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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-UMIN000009425 |
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Date of registration:
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01/12/2012 |
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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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A validity inspection study of the treat-to-target strategy with golimumab for the treatment of rheumatoid arthritis patient
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Scientific title:
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A validity inspection study of the treat-to-target strategy with golimumab for the treatment of rheumatoid arthritis patient - Go-Go trial |
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Date of first enrolment:
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2012/12/06 |
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Target sample size:
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150 |
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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=R000011073 |
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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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Tatsuya Koike |
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Address:
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Abenoku Asahimachi 1-4-3
Japan |
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Telephone:
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06-6646-6010 |
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Email:
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tatsuya@med.osaka-cu.ac.jp |
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Affiliation:
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Osaka City University Medical School Center for Senile Degenerative Disorders |
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Name:
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Tatsuya Koike |
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Address:
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Abenoku Asahimachi 1-4-3, Osaka, 545-8585, Japan
Japan |
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Telephone:
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06-6645-3984 |
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Email:
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tatsuya@med.osaka-cu.ac.jp |
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Affiliation:
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Osaka City University Medical School RheumatosurgeryCenter for Senile Degenerative Disorders |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: 1. Patients who show the allergic reaction for golimumab 2. The use of previous biologics is not included in exclusion criteria
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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The dose of golimumab should be fixed as 50 mg/month for all period. Treat-to-target strategy might be achieved by MTX or other DMARDs for one year. The goal of treatment is low disease activity.
Treat-to-target strategy will be started with 50 mg of golimumab for first 3 months and then 100 mg golimumab can be used for tight control of rheumatoid arthritis to achieve low disease activity (LDA). Also MTX or other DMARDs might be used for tight control. If the LDA is achieved, reduction of dose from 100 to 50 mg/month is allowed. Total period is one year.
Treat-to-target strategy will be started with 100 mg of golimumab for first 3 months. If the LDA is achieved, reduction of dose from 100 to 50 mg/month is performed. If not, physicians should control the disease activity using MTX or other DMARDs. Total period is one year.
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Primary Outcome(s)
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The rate of RRP (Radiographic rapid progression) at 6 and 12 months
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Secondary Outcome(s)
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1.The change of DAS28-ESR, DAS28-CRP, SDAI and remission rate based on these composite measures 2.The change of mTTS 3.The change of CRP, ESR, MMP-3 4.The change of HAQ score 5. Prevalence of adverse events
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Source(s) of Monetary Support
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Self funding
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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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31/12/2016 |
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URL:
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