Gouty Arthritis
Conditions
Keywords
Gouty, Gouty arthritis, Gout flares, Anti-interleukin-1β monoclonal antibody
Brief summary
This 24-week open-label extension study is designed to provide additional long-term safety data up to a total of 1-year for patients rolling over from the core study, and to collect further efficacy and tolerability data for all the patients, irrespective whether they have an acute flare of gout or not. Patients will be treated on demand with canakinumab (ACZ885) in this extension study.
Interventions
DRUGCanakinumab
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients who completed the core study CACZ885H2251. A patient is defined as completing the core study if he/she completed the study up to and including the last visit (Visit 9). * Patients who have signed a written informed consent before any trial procedure is performed.
Exclusion criteria
* Patients for whom continuation in the extension 1 is not considered appropriate by the treating physician. * Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive pregnancy test (serum or urine). * Female patients who were physiologically capable of becoming pregnant, unless they were: * Female patients whose career, lifestyle, or sexual orientation precluded intercourse with a male partner. * Female patients whose partners had been sterilized by vasectomy or other means. * Using an acceptable method of contraception with a failure rate (Pearl Index (PI)) \< 1. * Reliable contraception had to be maintained throughout the study and for 2 months after study drug discontinuation. Other protocol defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events and Serious Adverse Events | From start of study up to study completion (up to 14 months) | Adverse events (AEs) were defined as any unfavourable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events (SAEs) were defined as any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalisation, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgement of investigators represent significant hazards |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference Change From Baseline in Participant's Gout Pain During First Flare | Baseline and Day 7 | Gout pain was assessed using Visual analogue scale (VAS) with a range of 0 to 100 where 0= no pain, 100= unbearable pain. Difference from time of study drug administration (pre-dose) was reported. |
| Number of Participants Achieved Patient's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category | 24 weeks | Patient's global assessment of response to treatment is 5-point Likert scale:1.Excellent, 2.Good, 3.Acceptable, 4.Slight, 5.Poor. Lower the score better the outcome. |
| Number of Participants Achieved Physician's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category | 24 weeks | Physician's global assessment of response to treatment is 5-point Likert scale:1.Very good, 2.Good, 3.Fair, 4.Poor, 5.Very poor. Lower the score better the outcome. |
| Number of Participants Reported No Pain, No Swelling, Absent Erythema on Physician's Assessment of Tenderness, Swelling and Erythema in Most Affected Joint During the First Flare in Participants Treated With Canakinumab by Parameter, Visit and Group | 24 weeks | Tenderness was rated on a 0-3 point scale: 0=no pain, 1=patient states that there is pain, 2=patient states there is pain and winces, and 3=patient states there is pain, winces and withdraws on palpation or passive movement of the most affected joint. Swelling was rated on a 0-3 point scale: 0=no swelling, 1=palpable, 2=visible, and 3=bulging beyond the joint margins. Erythema was rated as present, absent, or not assessable. Assessments were performed at the flare and control visits. |
| Amount of Rescue Medication After Study Drug Intake in Participants Treated With Canakinumab by Flare Order, Medication and Group | 24 weeks | The amount of naproxen and prednisolone taken after receiving treatment for each of the first 3 flares was recorded. |
Countries
Argentina, Belgium, Colombia, Czechia, Germany, Guatemala, Hungary, Poland, Portugal, Russia, Singapore, Slovakia, South Africa, Spain, Taiwan, Turkey (Türkiye), United Kingdom, United States
Participant flow
Recruitment details
The study was conducted at 75 centers in 18 countries.
Pre-assignment details
A total of 341 participants enrolled in the study, out of which 330 participants completed the study.
