Trial Outcomes & Findings for PREventative Study Against URate-lowering Drug-induced Gout Exacerbations 1 (NCT NCT00829829)
NCT ID: NCT00829829
Last Updated: 2017-04-28
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
241 participants
Primary outcome timeframe
Day 1 to Day 112 (Week 16)
Results posted on
2017-04-28
Participant Flow
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.
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.
Participant milestones
| Measure |
Placebo
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.
|
Rilonacept 80 mg
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.
|
Rilonacept 160 mg
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 Study
STARTED
|
80
|
80
|
81
|
|
Overall Study
Treated
|
79
|
80
|
81
|
|
Overall Study
COMPLETED
|
58
|
64
|
70
|
|
Overall Study
NOT COMPLETED
|
22
|
16
|
11
|
Reasons for withdrawal
| Measure |
Placebo
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.
|
Rilonacept 80 mg
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.
|
Rilonacept 160 mg
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 Study
Protocol Violation
|
0
|
3
|
0
|
|
Overall Study
Adverse Event
|
4
|
4
|
3
|
|
Overall Study
Withdrawal by Subject
|
8
|
4
|
2
|
|
Overall Study
Decision by the Sponsor
|
1
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
7
|
3
|
3
|
|
Overall Study
Other than specified above
|
2
|
2
|
1
|
Baseline Characteristics
PREventative Study Against URate-lowering Drug-induced Gout Exacerbations 1
Baseline characteristics by cohort
| Measure |
Placebo
n=79 Participants
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.
|
Rilonacept 80 mg
n=80 Participants
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.
|
Rilonacept 160 mg
n=81 Participants
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
n=240 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
52.2 years
STANDARD_DEVIATION 13.6 • n=5 Participants
|
52.9 years
STANDARD_DEVIATION 12.5 • n=7 Participants
|
51.9 years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
52.3 years
STANDARD_DEVIATION 12.6 • n=4 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
76 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
223 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
77 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
234 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
64 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
193 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 112 (Week 16)Population: 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).
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.
Outcome measures
| Measure |
Placebo
n=79 Participants
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.
|
Rilonacept 80 mg
n=80 Participants
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.
|
Rilonacept 160 mg
n=80 Participants
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.
|
|---|---|---|---|
|
Number of Gout Flares Per Participant Assessed From Day 1 to Day 112 (Week 16)
|
1.06 Number of Gout flares per participant
Standard Deviation 1.59
|
0.29 Number of Gout flares per participant
Standard Deviation 0.77
|
0.21 Number of Gout flares per participant
Standard Deviation 0.54
|
SECONDARY outcome
Timeframe: Day 1 to Day 112 (Week 16)Population: 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).
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.
Outcome measures
| Measure |
Placebo
n=79 Participants
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.
|
Rilonacept 80 mg
n=80 Participants
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.
|
Rilonacept 160 mg
n=80 Participants
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.
|
|---|---|---|---|
|
Number of Modified Gout Flares Per Participant From Day 1 to Day 112 (Week 16)
|
1.19 modified gout flares
Standard Deviation 1.75
|
0.40 modified gout flares
Standard Deviation 0.91
|
0.28 modified gout flares
Standard Deviation 0.62
|
SECONDARY outcome
Timeframe: Day 1 to Day 112 (Week 16)Population: 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).
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.
Outcome measures
| Measure |
Placebo
n=79 Participants
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.
|
Rilonacept 80 mg
n=80 Participants
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.
|
Rilonacept 160 mg
n=81 Participants
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.
|
|---|---|---|---|
|
Percentage of Participants With at Least One Gout Flare From Day 1 to Day 112 (Week 16)
|
46.8 percentage of participants
|
18.8 percentage of participants
|
16.3 percentage of participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 112 (Week 16)Population: 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).
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.
Outcome measures
| Measure |
Placebo
n=79 Participants
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.
|
Rilonacept 80 mg
n=80 Participants
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.
|
Rilonacept 160 mg
n=81 Participants
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.
|
|---|---|---|---|
|
Percentage of Participants With at Least Two Gout Flares From Day 1 to Day 112 (Week 16)
|
31.6 percentage of participants
|
5.0 percentage of participants
|
3.8 percentage of participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 112 (Week 16)Population: 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).
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.
