UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008514 |
|---|---|
| Receipt number | 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 13:39:44 |
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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
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
chihiro.takahashi@z6.keio.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010008
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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