Canakinumab in the Treatment of Acute Gout Flares and Prevention of New Flares in Patients Unable to Use NSAIDs and/or Colchicine.
| Status: | Recruiting |
|---|---|
| Conditions: | Gout |
| Therapuetic Areas: | Rheumatology |
| Healthy: | No |
| Age Range: | 18 - 85 |
| Updated: | 3/30/2013 |
| Start Date: | August 2010 |
| Contact: | Novartis Pharmaceuticals |
| Phone: | +41-61-324-1111 |
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
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.
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.
We found this trial at
38
sites
Quality Clinical Research, Inc. Welcome to Quality Clinical Research. We originated here in Omaha, NE...
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Danville Regional Medical Center For more than 120 years, Danville Regional Medical Center has been...
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