Study for variations of safety and efficacy profile caused by division of weekly dose of methotrexate (preliminary study)

Not Applicable

• Conditions: Rheumatoid arthritis

• Registration Number: JPRN-UMIN000012473
• Lead Sponsor: Yokohama Minami Kyousai Hospital Santen Pharmaceutical CO.,Ltd.

Brief Summary

There were no significant differences in the average of age , disease duration (5.8yr), and baseline DAS28(CPR)(2.84) between two groups. There were also no differences in the improvement of DAS28(CPR)(-0.95 vs -0.75) between two groups and weekly MTX dose(11.5mg vs 11.4mg) . Three adverse events were observed only in 3-dose regimen group . The remarkable difference was observed in MTX-PGs(18.8%), 3-dose regimen group showed significantly higher concentration of MTX-PG1+2 than single-dose group. On the other hand, 3-doses regimen group showed slight lower MTX-PG4+5 than single-dose regimen group, and there was no difference in MTX-PG3. The efficacy did not show significant difference between two groups. Liver function may be affected by concentration of MTX-PG1+2, which elevated in divided dosage regimen group. Further investigation is required in a larger population.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-12-04
• Study Completion: 2014-12-11
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

(Complication) Patients who had any of the following diagnoses or medical history 1)Autoimmune disease, except for RA and Sjogren's syndrome, and malignancy. 2)Drug allergy 3)Severe heart, lung, liver, kidney and heamatological disorders (Treatment) 4)Patient who recived intramuscular, intoravenous or epidural injection of corticosteroids within 4 weeks prior to the entry or during study 5)Patient who recived intraarticular corticosteroid at dose of over 20mg/month of prednisolone, and patients who recieved intraarticular corticosteroid at any dose within 4weeks prior to study entry or the day for observation of first end point 6)Patient who recived systemic corticosteroid with a dose of>10mg of predonisolone within 4 weeks prior to the study or during the study and Patients whose corticosteroid dose were changed within 4 weeks prior to the day for observation of first end point 7)Patient who received NSAIDs with an overdosage within 4 weeks prior to the study entry or during the study (Surgery) 8)Patient who had surgery judged to have an influence on this study by doctor 9)Patient who had the following treatment or procedure:plasma exchange, leukocyte depleted therapy or arthrocentesis against affected joint. except for the arthrocenesis following intraarticular injection of corticosteroid, within 4 weeks prior to the study entry or during the study (Others) 10)Patient who is in pregnancy, lactating, or with a possibility of the pregnancy and woman who hopes for pregnancy during study or within 1 month after the end of this study, and man who wishes his partner be pregnant during the study or within 3 months after the end of this study 11)Patient who can not go to a hospital for check-up on an appointed day 12)When principal investigator or sub investigators of this study judge the patients disqualified as a subject of this study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adverse event rates by questionnaire in observation period

Secondary Outcome Measures

Name	Time	Method
SDAI of 12 weeks and 19 weeks from the start of observation period DAS28 of 12 weeks and 19weeks from the start of observation period Concentration of MTX polyglutamates in red blood cells Laboratory test values in observation period