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Study Utilizing Rilonacept in Gout Exacerbations (SURGE)

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ClinicalTrials.gov Identifier: NCT00855920
Recruitment Status : Completed
First Posted : March 5, 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 Acute Gout Flare
Interventions Drug: Rilonacept
Drug: Indomethacin
Other: Placebo (for Indomethacin)
Other: Placebo (for Rilonacept)
Enrollment 225
Recruitment Details The study was conducted at 80 study sites in North America between 16 March 2009 and 26 February 2010. A total of 747 participants were screened in the study.
Pre-assignment Details Out of 747 participants, 225 were randomized and treated in the study. Participants were randomized in 1:1:1 ratio to receive one of the three treatment groups (Placebo [for Rilonacept] + Indomethacin or Rilonacept 320 mg + Indomethacin or Rilonacept 320 mg + Placebo [for Indomethacin]) on Day 1 of the study.
Arm/Group Title Placebo (for Rilonacept) and Indomethacin Rilonacept and Indomethacin Rilonacept and Placebo (for Indomethacin)
Hide Arm/Group Description Two subcutaneous injections of Placebo (for Rilonacept) on Day 1 with Indomethacin orally thrice a day (TID) for 12 days (Indomethacin 50 mg for first 3 days and then, Indomethacin 25 mg for next 9 days). Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) on Day 1 with Indomethacin orally TID for 12 days (Indomethacin 50 mg for first 3 days and then, Indomethacin 25 mg for next 9 days). Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) on Day 1 with Placebo (for Indomethacin) orally TID for 12 days.
Period Title: Overall Study
Started 76 74 75
Safety Population 77 [1] 73 [1] 75
Completed 68 65 64
Not Completed 8 9 11
Reason Not Completed
Protocol Violation             0             0             2
Adverse Event             2             1             1
Lack of Efficacy             2             2             2
Withdrawal by Subject             2             3             2
Lost to Follow-up             1             0             2
Death             0             1             0
Decision by the sponsor             0             1             1
Other than specified above             1             1             1
[1]
1 participant from Rilonacept+Indomethacin arm received Placebo (for Rilonacept)+Indomethacin
Arm/Group Title Placebo (for Rilonacept) and Indomethacin Rilonacept and Indomethacin Rilonacept and Placebo (for Indomethacin) Total
Hide Arm/Group Description Two subcutaneous injections of Placebo (for Rilonacept) on Day 1 with Indomethacin orally TID for 12 days (Indomethacin 50 mg for first 3 days and then, Indomethacin 25 mg for next 9 days). Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) on Day 1 with Indomethacin orally TID for 12 days (Indomethacin 50 mg for first 3 days and then, Indomethacin 25 mg for next 9 days). Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) on Day 1 with Placebo (for Indomethacin) orally TID for 12 days. Total of all reporting groups
Overall Number of Baseline Participants 75 74 73 222
Hide Baseline Analysis Population Description
Baseline population included full analysis set (FAS) comprising of all randomized participants who received any study drug and had at least 1 post-baseline assessment.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 75 participants 74 participants 73 participants 222 participants
51.3  (10.90) 48.6  (9.95) 51.0  (10.83) 50.3  (10.59)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 75 participants 74 participants 73 participants 222 participants
Female
4
   5.3%
3
   4.1%
6
   8.2%
13
   5.9%
Male
71
  94.7%
71
  95.9%
67
  91.8%
209
  94.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 75 participants 74 participants 73 participants 222 participants
Hispanic or Latino
3
   4.0%
4
   5.4%
5
   6.8%
12
   5.4%
Not Hispanic or Latino
72
  96.0%
70
  94.6%
68
  93.2%
210
  94.6%
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 75 participants 74 participants 73 participants 222 participants
American Indian or Alaska Native
1
   1.3%
1
   1.4%
0
   0.0%
2
   0.9%
Asian
5
   6.7%
2
   2.7%
2
   2.7%
9
   4.1%
Native Hawaiian or Other Pacific Islander
0
   0.0%
2
   2.7%
0
   0.0%
2
   0.9%
Black or African American
15
  20.0%
15
  20.3%
11
  15.1%
41
  18.5%
White
54
  72.0%
54
  73.0%
60
  82.2%
168
  75.7%
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 Change From Baseline in Patient's Assessment of Pain Using a 5-Point Likert Scale (PAP-LS) in Index Joint to Averaged PAP-LS at 24, 48 and 72 Hours
Hide Description Participants were asked to complete a daily diary entry and assessed their pain in the past 24 hours using 5-point Likert Scale of 0 (None) to 4 (extreme pain), where; 0= none, 1= mild pain, 2= moderate pain, 3= severe pain, or 4= extreme pain. Change in PAP-LS in the index joint from baseline (Day 1) to the averaged PAP-LS values at 24, 48 and 72 hours was reported in this outcome measure (averaged PAP value= [PAP at 24 hours + PAP at 48 hours + PAP at 72 hours]/3).