Participants by arm
| Arm | Count |
|---|---|
| Core: Canakinumab, Extension: 150 mg Canakinumab Participants who were randomized to canakinumab in the core study (NCT00819585 \[CACZ885H2251\]), received single subcutaneous (SC) dose of 150 milligrams (mg) canakinumab (ACZ885) for at least one flare in this extension study (NCT00927810 \[CACZ885H2251E1\]). | 75 |
| Core: Canakinumab, Extension: No Canakinumab Participants who were randomized to canakinumab in the core study (NCT00819585 \[CACZ885H2251\]) and who did not received canakinumab in this extension study (NCT00927810 \[CACZ885H2251E1\]). | 181 |
| Core: Colchicine, Extension: 150 mg Canakinumab Participants who were randomized to colchicine in the core study (NCT00819585 \[CACZ885H2251\]), received single subcutaneous (SC) dose of 150 milligrams (mg) Canakinumab (ACZ885) for at least one flare in this extension study (NCT00927810 \[CACZ885H2251E1\]). | 25 |
| Core: Colchicine, Extension: No Canakinumab Participants who were randomized to colchicine in the core study (NCT00819585 \[CACZ885H2251\]) and who did not received canakinumab in this extension study (NCT00927810 \[CACZ885H2251E1\]). | 60 |
| Total | 341 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Abnormal laboratory value(s) | 0 | 1 | 0 | 0 |
| Overall Study | Death | 0 | 2 | 0 | 0 |
| Overall Study | Lost to Follow-up | 0 | 2 | 1 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 3 | 0 | 1 |
Baseline characteristics
| Characteristic | Core: Canakinumab, Extension: 150 mg Canakinumab | Core: Canakinumab, Extension: No Canakinumab | Core: Colchicine, Extension: 150 mg Canakinumab | Core: Colchicine, Extension: No Canakinumab | Total |
|---|---|---|---|---|---|
| Age, Continuous | 50.7 years STANDARD_DEVIATION 10.2 | 53.8 years STANDARD_DEVIATION 11.39 | 52.0 years STANDARD_DEVIATION 11 | 51.5 years STANDARD_DEVIATION 9.45 | 52.6 years STANDARD_DEVIATION 10.83 |
| Race/Ethnicity, Customized Asian | 11 Participants | 10 Participants | 2 Participants | 2 Participants | 25 Participants |
| Race/Ethnicity, Customized Black | 2 Participants | 6 Participants | 1 Participants | 1 Participants | 10 Participants |
| Race/Ethnicity, Customized Caucasian | 46 Participants | 143 Participants | 19 Participants | 49 Participants | 257 Participants |
| Race/Ethnicity, Customized Native American | 1 Participants | 3 Participants | 0 Participants | 1 Participants | 5 Participants |
| Race/Ethnicity, Customized Other | 15 Participants | 19 Participants | 3 Participants | 5 Participants | 42 Participants |
| Race/Ethnicity, Customized Pacific islander | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 2 Participants |
| Sex: Female, Male Female | 2 Participants | 13 Participants | 0 Participants | 7 Participants | 22 Participants |
| Sex: Female, Male Male | 73 Participants | 168 Participants | 25 Participants | 53 Participants | 319 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 55 | 0 / 54 | 0 / 54 | 0 / 54 | 0 / 53 | 0 / 53 | 1 / 108 | 0 / 75 | 2 / 181 | 0 / 25 | 0 / 60 |
| other Total, other adverse events | 21 / 55 | 15 / 54 | 14 / 54 | 14 / 54 | 15 / 53 | 14 / 53 | 21 / 108 | 21 / 75 | 19 / 181 | 6 / 25 | 4 / 60 |
| serious Total, serious adverse events | 2 / 55 | 2 / 54 | 3 / 54 | 3 / 54 | 3 / 53 | 1 / 53 | 6 / 108 | 4 / 75 | 6 / 181 | 0 / 25 | 1 / 60 |
Outcome results
Primary
Number of Participants With Adverse Events and Serious Adverse Events
Adverse events (AEs) were defined as any unfavourable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events (SAEs) were defined as any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalisation, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgement of investigators represent significant hazards
Time frame: From start of study up to study completion (up to 14 months)
Population: Safety Set 1 consisted of all participants from the core study who entered the extension study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Core: Canakinumab, Extension: 150 mg Canakinumab | Number of Participants With Adverse Events and Serious Adverse Events | 31 Participants |
| Core: Canakinumab, Extension: No Canakinumab | Number of Participants With Adverse Events and Serious Adverse Events | 52 Participants |
| Core: Colchicine, Extension: 150 mg Canakinumab | Number of Participants With Adverse Events and Serious Adverse Events | 9 Participants |
| Core: Colchicine, Extension: No Canakinumab | Number of Participants With Adverse Events and Serious Adverse Events | 15 Participants |
Secondary
Amount of Rescue Medication After Study Drug Intake in Participants Treated With Canakinumab by Flare Order, Medication and Group
The amount of naproxen and prednisolone taken after receiving treatment for each of the first 3 flares was recorded.
