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

Purpose

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.

Condition	Intervention	Phase
Arthritis, Gouty	Biological: canakinumab Drug: dexamethasone Other: placebo matching canakinumab Other: placebo matching dexamethasone	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Randomized, Double-blind, Double-dummy, Active-controlled, Parallel Group Study of a Single Dose of ACZ885 in Hospitalized Patients With Acute Gout

Resource links provided by NLM:

MedlinePlus related topics: Gout

Drug Information available for: Dexamethasone Dexamethasone acetate Dexamethasone sodium phosphate Canakinumab

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Percentage of Participants With Improvement in Gout at 72 Hours Post-dose Using a Likert Scale [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
72 hours following treatment, patients were asked the question: "How would you rate the improvement in your gout since receiving the study medication?" Patients rated their improvement on the Likert 5-point scale: 1=Excellent, 2=Good, 3=Acceptable,4=Slight and 5=Poor. Improvement was assessed by determining patients who scored a "good" or "excellent" response.

Secondary Outcome Measures:

Non-inferiority of a Single Dose of Canakinumab Compared to Dexamethasone During Treatment Period [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
Time to Recurrence of the Symptoms of Acute Gout (if Applicable) During Treatment Period [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Time to recurrence is defined as from the point of improvement (good to excellent on Likert scale) to recurrence.
Time to Walk Independently (if Applicable) During Treatment Period [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Number of Participants With Discontinuation of Treatment Due to Adverse Events, Deaths or Serious Adverse Events During the Study [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
Additional safety information can be found in the Adverse Event section.
Change in C-reactive Protein (CRP) From Baseline at Month 4 [ Time Frame: Baseline, Month 4 ] [ Designated as safety issue: No ]
Blood was collected at Baseline and Month 4 for CRP to identify the presence of inflammation, to determine its severity, and to monitor response to treatment. A negative change from baseline indicates improvement.
Change in Serum Amyloid A Protein (SAA) From Baseline at Month 4 [ Time Frame: Baseline, Month 4 ] [ Designated as safety issue: No ]
Blood was collected at Baseline and Month 4 for SAA to identify the presence of inflammation, to determine its severity, and to monitor response to treatment. A negative change from baseline indicates improvement.
ACZ885 (Canakinumab) Pharmacokinetics (PK) Serum Concentration During the Treatment Period [ Time Frame: Baseline, Days 0.25, 1, 3, 6, 20, 34, 55 and 119 ] [ Designated as safety issue: No ]
Blood was collected for ACZ885 (canakinumab) levels at baseline and Days 0.25, 1, 3, 6, 20, 34, 55 and 119. Serum was analyzed by means of a competitive Enzyme linked immunosorbant assay (ELISA).
Change From Baseline in Pain Using a Visual Analog Scale at Month 4 [ Time Frame: Baseline, Month 4 ] [ Designated as safety issue: No ]
Patients rated their pain on a 100 millimeter (mm) visual analog scale, ranging from no pain (0) to unbearable pain (100). A negative change from baseline indicates improvement.
Number of Patients Who Took Rescue Medication [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Patients who did not improve by 72 hours post-dose (i.e. patients who show a pain Visual Analog (VAS) decrease of less than 50 % from baseline (Day 1, pre-dose) would have been treated with rescue medication of methylprednisolone 80 mg intravenous or intramuscular once at the discretion of the clinical investigator.

Enrollment:	6
Study Start Date:	April 2008
Study Completion Date:	October 2009
Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Canakinumab Canakinumab 10 mg/kg intravenous infusion and placebo matching dexamethasone intravenous infusion on Day 1.	Biological: canakinumab 10 mg/kg intravenous infusion 250 mL over 2 hours. Other Names: ACZ885 Ilaris® Other: placebo matching dexamethasone Placebo intravenous infusion.
Active Comparator: Dexamethasone Dexamethasone 12 mg intravenous infusion and placebo matching canakinumab on Day 1.	Drug: dexamethasone 12 mg intravenous infusion 50 mL over 30 minutes. Other: placebo matching canakinumab 5% glucose in water intravenous infusion.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00663169

Locations

United States, Alabama
Novartis Investigator Site
Birmingham, Alabama, United States, 35249
United States, New Jersey
Novartis Investigator Site
New Brunswick, New Jersey, United States, 08901
Switzerland
Novartis Investigator Site
Lausanne, Switzerland
United Kingdom
Novartis Investigator Site
Glasgow, United Kingdom

Sponsors and Collaborators

Novartis

Investigators

Principal Investigator:

Novartis

Novartis investigator site

More Information

No publications provided

Responsible Party:	Novartis
ClinicalTrials.gov Identifier:	NCT00663169 History of Changes
Other Study ID Numbers:	CACZ885A2212
Study First Received:	April 18, 2008
Results First Received:	August 30, 2012
Last Updated:	December 4, 2012
Health Authority:	United States: Food and Drug Administration Switzerland: Swissmedic United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Novartis:

Arthritis Gouty
ACZ885
IL1B protein
Pain

Additional relevant MeSH terms:

Arthritis
Arthritis, Gouty
Joint Diseases
Musculoskeletal Diseases
Gout
Rheumatic Diseases
Purine-Pyrimidine Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
BB 1101
Antibodies, Monoclonal

Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors

ClinicalTrials.gov processed this record on May 22, 2013