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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00856206
First received: February 21, 2009
Last updated: March 20, 2017
Last verified: March 2017
  Purpose
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.

Condition Intervention Phase
Gout Biological: Rilonacept Other: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Regeneron Pharmaceuticals:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.

  • 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.

  • 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.

  • 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.


Enrollment: 1315
Study Start Date: March 2009
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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;;;
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00856206

  Show 124 Study Locations
Sponsors and Collaborators
Regeneron Pharmaceuticals
Investigators
Study Director: Robert Evans, PharmD Regeneron Pharmaceuticals
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00856206     History of Changes
Other Study ID Numbers: IL1T-GA-0815
Study First Received: February 21, 2009
Results First Received: March 20, 2017
Last Updated: March 20, 2017

Keywords provided by Regeneron Pharmaceuticals:
Gout
Intercritical Gout
Metabolism, Inborn Errors
Allopurinol
Metabolic Disease
Genetic Diseases, Inborn
Musculoskeletal Diseases
Joint Diseases
Arthritis
Rheumatic Diseases
Metabolic disorder
Purine Pyrimidine Metabolism, Inborn Errors

Additional relevant MeSH terms:
Gout
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Purine-Pyrimidine Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases

ClinicalTrials.gov processed this record on June 23, 2017