PREventative Study Against URate-lowering Drug-induced Gout Exacerbations 1 - Full Text View

Sponsor:	Regeneron Pharmaceuticals
Information provided by:	Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00829829

Purpose

The purpose of this clinical research study is to determine the safety and effectiveness of an experimental drug called rilonacept in subjects with gout who are beginning allopurinol treatment for gout. Subjects will participate in this study for approximately 22 weeks. Rilonacept is being studied for use in preventing allopurinol-induced gout flares.

Condition	Intervention	Phase
Intercritical Gout	Drug: rilonacept	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Multi-Center, Randomized, Double-Blind, Placebo Controlled Study of the Efficacy and Safety of Rilonacept for the Prophylaxis of Gout Flares During the Initiation of Allopurinol Therapy

Resource links provided by NLM:

MedlinePlus related topics: Gout Joint Disorders Metabolic Disorders

Drug Information available for: Allopurinol sodium Rilonacept Allopurinol

U.S. FDA Resources

Further study details as provided by Regeneron Pharmaceuticals:

Primary Outcome Measures:

number of flares during the treatment period [ Time Frame: 16 Weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

number of modified gout flares per subject from Day 1 to Week 16 [ Time Frame: 16 Weeks ] [ Designated as safety issue: Yes ]
proportion of subjects with at least one flare from Day 1 to Week 16 [ Time Frame: 16 Weeks ] [ Designated as safety issue: Yes ]
proportion of subjects with at least two flares from Day 1 to Week 16 [ Time Frame: 16 Weeks ] [ Designated as safety issue: Yes ]
mean number of gout flare days per subject assessed from Day 1 to Week 16 [ Time Frame: 16 Weeks ] [ Designated as safety issue: Yes ]
mean number of days with the subject's pain score of 5 or more (daily diary) per subject from Day 1 to Week 16 [ Time Frame: 16 Weeks ] [ Designated as safety issue: Yes ]

Enrollment:	241
Study Start Date:	February 2009
Study Completion Date:	June 2010
Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: 1 Placebo	Drug: rilonacept Placebo loading dose followed by placebo SC injections (2 mL) once a week for 16 weeks
Active Comparator: 2 rilonacept 80 mg	Drug: rilonacept rilonacept 160 mg SC loading dose followed by rilonacept 80 mg/2 mL SC injections once a week for 16 weeks
Active Comparator: 3 rilonacept 160 mg	Drug: rilonacept rilonacept 320 mg SC loading dose followed by rilonacept 160 mg/2 mL SC injections once a week for 16 weeks

Eligibility

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

Criteria

Inclusion Criteria:

Male or female 18 to 80 years of age
Previously met the preliminary criteria of the ARA for the classification of the acute arthritis of primary gout
At least 2 gout flares in the year prior to the Screening Visit
Serum uric acid greater than or equal to 7.5 mg/dL at the Screening Visit

Exclusion Criteria:

Acute gout flare within 2 weeks of the Screening Visit or during Screening
Persistent chronic or active infections
History of an allergic reaction to allopurinol
History or presence of cancer within 5 years of the Screening Visit
Previous exposure to rilonacept
Use of allopurinol, benzbromarone, febuxostat, probenecid or sulfinpyrazone within 3 months prior to the Screening Visit

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00829829

Show 91 Study Locations

Sponsors and Collaborators

Regeneron Pharmaceuticals

More Information

Additional Information:

Rilonacept This link exits the ClinicalTrials.gov site

Allopurinol This link exits the ClinicalTrials.gov site

Allopurinol sodium This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Robert Evans, PharmD / Director of Clinical Sciences, Regeneron Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:	NCT00829829 History of Changes
Other Study ID Numbers:	IL1T-GA-0810
Study First Received:	January 23, 2009
Last Updated:	June 1, 2011
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada; Canada: Ethics Review Committee

Keywords provided by Regeneron Pharmaceuticals:

Metabolism, Inborn Errors
Allopurinol
Metabolic Diseases
Genetic Diseases, Inborn
Musculoskeletal Diseases
Joint Diseases

Arthritis
Rheumatic Diseases
Metabolic disorder
Purine-Pyrimidine Metabolism, Inborn Errors
Gout

Additional relevant MeSH terms:

Gout
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Purine-Pyrimidine Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases
Allopurinol
Enzyme Inhibitors

Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Gout Suppressants
Antirheumatic Agents
Therapeutic Uses
Free Radical Scavengers
Antioxidants
Antimetabolites
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 09, 2012