Long-Term Safety and Tolerability of Canakinumab Prefilled Syringes in Frequently Flaring Acute Gouty Arthritis Patients

Study Overview
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Brief Summary
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This is a 36 week open-label extension of the canakinumab pre-filled syringe study for safety and tolerability in patients who have frequent flares of acute gouty arthritis.

Official Title
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A 36-week Open-label Extension Study of CACZ885H2361 on the Safety and Tolerability of Canakinumab 150 mg s.c. Pre-filled Syringe (PFS) in Treating Acute Gouty Arthritis Flares in Frequently Flaring Patients

Conditions
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Acute Gouty Arthritis

Intervention / Treatment
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* Drug: Canakinumab 150mg in prefilled syringe


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Compliance and completion of the canakinumab PFS core study Unchanged significant clinical medical history from entry into core study Exclusion criteria: Physician judgment of unsuitability for the study Pregnant or nursing women Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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
Interventional Model Description: Uncontrolled
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Canakinumab 150mg<br>Canakinumab 150mg in prefilled syringe subcutaneously | Drug: Canakinumab 150mg in prefilled syringe<br>* Canakinumab 150mg in prefilled syringe will be given in a single dose subcutaneously upon demand for gouty arthritis flares<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Reported Adverse Events |  | From start of the core study (CACZ885H2361 [NCT01356602]) upto end of the current study (48 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Probability of New Gout Flares at End of Study | The Kaplan-Meier estimates of the proportion of participants with first new gout flare, along with the associated 95% confidence intervals using Greenwood's formula were reported. The first new flare was observed either in the core or extension of the study right prior to the switch. The results were reported as Kaplan-Meier estimates. | Up to Day 337 | 
| Number of Participant With New Flares | The flare rate was calculated as the number of new flares over the period of observation in years. New flares that occurred before the first study medication dose in the extension 1 study were considered. | up to 36 weeks | 
| Change From Baseline in Pain Intensity on a 5-point Likert Scale | A Likert scale is a type of scale with a range of responses corresponding to an item such as pain. Participants were advised to score their current pain intensity in the most affected joint of the gouty arthritis flare on a 5-point Likert scale of 1 (None) to 5 (extreme pain), where; 1= none, 2= mild pain, 3= moderate pain, 4= severe pain, or 5= extreme pain (none, mild, moderate, severe, extreme). The higher value presented on the scale was the outcome (high intensity of pain). The respondent selects the best response that indicates the respondent's subjective evaluation of the item. The Last-observation-carried-forward (LOCF) method was used to impute post-dose pain intensity Likert measurements up to 14 days. | Baseline, upto 14 days post-dose | 
| Change From Baseline in Pain Intensity in the Most Affected Joint (on a 0-100 mm Visual Analogue Scale [VAS]) Over Time | Patients scored their current pain intensity in the most affected joint of the current gouty arthritis flare on a 0-100 VAS, ranging from no pain (0) to unbearable pain (100). Scores on the 100 mm linear scale were measured to the nearest millimeter from the left. | Baseline, 6, 12, 24, 48, 72 hours post-dose, and Day 4 - 14 post-dose | 
| Number of Participants Who Responded for Patient's Global Assessment of Response to Treatment | Participants were advised to make a global assessment of response to treatment using a 5-point Likert scale (1=excellent, 2=good, 3=acceptable, 4=slight, 5=poor). | 48 weeks post-dose | 
| Number of Participants Responded for Physician's Assessment of Tenderness, Swelling and Erythema of the Most Affected Joint | Tenderness was measured on a 0-3 point scale: no pain, participant states that there is pain, participant states there is pain and winces and participant states there is pain, winces and withdraws on palpation or passive movement of the affected study joint. Swelling was measured on a 0 - 3 point scale as follows: 0 = no swelling, 1 = palpable, 2= visible and 3 = bulging beyond the joint margins. Erythema was assessed as present, absent or not assessable. | Baseline, 7 days post-dose | 
| Number of Participants Responded for Physician's Global Assessment of Response to Treatment | The physician made a global assessment of the participant's response to treatment using a 5-point Likert scale: 1=very good, 2=good, 3=fair, 4=poor, 5=very poor. | 7 days post-dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gout, arthritis, gout flare, acute gout, gouty, rheumatic disease, uric acid, podagra