GoutPhase 2NCT00610363
Study of the Safety and Effectiveness of Rilonacept for the Prevention of Gout Flares
A Phase 2 study testing Rilonacept in people with Gout, run by Regeneron Pharmaceuticals at 34 sites in United States.
Trial summary
This was a clinical research study to determine the safety and effectiveness of an experimental drug called rilonacept in participants with gout who were beginning another additional treatment. Participants participated in this study for approximately 24 weeks. Read more about this study
- Who is it for?
- Ages 18 years and older
- 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
- 83 participants
- Where
- 34 sitesUnited States
- Study dates
- Nov 2007to Oct 2008
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female greater than 18 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.
Who cannot join
- Acute gout flare within 2 weeks of the screening visit and 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.
Trial locations and contacts
34 sites in 1 country.
34 sites in 1 country
United States34 sites
Study site
Albany, New York, 12206
Study site
Billings, Montana, 59101
Study site
Boise, Idaho, 83702
Study site
Charleston, South Carolina, 29406
Study site
Cincinnati, Ohio, 45242
Study site
Colorado Srings, Colorado, 80910
Study site
Dallas, Texas, 75235
Study site
DeLand, Florida, 32720
Study site
Duncansville, Pennsylvania, 16635
Study site
Dunwoody, Georgia, 30338
Study site
Grenville, South Carolina, 29601
Study site
Honolulu, Hawaii, 96814
Study site
Indianapolis, Indiana, 46268
Study site
Mayfield Village, Ohio, 44143
Study site
Monroe, North Carolina, 28112
Study site
Ocala, Florida, 34471
Study site
Oklahoma City, Oklahoma, 73112
Study site
Omaha, Nebraska, 68114
Study site
Orlando, Florida, 32804
Study site
Owensboro, Kentucky, 42303
Study site
Plainview, New York, 11803
Study site
Raleigh, North Carolina, 27612
Study site
Reno, Nevada, 89502
Study site
Roslyn, New York, 11576
Study site
San Diego, California, 92108
Study site
Santa Maria, California, 93454
Study site
South Bend, Indiana, 46601
Study site
Spokane, Washington, 99204
Study site
St. Petersburg, Florida, 33710
Study site
Tampa, Florida, 33614
Study site
Tampa, Florida
Study site
West Reading, Pennsylvania, 19611
Study site
Wheaton, Maryland, 20902
Study site
Whittier, California, 90601
About this study
Official title: A Multi-Center, Randomized, Double-Blind, Placebo Controlled Study, Tolerability, and Efficacy of Rilonacept for the Prevention of Gout Flares During Initiation of Allopurinol Therapy
This was a clinical research study to determine the safety and effectiveness of an experimental drug called rilonacept in participants with gout who were beginning another additional treatment. Participants participated in this study for approximately 24 weeks. Rilonacept was being studied for use in preventing gout attacks in participants who had gout.
- Conditions
- Gout
- Being tested
- Rilonacept, Placebo (for Rilonacept)
- Medical subject headings
- Gout
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RilonaceptBiological
Rilonacept 320 mg loading dose on Day 1 followed by Rilonacept 160 mg/2 mL injections qw for 17 weeks.
Placebo (for Rilonacept)Other
Placebo loading dose on Day 1 followed by single placebo injections (2 mL) qw for 17 weeks.
| 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 16. Receives: Other: Placebo (for 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 16. Receives: Biological: 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 84 (Week 12)
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 84 were counted, regardless whether the flares occurred during the treatment period or not.
Measured: Day 1 (Baseline) to Day 84 (Week 12)
Secondary outcomes (6)
Percentage of Participants With at Least One Gout Flare From Day 1 to Day 84 (Week 12)
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 (Baseline) to Day 84 (Week 12)
Mean Number of Gout Flares Per Month Per Participant From Day 1 to Day 84 (Week 12)
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. Mean number of flares per month = (total number of flares observed)/ (total number of days subject was in the period/28 days).
Measured: Day 1 (Baseline) to Day 84 (Week 12)
Mean Number of Gout Flare Days Per Participant From Day 1 to Day 84 (Week 12)
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. Mean number of gout flare days per participant was reported for this outcome measure.
Measured: Day 1 (Baseline) to Day 84 (Week 12)
Mean Number of Gout Flare Days Per Month Per Participant From Day 1 to Day 84 (Week 12)
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. Mean number of gout flare days per month per participant was reported for this outcome measure.
Measured: Day 1 (Baseline) to Day 84 (Week 12)
Number of Gout Flare Days With Participant's Pain Score of 5 or More (From Daily Diary) Per Participant From Day 1 to Day 84 (Week 12)
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 154) 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 154), 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 (Baseline) to Day 84 (Week 12)
Number of Gout Flare Days With Participant's Pain Score of 5 or More (From Daily Diary) Per Month Per Participant From Day 1 to Day 84 (Week 12)
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 (Baseline) to Day 84 (Week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2008 (estimated)
- Study startNov 2007
- Primary completionOct 2008
- Study completionOct 2008
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 (2)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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shirletta King-Davis, Study director, Regeneron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00610363
- Sponsor's protocol ID
- IL1T-GA-0619
- Status last verified
- Mar 2017
- First submitted
- 24 Jan 2008
- Last updated
- 2 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Schumacher HR Jr, Sundy JS, Terkeltaub R, Knapp HR, Mellis SJ, Stahl N, Yancopoulos GD, Soo Y, King-Davis S, Weinstein SP, Radin AR; 0619 Study Group. Rilonacept (interleukin-1 trap) in the prevention of acute gout flares during initiation of urate-lowering therapy: results of a phase II randomized, double-blind, placebo-controlled trial. Arthritis Rheum. 2012 Mar;64(3):876-84. doi: 10.1002/art.33412.
