinical immunology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluation of liver injury associated with phramacotherapy for rheumatoid arthritis.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Cause of liver injury
Key secondary outcomes

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Among of all patients who visited our hospital for three months, patients presented abnormal AST and ALT value for theree months.
RA patients treated with MTX (Current and Ex)
Key exclusion criteria None
Target sample size 850

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shunsuke Mori
Organization NHO Kumaoto Saishunsou National Hospital
Division name rheumatology
Zip code
Address 2659 Suya Kohshi, Kumamoto, Japan
TEL 81-96-242-1000
Email moris@saisyunsou1.hosp.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shunichi Tsutumiuchi
Organization NHO Kumaoto Saishunsou National Hospital
Division name Secretariat
Zip code
Address 2659 Suya Kohshi, Kumamoto, Japan
TEL 81-96-242-1000
Homepage URL
Email 8211syo1@hosp.go.jp

Sponsor
Institute NHO Kumamoto Saishunsou National Hospital
Institute
Department

Funding Source
Organization NHO Kumamoto Saishunsou National Hospital
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2016 Year 02 Month 08 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
We followed 846 RA patients with amean cumulative MTX dose of 2.48g and identified 51 patients presenting persistent transaminitis. According to multivariate logistic regression analysis, obesity (odds ratio [OR] 3.23, p<0.001), type 2 doabetes (OR 3.52, p=0.001), hypercholesterolemia (OR 2.56, p=0.004), and hyperuricemia (OR 3.52, p=0.019), which are recognized as risk factors for NAFLD, were independently associated with a risk of persistent aminitei. Among patients with persistent transaminitis, 42 showed fatty liver at ultrasonography. These patients had no evidence of alchoholic fatty liver, chronic viral hepatitis, autoimmune liver disease, or hereditary liver diseases. Biopsy specimens were obtained 32 patients, and we found that a NASH-like pattern was the most prevalent histological abnormality. These was no significant impact of MTX dose and duration on the histological severity.
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 Main results already published
Date of protocol fixation
2014 Year 12 Month 05 Day
Date of IRB
Anticipated trial start date
2014 Year 12 Month 05 Day
Last follow-up date
Date of closure to data entry
2016 Year 02 Month 29 Day
Date trial data considered complete
2018 Year 08 Month 24 Day
Date analysis concluded
2018 Year 08 Month 24 Day

Other
Other related information Risk factors and histological findings are similar between NAFLD/NASH and liver injury during low dose MTX treatment for RA, which suggests a strong association between both entities.NASH/NAFLD may be an underlying condition causing persistent transaminitis in MTX-treated RA patients.The results of this study illustrate the need for monitoring liver injury in RA patients with NAFLD risk factors during MTX treatment.

Management information
Registered date
2016 Year 02 Month 08 Day
Last modified on
2018 Year 10 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019625

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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