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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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8 August 2016 |
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Main ID: |
NCT01285752 |
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Date of registration:
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27/01/2011 |
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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 Study of AK106-001616 in Patients With Rheumatoid Arthritis (RA)
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Scientific title:
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Date of first enrolment:
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February 2011 |
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Target sample size:
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240 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01285752 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Czech Republic
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Germany
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Hungary
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Poland
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Slovakia
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Ukraine
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United Kingdom
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Diagnosis of RA (class I to III)
- Stable dose of methotrexate (at least 12 weeks)
Exclusion Criteria:
- Pregnant or breastfeeding
- Abnormal screening laboratory test values considered to be clinically significant
Age minimum:
18 Years
Age maximum:
65 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: Active comparator
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Drug: AK106-001616
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Secondary ID(s)
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AK106 II-02
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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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