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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-UMIN000017440 |
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Date of registration:
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07/05/2015 |
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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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In methotrexate resistant rheumatoid arthritis, switching methotrexate to tofacitinib versus adding tofacitinib to methotrexate, open labeled, multicenter randomized non-inferiority study.
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Scientific title:
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In methotrexate resistant rheumatoid arthritis, switching methotrexate to tofacitinib versus adding tofacitinib to methotrexate, open labeled, multicenter randomized non-inferiority study. - RAXEL study |
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Date of first enrolment:
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2015/05/18 |
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Target sample size:
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134 |
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Recruitment status: |
Complete: follow-up complete |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019412 |
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Study type:
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Interventional |
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Study design:
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Parallel Randomized
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Phase:
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Phase IV
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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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Sohei
Makita |
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Address:
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1-8-1, Inohana, Chuo-ku Chiba-shi, Chiba, 260-0856, Japan
2620856
Japan |
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Telephone:
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043-222-7171 |
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Email:
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makitasohei@chiba-u.jp |
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Affiliation:
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Graduate School of Medicine and School of Medicine, Chiba University the department of allergy and clinical immunology |
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Name:
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Hiroshi
Nakajima |
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Address:
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1-8-1, Inohana, Chuo-ku Chiba-shi, Chiba, 260-0856, Japan
Japan |
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Telephone:
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043-222-7171 |
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Email:
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nakajimh@faculty.chiba-u.jp |
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Affiliation:
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Graduate School of Medicine and School of Medicine, Chiba University the department of allergy and clinical immunology |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: (1)The patient suffering from autoimmune disease With the exception of the Sjogren's syndrome and thyroid disease. (2)Active tuberculosis, HIV, HBV or HCV infection has coexist. (3)There is a pregnancy hope. (4)There is a history of malignancy within the past 5 years. (5)There is a history of tuberculosis infection within the past one year. (6)There is a potential comorbidities requiring Intravenous glucocorticoid, Oral glucocorticoid, Immunosuppressant, biologics, Plasma exchange or IVIG during the study period. (7)Other, who is investigator or test sharing doctor was judged unsuitable to safely carry out the present study.
Age minimum:
18years-old
Age maximum:
90years-old
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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for 3 months Tofacitinib 5mg BID everyday
for 3 months Tofacitinib 5mg BID everyday for 3 months Methotrexate6mg-16mg/week
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Primary Outcome(s)
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Achievement rate of ACR20 at 12 weeks
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Secondary Outcome(s)
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Achievement rate of ACR20 at 4 and 8 weeks Achievement rate of ACR50 and 70 at 4, 8 and 12 weeks Achievement rate of remission at 4, 8 and 12 weeks DAS28-ESR and DAS28-CRP at 4, 8 and 12 weeks HAQ score at 4, 8 and 12weeks Tender joint counts and swollen joint counts at 4, 8 and 12 weeks
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Source(s) of Monetary Support
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none
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Ethics review
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Status: YES
Approval date: 22/02/2015
Contact:
shiken@office.chiba-u.jp
industrial revenue bond of Chiba university
043-226-2616
shiken@office.chiba-u.jp
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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18/05/2019 |
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URL:
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