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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000034715
Receipt No. R000039576
Scientific Title Impact of inflammatory cytokines to CYP3A or OATP1B activities in rheumatoid arthritis patient using endogenous substrate.
Date of disclosure of the study information 2018/11/12
Last modified on 2019/05/10

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Basic information
Public title Impact of inflammatory cytokines to CYP3A or OATP1B activities in rheumatoid arthritis patient using endogenous substrate.
Acronym Impact of inflammatory cytokines to CYP3A or OATP1B activities in rheumatoid arthritis patient using endogenous substrate.
Scientific Title Impact of inflammatory cytokines to CYP3A or OATP1B activities in rheumatoid arthritis patient using endogenous substrate.
Scientific Title:Acronym Impact of inflammatory cytokines to CYP3A or OATP1B activities in rheumatoid arthritis patient using endogenous substrate.
Region
Japan

Condition
Condition rheumatoid arthritis
Classification by specialty
Clinical immunology
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 We evaluate the correlation between inflammatory cytokine levels and CYP3A or OATP1B activities in RA patients using endogenous substrates, 4beta -OHC or CP-I, respectively.
Basic objectives2 Others
Basic objectives -Others Rheumatoid arthritis (RA) is one of the systemic inflammatory diseases, which has a major symptom of multiple arthritis and progressive joint destruction. Since the prevalence of RA is high in elderly women, most RA patients have various diseases and take medications such as hypertension and hyperlipidemia. Among these, the agents that are metabolized by CYP3A and/or transported into the liver by OATP1B are included. According to past animal experiment reports, inflammatory cytokines, especially IL-6 and TNF-alpha, which are key factors in the pathogenesis of RA inhibit the expression of CYP3A at the mRNA level by up-regulating inhibitory transcription factors. Recently, coproporphyrin-I (CP-I) was identified as a specific endogenous substrate of OATP1B1 and OATP1B3. Thus, we evaluate the correlation between inflammatory cytokine levels and CYP3A or OATP1B activities in RA patients using endogenous substrates, 4beta-hydroxycholesterol (4beta-OHC) or CP-I, respectively.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The prospective study will recruit 100 inpatients or outpatients for 18 years of age or over introduced to the Department of Rheumatology, Oita University Faculty of Medicine, who are not in remission state with DAS 28-CRP score (more than 2.3). Genetic polymorphisms of CYP3A or OATP1B was evaluated by identifying genotypes of single nucleotide polymorphism A6986G (CYP3A5*3) or A388G (SLOC1B1*1b) and T521C (SLOC1B1*5), respectively, using real-time PCR. The concentration of 4beta-OHC in plasma was quantified using gas chromatography-mass spectrometry (GC-MS) previously developed. The plasma CP-I concentration was determined using an ultra-performance liquid chromatography with tandem mass spectrometry (UPLC-MS/MS). The concentrations of inflammatory cytokines (IL-6, TNF-alpha, IL-1beta) in the plasma are measured using each ELISA. The correlation between inflammatory cytokines and plasma 4beta-OHC or CP-I concentration is statistically analyzed using Pearson correlation coefficient or Spearman rank correlation coefficient. Furthermore, using genotypes of CYP3A5*3 or SLOC1B1*1b and SLOC1B1*5, and background, the major factors that influences these concentrations are analyzed by multivariate logistic regression analysis.
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria RA patients who are not in remission state with DAS 28-CRP (more than 2.3)
Key exclusion criteria Not applicable
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Ryota
Middle name
Last name Tanaka
Organization Oita University Hospital
Division name Department of Clinical Pharmacy
Zip code 879-5593
Address 1-1 Hasama-machi, Yufu-City Oita 879-5593, Japan.
TEL 0975866113
Email rtanaka@oita-u.ac.jp

Public contact
Name of contact person
1st name Ryota
Middle name
Last name Tanaka
Organization Oita University Hospital
Division name Department of Clinical Pharmacy
Zip code 879-5593
Address 1-1 Hasama-machi, Yufu-City Oita 879-5593, Japan.
TEL 0975866113
Homepage URL
Email rtanaka@oita-u.ac.jp

Sponsor
Institute Oita University Hospital, Department of Clinical Pharmacy
Institute
Department

Funding Source
Organization Japan Science and Technology Agency
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor Department of Endocrinology, Metabolism, Rheumatology and Nephrology, Faculty of Medicine, Oita University
Name of secondary funder(s)

IRB Contact (For public release)
Organization Oita University Faculty of Medicine Ethics Committee
Address 1-1 Hasama-machi, Yufu-City Oita 879-5593, Japan.
Tel 0975865120
Email syomu@oita-u.ac.jp

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
2018 Year 11 Month 12 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 Enrolling by invitation
Date of protocol fixation
2018 Year 10 Month 31 Day
Date of IRB
2018 Year 12 Month 14 Day
Anticipated trial start date
2019 Year 01 Month 14 Day
Last follow-up date
2019 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Nothing

Management information
Registered date
2018 Year 10 Month 31 Day
Last modified on
2019 Year 05 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039576

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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