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PREventative Study Against URate-lowering Drug-induced Gout Exacerbations 1 (PRE-SURGE1)

Primary Purpose

Intercritical Gout

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Placebo
Rilonacept 80 mg
Rilonacept 160 mg
Sponsored by
Regeneron Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intercritical Gout focused on measuring Metabolism, Inborn Errors, Allopurinol, Metabolic Diseases, Genetic Diseases, Inborn, Musculoskeletal Diseases, Joint Diseases, Arthritis, Rheumatic Diseases, Metabolic disorder, Purine-Pyrimidine Metabolism, Inborn Errors, Gout

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female 18 to 80 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;
  • Serum uric acid greater than or equal to 7.5 mg/dL at the screening visit;

Exclusion Criteria:

  • Acute gout flare within 2 weeks of the screening visit or 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;
  • Previous exposure to Rilonacept;
  • Use of allopurinol, benzbromarone, febuxostat, probenecid or sulfinpyrazone within 3 months prior to the screening visit.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

Placebo

Rilonacept 80 mg

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 15.

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 15.

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 15.

Outcomes

Primary Outcome Measures

Number of Gout Flares Per Participant Assessed From Day 1 to Day 112 (Week 16)
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 112 were counted, regardless whether the flares occurred during the treatment period or not.

Secondary Outcome Measures

Number of Modified Gout Flares Per Participant From Day 1 to Day 112 (Week 16)
Modified gout flare was defined using modified definition of a gout flare as participant-reported articular pain typical of a gout attack that was deemed to require treatment with anti-inflammatory therapy. Number of modified gout flares per participant were reported for this outcome measure.
Percentage of Participants With at Least One Gout Flare From Day 1 to Day 112 (Week 16)
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.
Percentage of Participants With at Least Two Gout Flares From Day 1 to Day 112 (Week 16)
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 was reported for this outcome measure.
Number of Gout Flare Days Per Participant From Day 1 to Day 112 (Week 16)
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. Number of gout flare days 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 112 (Week 16)
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 23, 2009
Last Updated
March 20, 2017
Sponsor
Regeneron Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00829829
Brief Title
PREventative Study Against URate-lowering Drug-induced Gout Exacerbations 1
Acronym
PRE-SURGE1
Official Title
A Multi-Center, Randomized, Double-Blind, Placebo Controlled Study of the Efficacy and Safety of Rilonacept for the Prophylaxis of Gout Flares During the Initiation of Allopurinol Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

5. Study Description

Brief Summary
The purpose of this clinical research study was to determine the safety and effectiveness of an experimental drug called rilonacept in subjects with gout who are beginning allopurinol treatment for gout. Subjects will participate in this study for approximately 22 weeks. Rilonacept is being studied for use in preventing allopurinol-induced gout flares.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
241 (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 15.
Arm Title
Rilonacept 80 mg
Arm Type
Active Comparator
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 15.
Arm Title
Rilonacept 160 mg
Arm Type
Active Comparator
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 15.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo loading dose followed by placebo injections (2 mL) qw for 16 weeks.
Intervention Type
Drug
Intervention Name(s)
Rilonacept 80 mg
Intervention Description
Rilonacept 160 mg loading dose followed by Rilonacept 80 mg/2 mL injections qw for 16 weeks.
Intervention Type
Drug
Intervention Name(s)
Rilonacept 160 mg
Intervention Description
Rilonacept 320 mg loading dose followed by Rilonacept 160 mg/2 mL injections qw for 16 weeks.
Primary Outcome Measure Information:
Title
Number of Gout Flares Per Participant Assessed From Day 1 to Day 112 (Week 16)
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 112 were counted, regardless whether the flares occurred during the treatment period or not.
Time Frame
Day 1 to Day 112 (Week 16)
Secondary Outcome Measure Information:
Title
Number of Modified Gout Flares Per Participant From Day 1 to Day 112 (Week 16)
Description
Modified gout flare was defined using modified definition of a gout flare as participant-reported articular pain typical of a gout attack that was deemed to require treatment with anti-inflammatory therapy. Number of modified gout flares per participant were reported for this outcome measure.
Time Frame
Day 1 to Day 112 (Week 16)
Title
Percentage of Participants With at Least One Gout Flare From Day 1 to Day 112 (Week 16)
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 to Day 112 (Week 16)
Title
Percentage of Participants With at Least Two Gout Flares From Day 1 to Day 112 (Week 16)
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 was reported for this outcome measure.
Time Frame
Day 1 to Day 112 (Week 16)
Title
Number of Gout Flare Days Per Participant From Day 1 to Day 112 (Week 16)
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. Number of gout flare days per participant was reported for this outcome measure.
Time Frame
Day 1 to Day 112 (Week 16)
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 112 (Week 16)
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 to Day 112 (Week 16)

