GoutPhase 3UPSURGENCT01459796
Study of the Safety and Efficacy of Long-Term Rilonacept Treatment for the Prevention of Gout Flares
A Phase 3 study testing Rilonacept and Allopurinol in people with Gout, run by Regeneron Pharmaceuticals at 74 sites in United States.
Trial summary
The purpose of this study was to determine the safety and tolerability of rilonacept for participants with gout who were initiating allopurinol. 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 and Allopurinol
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 220 participants
- Where
- 74 sitesUnited States
- Study dates
- Nov 2011to Jun 2013
- 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 participants aged 18 to 80 years;
- Previously met the preliminary criteria of the ARA for the classification of the acute arthritis of primary gout;
- Serum uric acid greater than or equal to 7.5 mg/dL at the screening visit;
- A self-reported history of at least 2 gout flares in the year prior to screening.
Who cannot join
- Pregnant or nursing, or planning to become pregnant or father a child within 3 months after receiving the last dose of study drug;
- Participants requiring dialysis;
- Participants who had had an organ transplant;
- Persistent chronic or active infections;
- Previous exposure to rilonacept;
- Use of allopurinol, benzbromarone, febuxostat, probenecid or sulfinpyrazone within 84 days prior to the screening visit.
Trial locations and contacts
74 sites in 1 country.
74 sites in 1 country
United States74 sites
Study site
Akron, Ohio
Study site
Anderson, South Carolina
Study site
Arlington, Virginia
Study site
Atlanta, Georgia
Study site
Avon, Indiana
Study site
Birmingham, Alabama
Study site
Boise, Idaho
Study site
Bowling Green, Kentucky
Study site
Brooklyn, New York
Study site
Brownsburg, Indiana
Study site
Carlisle, Ohio
Study site
Cary, North Carolina
Study site
Charleston, South Carolina
Study site
Charlotte, North Carolina
Study site
Clearwater, Florida
Study site
Coeur d'Alene, Idaho
Study site
Columbia, South Carolina
Study site
Concord, California
Study site
Cumberland, Maryland
Study site
Dallas, Texas
Study site
DeLand, Florida
Study site
Delray Beach, Florida
Study site
Denver, Colorado
Study site
Edina, Minnesota
Study site
Elizabethtown, Kentucky
Study site
Evansville, Indiana
Study site
Fall River, Massachusetts
Study site
Fort Worth, Texas
Study site
Greensboro, North Carolina
Study site
Greenville, North Carolina
Study site
Greenville, South Carolina
Study site
Hagerstown, Maryland
Study site
Houston, Texas
Study site
Huntingdon Valley, Pennsylvania
Study site
Johnstown, Pennsylvania
Study site
Kalispell, Montana
Study site
La Jolla, California
Study site
Lake Jackson, Texas
Study site
Long Beach, California
Study site
Meridian, Idaho
Study site
Mesa, Arizona
Study site
New Orleans, Louisiana
Study site
New Port Richey, Florida
Study site
North Richland Hills, Texas
Study site
Ocala, Florida
Study site
Omaha, Nebraska
Study site
Orlando, Florida
Study site
Owensboro, Kentucky
Study site
Phoenix, Arizona
Study site
Pittsburgh, Pennsylvania
Study site
Portland, Oregon
Study site
Raleigh, North Carolina
Study site
Reading, Pennsylvania
Study site
Rock Hill, South Carolina
Study site
Salisbury, North Carolina
Study site
Salt Lake City, Utah
Study site
San Antonio, Texas
Study site
Scottsdale, Arizona
Study site
Searcy, Arkansas
Study site
Sierra Vista, Arizona
Study site
Simpsonville, South Carolina
Study site
Spokane, Washington
Study site
St Louis, Missouri
Study site
St. Petersburg, Florida
Study site
Statesville, North Carolina
Study site
Sugar Land, Texas
Study site
Tampa, Florida
Study site
Trumbull, Connecticut
Study site
Tucson, Arizona
Study site
Venice, Florida
Study site
Washington D.C., District of Columbia
Study site
Wheaton, Maryland
Study site
Whittier, California
Study site
Winston-Salem, North Carolina
About this study
Official title: A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Long-Term Rilonacept Treatment for the Prevention of Gout Flares
The purpose of this study was to determine the safety and tolerability of rilonacept for participants with gout who were initiating allopurinol.
