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

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1315

Phase

  • 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

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
Intervention / Treatment
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

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

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

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

March 1, 2009

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

February 21, 2009

First Submitted That Met QC Criteria

March 4, 2009

First Posted (Estimate)

March 5, 2009

Study Record Updates

Last Update Posted (Actual)

April 28, 2017

Last Update Submitted That Met QC Criteria

March 20, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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