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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000008514
Receipt No. R000010008
Scientific Title Elucidation of the pharmacokinetics of methotrexate and establishment of the optimum medication method in Japanese rheumatoid arthritis patients.
Date of disclosure of the study information 2012/07/24
Last modified on 2013/01/26

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Basic information
Public title Elucidation of the pharmacokinetics of methotrexate and establishment of the optimum medication method in Japanese rheumatoid arthritis patients.
Acronym Methotrexate as an anchor drug in Japanese rheumatoid arthritis monitored by erythrocyte polyglutamate concentration in Keio Rheumatology Expert Meeting.
Scientific Title Elucidation of the pharmacokinetics of methotrexate and establishment of the optimum medication method in Japanese rheumatoid arthritis patients.
Scientific Title:Acronym Methotrexate as an anchor drug in Japanese rheumatoid arthritis monitored by erythrocyte polyglutamate concentration in Keio Rheumatology Expert Meeting.
Region
Japan

Condition
Condition Rheumatoid Arthritis
Classification by specialty
Medicine in general Clinical immunology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To establish the optimum medication method of methotrexate(MTX) by monitoring the MTX-PG concentration in Japanese rheumatoid arthritis patients.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Low disease activity(SDAI<11 ) rate at week 12
Key secondary outcomes 1. Concentration of MTX-PG at week 4, 8, 12, 24 and 36
2. Remission rate (SDAI<3.3) at week 12,24 and 36
3. Radiological remission rate
4. Adverse effect 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 with rheumatoid arthritis diagnosed with ACR/EULAR classification criteria
2)Patients without use of previous MTX or biologic agents
3)Patients who will receive MTX treatment
4)Patients who can be treated with biologic agent treatment if efficacy of MTX is insufficient
Key exclusion criteria 1)Patients who cannot be treated with MTX
2)Patients who cannot be treated with biologic agents
3)Patients who are pregnant, who are nursing or who hope to be pregnant
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tsutomu Takeuchi
Organization Department of Internal Medicine, Keio University School of Medicine
Division name Division of Rheumatology
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, JAPAN
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Chihiro Takahashi
Organization Department of Internal Medicine, Keio University School of Medicine
Division name Division of Rheumatology, Department of Internal Medicine
Zip code
Address
TEL
Homepage URL
Email chihiro.takahashi@z6.keio.jp

Sponsor
Institute Keio University School of Medicine
Institute
Department

Funding Source
Organization Keio 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 東京医療センター(東京都)、都立大塚病院(東京都)、川崎市立川崎病院(神奈川県)、東京歯科大学市川総合病院(千葉県)

Other administrative information
Date of disclosure of the study information
2012 Year 07 Month 24 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
2012 Year 07 Month 24 Day
Date of IRB
Anticipated trial start date
2012 Year 07 Month 30 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information To establish the optimum medication method of methotrexate(MTX) by monitoring the MTX-PG concentration in Japanese rheumatoid arthritis patients.

Management information
Registered date
2012 Year 07 Month 24 Day
Last modified on
2013 Year 01 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010008

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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