Clinical trial for efficacy and safety related to weekly dosage regimens of methotrexate - Clinical trial for Adverse event related to Weekly dosage regimens of Methotrexate (ADDMe trial)

Yokohama Minami Kyousai Hospital0 sites120 target enrollmentFebruary 29, 2016

Overview

Phase: 未知
Intervention: Not specified
Conditions: Not specified
Sponsor: Yokohama Minami Kyousai Hospital
Enrollment: 120
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

February 29, 2016

End Date

August 31, 2017

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Yokohama Minami Kyousai Hospital

Eligibility Criteria

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 at any dose within 4weeks prior to study entry or first end point 6\)Pateint whose body weight is less than or equal to 40kg 7\)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 first end point 8\)Patient who received NSAIDs with an overdosage within 4 weeks prior to the study entry or during the study. 9\) Patient who is currently under treatment or treatmented with biologics, JAK inhibitor or immunosappressants within 8 weeks prior to the study entry. (Surgery) 10\)Patient who had surgery judged to have an influence on this study by doctor 11\)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) 12\)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 13\)Patient who can not go to a hospital for check\-up on an appointed day 14\)When principal investigator or sub investigators of this study judge the patients disqualified as a subject of this study