Gouty Arthritis
Conditions
Keywords
Gout, Inflammatory gout, acute gout
Brief summary
The purpose of this pivotal Phase III study is to support the registration of canakinumab for the indication of gout in China, a replicate of global studies CACZ885H2356 & CACZ885H2357 by demonstrating in patients with frequent flares of gout for whom NSAIDs and/or colchicine are contraindicated, not tolerated or ineffective, canakinumab 150 mg s.c. given upon acute gout flares relieves the signs and symptoms and prevents recurrence of gout flares compared to triamcinolone acetonide 40 mg i.m.
Interventions
DRUGCanakinumab, ACZ885
Canakinumab and placebo matching to triamcinolone acetonide
DRUGTriamcinolone acetonide
Triamcinolone acetonide 40 mg and placebo matching to canakinumab
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Meeting diagnosis criteria for acute arthritis of primary gout. * Start of acute gout flare within 5 days prior to study visit 1 * History of ≥ 3 gout flares within the 12 months prior to study start * Evidence of contraindication (absolute or relative), or intolerance, or lack of efficacy for either NSAIDs and/or colchicines
Exclusion criteria
* Requirement for administration of antibiotics against latent tuberculosis (TB), e.g., isoniazide * Refractory heart failure (Stage D). * Unstable cardiac arrhythmias or unstable symptomatic coronary ischemia * Secondary gout, chemotherapy induced gout, lead induced gout and transplant gout * Rheumatoid arthritis, evidence/suspicion of infectious/septic arthritis, or other acute inflammatory arthritis Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Change in the Gout Pain Intensity in the Target Joint Following ACZ885 Administration Measured by Visual Analog Scale (VAS) | at 72 hours post-dose | A higher score indicates greater pain intensity. Based on the distribution of pain VAS scores in postsurgical patients (knee replacement, hysterectomy, or laparoscopic myomectomy) who described their postoperative pain intensity as none, mild, moderate, or severe, the following cut points on the pain VAS have been recommended: no pain (0 - 4 mm), mild pain (5- 44 mm), moderate pain (45-74 mm), and severe pain (75- 100 mm) |
| Time to First New Flare: Survival Analysis by Treatment: Kaplan Meier Analysis | 12 weeks | Measure canakinumab 150 mg s.c. is superior to triamcinolone acetonide 40 mg i.m. with respect to the time to the first new gout flare in observation period of 12 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment | baseline through week 12 | Patients will score their current pain intensity in the most affected joint of the gout flare on a 5-point Likert scale (none, mild, moderate, severe, extreme). |
| Patient's Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale. | 72 hours through week 12 | Patients will score their response to pain on a 7-point Likert scale (excellent, good ,acceptable, slight,poor,very poor,not done). |
| Physician's Assessment of Tenderness: Frequency Table by Timepoint and Treatment | baseline 72 hours,7 days 4 weeks, 8 weeks and 12 weeks post dose | Physicians will score their response to pain on a 5-point Likert scale (no pain, pain,pain and winces,pain winces and withdraws and not assessed). |
| Physician's Assessment of Swelling: Frequency Table by Timepoint and Treatment | baseline 72 hours,7 days 4 weeks, 8 weeks and 12 weeks post dose | Physicians will score their response to pain on a 5-point Likert scale (no pain, pain,pain and winces,pain winces and withdraws and not assessed). |
| Physician's Assessment of Erythema: Frequency Table by Timepoint and Treatment | baseline 72 hours,7 days 4 weeks, 8 weeks and 12 weeks post dose | Physicians will score their response of erythema on a 4-point Likert scale (absent, present not assessed and not assessable). |
| Physician's Assessment of Range of Motion: Frequency Table by Timepoint and Treatment | baseline through week 12 | Physicians will score their response ofrange of motion on a 5-point Likert scale (normal,mildly restricted, moderately restricted, severely restricted and immolbilized). |
| The Number of Patients With at Least 1 New Gout Flare | 12 weeks | — |
| Time to Complete Resolution of Pain: Survival Analysis by Treatment | 12 weeks | Kaplan Meier estimate |
| Time to First Rescue Medication Intake | 12 weeks | — |
| Percent Patients Who Took Rescue Medication | 12 weeks | — |
| Amount of Rescue Medication Taken at Baseline Flare and Post Baseline Flare. | 12 weeks | Paracetamol / acetaminophen, Prednisolone and Prednisone taken at baseline flare and post baseline flare. |
| High Sensitivity C-reactive Protein [hsCRP] Measured in the Serum at 72 Hours Post Dose | 72 hours post dose | — |
| Time to at Least a 50% Reduction in Baseline Pain Intensity: Survival Analysis by Treatment | 12 weeks | Kaplan Meier estimate |
| Patients Assessment of Gout Pain Intensity in the Most Effected Joint (0-100mm VAS): Summary Statistics by Timepoint and Treatment | baseline through 12 weeks | A higher score indicates greater pain intensity. Based on the distribution of pain VAS scores in postsurgical patients (knee replacement, hysterectomy, or laparoscopic myomectomy) who described their postoperative pain intensity as none, mild, moderate, or severe, the following cut points on the pain VAS have been recommended: no pain (0 - 4 mm), mild pain (5- 44 mm), moderate pain (45-74 mm), and severe pain (75- 100 mm) |
Countries
Argentina, China, Poland, Singapore
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ACZ885 150 mg Patients were treated with canakinumab 150 mg s.c and matching placebo for triamcinolone acetonide i.m. | 67 |
| Triamcinolone Acetonide 40 mg triamcinolone acetonide 40 mg i.m. and matching placebo for canakinumab s.c. | 69 |
| Total | 136 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 2 |
| Overall Study | Lack of Efficacy | 0 | 2 |
| Overall Study | Lost to Follow-up | 3 | 1 |
| Overall Study | Protocol Violation | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 2 |
Baseline characteristics
| Characteristic | ACZ885 150 mg | Triamcinolone Acetonide 40 mg | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 9 Participants | 3 Participants | 12 Participants |
| Age, Categorical Between 18 and 65 years | 58 Participants | 66 Participants | 124 Participants |
| Age, Continuous | 50.2 years STANDARD_DEVIATION 11.98 | 49.2 years STANDARD_DEVIATION 11.37 | 49.7 years STANDARD_DEVIATION 11.64 |
| Sex: Female, Male Female | 1 Participants | 2 Participants | 3 Participants |
| Sex: Female, Male Male | 66 Participants | 67 Participants | 133 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 67 | 4 / 69 |
| serious Total, serious adverse events | 0 / 67 | 1 / 69 |
Outcome results
Primary
The Change in the Gout Pain Intensity in the Target Joint Following ACZ885 Administration Measured by Visual Analog Scale (VAS)
A higher score indicates greater pain intensity. Based on the distribution of pain VAS scores in postsurgical patients (knee replacement, hysterectomy, or laparoscopic myomectomy) who described their postoperative pain intensity as none, mild, moderate, or severe, the following cut points on the pain VAS have been recommended: no pain (0 - 4 mm), mild pain (5- 44 mm), moderate pain (45-74 mm), and severe pain (75- 100 mm)
Time frame: at 72 hours post-dose
Population: Full Analysis set
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| ACZ885 150 mg | The Change in the Gout Pain Intensity in the Target Joint Following ACZ885 Administration Measured by Visual Analog Scale (VAS) | 18.2 units on a scale | Standard Error 3.03 |
| Triamcinolone Acetonide 40 mg | The Change in the Gout Pain Intensity in the Target Joint Following ACZ885 Administration Measured by Visual Analog Scale (VAS) | 37.9 units on a scale | Standard Error 3.03 |
p-value: <0.000195% CI: [-28.2, -11.2]ANCOVA
Primary
Time to First New Flare: Survival Analysis by Treatment: Kaplan Meier Analysis
Measure canakinumab 150 mg s.c. is superior to triamcinolone acetonide 40 mg i.m. with respect to the time to the first new gout flare in observation period of 12 weeks
Time frame: 12 weeks
Population: Full Analysis Set
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| ACZ885 150 mg | Time to First New Flare: Survival Analysis by Treatment: Kaplan Meier Analysis | 5 Participants | 95% Confidence Interval 3.03 |
| Triamcinolone Acetonide 40 mg | Time to First New Flare: Survival Analysis by Treatment: Kaplan Meier Analysis | 17 Participants | 95% Confidence Interval 3.03 |
p-value: 0.004395% CI: [0.1, 0.71]Regression, Cox
Secondary
Amount of Rescue Medication Taken at Baseline Flare and Post Baseline Flare.
Paracetamol / acetaminophen, Prednisolone and Prednisone taken at baseline flare and post baseline flare.
