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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00829829
Other study ID # IL1T-GA-0810
Secondary ID
Status Completed
Phase Phase 3
First received January 23, 2009
Last updated April 26, 2012
Start date February 2009
Est. completion date June 2010

Study information

Verified date April 2012
Source Regeneron Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationCanada: Health CanadaCanada: Ethics Review Committee
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 241
Est. completion date June 2010
Est. primary completion date May 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
rilonacept
Placebo loading dose followed by placebo SC injections (2 mL) once a week for 16 weeks
rilonacept
rilonacept 160 mg SC loading dose followed by rilonacept 80 mg/2 mL SC injections once a week for 16 weeks
rilonacept
rilonacept 320 mg SC loading dose followed by rilonacept 160 mg/2 mL SC injections once a week for 16 weeks

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Regeneron Pharmaceuticals

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary number of flares during the treatment period 16 Weeks Yes
Secondary number of modified gout flares per subject from Day 1 to Week 16 16 Weeks Yes
Secondary proportion of subjects with at least one flare from Day 1 to Week 16 16 Weeks Yes
Secondary proportion of subjects with at least two flares from Day 1 to Week 16 16 Weeks Yes
Secondary mean number of gout flare days per subject assessed from Day 1 to Week 16 16 Weeks Yes
Secondary mean number of days with the subject's pain score of 5 or more (daily diary) per subject from Day 1 to Week 16 16 Weeks Yes
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05522504 - Distribution of Immune Cells and Their Subtypes in Peripheral Blood of Gout
Completed NCT01451645 - Efficacy and Safety of Colchicine for the Prevention of Gout Flares During the Initiation of Allopurinol Phase 4

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