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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000015433
Receipt No. 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

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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
Email 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
Email hide-to@umin.net

Sponsor
Institute Department of Medical Pharmaceutics , Graduate School of Medicine and Pharmaceutical Sciences for Research, University of Toyama
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017944

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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