Back to resultsStudy of the Safety and Efficacy of Long-Term Rilonacept Treatment for the Prevention of Gout Flares (UPSURGE)
Primary Purpose
Gout
Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Rilonacept
Placebo
Allopurinol
Sponsored by
About this trial
This is an interventional treatment trial for Gout
Eligibility Criteria
Inclusion Criteria:
Key Inclusion criteria:
- 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.
Exclusion Criteria:
Key Exclusion criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Placebo
Rilonacept 80 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 51.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Percentage of Participants With at Least One Gout Flare From Day 1 to Day 168 (Week 24)
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 at Week 24 was to be reported for this outcome measure.
Percentage of Participants With at Least Two Gout Flares From Day 1 to Day 168 (Week 24)
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 two gout flares at Week 24 was to be reported for this outcome measure.
Percentage of Participants With at Least One Gout Flare From Day 1 to Day 364 (Week 52)
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 at Week 52 was to be reported for this outcome measure.
Percentage of Participants With at Least Two Gout Flares From Day 1 to Day 364 (Week 52)
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 two gout flares at Week 52 was to be reported for this outcome measure.
Percentage of Participants With Rescue Medication From Day 1 to Day 364 (Week 52)
Participants who required rescue medication after having 2 or more gout flares during the treatment period were evaluated.
Full Information
NCT ID
NCT01459796
First Posted
October 12, 2011
Last Updated
June 19, 2017
Sponsor
Regeneron Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT01459796
Brief Title
Study of the Safety and Efficacy of Long-Term Rilonacept Treatment for the Prevention of Gout Flares
Acronym
UPSURGE
Official Title
A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Long-Term Rilonacept Treatment for the Prevention of Gout Flares
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Terminated
Study Start Date
November 2011 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (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
The purpose of this study was to determine the safety and tolerability of rilonacept for participants with gout who were initiating allopurinol.
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 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
220 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Experimental
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 51.
Arm Title
Rilonacept 80 mg
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Rilonacept
Intervention Description
Rilonacept 160 mg loading dose followed by Rilonacept 80 mg/2 mL injections qw for 52 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo loading dose followed by placebo injections (2 mL) qw for 52 weeks.
Intervention Type
Drug
Intervention Name(s)
Allopurinol
Intervention Description
Allopurinol 50 or 100 mg, orally daily for 52 weeks as background treatment.
Primary Outcome Measure Information:
Title
Percentage of Participants With Treatment Emergent Adverse Events (TEAEs)
Description
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.
Time Frame
Day 1 to Day 392 (Week 56)
Secondary Outcome Measure Information:
Title
Percentage of Participants With at Least One Gout Flare From Day 1 to Day 168 (Week 24)
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 at Week 24 was to be reported for this outcome measure.
Time Frame
Day 1 to Day 168 (Week 24)
Title
Percentage of Participants With at Least Two Gout Flares From Day 1 to Day 168 (Week 24)
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 two gout flares at Week 24 was to be reported for this outcome measure.
Time Frame
Day 1 to Day 168 (Week 24)
Title
Percentage of Participants With at Least One Gout Flare From Day 1 to Day 364 (Week 52)
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 at Week 52 was to be reported for this outcome measure.
Time Frame
Day 1 to Day 364 (Week 52)
Title
Percentage of Participants With at Least Two Gout Flares From Day 1 to Day 364 (Week 52)
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 two gout flares at Week 52 was to be reported for this outcome measure.
Time Frame
Day 1 to Day 364 (Week 52)
Title
Percentage of Participants With Rescue Medication From Day 1 to Day 364 (Week 52)
Description
Participants who required rescue medication after having 2 or more gout flares during the treatment period were evaluated.
Time Frame
Day 1 to Day 364 (Week 52)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Key Inclusion criteria:
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.
Exclusion Criteria:
Key Exclusion criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trial Management
Organizational Affiliation
Regeneron Pharmaceuticals
Official's Role
Study Director
Facility Information:
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Birmingham
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Mesa
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Phoenix
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New Orleans
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Cumberland
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Hagerstown
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Wheaton
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Edina
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Brooklyn
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Winston-Salem
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Carlisle
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Portland
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Johnstown
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Reading
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Anderson
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Charleston
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Columbia
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Greenville
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Rock Hill
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Simpsonville
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Dallas
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Fort Worth
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Houston
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Lake Jackson
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North Richland Hills
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San Antonio
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Sugar Land
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Salt Lake City
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Arlington
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Virginia
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Spokane
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Washington
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United States
12. IPD Sharing Statement
Learn more about this trial
Study of the Safety and Efficacy of Long-Term Rilonacept Treatment for the Prevention of Gout Flares
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