Acute flares of gout MedDRA version: 9.1 Level: LLT Classification code 10064900 Term: Gout flare
Conditions
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients who completed the core study CACZ885H2251. A patient is defined as completing the core study if he/she completed the study up to and including Visit 9. 2. Patients who have signed a written informed consent before any trial procedure is performed. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patients for whom continuation in the extension 1 is not considered appropriate by the treating physician. 2. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive pregnancy test (serum or urine). 3. Female patients being physiologically capable of becoming pregnant, UNLESS they are: o Female patients whose career, lifestyle, or sexual orientation precludes intercourse with a male partner o Female patients whose partners have been sterilized by vasectomy or other means. o Using an acceptable method of contraception with a failure rate (Pearl Index (PI)) < 1. Reliable contraception should be maintained throughout the study and for 2 months after study drug discontinuation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate, in the extension study, the safety and tolerability in gout patients A. who were randomized to canakinumab in the core study, and who have been treated with canakinumab (for at least one flare) in the extension study B. who were randomized to canakinumab in the core study, and who have not received treatment with canakinumab in the extension study C. who were randomized to colchicine in the core study, and who have been treated with canakinumab (for at least one flare) in the extension study D. who were randomized to colchicine in the core study, and who have not received treatment with canakinumab in the extension study;Secondary Objective: To evaluate the long term follow-up safety and tolerability of prophylactic treatment of canakinumab observed in the core + extension study in patients: B.who were randomized to canakinumab in the core study, and who have not received treatment with canakinumab in the extension study D.who were randomized to colchicine in the core study, and who have not received treatment with canakinumab in the extension study To assess, the efficacy of canakinumab in the treatment of recurrent acute flares of gout in the extension study in patients who were treated with canakinumab (for at least one flare) in the extension study, as measured by: Patient’s assessment of gout pain (VAS/Likert scale) Patient/Physician’s global assessment of response to treatment (Likert scale) Use of rescue medication after study drug intake Physician’s assessment of tenderness, swelling and erythema in most affected joint High sensitivity C-reactive protein (hsCRP) and serum amyloid A (SAA) protein;Primary end point(s): See main objective in section E.2.1 | — |
Countries
Czech Republic, Germany, Hungary, Portugal, Slovakia, Spain, United Kingdom
Outcome results
None listed