- Conditions
- Gout
- Being tested
- Rilonacept, Placebo, Allopurinol
- Medical subject headings
- Gout
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RilonaceptDrug
Rilonacept 160 mg loading dose followed by Rilonacept 80 mg/2 mL injections qw for 52 weeks.
PlaceboDrug
Placebo loading dose followed by placebo injections (2 mL) qw for 52 weeks.
AllopurinolDrug
Allopurinol 50 or 100 mg, orally daily for 52 weeks as background treatment.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Experimental | Two subcutaneous injections of Placebo (for Rilonacept) as a loading dose on Day 1 followed by a single injection once a week (qw) from Week 1 to Week 51. Receives: Drug: Placebo; Drug: Allopurinol |
| 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 51. Receives: Drug: Rilonacept; Drug: Allopurinol |
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. TEAEs were defined as AEs that developed or worsened or became serious during on-treatment period (time from the administration of first dose of study drug up to and including 35 days after the last dose of study drug). A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs.
Measured: Day 1 to Day 392 (Week 56)
Secondary outcomes (5)
Percentage of Participants With at Least One Gout Flare From Day 1 to Day 168 (Week 24)
Gout flare was defined as acute articular pain typical of a gout attack that required treatment with an anti-inflammatory therapeutic: had at least 3 of the following 4 signs or symptoms: joint swelling, tenderness, redness, and pain; and with at least 1 of the following: rapid onset of pain, decreased range of motion, joint warmth or other symptoms similar to a prior gout flare. Percentage of participants with at least one gout flare at Week 24 was to be reported for this outcome measure.
Measured: Day 1 to Day 168 (Week 24)
Percentage of Participants With at Least Two Gout Flares From Day 1 to Day 168 (Week 24)
Gout flare was defined as acute articular pain typical of a gout attack that required treatment with an anti-inflammatory therapeutic: had at least 3 of the following 4 signs or symptoms: joint swelling, tenderness, redness, and pain, and with at least 1 of the following: rapid onset of pain, decreased range of motion, joint warmth or other symptoms similar to a prior gout flare. Percentage of participants with at least two gout flares at Week 24 was to be reported for this outcome measure.
Measured: Day 1 to Day 168 (Week 24)
Percentage of Participants With at Least One Gout Flare From Day 1 to Day 364 (Week 52)
Gout flare was defined as acute articular pain typical of a gout attack that required treatment with an anti-inflammatory therapeutic: had at least 3 of the following 4 signs or symptoms: joint swelling, tenderness, redness, and pain; and with at least 1 of the following: rapid onset of pain, decreased range of motion, joint warmth or other symptoms similar to a prior gout flare. Percentage of participants with at least one gout flare at Week 52 was to be reported for this outcome measure.
Measured: Day 1 to Day 364 (Week 52)
Percentage of Participants With at Least Two Gout Flares From Day 1 to Day 364 (Week 52)
Gout flare was defined as acute articular pain typical of a gout attack that required treatment with an anti-inflammatory therapeutic: had at least 3 of the following 4 signs or symptoms: joint swelling, tenderness, redness, and pain, and with at least 1 of the following: rapid onset of pain, decreased range of motion, joint warmth or other symptoms similar to a prior gout flare. Percentage of participants with at least two gout flares at Week 52 was to be reported for this outcome measure.
Measured: Day 1 to Day 364 (Week 52)
Percentage of Participants With Rescue Medication From Day 1 to Day 364 (Week 52)
Participants who required rescue medication after having 2 or more gout flares during the treatment period were evaluated.