Time frame: 12 weeks
Population: FAS
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ACZ885 150 mg | Amount of Rescue Medication Taken at Baseline Flare and Post Baseline Flare. | Baseline flare Paracetamol / acetaminophen | 342.5 mg | Standard Deviation 680.53 |
| ACZ885 150 mg | Amount of Rescue Medication Taken at Baseline Flare and Post Baseline Flare. | Last post-baseline flare Paraceta/acetamin n=4,9 | 287.5 mg | Standard Deviation 337.58 |
| ACZ885 150 mg | Amount of Rescue Medication Taken at Baseline Flare and Post Baseline Flare. | Baseline Flare Prednisone | 0.7 mg | Standard Deviation 5.52 |
| ACZ885 150 mg | Amount of Rescue Medication Taken at Baseline Flare and Post Baseline Flare. | Last post-baseline flare Prednisolone n=4,9 | 5.0 mg | Standard Deviation 10 |
| ACZ885 150 mg | Amount of Rescue Medication Taken at Baseline Flare and Post Baseline Flare. | Baseline flare Prednisolol | 1.1 mg | Standard Deviation 4.25 |
| ACZ885 150 mg | Amount of Rescue Medication Taken at Baseline Flare and Post Baseline Flare. | Last post-baseline flare Prednisone n=4,9 | 0.0 mg | Standard Deviation 0 |
| ACZ885 150 mg | Amount of Rescue Medication Taken at Baseline Flare and Post Baseline Flare. | Baseline flare Codeine | 0.0 mg | Standard Deviation 0 |
| Triamcinolone Acetonide 40 mg | Amount of Rescue Medication Taken at Baseline Flare and Post Baseline Flare. | Last post-baseline flare Prednisone n=4,9 | 0.6 mg | Standard Deviation 1.67 |
| Triamcinolone Acetonide 40 mg | Amount of Rescue Medication Taken at Baseline Flare and Post Baseline Flare. | Baseline flare Paracetamol / acetaminophen | 451.4 mg | Standard Deviation 744.19 |
| Triamcinolone Acetonide 40 mg | Amount of Rescue Medication Taken at Baseline Flare and Post Baseline Flare. | Baseline flare Prednisolol | 5.0 mg | Standard Deviation 15.29 |
| Triamcinolone Acetonide 40 mg | Amount of Rescue Medication Taken at Baseline Flare and Post Baseline Flare. | Baseline Flare Prednisone | 5.2 mg | Standard Deviation 30.42 |
| Triamcinolone Acetonide 40 mg | Amount of Rescue Medication Taken at Baseline Flare and Post Baseline Flare. | Baseline flare Codeine | 0.4 mg | Standard Deviation 3.61 |
| Triamcinolone Acetonide 40 mg | Amount of Rescue Medication Taken at Baseline Flare and Post Baseline Flare. | Last post-baseline flare Paraceta/acetamin n=4,9 | 222.2 mg | Standard Deviation 666.67 |
| Triamcinolone Acetonide 40 mg | Amount of Rescue Medication Taken at Baseline Flare and Post Baseline Flare. | Last post-baseline flare Prednisolone n=4,9 | 4.4 mg | Standard Deviation 8.82 |
Secondary
High Sensitivity C-reactive Protein [hsCRP] Measured in the Serum at 72 Hours Post Dose
Time frame: 72 hours post dose
| Arm | Measure | Value (MEAN) |
|---|---|---|
| ACZ885 150 mg | High Sensitivity C-reactive Protein [hsCRP] Measured in the Serum at 72 Hours Post Dose | 5.5 mg/L |
| Triamcinolone Acetonide 40 mg | High Sensitivity C-reactive Protein [hsCRP] Measured in the Serum at 72 Hours Post Dose | 7.2 mg/L |
Secondary
Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment
Patients will score their current pain intensity in the most affected joint of the gout flare on a 5-point Likert scale (none, mild, moderate, severe, extreme).
Time frame: baseline through week 12
Population: Full Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ACZ885 150 mg | Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment | 6 hours post-dose extreme | 2 participants |
| ACZ885 150 mg | Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment | 72 hours post-dose severe | 0 participants |
| ACZ885 150 mg | Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment | baseline mild | 2 participants |
| ACZ885 150 mg | Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment | 72 hours post-dose extreme | 0 participants |
| ACZ885 150 mg | Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment | 12 hours post-dose none | 1 participants |
| ACZ885 150 mg | Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment | 4 days post-dose none | 21 participants |
| ACZ885 150 mg | Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment | baseline severe | 37 participants |
| ACZ885 150 mg | Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment | 4 days post-dose mild | 39 participants |
| ACZ885 150 mg | Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment | 12 hours post-dose mild | 28 participants |
| ACZ885 150 mg | Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment | 4 days post-dose moderate | 7 participants |
| ACZ885 150 mg | Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment | baseline moderate | 25 participants |
| ACZ885 150 mg | Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment | 4 days post-dose severe | 0 participants |
| ACZ885 150 mg | Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment | 12 hours post-dose moderate | 28 participants |
| ACZ885 150 mg | Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment | 4 days post-dose extreme | 0 participants |
| ACZ885 150 mg | Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment | 12 hours post-dose extreme | 1 participants |
| ACZ885 150 mg | Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment | 7 days post-dose none | 32 participants |
| ACZ885 150 mg | Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment | baseline extreme | 3 participants |
| ACZ885 150 mg | Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment | 7 days post-dose mild | 29 participants |
| ACZ885 150 mg | Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment | 24 hours post-dose none | 3 participants |
| ACZ885 150 mg | Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment | 7 days post-dose moderate | 5 participants |
| ACZ885 150 mg | Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment | 48 hours post-dose extreme | 0 participants |
| ACZ885 150 mg | Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment | 7 days post-dose severe | 1 participants |
| ACZ885 150 mg | Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment | 24 hours post-dose mild | 40 participants |
| ACZ885 150 mg | Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment | 7 days post-dose extreme | 0 participants |
| ACZ885 150 mg | Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment | 6 hours post-dose none | 0 participants |
| ACZ885 150 mg | Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment | 4 weeks post-dose none | 43 participants |
| ACZ885 150 mg | Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment | 24 hours post-dose moderate | 19 participants |
| ACZ885 150 mg | Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment | 4 weeks post-dose mild | 17 participants |
| ACZ885 150 mg | Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment | 12 hours post-dose severe | 7 participants |
| ACZ885 150 mg | Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment | 4 weeks post-dose moderate | 4 participants |
| ACZ885 150 mg | Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment | 24 hours post-dose severe | 2 participants |
| ACZ885 150 mg | Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment | 4 weeks post-dose severe | 1 participants |
| ACZ885 150 mg | Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment | 6 hours post-dose mild | 18 participants |
| ACZ885 150 mg | Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment | 4 weeks post-dose extreme | 0 participants |
| ACZ885 150 mg | Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment | 24 hours post-dose extreme | 1 participants |
| ACZ885 150 mg | Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment | 8 weeks post-dose none | 39 participants |
| ACZ885 150 mg | Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment | 72 hours post-dose none | 14 participants |
| ACZ885 150 mg | Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment | 8 weeks post-dose mild | 22 participants |
| ACZ885 150 mg | Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment | 48 hours post-dose none | 10 participants |
| ACZ885 150 mg | Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment | 8 weeks post-dose moderate | 2 participants |
| ACZ885 150 mg | Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment | 6 hours post-dose moderate | 28 participants |
| ACZ885 150 mg | Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment | 8 weeks post-dose severe | 2 participants |
| ACZ885 150 mg | Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment | 48 hours post-dose mild | 48 participants |
| ACZ885 150 mg | Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment | 8 weeks post-dose extreme | 0 participants |
| ACZ885 150 mg | Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment | baseline none | 0 participants |
| ACZ885 150 mg | Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment | 12 weeks post-dose none | 41 participants |
| ACZ885 150 mg | Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment | 48 hours post-dose moderate | 7 participants |
| ACZ885 150 mg | Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment | 12 weeks post-dose mild | 18 participants |
| ACZ885 150 mg | Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment | 6 hours post-dose severe | 17 participants |
| ACZ885 150 mg | Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment | 12 weeks post-dose moderate | 3 participants |
| ACZ885 150 mg | Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment | 72 hours post-dose mild | 45 participants |
| ACZ885 150 mg | Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment | 12 weeks post-dose severe | 2 participants |
| ACZ885 150 mg | Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment | 48 hours post-dose severe | 2 participants |
| ACZ885 150 mg | Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment | 12 weeks post-dose extreme | 0 participants |
| ACZ885 150 mg | Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment | 72 hours post-dose moderate | 8 participants |
| Triamcinolone Acetonide 40 mg | Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment | 12 weeks post-dose extreme | 1 participants |
| Triamcinolone Acetonide 40 mg | Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment | baseline severe | 44 participants |
| Triamcinolone Acetonide 40 mg | Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment | 12 hours post-dose moderate | 26 participants |
| Triamcinolone Acetonide 40 mg | Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment | 12 hours post-dose severe | 21 participants |
| Triamcinolone Acetonide 40 mg | Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment | 48 hours post-dose moderate | 20 participants |
| Triamcinolone Acetonide 40 mg | Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment | 48 hours post-dose severe | 14 participants |
| Triamcinolone Acetonide 40 mg | Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment | 48 hours post-dose extreme | 2 participants |
| Triamcinolone Acetonide 40 mg | Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment | baseline none | 0 participants |
| Triamcinolone Acetonide 40 mg | Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment | baseline mild | 3 participants |
| Triamcinolone Acetonide 40 mg | Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment | baseline extreme | 4 participants |
| Triamcinolone Acetonide 40 mg | Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment | 6 hours post-dose none | 0 participants |