Time frame: 24 weeks
Population: Efficacy Set consisted of all participants who received at least one dose of canakinumab in this extension study (NCT00927810 \[CACZ885H2251E1\]. Here the number of participants analyzed signifies participants who were evaluable for this measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Core: Canakinumab, Extension: 150 mg Canakinumab | Amount of Rescue Medication After Study Drug Intake in Participants Treated With Canakinumab by Flare Order, Medication and Group | 2.Gout flare-Naproxen | 650.0 milligrams (mg) | Standard Deviation 642.79 |
| Core: Canakinumab, Extension: 150 mg Canakinumab | Amount of Rescue Medication After Study Drug Intake in Participants Treated With Canakinumab by Flare Order, Medication and Group | 3.Gout flare-Prednisolone | 0.0 milligrams (mg) | Standard Deviation 0 |
| Core: Canakinumab, Extension: 150 mg Canakinumab | Amount of Rescue Medication After Study Drug Intake in Participants Treated With Canakinumab by Flare Order, Medication and Group | 2.Gout flare-Prednisolone | 1.3 milligrams (mg) | Standard Deviation 3.11 |
| Core: Canakinumab, Extension: 150 mg Canakinumab | Amount of Rescue Medication After Study Drug Intake in Participants Treated With Canakinumab by Flare Order, Medication and Group | 1.Gout flare-Prednisolone | 4.6 milligrams (mg) | Standard Deviation 20.84 |
| Core: Canakinumab, Extension: 150 mg Canakinumab | Amount of Rescue Medication After Study Drug Intake in Participants Treated With Canakinumab by Flare Order, Medication and Group | 3.Gout flare-Naproxen | 250.0 milligrams (mg) | Standard Deviation 500 |
| Core: Canakinumab, Extension: 150 mg Canakinumab | Amount of Rescue Medication After Study Drug Intake in Participants Treated With Canakinumab by Flare Order, Medication and Group | 1.Gout flare-Naproxen | 1086.8 milligrams (mg) | Standard Deviation 1592.72 |
| Core: Canakinumab, Extension: No Canakinumab | Amount of Rescue Medication After Study Drug Intake in Participants Treated With Canakinumab by Flare Order, Medication and Group | 3.Gout flare-Prednisolone | 0.0 milligrams (mg) | Standard Deviation 0 |
| Core: Canakinumab, Extension: No Canakinumab | Amount of Rescue Medication After Study Drug Intake in Participants Treated With Canakinumab by Flare Order, Medication and Group | 1.Gout flare-Naproxen | 954.6 milligrams (mg) | Standard Deviation 1130.19 |
| Core: Canakinumab, Extension: No Canakinumab | Amount of Rescue Medication After Study Drug Intake in Participants Treated With Canakinumab by Flare Order, Medication and Group | 1.Gout flare-Prednisolone | 4.2 milligrams (mg) | Standard Deviation 20.41 |
| Core: Canakinumab, Extension: No Canakinumab | Amount of Rescue Medication After Study Drug Intake in Participants Treated With Canakinumab by Flare Order, Medication and Group | 2.Gout flare-Naproxen | 200.0 milligrams (mg) | Standard Deviation 447.21 |
| Core: Canakinumab, Extension: No Canakinumab | Amount of Rescue Medication After Study Drug Intake in Participants Treated With Canakinumab by Flare Order, Medication and Group | 2.Gout flare-Prednisolone | 0.0 milligrams (mg) | Standard Deviation 0 |
| Core: Canakinumab, Extension: No Canakinumab | Amount of Rescue Medication After Study Drug Intake in Participants Treated With Canakinumab by Flare Order, Medication and Group | 3.Gout flare-Naproxen | 0.0 milligrams (mg) | Standard Deviation 0 |
Secondary
Difference Change From Baseline in Participant's Gout Pain During First Flare
Gout pain was assessed using Visual analogue scale (VAS) with a range of 0 to 100 where 0= no pain, 100= unbearable pain. Difference from time of study drug administration (pre-dose) was reported.
Time frame: Baseline and Day 7
Population: Efficacy Set consisted of all participants who received at least one dose of canakinumab in this extension study (NCT00927810 \[CACZ885H2251E1\]. Here the number of participants analyzed signifies participants who were evaluable for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Core: Canakinumab, Extension: 150 mg Canakinumab | Difference Change From Baseline in Participant's Gout Pain During First Flare | -51.7 units on a scale | Standard Deviation 15.86 |
| Core: Canakinumab, Extension: No Canakinumab | Difference Change From Baseline in Participant's Gout Pain During First Flare | -67.4 units on a scale | Standard Deviation 21.69 |
Secondary
Number of Participants Achieved Patient's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category
Patient's global assessment of response to treatment is 5-point Likert scale:1.Excellent, 2.Good, 3.Acceptable, 4.Slight, 5.Poor. Lower the score better the outcome.
Time frame: 24 weeks
Population: Efficacy Set consisted of all participants who received at least one dose of canakinumab in this extension study (NCT00927810 \[CACZ885H2251E1\]. Here the number of participants analyzed signifies participants who were evaluable for this measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Core: Canakinumab, Extension: 150 mg Canakinumab | Number of Participants Achieved Patient's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category | 1. Gout Flare: Poor | 0 Participants |
| Core: Canakinumab, Extension: 150 mg Canakinumab | Number of Participants Achieved Patient's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category | 2. Gout Flare: Slight | 0 Participants |
| Core: Canakinumab, Extension: 150 mg Canakinumab | Number of Participants Achieved Patient's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category | 1. Gout Flare: Good | 17 Participants |
| Core: Canakinumab, Extension: 150 mg Canakinumab | Number of Participants Achieved Patient's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category | 2. Gout Flare: Poor | 0 Participants |
| Core: Canakinumab, Extension: 150 mg Canakinumab | Number of Participants Achieved Patient's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category | 2. Gout Flare: Excellent | 4 Participants |
| Core: Canakinumab, Extension: 150 mg Canakinumab | Number of Participants Achieved Patient's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category | 3. Gout Flare: Excellent | 2 Participants |
| Core: Canakinumab, Extension: 150 mg Canakinumab | Number of Participants Achieved Patient's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category | 1. Gout Flare: Slight | 1 Participants |
| Core: Canakinumab, Extension: 150 mg Canakinumab | Number of Participants Achieved Patient's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category | 3. Gout Flare: Good | 1 Participants |
| Core: Canakinumab, Extension: 150 mg Canakinumab | Number of Participants Achieved Patient's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category | 2. Gout Flare: Good | 6 Participants |
| Core: Canakinumab, Extension: 150 mg Canakinumab | Number of Participants Achieved Patient's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category | 3. Gout Flare: Acceptable | 0 Participants |
| Core: Canakinumab, Extension: 150 mg Canakinumab | Number of Participants Achieved Patient's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category | 1. Gout Flare: Acceptable | 5 Participants |
| Core: Canakinumab, Extension: 150 mg Canakinumab | Number of Participants Achieved Patient's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category | 3. Gout Flare: Slight | 0 Participants |
| Core: Canakinumab, Extension: 150 mg Canakinumab | Number of Participants Achieved Patient's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category | 2. Gout Flare: Acceptable | 1 Participants |
| Core: Canakinumab, Extension: 150 mg Canakinumab | Number of Participants Achieved Patient's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category | 3. Gout Flare: Poor | 0 Participants |
| Core: Canakinumab, Extension: 150 mg Canakinumab | Number of Participants Achieved Patient's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category | 1. Gout Flare: Excellent | 40 Participants |
| Core: Canakinumab, Extension: No Canakinumab | Number of Participants Achieved Patient's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category | 3. Gout Flare: Poor | 0 Participants |
| Core: Canakinumab, Extension: No Canakinumab | Number of Participants Achieved Patient's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category | 1. Gout Flare: Excellent | 7 Participants |
| Core: Canakinumab, Extension: No Canakinumab | Number of Participants Achieved Patient's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category | 1. Gout Flare: Good | 14 Participants |
