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Review of Safety Using Rilonacept in Preventing Gout Exacerbations (RE-SURGE)

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ClinicalTrials.gov Identifier: NCT00856206
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: Prevention
Condition Gout
Interventions Biological: Rilonacept
Other: Placebo
Enrollment 1315
Recruitment Details The study was conducted at 71 study sites in United States and rest of world (ROW) between 23 March 2009 and 14 January 2011. A total of 2311 participants were screened in the study.
Pre-assignment Details Out of 2311 participants, 1315 were randomized and treated in the study. Participants were randomized in 3:1 ratio to receive Rilonacept 160 mg or placebo.
Arm/Group Title Placebo 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 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 330 985
Completed 276 824
Not Completed 54 161
Reason Not Completed
Protocol Violation             6             18
Adverse Event             10             46
Lack of Efficacy             1             2
Withdrawal by Subject             15             36
Lost to Follow-up             13             39
Death             2             2
Decision by the Sponsor             4             8
Other than specified above             3             10
Arm/Group Title Placebo 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 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 330 985 1315
Hide Baseline Analysis Population Description
Baseline population included all randomized participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 330 participants 985 participants 1315 participants
52.4  (10.55) 52.8  (11.48) 52.7  (11.25)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 330 participants 985 participants 1315 participants
Female
33
  10.0%
128
  13.0%
161
  12.2%
Male
297
  90.0%
857
  87.0%
1154
  87.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 330 participants 985 participants 1315 participants
Hispanic or Latino
11
   3.3%
38
   3.9%
49
   3.7%
Not Hispanic or Latino
319
  96.7%
947
  96.1%
1266
  96.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 330 participants 985 participants 1315 participants
American Indian or Alaska Native
2
   0.6%
7
   0.7%
9
   0.7%
Asian
47
  14.2%
115
  11.7%
162
  12.3%
Native Hawaiian or Other Pacific Islander
1
   0.3%
3
   0.3%
4
   0.3%
Black or African American
70
  21.2%
202
  20.5%
272
  20.7%
White
210
  63.6%
658
  66.8%
868
  66.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
Hide Description Any untoward medical occurrence in a participant who received investigational medicinal product (IMP) was considered an AE without regard to possibility of causal relationship with this treatment. Treatment-emergent adverse events (TEAEs) were defined as AEs that developed or worsened or became serious during on-treatment period (time from the administration of first dose of study drug up to 35 days after the last dose of study drug). A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs.
Time Frame Baseline up to Week 20
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set that included all participants who received any study drug and safety analyses were based on the treatment received.
Arm/Group Title Placebo 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 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 330 985
Measure Type: Number
Unit of Measure: percentage of participants
With at least 1 TEAE 59.1 66.6
With TEAEs related to study drug 13.0 27.5
With serious TEAEs 3.9 3.1
With TEAEs resulting in drug withdrawal 3.3 5.0
With serious TEAEs resulting in drug withdrawal 1.8 1.1
With TEAEs leading to study discontinuation 3.0 4.7
With serious TEAE leading to study discontinuation 1.5 1.0
Treatment emergent deaths 0.3 0.2
2.Secondary 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 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 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 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 323 952
Mean (Standard Deviation)
Unit of Measure: Gout flares
1.73  (2.69) 0.51  (1.17)
3.Secondary Outcome
Title Percentage of Participants With at Least One Flare 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. Percentage of participants with at least one gout flare 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
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 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 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 330 985
Measure Type: Number
Unit of Measure: percentage of participants
51.1 25.7
4.Secondary Outcome
Title Percentage of Participants With at Least Two Flares 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. Percentage of participants with at least two gout flare 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
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 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 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 330 985
Measure Type: Number
Unit of Measure: percentage of participants
34.7 11.7
5.Secondary Outcome
Title Number of Gout Flare Days Per Participant 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. Flare days were counted up to Week 16, regardless of whether or not the flares occurred during the treatment period.