| Triamcinolone Acetonide 40 mg | Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment | 6 hours post-dose mild | 14 participants |
| Triamcinolone Acetonide 40 mg | Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment | 6 hours post-dose moderate | 26 participants |
| Triamcinolone Acetonide 40 mg | Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment | 6 hours post-dose severe | 29 participants |
| Triamcinolone Acetonide 40 mg | Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment | 6 hours post-dose extreme | 0 participants |
| Triamcinolone Acetonide 40 mg | Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment | 12 hours post-dose none | 2 participants |
| Triamcinolone Acetonide 40 mg | Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment | 12 hours post-dose mild | 19 participants |
| Triamcinolone Acetonide 40 mg | Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment | 12 hours post-dose extreme | 1 participants |
| Triamcinolone Acetonide 40 mg | Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment | 24 hours post-dose none | 4 participants |
| Triamcinolone Acetonide 40 mg | Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment | 24 hours post-dose mild | 20 participants |
| Triamcinolone Acetonide 40 mg | Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment | 24 hours post-dose moderate | 25 participants |
| Triamcinolone Acetonide 40 mg | Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment | 24 hours post-dose severe | 20 participants |
| Triamcinolone Acetonide 40 mg | Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment | 24 hours post-dose extreme | 0 participants |
| Triamcinolone Acetonide 40 mg | Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment | 48 hours post-dose none | 10 participants |
| Triamcinolone Acetonide 40 mg | Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment | 48 hours post-dose mild | 21 participants |
| Triamcinolone Acetonide 40 mg | Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment | 72 hours post-dose none | 12 participants |
| Triamcinolone Acetonide 40 mg | Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment | 72 hours post-dose mild | 26 participants |
| Triamcinolone Acetonide 40 mg | Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment | 72 hours post-dose moderate | 16 participants |
| Triamcinolone Acetonide 40 mg | Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment | 72 hours post-dose severe | 9 participants |
| Triamcinolone Acetonide 40 mg | Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment | 72 hours post-dose extreme | 4 participants |
| Triamcinolone Acetonide 40 mg | Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment | 4 days post-dose none | 14 participants |
| Triamcinolone Acetonide 40 mg | Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment | 4 days post-dose mild | 29 participants |
| Triamcinolone Acetonide 40 mg | Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment | 4 days post-dose moderate | 13 participants |
| Triamcinolone Acetonide 40 mg | Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment | 4 days post-dose severe | 10 participants |
| Triamcinolone Acetonide 40 mg | Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment | 4 days post-dose extreme | 0 participants |
| Triamcinolone Acetonide 40 mg | Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment | 7 days post-dose none | 23 participants |
| Triamcinolone Acetonide 40 mg | Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment | 7 days post-dose mild | 25 participants |
| Triamcinolone Acetonide 40 mg | Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment | 7 days post-dose moderate | 10 participants |
| Triamcinolone Acetonide 40 mg | Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment | 7 days post-dose severe | 8 participants |
| Triamcinolone Acetonide 40 mg | Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment | 7 days post-dose extreme | 0 participants |
| Triamcinolone Acetonide 40 mg | Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment | 4 weeks post-dose none | 24 participants |
| Triamcinolone Acetonide 40 mg | Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment | 4 weeks post-dose mild | 25 participants |
| Triamcinolone Acetonide 40 mg | Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment | 4 weeks post-dose moderate | 6 participants |
| Triamcinolone Acetonide 40 mg | Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment | 4 weeks post-dose severe | 0 participants |
| Triamcinolone Acetonide 40 mg | Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment | 4 weeks post-dose extreme | 0 participants |
| Triamcinolone Acetonide 40 mg | Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment | 8 weeks post-dose none | 30 participants |
| Triamcinolone Acetonide 40 mg | Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment | 8 weeks post-dose mild | 21 participants |
| Triamcinolone Acetonide 40 mg | Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment | 8 weeks post-dose moderate | 6 participants |
| Triamcinolone Acetonide 40 mg | Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment | 8 weeks post-dose severe | 2 participants |
| Triamcinolone Acetonide 40 mg | Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment | 8 weeks post-dose extreme | 0 participants |
| Triamcinolone Acetonide 40 mg | Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment | 12 weeks post-dose none | 25 participants |
| Triamcinolone Acetonide 40 mg | Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment | 12 weeks post-dose mild | 28 participants |
| Triamcinolone Acetonide 40 mg | Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment | 12 weeks post-dose moderate | 8 participants |
| Triamcinolone Acetonide 40 mg | Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment | 12 weeks post-dose severe | 1 participants |
| Triamcinolone Acetonide 40 mg | Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment | baseline moderate | 18 participants |
Secondary
Patients Assessment of Gout Pain Intensity in the Most Effected Joint (0-100mm VAS): Summary Statistics by Timepoint and Treatment
A higher score indicates greater pain intensity. Based on the distribution of pain VAS scores in postsurgical patients (knee replacement, hysterectomy, or laparoscopic myomectomy) who described their postoperative pain intensity as none, mild, moderate, or severe, the following cut points on the pain VAS have been recommended: no pain (0 - 4 mm), mild pain (5- 44 mm), moderate pain (45-74 mm), and severe pain (75- 100 mm)
Time frame: baseline through 12 weeks
Population: Full Analysis set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ACZ885 150 mg | Patients Assessment of Gout Pain Intensity in the Most Effected Joint (0-100mm VAS): Summary Statistics by Timepoint and Treatment | baseline | 72.3 unit on a scale | Standard Deviation 13.18 |
| ACZ885 150 mg | Patients Assessment of Gout Pain Intensity in the Most Effected Joint (0-100mm VAS): Summary Statistics by Timepoint and Treatment | 6 hours post-dose | 53.0 unit on a scale | Standard Deviation 22.06 |
| ACZ885 150 mg | Patients Assessment of Gout Pain Intensity in the Most Effected Joint (0-100mm VAS): Summary Statistics by Timepoint and Treatment | 12 hours post-dose | 41.7 unit on a scale | Standard Deviation 19.56 |
| ACZ885 150 mg | Patients Assessment of Gout Pain Intensity in the Most Effected Joint (0-100mm VAS): Summary Statistics by Timepoint and Treatment | 24 hours post-dose | 30.9 unit on a scale | Standard Deviation 18.23 |
| ACZ885 150 mg | Patients Assessment of Gout Pain Intensity in the Most Effected Joint (0-100mm VAS): Summary Statistics by Timepoint and Treatment | 48 hours post-dose | 22.0 unit on a scale | Standard Deviation 18.64 |
| ACZ885 150 mg | Patients Assessment of Gout Pain Intensity in the Most Effected Joint (0-100mm VAS): Summary Statistics by Timepoint and Treatment | 72 hours post-dose | 17.4 unit on a scale | Standard Deviation 17.02 |
| ACZ885 150 mg | Patients Assessment of Gout Pain Intensity in the Most Effected Joint (0-100mm VAS): Summary Statistics by Timepoint and Treatment | 7 days post-dose | 10.1 unit on a scale | Standard Deviation 15.61 |
| ACZ885 150 mg | Patients Assessment of Gout Pain Intensity in the Most Effected Joint (0-100mm VAS): Summary Statistics by Timepoint and Treatment | 4 weeks post-dose | 9.5 unit on a scale | Standard Deviation 17.25 |
| ACZ885 150 mg | Patients Assessment of Gout Pain Intensity in the Most Effected Joint (0-100mm VAS): Summary Statistics by Timepoint and Treatment | 8 weeks post-dose | 6.8 unit on a scale | Standard Deviation 13.64 |
| ACZ885 150 mg | Patients Assessment of Gout Pain Intensity in the Most Effected Joint (0-100mm VAS): Summary Statistics by Timepoint and Treatment | 12 weeks post-dose | 6.8 unit on a scale | Standard Deviation 12.92 |
| Triamcinolone Acetonide 40 mg | Patients Assessment of Gout Pain Intensity in the Most Effected Joint (0-100mm VAS): Summary Statistics by Timepoint and Treatment | 4 weeks post-dose | 17.9 unit on a scale | Standard Deviation 25.31 |
| Triamcinolone Acetonide 40 mg | Patients Assessment of Gout Pain Intensity in the Most Effected Joint (0-100mm VAS): Summary Statistics by Timepoint and Treatment | baseline | 74.5 unit on a scale | Standard Deviation 12.88 |
| Triamcinolone Acetonide 40 mg | Patients Assessment of Gout Pain Intensity in the Most Effected Joint (0-100mm VAS): Summary Statistics by Timepoint and Treatment | 72 hours post-dose | 36.6 unit on a scale | Standard Deviation 30.62 |
| Triamcinolone Acetonide 40 mg | Patients Assessment of Gout Pain Intensity in the Most Effected Joint (0-100mm VAS): Summary Statistics by Timepoint and Treatment | 6 hours post-dose | 58.8 unit on a scale | Standard Deviation 23.83 |
| Triamcinolone Acetonide 40 mg | Patients Assessment of Gout Pain Intensity in the Most Effected Joint (0-100mm VAS): Summary Statistics by Timepoint and Treatment | 12 weeks post-dose | 13.0 unit on a scale | Standard Deviation 19.77 |
| Triamcinolone Acetonide 40 mg | Patients Assessment of Gout Pain Intensity in the Most Effected Joint (0-100mm VAS): Summary Statistics by Timepoint and Treatment | 12 hours post-dose | 51.8 unit on a scale | Standard Deviation 27.07 |
| Triamcinolone Acetonide 40 mg | Patients Assessment of Gout Pain Intensity in the Most Effected Joint (0-100mm VAS): Summary Statistics by Timepoint and Treatment | 7 days post-dose | 24.0 unit on a scale | Standard Deviation 27.31 |
| Triamcinolone Acetonide 40 mg | Patients Assessment of Gout Pain Intensity in the Most Effected Joint (0-100mm VAS): Summary Statistics by Timepoint and Treatment | 24 hours post-dose | 48.6 unit on a scale | Standard Deviation 29.13 |
| Triamcinolone Acetonide 40 mg | Patients Assessment of Gout Pain Intensity in the Most Effected Joint (0-100mm VAS): Summary Statistics by Timepoint and Treatment | 8 weeks post-dose | 16.0 unit on a scale | Standard Deviation 24.24 |
| Triamcinolone Acetonide 40 mg | Patients Assessment of Gout Pain Intensity in the Most Effected Joint (0-100mm VAS): Summary Statistics by Timepoint and Treatment | 48 hours post-dose | 43.9 unit on a scale | Standard Deviation 30.69 |
Secondary
Patient's Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale.
Patients will score their response to pain on a 7-point Likert scale (excellent, good ,acceptable, slight,poor,very poor,not done).