| Core: Canakinumab, Extension: No Canakinumab | Number of Participants Achieved Patient's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category | 1. Gout Flare: Acceptable | 0 Participants |
| Core: Canakinumab, Extension: No Canakinumab | Number of Participants Achieved Patient's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category | 1. Gout Flare: Slight | 0 Participants |
| Core: Canakinumab, Extension: No Canakinumab | Number of Participants Achieved Patient's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category | 1. Gout Flare: Poor | 0 Participants |
| Core: Canakinumab, Extension: No Canakinumab | Number of Participants Achieved Patient's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category | 2. Gout Flare: Excellent | 4 Participants |
| Core: Canakinumab, Extension: No Canakinumab | Number of Participants Achieved Patient's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category | 2. Gout Flare: Good | 1 Participants |
| Core: Canakinumab, Extension: No Canakinumab | Number of Participants Achieved Patient's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category | 2. Gout Flare: Acceptable | 0 Participants |
| Core: Canakinumab, Extension: No Canakinumab | Number of Participants Achieved Patient's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category | 2. Gout Flare: Slight | 0 Participants |
| Core: Canakinumab, Extension: No Canakinumab | Number of Participants Achieved Patient's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category | 2. Gout Flare: Poor | 0 Participants |
| Core: Canakinumab, Extension: No Canakinumab | Number of Participants Achieved Patient's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category | 3. Gout Flare: Excellent | 0 Participants |
| Core: Canakinumab, Extension: No Canakinumab | Number of Participants Achieved Patient's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category | 3. Gout Flare: Good | 1 Participants |
| Core: Canakinumab, Extension: No Canakinumab | Number of Participants Achieved Patient's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category | 3. Gout Flare: Acceptable | 0 Participants |
| Core: Canakinumab, Extension: No Canakinumab | Number of Participants Achieved Patient's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category | 3. Gout Flare: Slight | 0 Participants |
Secondary
Number of Participants Achieved Physician's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category
Physician's global assessment of response to treatment is 5-point Likert scale:1.Very good, 2.Good, 3.Fair, 4.Poor, 5.Very poor. Lower the score better the outcome.
Time frame: 24 weeks
Population: Efficacy Set consisted of all participants who received at least one dose of canakinumab in this extension study (NCT00927810 \[CACZ885H2251E1\]. Here the number of participants analyzed signifies participants who were evaluable for this measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Core: Canakinumab, Extension: 150 mg Canakinumab | Number of Participants Achieved Physician's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category | 1. Gout Flare: Very Good | 37 Participants |
| Core: Canakinumab, Extension: 150 mg Canakinumab | Number of Participants Achieved Physician's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category | 1. Gout Flare: Fair | 2 Participants |
| Core: Canakinumab, Extension: 150 mg Canakinumab | Number of Participants Achieved Physician's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category | 1. Gout Flare: Poor | 2 Participants |
| Core: Canakinumab, Extension: 150 mg Canakinumab | Number of Participants Achieved Physician's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category | 1. Gout Flare: Very Poor | 0 Participants |
| Core: Canakinumab, Extension: 150 mg Canakinumab | Number of Participants Achieved Physician's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category | 2. Gout Flare: Good | 7 Participants |
| Core: Canakinumab, Extension: 150 mg Canakinumab | Number of Participants Achieved Physician's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category | 2. Gout Flare: Fair | 0 Participants |
| Core: Canakinumab, Extension: 150 mg Canakinumab | Number of Participants Achieved Physician's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category | 2. Gout Flare: Poor | 0 Participants |
| Core: Canakinumab, Extension: 150 mg Canakinumab | Number of Participants Achieved Physician's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category | 3. Gout Flare: Very Good | 1 Participants |
| Core: Canakinumab, Extension: 150 mg Canakinumab | Number of Participants Achieved Physician's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category | 3. Gout Flare: Good | 2 Participants |
