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This is an exploratory proof-of-concept study to evaluate the safety and efficacy of canakinumab (ACZ885) for inflammation and pain associated with acute gouty arthritis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Canakinumab | Experimental | Canakinumab 10 mg/kg intravenous infusion and placebo matching dexamethasone intravenous infusion on Day 1. |
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| Dexamethasone | Active Comparator | Dexamethasone 12 mg intravenous infusion and placebo matching canakinumab on Day 1. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| canakinumab | Biological | 10 mg/kg intravenous infusion 250 mL over 2 hours. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Improvement in Gout at 72 Hours Post-dose Using a Likert Scale | 72 hours following treatment, patients were asked the question: "How would you rate the improvement in your gout since receiving the study medication?" Patients rated their improvement on the Likert 5-point scale: 1=Excellent, 2=Good, 3=Acceptable,4=Slight and 5=Poor. Improvement was assessed by determining patients who scored a "good" or "excellent" response. | 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Non-inferiority of a Single Dose of Canakinumab Compared to Dexamethasone During Treatment Period | 72 hours | |
| Time to Recurrence of the Symptoms of Acute Gout (if Applicable) During Treatment Period | Time to recurrence is defined as from the point of improvement (good to excellent on Likert scale) to recurrence. |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis | Novartis investigator site | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigator Site | Birmingham | Alabama | 35249 | United States | ||
| Novartis Investigator Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | Canakinumab | Canakinumab 10 mg/kg intravenous infusion and placebo matching dexamethasone intravenous infusion on Day 1. |
| FG001 | Dexamethasone | Dexamethasone 12 mg intravenous infusion and placebo matching canakinumab on Day 1. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| dexamethasone | Drug | 12 mg intravenous infusion 50 mL over 30 minutes. |
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| placebo matching canakinumab | Other | 5% glucose in water intravenous infusion. |
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| placebo matching dexamethasone | Other | Placebo intravenous infusion. |
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| 4 months |
| Time to Walk Independently (if Applicable) During Treatment Period | 4 months |
| Number of Participants With Discontinuation of Treatment Due to Adverse Events, Deaths or Serious Adverse Events During the Study | Additional safety information can be found in the Adverse Event section. | 4 months |
| Change in C-reactive Protein (CRP) From Baseline at Month 4 | Blood was collected at Baseline and Month 4 for CRP to identify the presence of inflammation, to determine its severity, and to monitor response to treatment. A negative change from baseline indicates improvement. | Baseline, Month 4 |
| Change in Serum Amyloid A Protein (SAA) From Baseline at Month 4 | Blood was collected at Baseline and Month 4 for SAA to identify the presence of inflammation, to determine its severity, and to monitor response to treatment. A negative change from baseline indicates improvement. | Baseline, Month 4 |
| ACZ885 (Canakinumab) Pharmacokinetics (PK) Serum Concentration During the Treatment Period | Blood was collected for ACZ885 (canakinumab) levels at baseline and Days 0.25, 1, 3, 6, 20, 34, 55 and 119. Serum was analyzed by means of a competitive Enzyme linked immunosorbant assay (ELISA). | Baseline, Days 0.25, 1, 3, 6, 20, 34, 55 and 119 |
| Change From Baseline in Pain Using a Visual Analog Scale at Month 4 | Patients rated their pain on a 100 millimeter (mm) visual analog scale, ranging from no pain (0) to unbearable pain (100). A negative change from baseline indicates improvement. | Baseline, Month 4 |
| Number of Patients Who Took Rescue Medication | Patients who did not improve by 72 hours post-dose (i.e. patients who show a pain Visual Analog (VAS) decrease of less than 50 % from baseline (Day 1, pre-dose) would have been treated with rescue medication of methylprednisolone 80 mg intravenous or intramuscular once at the discretion of the clinical investigator. | 4 months |
| New Brunswick |
| New Jersey |
| 08901 |
| United States |
| Novartis Investigator Site | Lausanne | Switzerland |
| Novartis Investigator Site | Glasgow | United Kingdom |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Canakinumab | Canakinumab 10 mg/kg intravenous infusion and placebo matching dexamethasone intravenous infusion on Day 1. |
| BG001 | Dexamethasone | Dexamethasone 12 mg intravenous infusion and placebo matching canakinumab on Day 1. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Improvement in Gout at 72 Hours Post-dose Using a Likert Scale | 72 hours following treatment, patients were asked the question: "How would you rate the improvement in your gout since receiving the study medication?" Patients rated their improvement on the Likert 5-point scale: 1=Excellent, 2=Good, 3=Acceptable,4=Slight and 5=Poor. Improvement was assessed by determining patients who scored a "good" or "excellent" response. | Pharmacodynamic set included all randomized subjects with evaluable (or complete) pharmacodynamic parameter data. | Posted | Number | Percentage of participants | 72 hours |
