Canakinumab in the Treatment of Gouty Arthritis Flare(s) and Prevention of New Flares in Patients With Chronic Kidney Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to confirm the efficacy and safety results obtained in a chronic kidney disease (CKD) subgroup of patients participating in Phase III studies in a larger, independent patient population with difficult to treat gouty arthritis and moderate to severe CKD (stage 3 - 4).

Official Title
-----------------
A Randomized Double-blind Active-controlled Trial of Canakinumab Versus Triamcinolone Acetonide on Reducing the Proportion of Patients With Any New Gouty Arthritis Flare(s) in Patients With Chronic Kidney Disease

Conditions
-----------------
Acute Gouty Arthritis

Intervention / Treatment
-----------------
* Drug: ACZ885
* Drug: Triamcinelone acetonide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Confirmed diagnosis of gouty arthritis History of ≥ 3 gouty arthritis flares within the previous 12 months Confirmed diagnosis/ documented history of chronic kidney disease (CKD) Stages 3or4 Onset of current acute gouty arthritis flare within 3 days prior to randomization Exclusion criteria: Hemodialysis CKD Stage 5 Organ transplantation Rheumatoid arthritis, evidence/suspicion of infectious/septic arthritis, or other acute inflammatory arthritis Live vaccinations within 3 months prior to randomization Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>Canakinumab 150 mg s.c. | Drug: ACZ885<br>* Canakinumab 150 mg s.c.<br>|
| Experimental: Arm 2<br>Triamcinelone acetonide 40 mg i.m. | Drug: Triamcinelone acetonide<br>* Triamcinelone acetonide 40 mg i.m.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients experiencing new gouty arthritis flares during 12-week follow-up from dosing |  | 12 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The time to the first new gout flare |  | 12 Weeks | 
| Score on Visual Analog Scale at 72 hours to measure gouty arthritis pain intensity and resolution |  | 12 weeks | 
| Number of patients needing rescue medication use during acute gouty arthritis flare(s) |  | 12 Weeks | 
| Measurement of efficacy using inflammatory markers |  | 12 Weeks | 
| Time to 50% reduction of baseline pain intensity in the most affected joint |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Frequent flares, Frequent attacks, gout, gouty arthritis, Chronic kidney disease, renal impairment, Anti-interleukin-1β monoclonal antibody, anti-inflammatory therapy