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: Male or female 18 to 80 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; Serum uric acid greater than or equal to 7.5 mg/dL at the screening visit; Exclusion Criteria: Acute gout flare within 2 weeks of the screening visit or 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; Previous exposure to Rilonacept; Use of allopurinol, benzbromarone, febuxostat, probenecid or sulfinpyrazone within 3 months prior to the screening visit.
Facility Information:
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85296
Country
United States
City
Peoria
State/Province
Arizona
ZIP/Postal Code
85381
Country
United States
City
Searcy
State/Province
Arkansas
ZIP/Postal Code
72143
Country
United States
City
Concord
State/Province
California
ZIP/Postal Code
94520
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
City
Santa Maria
State/Province
California
ZIP/Postal Code
93454
Country
United States
City
Trumball
State/Province
Connecticut
ZIP/Postal Code
06611
Country
United States
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20003
Country
United States
City
Daytona Beach
State/Province
Florida
ZIP/Postal Code
32117
Country
United States
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33446
Country
United States
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32205
Country
United States
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
City
Naples
State/Province
Florida
ZIP/Postal Code
34102
Country
United States
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33702
Country
United States
City
Gainsville
State/Province
Georgia
ZIP/Postal Code
30501
Country
United States
City
Rome
State/Province
Georgia
ZIP/Postal Code
30165
Country
United States
City
Tucker
State/Province
Georgia
ZIP/Postal Code
30084
Country
United States
City
Woodstock
State/Province
Georgia
ZIP/Postal Code
30188
Country
United States
City
Boise
State/Province
Idaho
ZIP/Postal Code
83713
Country
United States
City
Avon
State/Province
Indiana
ZIP/Postal Code
46123
Country
United States
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46601
Country
United States
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67208
Country
United States
City
Bowling Green
State/Province
Kentucky
ZIP/Postal Code
42101
Country
United States
City
Owensboro
State/Province
Kentucky
ZIP/Postal Code
42303
Country
United States
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21286
Country
United States
City
Ellicott City
State/Province
Maryland
ZIP/Postal Code
21042
Country
United States
City
Resistertown
State/Province
Maryland
ZIP/Postal Code
01136
Country
United States
City
Troy
State/Province
Michigan
ZIP/Postal Code
48098
Country
United States
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39202
Country
United States
City
Florissant
State/Province
Missouri
ZIP/Postal Code
63031
Country
United States
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89123
Country
United States
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89146
Country
United States
City
Berkeley Heights
State/Province
New Jersey
ZIP/Postal Code
07922
Country
United States
City
Freehold
State/Province
New Jersey
ZIP/Postal Code
07728
Country
United States
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11201
Country
United States
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27408
Country
United States
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28601
Country
United States
City
Morehead City
State/Province
North Carolina
ZIP/Postal Code
28516
Country
United States
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
City
Salisbury
State/Province
North Carolina
ZIP/Postal Code
28144
Country
United States
City
Akron
State/Province
Ohio
ZIP/Postal Code
44313
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45246
Country
United States
City
Middleburg Heights
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
City
Perrysburg
State/Province
Ohio
ZIP/Postal Code
43551
Country
United States
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
City
Fountain Hill
State/Province
Pennsylvania
ZIP/Postal Code
18105
Country
United States
City
Huntingdon Valley
