An Open-label Extension Study of CACZ885H2357E1 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
| City: |
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Bristol |
| State: |
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Tennessee |
| Zip Code: |
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37620 |
| Conditions: |
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Acute Gout |
| Purpose: |
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The purpose of this second extension study is to collect long-term safety and tolerability
data and additional efficacy data in patients who are treated on demand upon flare with
canakinumab.
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| Study Summary: |
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| Criteria: |
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Inclusion Criteria:
Patients who have either:
- Completed the first extension study CACZ885H2357E1 or
- Experienced a ninth new flare within the core study CACZ885H2357 and the first
extension study CACZ885H2357E1
Exclusion Criteria:
- Continuation in this extension study is considered inappropriate by the treating
physician
- Pregnant or nursing (lactating) women
- Female patients being physiologically capable of becoming pregnant UNLESS they are
using an acceptable method of contraception with a failure rate (Pearl Index (PI)) <
1 Other protocol defined inclusion/exclusion criteria may apply.
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| NCT ID: |
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NCT01194921 |
| Primary Contact: |
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Study Director
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Phone: +41-61-324-1111
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| Backup Contact: |
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N/A |
| Location Contact: |
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Bristol, Tennessee 37620
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 24, 2013 |
| Modifications to this listing: |
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