Study Utilizing Rilonacept in Gout Exacerbations - Full Text View

Sponsor:	Regeneron Pharmaceuticals
Information provided by:	Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00855920

Purpose

This purpose of this clinical research is to determine the efficacy and safety of an experimental drug called rilonacept in subjects with an acute gout attack. Subjects will participate in in this study for 30 days. Rilonacept alone is being compared with indomethacin alone and the combination of rilonacept plus indomethacin in treating acute gout flares.

Condition	Intervention	Phase
Acute Gout Flare	Drug: rilonacept Drug: indomethacin Other: placebo	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, Active-Controlled Study of the Safety and Efficacy of Rilonacept Administered Subcutaneously for the Treatment of an Acute Gout Flare

Resource links provided by NLM:

MedlinePlus related topics: Gout Joint Disorders Metabolic Disorders

Drug Information available for: Indomethacin Rilonacept

U.S. FDA Resources

Further study details as provided by Regeneron Pharmaceuticals:

Primary Outcome Measures:

The change in PAP (patient's assessment of pain) in the index joint from baseline measured over 72 hours [ Time Frame: 72 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

The change from baseline in PAP at Days 2, 3 and 4 [ Time Frame: 4 days ] [ Designated as safety issue: Yes ]

Enrollment:	225
Study Start Date:	March 2009
Study Completion Date:	February 2010
Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Group 1 indomethacin and placebo	Drug: indomethacin oral indomethacin for 12 days (50mg TID for 3 days, then 25mg TID x 9 days) Other: placebo placebo one time dose
Active Comparator: Group 2 rilonacept and indomethacin	Drug: rilonacept rilonacept 320 mg SC injection at baseline Drug: indomethacin oral indomethacin for 12 days (50mg TID for 3 days, then 25mg TID x 9 days)
Active Comparator: Group 3 rilonacept and placebo	Drug: rilonacept rilonacept 320 mg SC injection at baseline Other: placebo oral placebo TID x 12 days

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or female 18 - 70 years of age
Previously met the preliminary criteria of ARA for the classification of the acute arthritis of primary gout
Presenting with an acute attack (flare) of gout within 48 hours of pain onset and pain of at least moderate severity
Must have at least 1 on the 0-3 scale for the swelling and the tenderness assessments of the gouty index joint
Current presentation of acute gout flare in 3 joints or less

Exclusion Criteria:

Treatment with any NSAIDs or opiates within 48 hours prior to baseline assessments. Treatment with long-acting NSAIDs within 1 month prior to baseline visit. Treatment with naproxen, meloxicam, nabumetone, celecoxib and indomethacin SR within 5 days prior to baseline visit.
Treatment with oral analgesics within 6 hours before baseline assessments. Treatment with topical analgesics within 12 hours before baseline assessments
History of NSAID intolerance
Subjects with history of chronic, gouty arthritis

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00855920

Show 44 Study Locations

Sponsors and Collaborators

Regeneron Pharmaceuticals

Investigators

Study Director:

Robert Evans, PharmD

Regeneron Pharmaceuticals

More Information

Additional Information:

Rilonacept This link exits the ClinicalTrials.gov site

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Robert Evans, PharmD / Director of Clinical Sciences, Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00855920 History of Changes
Other Study ID Numbers:	IL1T-GA-0814
Study First Received:	February 13, 2009
Last Updated:	June 23, 2011
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada

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
Flare

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
Indomethacin
Gout Suppressants
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions

Tocolytic Agents
Reproductive Control Agents
Physiological Effects of Drugs
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Cardiovascular Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 09, 2012