Study of the Safety and Efficacy of Long-Term Rilonacept Treatment for the Prevention of Gout Flares

NCT01459796 | Terminated Phase 3 Results DMC

• 1 other identifier: IL1T-GA-1101
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 74

Brief Summary

The purpose of this study was to determine the safety and tolerability of rilonacept for participants with gout who were initiating allopurinol.

Conditions

Gout

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Treatment Emergent Adverse Events (TEAEs)

  Any untoward medical occurrence in a participant who received investigational medicinal product (IMP) was considered an AE without regard to possibility of causal relationship with this treatment. TEAEs were defined as AEs that developed or worsened or became serious during on-treatment period (time from the administration of first dose of study drug up to and including 35 days after the last dose of study drug). A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs.

  Day 1 to Day 392 (Week 56)

Secondary Outcomes (5)

• Percentage of Participants With at Least One Gout Flare From Day 1 to Day 168 (Week 24)

  Day 1 to Day 168 (Week 24)

• Percentage of Participants With at Least Two Gout Flares From Day 1 to Day 168 (Week 24)

  Day 1 to Day 168 (Week 24)

• Percentage of Participants With at Least One Gout Flare From Day 1 to Day 364 (Week 52)

  Day 1 to Day 364 (Week 52)

• Percentage of Participants With at Least Two Gout Flares From Day 1 to Day 364 (Week 52)

  Day 1 to Day 364 (Week 52)

• Percentage of Participants With Rescue Medication From Day 1 to Day 364 (Week 52)

  Day 1 to Day 364 (Week 52)

Study Arms (2)

Placebo

EXPERIMENTAL

Two subcutaneous injections of Placebo (for Rilonacept) as a loading dose on Day 1 followed by a single injection once a week (qw) from Week 1 to Week 51.

Drug: Placebo; Drug: Allopurinol

Rilonacept 80 mg

EXPERIMENTAL

Two subcutaneous injections of Rilonacept 80 mg (for a total of 160 mg) as a loading dose on Day 1, followed by a single 80 mg injection of Rilonacept qw from Week 1 to Week 51.

Drug: Rilonacept; Drug: Allopurinol

Interventions

Rilonacept DRUG

Rilonacept 160 mg loading dose followed by Rilonacept 80 mg/2 mL injections qw for 52 weeks.

Rilonacept 80 mg

Placebo DRUG

Placebo loading dose followed by placebo injections (2 mL) qw for 52 weeks.

Placebo

Allopurinol DRUG

Allopurinol 50 or 100 mg, orally daily for 52 weeks as background treatment.

Placebo; Rilonacept 80 mg

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female participants aged 18 to 80 years;
• Previously met the preliminary criteria of the ARA for the classification of the acute arthritis of primary gout;
• Serum uric acid greater than or equal to 7.5 mg/dL at the screening visit;
• A self-reported history of at least 2 gout flares in the year prior to screening.

You may not qualify if:

• Pregnant or nursing, or planning to become pregnant or father a child within 3 months after receiving the last dose of study drug;
• Participants requiring dialysis;
• Participants who had had an organ transplant;
• Persistent chronic or active infections;
• Previous exposure to rilonacept;
• Use of allopurinol, benzbromarone, febuxostat, probenecid or sulfinpyrazone within 84 days prior to the screening visit.

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead

Study Sites (74)

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Birmingham, Alabama, United States

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Mesa, Arizona, United States

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Phoenix, Arizona, United States

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Scottsdale, Arizona, United States

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Sierra Vista, Arizona, United States

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Tucson, Arizona, United States

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Searcy, Arkansas, United States

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Concord, California, United States

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La Jolla, California, United States

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Long Beach, California, United States

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Whittier, California, United States

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Denver, Colorado, United States

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Trumbull, Connecticut, United States

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Washington D.C., District of Columbia, United States

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Clearwater, Florida, United States

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DeLand, Florida, United States

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Delray Beach, Florida, United States

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New Port Richey, Florida, United States

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Ocala, Florida, United States

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Orlando, Florida, United States

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St. Petersburg, Florida, United States

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Tampa, Florida, United States

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Venice, Florida, United States

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Atlanta, Georgia, United States

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Boise, Idaho, United States

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Coeur d'Alene, Idaho, United States

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Meridian, Idaho, United States

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Avon, Indiana, United States

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Brownsburg, Indiana, United States

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Evansville, Indiana, United States

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Bowling Green, Kentucky, United States

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Elizabethtown, Kentucky, United States

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Owensboro, Kentucky, United States

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New Orleans, Louisiana, United States

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Cumberland, Maryland, United States

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Hagerstown, Maryland, United States

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Wheaton, Maryland, United States

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Fall River, Massachusetts, United States

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Edina, Minnesota, United States

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St Louis, Missouri, United States

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Kalispell, Montana, United States

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Omaha, Nebraska, United States

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Brooklyn, New York, United States

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Cary, North Carolina, United States

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Charlotte, North Carolina, United States

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Greensboro, North Carolina, United States

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Greenville, North Carolina, United States

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Raleigh, North Carolina, United States

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Salisbury, North Carolina, United States

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Statesville, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Akron, Ohio, United States

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Carlisle, Ohio, United States

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Portland, Oregon, United States

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Huntingdon Valley, Pennsylvania, United States

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Johnstown, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Reading, Pennsylvania, United States

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Anderson, South Carolina, United States

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Charleston, South Carolina, United States

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Columbia, South Carolina, United States

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Greenville, South Carolina, United States

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Rock Hill, South Carolina, United States

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Simpsonville, South Carolina, United States

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Dallas, Texas, United States

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Fort Worth, Texas, United States

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Houston, Texas, United States

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Lake Jackson, Texas, United States

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North Richland Hills, Texas, United States

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San Antonio, Texas, United States

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Sugar Land, Texas, United States

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Salt Lake City, Utah, United States

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Arlington, Virginia, United States

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Spokane, Washington, United States

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MeSH Terms

Conditions

Gout

Interventions

rilonacept; Allopurinol

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Clinical Trial Management
• Organization: Regeneron Pharmaceuticals, Inc.

clinicaltrials@regeneron.com

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2011
• First Posted: October 26, 2011
• Study Start: November 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: July 18, 2017
• Results First Posted: July 18, 2017

Record last verified: 2017-06

Locations

US (74)