| Core: Canakinumab, Extension: 150 mg Canakinumab | Number of Participants Achieved Physician's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category | 3. Gout Flare: Poor | 0 Participants |
| Core: Canakinumab, Extension: 150 mg Canakinumab | Number of Participants Achieved Physician's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category | 3. Gout Flare: Very poor | 0 Participants |
| Core: Canakinumab, Extension: 150 mg Canakinumab | Number of Participants Achieved Physician's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category | 1. Gout Flare: Good | 28 Participants |
| Core: Canakinumab, Extension: 150 mg Canakinumab | Number of Participants Achieved Physician's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category | 2. Gout Flare: Very good | 5 Participants |
| Core: Canakinumab, Extension: 150 mg Canakinumab | Number of Participants Achieved Physician's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category | 2. Gout Flare: Very poor | 0 Participants |
| Core: Canakinumab, Extension: 150 mg Canakinumab | Number of Participants Achieved Physician's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category | 3. Gout Flare: Fair | 0 Participants |
| Core: Canakinumab, Extension: No Canakinumab | Number of Participants Achieved Physician's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category | 1. Gout Flare: Very Poor | 0 Participants |
| Core: Canakinumab, Extension: No Canakinumab | Number of Participants Achieved Physician's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category | 3. Gout Flare: Fair | 0 Participants |
| Core: Canakinumab, Extension: No Canakinumab | Number of Participants Achieved Physician's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category | 1. Gout Flare: Fair | 0 Participants |
| Core: Canakinumab, Extension: No Canakinumab | Number of Participants Achieved Physician's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category | 3. Gout Flare: Good | 1 Participants |
| Core: Canakinumab, Extension: No Canakinumab | Number of Participants Achieved Physician's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category | 1. Gout Flare: Poor | 0 Participants |
| Core: Canakinumab, Extension: No Canakinumab | Number of Participants Achieved Physician's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category | 3. Gout Flare: Poor | 0 Participants |
| Core: Canakinumab, Extension: No Canakinumab | Number of Participants Achieved Physician's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category | 2. Gout Flare: Very good | 3 Participants |
| Core: Canakinumab, Extension: No Canakinumab | Number of Participants Achieved Physician's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category | 2. Gout Flare: Poor | 0 Participants |
| Core: Canakinumab, Extension: No Canakinumab | Number of Participants Achieved Physician's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category | 2. Gout Flare: Good | 2 Participants |
| Core: Canakinumab, Extension: No Canakinumab | Number of Participants Achieved Physician's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category | 1. Gout Flare: Very Good | 13 Participants |
| Core: Canakinumab, Extension: No Canakinumab | Number of Participants Achieved Physician's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category | 2. Gout Flare: Fair | 0 Participants |
| Core: Canakinumab, Extension: No Canakinumab | Number of Participants Achieved Physician's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category | 3. Gout Flare: Very poor | 0 Participants |
| Core: Canakinumab, Extension: No Canakinumab | Number of Participants Achieved Physician's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category | 2. Gout Flare: Very poor | 0 Participants |
| Core: Canakinumab, Extension: No Canakinumab | Number of Participants Achieved Physician's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category | 1. Gout Flare: Good | 10 Participants |
| Core: Canakinumab, Extension: No Canakinumab | Number of Participants Achieved Physician's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category | 3. Gout Flare: Very Good | 0 Participants |
Secondary
Number of Participants Reported No Pain, No Swelling, Absent Erythema on Physician's Assessment of Tenderness, Swelling and Erythema in Most Affected Joint During the First Flare in Participants Treated With Canakinumab by Parameter, Visit and Group
Tenderness was rated on a 0-3 point scale: 0=no pain, 1=patient states that there is pain, 2=patient states there is pain and winces, and 3=patient states there is pain, winces and withdraws on palpation or passive movement of the most affected joint. Swelling was rated on a 0-3 point scale: 0=no swelling, 1=palpable, 2=visible, and 3=bulging beyond the joint margins. Erythema was rated as present, absent, or not assessable. Assessments were performed at the flare and control visits.
