GoutPhase 3NCT00856206

Review of Safety Using Rilonacept in Preventing Gout Exacerbations (RE-SURGE)

A Phase 3 study testing Rilonacept in people with Gout, run by Regeneron Pharmaceuticals at 124 sites in 6 countries.

Completed

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

Trial summary

The purpose of this clinical research study is to determine the safety and effectiveness of an experimental drug called rilonacept in subjects with gout who are on urate-lowering therapy. Subjects will participate in this study for approximately 20 weeks. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Gout
What is being tested?: Rilonacept
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,315 participants
Where: 124 sitesin 6 countries
Study dates: Mar 2009to Jan 2011
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 American Rheumatism Associatio (ARA) for the classification of acute gout arthritis of primary gout;
Subjects with history of gout, initiating or currently on urate lowering; therapy who are at risk of gout flare.

Who cannot join

Acute gout flare within 2 weeks prior to the screening visit and during the screening visit;
Persistent chronic or active infections;
History of an allergic reaction to allopurinol;
History or presence of cancer within 5 years of the Screening Visit;;;

Trial locations and contacts

124 sites in 6 countries.

Country

City, postcode or hospital

124 sites in 6 countries

United States77 sites

Study site
Alabaster, Alabama
Study site
Albuquerque, New Mexico
Study site
Anderson, South Carolina
Study site
Arlington, Texas
Study site
Atlanta, Georgia
Study site
Baltimore, Maryland
Study site
Billings, Montana
Study site
Bingham Farms, Michigan
Study site
Boise, Idaho
Study site
Bowling Green, Kentucky
Study site
Brooklyn, New York
Study site
Brooklyn Center, Minnesota
Study site
Brooksville, Florida
Study site
Brownsburg, Indiana
Study site
Burbank, California
Study site
Canton, Georgia
Study site
Carrollton, Texas
Study site
Cincinnati, Ohio
Study site
Clearwater, Florida
Study site
Cleveland, Ohio
Study site
Corsicana, Texas
Study site
Dallas, Texas
Study site
DeBary, Florida
Study site
Decatur, Georgia
Study site
DeLand, Florida
Study site
Duncansville, Pennsylvania
Study site
Durham, North Carolina
Study site
Elizabeth, New Jersey
Study site
Elizabethtown, Kentucky
Study site
Evansville, Indiana
Study site
Greenfield, Indiana
Study site
Hickory, North Carolina
Study site
Houston, Texas
Study site
Jacksonville, Florida
Study site
Johnson City, Tennessee
Study site
Kalispell, Montana
Study site
Lake Jackson, Texas
Study site
Lexington, Kentucky
Study site
Lincoln, Nebraska
Study site
Long Beach, California
Study site
Los Angeles, California
Study site
Mesa, Arizona
Study site
Middleburg Heights, Ohio
Study site
Mineola, New York
Study site
Monck's Corner, South Carolina
Study site
Mooresville, North Carolina
Study site
Morganton, North Carolina
Study site
Morrisville, Pennsylvania
Study site
Naples, Florida
Study site
New Orleans, Louisiana
Study site
New York, New York
Study site
Norfolk, Virginia
Study site
Oak Creek, Wisconsin
Study site
Ogden, Utah
Study site
Orangeburg, South Carolina
Study site
Palm Harbor, Florida
Study site
Richmond, Virginia
Study site
Richmond Heights, Missouri
Study site
Ridley Park, Pennsylvania
Study site
Roslyn, New York
Study site
Salt Lake City, Utah
Study site
San Antonio, Texas
Study site
Sandy Springs, Georgia
Study site
Seattle, Washington
Study site
Southlake, Texas
Study site
Springfield, Massachusetts
Study site
St Louis, Missouri
Study site
St. Petersburg, Florida
Study site
Stockbridge, Georgia
Study site
Sugarland, Texas
Study site
Tampa, Florida
Study site
Upland, California
Study site
Wauwatosa, Wisconsin
Study site
West Jordan, Utah
Study site
Willow Grove, Pennsylvania
Study site
Winston-Salem, North Carolina
Study site
Worcester, Massachusetts

