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

March 20, 2017 updated by: Regeneron Pharmaceuticals

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

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. Rilonacept is being studied for use in preventing gout flares in subjects on urate-lowering therapy.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1315

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • BY
      • Kuenzing, BY, Germany
    • HE
      • Dietzenbach, HE, Germany
    • HH
      • Hamburg, HH, Germany
    • NW
      • Essen, NW, Germany
      • Goch, NW, Germany
      • Siegen, NW, Germany
    • RP
      • Rhaunen, RP, Germany
  • India
    • Andh Prad
      • Secundrabad, Andh Prad, India
    • Delhi
      • New Dehli, Delhi, India
    • Gujarat
      • Ahmedabad, Gujarat, India
      • Gandhinagar, Gujarat, India
    • Karna
      • Bangalore, Karna, India
      • Mangalore, Karna, India
    • Mahara
      • Mumbai, Mahara, India
    • W Bengal
      • Kolkatta, W Bengal, India
  • Indonesia
      • Bandung, Indonesia
      • Daerah Istimewa Yogyakarta, Indonesia
      • Malang, Indonesia
      • South Sumatra, Indonesia
    • Bali
      • Denpasar, Bali, Indonesia
    • South Sulawesi
      • Makassar, South Sulawesi, Indonesia
    • West Sumatra
      • Padang, West Sumatra, Indonesia
  • South Africa
      • Mpumalanga, South Africa
    • E Cape
      • Port Elizabeth, E Cape, South Africa
    • Free State
      • Bloemfontein, Free State, South Africa
    • Gauteng
      • Benoni, Gauteng, South Africa
      • Centurion, Gauteng, South Africa
      • Eldoraigne, Gauteng, South Africa
      • Johannesburg, Gauteng, South Africa
      • Kempton Park, Gauteng, South Africa
      • Krugersdorp, Gauteng, South Africa
      • Lenasia, Gauteng, South Africa
      • Limpopo, Gauteng, South Africa
      • Pretoria, Gauteng, South Africa
      • Rustenburg, Gauteng, South Africa
      • Soweto, Gauteng, South Africa
    • KZ-Natal
      • Dundee, KZ-Natal, South Africa
      • Durban North, KZ-Natal, South Africa
      • Phoenix, KZ-Natal, South Africa
      • Verulam, KZ-Natal, South Africa
    • Mpumalanga
      • Breyten, Mpumalanga, South Africa
      • Durban, Mpumalanga, South Africa
    • W Cape
      • Cape Town, W Cape, South Africa
  • Taiwan
      • Changhua, Taiwan
      • Hualien, Taiwan
      • Tainan, Taiwan
      • Taipei, Taiwan
  • United States
    • Alabama
      • Alabaster, Alabama, United States
    • Arizona
      • Mesa, Arizona, United States
    • California
      • Burbank, California, United States
      • Long Beach, California, United States
      • Los Angeles, California, United States
      • Upland, California, United States
    • Florida
      • Brooksville, Florida, United States
      • Clearwater, Florida, United States
      • Debary, Florida, United States
      • Deland, Florida, United States
      • Jacksonville, Florida, United States
      • Naples, Florida, United States
      • Palm Harbor, Florida, United States
      • St. Petersburg, Florida, United States
      • Tampa, Florida, United States
    • Georgia
      • Atlanta, Georgia, United States
      • Canton, Georgia, United States
      • Decatur, Georgia, United States
      • Sandy Springs, Georgia, United States
      • Stockbridge, Georgia, United States
    • Idaho
      • Boise, Idaho, United States
    • Indiana
      • Brownsburg, Indiana, United States
      • Evansville, Indiana, United States
      • Greenfield, Indiana, United States
    • Kentucky
      • Bowling Green, Kentucky, United States
      • Elizabethtown, Kentucky, United States
      • Lexington, Kentucky, United States
    • Louisiana
      • New Orleans, Louisiana, United States
    • Maryland
      • Baltimore, Maryland, United States
    • Massachusetts
      • Springfield, Massachusetts, United States
      • Worcester, Massachusetts, United States
    • Michigan
      • Bingham Farms, Michigan, United States
    • Minnesota
      • Brooklyn Center, Minnesota, United States
    • Missouri
      • Richmond Heights, Missouri, United States
      • St. Louis, Missouri, United States
    • Montana
      • Billings, Montana, United States
      • Kalispell, Montana, United States
    • Nebraska
      • Lincoln, Nebraska, United States
    • New Jersey
      • Elizabeth, New Jersey, United States
    • New Mexico
      • Albuquerque, New Mexico, United States
    • New York
      • Brooklyn, New York, United States
      • Mineola, New York, United States
      • New York, New York, United States
      • Roslyn, New York, United States
    • North Carolina
      • Durham, North Carolina, United States
      • Hickory, North Carolina, United States
      • Mooresville, North Carolina, United States
      • Morganton, North Carolina, United States
      • Winston-Salem, North Carolina, United States
    • Ohio
      • Cincinnati, Ohio, United States
      • Cleveland, Ohio, United States
      • Middleburg Heights, Ohio, United States
    • Pennsylvania
      • Duncansville, Pennsylvania, United States
      • Morrisville, Pennsylvania, United States
      • Ridley Park, Pennsylvania, United States
      • Willow Grove, Pennsylvania, United States
    • South Carolina
      • Anderson, South Carolina, United States
      • Monck's Corner, South Carolina, United States
      • Orangeburg, South Carolina, United States
    • Tennessee
      • Johnson City, Tennessee, United States
    • Texas
      • Arlington, Texas, United States
      • Carrollton, Texas, United States
      • Corsicana, Texas, United States
      • Dallas, Texas, United States
      • Houston, Texas, United States
      • Lake Jackson, Texas, United States
      • San Antonio, Texas, United States
      • Southlake, Texas, United States
      • Sugarland, Texas, United States
    • Utah
      • Ogden, Utah, United States
      • Salt Lake City, Utah, United States
      • West Jordan, Utah, United States
    • Virginia
      • Norfolk, Virginia, United States
      • Richmond, Virginia, United States
    • Washington
      • Seattle, Washington, United States
    • Wisconsin
      • Oak Creek, Wisconsin, United States
      • Wauwatosa, Wisconsin, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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;;;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
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.
Other: Placebo
Placebo subcutaneous injection once a week
Experimental: Rilonacept 160 mg
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.
Biological: Rilonacept
Rilonacept 160 mg subcutaneous injection once a week

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline up to Week 20

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Gout Flares Per Participant Assessed From Day 1 to Day 112 (Week 16)
Time Frame: 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.
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)
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.
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)
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.
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)
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.
Day 1 to Day 112 (Week 16)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Regeneron Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 21, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 5, 2009

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 28, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 20, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IL1T-GA-0815

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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