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PREventative Study Against URate-lowering Drug-induced Gout Exacerbations 1 (PRE-SURGE1)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00829829
First Posted: January 27, 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
January 23, 2009
January 27, 2009
March 20, 2017
April 28, 2017
April 28, 2017
February 2009
May 2010   (Final data collection date for primary outcome measure)
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.
number of flares during the treatment period [ Time Frame: 16 Weeks ]
Complete list of historical versions of study NCT00829829 on ClinicalTrials.gov Archive Site
  • Number of Modified Gout Flares Per Participant From Day 1 to Day 112 (Week 16) [ Time Frame: Day 1 to Day 112 (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 Gout Flare From Day 1 to Day 112 (Week 16) [ Time Frame: Day 1 to Day 112 (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 Gout Flares From Day 1 to Day 112 (Week 16) [ Time Frame: Day 1 to Day 112 (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 112 (Week 16) [ Time Frame: Day 1 to Day 112 (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 112 (Week 16) [ Time Frame: Day 1 to Day 112 (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.
  • number of modified gout flares per subject from Day 1 to Week 16 (a gout flare for this analysis will be defined as subject reported articular pain typical of a gout attack that is deemed to require treatment with an anti-inflammatory agent) [ Time Frame: 16 Weeks ]
  • proportion of subjects with at least one flare from Day 1 to Week 16 [ Time Frame: 16 Weeks ]
  • proportion of subjects with at least two flares from Day 1 to Week 16 [ Time Frame: 16 Weeks ]
  • mean number of gout flare days per subject assessed from Day 1 to Week 16 [ Time Frame: 16 Weeks ]
  • mean number of days with the subject's pain score of 5 or more (daily diary) per subject from Day 1 to Week 16 [ Time Frame: 16 Weeks ]
Not Provided
Not Provided
 
PREventative Study Against URate-lowering Drug-induced Gout Exacerbations 1
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
The purpose of this clinical research study was to determine the safety and effectiveness of an experimental drug called rilonacept in subjects with gout who are beginning allopurinol treatment for gout. Subjects will participate in this study for approximately 22 weeks. Rilonacept is being studied for use in preventing allopurinol-induced gout flares.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Intercritical Gout
  • Other: Placebo
    Placebo loading dose followed by placebo injections (2 mL) qw for 16 weeks.
  • Drug: Rilonacept 80 mg
    Rilonacept 160 mg loading dose followed by Rilonacept 80 mg/2 mL injections qw for 16 weeks.
  • Drug: Rilonacept 160 mg
    Rilonacept 320 mg loading dose followed by Rilonacept 160 mg/2 mL injections qw for 16 weeks.
  • 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.
    Intervention: Other: Placebo
  • Active Comparator: 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.
    Intervention: Drug: Rilonacept 80 mg
  • Active Comparator: 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.
    Intervention: Drug: Rilonacept 160 mg
Schumacher HR Jr, Evans RR, Saag KG, Clower J, Jennings W, Weinstein SP, Yancopoulos GD, Wang J, Terkeltaub R. Rilonacept (interleukin-1 trap) for prevention of gout flares during initiation of uric acid-lowering therapy: results from a phase III randomized, double-blind, placebo-controlled, confirmatory efficacy study. Arthritis Care Res (Hoboken). 2012 Oct;64(10):1462-70. doi: 10.1002/acr.21690.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
241
June 2010
May 2010   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   United States
 
 
NCT00829829
IL1T-GA-0810
Not Provided
Not Provided
Not Provided
Regeneron Pharmaceuticals
Regeneron Pharmaceuticals
Not Provided
Not Provided
Regeneron Pharmaceuticals
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP