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

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.
ClinicalTrials.gov Identifier: NCT00958438
Recruitment Status : Completed
First Posted : August 13, 2009
Results First Posted : April 28, 2017
Last Update Posted : April 28, 2017
Sponsor:
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Gout
Interventions Drug: Placebo
Drug: Rilonacept
Enrollment 248
Recruitment Details The study was conducted at 57 study sites in European Union (EU) and rest of world (ROW) between 7 March 2009 and 17 December 2010. A total of 471 participants were screened in the study.
Pre-assignment Details Out of 471 participants, 248 were randomized and treated in the study. Participants were randomized in 1:1:1 ratio to receive Placebo or Rilonacept 80 mg or Rilonacept 160 mg.
Arm/Group Title Placebo Rilonacept 80 mg Rilonacept 160 mg
Hide Arm/Group Description 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. 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. 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.
Period Title: Overall Study
Started 82 82 84
Completed 72 72 78
Not Completed 10 10 6
Reason Not Completed
Protocol Violation             3             2             2
Withdrawal by Subject             4             2             1
Adverse Event             0             3             0
Physician Decision             1             0             1
Other than specified above             2             3             2
Arm/Group Title Placebo Rilonacept 80 mg Rilonacept 160 mg Total
Hide Arm/Group Description 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. 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. 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. Total of all reporting groups
Overall Number of Baseline Participants 82 82 84 248
Hide Baseline Analysis Population Description
Baseline population included all randomized participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 82 participants 82 participants 84 participants 248 participants
51.7  (12.87) 52.6  (11.47) 49  (11.77) 51.1  (12.10)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 82 participants 82 participants 84 participants 248 participants
Female
5
   6.1%
5
   6.1%
7
   8.3%
17
   6.9%
Male
77
  93.9%
77
  93.9%
77
  91.7%
231
  93.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 82 participants 82 participants 84 participants 248 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
82
 100.0%
82
 100.0%
84
 100.0%
248
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 82 participants 82 participants 84 participants 248 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
29
  35.4%
23
  28.0%
30
  35.7%
82
  33.1%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
10
  12.2%
14
  17.1%
10
  11.9%
34
  13.7%
White
43
  52.4%
45
  54.9%
44
  52.4%
132
  53.2%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Number of Gout Flares Per Participant Assessed From Day 1 to Day 113 (Week 16)
Hide Description 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.
Time Frame Day 1 to Day 113 (Week 16)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) that included all randomized participants who received any study medication, and was based on the treatment allocated by the Interactive voice response system (IVRS) at randomization (as randomized). Here, number of participants analyzed=participants with available data for this endpoint.
Arm/Group Title Placebo Rilonacept 80 mg Rilonacept 160 mg
Hide Arm/Group Description:
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.
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.
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.
Overall Number of Participants Analyzed 82 82 83
Mean (Standard Deviation)
Unit of Measure: Gout flares
1.23  (1.57) 0.35  (0.67) 0.34  (0.86)
2.Secondary Outcome
Title Number of Modified Gout Flares Per Participant From Day 1 to Day 113 (Week 16)
Hide Description 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.
Time Frame Day 1 to Day 113 (Week 16)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS that included all randomized participants who received any study medication, and was based on the treatment allocated by the IVRS at randomization (as randomized). Here, number of participants analyzed=participants with available data for this endpoint.
Arm/Group Title Placebo Rilonacept 80 mg Rilonacept 160 mg
Hide Arm/Group Description:
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.
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.
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.
Overall Number of Participants Analyzed 82 82 83
Mean (Standard Deviation)
Unit of Measure: Gout flares
1.51  (1.87) 0.62  (1.32) 0.48  (0.99)
3.Secondary Outcome
Title Percentage of Participants With at Least One Flare From Day 1 to Day 113 (Week 16)
Hide Description 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.
Time Frame Day 1 to Day 113 (Week 16)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS that included all randomized participants who received any study medication, and was based on the treatment allocated by the IVRS at randomization (as randomized).
Arm/Group Title Placebo Rilonacept 80 mg Rilonacept 160 mg
Hide Arm/Group Description:
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.
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.
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.
Overall Number of Participants Analyzed 82 82 84
Measure Type: Number
Unit of Measure: percentage of participants
56.1 25.6 20.5
4.Secondary Outcome
Title Percentage of Participants With at Least Two Flares From Day 1 to Day 113 (Week 16)
Hide Description 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.
Time Frame Day 1 to Day 113 (Week 16)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS that included all randomized participants who received any study medication, and was based on the treatment allocated by the IVRS at randomization (as randomized).
Arm/Group Title Placebo Rilonacept 80 mg Rilonacept 160 mg
Hide Arm/Group Description:
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.
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.
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.
Overall Number of Participants Analyzed 82 82 84
Measure Type: Number
Unit of Measure: percentage of participants
32.9 8.5 6.0
5.Secondary Outcome
Title Number of Gout Flare Days Per Participant From Day 1 to Day 113 (Week 16)
Hide Description 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.
Time Frame Day 1 to Day 113 (Week 16)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS that included all randomized participants who received any study medication, and was based on the treatment allocated by the IVRS at randomization (as randomized). Here, number of participants analyzed=participants with available data for this endpoint.
Arm/Group Title Placebo Rilonacept 80 mg Rilonacept 160 mg
Hide Arm/Group Description:
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.
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.
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.
Overall Number of Participants Analyzed 82 82 83
Mean (Standard Deviation)
Unit of Measure: Gout flare days
11.7  (21.0) 4.30  (17.13) 1.86  (5.80)
6.Secondary Outcome
Title 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)
Hide Description 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.
Time Frame Day 1 to Day 113 (Week 16)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS that included all randomized participants who received any study medication, and was based on the treatment allocated by IVRS at randomization (as randomized). Here, number of participants analyzed=participants with available data for this endpoint.
Arm/Group Title Placebo Rilonacept 80 mg Rilonacept 160 mg
Hide Arm/Group Description:
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.
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.
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.
Overall Number of Participants Analyzed 82 82 83
Mean (Standard Deviation)
Unit of Measure: Gout flare days
4.28  (7.67) 1.67  (8.43) 0.88  (2.66)
Time Frame Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product
Adverse Event Reporting Description Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the ‘on treatment period’ (time from the administration of first dose of study drug up to 35 days after the last dose of study drug).
 
Arm/Group Title Placebo Rilonacept 80 mg Rilonacept 160 mg
Hide Arm/Group Description Two subcutaneous injections of Placebo (for Rilonacept ) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15. 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. 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.
All-Cause Mortality
Placebo Rilonacept 80 mg Rilonacept 160 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Rilonacept 80 mg Rilonacept 160 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/82 (4.88%)      5/82 (6.10%)      3/84 (3.57%)    
Cardiac disorders       
Cardiac failure  1  0/82 (0.00%)  0 0/82 (0.00%)  0 1/84 (1.19%)  1
Cor pulmonale  1  0/82 (0.00%)  0 0/82 (0.00%)  0 1/84 (1.19%)  1
Gastrointestinal disorders       
Umbilical hernia, obstructive  1  1/82 (1.22%)  1 0/82 (0.00%)  0 0/84 (0.00%)  0
Infections and infestations       
Appendicitis  1  0/82 (0.00%)  0 1/82 (1.22%)  1 0/84 (0.00%)  0
Pyelonephritis  1  0/82 (0.00%)  0 1/82 (1.22%)  1 0/84 (0.00%)  0
Injury, poisoning and procedural complications       
Contusion  1  1/82 (1.22%)  1 0/82 (0.00%)  0 0/84 (0.00%)  0
Fall  1  1/82 (1.22%)  1 0/82 (0.00%)  0 0/84 (0.00%)  0
Post procedural complication  1  0/82 (0.00%)  0 1/82 (1.22%)  1 0/84 (0.00%)  0
Road traffic accident  1  1/82 (1.22%)  1 0/82 (0.00%)  0 0/84 (0.00%)  0
Tendon rupture  1  1/82 (1.22%)  1 0/82 (0.00%)  0 0/84 (0.00%)  0
Upper limb fracture  1  1/82 (1.22%)  1 0/82 (0.00%)  0 0/84 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Gastric cancer  1  0/82 (0.00%)  0 1/82 (1.22%)  1 0/84 (0.00%)  0
Nervous system disorders       
Carpal tunnel syndrome  1  0/82 (0.00%)  0 1/82 (1.22%)  1 0/84 (0.00%)  0
Renal and urinary disorders       
Nephrolithiasis  1  0/82 (0.00%)  0 1/82 (1.22%)  1 0/84 (0.00%)  0
Skin and subcutaneous tissue disorders       
Ingrowing nail  1  0/82 (0.00%)  0 0/82 (0.00%)  0 1/84 (1.19%)  1
Vascular disorders       
Haematoma  1  1/82 (1.22%)  1 0/82 (0.00%)  0 0/84 (0.00%)  0
Hypertension  1  1/82 (1.22%)  1 0/82 (0.00%)  0 0/84 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (12.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Rilonacept 80 mg Rilonacept 160 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   12/82 (14.63%)      20/82 (24.39%)      20/84 (23.81%)    
General disorders       
Injection site erythema  1  0/82 (0.00%)  0 6/82 (7.32%)  21 7/84 (8.33%)  20
Infections and infestations       
Influenza  1  6/82 (7.32%)  6 5/82 (6.10%)  5 5/84 (5.95%)  5
Nasopharyngitis  1  2/82 (2.44%)  2 3/82 (3.66%)  6 6/84 (7.14%)  6
Injury, poisoning and procedural complications       
Accidental overdose  1  2/82 (2.44%)  3 6/82 (7.32%)  6 4/84 (4.76%)  5
Nervous system disorders       
Headache  1  2/82 (2.44%)  2 5/82 (6.10%)  6 1/84 (1.19%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (12.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
PI/Institution will provide a copy of any publication to Sponsor prior to submission for review. Sponsor may request to remove confidential information from submission, provided that removal does not preclude the complete and accurate presentation and interpretation of the study results.
Results Point of Contact
Name/Title: Clinical Trial Management
Organization: Regeneron Pharmaceuticals, Inc.
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