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Acute Gout FlarePhase 3SURGENCT00855920

Study Utilizing Rilonacept in Gout Exacerbations

A Phase 3 study testing Rilonacept and Indomethacin in people with Acute Gout Flare, run by Regeneron Pharmaceuticals at 44 sites in United States.

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

This purpose of this clinical research was to determine the efficacy and safety of an experimental drug called Rilonacept in participants with an acute gout attack. Participants participated in this study for 30 days. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Acute Gout Flare
What is being tested?
Rilonacept and Indomethacin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
225 participants
Where
44 sitesUnited States
Study dates
Mar 2009to Feb 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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female 18 - 70 years of age
  • Previously met the preliminary criteria of ARA for the classification of the acute arthritis of primary gout
  • Presenting with an acute attack (flare) of gout within 48 hours of pain onset and pain of at least moderate severity
  • Must have at least 1 on the 0-3 scale for the swelling and the tenderness assessments of the gouty index joint
  • Current presentation of acute gout flare in 3 joints or less

Who cannot join

  • Treatment with any non-steroidal anti-inflammatory drug (NSAIDs) or opiates within 48 hours prior to baseline assessments. Treatment with long-acting NSAIDs within 1 month prior to baseline visit. Treatment with naproxen, meloxicam, nabumetone, celecoxib and indomethacin SR within 5 days prior to baseline visit.
  • Treatment with oral analgesics within 6 hours before baseline assessments. Treatment with topical analgesics within 12 hours before baseline assessments
  • History of NSAID intolerance
  • Participants with history of chronic, gouty arthritis

Trial locations and contacts

44 sites in 1 country.

44 sites in 1 country

United States44 sites

  • Study site

    Albany, New York

  • Study site

    Albuquerque, New Mexico

  • Study site

    Baltimore, Maryland

  • Study site

    Billings, Montana

  • Study site

    Birmingham, Alabama

  • Study site

    Boise, Idaho

  • Study site

    Bristol, Tennessee

  • Study site

    Burbank, California

  • Study site

    Burlington, North Carolina

  • Study site

    Cary, North Carolina

  • Study site

    Clearwater, Florida

  • Study site

    Dallas, Texas

  • Study site

    DeBary, Florida

  • Study site

    DeLand, Florida

  • Study site

    Detroit, Michigan, 48221

  • Study site

    Elizabethtown, Kentucky

  • Study site

    Forth Worth, Texas

  • Study site

    Greenville, South Carolina

  • Study site

    Houston, Texas

  • Study site

    Huntsville, Alabama

  • Study site

    Irving, Texas

  • Study site

    Johnstown, Pennsylvania

  • Study site

    Jupiter, Florida

  • Study site

    Lake Oswego, Oregon

  • Study site

    Limerick, Pennsylvania

  • Study site

    Mesa, Arizona

  • Study site

    Mesquite, Texas

  • Study site

    Norristown, Pennsylvania

  • Study site

    North Richland Hills, Texas

  • Study site

    Oklahoma City, Oklahoma

  • Study site

    Orange Park, Florida

  • Study site

    Orlando, Florida

  • Study site

    Oviedo, Florida

  • Study site

    Phoenix, Arizona

  • Study site

    Portland, Oregon

  • Study site

    Raleigh, North Carolina, 27612

  • Study site

    Raleigh, North Carolina

  • Study site

    San Antonio, Texas

  • Study site

    Sierra Vista, Arizona

  • Study site

    Stevenville, Michigan

  • Study site

    Wheaton, Maryland

  • Study site

    Whittier, California

  • Study site

    Willoughby Hills, Ohio

  • Study site

    Wilmington, North Carolina

Other trials in United States

About this study

Official title: A Multi-Center, Randomized, Double-Blind, Active-Controlled Study of the Safety and Efficacy of Rilonacept Administered Subcutaneously for the Treatment of an Acute Gout Flare

This purpose of this clinical research was to determine the efficacy and safety of an experimental drug called Rilonacept in participants with an acute gout attack. Participants participated in this study for 30 days. Rilonacept alone was being compared with Indomethacin alone and the combination of Rilonacept plus Indomethacin in treating acute gout flares.

Being tested
Rilonacept, Indomethacin, Placebo (for Indomethacin), Placebo (for Rilonacept)
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, Flare
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.

  • RilonaceptDrug

    Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) on Day 1 (Baseline).

  • IndomethacinDrug

    Indomethacin orally TID for 12 days (Indomethacin 50 mg for first 3 days and then, Indomethacin 25 mg for next 9 days).

  • Placebo (for Indomethacin)Other

    Placebo (for Indomethacin) orally TID for 12 days.

  • Placebo (for Rilonacept)Other

    Two subcutaneous injections of Placebo (for Rilonacept) on Day 1 (Baseline).

