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

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

Status

Withdrawn

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01593527

Enrollment

Registered

2012-05-08

Start date

2012-09-30

Completion date

2012-09-30

Last updated

2017-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Gouty Arthritis

Keywords

Frequent flares, Frequent attacks, gout, gouty arthritis, Chronic kidney disease, renal impairment, Anti-interleukin-1β monoclonal antibody, anti-inflammatory therapy

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).

Interventions

DRUGACZ885

Canakinumab 150 mg s.c.

DRUGTriamcinelone acetonide

Triamcinelone acetonide 40 mg i.m.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

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/

Design outcomes

Primary

Measure	Time frame
Proportion of patients experiencing new gouty arthritis flares during 12-week follow-up from dosing	12 Weeks

Secondary

Measure	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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026