Other trials in United States

South Africa21 sites

Study site
Benoni, Gauteng
Study site
Bloemfontein, Free State
Study site
Breyten, Mpumalanga
Study site
Cape Town, W Cape
Study site
Centurion, Gauteng
Study site
Dundee, KZ-Natal
Study site
Durban, Mpumalanga
Study site
Durban North, KZ-Natal
Study site
Eldoraigne, Gauteng
Study site
Johannesburg, Gauteng
Study site
Kempton Park, Gauteng
Study site
Krugersdorp, Gauteng
Study site
Lenasia, Gauteng
Study site
Limpopo, Gauteng
Study site
Mpumalanga
Study site
Phoenix, KZ-Natal
Study site
Port Elizabeth, E Cape
Study site
Pretoria, Gauteng
Study site
Rustenburg, Gauteng
Study site
Soweto, Gauteng
Study site
Verulam, KZ-Natal

Other trials in South Africa

India8 sites

Study site
Ahmedabad, Gujarat
Study site
Bangalore, Karna
Study site
Gandhinagar, Gujarat
Study site
Kolkata, West Bengal
Study site
Mangalore, Karna
Study site
Mumbai, Mahara
Study site
New Dehli, National Capital Territory of Delhi
Study site
Secundrabad, Andh Prad

Other trials in India

Germany7 sites

Study site
Dietzenbach, Hesse
Study site
Essen, North Rhine-Westphalia
Study site
Goch, North Rhine-Westphalia
Study site
Hamburg, Free and Hanseatic City of Hamburg
Study site
Künzing, Bavaria
Study site
Rhaunen, Rhineland-Palatinate
Study site
Siegen, North Rhine-Westphalia

Other trials in Germany

Indonesia7 sites

Study site
Bandung
Study site
Denpasar, Bali
Study site
Makassar, South Sulawesi
Study site
Malang
Study site
Padang, West Sumatra
Study site
South Sumatra
Study site
Yogyakarta

Other trials in Indonesia

Taiwan4 sites

Study site
Changhua
Study site
Hualien City
Study site
Tainan
Study site
Taipei

Other trials in Taiwan

About this study

Official title: A Multi-Center, Randomized, Double-Blind, Placebo Controlled Trial of the Safety of Rilonacept for the Prophylaxis of Gout Flares in Patients on Urate- Lowering Therapy

Conditions: Gout
Being tested: Rilonacept, Placebo
Keywords: Metabolism, Inborn Errors, Allopurinol, Metabolic Disease, Genetic Diseases, Inborn, Musculoskeletal Diseases, Joint Diseases, Arthritis, Rheumatic Diseases, Metabolic disorder, Purine Pyrimidine Metabolism, Inborn Errors, Gout, Intercritical Gout
Medical subject headings: Gout, Metabolism, Inborn Errors, Metabolic Diseases, Genetic Diseases, Inborn, Musculoskeletal Diseases, Joint Diseases, Arthritis, Rheumatic Diseases

What participants receive

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

RilonaceptBiological
Rilonacept 160 mg subcutaneous injection once a week
PlaceboOther
Placebo subcutaneous injection once a week

Study groups in NCT00856206
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 160 mg	Experimental	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: Biological: Rilonacept

What is being measured

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

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. Treatment-emergent adverse events (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 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.
Measured: Baseline up to Week 20

Secondary outcomes (4)

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)
Percentage of Participants With at Least One Flare 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. Percentage of participants with at least one gout flare 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)
Percentage of Participants With at Least Two Flares 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. Percentage of participants with at least two gout flare 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)
Number of Gout Flare Days Per Participant 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. Flare days were counted up to Week 16, regardless of whether or not the flares occurred during the treatment period.
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.

Mar 2009Jan 2011

First posted5 Mar 2009 (estimated)
Study startMar 2009
Primary completionJan 2011
Study completionJan 2011

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 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: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 1,315 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00856206
Sponsor's protocol ID: IL1T-GA-0815
Status last verified: Mar 2017
First submitted: 21 Feb 2009
Last updated: 28 Apr 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Sundy JS, Schumacher HR, Kivitz A, Weinstein SP, Wu R, King-Davis S, Evans RR. Rilonacept for gout flare prevention in patients receiving uric acid-lowering therapy: results of RESURGE, a phase III, international safety study. J Rheumatol. 2014 Aug;41(8):1703-11. doi: 10.3899/jrheum.131226. Epub 2014 Jul 15.
PubMed 25028379

