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Study of the Safety and Efficacy of Long-Term Rilonacept Treatment for the Prevention of Gout Flares (UPSURGE)

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ClinicalTrials.gov Identifier: NCT01459796
Recruitment Status : Terminated
First Posted : October 26, 2011
Results First Posted : July 18, 2017
Last Update Posted : July 18, 2017
Sponsor:
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Gout
Interventions Drug: Rilonacept
Drug: Placebo
Drug: Allopurinol
Enrollment 220
Recruitment Details The study was conducted at 60 study sites in the United States (US) from 12 November 2011 to 02 November 2012. A total of 485 participants were screened in the study.
Pre-assignment Details Out of 485 participants, 220 were randomized and treated in the study. Participants were randomized in 4:3 ratio to receive either Rilonacept 80 mg or Placebo.
Arm/Group Title Placebo Rilonacept 80 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 51. 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 51.
Period Title: Overall Study
Started 94 126
Completed 0 0
Not Completed 94 126
Reason Not Completed
Non compliance with protocol             2             4
Adverse Event             5             5
Withdrawal by Subject             6             3
Lost to Follow-up             5             4
Reason unspecified             1             2
Decision by the sponsor             75             108
Arm/Group Title Placebo Rilonacept 80 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 51. 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 51. Total of all reporting groups
Overall Number of Baseline Participants 94 126 220
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 web response system (IWRS) at randomization (as randomized).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 94 participants 126 participants 220 participants
51.5  (10.69) 52.1  (11.18) 51.9  (10.95)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 94 participants 126 participants 220 participants
Female
8
   8.5%
15
  11.9%
23
  10.5%
Male
86
  91.5%
111
  88.1%
197
  89.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 94 participants 126 participants 220 participants
Hispanic or Latino
7
   7.4%
6
   4.8%
13
   5.9%
Not Hispanic or Latino
87
  92.6%
120
  95.2%
207
  94.1%
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 94 participants 126 participants 220 participants
American Indian or Alaska Native
1
   1.1%
0
   0.0%
1
   0.5%
Asian
2
   2.1%
9
   7.1%
11
   5.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
3
   2.4%
3
   1.4%
Black or African American
16
  17.0%
27
  21.4%
43
  19.5%
White
75
  79.8%
87
  69.0%
162
  73.6%
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. 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 and including 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 Day 1 to Day 392 (Week 56)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set (SAF) that included all randomized participants who received any study medication and was based on the treatment received (as treated).
Arm/Group Title Placebo Rilonacept 80 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 51.
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 51.
Overall Number of Participants Analyzed 94 126
Measure Type: Number
Unit of Measure: percentage of participants
With at least one TEAE 68.1 68.3
With TEAEs related to study drug 12.8 19.0
With serious TEAEs 5.3 4.0
With TEAEs resulting in study drug discontinuation 10.6 6.3
With TEAEs resulting in death 0.0 0.0
2.Secondary Outcome
Title Percentage of Participants With at Least One Gout Flare From Day 1 to Day 168 (Week 24)
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 at Week 24 was to be reported for this outcome measure.
Time Frame Day 1 to Day 168 (Week 24)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
As per sponsor's discretion, the study was discontinued due to which data for this outcome measure was not collected and hence, not analyzed and reported.
Arm/Group Title Placebo Rilonacept 80 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 51.
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 51.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Percentage of Participants With at Least Two Gout Flares From Day 1 to Day 168 (Week 24)
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 at Week 24 was to be reported for this outcome measure.
Time Frame Day 1 to Day 168 (Week 24)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
As per sponsor's discretion, the study was discontinued due to which data for this outcome measure was not collected and hence, not analyzed and reported.
Arm/Group Title Placebo Rilonacept 80 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 51.
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 51.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Percentage of Participants With at Least One Gout Flare From Day 1 to Day 364 (Week 52)
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 at Week 52 was to be reported for this outcome measure.
Time Frame Day 1 to Day 364 (Week 52)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
As per sponsor's discretion, the study was discontinued due to which data for this outcome measure was not collected and hence, not analyzed and reported.
Arm/Group Title Placebo Rilonacept 80 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 51.
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 51.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Percentage of Participants With at Least Two Gout Flares From Day 1 to Day 364 (Week 52)
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 at Week 52 was to be reported for this outcome measure.
Time Frame Day 1 to Day 364 (Week 52)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
As per sponsor's discretion, the study was discontinued due to which data for this outcome measure was not collected and hence, not analyzed and reported.
Arm/Group Title Placebo Rilonacept 80 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 51.
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 51.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Percentage of Participants With Rescue Medication From Day 1 to Day 364 (Week 52)
Hide Description Participants who required rescue medication after having 2 or more gout flares during the treatment period were evaluated.
Time Frame Day 1 to Day 364 (Week 52)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set (SAF) that included all randomized participants who received any study medication and was based on the treatment received (as treated).
Arm/Group Title Placebo Rilonacept 80 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 51.
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 51.
Overall Number of Participants Analyzed 94 126
Measure Type: Number
Unit of Measure: percentage of participants
22.3 8.7
Time Frame Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 56) 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 and including 35 days after the last dose of study drug). Analysis was performed on safety analysis set (SAF).
 
Arm/Group Title Placebo Rilonacept 80 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 51. 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 51.
All-Cause Mortality
Placebo Rilonacept 80 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Rilonacept 80 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/94 (5.32%)      5/126 (3.97%)    
Cardiac disorders     
Myocardial infarction  1  0/94 (0.00%)  0 1/126 (0.79%)  2
General disorders     
Drug interaction  1  1/94 (1.06%)  1 0/126 (0.00%)  0
Infections and infestations     
Cellulitis  1  1/94 (1.06%)  1 1/126 (0.79%)  1
Injury, poisoning and procedural complications     
Femur fracture  1  0/94 (0.00%)  0 1/126 (0.79%)  1
Limb traumatic amputation  1  1/94 (1.06%)  1 0/126 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Hepatic neoplasm malignant  1  0/94 (0.00%)  0 1/126 (0.79%)  1
Psychiatric disorders     
Schizoaffective disorder  1  1/94 (1.06%)  1 0/126 (0.00%)  0
Suicidal ideation  1  1/94 (1.06%)  1 0/126 (0.00%)  0
Renal and urinary disorders     
Nephrolithiasis  1  0/94 (0.00%)  0 1/126 (0.79%)  1
Skin and subcutaneous tissue disorders     
Rash maculo-papular  1  0/94 (0.00%)  0 1/126 (0.79%)  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 80 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   31/94 (32.98%)      43/126 (34.13%)    
Gastrointestinal disorders     
Diarrhoea  1  3/94 (3.19%)  3 9/126 (7.14%)  9
Nausea  1  5/94 (5.32%)  23 2/126 (1.59%)  2
General disorders     
Injection site erythema  1  2/94 (2.13%)  3 9/126 (7.14%)  27
Infections and infestations     
Nasopharyngitis  1  3/94 (3.19%)  3 8/126 (6.35%)  8
Upper respiratory tract infection  1  3/94 (3.19%)  4 10/126 (7.94%)  12
Musculoskeletal and connective tissue disorders     
Arthralgia  1  9/94 (9.57%)  10 9/126 (7.14%)  9
Pain in extremity  1  6/94 (6.38%)  7 7/126 (5.56%)  9
Nervous system disorders     
Headache  1  6/94 (6.38%)  11 11/126 (8.73%)  55
Vascular disorders     
Hypertension  1  2/94 (2.13%)  5 8/126 (6.35%)  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: NCT01459796     History of Changes
Other Study ID Numbers: IL1T-GA-1101
First Submitted: October 12, 2011
First Posted: October 26, 2011
Results First Submitted: April 23, 2017
Results First Posted: July 18, 2017
Last Update Posted: July 18, 2017