State/Province
Pennsylvania
ZIP/Postal Code
19006
Country
United States
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17601
Country
United States
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29204
Country
United States
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29651
Country
United States
City
North Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
City
Rock Hill
State/Province
South Carolina
ZIP/Postal Code
29732
Country
United States
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75224
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
City
Longview
State/Province
Texas
ZIP/Postal Code
75605
Country
United States
City
Richardson
State/Province
Texas
ZIP/Postal Code
75080
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
City
Burke
State/Province
Virginia
ZIP/Postal Code
22015
Country
United States
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23219
Country
United States
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2X3X7
Country
Canada
City
Burnaby
State/Province
British Columbia
ZIP/Postal Code
V5G1T4
Country
Canada
City
Kamloops
State/Province
British Columbia
ZIP/Postal Code
V2C1K7
Country
Canada
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y3G8
Country
Canada
City
Quesnel
State/Province
British Columbia
ZIP/Postal Code
V2J2K3
Country
Canada
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8R 6V4
Country
Canada
City
Mt. Pearl
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1N1W7
Country
Canada
City
St. John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1E2E2
Country
Canada
City
Brampton
State/Province
Ontario
ZIP/Postal Code
L6W3E1
Country
Canada
City
Corunna
State/Province
Ontario
ZIP/Postal Code
N0N1G0
Country
Canada
City
Fort Erie
State/Province
Ontario
ZIP/Postal Code
L2A1Z3
Country
Canada
City
Kitchener
State/Province
Ontario
ZIP/Postal Code
N2M5N6
Country
Canada
City
Listowel
State/Province
Ontario
ZIP/Postal Code
N4W2P4
Country
Canada
City
London
State/Province
Ontario
ZIP/Postal Code
N5Z3L2
Country
Canada
City
London
State/Province
Ontario
ZIP/Postal Code
N6B2E5
Country
Canada
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L5M2V8
Country
Canada
City
Newmarket
State/Province
Ontario
ZIP/Postal Code
L3Y5G8
Country
Canada
City
Sudbury
State/Province
Ontario
ZIP/Postal Code
P3E1H5
Country
Canada
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M9W4L6
Country
Canada
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8X5A6
Country
Canada
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T2M4
Country
Canada
City
Trois-Rivieres
State/Province
Quebec
ZIP/Postal Code
G8Z1YZ
Country
Canada
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7K0H6
Country
Canada
City
Quebec
ZIP/Postal Code
G1V3M7
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
22549879
Citation
Schumacher HR Jr, Evans RR, Saag KG, Clower J, Jennings W, Weinstein SP, Yancopoulos GD, Wang J, Terkeltaub R. Rilonacept (interleukin-1 trap) for prevention of gout flares during initiation of uric acid-lowering therapy: results from a phase III randomized, double-blind, placebo-controlled, confirmatory efficacy study. Arthritis Care Res (Hoboken). 2012 Oct;64(10):1462-70. doi: 10.1002/acr.21690.
Results Reference
derived
Links:
URL
http://druginfo.nlm.nih.gov/drugportal/ProxyServlet?mergeData=true&objectHandle=DBMaint&APPLICATION_NAME=drugportal&actionHandle=default&nextPage=jsp/drugportal/ResultScreen.jsp&TXTSUPERLISTID=501081761&QV1=RILONACEPT
Description
Rilonacept
URL
http://druginfo.nlm.nih.gov/drugportal/ProxyServlet?mergeData=true&objectHandle=DBMaint&APPLICATION_NAME=drugportal&actionHandle=default&nextPage=jsp/drugportal/ResultScreen.jsp&TXTSUPERLISTID=000315300&QV1=ALLOPURINOL
Description
Allopurinol
URL
http://druginfo.nlm.nih.gov/drugportal/ProxyServlet?mergeData=true&objectHandle=DBMaint&APPLICATION_NAME=drugportal&actionHandle=default&nextPage=jsp/drugportal/ResultScreen.jsp&TXTSUPERLISTID=017795210&QV1=ALLOPURINOL+SODIUM
Description
Allopurinol sodium

Learn more about this trial

PREventative Study Against URate-lowering Drug-induced Gout Exacerbations 1

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