Time Frame Day 1 to Day 112 (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 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 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 323 952
Mean (Standard Deviation)
Unit of Measure: Gout flare Days
7.66  (11.79) 2.66  (7.69)
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 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 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 160 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Rilonacept 160 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   13/330 (3.94%)      31/985 (3.15%)    
Blood and lymphatic system disorders     
Anaemia  1  0/330 (0.00%)  0 2/985 (0.20%)  2
Cardiac disorders     
Acute coronary syndrome  1  1/330 (0.30%)  1 1/985 (0.10%)  1
Atrial fibrillation  1  0/330 (0.00%)  0 2/985 (0.20%)  2
Myocardial infarction  1  0/330 (0.00%)  0 2/985 (0.20%)  2
Gastrointestinal disorders     
Gastric ulcer haemorrhage  1  0/330 (0.00%)  0 1/985 (0.10%)  1
Gastroduodenitis  1  0/330 (0.00%)  0 1/985 (0.10%)  1
Intestinal perforation  1  0/330 (0.00%)  0 1/985 (0.10%)  1
Large intestine perforation  1  1/330 (0.30%)  1 0/985 (0.00%)  0
Pancreatitis  1  0/330 (0.00%)  0 1/985 (0.10%)  1
Pancreatitis acute  1  1/330 (0.30%)  1 0/985 (0.00%)  0
Peptic ulcer perforation  1  0/330 (0.00%)  0 1/985 (0.10%)  1
Upper gastrointestinal haemorrhage  1  0/330 (0.00%)  0 1/985 (0.10%)  1
General disorders     
Cyst  1  1/330 (0.30%)  1 0/985 (0.00%)  0
Death  1  1/330 (0.30%)  1 0/985 (0.00%)  0
Pyrexia  1  0/330 (0.00%)  0 1/985 (0.10%)  1
Hepatobiliary disorders     
Bile duct stone  1  0/330 (0.00%)  0 1/985 (0.10%)  1
Cholangitis  1  0/330 (0.00%)  0 1/985 (0.10%)  1
Cholelithiasis  1  0/330 (0.00%)  0 1/985 (0.10%)  1
Infections and infestations     
Arthritis bacterial  1  0/330 (0.00%)  0 1/985 (0.10%)  1
Bronchitis  1  0/330 (0.00%)  0 1/985 (0.10%)  1
Cellulitis  1  2/330 (0.61%)  2 1/985 (0.10%)  1
Diverticulitis  1  0/330 (0.00%)  0 1/985 (0.10%)  1
Meningitis viral  1  1/330 (0.30%)  1 0/985 (0.00%)  0
Sepsis  1  0/330 (0.00%)  0 1/985 (0.10%)  1
Urinary tract infection  1  0/330 (0.00%)  0 1/985 (0.10%)  1
Injury, poisoning and procedural complications     
Animal bite  1  0/330 (0.00%)  0 1/985 (0.10%)  1
Metabolism and nutrition disorders     
Diabetes mellitus  1  1/330 (0.30%)  1 0/985 (0.00%)  0
Gout  1  1/330 (0.30%)  1 2/985 (0.20%)  2
Musculoskeletal and connective tissue disorders     
Back pain  1  0/330 (0.00%)  0 1/985 (0.10%)  1
Gouty tophus  1  0/330 (0.00%)  0 1/985 (0.10%)  1
Osteoarthritis  1  0/330 (0.00%)  0 1/985 (0.10%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Breast cancer  1  0/330 (0.00%)  0 1/985 (0.10%)  1
Oropharyngeal cancer stage unspecified  1  0/330 (0.00%)  0 1/985 (0.10%)  1
Prostate cancer  1  0/330 (0.00%)  0 2/985 (0.20%)  2
Nervous system disorders     
Cerebrovascular accident  1  1/330 (0.30%)  1 2/985 (0.20%)  2
Nerve compression  1  0/330 (0.00%)  0 1/985 (0.10%)  1
Transient ischaemic attack  1  0/330 (0.00%)  0 1/985 (0.10%)  1
Psychiatric disorders     
Bipolar disorder  1  1/330 (0.30%)  1 1/985 (0.10%)  1
Renal and urinary disorders     
Renal impairment  1  0/330 (0.00%)  0 1/985 (0.10%)  1
Skin and subcutaneous tissue disorders     
Drug eruption  1  1/330 (0.30%)  1 1/985 (0.10%)  1
Vascular disorders     
Aneurysm  1  0/330 (0.00%)  0 1/985 (0.10%)  1
Bleeding varicose vein  1  0/330 (0.00%)  0 1/985 (0.10%)  1
Hypertension  1  1/330 (0.30%)  1 1/985 (0.10%)  1
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 160 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   74/330 (22.42%)      266/985 (27.01%)    
General disorders     
Injection site erythema  1  1/330 (0.30%)  1 61/985 (6.19%)  195
Injury, poisoning and procedural complications     
Accidental overdose  1  20/330 (6.06%)  21 54/985 (5.48%)  61
Musculoskeletal and connective tissue disorders     
Arthralgia  1  20/330 (6.06%)  41 65/985 (6.60%)  85
Pain in extremity  1  15/330 (4.55%)  21 52/985 (5.28%)  74
Nervous system disorders     
Headache  1  26/330 (7.88%)  45 90/985 (9.14%)  169
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: NCT00856206     History of Changes
Other Study ID Numbers: IL1T-GA-0815
First Submitted: February 21, 2009
First Posted: March 5, 2009
Results First Submitted: March 20, 2017
Results First Posted: April 28, 2017
Last Update Posted: April 28, 2017