Intercritical GoutPhase 3PRE-SURGE1NCT00829829

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

A Phase 3 study testing Rilonacept 80 mg and Rilonacept 160 mg in people with Intercritical Gout, run by Regeneron Pharmaceuticals at 91 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Intercritical Gout
What is being tested?: Rilonacept 80 mg and Rilonacept 160 mg
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 241 participants
Where: 91 sitesin 2 countries
Study dates: Feb 2009to Jun 2010
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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;

Who cannot join

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.

Trial locations and contacts

91 sites in 2 countries.

Country

City, postcode or hospital

91 sites in 2 countries

United States67 sites

Study site
Akron, Ohio, 44313
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Avon, Indiana, 46123
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Baltimore, Maryland, 21286
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Berkeley Heights, New Jersey, 07922
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Birmingham, Alabama, 35294
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Boise, Idaho, 83713
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Bowling Green, Kentucky, 42101
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Brooklyn, New York, 11201
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Burke, Virginia, 22015
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Charleston, South Carolina, 29406
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Cincinnati, Ohio, 45246
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Columbia, South Carolina, 29204
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Concord, California, 94520
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Dallas, Texas, 75224
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Dallas, Texas, 75231
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Daytona Beach, Florida, 32117
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Delray Beach, Florida, 33446
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Duncansville, Pennsylvania, 16635
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Ellicott City, Maryland, 21042
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Evansville, Indiana, 47714
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Florissant, Missouri, 63031
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Fountain Hill, Pennsylvania, 18105
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Freehold, New Jersey, 07728
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Gainsville, Georgia, 30501
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Gilbert, Arizona, 85296
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Greensboro, North Carolina, 27408
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Greer, South Carolina, 29651
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Hickory, North Carolina, 28601
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Houston, Texas, 77074
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Huntingdon Valley, Pennsylvania, 19006
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Jackson, Mississippi, 39202
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Jacksonville, Florida, 32205
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Jupiter, Florida, 33458
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Lancaster, Pennsylvania, 17601
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Las Vegas, Nevada, 89123
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Las Vegas, Nevada, 89146
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Longview, Texas, 75605
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Memphis, Tennessee, 38120
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Middleburg Heights, Ohio, 44130
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Morehead City, North Carolina, 28516
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Naples, Florida, 34102
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North Charleston, South Carolina, 29406
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Owensboro, Kentucky, 42303
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Peoria, Arizona, 85381
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Perrysburg, Ohio, 43551
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Raleigh, North Carolina, 27607
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Raleigh, North Carolina, 27612
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Resistertown, Maryland, 01136
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Richardson, Texas, 75080
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Richmond, Virginia, 23219
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Rock Hill, South Carolina, 29732
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Rome, Georgia, 30165
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Salisbury, North Carolina, 28144
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San Antonio, Texas, 78229
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San Diego, California, 92103
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Santa Maria, California, 93454
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Searcy, Arkansas, 72143
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South Bend, Indiana, 46601
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Spokane, Washington, 99204
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St. Petersburg, Florida, 33702
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Tacoma, Washington, 98405
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Troy, Michigan, 48098
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Trumball, Connecticut, 06611
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Tucker, Georgia, 30084
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Washington D.C., District of Columbia, 20003
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Wichita, Kansas, 67208
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Woodstock, Georgia, 30188

Other trials in United States

Canada24 sites

Study site
Brampton, Ontario, L6W3E1
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Burnaby, British Columbia, V5G1T4
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Calgary, Alberta, T2X3X7
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Corunna, Ontario, N0N1G0
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Fort Erie, Ontario, L2A1Z3
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Greater Sudbury, Ontario, P3E1H5
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Kamloops, British Columbia, V2C1K7
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Kelowna, British Columbia, V1Y3G8
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Kitchener, Ontario, N2M5N6
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Listowel, Ontario, N4W2P4
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London, Ontario, N5Z3L2
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London, Ontario, N6B2E5
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Mississauga, Ontario, L5M2V8
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Montreal, Quebec, H1T2M4
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Mount Pearl, Newfoundland and Labrador, A1N1W7
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Newmarket, Ontario, L3Y5G8
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Québec, Quebec, G1V3M7
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Quesnel, British Columbia, V2J2K3
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Saskatoon, Saskatchewan, S7K0H6
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St. John's, Newfoundland and Labrador, A1E2E2
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Toronto, Ontario, M9W4L6
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Trois-Rivières, Quebec, G8Z1YZ
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Victoria, British Columbia, V8R 6V4
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Windsor, Ontario, N8X5A6

Other trials in Canada

About this study

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

Conditions: Intercritical Gout
Being tested: Placebo, Rilonacept 80 mg, Rilonacept 160 mg
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
Medical subject headings: Metabolism, Inborn Errors, Metabolic Diseases, Genetic Diseases, Inborn, Musculoskeletal Diseases, Joint Diseases, Arthritis, Rheumatic Diseases, Purine-Pyrimidine Metabolism, Inborn Errors

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PlaceboOther
Placebo loading dose followed by placebo injections (2 mL) qw for 16 weeks.
Rilonacept 80 mgDrug
Rilonacept 160 mg loading dose followed by Rilonacept 80 mg/2 mL injections qw for 16 weeks.
Rilonacept 160 mgDrug
Rilonacept 320 mg loading dose followed by Rilonacept 160 mg/2 mL injections qw for 16 weeks.