Time frame: 72 hours through week 12
Population: Full Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ACZ885 150 mg | Patient's Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale. | 72 hours post-dose slight | 4 participants |
| ACZ885 150 mg | Patient's Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale. | 4 weeks post-dose poor | 0 participants |
| ACZ885 150 mg | Patient's Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale. | 7 days post-dose acceptable | 9 participants |
| ACZ885 150 mg | Patient's Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale. | 4 weeks post-dose very poor | 0 participants |
| ACZ885 150 mg | Patient's Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale. | 72 hours post-dose good | 40 participants |
| ACZ885 150 mg | Patient's Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale. | 4 weeks post-dose not done | 0 participants |
| ACZ885 150 mg | Patient's Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale. | 7 days post-dose slight | 1 participants |
| ACZ885 150 mg | Patient's Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale. | 8 weeks post-dose excellent | 18 participants |
| ACZ885 150 mg | Patient's Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale. | 72 hours post-dose poor | 1 participants |
| ACZ885 150 mg | Patient's Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale. | 8 weeks post-dose good | 35 participants |
| ACZ885 150 mg | Patient's Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale. | 7 days post-dose poor | 1 participants |
| ACZ885 150 mg | Patient's Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale. | 8 weeks post-dose acceptable | 10 participants |
| ACZ885 150 mg | Patient's Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale. | 72 hours post-dose excellent | 7 participants |
| ACZ885 150 mg | Patient's Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale. | 8 weeks post-dose slight | 2 participants |
| ACZ885 150 mg | Patient's Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale. | 7 days post-dose very poor | 0 participants |
| ACZ885 150 mg | Patient's Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale. | 8 weeks post-dose poor | 0 participants |
| ACZ885 150 mg | Patient's Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale. | 72 hours post-dose very poor | 0 participants |
| ACZ885 150 mg | Patient's Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale. | 8 weeks post-dose very poor | 0 participants |
| ACZ885 150 mg | Patient's Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale. | 7 days post-dose not done | 0 participants |
| ACZ885 150 mg | Patient's Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale. | 8 weeks post-dose not done | 0 participants |
| ACZ885 150 mg | Patient's Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale. | 72 hours post-dose acceptable | 14 participants |
| ACZ885 150 mg | Patient's Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale. | 12 weeks post-dose excellent | 16 participants |
| ACZ885 150 mg | Patient's Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale. | 4 weeks post-dose excellent | 15 participants |
| ACZ885 150 mg | Patient's Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale. | 12 weeks post-dose good | 37 participants |
| ACZ885 150 mg | Patient's Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale. | 72 hours post-dose not done | 0 participants |
| ACZ885 150 mg | Patient's Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale. | 12 weeks post-dose acceptable | 10 participants |
| ACZ885 150 mg | Patient's Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale. | 4 weeks post-dose good | 33 participants |
| ACZ885 150 mg | Patient's Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale. | 12 weeks post-dose slight | 0 participants |
| ACZ885 150 mg | Patient's Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale. | 7 days post-dose excellent | 16 participants |
| ACZ885 150 mg | Patient's Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale. | 12 weeks post-dose poor | 1 participants |
| ACZ885 150 mg | Patient's Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale. | 4 weeks post-dose acceptable | 13 participants |
| ACZ885 150 mg | Patient's Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale. | 12 weeks post-dose very poor | 0 participants |
| ACZ885 150 mg | Patient's Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale. | 7 days post-dose good | 38 participants |
| ACZ885 150 mg | Patient's Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale. | 12 weeks post-dose not done | 3 participants |
| ACZ885 150 mg | Patient's Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale. | 4 weeks post-dose slight | 4 participants |
| Triamcinolone Acetonide 40 mg | Patient's Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale. | 12 weeks post-dose not done | 3 participants |
| Triamcinolone Acetonide 40 mg | Patient's Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale. | 72 hours post-dose excellent | 3 participants |
| Triamcinolone Acetonide 40 mg | Patient's Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale. | 72 hours post-dose good | 17 participants |
| Triamcinolone Acetonide 40 mg | Patient's Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale. | 72 hours post-dose acceptable | 18 participants |
| Triamcinolone Acetonide 40 mg | Patient's Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale. | 72 hours post-dose slight | 11 participants |
| Triamcinolone Acetonide 40 mg | Patient's Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale. | 72 hours post-dose poor | 10 participants |
| Triamcinolone Acetonide 40 mg | Patient's Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale. | 72 hours post-dose very poor | 0 participants |
| Triamcinolone Acetonide 40 mg | Patient's Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale. | 7 days post-dose excellent | 4 participants |
| Triamcinolone Acetonide 40 mg | Patient's Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale. | 7 days post-dose good | 20 participants |
| Triamcinolone Acetonide 40 mg | Patient's Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale. | 7 days post-dose acceptable | 18 participants |
| Triamcinolone Acetonide 40 mg | Patient's Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale. | 7 days post-dose slight | 7 participants |
| Triamcinolone Acetonide 40 mg | Patient's Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale. | 7 days post-dose poor | 16 participants |
| Triamcinolone Acetonide 40 mg | Patient's Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale. | 7 days post-dose very poor | 0 participants |
| Triamcinolone Acetonide 40 mg | Patient's Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale. | 7 days post-dose not done | 1 participants |
| Triamcinolone Acetonide 40 mg | Patient's Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale. | 4 weeks post-dose excellent | 6 participants |
| Triamcinolone Acetonide 40 mg | Patient's Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale. | 4 weeks post-dose good | 19 participants |
| Triamcinolone Acetonide 40 mg | Patient's Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale. | 4 weeks post-dose acceptable | 14 participants |
| Triamcinolone Acetonide 40 mg | Patient's Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale. | 4 weeks post-dose slight | 7 participants |
| Triamcinolone Acetonide 40 mg | Patient's Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale. | 4 weeks post-dose poor | 9 participants |
| Triamcinolone Acetonide 40 mg | Patient's Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale. | 4 weeks post-dose very poor | 0 participants |
| Triamcinolone Acetonide 40 mg | Patient's Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale. | 4 weeks post-dose not done | 2 participants |
| Triamcinolone Acetonide 40 mg | Patient's Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale. | 8 weeks post-dose excellent | 8 participants |
| Triamcinolone Acetonide 40 mg | Patient's Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale. | 8 weeks post-dose good | 16 participants |
| Triamcinolone Acetonide 40 mg | Patient's Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale. | 8 weeks post-dose acceptable | 18 participants |
| Triamcinolone Acetonide 40 mg | Patient's Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale. | 8 weeks post-dose slight | 9 participants |
| Triamcinolone Acetonide 40 mg | Patient's Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale. | 8 weeks post-dose poor | 8 participants |
| Triamcinolone Acetonide 40 mg | Patient's Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale. | 8 weeks post-dose very poor | 0 participants |
| Triamcinolone Acetonide 40 mg | Patient's Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale. | 8 weeks post-dose not done | 1 participants |
| Triamcinolone Acetonide 40 mg | Patient's Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale. | 12 weeks post-dose excellent | 4 participants |
| Triamcinolone Acetonide 40 mg | Patient's Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale. | 12 weeks post-dose good | 21 participants |
| Triamcinolone Acetonide 40 mg | Patient's Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale. | 12 weeks post-dose acceptable | 21 participants |
| Triamcinolone Acetonide 40 mg | Patient's Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale. | 12 weeks post-dose slight | 7 participants |
| Triamcinolone Acetonide 40 mg | Patient's Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale. | 12 weeks post-dose poor | 9 participants |
| Triamcinolone Acetonide 40 mg | Patient's Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale. | 12 weeks post-dose very poor | 0 participants |
| Triamcinolone Acetonide 40 mg | Patient's Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale. | 72 hours post-dose not done | 1 participants |
Secondary
Percent Patients Who Took Rescue Medication
Time frame: 12 weeks
Population: FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ACZ885 150 mg | Percent Patients Who Took Rescue Medication | Last post-baseline flare (n=3,4) | 75.0 percentage |
| ACZ885 150 mg | Percent Patients Who Took Rescue Medication | Baseline flare (n= 29,42) | 43.3 percentage |
| Triamcinolone Acetonide 40 mg | Percent Patients Who Took Rescue Medication | Baseline flare (n= 29,42) | 60.9 percentage |
| Triamcinolone Acetonide 40 mg | Percent Patients Who Took Rescue Medication | Last post-baseline flare (n=3,4) | 44.4 percentage |
Secondary
Physician's Assessment of Erythema: Frequency Table by Timepoint and Treatment
Physicians will score their response of erythema on a 4-point Likert scale (absent, present not assessed and not assessable).