PubMed 22223180Khanna D, Sarkin AJ, Khanna PP, Shieh MM, Kavanaugh AF, Terkeltaub RA, Lee SJ, Singh JA, Hirsch JD. Minimally important differences of the gout impact scale in a randomized controlled trial. Rheumatology (Oxford). 2011 Jul;50(7):1331-6. doi: 10.1093/rheumatology/ker023. Epub 2011 Mar 3.
PubMed 21372003
Study at a glance
From the registry record, last updated by the sponsor on 2 May 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, Tolerability, and Efficacy of Rilonacept for the Prevention of Gout Flares During Initiation of Allopurinol Therapy
- ClinicalTrials.gov ID
- NCT00610363
- Acronym / sponsor ID
- IL1T-GA-0619
- Conditions
- Gout
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 7 Feb 2008 (estimated)
- Results
- Posted 2 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This was a clinical research study to determine the safety and effectiveness of an experimental drug called rilonacept in participants with gout who were beginning another additional treatment. Participants participated in this study for approximately 24 weeks. Rilonacept was being studied for use in preventing gout attacks in participants who had gout.
Study design
- Primary purpose
- Treatment
- 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: Placebo (for Rilonacept)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 16. |
| 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 16. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female greater than 18 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.
Key exclusion criteria (4 listed)
- Acute gout flare within 2 weeks of the screening visit and 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.
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 320 mg loading dose on Day 1 followed by Rilonacept 160 mg/2 mL injections qw for 17 weeks. | Biological | Rilonacept 160 mg |
| Placebo (for Rilonacept)Placebo loading dose on Day 1 followed by single placebo injections (2 mL) qw for 17 weeks. | Other | Placebo |
Primary outcome
Number of Gout Flares Per Participant Assessed From Day 1 to Day 84 (Week 12)
Time frame: Day 1 (Baseline) to Day 84 (Week 12)
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 84 were counted, regardless whether the flares occurred during the treatment period or not.
6 secondary outcomes
Percentage of Participants With at Least One Gout Flare From Day 1 to Day 84 (Week 12)
Time frame: Day 1 (Baseline) to Day 84 (Week 12)
Mean Number of Gout Flares Per Month Per Participant From Day 1 to Day 84 (Week 12)
Time frame: Day 1 (Baseline) to Day 84 (Week 12)
Mean Number of Gout Flare Days Per Participant From Day 1 to Day 84 (Week 12)
Time frame: Day 1 (Baseline) to Day 84 (Week 12)
Mean Number of Gout Flare Days Per Month Per Participant From Day 1 to Day 84 (Week 12)
Time frame: Day 1 (Baseline) to Day 84 (Week 12)
Number of Gout Flare Days With Participant's Pain Score of 5 or More (From Daily Diary) Per Participant From Day 1 to Day 84 (Week 12)
Time frame: Day 1 (Baseline) to Day 84 (Week 12)
Number of Gout Flare Days With Participant's Pain Score of 5 or More (From Daily Diary) Per Month Per Participant From Day 1 to Day 84 (Week 12)
Time frame: Day 1 (Baseline) to Day 84 (Week 12)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22223180Schumacher HR Jr, Sundy JS, Terkeltaub R, Knapp HR, Mellis SJ, Stahl N, Yancopoulos GD, Soo Y, King-Davis S, Weinstein SP, Radin AR; 0619 Study Group. Rilonacept (interleukin-1 trap) in the prevention of acute gout flares during initiation of urate-lowering therapy: results of a phase II randomized, double-blind, placebo-controlled trial. Arthritis Rheum. 2012 Mar;64(3):876-84. doi: 10.1002/art.33412.
- Derived from this study: PubMed 21372003Khanna D, Sarkin AJ, Khanna PP, Shieh MM, Kavanaugh AF, Terkeltaub RA, Lee SJ, Singh JA, Hirsch JD. Minimally important differences of the gout impact scale in a randomized controlled trial. Rheumatology (Oxford). 2011 Jul;50(7):1331-6. doi: 10.1093/rheumatology/ker023. Epub 2011 Mar 3.
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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.
Shirletta King-Davis study director
Regeneron Pharmaceuticals
34 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rilonacept in people with Gout, run by Regeneron Pharmaceuticals at 34 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 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 2 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 2 May 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 84 (Week 12) (time frame: Day 1 (Baseline) to Day 84 (Week 12)). 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 NCT00610363, which also lists 2 linked publications.
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 2 May 2017.