Long Term Study of Canakinumab (ACZ885) in Patients With Gout

Study Overview
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Brief Summary
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This 24-week open-label extension study is designed to provide additional long-term safety data up to a total of 1-year for patients rolling over from the core study, and to collect further efficacy and tolerability data for all the patients, irrespective whether they have an acute flare of gout or not. Patients will be treated on demand with canakinumab (ACZ885) in this extension study.

Official Title
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A 24-week Open-label, Multicenter, Follow-up and Extension Study to CACZ885H2251, to Assess Safety, Tolerability and Efficacy of Canakinumab (ACZ885) in Patients With Gout Who Were Given Canakinumab at the Time of Gout Flare

Conditions
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Gouty Arthritis

Intervention / Treatment
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* Drug: Canakinumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 the last visit (Visit 9). Patients who have signed a written informed consent before any trial procedure is performed. Exclusion Criteria: Patients for whom continuation in the extension 1 is not considered appropriate by the treating physician. 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). Female patients who were physiologically capable of becoming pregnant, unless they were: Female patients whose career, lifestyle, or sexual orientation precluded intercourse with a male partner. Female patients whose partners had been sterilized by vasectomy or other means. Using an acceptable method of contraception with a failure rate (Pearl Index (PI)) < 1. Reliable contraception had to be maintained throughout the study and for 2 months after study drug discontinuation. Other protocol defined inclusion/exclusion criteria may apply

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: canakinumab<br> | Drug: Canakinumab<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Events and Serious Adverse Events | Adverse events (AEs) were defined as any unfavourable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events (SAEs) were defined as any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalisation, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgement of investigators represent significant hazards | From start of study up to study completion (up to 14 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference Change From Baseline in Participant's Gout Pain During First Flare | Gout pain was assessed using Visual analogue scale (VAS) with a range of 0 to 100 where 0= no pain, 100= unbearable pain. Difference from time of study drug administration (pre-dose) was reported. | Baseline and Day 7 | 
| Number of Participants Achieved Patient's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category | Patient's global assessment of response to treatment is 5-point Likert scale:1.Excellent, 2.Good, 3.Acceptable, 4.Slight, 5.Poor. Lower the score better the outcome. | 24 weeks | 
| Number of Participants Achieved Physician's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category | Physician's global assessment of response to treatment is 5-point Likert scale:1.Very good, 2.Good, 3.Fair, 4.Poor, 5.Very poor. Lower the score better the outcome. | 24 weeks | 
| Number of Participants Reported No Pain, No Swelling, Absent Erythema on Physician's Assessment of Tenderness, Swelling and Erythema in Most Affected Joint During the First Flare in Participants Treated With Canakinumab by Parameter, Visit and Group | Tenderness was rated on a 0-3 point scale: 0=no pain, 1=patient states that there is pain, 2=patient states there is pain and winces, and 3=patient states there is pain, winces and withdraws on palpation or passive movement of the most affected joint. Swelling was rated on a 0-3 point scale: 0=no swelling, 1=palpable, 2=visible, and 3=bulging beyond the joint margins. Erythema was rated as present, absent, or not assessable. Assessments were performed at the flare and control visits. | 24 weeks | 
| Amount of Rescue Medication After Study Drug Intake in Participants Treated With Canakinumab by Flare Order, Medication and Group | The amount of naproxen and prednisolone taken after receiving treatment for each of the first 3 flares was recorded. | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gouty, Gouty arthritis, Gout flares, Anti-interleukin-1β monoclonal antibody