UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020926 |
|---|---|
| Receipt number | 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 15:33:45 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
8211syo1@hosp.go.jp
Sponsor or person
Institute
NHO Kumamoto Saishunsou National Hospital
Institute
Department
Personal name
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
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
Value
https://center6.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 |
