Study Utilizing Rilonacept in Gout Exacerbations

NCT00855920 | Completed Phase 3 Results DMC

• 1 other identifier: IL1T-GA-0814
• Study Type: interventional
• Target: 225
• Locations: 1 country
• Sites: 44

Brief Summary

This purpose of this clinical research was to determine the efficacy and safety of an experimental drug called Rilonacept in participants with an acute gout attack. Participants participated in this study for 30 days. Rilonacept alone was being compared with Indomethacin alone and the combination of Rilonacept plus Indomethacin in treating acute gout flares.

Conditions

Acute Gout Flare

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Patient's Assessment of Pain Using a 5-Point Likert Scale (PAP-LS) in Index Joint to Averaged PAP-LS at 24, 48 and 72 Hours

  Participants were asked to complete a daily diary entry and assessed their pain in the past 24 hours using 5-point Likert Scale of 0 (None) to 4 (extreme pain), where; 0= none, 1= mild pain, 2= moderate pain, 3= severe pain, or 4= extreme pain. Change in PAP-LS in the index joint from baseline (Day 1) to the averaged PAP-LS values at 24, 48 and 72 hours was reported in this outcome measure (averaged PAP value= \[PAP at 24 hours + PAP at 48 hours + PAP at 72 hours\]/3).

  Pre-dose on Day 1 (Baseline); post-dose at 4, 8, 12, 24, 48, 72 hours and then daily up to Day 13 or until gout flare ends

Secondary Outcomes (3)

• Change From Baseline in Patient's Assessment of Pain Using a 5-Point Likert Scale (PAP-LS) in Index Joint at 72 Hours

  Baseline (Day 1) to 72 hours

• Change From Baseline in Patient's Assessment of Pain Using a 5-Point Likert Scale (PAP-LS) in Index Joint at 48 Hours

  Baseline (Day 1) to 48 hours

• Change From Baseline in Patient's Assessment of Pain Using a 5-Point Likert Scale (PAP-LS) in Index Joint at 24 Hours

  Baseline (Day 1) to 24 hours

Study Arms (3)

Placebo (for Rilonacept) and Indomethacin

ACTIVE COMPARATOR

Two subcutaneous injections of Placebo (for Rilonacept) on Day 1 with Indomethacin orally thrice a day (TID) for 12 days (Indomethacin 50 mg for first 3 days and then, Indomethacin 25 mg for next 9 days).

Drug: Indomethacin; Other: Placebo (for Rilonacept)

Rilonacept and Indomethacin

ACTIVE COMPARATOR

Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) on Day 1 with Indomethacin orally TID for 12 days (Indomethacin 50 mg for first 3 days and then, Indomethacin 25 mg for next 9 days).

Drug: Rilonacept; Drug: Indomethacin

Rilonacept and Placebo (for Indomethacin)

ACTIVE COMPARATOR

Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) on Day 1 with Placebo (for Indomethacin) orally TID for 12 days.

Drug: Rilonacept; Other: Placebo (for Indomethacin)

Interventions

Rilonacept DRUG

Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) on Day 1 (Baseline).

Rilonacept and Indomethacin; Rilonacept and Placebo (for Indomethacin)

Indomethacin DRUG

Indomethacin orally TID for 12 days (Indomethacin 50 mg for first 3 days and then, Indomethacin 25 mg for next 9 days).

Placebo (for Rilonacept) and Indomethacin; Rilonacept and Indomethacin

Placebo (for Indomethacin) OTHER

Placebo (for Indomethacin) orally TID for 12 days.

Rilonacept and Placebo (for Indomethacin)

Placebo (for Rilonacept) OTHER

Two subcutaneous injections of Placebo (for Rilonacept) on Day 1 (Baseline).

Placebo (for Rilonacept) and Indomethacin

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Treatment with any non-steroidal anti-inflammatory drug (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
• Participants with history of chronic, gouty arthritis

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead

Study Sites (44)

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Birmingham, Alabama, United States

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Huntsville, Alabama, United States

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Mesa, Arizona, United States

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Phoenix, Arizona, United States

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Sierra Vista, Arizona, United States

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Burbank, California, United States

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Whittier, California, United States

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Clearwater, Florida, United States

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DeBary, Florida, United States

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DeLand, Florida, United States

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Jupiter, Florida, United States

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Orange Park, Florida, United States

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Orlando, Florida, United States

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Oviedo, Florida, United States

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Boise, Idaho, United States

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Elizabethtown, Kentucky, United States

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Baltimore, Maryland, United States

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Wheaton, Maryland, United States

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Detroit, Michigan, 48221, United States

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Stevenville, Michigan, United States

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Billings, Montana, United States

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Albuquerque, New Mexico, United States

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Albany, New York, United States

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Burlington, North Carolina, United States

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Cary, North Carolina, United States

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Raleigh, North Carolina, 27612, United States

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Raleigh, North Carolina, United States

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Wilmington, North Carolina, United States

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Willoughby Hills, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Lake Oswego, Oregon, United States

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Portland, Oregon, United States

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Johnstown, Pennsylvania, United States

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Limerick, Pennsylvania, United States

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Norristown, Pennsylvania, United States

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Greenville, South Carolina, United States

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Bristol, Tennessee, United States

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Dallas, Texas, United States

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Forth Worth, Texas, United States

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Houston, Texas, United States

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Irving, Texas, United States

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Mesquite, Texas, United States

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North Richland Hills, Texas, United States

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San Antonio, Texas, United States

Location

Related Publications (1)

• Terkeltaub RA, Schumacher HR, Carter JD, Baraf HS, Evans RR, Wang J, King-Davis S, Weinstein SP. Rilonacept in the treatment of acute gouty arthritis: a randomized, controlled clinical trial using indomethacin as the active comparator. Arthritis Res Ther. 2013 Feb 1;15(1):R25. doi: 10.1186/ar4159.

  PMID: 23375025 DERIVED

Related Links

• Rilonacept
• Related Info

MeSH Terms

Conditions

Metabolism, Inborn Errors; Metabolic Diseases; Genetic Diseases, Inborn; Musculoskeletal Diseases; Joint Diseases; Arthritis; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Gout

Interventions

rilonacept; Indomethacin

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Nutritional and Metabolic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Crystal Arthropathies

Intervention Hierarchy (Ancestors)

Indoles; 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

• Robert Evans, PharmD

  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: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2009
• First Posted: March 5, 2009
• Study Start: March 1, 2009
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: April 28, 2017
• Results First Posted: April 28, 2017

Record last verified: 2017-03

Locations

US (44)