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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-UMIN000009887 |
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Date of registration:
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01/04/2013 |
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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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Associations between the initial concentration of serum TNF alpha and effects due to increasing a dose of Infliximab, and between effects of infliximab and the concentration of serum IL-6
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Scientific title:
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Associations between the initial concentration of serum TNF alpha and effects due to increasing a dose of Infliximab, and between effects of infliximab and the concentration of serum IL-6 - Associations between the initial concentration of serum TNF alpha and effects due to increasing a dose of Infliximab, and between effects of infliximab and the concentration of serum IL-6 |
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Date of first enrolment:
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2013/04/01 |
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Target sample size:
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100 |
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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=R000011514 |
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Study type:
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Interventional |
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Study design:
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Parallel Non-randomized
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Phase:
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Not applicable
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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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Hiroshi Okuno |
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Address:
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Japan |
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Telephone:
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022-717-7245 |
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Email:
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okuno@med.tohoku.ac.jp |
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Affiliation:
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Tohoku University Hospital Orthopaedic surgery |
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Name:
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Hiroshi Okuno |
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Address:
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1-1 Seiryo-machi, Aoba-ku, Sendai, JAPAN
Japan |
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Telephone:
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022-717-7245 |
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Email:
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Affiliation:
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Tohoku University Hospital Department of Orthopaedic surgery |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: 1. Patients with severe infectious disease 2. Patients with active tuberculosis 3. Patients with allergy to infliximab or mouse protein 4. Patients with demyelinated disease 5. Patients with congestive heart failure
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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When 3mg/kg of infliximab brings poor results to RA patients, we will change a dose of infliximab according to the initial concentration of serum TNF alpha. If the initial concentration of serum TNF alpha is less than 1.1 pg/ml, we will raise the dose of infliximab to 6 mg/kg.
When 3mg/kg of infliximab brings poor results to RA patients, we will change a dose of infliximab according to the initial concentration of serum TNF alpha. If the initial concentration of serum TNF alpha is more than 1.1 pg/ml, we will raise the dose of infliximab to 10 mg/kg.
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Primary Outcome(s)
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Disease Activity Score-28 (DAS28-CRP/ESR) Simplified Disease Activity Index (SDAI) Clinical Disease Activity Index (CDAI)
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Secondary Outcome(s)
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Van der Heijde' modified Sharp score
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Source(s) of Monetary Support
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research fund of Orthopaedic surgery in Tohoku University Hospital
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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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Yes |
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Date Posted:
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Date Completed:
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31/03/2018 |
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URL:
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