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: 13.1 Level: PT Classification code 10018627 Term: Gout System Organ Class: 10027433 - Metabolism and nutrition disorders
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. Patients who have either: • Completed the first extension study CACZ885H2356E1 (a patient is defined as completing the first extension study if they completed the study up to and including Visit 10) or • Experienced a ninth new flare requiring treatment with study drug within the core study CACZ885H2356 and the first extension study CACZ885H2356E1 Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 108 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 27
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 s.c.;Secondary Objective: • To evaluate the long-term efficacy of canakinumab 150 mg s.c. with respect to the treatment of signs and symptoms of new gout flares, defined as: - To evaluate the time to the first new gout flare - Frequency of new gout flares - Patient’s assessment of gout pain intensity in the currently 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 global assessment of response to treatment (Likert scale) over time • To evaluate the efficacy of canakinumab 150 mg s.c. with regards to inflammatory markers (high sensitivity C-reactive protein [hsCRP] and serum amyloid A protein [SAA]) • To evaluate the immunogenicity of canakinumab 150 mg s.c. • To evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of canakinumab 150 mg s.c. ;Primary end point(s): The primary objective of this study is to confirm the long-term safety and tolerability of canakinumab 150 mg s.c.;Timepoint(s) of evaluation of this end point: Upon study completion in all countries. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): not applicable;Timepoint(s) of evaluation of this end point: not applicable | — |
Countries
Australia, Belgium, Canada, Colombia, Estonia, Germany, Guatemala, Latvia, Lithuania, Mexico, Peru, Russian Federation, Singapore, Sweden, Switzerland, Ukraine
Contacts
Public ContactClinical Trial Information Desk
Novartis Pharma Services Inc. representative office in Lithuania
Outcome results
None listed