GoutPhase 3NCT00958438

PREventative Study Against URate-Lowering Drug-Induced Gout Exacerbations (PRE-SURGE 2)

A Phase 3 study testing Rilonacept in people with Gout, run by Regeneron Pharmaceuticals at 61 sites in 5 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 was to determine the safety and effectiveness of an experimental drug called rilonacept in participants with gout who are beginning allopurinol treatment for gout. Participants 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: 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: 248 participants
Where: 61 sitesin 5 countries
Study dates: Jul 2009to Dec 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

61 sites in 5 countries.

Country

City, postcode or hospital

61 sites in 5 countries

South Africa23 sites

Study site
Benoni
Study site
Bloemfontein
Study site
Breyten
Study site
Cape Town
Study site
Dundee
Study site
Durban
Study site
Durban North
Study site
eManzimtoti
Study site
Gauteng
Study site
Johannesburg
Study site
Kempton Park
Study site
Krugersdorp
Study site
KZ-Natal
Study site
Lenasia
Study site
Lyttleton
Study site
Middleburg
Study site
Port Elizabeth
Study site
Pretoria
Study site
Roodepoort
Study site
Scottburgh
Study site
Somerset West
Study site
Soweto
Study site
Worcester

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Germany11 sites

Study site
Berlin
Study site
Essen
Study site
Goch
Study site
Hamburg
Study site
Kassel
Study site
Künzing
Study site
Lollar
Study site
Magdeburg
Study site
München
Study site
Rhaunen
Study site
Siegen

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India10 sites

Study site
Ahmedabad
Study site
Bangalore
Study site
Gandhinagar
Study site
Hyderabaad
Study site
Kolkata
Study site
Mangalore
Study site
Pune
Study site
Secunderabad
Study site
Vadodara
Study site
Varanasi

Other trials in India

Taiwan9 sites

Study site
Changhua
Study site
Dalin Town
Study site
Hualien City
Study site
Kaohsiung City
Study site
Kwei-Shan
Study site
Taichung
Study site
Tainan
Study site
Taipei
Study site
Yungkang City, Tainan

Other trials in Taiwan

Indonesia8 sites

Study site
Denpasar
Study site
Jakarta
Study site
Kemerdekaan
Study site
Palembang
Study site
Semarang
Study site
South Sulawesi
Study site
West Java
Study site
Yogyakarta

Other trials in Indonesia

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: Gout
Being tested: Placebo, Rilonacept
Keywords: Intercritical Gout, 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: 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.

PlaceboDrug
Placebo loading dose followed by placebo subcutaneous (SC) injection (2 mL) once a week for 16 weeks.
RilonaceptDrug
Rilonacept 160 mg SC loading dose followed by Rilonacept 80 mg/2 mL SC injections once a week for 16 weeks.
RilonaceptDrug
Rilonacept 320 mg SC loading dose followed by Rilonacept 160 mg/2 mL SC injections once a week for 16 weeks.

Study groups in NCT00958438
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: Drug: Placebo
Rilonacept 80 mg	Experimental	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
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: Drug: Rilonacept

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 113 (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 flares per participant was reported for this outcome measure.
Measured: Day 1 to Day 113 (Week 16)

Secondary outcomes (5)

Number of Modified Gout Flares Per Participant From Day 1 to Day 113 (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 113 (Week 16)
Percentage of Participants With at Least One Flare From Day 1 to Day 113 (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 113 (Week 16)
Percentage of Participants With at Least Two Flares From Day 1 to Day 113 (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 113 (Week 16)
Number of Gout Flare Days Per Participant From Day 1 to Day 113 (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 113 (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 113 (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 113 (Week 16)

Timeline

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

Jul 2009Dec 2010

First posted13 Aug 2009 (estimated)
Study startJul 2009
Primary completionDec 2010
Study completionDec 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 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: 248 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00958438
Sponsor's protocol ID: IL1T-GA-0816
Other IDs: 2008-007762-39, 2008
Status last verified: Mar 2017
First submitted: 11 Aug 2009
Last updated: 28 Apr 2017
Results posted: Yes, on ClinicalTrials.gov

Publications

Mitha E, Schumacher HR, Fouche L, Luo SF, Weinstein SP, Yancopoulos GD, Wang J, King-Davis S, Evans RR. Rilonacept for gout flare prevention during initiation of uric acid-lowering therapy: results from the PRESURGE-2 international, phase 3, randomized, placebo-controlled trial. Rheumatology (Oxford). 2013 Jul;52(7):1285-92. doi: 10.1093/rheumatology/ket114. Epub 2013 Mar 13.
PubMed 23485476

