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

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: NCT00829829
Recruitment Status : Completed
First Posted : January 27, 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 Intercritical Gout
Interventions Other: Placebo
Drug: Rilonacept 80 mg
Drug: Rilonacept 160 mg
Enrollment 241
Recruitment Details The study was conducted at 49 study sites in Unites States (US) and 15 study sites in Canada between 5 March 2009 and 18 May 2010. A total of 468 participants were screened in the study.
Pre-assignment Details Out of 468 participants, 241 were randomized and 240 treated in the study. Participants were randomized in 1:1:1 ratio to receive either 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 80 80 81
Treated [1] 79 80 81
Completed 58 64 70
Not Completed 22 16 11
Reason Not Completed
Protocol Violation             0             3             0
Adverse Event             4             4             3
Withdrawal by Subject             8             4             2
Decision by the Sponsor             1             0             2
Lost to Follow-up             7             3             3
Other than specified above             2             2             1
[1]
Participants treated were included in safety population.
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 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 79 80 81 240
Hide Baseline Analysis Population Description
Baseline population included full analysis set (FAS) comprising of all randomized participants who received any study medication and was based on treatment allocated by Interactive voice response system (IVRS) at randomization (as randomized).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 79 participants 80 participants 81 participants 240 participants
52.2  (13.6) 52.9  (12.5) 51.9  (11.6) 52.3  (12.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 79 participants 80 participants 81 participants 240 participants
Female
3
   3.8%
9
  11.3%
5
   6.2%
17
   7.1%
Male
76
  96.2%
71
  88.8%
76
  93.8%
223
  92.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 79 participants 80 participants 81 participants 240 participants
Hispanic or Latino
2
   2.5%
2
   2.5%
2
   2.5%
6
   2.5%
Not Hispanic or Latino
77
  97.5%
78
  97.5%
79
  97.5%
234
  97.5%
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 79 participants 80 participants 81 participants 240 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
4
   5.1%
5
   6.3%
1
   1.2%
10
   4.2%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
1
   1.2%
1
   0.4%
Black or African American
11
  13.9%
15
  18.8%
10
  12.3%
36
  15.0%
White
64
  81.0%
60
  75.0%
69
  85.2%
193
  80.4%
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 112 (Week 16)
Hide Description 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.
Time Frame Day 1 to Day 112 (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 IIVRS 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 79 80 80
Mean (Standard Deviation)
Unit of Measure: Number of Gout flares per participant
1.06  (1.59) 0.29  (0.77) 0.21  (0.54)
2.Secondary Outcome
Title Number of Modified Gout Flares Per Participant From Day 1 to Day 112 (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 112 (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 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 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 79 80 80
Mean (Standard Deviation)
Unit of Measure: modified gout flares
1.19  (1.75) 0.40  (0.91) 0.28  (0.62)
3.Secondary Outcome
Title Percentage of Participants With at Least One Gout Flare From Day 1 to Day 112 (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 112 (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 IIVRS 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 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 79 80 81
Measure Type: Number
Unit of Measure: percentage of participants
46.8 18.8 16.3
4.Secondary Outcome
Title Percentage of Participants With at Least Two Gout Flares From Day 1 to Day 112 (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 112 (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 IIVRS 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 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 79 80 81
Measure Type: Number
Unit of Measure: percentage of participants
31.6 5.0 3.8
5.Secondary Outcome
Title Number of Gout Flare Days Per Participant From Day 1 to Day 112 (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 112 (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 IIVRS 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 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 79 80 80
Mean (Standard Deviation)
Unit of Measure: Gout flare Days
5.52  (9.73) 2.36  (11.35) 0.98  (2.95)
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 112 (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 112 (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 IIVRS 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 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 79 80 80
Mean (Standard Deviation)
Unit of Measure: Gout flare days
2.13  (3.20) 0.85  (3.93) 0.35  (1.30)
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). Analysis was performed on safety population included all participants who received any study medication and was based on the treatment received.
 
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   3/79 (3.80%)      3/80 (3.75%)      3/81 (3.70%)    
Cardiac disorders       
Coronary artery disease  1  0/79 (0.00%)  0 0/80 (0.00%)  0 1/81 (1.23%)  1
Gastrointestinal disorders       
Abdominal hernia obstructive  1  0/79 (0.00%)  0 1/80 (1.25%)  1 0/81 (0.00%)  0
Infections and infestations       
Liver abscess  1  0/79 (0.00%)  0 1/80 (1.25%)  1 0/81 (0.00%)  0
Injury, poisoning and procedural complications       
Accidental overdose  1  1/79 (1.27%)  1 0/80 (0.00%)  0 0/81 (0.00%)  0
Metabolism and nutrition disorders       
Gout  1  0/79 (0.00%)  0 0/80 (0.00%)  0 1/81 (1.23%)  1
Musculoskeletal and connective tissue disorders       
Musculoskeletal chest pain  1  1/79 (1.27%)  1 0/80 (0.00%)  0 0/81 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Squamous cell carcinoma  1  0/79 (0.00%)  0 1/80 (1.25%)  1 0/81 (0.00%)  0
Pregnancy, puerperium and perinatal conditions       
Abortion spontaneous  1  0/79 (0.00%)  0 0/80 (0.00%)  0 1/81 (1.23%)  1
Psychiatric disorders       
Depression  1  1/79 (1.27%)  1 0/80 (0.00%)  0 0/81 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Pneumonitis  1  1/79 (1.27%)  1 0/80 (0.00%)  0 0/81 (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   8/79 (10.13%)      16/80 (20.00%)      17/81 (20.99%)    
General disorders       
Injection site erythema  1  0/79 (0.00%)  0 4/80 (5.00%)  4 3/81 (3.70%)  9
Injection site reaction  1  0/79 (0.00%)  0 1/80 (1.25%)  1 5/81 (6.17%)  10
Infections and infestations       
Bronchitis  1  1/79 (1.27%)  1 4/80 (5.00%)  4 0/81 (0.00%)  0
Upper respiratory tract infection  1  2/79 (2.53%)  2 4/80 (5.00%)  4 5/81 (6.17%)  5
Musculoskeletal and connective tissue disorders       
Pain in extremity  1  4/79 (5.06%)  6 2/80 (2.50%)  3 3/81 (3.70%)  3
Nervous system disorders       
Headache  1  1/79 (1.27%)  1 5/80 (6.25%)  6 2/81 (2.47%)  2
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. Phone:
Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00829829     History of Changes
Other Study ID Numbers: IL1T-GA-0810
First Submitted: January 23, 2009
First Posted: January 27, 2009
Results First Submitted: March 20, 2017
Results First Posted: April 28, 2017
Last Update Posted: April 28, 2017