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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00610363
First received: January 24, 2008
Last updated: September 27, 2013
Last verified: June 2011

January 24, 2008
September 27, 2013
November 2007
October 2008   (final data collection date for primary outcome measure)
number of flares during the treatment period [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00610363 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Study of the Safety and Effectiveness of Rilonacept for the Prevention of Gout Flares
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Gout
  • Biological: rilonacept
    160mg sc once a week
  • Other: placebo
    placebo sc once a week
  • Experimental: 1
    rilonacept
    Intervention: Biological: rilonacept
  • Placebo Comparator: 2
    placebo
    Intervention: Other: placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
83
October 2008
October 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00610363
IL1T-GA-0619
Yes
Regeneron Pharmaceuticals
Regeneron Pharmaceuticals
Not Provided
Study Director: Shirletta King-Davis Regeneron Pharmaceuticals
Regeneron Pharmaceuticals
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP