Efficacy and Safety of a Single Dose of Canakinumab (ACZ885) in Hospitalized Patients With Acute Gout

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2009-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is an exploratory proof-of-concept study to evaluate the safety and efficacy of canakinumab (ACZ885) for inflammation and pain associated with acute gouty arthritis.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Canakinumab in the Treatment of Acute Gout Flares and Prevention of New Flares in Patients Unable to Use Non-steroidal Anti-inflammatory Drugs (NSAIDs) and/or Colchicine Including a 12 Weeks Extension and an Open-label 48 Weeks Extension Study

NCT01029652

Acute Gout

COMPLETED PHASE3

Canakinumab in the Treatment of Acute Gout Flares and Prevention of New Flares in Patients Unable to Use Non-steroidal Anti-inflammatory Drugs (NSAIDs) and/or Colchicines Including a 12 Week Extension and a 1 Year Open-label Extension Study.

NCT01080131

Acute Gout

COMPLETED PHASE3

Safety & Efficacy of Canakinumab (ACZ885) in Patients With Frequent Flares for Whom Nonsterodial Anti-Inflammatory Drug (NSAIDs) and/ or Colchicine Are Contraindicated, Not Tolerated or Ineffective

NCT01362608

Gouty Arthritis

TERMINATED PHASE3

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

NCT01593527

Acute Gouty Arthritis

WITHDRAWN PHASE3

A Study of the Efficacy of Canakinumab in Prevention of Acute Flares in Chronic Gout Patients Initiating Allopurinol Therapy (Core Study) and a Long-term Study of the Efficacy and Safety of Canakinumab in Patients With Gout (Extension Study)

NCT00819585

Gout

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Arthritis, Gouty

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Canakinumab

Canakinumab 10 mg/kg intravenous infusion and placebo matching dexamethasone intravenous infusion on Day 1.

Group Type EXPERIMENTAL

canakinumab

Intervention Type BIOLOGICAL

10 mg/kg intravenous infusion 250 mL over 2 hours.

placebo matching dexamethasone

Intervention Type OTHER

Placebo intravenous infusion.

Dexamethasone

Dexamethasone 12 mg intravenous infusion and placebo matching canakinumab on Day 1.

Group Type ACTIVE_COMPARATOR

dexamethasone

Intervention Type DRUG

12 mg intravenous infusion 50 mL over 30 minutes.

placebo matching canakinumab

Intervention Type OTHER

5% glucose in water intravenous infusion.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

canakinumab

10 mg/kg intravenous infusion 250 mL over 2 hours.

Intervention Type BIOLOGICAL

dexamethasone

12 mg intravenous infusion 50 mL over 30 minutes.

Intervention Type DRUG

placebo matching canakinumab

5% glucose in water intravenous infusion.

Intervention Type OTHER

placebo matching dexamethasone

Placebo intravenous infusion.

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

ACZ885 Ilaris®

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* score over 50 on the 0-100 VAS pain scale
* acute, confirmed gout flare for no longer than 3 days

Exclusion Criteria

* Treatment with biological anti-tumor necrosis factor (anti-TNF) within the past 3 months
* Anti-inflammatory medication for the treatment of acute gout within the previous 24 hours
* Pregnant or breastfeeding women
* Major surgery with high infection risk
* History of severe allergy to food or drugs
* History or risk of tuberculosis
* Active infection

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No