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

Sponsor:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00663169

Purpose

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

Condition	Intervention	Phase
Arthritis, Gouty	Biological: ACZ885	Phase II

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: ACZ 885

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Self-assessed response to treatment at 72 hours post-dose. [ Time Frame: 72 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

non-inferiority of a single dose of ACZ885 compared to the active comparator during treatment period [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
safety, tolerability and immunogenicity following administration of ACZ885 to patients with acute gout during treatment period [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
time to walk independently and time to recurrence of the symptoms of acute gout (if applicable) during treatment period [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
change in C-reactive protein (CRP) and serum amyloid A protein (SAA) from baseline to last visit [ Time Frame: 4 months ] [ Designated as safety issue: No ]
pharmacokinetics (PK) of ACZ885 during treatment period [ Time Frame: 4 months ] [ Designated as safety issue: No ]
change in pain following ACZ885 administration via a 0-100 mm Visual Analog Scale during treatment period [ Time Frame: 4 months ] [ Designated as safety issue: No ]

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

Arms	Assigned Interventions
Active Comparator: 1	Biological: ACZ885
Experimental: 2	Biological: ACZ885

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-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:	External Affairs, Novartis
ClinicalTrials.gov Identifier:	NCT00663169 History of Changes
Other Study ID Numbers:	CACZ885A2212
Study First Received:	April 18, 2008
Last Updated:	September 21, 2010
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

ClinicalTrials.gov processed this record on February 09, 2012