Time Frame Pre-dose on Day 1 (Baseline); post-dose at 4, 8, 12, 24, 48, 72 hours and then daily up to Day 13 or until gout flare ends
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) that included of all randomized participants who received any study drug and had at least 1 post-baseline assessment.
Arm/Group Title Placebo (for Rilonacept) and Indomethacin Rilonacept and Indomethacin Rilonacept and Placebo (for Indomethacin)
Hide Arm/Group Description:
Two subcutaneous injections of Placebo (for Rilonacept) on Day 1 with Indomethacin orally TID for 12 days (Indomethacin 50 mg for first 3 days and then, Indomethacin 25 mg for next 9 days).
Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) on Day 1 with Indomethacin orally TID for 12 days (Indomethacin 50 mg for first 3 days and then, Indomethacin 25 mg for next 9 days).
Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) on Day 1 with Placebo (for Indomethacin) orally TID for 12 days.
Overall Number of Participants Analyzed 75 74 73
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.40  (0.956) -1.55  (0.919) -0.69  (0.970)
2.Secondary Outcome
Title Change From Baseline in Patient's Assessment of Pain Using a 5-Point Likert Scale (PAP-LS) in Index Joint at 72 Hours
Hide Description Participants were asked to complete a daily diary entry and assessed their pain in the past 24 hours using 5-point Likert Scale of 0 (None) to 4 (extreme pain), where; 0= none, 1= mild pain, 2= moderate pain, 3= severe pain, or 4= extreme pain.
Time Frame Baseline (Day 1) to 72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) that included all randomized participants who received any study drug and had at least 1 post-baseline assessment. Here, number of participants analyzed=participants with available data for this endpoint.
Arm/Group Title Placebo (for Rilonacept) and Indomethacin Rilonacept and Indomethacin Rilonacept and Placebo (for Indomethacin)
Hide Arm/Group Description:
Two subcutaneous injections of Placebo (for Rilonacept) on Day 1 with Indomethacin orally TID for 12 days (Indomethacin 50 mg for first 3 days and then, Indomethacin 25 mg for next 9 days).
Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) on Day 1 with Indomethacin orally TID for 12 days (Indomethacin 50 mg for first 3 days and then, Indomethacin 25 mg for next 9 days).
Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) on Day 1 with Placebo (for Indomethacin) orally TID for 12 days.
Overall Number of Participants Analyzed 41 30 28
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.41  (0.865) -1.57  (1.104) -1.29  (0.976)
3.Secondary Outcome
Title Change From Baseline in Patient's Assessment of Pain Using a 5-Point Likert Scale (PAP-LS) in Index Joint at 48 Hours
Hide Description Participants were asked to complete a daily diary entry and assessed their pain in the past 24 hours using 5-point Likert Scale of 0 (None) to 4 (extreme pain), where; 0= none, 1= mild pain, 2= moderate pain, 3= severe pain, or 4= extreme pain.
Time Frame Baseline (Day 1) to 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) that included all randomized participants who received any study drug and had at least 1 post-baseline assessment. Here, number of participants analyzed=participants with available data for this endpoint.
Arm/Group Title Placebo (for Rilonacept) and Indomethacin Rilonacept and Indomethacin Rilonacept and Placebo (for Indomethacin)
Hide Arm/Group Description:
Two subcutaneous injections of Placebo (for Rilonacept) on Day 1 with Indomethacin orally TID for 12 days (Indomethacin 50 mg for first 3 days and then, Indomethacin 25 mg for next 9 days).
Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) on Day 1 with Indomethacin orally TID for 12 days (Indomethacin 50 mg for first 3 days and then, Indomethacin 25 mg for next 9 days).
Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) on Day 1 with Placebo (for Indomethacin) orally TID for 12 days.
