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

Primary Purpose

Gout

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Rilonacept
Placebo (for Rilonacept)
Sponsored by
Regeneron Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gout

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Rilonacept 160 mg

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Number of Gout Flares Per Participant Assessed From Day 1 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 Outcome Measures

Percentage of Participants With at Least One Gout Flare From Day 1 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.
Mean Number of Gout Flares Per Month Per Participant From Day 1 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).
Mean Number of Gout Flare Days Per Participant From Day 1 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.
Mean Number of Gout Flare Days Per Month Per Participant From Day 1 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.
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)
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.
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)
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.

Full Information

First Posted
January 24, 2008
Last Updated
March 20, 2017
Sponsor
Regeneron Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00610363
Brief Title
Study of the Safety and Effectiveness of Rilonacept for the Prevention of Gout Flares
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Regeneron Pharmaceuticals

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gout

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
83 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Rilonacept 160 mg
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Rilonacept
Intervention Description
Rilonacept 320 mg loading dose on Day 1 followed by Rilonacept 160 mg/2 mL injections qw for 17 weeks.
Intervention Type
Other
Intervention Name(s)
Placebo (for Rilonacept)
Intervention Description
Placebo loading dose on Day 1 followed by single placebo injections (2 mL) qw for 17 weeks.
Primary Outcome Measure Information:
Title
Number of Gout Flares Per Participant Assessed From Day 1 to Day 84 (Week 12)
Description
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.
Time Frame
Day 1 (Baseline) to Day 84 (Week 12)
Secondary Outcome Measure Information:
Title
Percentage of Participants With at Least One Gout Flare From Day 1 to Day 84 (Week 12)
Description
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.
Time Frame
Day 1 (Baseline) to Day 84 (Week 12)
Title
Mean Number of Gout Flares Per Month Per Participant From Day 1 to Day 84 (Week 12)
Description
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).
Time Frame
Day 1 (Baseline) to Day 84 (Week 12)
Title
Mean Number of Gout Flare Days Per Participant From Day 1 to Day 84 (Week 12)
Description
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.
Time Frame
Day 1 (Baseline) to Day 84 (Week 12)
Title
Mean Number of Gout Flare Days Per Month Per Participant From Day 1 to Day 84 (Week 12)
Description
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.
Time Frame
Day 1 (Baseline) to Day 84 (Week 12)
Title
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)
Description
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.
Time Frame
Day 1 (Baseline) to Day 84 (Week 12)
Title
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)
Description
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.
Time Frame
Day 1 (Baseline) to Day 84 (Week 12)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shirletta King-Davis
Organizational Affiliation
Regeneron Pharmaceuticals
Official's Role
Study Director
Facility Information:
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
City
Santa Maria
State/Province
California
ZIP/Postal Code
93454
Country
United States
City
Whittier
State/Province
California
ZIP/Postal Code
90601
Country
United States
City
Colorado Srings
State/Province
Colorado
ZIP/Postal Code
80910
Country
United States
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33710
Country
United States
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
City
Tampa
State/Province
Florida
Country
United States
City
Dunwoody
State/Province
Georgia
ZIP/Postal Code
30338
Country
United States
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96814
Country
United States
City
Boise
State/Province
Idaho
ZIP/Postal Code
83702
Country
United States
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46268
Country
United States
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46601
Country
United States
City
Owensboro
State/Province
Kentucky
ZIP/Postal Code
42303
Country
United States
City
Wheaton
State/Province
Maryland
ZIP/Postal Code
20902
Country
United States
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
City
Albany
State/Province
New York
ZIP/Postal Code
12206
Country
United States
City
Plainview
State/Province
New York
ZIP/Postal Code
11803
Country
United States
City
Roslyn
State/Province
New York
ZIP/Postal Code
11576
Country
United States
City
Monroe
State/Province
North Carolina
ZIP/Postal Code
28112
Country
United States
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
City
Mayfield Village
State/Province
Ohio
ZIP/Postal Code
44143
Country
United States
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
City
West Reading
State/Province
Pennsylvania
ZIP/Postal Code
19611
Country
United States
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
City
Grenville
State/Province
South Carolina
ZIP/Postal Code
29601
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22223180
Citation
Schumacher HR Jr, Sundy JS, Terkeltaub R, Knapp HR, Mellis SJ, Stahl N, Yancopoulos GD, Soo Y, King-Davis S, Weinstein SP, Radin AR; 0619 Study Group. Rilonacept (interleukin-1 trap) in the prevention of acute gout flares during initiation of urate-lowering therapy: results of a phase II randomized, double-blind, placebo-controlled trial. Arthritis Rheum. 2012 Mar;64(3):876-84. doi: 10.1002/art.33412.
Results Reference
derived
PubMed Identifier
21372003
Citation
Khanna D, Sarkin AJ, Khanna PP, Shieh MM, Kavanaugh AF, Terkeltaub RA, Lee SJ, Singh JA, Hirsch JD. Minimally important differences of the gout impact scale in a randomized controlled trial. Rheumatology (Oxford). 2011 Jul;50(7):1331-6. doi: 10.1093/rheumatology/ker023. Epub 2011 Mar 3.
Results Reference
derived

Learn more about this trial

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

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