Time frame: baseline 72 hours,7 days 4 weeks, 8 weeks and 12 weeks post dose
Population: Full analysis set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ACZ885 150 mg | Physician's Assessment of Erythema: Frequency Table by Timepoint and Treatment | Baseline Absent | 19 participants |
| ACZ885 150 mg | Physician's Assessment of Erythema: Frequency Table by Timepoint and Treatment | 4 weeks post-dose not assessable | 1 participants |
| ACZ885 150 mg | Physician's Assessment of Erythema: Frequency Table by Timepoint and Treatment | Baseline present | 48 participants |
| ACZ885 150 mg | Physician's Assessment of Erythema: Frequency Table by Timepoint and Treatment | Baseline not assessed | 0 participants |
| ACZ885 150 mg | Physician's Assessment of Erythema: Frequency Table by Timepoint and Treatment | 8 weeks post-dose absent | 65 participants |
| ACZ885 150 mg | Physician's Assessment of Erythema: Frequency Table by Timepoint and Treatment | 12 weeks post-dose present | 1 participants |
| ACZ885 150 mg | Physician's Assessment of Erythema: Frequency Table by Timepoint and Treatment | Baseline not assessable | 0 participants |
| ACZ885 150 mg | Physician's Assessment of Erythema: Frequency Table by Timepoint and Treatment | 72 hours post-dose absent | 54 participants |
| ACZ885 150 mg | Physician's Assessment of Erythema: Frequency Table by Timepoint and Treatment | 72 hours post-dose present | 11 participants |
| ACZ885 150 mg | Physician's Assessment of Erythema: Frequency Table by Timepoint and Treatment | 72 hours post-dose not assessed | 0 participants |
| ACZ885 150 mg | Physician's Assessment of Erythema: Frequency Table by Timepoint and Treatment | 72 hrs post-dose not assessable | 1 participants |
| ACZ885 150 mg | Physician's Assessment of Erythema: Frequency Table by Timepoint and Treatment | 7 days post-dose absent | 62 participants |
| ACZ885 150 mg | Physician's Assessment of Erythema: Frequency Table by Timepoint and Treatment | 7 days post-dose present | 3 participants |
| ACZ885 150 mg | Physician's Assessment of Erythema: Frequency Table by Timepoint and Treatment | 7 days post-dose not assessed | 0 participants |
| ACZ885 150 mg | Physician's Assessment of Erythema: Frequency Table by Timepoint and Treatment | 7 days post-dose not assessable | 1 participants |
| ACZ885 150 mg | Physician's Assessment of Erythema: Frequency Table by Timepoint and Treatment | 4 weeks post-dose absent | 63 participants |
| ACZ885 150 mg | Physician's Assessment of Erythema: Frequency Table by Timepoint and Treatment | 4 weeks post-dose present | 1 participants |
| ACZ885 150 mg | Physician's Assessment of Erythema: Frequency Table by Timepoint and Treatment | 4 weeks post-dose not assessed | 0 participants |
| ACZ885 150 mg | Physician's Assessment of Erythema: Frequency Table by Timepoint and Treatment | 8 weeks post-dose present | 0 participants |
| ACZ885 150 mg | Physician's Assessment of Erythema: Frequency Table by Timepoint and Treatment | 8 weeks post-dose not assessed | 0 participants |
| ACZ885 150 mg | Physician's Assessment of Erythema: Frequency Table by Timepoint and Treatment | 8 weeks post-dose not assessable | 0 participants |
| ACZ885 150 mg | Physician's Assessment of Erythema: Frequency Table by Timepoint and Treatment | 12 weeks post-dose absent | 62 participants |
| ACZ885 150 mg | Physician's Assessment of Erythema: Frequency Table by Timepoint and Treatment | 12 weeks post-dose not assessed | 0 participants |
| ACZ885 150 mg | Physician's Assessment of Erythema: Frequency Table by Timepoint and Treatment | 12 wks post-dose not assessable | 1 participants |
| Triamcinolone Acetonide 40 mg | Physician's Assessment of Erythema: Frequency Table by Timepoint and Treatment | 4 weeks post-dose present | 6 participants |
| Triamcinolone Acetonide 40 mg | Physician's Assessment of Erythema: Frequency Table by Timepoint and Treatment | Baseline Absent | 19 participants |
| Triamcinolone Acetonide 40 mg | Physician's Assessment of Erythema: Frequency Table by Timepoint and Treatment | 7 days post-dose absent | 57 participants |
| Triamcinolone Acetonide 40 mg | Physician's Assessment of Erythema: Frequency Table by Timepoint and Treatment | 12 wks post-dose not assessable | 0 participants |
| Triamcinolone Acetonide 40 mg | Physician's Assessment of Erythema: Frequency Table by Timepoint and Treatment | Baseline present | 50 participants |
| Triamcinolone Acetonide 40 mg | Physician's Assessment of Erythema: Frequency Table by Timepoint and Treatment | 7 days post-dose present | 8 participants |
| Triamcinolone Acetonide 40 mg | Physician's Assessment of Erythema: Frequency Table by Timepoint and Treatment | Baseline not assessed | 0 participants |
| Triamcinolone Acetonide 40 mg | Physician's Assessment of Erythema: Frequency Table by Timepoint and Treatment | 4 weeks post-dose not assessed | 0 participants |
| Triamcinolone Acetonide 40 mg | Physician's Assessment of Erythema: Frequency Table by Timepoint and Treatment | 4 weeks post-dose not assessable | 0 participants |
| Triamcinolone Acetonide 40 mg | Physician's Assessment of Erythema: Frequency Table by Timepoint and Treatment | 8 weeks post-dose not assessable | 0 participants |
| Triamcinolone Acetonide 40 mg | Physician's Assessment of Erythema: Frequency Table by Timepoint and Treatment | 8 weeks post-dose absent | 56 participants |
| Triamcinolone Acetonide 40 mg | Physician's Assessment of Erythema: Frequency Table by Timepoint and Treatment | 12 weeks post-dose absent | 61 participants |
| Triamcinolone Acetonide 40 mg | Physician's Assessment of Erythema: Frequency Table by Timepoint and Treatment | 7 days post-dose not assessed | 0 participants |
| Triamcinolone Acetonide 40 mg | Physician's Assessment of Erythema: Frequency Table by Timepoint and Treatment | 12 weeks post-dose present | 1 participants |
| Triamcinolone Acetonide 40 mg | Physician's Assessment of Erythema: Frequency Table by Timepoint and Treatment | 8 weeks post-dose present | 3 participants |
| Triamcinolone Acetonide 40 mg | Physician's Assessment of Erythema: Frequency Table by Timepoint and Treatment | Baseline not assessable | 0 participants |
| Triamcinolone Acetonide 40 mg | Physician's Assessment of Erythema: Frequency Table by Timepoint and Treatment | 7 days post-dose not assessable | 0 participants |
| Triamcinolone Acetonide 40 mg | Physician's Assessment of Erythema: Frequency Table by Timepoint and Treatment | 72 hours post-dose absent | 41 participants |
| Triamcinolone Acetonide 40 mg | Physician's Assessment of Erythema: Frequency Table by Timepoint and Treatment | 12 weeks post-dose not assessed | 0 participants |
| Triamcinolone Acetonide 40 mg | Physician's Assessment of Erythema: Frequency Table by Timepoint and Treatment | 72 hours post-dose present | 15 participants |
| Triamcinolone Acetonide 40 mg | Physician's Assessment of Erythema: Frequency Table by Timepoint and Treatment | 4 weeks post-dose absent | 49 participants |
| Triamcinolone Acetonide 40 mg | Physician's Assessment of Erythema: Frequency Table by Timepoint and Treatment | 72 hours post-dose not assessed | 0 participants |
| Triamcinolone Acetonide 40 mg | Physician's Assessment of Erythema: Frequency Table by Timepoint and Treatment | 8 weeks post-dose not assessed | 0 participants |
| Triamcinolone Acetonide 40 mg | Physician's Assessment of Erythema: Frequency Table by Timepoint and Treatment | 72 hrs post-dose not assessable | 0 participants |
Secondary
Physician's Assessment of Range of Motion: Frequency Table by Timepoint and Treatment
Physicians will score their response ofrange of motion on a 5-point Likert scale (normal,mildly restricted, moderately restricted, severely restricted and immolbilized).
Time frame: baseline through week 12
Population: Full Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ACZ885 150 mg | Physician's Assessment of Range of Motion: Frequency Table by Timepoint and Treatment | baseline immobilzed | 5 participants |
| ACZ885 150 mg | Physician's Assessment of Range of Motion: Frequency Table by Timepoint and Treatment | 4 weeks post-dose normal | 49 participants |
| ACZ885 150 mg | Physician's Assessment of Range of Motion: Frequency Table by Timepoint and Treatment | 72 hours post-dose normal | 20 participants |
| ACZ885 150 mg | Physician's Assessment of Range of Motion: Frequency Table by Timepoint and Treatment | 72 hours post-dose moderately restricted | 11 participants |
| ACZ885 150 mg | Physician's Assessment of Range of Motion: Frequency Table by Timepoint and Treatment | 72 hours post-dose mildly restricted | 33 participants |
| ACZ885 150 mg | Physician's Assessment of Range of Motion: Frequency Table by Timepoint and Treatment | 7 days post-dose mildly restricted | 25 participants |
| ACZ885 150 mg | Physician's Assessment of Range of Motion: Frequency Table by Timepoint and Treatment | 4 weeks post-dose severely restricted | 1 participants |
| ACZ885 150 mg | Physician's Assessment of Range of Motion: Frequency Table by Timepoint and Treatment | 7 days post-dose moderately restricted | 4 participants |
| ACZ885 150 mg | Physician's Assessment of Range of Motion: Frequency Table by Timepoint and Treatment | 4 weeks post-dose mildly restricted | 12 participants |