Time frame: 24 weeks
Population: Efficacy Set consisted of all participants who received at least one dose of canakinumab in this extension study (NCT00927810 \[CACZ885H2251E1\]. Here the number of participants analyzed signifies participants who were evaluable for this measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Core: Canakinumab, Extension: 150 mg Canakinumab | Number of Participants Reported No Pain, No Swelling, Absent Erythema on Physician's Assessment of Tenderness, Swelling and Erythema in Most Affected Joint During the First Flare in Participants Treated With Canakinumab by Parameter, Visit and Group | Erythema-Control Visit-Absent | 66 Participants |
| Core: Canakinumab, Extension: 150 mg Canakinumab | Number of Participants Reported No Pain, No Swelling, Absent Erythema on Physician's Assessment of Tenderness, Swelling and Erythema in Most Affected Joint During the First Flare in Participants Treated With Canakinumab by Parameter, Visit and Group | Joint swelling-Control Visit-No swelling | 61 Participants |
| Core: Canakinumab, Extension: 150 mg Canakinumab | Number of Participants Reported No Pain, No Swelling, Absent Erythema on Physician's Assessment of Tenderness, Swelling and Erythema in Most Affected Joint During the First Flare in Participants Treated With Canakinumab by Parameter, Visit and Group | Tenderness-Flare Visit- No pain | 2 Participants |
| Core: Canakinumab, Extension: 150 mg Canakinumab | Number of Participants Reported No Pain, No Swelling, Absent Erythema on Physician's Assessment of Tenderness, Swelling and Erythema in Most Affected Joint During the First Flare in Participants Treated With Canakinumab by Parameter, Visit and Group | Erythema-Flare Visit-Absent | 21 Participants |
| Core: Canakinumab, Extension: 150 mg Canakinumab | Number of Participants Reported No Pain, No Swelling, Absent Erythema on Physician's Assessment of Tenderness, Swelling and Erythema in Most Affected Joint During the First Flare in Participants Treated With Canakinumab by Parameter, Visit and Group | Tenderness-Control Visit- No pain | 60 Participants |
| Core: Canakinumab, Extension: 150 mg Canakinumab | Number of Participants Reported No Pain, No Swelling, Absent Erythema on Physician's Assessment of Tenderness, Swelling and Erythema in Most Affected Joint During the First Flare in Participants Treated With Canakinumab by Parameter, Visit and Group | Joint swelling-Flare Visit-No swelling | 5 Participants |
| Core: Canakinumab, Extension: No Canakinumab | Number of Participants Reported No Pain, No Swelling, Absent Erythema on Physician's Assessment of Tenderness, Swelling and Erythema in Most Affected Joint During the First Flare in Participants Treated With Canakinumab by Parameter, Visit and Group | Tenderness-Control Visit- No pain | 21 Participants |
| Core: Canakinumab, Extension: No Canakinumab | Number of Participants Reported No Pain, No Swelling, Absent Erythema on Physician's Assessment of Tenderness, Swelling and Erythema in Most Affected Joint During the First Flare in Participants Treated With Canakinumab by Parameter, Visit and Group | Joint swelling-Control Visit-No swelling | 22 Participants |
| Core: Canakinumab, Extension: No Canakinumab | Number of Participants Reported No Pain, No Swelling, Absent Erythema on Physician's Assessment of Tenderness, Swelling and Erythema in Most Affected Joint During the First Flare in Participants Treated With Canakinumab by Parameter, Visit and Group | Joint swelling-Flare Visit-No swelling | 0 Participants |
| Core: Canakinumab, Extension: No Canakinumab | Number of Participants Reported No Pain, No Swelling, Absent Erythema on Physician's Assessment of Tenderness, Swelling and Erythema in Most Affected Joint During the First Flare in Participants Treated With Canakinumab by Parameter, Visit and Group | Erythema-Flare Visit-Absent | 4 Participants |
| Core: Canakinumab, Extension: No Canakinumab | Number of Participants Reported No Pain, No Swelling, Absent Erythema on Physician's Assessment of Tenderness, Swelling and Erythema in Most Affected Joint During the First Flare in Participants Treated With Canakinumab by Parameter, Visit and Group | Erythema-Control Visit-Absent | 24 Participants |
| Core: Canakinumab, Extension: No Canakinumab | Number of Participants Reported No Pain, No Swelling, Absent Erythema on Physician's Assessment of Tenderness, Swelling and Erythema in Most Affected Joint During the First Flare in Participants Treated With Canakinumab by Parameter, Visit and Group | Tenderness-Flare Visit- No pain | 0 Participants |