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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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16 December 2017 |
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Main ID: |
NCT01470989 |
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Date of registration:
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16/08/2011 |
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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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ß-RELIEVED - REsponse in Acute fLare and In prEVEntion of episoDes of Re-flare in Gout - Extension 3 (E3)
ß-RELIEVED |
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Scientific title:
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An Open-label Extension Study of CACZ885H2356E2 and CACZ885H2357E2 on the Treatment and Prevention of Gout Flares in Patients With Frequent Flares for Whom NSAIDs and/or Colchicine Are Contraindicated, Not Tolerated or Ineffective |
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Date of first enrolment:
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November 2011 |
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Target sample size:
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135 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01470989 |
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Study type:
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Interventional |
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Study design:
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Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 3
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Countries of recruitment
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Australia
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Canada
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Estonia
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Germany
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Latvia
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Lithuania
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Russian Federation
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Ukraine
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United States
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Contacts
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Name:
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Novartis Pharmaceuticals |
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Address:
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Telephone:
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Email:
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Affiliation:
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Novartis Pharmaceuticals |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients who have completed the second extension studies CACZ885H2356E2 or
CACZ885H2357E2
- Patients treated with canakinumab in the core studies or subsequent extensions
Exclusion Criteria:
- Pregnant or nursing (lactating) women
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Acute Gouty Arthritis Flares
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Intervention(s)
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Drug: ACZ885
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Primary Outcome(s)
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safety and tolerability
[Time Frame: 18 months]
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Secondary Outcome(s)
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long-term efficacy
[Time Frame: 18 months]
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Secondary ID(s)
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2011-003414-17
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CACZ885H2357E3
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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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