| ACZ885 150 mg | Physician's Assessment of Range of Motion: Frequency Table by Timepoint and Treatment | 8 weeks post-dose moderately restricted | 1 participants |
| ACZ885 150 mg | Physician's Assessment of Range of Motion: Frequency Table by Timepoint and Treatment | 4 weeks post-dose moderately restricted | 3 participants |
| ACZ885 150 mg | Physician's Assessment of Range of Motion: Frequency Table by Timepoint and Treatment | 8 weeks post-dose severely restricted | 1 participants |
| ACZ885 150 mg | Physician's Assessment of Range of Motion: Frequency Table by Timepoint and Treatment | 4 weeks post-dose immobilized | 0 participants |
| ACZ885 150 mg | Physician's Assessment of Range of Motion: Frequency Table by Timepoint and Treatment | 72 hours post-dose immobilized | 0 participants |
| ACZ885 150 mg | Physician's Assessment of Range of Motion: Frequency Table by Timepoint and Treatment | 8 weeks post-dose normal | 51 participants |
| ACZ885 150 mg | Physician's Assessment of Range of Motion: Frequency Table by Timepoint and Treatment | baseline normal | 0 participants |
| ACZ885 150 mg | Physician's Assessment of Range of Motion: Frequency Table by Timepoint and Treatment | 8 weeks post-dose mildly restricted | 12 participants |
| ACZ885 150 mg | Physician's Assessment of Range of Motion: Frequency Table by Timepoint and Treatment | 7 days post-dose severely restricted | 1 participants |
| ACZ885 150 mg | Physician's Assessment of Range of Motion: Frequency Table by Timepoint and Treatment | 8 weeks post-dose immobilized | 0 participants |
| ACZ885 150 mg | Physician's Assessment of Range of Motion: Frequency Table by Timepoint and Treatment | baseline mildly restricted | 3 participants |
| ACZ885 150 mg | Physician's Assessment of Range of Motion: Frequency Table by Timepoint and Treatment | 12 weeks post-dose normal | 50 participants |
| ACZ885 150 mg | Physician's Assessment of Range of Motion: Frequency Table by Timepoint and Treatment | 72 hours post-dose severely restricted | 2 participants |
| ACZ885 150 mg | Physician's Assessment of Range of Motion: Frequency Table by Timepoint and Treatment | 12 weeks post-dose mildly restrcted | 1 participants |
| ACZ885 150 mg | Physician's Assessment of Range of Motion: Frequency Table by Timepoint and Treatment | baseline moderately restricted | 32 participants |
| ACZ885 150 mg | Physician's Assessment of Range of Motion: Frequency Table by Timepoint and Treatment | 12 weeks post-dose moderately restricted | 2 participants |
| ACZ885 150 mg | Physician's Assessment of Range of Motion: Frequency Table by Timepoint and Treatment | 7 days post-dose immobilized | 0 participants |
| ACZ885 150 mg | Physician's Assessment of Range of Motion: Frequency Table by Timepoint and Treatment | 12 weeks post-dose severely restricted | 1 participants |
| ACZ885 150 mg | Physician's Assessment of Range of Motion: Frequency Table by Timepoint and Treatment | baseline severely restricted | 27 participants |
| ACZ885 150 mg | Physician's Assessment of Range of Motion: Frequency Table by Timepoint and Treatment | 12 weeks post-dose immobilized | 0 participants |
| ACZ885 150 mg | Physician's Assessment of Range of Motion: Frequency Table by Timepoint and Treatment | 7 days post-dose normal | 35 participants |
| Triamcinolone Acetonide 40 mg | Physician's Assessment of Range of Motion: Frequency Table by Timepoint and Treatment | 12 weeks post-dose immobilized | 0 participants |
| Triamcinolone Acetonide 40 mg | Physician's Assessment of Range of Motion: Frequency Table by Timepoint and Treatment | 72 hours post-dose mildly restricted | 19 participants |
| Triamcinolone Acetonide 40 mg | Physician's Assessment of Range of Motion: Frequency Table by Timepoint and Treatment | 72 hours post-dose severely restricted | 7 participants |
| Triamcinolone Acetonide 40 mg | Physician's Assessment of Range of Motion: Frequency Table by Timepoint and Treatment | 72 hours post-dose immobilized | 1 participants |
| Triamcinolone Acetonide 40 mg | Physician's Assessment of Range of Motion: Frequency Table by Timepoint and Treatment | 7 days post-dose normal | 26 participants |
| Triamcinolone Acetonide 40 mg | Physician's Assessment of Range of Motion: Frequency Table by Timepoint and Treatment | 7 days post-dose moderately restricted | 15 participants |
| Triamcinolone Acetonide 40 mg | Physician's Assessment of Range of Motion: Frequency Table by Timepoint and Treatment | 7 days post-dose severely restricted | 3 participants |
| Triamcinolone Acetonide 40 mg | Physician's Assessment of Range of Motion: Frequency Table by Timepoint and Treatment | 7 days post-dose immobilized | 1 participants |
| Triamcinolone Acetonide 40 mg | Physician's Assessment of Range of Motion: Frequency Table by Timepoint and Treatment | 4 weeks post-dose moderately restricted | 7 participants |
| Triamcinolone Acetonide 40 mg | Physician's Assessment of Range of Motion: Frequency Table by Timepoint and Treatment | 8 weeks post-dose mildly restricted | 18 participants |
| Triamcinolone Acetonide 40 mg | Physician's Assessment of Range of Motion: Frequency Table by Timepoint and Treatment | 8 weeks post-dose severely restricted | 3 participants |
| Triamcinolone Acetonide 40 mg | Physician's Assessment of Range of Motion: Frequency Table by Timepoint and Treatment | baseline normal | 0 participants |
| Triamcinolone Acetonide 40 mg | Physician's Assessment of Range of Motion: Frequency Table by Timepoint and Treatment | baseline mildly restricted | 6 participants |
| Triamcinolone Acetonide 40 mg | Physician's Assessment of Range of Motion: Frequency Table by Timepoint and Treatment | baseline moderately restricted | 24 participants |
| Triamcinolone Acetonide 40 mg | Physician's Assessment of Range of Motion: Frequency Table by Timepoint and Treatment | baseline severely restricted | 39 participants |
| Triamcinolone Acetonide 40 mg | Physician's Assessment of Range of Motion: Frequency Table by Timepoint and Treatment | baseline immobilzed | 0 participants |
| Triamcinolone Acetonide 40 mg | Physician's Assessment of Range of Motion: Frequency Table by Timepoint and Treatment | 72 hours post-dose moderately restricted | 14 participants |
| Triamcinolone Acetonide 40 mg | Physician's Assessment of Range of Motion: Frequency Table by Timepoint and Treatment | 7 days post-dose mildly restricted | 20 participants |
| Triamcinolone Acetonide 40 mg | Physician's Assessment of Range of Motion: Frequency Table by Timepoint and Treatment | 4 weeks post-dose normal | 25 participants |
| Triamcinolone Acetonide 40 mg | Physician's Assessment of Range of Motion: Frequency Table by Timepoint and Treatment | 4 weeks post-dose mildly restricted | 22 participants |
| Triamcinolone Acetonide 40 mg | Physician's Assessment of Range of Motion: Frequency Table by Timepoint and Treatment | 4 weeks post-dose severely restricted | 1 participants |
| Triamcinolone Acetonide 40 mg | Physician's Assessment of Range of Motion: Frequency Table by Timepoint and Treatment | 4 weeks post-dose immobilized | 0 participants |
| Triamcinolone Acetonide 40 mg | Physician's Assessment of Range of Motion: Frequency Table by Timepoint and Treatment | 8 weeks post-dose normal | 32 participants |
| Triamcinolone Acetonide 40 mg | Physician's Assessment of Range of Motion: Frequency Table by Timepoint and Treatment | 8 weeks post-dose moderately restricted | 6 participants |
| Triamcinolone Acetonide 40 mg | Physician's Assessment of Range of Motion: Frequency Table by Timepoint and Treatment | 8 weeks post-dose immobilized | 0 participants |
| Triamcinolone Acetonide 40 mg | Physician's Assessment of Range of Motion: Frequency Table by Timepoint and Treatment | 12 weeks post-dose normal | 30 participants |
| Triamcinolone Acetonide 40 mg | Physician's Assessment of Range of Motion: Frequency Table by Timepoint and Treatment | 12 weeks post-dose mildly restrcted | 23 participants |
| Triamcinolone Acetonide 40 mg | Physician's Assessment of Range of Motion: Frequency Table by Timepoint and Treatment | 12 weeks post-dose moderately restricted | 6 participants |
| Triamcinolone Acetonide 40 mg | Physician's Assessment of Range of Motion: Frequency Table by Timepoint and Treatment | 12 weeks post-dose severely restricted | 3 participants |
| Triamcinolone Acetonide 40 mg | Physician's Assessment of Range of Motion: Frequency Table by Timepoint and Treatment | 72 hours post-dose normal | 15 participants |
Secondary
Physician's Assessment of Swelling: Frequency Table by Timepoint and Treatment
Physicians will score their response to pain on a 5-point Likert scale (no pain, pain,pain and winces,pain winces and withdraws and not assessed).
Time frame: baseline 72 hours,7 days 4 weeks, 8 weeks and 12 weeks post dose
Population: Full analysis set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ACZ885 150 mg | Physician's Assessment of Swelling: Frequency Table by Timepoint and Treatment | 12 weeks post-dose not assessed | 0 participants |
| ACZ885 150 mg | Physician's Assessment of Swelling: Frequency Table by Timepoint and Treatment | Baseline Palpable | 13 participants |
| ACZ885 150 mg | Physician's Assessment of Swelling: Frequency Table by Timepoint and Treatment | 72 hours post-dose No swelling | 38 participants |