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 3
A Study of Dotinurad Versus Allopurinol in Tophaceous Gout
Tophaceous Gout
RecruitingPhase 3
A Study of Dotinurad Versus Allopurinol in Participants With Gout
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
Recruiting
Pharmacist-Led Treat-to-Target Urate Lowering Therapy in Patients With Gout
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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 Study of the Efficacy and Safety of Rilonacept for the Prophylaxis of Gout Flares During the Initiation of Allopurinol Therapy
ClinicalTrials.gov ID: NCT00958438
Acronym / sponsor ID: IL1T-GA-0816
Conditions: Gout
Keywords: Intercritical Gout, Metabolism, Inborn Errors, Allopurinol, Metabolic Diseases, Genetic Diseases, Inborn, Musculoskeletal Diseases, Joint Diseases, Arthritis
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 248 participants (actual)
Lead sponsor: Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Jul 2009
Primary completion: Dec 2010 (actual)
Study completion: Dec 2010 (actual)
First posted: 13 Aug 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	Drug: 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	Experimental	Drug: RilonaceptTwo 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	Experimental	Drug: 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 (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 subcutaneous (SC) injection (2 mL) once a week for 16 weeks.	Drug	Placebo
RilonaceptRilonacept 160 mg SC loading dose followed by Rilonacept 80 mg/2 mL SC injections once a week for 16 weeks.	Drug	Rilonacept 80 mg
RilonaceptRilonacept 320 mg SC loading dose followed by Rilonacept 160 mg/2 mL SC injections once a week for 16 weeks.	Drug	Rilonacept 160 mg

Primary outcome

Number of Gout Flares Per Participant Assessed From Day 1 to Day 113 (Week 16)
Time frame: Day 1 to Day 113 (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 flares per participant was reported for this outcome measure.

5 secondary outcomes

Number of Modified Gout Flares Per Participant From Day 1 to Day 113 (Week 16)
Time frame: Day 1 to Day 113 (Week 16)
Percentage of Participants With at Least One Flare From Day 1 to Day 113 (Week 16)
Time frame: Day 1 to Day 113 (Week 16)
Percentage of Participants With at Least Two Flares From Day 1 to Day 113 (Week 16)
Time frame: Day 1 to Day 113 (Week 16)
Number of Gout Flare Days Per Participant From Day 1 to Day 113 (Week 16)
Time frame: Day 1 to Day 113 (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 113 (Week 16)
Time frame: Day 1 to Day 113 (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	82	72
Rilonacept 80 mg	82	72
Rilonacept 160 mg	84	78

Primary outcome: Number of Gout Flares Per Participant Assessed From Day 1 to Day 113 (Week 16)

Time frame: Day 1 to Day 113 (Week 16). Mean (Standard Deviation). Unit: Gout flares

Measure	Placebo n = 82	Rilonacept 80 mg n = 82	Rilonacept 160 mg n = 83
Value	1.23 (1.57)	0.35 (0.67)	0.34 (0.86)

Population analysed: Full analysis set (FAS) that included all randomized participants who received any study medication, and was based on the treatment allocated by the Interactive voice response system (IVRS) at randomization (as randomized). Here, number of participants analyzed=participants with available data for this endpoint.

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	4 of 82 (4.9%)	12 of 82 (14.6%)	Not reported
Rilonacept 80 mg	5 of 82 (6.1%)	20 of 82 (24.4%)	Not reported
Rilonacept 160 mg	3 of 84 (3.6%)	20 of 84 (23.8%)	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 23485476Mitha E, Schumacher HR, Fouche L, Luo SF, Weinstein SP, Yancopoulos GD, Wang J, King-Davis S, Evans RR. Rilonacept for gout flare prevention during initiation of uric acid-lowering therapy: results from the PRESURGE-2 international, phase 3, randomized, placebo-controlled trial. Rheumatology (Oxford). 2013 Jul;52(7):1285-92. doi: 10.1093/rheumatology/ket114. Epub 2013 Mar 13.
RilonaceptLink provided by the sponsor.
AllopurinolLink provided by the sponsor.
Allopurinol sodiumLink provided by the sponsor.

Related trials for Gout

RecruitingPhase 3
A Study of Dotinurad Versus Allopurinol in Tophaceous Gout
Tophaceous Gout
RecruitingPhase 3
A Study of Dotinurad Versus Allopurinol in Participants With Gout
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
Recruiting
Pharmacist-Led Treat-to-Target Urate Lowering Therapy in Patients With Gout
Gout, Gouty Arthritis

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

61 sites in 5 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 61 sites in 5 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 61 sites in South Africa, Germany, India, Taiwan, Indonesia. 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 113 (Week 16) (time frame: Day 1 to Day 113 (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 NCT00958438, 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.