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 4
Treat-to-Target Serum Urate Versus Treat-to-Avoid Symptoms in Gout
Gout
RecruitingPhase 3
A Study of Dotinurad Versus Allopurinol in Participants With Gout
Gout
RecruitingPhase 3
A Study of Dotinurad Versus Allopurinol in Tophaceous Gout
Tophaceous Gout
Not yet recruitingPhase 3
Combined Metabolic Activator Supplementation in Subjects Diagnosed With Gout
Gout Disease
Enrolling by invitation
The Remote Monitoring of Gout Study
Gout Initiating Urate-loweringUrate-lowering Therapy

All Gout trials

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 Trial of the Safety of Rilonacept for the Prophylaxis of Gout Flares in Patients on Urate- Lowering Therapy
ClinicalTrials.gov ID: NCT00856206
Acronym / sponsor ID: IL1T-GA-0815
Conditions: Gout
Keywords: Metabolism, Inborn Errors, Allopurinol, Metabolic Disease, Genetic Diseases, Inborn, Musculoskeletal Diseases, Joint Diseases, Arthritis, Rheumatic Diseases
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,315 participants (actual)
Lead sponsor: Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Mar 2009
Primary completion: Jan 2011 (actual)
Study completion: Jan 2011 (actual)
First posted: 5 Mar 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: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

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 160 mg	Experimental	Biological: RilonaceptTwo 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 (3 listed)

Male or female 18 to 80 years of age;
Previously met the preliminary criteria of American Rheumatism Associatio (ARA) for the classification of acute gout arthritis of primary gout;
Subjects with history of gout, initiating or currently on urate lowering; therapy who are at risk of gout flare.

Key exclusion criteria (4 listed)

Acute gout flare within 2 weeks prior to the screening visit and during the screening visit;
Persistent chronic or active infections;
History of an allergic reaction to allopurinol;
History or presence of cancer within 5 years of the Screening Visit;;;

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
RilonaceptRilonacept 160 mg subcutaneous injection once a week	Biological	Rilonacept 160 mg
PlaceboPlacebo subcutaneous injection once a week	Other	Placebo

Primary outcome

Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time frame: Baseline up to Week 20
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. Treatment-emergent adverse events (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 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.

4 secondary outcomes

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

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	330	276
Rilonacept 160 mg	985	824

Primary outcome: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)

Time frame: Baseline up to Week 20. Number. Unit: percentage of participants

Measure	Placebo n = 330	Rilonacept 160 mg n = 985
With at least 1 TEAE	59.1	66.6
With TEAEs related to study drug	13.0	27.5
With serious TEAEs	3.9	3.1
With TEAEs resulting in drug withdrawal	3.3	5.0
With serious TEAEs resulting in drug withdrawal	1.8	1.1
With TEAEs leading to study discontinuation	3.0	4.7
With serious TEAE leading to study discontinuation	1.5	1.0
Treatment emergent deaths	0.3	0.2

Population analysed: Safety analysis set that included all participants who received any study drug and safety analyses were based on the treatment received.

4 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	13 of 330 (3.9%)	74 of 330 (22.4%)	Not reported
Rilonacept 160 mg	31 of 985 (3.1%)	266 of 985 (27%)	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 25028379Sundy JS, Schumacher HR, Kivitz A, Weinstein SP, Wu R, King-Davis S, Evans RR. Rilonacept for gout flare prevention in patients receiving uric acid-lowering therapy: results of RESURGE, a phase III, international safety study. J Rheumatol. 2014 Aug;41(8):1703-11. doi: 10.3899/jrheum.131226. Epub 2014 Jul 15.

Related trials for Gout

RecruitingPhase 4
Treat-to-Target Serum Urate Versus Treat-to-Avoid Symptoms in Gout
Gout
RecruitingPhase 3
A Study of Dotinurad Versus Allopurinol in Participants With Gout
Gout
RecruitingPhase 3
A Study of Dotinurad Versus Allopurinol in Tophaceous Gout
Tophaceous Gout
Not yet recruitingPhase 3
Combined Metabolic Activator Supplementation in Subjects Diagnosed With Gout
Gout Disease
Enrolling by invitation
The Remote Monitoring of Gout Study
Gout Initiating Urate-loweringUrate-lowering Therapy

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.

Robert Evans, PharmD study director

Regeneron Pharmaceuticals

124 sites in 6 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rilonacept in people with Gout, run by Regeneron Pharmaceuticals at 124 sites in 6 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 3 inclusion and 4 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 124 sites in United States, South Africa, India, Germany, Indonesia and 1 more country. 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?

Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) (time frame: Baseline up to Week 20). 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 NCT00856206, 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.