UMIN-CTR Clinical Trial

Basic information
Public title	Prediction of the therapeutic response and adverse events to methotrexate by monitoring methotrexate-polyglutamates (MTX-PGs) concentration in erythrocytes in Japanese patients with rheumatoid arthritis (RA).
Acronym	Study in Japanese patients with RA for prediction of the therapeutic response and adverse events to methotrexate by monitoring MTX-PG concentrations in erythrocytes.
Scientific Title	Prediction of the therapeutic response and adverse events to methotrexate by monitoring methotrexate-polyglutamates (MTX-PGs) concentration in erythrocytes in Japanese patients with rheumatoid arthritis (RA).
Scientific Title:Acronym	Study in Japanese patients with RA for prediction of the therapeutic response and adverse events to methotrexate by monitoring MTX-PG concentrations in erythrocytes.
Region	Japan

Condition
Condition	Rheumatoid arthritis
Classification by specialty	Clinical immunology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the pharmacokinetics and pharmacodynamics of MTX-PGs in erythrocytes in patients with RA and correlate them with their effects and adverse events.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	DAS28CRP improvement from baseline (delta DAS28CRP) > 1.2 at 24 weeks
Key secondary outcomes	1. MTX-PG levels at 12 and 24 weeks 2. DAS28CRP improvement from baseline (delta DAS28CRP) > 1.2 at 12 and 24 weeks 3. MTX-PG levels at 0, 1 and 6 hours 4. Radiological remission rate 5. Adverse event rate

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	1. Patients who met the 2010 American College of Rheumatology (ACR) /European League Against Rheumatism (EULAR) criteria for RA. 2. MTX-naive patients who are going to start oral MTX treatment and patients who have already been treated with a stable dose of MTX.
Key exclusion criteria	1. Patients who have already been treated with Leflunomide and biologics. 2. Patients who can not be treated with MTX. 3. Patients who are pregnant, breast-feed, and desire to be pregnant.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Middle name Last name Katsuya Nagatani
Organization	Jichi Medical University
Division name	Division of Rheumatology and Clinical Immunology, Department of Medicine
Zip code
Address	3311-1 Yakushiji, Shimotsuke-shi, Tochigi 329-0498, JAPAN
TEL	0285-58-7358
Email	knagatani@jichi.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Katsuya Nagatani
Organization	Jichi Medical University
Division name	Division of Rheumatology and Clinical Immunology, Department of Medicine
Zip code
Address	3311-1 Yakushiji, Shimotsuke-shi, Tochigi 329-0498, JAPAN
TEL	0285-58-7358
Homepage URL
Email	knagatani@jichi.ac.jp

Sponsor
Institute	Jichi Medical University
Institute
Department

Funding Source
Organization	Jichi Medical University
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	2015 Year 12 Month 09 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications	https://www.ncbi.nlm.nih.gov/pubmed/27435295
Number of participants that the trial has enrolled	56
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	Completed
Date of protocol fixation	2013 Year 07 Month 01 Day
Date of IRB	2013 Year 07 Month 01 Day
Anticipated trial start date	2013 Year 07 Month 01 Day
Last follow-up date	2019 Year 09 Month 12 Day
Date of closure to data entry	2019 Year 09 Month 12 Day
Date trial data considered complete	2019 Year 09 Month 12 Day
Date analysis concluded	2019 Year 09 Month 12 Day

Other

Other related information

Patients with RA who give their written informed consent of this study and seen in the Division of Rheumatology and Clinical Immunology, Department of Medicine, Jichi Medical University, Tochigi, Japan and associated hospitals are enrolled in this study after July 2013. This study is performed using prospective longitudinal and cross-sectional study designs including adult MTX-naive patients who are going to start oral MTX treatment and patients who have already been treated with a stable dose of MTX at the time of inclusion in the study. The patients provide about 2 mL of their blood which is needed to estimate MTX-PGs in erythrocytes.

Management information
Registered date	2015 Year 12 Month 09 Day
Last modified on	2019 Year 09 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023257