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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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JPRN |
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Last refreshed on:
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17 October 2023 |
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Main ID: |
JPRN-UMIN000015433 |
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Date of registration:
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01/11/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Safety study of methotrexate low-dose once daily administration in rheumatoid arthritis patients
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Scientific title:
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Safety study of methotrexate low-dose once daily administration in rheumatoid arthritis patients - Safety study of MTX once daily administration in RA patients |
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Date of first enrolment:
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2015/03/01 |
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Target sample size:
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35 |
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Recruitment status: |
Recruiting |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017944 |
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Study type:
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Interventional |
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Study design:
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Single arm Non-randomized
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Phase:
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Not selected
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Countries of recruitment
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Japan
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Contacts
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Name:
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Hideto To |
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Address:
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2630 Sugitani, Toyama
Japan |
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Telephone:
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0764158811 |
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Email:
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hide-to@umin.net |
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Affiliation:
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Graduate School of Medicine and Pharmaceutical Sciences for Research, University of Toyama Department of Medical Pharmaceutics |
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Name:
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Hideto To |
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Address:
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2630 Sugitani, Toyama
Japan |
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Telephone:
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0764158811 |
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Email:
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hide-to@umin.net |
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Affiliation:
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Graduate School of Medicine and Pharmaceutical Sciences for Research, University of Toyama Department of Medical Pharmaceutics |
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Key inclusion & exclusion criteria
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Inclusion criteria:
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
Age minimum:
20years-old
Age maximum:
Not applicable
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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rheumatoid arthritis
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Intervention(s)
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methotrexate
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Primary Outcome(s)
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myelosuppression, ALT, AST, LDH, ALP, gamma-GTP,BUN, Scr, eGFR, CK, interstitial pneumonia
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Secondary Outcome(s)
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DAS28-CRP,European League Against Rheumatism (EULAR) criteria, clinical disease activity index (CDAI), simplified disease activity index (SDAI), odified Health Assessment Questionnaire
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Source(s) of Monetary Support
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Japan Research Foundation for Clinical Pharmacology
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Ethics review
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Status: YES
Approval date:
Contact:
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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