| ACZ885 150 mg | Physician's Assessment of Swelling: Frequency Table by Timepoint and Treatment | 7 days post-dose Palpable | 9 participants |
| ACZ885 150 mg | Physician's Assessment of Swelling: Frequency Table by Timepoint and Treatment | 7 days post-dose Bulging beyond the joint margins | 1 participants |
| ACZ885 150 mg | Physician's Assessment of Swelling: Frequency Table by Timepoint and Treatment | 12 weeks post-dose Visible | 2 participants |
| ACZ885 150 mg | Physician's Assessment of Swelling: Frequency Table by Timepoint and Treatment | Baseline No swelling | 1 participants |
| ACZ885 150 mg | Physician's Assessment of Swelling: Frequency Table by Timepoint and Treatment | Baseline Visible | 29 participants |
| ACZ885 150 mg | Physician's Assessment of Swelling: Frequency Table by Timepoint and Treatment | Baseline Bulging beyond the joint margins | 24 participants |
| ACZ885 150 mg | Physician's Assessment of Swelling: Frequency Table by Timepoint and Treatment | Baseline not assessed | 0 participants |
| ACZ885 150 mg | Physician's Assessment of Swelling: Frequency Table by Timepoint and Treatment | 72 hours post-dose Palpable | 15 participants |
| ACZ885 150 mg | Physician's Assessment of Swelling: Frequency Table by Timepoint and Treatment | 72 hours post-dose Visible | 12 participants |
| ACZ885 150 mg | Physician's Assessment of Swelling: Frequency Table by Timepoint and Treatment | 72 hrs post-dose Bulging beyond the joint margins | 1 participants |
| ACZ885 150 mg | Physician's Assessment of Swelling: Frequency Table by Timepoint and Treatment | 72 hours post-dose not assessed | 0 participants |
| ACZ885 150 mg | Physician's Assessment of Swelling: Frequency Table by Timepoint and Treatment | 7 days post-dose No swelling | 53 participants |
| ACZ885 150 mg | Physician's Assessment of Swelling: Frequency Table by Timepoint and Treatment | 7 days post-dose Visible | 3 participants |
| ACZ885 150 mg | Physician's Assessment of Swelling: Frequency Table by Timepoint and Treatment | 7 days post-dose not assessed0 | 0 participants |
| ACZ885 150 mg | Physician's Assessment of Swelling: Frequency Table by Timepoint and Treatment | 4 weeks post-dose No swelling | 60 participants |
| ACZ885 150 mg | Physician's Assessment of Swelling: Frequency Table by Timepoint and Treatment | 4 weeks post-dose Palpable | 2 participants |
| ACZ885 150 mg | Physician's Assessment of Swelling: Frequency Table by Timepoint and Treatment | 4 weeks post-dose Visible | 3 participants |
| ACZ885 150 mg | Physician's Assessment of Swelling: Frequency Table by Timepoint and Treatment | 4 weeks post-dose Bulging beyond the joint margins | 0 participants |
| ACZ885 150 mg | Physician's Assessment of Swelling: Frequency Table by Timepoint and Treatment | 4 weeks post-dose not assessed | 0 participants |
| ACZ885 150 mg | Physician's Assessment of Swelling: Frequency Table by Timepoint and Treatment | 8 weeks post-dose No swelling | 63 participants |
| ACZ885 150 mg | Physician's Assessment of Swelling: Frequency Table by Timepoint and Treatment | 8 weeks post-dose Palpable | 0 participants |
| ACZ885 150 mg | Physician's Assessment of Swelling: Frequency Table by Timepoint and Treatment | 8 weeks post-dose Visible | 2 participants |
| ACZ885 150 mg | Physician's Assessment of Swelling: Frequency Table by Timepoint and Treatment | 8 weeks post-dose Bulging beyond the joint margins | 0 participants |
| ACZ885 150 mg | Physician's Assessment of Swelling: Frequency Table by Timepoint and Treatment | 8 weeks post-dose not assessed | 0 participants |
| ACZ885 150 mg | Physician's Assessment of Swelling: Frequency Table by Timepoint and Treatment | 12 weeks post-dose No swelling | 61 participants |
| ACZ885 150 mg | Physician's Assessment of Swelling: Frequency Table by Timepoint and Treatment | 12 weeks post-dose Palpable | 1 participants |
| ACZ885 150 mg | Physician's Assessment of Swelling: Frequency Table by Timepoint and Treatment | 12 wks post-dose Bulging beyond the joint margins | 0 participants |
| Triamcinolone Acetonide 40 mg | Physician's Assessment of Swelling: Frequency Table by Timepoint and Treatment | 8 weeks post-dose No swelling | 49 participants |
| Triamcinolone Acetonide 40 mg | Physician's Assessment of Swelling: Frequency Table by Timepoint and Treatment | 7 days post-dose Visible | 9 participants |
| Triamcinolone Acetonide 40 mg | Physician's Assessment of Swelling: Frequency Table by Timepoint and Treatment | Baseline Palpable | 12 participants |
| Triamcinolone Acetonide 40 mg | Physician's Assessment of Swelling: Frequency Table by Timepoint and Treatment | 8 weeks post-dose not assessed | 0 participants |
| Triamcinolone Acetonide 40 mg | Physician's Assessment of Swelling: Frequency Table by Timepoint and Treatment | 72 hours post-dose No swelling | 22 participants |
| Triamcinolone Acetonide 40 mg | Physician's Assessment of Swelling: Frequency Table by Timepoint and Treatment | 7 days post-dose No swelling | 35 participants |
| Triamcinolone Acetonide 40 mg | Physician's Assessment of Swelling: Frequency Table by Timepoint and Treatment | 7 days post-dose not assessed0 | 0 participants |
| Triamcinolone Acetonide 40 mg | Physician's Assessment of Swelling: Frequency Table by Timepoint and Treatment | 7 days post-dose Palpable | 18 participants |
| Triamcinolone Acetonide 40 mg | Physician's Assessment of Swelling: Frequency Table by Timepoint and Treatment | 8 weeks post-dose Palpable | 6 participants |
| Triamcinolone Acetonide 40 mg | Physician's Assessment of Swelling: Frequency Table by Timepoint and Treatment | 7 days post-dose Bulging beyond the joint margins | 3 participants |
| Triamcinolone Acetonide 40 mg | Physician's Assessment of Swelling: Frequency Table by Timepoint and Treatment | 12 weeks post-dose Palpable | 6 participants |
| Triamcinolone Acetonide 40 mg | Physician's Assessment of Swelling: Frequency Table by Timepoint and Treatment | 4 weeks post-dose No swelling | 40 participants |
| Triamcinolone Acetonide 40 mg | Physician's Assessment of Swelling: Frequency Table by Timepoint and Treatment | 12 weeks post-dose Visible | 2 participants |
| Triamcinolone Acetonide 40 mg | Physician's Assessment of Swelling: Frequency Table by Timepoint and Treatment | 12 weeks post-dose not assessed | 0 participants |
| Triamcinolone Acetonide 40 mg | Physician's Assessment of Swelling: Frequency Table by Timepoint and Treatment | Baseline No swelling | 3 participants |
| Triamcinolone Acetonide 40 mg | Physician's Assessment of Swelling: Frequency Table by Timepoint and Treatment | 4 weeks post-dose Palpable | 9 participants |
| Triamcinolone Acetonide 40 mg | Physician's Assessment of Swelling: Frequency Table by Timepoint and Treatment | Baseline Visible | 39 participants |
| Triamcinolone Acetonide 40 mg | Physician's Assessment of Swelling: Frequency Table by Timepoint and Treatment | 8 weeks post-dose Visible | 4 participants |
| Triamcinolone Acetonide 40 mg | Physician's Assessment of Swelling: Frequency Table by Timepoint and Treatment | Baseline Bulging beyond the joint margins | 15 participants |
| Triamcinolone Acetonide 40 mg | Physician's Assessment of Swelling: Frequency Table by Timepoint and Treatment | 4 weeks post-dose Visible | 4 participants |
| Triamcinolone Acetonide 40 mg | Physician's Assessment of Swelling: Frequency Table by Timepoint and Treatment | Baseline not assessed | 0 participants |
| Triamcinolone Acetonide 40 mg | Physician's Assessment of Swelling: Frequency Table by Timepoint and Treatment | 12 weeks post-dose No swelling | 52 participants |
| Triamcinolone Acetonide 40 mg | Physician's Assessment of Swelling: Frequency Table by Timepoint and Treatment | 72 hours post-dose Palpable | 15 participants |
| Triamcinolone Acetonide 40 mg | Physician's Assessment of Swelling: Frequency Table by Timepoint and Treatment | 4 weeks post-dose Bulging beyond the joint margins | 2 participants |
| Triamcinolone Acetonide 40 mg | Physician's Assessment of Swelling: Frequency Table by Timepoint and Treatment | 72 hours post-dose Visible | 18 participants |
| Triamcinolone Acetonide 40 mg | Physician's Assessment of Swelling: Frequency Table by Timepoint and Treatment | 8 weeks post-dose Bulging beyond the joint margins | 0 participants |
| Triamcinolone Acetonide 40 mg | Physician's Assessment of Swelling: Frequency Table by Timepoint and Treatment | 72 hrs post-dose Bulging beyond the joint margins | 1 participants |
| Triamcinolone Acetonide 40 mg | Physician's Assessment of Swelling: Frequency Table by Timepoint and Treatment | 4 weeks post-dose not assessed | 0 participants |
| Triamcinolone Acetonide 40 mg | Physician's Assessment of Swelling: Frequency Table by Timepoint and Treatment | 72 hours post-dose not assessed | 0 participants |
| Triamcinolone Acetonide 40 mg | Physician's Assessment of Swelling: Frequency Table by Timepoint and Treatment | 12 wks post-dose Bulging beyond the joint margins | 2 participants |
Secondary
Physician's Assessment of Tenderness: Frequency Table by Timepoint and Treatment
Physicians will score their response to pain on a 5-point Likert scale (no pain, pain,pain and winces,pain winces and withdraws and not assessed).
