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Completed

NCT Number: NCT00610363

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

This was a clinical research study to determine the safety and effectiveness of an experimental drug called rilonacept in participants with gout who were beginning another additional treatment. Participants participated in this study for approximately 24 weeks. Rilonacept was being studied for use in preventing gout attacks in participants who had gout.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

San Diego, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female greater than 18 years of age;
  • Previously met the preliminary criteria of the American Rheumatism Association (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.

Treatment and study plan

Rilonacept

Biological

Rilonacept 320 mg loading dose on Day 1 followed by Rilonacept 160 mg/2 mL injections qw for 17 weeks.

Placebo (for Rilonacept)

Other

Placebo loading dose on Day 1 followed by single placebo injections (2 mL) qw for 17 weeks.

Primary outcomes

  1. Number of Gout Flares Per Participant Assessed From Day 1 to Day 84 (Week 12)

    Time frame: Day 1 (Baseline) to Day 84 (Week 12)

    A gout flare was defined as participant reported acute articular pain typical of a gout attack that required treatment with an anti-inflammatory therapeutic: had at least 3 of the following 4 signs or symptoms: joint swelling, tenderness, redness, and pain and with at least 1 of the following: rapid onset of pain, decreased range of motion, joint warmth or other symptoms similar to a prior gout flare. Number of gout flares per participant was reported for this outcome measure. For drop-outs, only flares occurred before Day 84 were counted, regardless whether the flares occurred during the treatment period or not.

Secondary outcomes

  1. Percentage of Participants With at Least One Gout Flare From Day 1 to Day 84 (Week 12)

    Time frame: Day 1 (Baseline) to Day 84 (Week 12)

    Gout flare was defined as acute articular pain typical of a gout attack that required treatment with an anti-inflammatory therapeutic: had at least 3 of the following 4 signs or symptoms: joint swelling, tenderness, redness, and pain; and with at least 1 of the following: rapid onset of pain, decreased range of motion, joint warmth or other symptoms similar to a prior gout flare. Percentage of participants with at least one gout flare was reported for this outcome measure.

  2. Mean Number of Gout Flares Per Month Per Participant From Day 1 to Day 84 (Week 12)

    Time frame: Day 1 (Baseline) to Day 84 (Week 12)

    Gout flare was defined as acute articular pain typical of a gout attack that required treatment with an anti-inflammatory therapeutic: had at least 3 of the following 4 signs or symptoms: joint swelling, tenderness, redness, and pain, and with at least 1 of the following: rapid onset of pain, decreased range of motion, joint warmth or other symptoms similar to a prior gout flare. Mean number of flares per month = (total number of flares observed)/ (total number of days subject was in the period/28 days).

  3. Mean Number of Gout Flare Days Per Participant From Day 1 to Day 84 (Week 12)

    Time frame: Day 1 (Baseline) to Day 84 (Week 12)

    Gout flare was defined as acute articular pain typical of a gout attack that required treatment with an anti-inflammatory therapeutic: had at least 3 of the following 4 signs or symptoms: joint swelling, tenderness, redness, and pain, and with at least 1 of the following: rapid onset of pain, decreased range of motion, joint warmth or other symptoms similar to a prior gout flare. Mean number of gout flare days per participant was reported for this outcome measure.

  4. Mean Number of Gout Flare Days Per Month Per Participant From Day 1 to Day 84 (Week 12)

    Time frame: Day 1 (Baseline) to Day 84 (Week 12)

    Gout flare was defined as acute articular pain typical of a gout attack that required treatment with an anti-inflammatory therapeutic: had at least 3 of the following 4 signs or symptoms: joint swelling, tenderness, redness, and pain, and with at least 1 of the following: rapid onset of pain, decreased range of motion, joint warmth or other symptoms similar to a prior gout flare. Mean number of gout flare days per month per participant was reported for this outcome measure.

  5. Number of Gout Flare Days With Participant's Pain Score of 5 or More (From Daily Diary) Per Participant From Day 1 to Day 84 (Week 12)

    Time frame: Day 1 (Baseline) to Day 84 (Week 12)

    Participants were asked to complete a telephone diary by calling the IVRS daily beginning at the baseline visit (Day 1) through the follow-up visit (Day 154) and reported their general well-being, gout symptoms, and weekly study drug administrations. At the onset of pain from a gout flare, participants were to answer additional diary questions regarding their gout flare and had to continue daily flare assessments until they reported the flare had ended. If a flare occurred just prior to the follow-up visit (Day 154), participants were to continue completing the daily diary until the flare resolved. Gout flare pain was assessed on a scale from 0 to 10 (with 0=no pain and 10=severe pain) within the past 24 hours.

  6. Number of Gout Flare Days With Participant's Pain Score of 5 or More (From Daily Diary) Per Month Per Participant From Day 1 to Day 84 (Week 12)

    Time frame: Day 1 (Baseline) to Day 84 (Week 12)

    Participants were asked to complete a telephone diary by calling the IVRS daily beginning at the baseline visit (Day 1) through the follow-up visit (Day 141) and reported their general well-being, gout symptoms, and weekly study drug administrations. At the onset of pain from a gout flare, participants were to answer additional diary questions regarding their gout flare and had to continue daily flare assessments until they reported the flare had ended. If a flare occurred just prior to the follow-up visit (Day 141), participants were to continue completing the daily diary until the flare resolved. Gout flare pain was assessed on a scale from 0 to 10 (with 0=no pain and 10=severe pain) within the past 24 hours.

Sponsors and collaborators

Lead sponsor

Regeneron Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Feb 7, 2008
Registry last updated
May 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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