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PREventative Study Against URate-Lowering Drug-Induced Gout Exacerbations (PRE-SURGE 2)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00958438
First Posted: August 13, 2009
Last Update Posted: April 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
  Purpose
The purpose of this clinical research study was to determine the safety and effectiveness of an experimental drug called rilonacept in participants with gout who are beginning allopurinol treatment for gout. Participants will participate in this study for approximately 22 weeks. Rilonacept was being studied for use in preventing allopurinol-induced gout flares.

Condition Intervention Phase
Gout Drug: Placebo Drug: Rilonacept Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multi-Center, Randomized, Double-Blind, Placebo Controlled Study of the Efficacy and Safety of Rilonacept for the Prophylaxis of Gout Flares During the Initiation of Allopurinol Therapy

Resource links provided by NLM:


Further study details as provided by Regeneron Pharmaceuticals:

Primary Outcome Measures:
  • Number of Gout Flares Per Participant Assessed From Day 1 to Day 113 (Week 16) [ Time Frame: Day 1 to Day 113 (Week 16) ]
    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. Number of gout flares per participant was reported for this outcome measure.


Secondary Outcome Measures:
  • Number of Modified Gout Flares Per Participant From Day 1 to Day 113 (Week 16) [ Time Frame: Day 1 to Day 113 (Week 16) ]
    Modified gout flare was defined using modified definition of a gout flare as participant-reported articular pain typical of a gout attack that was deemed to require treatment with anti-inflammatory therapy. Number of modified gout flares per participant were reported for this outcome measure.

  • Percentage of Participants With at Least One Flare From Day 1 to Day 113 (Week 16) [ Time Frame: Day 1 to Day 113 (Week 16) ]
    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.

  • Percentage of Participants With at Least Two Flares From Day 1 to Day 113 (Week 16) [ Time Frame: Day 1 to Day 113 (Week 16) ]
    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 two gout flares was reported for this outcome measure.

  • Number of Gout Flare Days Per Participant From Day 1 to Day 113 (Week 16) [ Time Frame: Day 1 to Day 113 (Week 16) ]
    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. Number of gout flare days per participant was reported for this outcome measure.

  • Number of Gout Flare Days With Participant's Pain Score of 5 or More (From Daily Diary) Per Participant From Day 1 to Day 113 (Week 16) [ Time Frame: Day 1 to Day 113 (Week 16) ]
    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.


Enrollment: 248
Study Start Date: July 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (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.
Drug: Placebo
Placebo loading dose followed by placebo subcutaneous (SC) injection (2 mL) once a week for 16 weeks.
Experimental: Rilonacept 80 mg
Two subcutaneous injections of Rilonacept 80 mg (for a total of 160 mg) as a loading dose on Day 1, followed by a single 80 mg injection of Rilonacept qw from Week 1 to Week 15.
Drug: Rilonacept
Rilonacept 160 mg SC loading dose followed by Rilonacept 80 mg/2 mL SC injections once a week for 16 weeks.
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.
Drug: Rilonacept
Rilonacept 320 mg SC loading dose followed by Rilonacept 160 mg/2 mL SC injections once a week for 16 weeks.

  Eligibility

Information from the National Library of Medicine

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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 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;
  • Serum uric acid greater than or equal to 7.5 mg/dL at the screening visit.

Exclusion Criteria:

  • Acute gout flare within 2 weeks of the screening visit or 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;
  • Previous exposure to Rilonacept;
  • Use of allopurinol, benzbromarone, febuxostat, probenecid or sulfinpyrazone within 3 months prior to the screening visit.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00958438


  Show 61 Study Locations
Sponsors and Collaborators
Regeneron Pharmaceuticals
Investigators
Study Director: Robert Evans, PharmD Regeneron Pharmaceuticals
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00958438     History of Changes
Other Study ID Numbers: IL1T-GA-0816
2008-007762-39 ( EudraCT Number )
First Submitted: August 11, 2009
First Posted: August 13, 2009
Results First Submitted: March 20, 2017
Results First Posted: April 28, 2017
Last Update Posted: April 28, 2017
Last Verified: March 2017

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

Additional relevant MeSH terms:
Genetic Diseases, Inborn
Gout
Arthritis
Joint Diseases
Musculoskeletal Diseases
Crystal Arthropathies
Rheumatic Diseases
Purine-Pyrimidine Metabolism, Inborn Errors
Metabolism, Inborn Errors
Metabolic Diseases
Allopurinol
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Gout Suppressants
Antirheumatic Agents
Free Radical Scavengers
Antioxidants
Protective Agents
Physiological Effects of Drugs