Measured: Day 1 to Day 364 (Week 52)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2011 (estimated)
- Study startNov 2011
- Primary completionJun 2013
- Study completionJun 2013
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.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Management, Study director, Regeneron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01459796
- Sponsor's protocol ID
- IL1T-GA-1101
- Acronym
- UPSURGE
- Status last verified
- Jun 2017
- First submitted
- 12 Oct 2011
- Last updated
- 18 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 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 Safety and Efficacy of Long-Term Rilonacept Treatment for the Prevention of Gout Flares
- ClinicalTrials.gov ID
- NCT01459796
- Acronym / sponsor ID
- UPSURGE / IL1T-GA-1101
- Conditions
- Gout
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 26 Oct 2011 (estimated)
- Results
- Posted 18 Jul 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to determine the safety and tolerability of rilonacept for participants with gout who were initiating allopurinol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Experimental | Drug: Placebo, Drug: AllopurinolTwo subcutaneous injections of Placebo (for Rilonacept) as a loading dose on Day 1 followed by a single injection once a week (qw) from Week 1 to Week 51. |
| Rilonacept 80 mg | Experimental | Drug: Rilonacept, Drug: AllopurinolTwo subcutaneous injections of Rilonacept 80 mg (for a total of 160 mg) as a loading dose on Day 1, followed by a single 80 mg injection of Rilonacept qw from Week 1 to Week 51. |
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 participants aged 18 to 80 years;
- Previously met the preliminary criteria of the ARA for the classification of the acute arthritis of primary gout;
- Serum uric acid greater than or equal to 7.5 mg/dL at the screening visit;
- A self-reported history of at least 2 gout flares in the year prior to screening.
Key exclusion criteria (6 listed)
- Pregnant or nursing, or planning to become pregnant or father a child within 3 months after receiving the last dose of study drug;
- Participants requiring dialysis;
- Participants who had had an organ transplant;
- Persistent chronic or active infections;
- Previous exposure to rilonacept;
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 loading dose followed by Rilonacept 80 mg/2 mL injections qw for 52 weeks. | Drug | Rilonacept 80 mg |
| PlaceboPlacebo loading dose followed by placebo injections (2 mL) qw for 52 weeks. | Drug | Placebo |
| AllopurinolAllopurinol 50 or 100 mg, orally daily for 52 weeks as background treatment. | Drug | Placebo, Rilonacept 80 mg |
Primary outcome
Percentage of Participants With Treatment Emergent Adverse Events (TEAEs)
Time frame: Day 1 to Day 392 (Week 56)
Any untoward medical occurrence in a participant who received investigational medicinal product (IMP) was considered an AE without regard to possibility of causal relationship with this treatment. TEAEs were defined as AEs that developed or worsened or became serious during on-treatment period (time from the administration of first dose of study drug up to and including 35 days after the last dose of study drug). A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs.
5 secondary outcomes
Percentage of Participants With at Least One Gout Flare From Day 1 to Day 168 (Week 24)
Time frame: Day 1 to Day 168 (Week 24)
Percentage of Participants With at Least Two Gout Flares From Day 1 to Day 168 (Week 24)
Time frame: Day 1 to Day 168 (Week 24)
Percentage of Participants With at Least One Gout Flare From Day 1 to Day 364 (Week 52)
Time frame: Day 1 to Day 364 (Week 52)
Percentage of Participants With at Least Two Gout Flares From Day 1 to Day 364 (Week 52)
Time frame: Day 1 to Day 364 (Week 52)
Percentage of Participants With Rescue Medication From Day 1 to Day 364 (Week 52)
Time frame: Day 1 to Day 364 (Week 52)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Clinical Trial Management study director
Regeneron Pharmaceuticals
74 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rilonacept and Allopurinol in people with Gout, run by Regeneron Pharmaceuticals at 74 sites in United States.
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: stopped early, as of the sponsor's last update on 18 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 74 sites in United States. 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. 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 18 Jul 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: Day 1 to Day 392 (Week 56)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jul 2017.