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| Secondary | Non-inferiority of a Single Dose of Canakinumab Compared to Dexamethasone During Treatment Period | Since the study only recruited 6 subjects this analysis was not done. | Posted | 72 hours |
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| Secondary | Time to Recurrence of the Symptoms of Acute Gout (if Applicable) During Treatment Period | Time to recurrence is defined as from the point of improvement (good to excellent on Likert scale) to recurrence. | Since the study recruited only 6 subjects this analysis was not done. | Posted | 4 months |
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| Secondary | Time to Walk Independently (if Applicable) During Treatment Period | Since the study recruited only 6 subjects this analysis was not done. | Posted | 4 months |
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| Secondary | Number of Participants With Discontinuation of Treatment Due to Adverse Events, Deaths or Serious Adverse Events During the Study | Additional safety information can be found in the Adverse Event section. | Posted | Number | Participants | 4 months |
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| Secondary | Change in C-reactive Protein (CRP) From Baseline at Month 4 | Blood was collected at Baseline and Month 4 for CRP to identify the presence of inflammation, to determine its severity, and to monitor response to treatment. A negative change from baseline indicates improvement. | Pharmacodynamic set included all randomized patients with evaluable (or complete) pharmacodynamic parameter data. | Posted | Mean | Standard Deviation | mg/L | Baseline, Month 4 |
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| Secondary | Change in Serum Amyloid A Protein (SAA) From Baseline at Month 4 | Blood was collected at Baseline and Month 4 for SAA to identify the presence of inflammation, to determine its severity, and to monitor response to treatment. A negative change from baseline indicates improvement. | Pharmacodynamic set included all randomized patients with evaluable (or complete) pharmacodynamic parameter data. | Posted | Mean | Standard Deviation | mg/L | Baseline, Month 4 |
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| Secondary | ACZ885 (Canakinumab) Pharmacokinetics (PK) Serum Concentration During the Treatment Period | Blood was collected for ACZ885 (canakinumab) levels at baseline and Days 0.25, 1, 3, 6, 20, 34, 55 and 119. Serum was analyzed by means of a competitive Enzyme linked immunosorbant assay (ELISA). | Pharmacodynamic set included all randomized subjects with evaluable (or complete) pharmacodynamic parameter data. | Posted | Mean | Standard Deviation | μg/mL | Baseline, Days 0.25, 1, 3, 6, 20, 34, 55 and 119 |
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| Secondary | Change From Baseline in Pain Using a Visual Analog Scale at Month 4 | Patients rated their pain on a 100 millimeter (mm) visual analog scale, ranging from no pain (0) to unbearable pain (100). A negative change from baseline indicates improvement. | Pharmacodynamic set included all randomized subjects with evaluable (or complete) pharmacodynamic parameter data. | Posted | Mean | Standard Deviation | Score on a scale | Baseline, Month 4 |
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| Secondary | Number of Patients Who Took Rescue Medication | Patients who did not improve by 72 hours post-dose (i.e. patients who show a pain Visual Analog (VAS) decrease of less than 50 % from baseline (Day 1, pre-dose) would have been treated with rescue medication of methylprednisolone 80 mg intravenous or intramuscular once at the discretion of the clinical investigator. | All participants. | Posted | Number | Participants | 4 months |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Canakinumab | Canakinumab 10 mg/kg intravenous infusion and placebo matching dexamethasone intravenous infusion on Day 1. | 0 | 3 | 2 | 3 | ||
| EG001 | Dexamethasone | Dexamethasone 12 mg intravenous infusion and placebo matching canakinumab on Day 1. | 1 | 3 | 3 | 3 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gout | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ocular hyperaemia | Eye disorders | MedDRA | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Joint injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | MedDRA | Systematic Assessment |
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| Blood urine present | Investigations | MedDRA | Systematic Assessment |
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| Gout | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
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| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
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| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 |
| ID | Term |
|---|---|
| D015210 | Arthritis, Gouty |
| D010146 | Pain |
| ID | Term |
|---|---|
| D006073 | Gout |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D000070657 | Crystal Arthropathies |
| D012216 | Rheumatic Diseases |
| D011686 | Purine-Pyrimidine Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C541220 | canakinumab |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
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| Male |
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