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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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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00716248 |
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Date of registration:
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08/07/2008 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Bucillamine Study of Holding Remission After Infliximab Dose-off
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Scientific title:
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The Bucillamine Study of Holding Remission After Infliximab Dose-off in Patients With Rheumatoid Arthritis Receiving Methotrexate |
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Date of first enrolment:
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January 2007 |
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Target sample size:
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40 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00716248 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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Phase:
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Phase 4
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Countries of recruitment
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Japan
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- RA according to American College of Radiology (ACR) classification criteria
- Age of 20 or greater
- DAS28-ESR < 3.2 or DAS28-CRP < 2.6 for more than 6 months
Exclusion Criteria:
- Previously teated with bucillamine
- Pregnancy or lactation
Age minimum:
20 Years
Age maximum:
N/A
Gender:
Both
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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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Drug: bucillamine
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Drug: methotrexate
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Primary Outcome(s)
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The rate of disease flare
[Time Frame: 2 years]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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