Overall Number of Participants Analyzed 56 52 49
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.36  (0.883) -1.54  (0.959) -1.08  (1.057)
4.Secondary Outcome
Title Change From Baseline in Patient's Assessment of Pain Using a 5-Point Likert Scale (PAP-LS) in Index Joint at 24 Hours
Hide Description Participants were asked to complete a daily diary entry and assessed their pain in the past 24 hours using 5-point Likert Scale of 0 (None) to 4 (extreme pain), where; 0= none, 1= mild pain, 2= moderate pain, 3= severe pain, or 4= extreme pain.
Time Frame Baseline (Day 1) to 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) that included all randomized participants who received any study drug and had at least 1 post-baseline assessment. Here, number of participants analyzed=participants with available data for this endpoint.
Arm/Group Title Placebo (for Rilonacept) and Indomethacin Rilonacept and Indomethacin Rilonacept and Placebo (for Indomethacin)
Hide Arm/Group Description:
Two subcutaneous injections of Placebo (for Rilonacept) on Day 1 with Indomethacin orally TID for 12 days (Indomethacin 50 mg for first 3 days and then, Indomethacin 25 mg for next 9 days).
Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) on Day 1 with Indomethacin orally TID for 12 days (Indomethacin 50 mg for first 3 days and then, Indomethacin 25 mg for next 9 days).
Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) on Day 1 with Placebo (for Indomethacin) orally TID for 12 days.
Overall Number of Participants Analyzed 74 70 66
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.16  (1.021) -1.44  (0.895) -0.55  (0.845)
Time Frame Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Day 31) 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 dosing [Day 1] of study drug up to 35 days after the dose of study medication). Analysis was performed on safety population that included all participants who received any study drug and were analyzed according to the treatment actually received (as treated).
 
Arm/Group Title Placebo (for Rilonacept) and Indomethacin Rilonacept and Indomethacin Rilonacept and Placebo (for Indomethacin)
Hide Arm/Group Description Two subcutaneous injections of Placebo (for Rilonacept) on Day 1 with Indomethacin orally TID for 12 days (Indomethacin 50 mg for first 3 days and then, Indomethacin 25 mg for next 9 days). One participant randomized to treatment for Rilonacept and Indomethacin, received treatment for Placebo [for Rilonacept] and Indomethacin and analyzed in this arm. Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) on Day 1 with Indomethacin orally TID for 12 days (Indomethacin 50 mg for first 3 days and then, Indomethacin 25 mg for next 9 days). One participant randomized to treatment for Rilonacept and Indomethacin, received treatment for Placebo [for Rilonacept] and Indomethacin and analyzed in arm (Placebo [for Rilonacept] and Indomethacin). Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) on Day 1 with Placebo (for Indomethacin) orally TID for 12 days.
All-Cause Mortality
Placebo (for Rilonacept) and Indomethacin Rilonacept and Indomethacin Rilonacept and Placebo (for Indomethacin)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo (for Rilonacept) and Indomethacin Rilonacept and Indomethacin Rilonacept and Placebo (for Indomethacin)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/77 (0.00%)      3/73 (4.11%)      0/75 (0.00%)    
Cardiac disorders       
Hypertensive cardiomyopathy  1  0/77 (0.00%)  0 1/73 (1.37%)  1 0/75 (0.00%)  0
Myocardial infarction  1  0/77 (0.00%)  0 1/73 (1.37%)  1 0/75 (0.00%)  0
Gastrointestinal disorders       
Colitis ulcerative  1  0/77 (0.00%)  0 1/73 (1.37%)  1 0/75 (0.00%)  0
Renal and urinary disorders       
Tubulointerstitial nephritis  1  0/77 (0.00%)  0 1/73 (1.37%)  1 0/75 (0.00%)  0
Skin and subcutaneous tissue disorders       
Pyoderma gangrenosum  1  0/77 (0.00%)  0 1/73 (1.37%)  1 0/75 (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 (for Rilonacept) and Indomethacin Rilonacept and Indomethacin Rilonacept and Placebo (for Indomethacin)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/77 (10.39%)      7/73 (9.59%)      7/75 (9.33%)    
Nervous system disorders       
Dizziness  1  4/77 (5.19%)  4 3/73 (4.11%)  3 2/75 (2.67%)  2
Headache  1  6/77 (7.79%)  6 4/73 (5.48%)  4 7/75 (9.33%)  8
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: NCT00855920     History of Changes
Other Study ID Numbers: IL1T-GA-0814
First Submitted: February 13, 2009
First Posted: March 5, 2009
Results First Submitted: March 20, 2017
Results First Posted: April 28, 2017
Last Update Posted: April 28, 2017