Study groups in NCT00855920
Study groupRoleWhat they receive
Placebo (for Rilonacept) and IndomethacinActive comparatorTwo subcutaneous injections of Placebo (for Rilonacept) on Day 1 with Indomethacin orally thrice a day (TID) for 12 days (Indomethacin 50 mg for first 3 days and then, Indomethacin 25 mg for next 9 days).
Receives: Drug: Indomethacin; Other: Placebo (for Rilonacept)
Rilonacept and IndomethacinActive comparatorTwo subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) on Day 1 with Indomethacin orally TID for 12 days (Indomethacin 50 mg for first 3 days and then, Indomethacin 25 mg for next 9 days).
Receives: Drug: Rilonacept; Drug: Indomethacin
Rilonacept and Placebo (for Indomethacin)Active comparatorTwo subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) on Day 1 with Placebo (for Indomethacin) orally TID for 12 days.
Receives: Drug: Rilonacept; Other: Placebo (for Indomethacin)

What is being measured

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

  1. Change From Baseline in Patient's Assessment of Pain Using a 5-Point Likert Scale (PAP-LS) in Index Joint to Averaged PAP-LS at 24, 48 and 72 Hours

    Participants were asked to complete a daily diary entry and assessed their pain in the past 24 hours using 5-point Likert Scale of 0 (None) to 4 (extreme pain), where; 0= none, 1= mild pain, 2= moderate pain, 3= severe pain, or 4= extreme pain. Change in PAP-LS in the index joint from baseline (Day 1) to the averaged PAP-LS values at 24, 48 and 72 hours was reported in this outcome measure (averaged PAP value= [PAP at 24 hours + PAP at 48 hours + PAP at 72 hours]/3).

    Measured: Pre-dose on Day 1 (Baseline); post-dose at 4, 8, 12, 24, 48, 72 hours and then daily up to Day 13 or until gout flare ends

Secondary outcomes (3)

  1. Change From Baseline in Patient's Assessment of Pain Using a 5-Point Likert Scale (PAP-LS) in Index Joint at 72 Hours

    Participants were asked to complete a daily diary entry and assessed their pain in the past 24 hours using 5-point Likert Scale of 0 (None) to 4 (extreme pain), where; 0= none, 1= mild pain, 2= moderate pain, 3= severe pain, or 4= extreme pain.

    Measured: Baseline (Day 1) to 72 hours

  2. Change From Baseline in Patient's Assessment of Pain Using a 5-Point Likert Scale (PAP-LS) in Index Joint at 48 Hours

    Participants were asked to complete a daily diary entry and assessed their pain in the past 24 hours using 5-point Likert Scale of 0 (None) to 4 (extreme pain), where; 0= none, 1= mild pain, 2= moderate pain, 3= severe pain, or 4= extreme pain.

    Measured: Baseline (Day 1) to 48 hours

  3. Change From Baseline in Patient's Assessment of Pain Using a 5-Point Likert Scale (PAP-LS) in Index Joint at 24 Hours

    Participants were asked to complete a daily diary entry and assessed their pain in the past 24 hours using 5-point Likert Scale of 0 (None) to 4 (extreme pain), where; 0= none, 1= mild pain, 2= moderate pain, 3= severe pain, or 4= extreme pain.

    Measured: Baseline (Day 1) to 24 hours

Timeline

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

  1. First posted5 Mar 2009 (estimated)
  2. Study startMar 2009
  3. Primary completionFeb 2010
  4. Study completionFeb 2010

Resources

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
225 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00855920
Sponsor's protocol ID
IL1T-GA-0814
Acronym
SURGE
Status last verified
Mar 2017
First submitted
13 Feb 2009
Last updated
28 Apr 2017
Data monitoring committee
Yes

Publications

  • Terkeltaub RA, Schumacher HR, Carter JD, Baraf HS, Evans RR, Wang J, King-Davis S, Weinstein SP. Rilonacept in the treatment of acute gouty arthritis: a randomized, controlled clinical trial using indomethacin as the active comparator. Arthritis Res Ther. 2013 Feb 1;15(1):R25. doi: 10.1186/ar4159.

    PubMed 23375025

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rilonacept and Indomethacin in people with Acute Gout Flare, run by Regeneron Pharmaceuticals at 44 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 5 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 44 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 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?

Change From Baseline in Patient's Assessment of Pain Using a 5-Point Likert Scale (PAP-LS) in Index Joint to Averaged PAP-LS at 24, 48 and 72 Hours (time frame: Pre-dose on Day 1 (Baseline); post-dose at 4, 8, 12, 24, 48, 72 hours and then daily up to Day 13 or until gout flare ends). 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 NCT00855920, 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.

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