UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020134 |
|---|---|
| Receipt number | R000023257 |
| 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). |
| Date of disclosure of the study information | 2015/12/09 |
| Last modified on | 2019/09/12 18:37:49 |
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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
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
knagatani@jichi.ac.jp
Sponsor or person
Institute
Jichi Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023257
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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