β-RELIEVED - REsponse in Acute fLare and In prEVEntion of episoDes of Re-flare in Gout - Extension 3 (E3)

Study Overview
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Brief Summary
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This was an 18-month, multi-center, open-label, clinical extension study. Patients completing earlier second extension studies (CACZ885H2356E2 and CACZ885H2357E2) continued to be treated in this combined extension 3 study for any new gouty arthritis flare on demand with one subcutaneous (s.c.) injection of canakinumab 150 mg.

Official Title
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An Open-label Extension Study of CACZ885H2356E2 and CACZ885H2357E2 on the Treatment and Prevention of Gout Flares in Patients With Frequent Flares for Whom NSAIDs and/or Colchicine Are Contraindicated, Not Tolerated or Ineffective

Conditions
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Acute Gouty Arthritis Flares

Intervention / Treatment
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* Drug: ACZ885
* Drug: Triamcinolone acetonide 40 mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who have completed the second extension studies CACZ885H2356E2 or CACZ885H2357E2 Patients treated with canakinumab in the core studies or subsequent extensions Exclusion Criteria: - Pregnant or nursing (lactating) women

Ages Eligible for Study
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Minimum Age: 18 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>canakinumab 150 mg s.c. | Drug: ACZ885<br>* canakinumab 150 mg s.c., given on demand upon new flares<br>* Other names: Canakinumab;Drug: Triamcinolone acetonide 40 mg<br>* Participants received 40 mg intramuscular (IM)<br>* Other names: Triamcinolone acetonide;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Incidence Rate (IR) of Adverse Events, Serious Adverse Events and Death Per 100 Patient-years in Participants | Adverse events (AEs) were defined as any unfavorable 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) hospitalization, 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 the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of New Flares Per Participant | Flare rate was calculated as the number of new flares over the period of observation in years. New flares occurred before first study medication dose in extension 3 study were considered. | From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks) | 
| Patient's Assessment of Gout Pain Intensity in the Most Affected Joint | Participant scored their current pain intensity in the most affected joint of the gout flare on a 5-point Likert Scale (none or mild). | up to 7 days post-dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gouty arthritis