Outcome measures
| Measure |
Placebo
n=79 Participants
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.
|
Rilonacept 80 mg
n=80 Participants
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.
|
Rilonacept 160 mg
n=80 Participants
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.
|
|---|---|---|---|
|
Number of Gout Flare Days Per Participant From Day 1 to Day 112 (Week 16)
|
5.52 Gout flare Days
Standard Deviation 9.73
|
2.36 Gout flare Days
Standard Deviation 11.35
|
0.98 Gout flare Days
Standard Deviation 2.95
|
SECONDARY outcome
Timeframe: Day 1 to Day 112 (Week 16)Population: 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).
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.
Outcome measures
| Measure |
Placebo
n=79 Participants
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.
|
Rilonacept 80 mg
n=80 Participants
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.
|
Rilonacept 160 mg
n=80 Participants
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.
|
|---|---|---|---|
|
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)
|
2.13 Gout flare days
Standard Deviation 3.20
|
0.85 Gout flare days
Standard Deviation 3.93
|
0.35 Gout flare days
Standard Deviation 1.30
|
Adverse Events
Placebo
Serious events: 3 serious events
Other events: 8 other events
Deaths: 0 deaths
Rilonacept 80 mg
Serious events: 3 serious events
Other events: 16 other events
Deaths: 0 deaths
Rilonacept 160 mg
Serious events: 3 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=79 participants at risk
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.
|
Rilonacept 80 mg
n=80 participants at risk
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.
|
Rilonacept 160 mg
n=81 participants at risk
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.
|
|---|---|---|---|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/79 • 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.
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.
|
0.00%
0/80 • 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.
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.
|
1.2%
1/81 • Number of events 1 • 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.
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.
|
|
Gastrointestinal disorders
Abdominal hernia obstructive
|
0.00%
0/79 • 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.
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.
|
1.2%
1/80 • Number of events 1 • 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.
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.
|
0.00%
0/81 • 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.
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.
|
|
Infections and infestations
Liver abscess
|
0.00%
0/79 • 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.
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.
|
1.2%
1/80 • Number of events 1 • 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.
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.
|
0.00%
0/81 • 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.
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.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
1.3%
1/79 • Number of events 1 • 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.
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.
|
0.00%
0/80 • 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.
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.
|
0.00%
0/81 • 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.
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.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/79 • 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.
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.
|
0.00%
0/80 • 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.
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.
|
1.2%
1/81 • Number of events 1 • 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.
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.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
1.3%
1/79 • Number of events 1 • 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.
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.
|
0.00%
0/80 • 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.
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.
|
0.00%
0/81 • 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.
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/79 • 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.
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.
|
1.2%
1/80 • Number of events 1 • 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.
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.
|
0.00%
0/81 • 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.
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.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/79 • 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.
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.
|
0.00%
0/80 • 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.
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.
|
1.2%
1/81 • Number of events 1 • 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.
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.
|
|
Psychiatric disorders
Depression
|
1.3%
1/79 • Number of events 1 • 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.
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.
|
0.00%
0/80 • 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.
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.
|
0.00%
0/81 • 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.
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.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.3%
1/79 • Number of events 1 • 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.
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.
|
0.00%
0/80 • 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.
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.
|
0.00%
0/81 • 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.
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.
|
Other adverse events
| Measure |
Placebo
n=79 participants at risk
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.
|
Rilonacept 80 mg
n=80 participants at risk
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.
|
Rilonacept 160 mg
n=81 participants at risk
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.
|
|---|---|---|---|
|
General disorders
Injection site erythema
|
0.00%
0/79 • 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.
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.
|
5.0%
4/80 • Number of events 4 • 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.
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.
|
3.7%
3/81 • Number of events 9 • 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.
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.
|
|
General disorders
Injection site reaction
|
0.00%
0/79 • 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.
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.
|
1.2%
1/80 • Number of events 1 • 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.
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.
|
6.2%
5/81 • Number of events 10 • 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.
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.
|
|
Infections and infestations
Bronchitis
|
1.3%
1/79 • Number of events 1 • 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.
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.
|
5.0%
4/80 • Number of events 4 • 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.
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.
|
0.00%
0/81 • 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.
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.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.5%
2/79 • Number of events 2 • 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.
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.
|
5.0%
4/80 • Number of events 4 • 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.
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.
|
6.2%
5/81 • Number of events 5 • 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.
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.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.1%
4/79 • Number of events 6 • 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.
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.
|
2.5%
2/80 • Number of events 3 • 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.
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.
|
3.7%
3/81 • Number of events 3 • 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.
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.
|
|
Nervous system disorders
Headache
|
1.3%
1/79 • Number of events 1 • 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.
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.
|
6.2%
5/80 • Number of events 6 • 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.
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.
|
2.5%
2/81 • Number of events 2 • 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.
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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER