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Study of the Safety and Effectiveness of Rilonacept for the Prevention of Gout Flares

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ClinicalTrials.gov Identifier: NCT00610363
Recruitment Status : Completed
First Posted : February 7, 2008
Results First Posted : May 2, 2017
Last Update Posted : May 2, 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 Biological: Rilonacept
Other: Placebo (for Rilonacept)
Enrollment 83
Recruitment Details The study was conducted at 27 study sites in United States (US) between 19 November 2007 and 16 October 2008. A total of 154 participants were screened in the study.
Pre-assignment Details Out of 154 participants, 83 were randomized and treated in the study. Participants were randomized in 1:1 ratio to receive either Placebo or Rilonacept 160 mg.
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 16. 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 16.
Period Title: Overall Study
Started 42 41
Completed 31 38
Not Completed 11 3
Reason Not Completed
Non-compliance with protocol             0             1
Adverse Event             3             1
Lack of Efficacy             2             0
Lost to Follow-up             4             0
Withdrawal by Subject             1             0
Other than specified above             1             1
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 16. 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 16. Total of all reporting groups
Overall Number of Baseline Participants 42 41 83
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 42 participants 41 participants 83 participants
50.1  (11.59) 51.9  (10.61) 51.0  (11.09)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants 41 participants 83 participants
Female
2
   4.8%
1
   2.4%
3
   3.6%
Male
40
  95.2%
40
  97.6%
80
  96.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants 41 participants 83 participants
Hispanic or Latino
1
   2.4%
1
   2.4%
2
   2.4%
Not Hispanic or Latino
41
  97.6%
40
  97.6%
81
  97.6%
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 42 participants 41 participants 83 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
2
   4.9%
2
   2.4%
Native Hawaiian or Other Pacific Islander
1
   2.4%
1
   2.4%
2
   2.4%
Black or African American
3
   7.1%
2
   4.9%
5
   6.0%
White
38
  90.5%
36
  87.8%
74
  89.2%
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 Number of Gout Flares Per Participant Assessed From Day 1 to Day 84 (Week 12)
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 84 were counted, regardless whether the flares occurred during the treatment period or not.
Time Frame Day 1 (Baseline) to Day 84 (Week 12)
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 treatment allocated by 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 16.
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 16.
Overall Number of Participants Analyzed 42 41
Mean (Standard Deviation)
Unit of Measure: Number of gout flares per participant
0.79  (1.071) 0.15  (0.358)
2.Secondary Outcome
Title Percentage of Participants With at Least One Gout Flare From Day 1 to Day 84 (Week 12)
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 (Baseline) to Day 84 (Week 12)
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 treatment allocated by 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 16.
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 16.
Overall Number of Participants Analyzed 42 41
Measure Type: Number
Unit of Measure: percentage of participants
45.2 14.6
3.Secondary Outcome
Title Mean Number of Gout Flares Per Month Per Participant From Day 1 to Day 84 (Week 12)
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. Mean number of flares per month = (total number of flares observed)/ (total number of days subject was in the period/28 days).
Time Frame Day 1 (Baseline) to Day 84 (Week 12)
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 treatment allocated by 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 16.
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 16.
Overall Number of Participants Analyzed 42 41
Mean (Standard Deviation)
Unit of Measure: number of gout flares
0.30  (0.424) 0.06  (0.178)
4.Secondary Outcome
Title Mean Number of Gout Flare Days Per Participant From Day 1 to Day 84 (Week 12)
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. Mean number of gout flare days per participant was reported for this outcome measure.
Time Frame Day 1 (Baseline) to Day 84 (Week 12)
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 treatment allocated by 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 16.
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 16.
Overall Number of Participants Analyzed 42 41
Mean (Standard Deviation)
Unit of Measure: Gout flare days
5.17  (8.015) 1.41  (5.230)
5.Secondary Outcome
Title Mean Number of Gout Flare Days Per Month Per Participant From Day 1 to Day 84 (Week 12)
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. Mean number of gout flare days per month per participant was reported for this outcome measure.
Time Frame Day 1 (Baseline) to Day 84 (Week 12)
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 treatment allocated by 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 16.
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 16.
Overall Number of Participants Analyzed 42 41
Mean (Standard Deviation)
Unit of Measure: Gout flare days
2.09  (3.608) 0.52  (1.779)
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 84 (Week 12)
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 154) 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 154), 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 (Baseline) to Day 84 (Week 12)
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 treatment allocated by 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 16.
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 16.
Overall Number of Participants Analyzed 42 41
Mean (Standard Deviation)
Unit of Measure: Gout flare days
2.02  (4.51) 0.22  (0.79)
7.Secondary Outcome
Title Number of Gout Flare Days With Participant’s Pain Score of 5 or More (From Daily Diary) Per Month Per Participant From Day 1 to Day 84 (Week 12)
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 (Baseline) to Day 84 (Week 12)
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 treatment allocated by 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 16.
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 16.
Overall Number of Participants Analyzed 42 41
Mean (Standard Deviation)
Unit of Measure: Gout flare days
0.87  (2.05) 0.07  (0.26)
Time Frame Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 22) regardless of seriousness or relationship to investigational product.
Adverse Event Reporting Description Reported adverse events are treatment-emergent adverse events that developed/worsened during the ‘on treatment period’ (time from the administration of first dose of study drug through the period ending 42 days after the last dose of study drug). Analysis was performed on safety population the included all participants who received any study medication and were analyzed according to the treatment actually received (as treated).
 
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 16. 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 16.
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   2/42 (4.76%)      1/41 (2.44%)    
Cardiac disorders     
Angina pectoris  1  1/42 (2.38%)  1 0/41 (0.00%)  0
Investigations     
Blood creatinine increased  1  1/42 (2.38%)  1 0/41 (0.00%)  0
Blood urea increased  1  1/42 (2.38%)  1 0/41 (0.00%)  0
Creatinine renal clearance decreased  1  1/42 (2.38%)  1 0/41 (0.00%)  0
Protein urine present  1  1/42 (2.38%)  1 0/41 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Prostate cancer  1  0/42 (0.00%)  0 1/41 (2.44%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, meddra (10)
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   8/42 (19.05%)      6/41 (14.63%)    
Infections and infestations     
Bronchitis  1  3/42 (7.14%)  3 0/41 (0.00%)  0
Metabolism and nutrition disorders     
Gout  1  3/42 (7.14%)  7 3/41 (7.32%)  4
Musculoskeletal and connective tissue disorders     
Arthralgia  1  3/42 (7.14%)  5 1/41 (2.44%)  1
Respiratory, thoracic and mediastinal disorders     
Nasal congestion  1  0/42 (0.00%)  0 3/41 (7.32%)  3
Indicates events were collected by systematic assessment
1
Term from vocabulary, meddra (10)
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: NCT00610363     History of Changes
Other Study ID Numbers: IL1T-GA-0619
First Submitted: January 24, 2008
First Posted: February 7, 2008
Results First Submitted: March 20, 2017
Results First Posted: May 2, 2017
Last Update Posted: May 2, 2017