Study of the Safety and Effectiveness of Rilonacept for the Prevention of Gout Flares - Full Text View

Study of the Safety and Effectiveness of Rilonacept for the Prevention of Gout Flares

This study is currently recruiting participants.
Verified by Regeneron Pharmaceuticals, January 2008

Sponsored by:	Regeneron Pharmaceuticals
Information provided by:	Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00610363

Purpose

This is a clinical research study to determine the safety and effectiveness of an experimental drug called rilonacept in subjects with gout who are beginning another additional treatment. Subjects will participate in this study for approximately 24 weeks. Rilonacept is being studied for use in preventing gout attacks in patients who have gout.

Condition	Intervention	Phase
Gout	Biological: rilonacept	Phase II

MedlinePlus related topics:

Gout

ChemIDplus related topics:

Rilonacept Allopurinol Allopurinol sodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	A Multi-Center, Randomized, Double-Blind, Placebo Controlled Study, Tolerability, and Efficacy of Rilonacept for the Prevention of Gout Flares During Initiation of Allopurinol Therapy

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 ]

Estimated Enrollment:	80
Study Start Date:	November 2007
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Intervention Details:

160mg once a week

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or female greater than 18 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

Exclusion Criteria:

Acute gout flare within 2 weeks of the Screening visit and 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00610363

Contacts


Contact: Cyndy Hughes	505-286-8683	hughes.cynthial@kendle.com

Show 36 Study Locations

Sponsors and Collaborators

Regeneron Pharmaceuticals

More Information

Responsible Party:	Regeneron Pharmaceuticals, Inc ( Robert Evans, PharmD/ Director of Clinical Sciences )
Study ID Numbers:	IL1T-GA-0619
First Received:	January 24, 2008
Last Updated:	January 24, 2008
ClinicalTrials.gov Identifier:	NCT00610363
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Metabolism, Inborn Errors

Allopurinol

Metabolic Diseases

Genetic Diseases, Inborn

Musculoskeletal Diseases

Joint Diseases

Arthritis

Rheumatic Diseases

Metabolic disorder

Purine-Pyrimidine Metabolism, Inborn Errors

Gout

ClinicalTrials.gov processed this record on October 15, 2008