Safety and tolerability of ACZ885 (Canakinumab) in patients with gout

Conditions: 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: 14.0Level: PTClassification code 10018627Term: GoutSystem Organ Class: 10027433 - Metabolism and nutrition disorders
Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Registration Number: EUCTR2011-003414-17-DE

Lead Sponsor: ovartis Pharma Services AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 200

Inclusion Criteria

1. Patients who have completed the second extension studies
2. Patients who have already been treated with canakinumab in the core studies or subsequent extensions
*Other protocol-defined inclusion/exclusion criteria may apply
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 180
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

1. Continuation in this extension study is considered inappropriate by the treating physician
*Other protocol-defined inclusion/exclusion criteria may apply

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The purpose of this third extension study is to provide additional long-term safety and tolerability data of canakinumab over an 18-month time period on patients who have completed the extension studies CACZ885H2356E2 or CACZ885H2357E2.;Secondary Objective: The study will provide additional safety data of repeated treatment with on-demand use of canakinumab in patients with gouty arthritis. The study may further be used to optimize patients’ Urate Lowering Therapy (ULT) as needed, and collect further safety data on the concomitant use of canakinumab with different ULT regimens.;Primary end point(s): Assess the long-term safety and tolerability of canakinumab;Timepoint(s) of evaluation of this end point: 18 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1) Evaluate the long-term efficacy of canakinumab<br>2) Evaluate the efficacy of canakinumab with regards to inflammatory markers (hsCRP)<br>3) Evaluate the immunogenicity of canakinumab<br>4) Evaluate the safety in the concomitant use of canakinumab with different ULT regimens;Timepoint(s) of evaluation of this end point: 18 months