UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015433 |
|---|---|
| Receipt number | R000017944 |
| Scientific Title | Safety study of methotrexate low-dose once daily administration in rheumatoid arthritis patients |
| Date of disclosure of the study information | 2014/11/01 |
| Last modified on | 2015/04/14 09:06:17 |
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Basic information
Public title
Safety study of methotrexate low-dose once daily administration in rheumatoid arthritis patients
Acronym
Safety study of MTX once daily administration in RA patients
Scientific Title
Safety study of methotrexate low-dose once daily administration in rheumatoid arthritis patients
Scientific Title:Acronym
Safety study of MTX once daily administration in RA patients
Region
| Japan |
Condition
Condition
rheumatoid arthritis
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To estimate safety, methotrexate was given once daily in RA patients.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
myelosuppression, ALT, AST, LDH, ALP, gamma-GTP,BUN, Scr, eGFR, CK, interstitial pneumonia
Key secondary outcomes
DAS28-CRP,European League Against Rheumatism (EULAR) criteria, clinical disease activity index (CDAI), simplified disease activity index (SDAI), odified Health Assessment Questionnaire
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
methotrexate
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who satisfied the following inclusion criteria were selected for enrollment in the study: Patients (1) RA patients , (2) patients have received methotrexate and (3) 20- years of age, and (4)Dose is 4, 6 or 8 mg/dweek,(5) patients have notreceived biological products, (6) leukocyte counts > 3000/microL
each patient included in the study gave a written informed consent.
Key exclusion criteria
Patients were excluded from the study if any of the following criteria applied: (1) concurrent pregnancy, (2) the presence of serious complications in the heart, lung, kidney, etc., (3) perform of surgical operation for rheumatoid arthritis within a period of 6 months before administration (4) use of glucocorticoids(10.1 mg/day) within a period of one month before administration , (5)patients have received biological products, tacrolimus, mizoribin or (6) any other reason for which the investigator judged the patient to be unfit for study
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideto To |
Organization
Graduate School of Medicine and Pharmaceutical Sciences for Research, University of Toyama
Division name
Department of Medical Pharmaceutics
Zip code
Address
2630 Sugitani, Toyama
TEL
0764158811
hide-to@umin.net
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideto To |
Organization
Graduate School of Medicine and Pharmaceutical Sciences for Research, University of Toyama
Division name
Department of Medical Pharmaceutics
Zip code
Address
2630 Sugitani, Toyama
TEL
0764158811
Homepage URL
hide-to@umin.net
Sponsor or person
Institute
Department of Medical Pharmaceutics , Graduate School of Medicine and Pharmaceutical Sciences for Research, University of Toyama
Institute
Department
Personal name
Funding Source
Organization
Japan Research Foundation for Clinical Pharmacology
Organization
Division
Category of Funding Organization
Non profit foundation
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
| 2014 | Year | 11 | Month | 01 | 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
| 2014 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 03 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 10 | Month | 14 | Day |
Last modified on
| 2015 | Year | 04 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017944
| 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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