Study groups in NCT00829829
Study group	Role	What they receive
Placebo	Placebo comparator	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. Receives: Other: Placebo
Rilonacept 80 mg	Active comparator	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. Receives: Drug: Rilonacept 80 mg
Rilonacept 160 mg	Active comparator	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. Receives: Drug: Rilonacept 160 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Day 1 to Day 112 (Week 16)

Secondary outcomes (5)

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.
Measured: Day 1 to Day 112 (Week 16)
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.
Measured: Day 1 to Day 112 (Week 16)
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.
Measured: Day 1 to Day 112 (Week 16)
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.
Measured: Day 1 to Day 112 (Week 16)
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.
Measured: Day 1 to Day 112 (Week 16)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2009Jun 2010

First posted27 Jan 2009 (estimated)
Study startFeb 2009
Primary completionMay 2010
Study completionJun 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Intercritical GoutStudies of the same condition, open and under way.
More trials run by Regeneron PharmaceuticalsThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 241 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00829829
Sponsor's protocol ID: IL1T-GA-0810
Acronym: PRE-SURGE1
Status last verified: Mar 2017
First submitted: 23 Jan 2009
Last updated: 28 Apr 2017
Results posted: Yes, on ClinicalTrials.gov

Publications

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.
PubMed 22549879

Study at a glance

From the registry record, last updated by the sponsor on 28 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00829829
Acronym / sponsor ID: PRE-SURGE1 / IL1T-GA-0810
Conditions: Intercritical Gout
Keywords: Metabolism, Inborn Errors, Allopurinol, Metabolic Diseases, Genetic Diseases, Inborn, Musculoskeletal Diseases, Joint Diseases, Arthritis, Rheumatic Diseases
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 241 participants (actual)
Lead sponsor: Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Feb 2009
Primary completion: May 2010 (actual)
Study completion: Jun 2010 (actual)
First posted: 27 Jan 2009 (estimated)
Results: Posted 28 Apr 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Placebo	Placebo comparator	Other: PlaceboTwo 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.
Rilonacept 80 mg	Active comparator	Drug: Rilonacept 80 mgTwo 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.
Rilonacept 160 mg	Active comparator	Drug: Rilonacept 160 mgTwo 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.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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;

Key exclusion criteria (6 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PlaceboPlacebo loading dose followed by placebo injections (2 mL) qw for 16 weeks.	Other	Placebo
Rilonacept 80 mgRilonacept 160 mg loading dose followed by Rilonacept 80 mg/2 mL injections qw for 16 weeks.	Drug	Rilonacept 80 mg
Rilonacept 160 mgRilonacept 320 mg loading dose followed by Rilonacept 160 mg/2 mL injections qw for 16 weeks.	Drug	Rilonacept 160 mg

Primary outcome

Number of Gout Flares Per Participant Assessed From Day 1 to Day 112 (Week 16)
Time frame: 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.

5 secondary outcomes

Number of Modified Gout Flares Per Participant From Day 1 to Day 112 (Week 16)
Time frame: Day 1 to Day 112 (Week 16)
Percentage of Participants With at Least One Gout Flare From Day 1 to Day 112 (Week 16)
Time frame: Day 1 to Day 112 (Week 16)
Percentage of Participants With at Least Two Gout Flares From Day 1 to Day 112 (Week 16)
Time frame: Day 1 to Day 112 (Week 16)
Number of Gout Flare Days Per Participant From Day 1 to Day 112 (Week 16)
Time frame: Day 1 to Day 112 (Week 16)
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)
Time frame: Day 1 to Day 112 (Week 16)

Results and safety

Results posted to the registry on 28 Apr 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	80	58
Rilonacept 80 mg	80	64
Rilonacept 160 mg	81	70

Primary outcome: Number of Gout Flares Per Participant Assessed From Day 1 to Day 112 (Week 16)

Time frame: Day 1 to Day 112 (Week 16). Mean (Standard Deviation). Unit: Number of Gout flares per participant

Measure	Placebo n = 79	Rilonacept 80 mg n = 80	Rilonacept 160 mg n = 80
Value	1.06 (1.59)	0.29 (0.77)	0.21 (0.54)

Population analysed: Full analysis set (FAS) that included all randomized participants who received any study medication and was based on the treatment allocated by IIVRS at randomization (as randomized).

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	3 of 79 (3.8%)	8 of 79 (10.1%)	Not reported
Rilonacept 80 mg	3 of 80 (3.8%)	16 of 80 (20%)	Not reported
Rilonacept 160 mg	3 of 81 (3.7%)	17 of 81 (21%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 22549879Schumacher 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.
RilonaceptLink provided by the sponsor.
AllopurinolLink provided by the sponsor.
Allopurinol sodiumLink provided by the sponsor.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

91 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rilonacept 80 mg and Rilonacept 160 mg in people with Intercritical Gout, run by Regeneron Pharmaceuticals at 91 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 91 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Gout Flares Per Participant Assessed From Day 1 to Day 112 (Week 16) (time frame: Day 1 to Day 112 (Week 16)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00829829, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2017.