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

March 20, 2017 updated by: Regeneron Pharmaceuticals

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 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

83

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92108
      • Santa Maria, California, United States, 93454
      • Whittier, California, United States, 90601
    • Colorado
      • Colorado Srings, Colorado, United States, 80910
    • Florida
      • DeLand, Florida, United States, 32720
      • Ocala, Florida, United States, 34471
      • Orlando, Florida, United States, 32804
      • St. Petersburg, Florida, United States, 33710
      • Tampa, Florida, United States
      • Tampa, Florida, United States, 33614
    • Georgia
      • Dunwoody, Georgia, United States, 30338
    • Hawaii
      • Honolulu, Hawaii, United States, 96814
    • Idaho
      • Boise, Idaho, United States, 83702
    • Indiana
      • Indianapolis, Indiana, United States, 46268
      • South Bend, Indiana, United States, 46601
    • Kentucky
      • Owensboro, Kentucky, United States, 42303
    • Maryland
      • Wheaton, Maryland, United States, 20902
    • Montana
      • Billings, Montana, United States, 59101
    • Nebraska
      • Omaha, Nebraska, United States, 68114
    • Nevada
      • Reno, Nevada, United States, 89502
    • New York
      • Albany, New York, United States, 12206
      • Plainview, New York, United States, 11803
      • Roslyn, New York, United States, 11576
    • North Carolina
      • Monroe, North Carolina, United States, 28112
      • Raleigh, North Carolina, United States, 27612
    • Ohio
      • Cincinnati, Ohio, United States, 45242
      • Mayfield Village, Ohio, United States, 44143
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
      • West Reading, Pennsylvania, United States, 19611
    • South Carolina
      • Charleston, South Carolina, United States, 29406
      • Grenville, South Carolina, United States, 29601
    • Texas
      • Dallas, Texas, United States, 75235
    • Washington
      • Spokane, Washington, United States, 99204

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
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 16.
Other: Placebo (for Rilonacept)
Placebo loading dose on Day 1 followed by single placebo injections (2 mL) qw for 17 weeks.
Experimental: Rilonacept 160 mg
Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 16.
Biological: Rilonacept
Rilonacept 320 mg loading dose on Day 1 followed by Rilonacept 160 mg/2 mL injections qw for 17 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 1 (Baseline) to Day 84 (Week 12)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 1 (Baseline) to Day 84 (Week 12)
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).
Day 1 (Baseline) to Day 84 (Week 12)
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.
Day 1 (Baseline) to Day 84 (Week 12)
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.
Day 1 (Baseline) to Day 84 (Week 12)
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.
Day 1 (Baseline) to Day 84 (Week 12)
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.
Day 1 (Baseline) to Day 84 (Week 12)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Regeneron Pharmaceuticals

Investigators

  • Study Director: Shirletta King-Davis, Regeneron Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

October 1, 2008

Study Registration Dates

First Submitted

January 24, 2008

First Submitted That Met QC Criteria

January 24, 2008

First Posted (Estimate)

February 7, 2008

Study Record Updates

Last Update Posted (Actual)

May 2, 2017

Last Update Submitted That Met QC Criteria

March 20, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IL1T-GA-0619

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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