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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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2 March 2015 |
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Main ID: |
NCT02371096 |
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Date of registration:
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05/02/2015 |
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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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Comparative Pharmacokinetic Trial of RGB-03 and MabThera
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Scientific title:
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Date of first enrolment:
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January 2015 |
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Target sample size:
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Recruitment status: |
Not yet recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT02371096 |
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Study type:
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Interventional |
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Study design:
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N/A
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Phase:
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Phase 1
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Active Rheumatoid Arthritis
- Inadequate response or intolerance to other DMARDs and anti-TNFs
- Treatment with Methotrexate
Exclusion Criteria:
- Previous treatment with rituximab
- Patients with systemic manifestations of rheumatoid arthritis
- Patients seropositive for HIV, HCV, HBV
- Female patients nursing
Other protocol-defined inclusion/exclusion criteria may apply.
Age minimum:
18 Years
Age maximum:
75 Years
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: MabThera (rituximab)
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Drug: RGB-03
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Primary Outcome(s)
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Area under the serum concentration versus time curve (AUC)
[Time Frame: 0-24 weeks]
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Secondary ID(s)
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RGB-03-104
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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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