Treatment and prevention of gout flares in patients with frequent flares for whom NSAIDs and/ or colchicine are contraindicated, not tolerated or ineffective MedDRA version: 12.1 Level: LLT Classification code 10018627 Term: Gout
Conditions
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients eligible for inclusion in this study have to fulfill all of the following criteria: 1. Signed written informed consent before any study procedure is performed. 2. Completion of the core study CACZ885H2356. A patient is defined as completing the core study if they completed the study up to and including Visit 7. 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: Patients fulfilling any of the following criteria are not eligible for inclusion in this study: 1. Continuation in this extension study is considered inappropriate by the treating physician. 2. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception, confirmed by a positive pregnancy test (serum or urine), and until the termination of gestation. 3. Female patients being physiologically capable of becoming pregnant UNLESS they are: • Female patients whose career, lifestyle, or sexual orientation precludes intercourse with a male partner • Female patients whose partners have been sterilized by vasectomy or other means • 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 last study drug administration.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to confirm the long-term safety and tolerability of canakinumab 150 mg subcutaneously (s.c) compared to triamcinolone acetonide 40 mg intramuscularly (i.m).;Secondary Objective: • To evaluate the time to the first new gout flare • To evaluate the frequency of new gout flares • To evaluate the severity of new gout flares • To evaluate the efficacy with respect to the treatment of signs and symptoms of each new gout flare, defined as: - Patient’s assessment of gout pain intensity in the most affected joint (on a 0-100 mm VAS) over time - Patient’s assessment of gout pain intensity in the most affected joint (Likert scale) over time - Patient’s global assessment of response to treatment (Likert scale) over time - Physician’s assessment of tenderness, swelling and erythema over time - Physician’s assessment of range of motion of the most affected joint (Likert scale) over time - Physician’s global assessment of response to treatment (Likert scale) over time - Rescue medication use during new gout flares [...] ;Primary end point(s): The primary objective of this study is to confirm the long-term safety and tolerability of canakinumab 150 mg subcutaneously (s.c) compared to triamcinolone acetonide 40 mg intramuscularly (i.m). | — |
Countries
Belgium, Estonia, Germany, Latvia, Lithuania, Sweden
Outcome results
None listed