Time frame: baseline 72 hours,7 days 4 weeks, 8 weeks and 12 weeks post dose
Population: Full analysis set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ACZ885 150 mg | Physician's Assessment of Tenderness: Frequency Table by Timepoint and Treatment | 8 weeks post-dose pain and winces | 0 participants |
| ACZ885 150 mg | Physician's Assessment of Tenderness: Frequency Table by Timepoint and Treatment | 7 days post-dose pain | 23 participants |
| ACZ885 150 mg | Physician's Assessment of Tenderness: Frequency Table by Timepoint and Treatment | Baseline pain, winces and withdraws | 21 participants |
| ACZ885 150 mg | Physician's Assessment of Tenderness: Frequency Table by Timepoint and Treatment | 7 days post-dose pain and winces | 2 participants |
| ACZ885 150 mg | Physician's Assessment of Tenderness: Frequency Table by Timepoint and Treatment | 8 weeks post-dose no pain | 54 participants |
| ACZ885 150 mg | Physician's Assessment of Tenderness: Frequency Table by Timepoint and Treatment | Baseline not assessed | 0 participants |
| ACZ885 150 mg | Physician's Assessment of Tenderness: Frequency Table by Timepoint and Treatment | 4 weeks post-dose no pain | 54 participants |
| ACZ885 150 mg | Physician's Assessment of Tenderness: Frequency Table by Timepoint and Treatment | 8 weeks post-dose not assessed | 0 participants |
| ACZ885 150 mg | Physician's Assessment of Tenderness: Frequency Table by Timepoint and Treatment | 4 weeks post-dose pain | 10 participants |
| ACZ885 150 mg | Physician's Assessment of Tenderness: Frequency Table by Timepoint and Treatment | 72 hours post-dose no pain | 23 participants |
| ACZ885 150 mg | Physician's Assessment of Tenderness: Frequency Table by Timepoint and Treatment | 4 weeks post-dose pain and winces | 1 participants |
| ACZ885 150 mg | Physician's Assessment of Tenderness: Frequency Table by Timepoint and Treatment | Baseline no pain | 0 participants |
| ACZ885 150 mg | Physician's Assessment of Tenderness: Frequency Table by Timepoint and Treatment | 4 weeks post-dose pain, winces and withdraws | 0 participants |
| ACZ885 150 mg | Physician's Assessment of Tenderness: Frequency Table by Timepoint and Treatment | 72 hours post-dose pain | 37 participants |
| ACZ885 150 mg | Physician's Assessment of Tenderness: Frequency Table by Timepoint and Treatment | 4 weeks post-dose not assessed | 0 participants |
| ACZ885 150 mg | Physician's Assessment of Tenderness: Frequency Table by Timepoint and Treatment | 7 days post-dose not assessed | 0 participants |
| ACZ885 150 mg | Physician's Assessment of Tenderness: Frequency Table by Timepoint and Treatment | 8 weeks post-dose pain | 11 participants |
| ACZ885 150 mg | Physician's Assessment of Tenderness: Frequency Table by Timepoint and Treatment | 72 hours post-dose pain and winces | 5 participants |
| ACZ885 150 mg | Physician's Assessment of Tenderness: Frequency Table by Timepoint and Treatment | 8 weeks post-dose pain winces and withdraws | 0 participants |
| ACZ885 150 mg | Physician's Assessment of Tenderness: Frequency Table by Timepoint and Treatment | Baseline pain | 15 participants |
| ACZ885 150 mg | Physician's Assessment of Tenderness: Frequency Table by Timepoint and Treatment | 12 weeks post-dose no pain | 53 participants |
| ACZ885 150 mg | Physician's Assessment of Tenderness: Frequency Table by Timepoint and Treatment | 72 hours post-dose pain, winces and withdraws | 1 participants |
| ACZ885 150 mg | Physician's Assessment of Tenderness: Frequency Table by Timepoint and Treatment | 12 weeks post-dose pain | 7 participants |
| ACZ885 150 mg | Physician's Assessment of Tenderness: Frequency Table by Timepoint and Treatment | 7 days post-dose pain , winces and withdraws | 0 participants |
| ACZ885 150 mg | Physician's Assessment of Tenderness: Frequency Table by Timepoint and Treatment | 12 weeks post-dose pain and winces | 2 participants |
| ACZ885 150 mg | Physician's Assessment of Tenderness: Frequency Table by Timepoint and Treatment | 72 hours post-dose not assessed | 0 participants |
| ACZ885 150 mg | Physician's Assessment of Tenderness: Frequency Table by Timepoint and Treatment | 12 weeks post-dose pain, winces and withdraws | 2 participants |
| ACZ885 150 mg | Physician's Assessment of Tenderness: Frequency Table by Timepoint and Treatment | Baseline pain and winces | 31 participants |
| ACZ885 150 mg | Physician's Assessment of Tenderness: Frequency Table by Timepoint and Treatment | 12 weeks post-dose not assessed | 0 participants |
| ACZ885 150 mg | Physician's Assessment of Tenderness: Frequency Table by Timepoint and Treatment | 7 days post-dose no pain | 41 participants |
| Triamcinolone Acetonide 40 mg | Physician's Assessment of Tenderness: Frequency Table by Timepoint and Treatment | 12 weeks post-dose not assessed | 0 participants |
| Triamcinolone Acetonide 40 mg | Physician's Assessment of Tenderness: Frequency Table by Timepoint and Treatment | 8 weeks post-dose no pain | 38 participants |
| Triamcinolone Acetonide 40 mg | Physician's Assessment of Tenderness: Frequency Table by Timepoint and Treatment | 8 weeks post-dose pain | 19 participants |
| Triamcinolone Acetonide 40 mg | Physician's Assessment of Tenderness: Frequency Table by Timepoint and Treatment | 8 weeks post-dose pain winces and withdraws | 1 participants |
| Triamcinolone Acetonide 40 mg | Physician's Assessment of Tenderness: Frequency Table by Timepoint and Treatment | Baseline no pain | 0 participants |
| Triamcinolone Acetonide 40 mg | Physician's Assessment of Tenderness: Frequency Table by Timepoint and Treatment | Baseline pain | 16 participants |
| Triamcinolone Acetonide 40 mg | Physician's Assessment of Tenderness: Frequency Table by Timepoint and Treatment | Baseline pain and winces | 29 participants |
| Triamcinolone Acetonide 40 mg | Physician's Assessment of Tenderness: Frequency Table by Timepoint and Treatment | Baseline pain, winces and withdraws | 24 participants |
| Triamcinolone Acetonide 40 mg | Physician's Assessment of Tenderness: Frequency Table by Timepoint and Treatment | Baseline not assessed | 0 participants |
| Triamcinolone Acetonide 40 mg | Physician's Assessment of Tenderness: Frequency Table by Timepoint and Treatment | 72 hours post-dose no pain | 16 participants |
| Triamcinolone Acetonide 40 mg | Physician's Assessment of Tenderness: Frequency Table by Timepoint and Treatment | 72 hours post-dose pain | 26 participants |
| Triamcinolone Acetonide 40 mg | Physician's Assessment of Tenderness: Frequency Table by Timepoint and Treatment | 72 hours post-dose pain and winces | 11 participants |
| Triamcinolone Acetonide 40 mg | Physician's Assessment of Tenderness: Frequency Table by Timepoint and Treatment | 72 hours post-dose pain, winces and withdraws | 3 participants |
| Triamcinolone Acetonide 40 mg | Physician's Assessment of Tenderness: Frequency Table by Timepoint and Treatment | 72 hours post-dose not assessed | 0 participants |
| Triamcinolone Acetonide 40 mg | Physician's Assessment of Tenderness: Frequency Table by Timepoint and Treatment | 7 days post-dose no pain | 26 participants |
| Triamcinolone Acetonide 40 mg | Physician's Assessment of Tenderness: Frequency Table by Timepoint and Treatment | 7 days post-dose pain | 27 participants |
| Triamcinolone Acetonide 40 mg | Physician's Assessment of Tenderness: Frequency Table by Timepoint and Treatment | 7 days post-dose pain and winces | 10 participants |
| Triamcinolone Acetonide 40 mg | Physician's Assessment of Tenderness: Frequency Table by Timepoint and Treatment | 7 days post-dose not assessed | 0 participants |
| Triamcinolone Acetonide 40 mg | Physician's Assessment of Tenderness: Frequency Table by Timepoint and Treatment | 4 weeks post-dose no pain | 30 participants |
| Triamcinolone Acetonide 40 mg | Physician's Assessment of Tenderness: Frequency Table by Timepoint and Treatment | 4 weeks post-dose pain | 19 participants |
| Triamcinolone Acetonide 40 mg | Physician's Assessment of Tenderness: Frequency Table by Timepoint and Treatment | 4 weeks post-dose pain and winces | 3 participants |
| Triamcinolone Acetonide 40 mg | Physician's Assessment of Tenderness: Frequency Table by Timepoint and Treatment | 4 weeks post-dose pain, winces and withdraws | 3 participants |
| Triamcinolone Acetonide 40 mg | Physician's Assessment of Tenderness: Frequency Table by Timepoint and Treatment | 4 weeks post-dose not assessed | 0 participants |
| Triamcinolone Acetonide 40 mg | Physician's Assessment of Tenderness: Frequency Table by Timepoint and Treatment | 8 weeks post-dose pain and winces | 1 participants |
| Triamcinolone Acetonide 40 mg | Physician's Assessment of Tenderness: Frequency Table by Timepoint and Treatment | 8 weeks post-dose not assessed | 0 participants |
| Triamcinolone Acetonide 40 mg | Physician's Assessment of Tenderness: Frequency Table by Timepoint and Treatment | 12 weeks post-dose no pain | 39 participants |
| Triamcinolone Acetonide 40 mg | Physician's Assessment of Tenderness: Frequency Table by Timepoint and Treatment | 12 weeks post-dose pain | 22 participants |
| Triamcinolone Acetonide 40 mg | Physician's Assessment of Tenderness: Frequency Table by Timepoint and Treatment | 12 weeks post-dose pain and winces | 1 participants |
| Triamcinolone Acetonide 40 mg | Physician's Assessment of Tenderness: Frequency Table by Timepoint and Treatment | 12 weeks post-dose pain, winces and withdraws | 0 participants |
| Triamcinolone Acetonide 40 mg | Physician's Assessment of Tenderness: Frequency Table by Timepoint and Treatment | 7 days post-dose pain , winces and withdraws | 2 participants |
Secondary
The Number of Patients With at Least 1 New Gout Flare
Time frame: 12 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ACZ885 150 mg | The Number of Patients With at Least 1 New Gout Flare | 1 new flare | 3 participants |
| ACZ885 150 mg | The Number of Patients With at Least 1 New Gout Flare | 2 new flares | 0 participants |
| ACZ885 150 mg | The Number of Patients With at Least 1 New Gout Flare | 3 new flares | 0 participants |
| ACZ885 150 mg | The Number of Patients With at Least 1 New Gout Flare | > 3 new flares | 2 participants |
| Triamcinolone Acetonide 40 mg | The Number of Patients With at Least 1 New Gout Flare | > 3 new flares | 1 participants |
| Triamcinolone Acetonide 40 mg | The Number of Patients With at Least 1 New Gout Flare | 1 new flare | 15 participants |
| Triamcinolone Acetonide 40 mg | The Number of Patients With at Least 1 New Gout Flare | 3 new flares | 0 participants |
| Triamcinolone Acetonide 40 mg | The Number of Patients With at Least 1 New Gout Flare | 2 new flares | 1 participants |
Secondary
Time to at Least a 50% Reduction in Baseline Pain Intensity: Survival Analysis by Treatment
Kaplan Meier estimate
Time frame: 12 weeks
Population: Full analysis set
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| ACZ885 150 mg | Time to at Least a 50% Reduction in Baseline Pain Intensity: Survival Analysis by Treatment | 24.0 hours |
| Triamcinolone Acetonide 40 mg | Time to at Least a 50% Reduction in Baseline Pain Intensity: Survival Analysis by Treatment | 48.0 hours |
Secondary
Time to Complete Resolution of Pain: Survival Analysis by Treatment
Kaplan Meier estimate
Time frame: 12 weeks
Population: Full analysis set
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| ACZ885 150 mg | Time to Complete Resolution of Pain: Survival Analysis by Treatment | 168.0 hours |
| Triamcinolone Acetonide 40 mg | Time to Complete Resolution of Pain: Survival Analysis by Treatment | 168.0 hours |
Secondary
Time to First Rescue Medication Intake
Time frame: 12 weeks
Population: FAS
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ACZ885 150 mg | Time to First Rescue Medication Intake | 31.8 hours | Standard Deviation 30.45 |
| Triamcinolone Acetonide 40 mg | Time to First Rescue Medication Intake | 41.5 hours | Standard Deviation 38.8 |