A Phase 2 interventional study of canakinumab and dexamethasone in Arthritis, Gouty, sponsored by Novartis. Completed at 4 sites in 3 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2013-01-07.
Sponsored by Novartis · Phase 2, Interventional, and Treatment
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.
3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.
This study's enrollment of 6 is below the median of 90 across 2,377 interventional studies indexed under Arthritis.
Browse Arthritis studies →Novartis is the lead sponsor of 703 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
Canakinumab 10 mg/kg intravenous infusion and placebo matching dexamethasone intravenous infusion on Day 1.
Biological: canakinumab · Other: placebo matching dexamethasone
Dexamethasone 12 mg intravenous infusion and placebo matching canakinumab on Day 1.
Drug: dexamethasone · Other: placebo matching canakinumab
10 mg/kg intravenous infusion 250 mL over 2 hours.
Also known as: ACZ885, Ilaris®
12 mg intravenous infusion 50 mL over 30 minutes.
5% glucose in water intravenous infusion.
Placebo intravenous infusion.
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.
Time frame: 72 hours
Non-inferiority of a Single Dose of Canakinumab Compared to Dexamethasone During Treatment Period
Time frame: 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.
Time frame: 4 months
Time to Walk Independently (if Applicable) During Treatment Period
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 4 months
| Milestone | Canakinumab | Dexamethasone |
|---|---|---|
| Started | 3 | 3 |
| Completed | 3 | 3 |
| Not completed | 0 | 0 |
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.
| Percentage of participants | Canakinumab | Dexamethasone |
|---|---|---|
| Percentage of Participants With Improvement in Gout at 72 Hours Post-dose Using a Likert Scale | 100 | 100 |
No measurements were reported for this outcome.
Time to recurrence is defined as from the point of improvement (good to excellent on Likert scale) to recurrence.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
Additional safety information can be found in the Adverse Event section.
| Participants | Canakinumab | Dexamethasone |
|---|---|---|
| Discontinuation from treatment | 0 | 0 |
| Death | 0 | 0 |
| Serious Adverse Event | 0 | 1 |
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.
| mg/L | Canakinumab | Dexamethasone |
|---|---|---|
| Change in C-reactive Protein (CRP) From Baseline at Month 4 | -22.23 ± 16.822 | -30.30 ± 51.963 |
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.
| mg/L | Canakinumab | Dexamethasone |
|---|---|---|
| Change in Serum Amyloid A Protein (SAA) From Baseline at Month 4 | -579.980 ± 563.7449 | -260.327 ± 463.8600 |
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).
| μg/mL | Canakinumab |
|---|---|
| Baseline | 0.0 ± 0.00 |
| Day 0.25 | 221.5 ± 143.58 |
| Day 1 (n=2) | 276.5 ± 26.163 |
| Day 3 (n=1) | 92.3 ± NA |
| Day 6 | 136.6 ± 41,532 |
| Day 20 | 72.37 ± 11.154 |
| Day 34 | 52.87 ± 13.194 |
| Day 55 | 31.67 ± 8.4884 |
| Day 119 | 7.643 ± 4.6151 |
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.
| Score on a scale | Canakinumab | Dexamethasone |
|---|---|---|
| Change From Baseline in Pain Using a Visual Analog Scale at Month 4 | -62.0 ± 3.61 | -65.7 ± 17.62 |
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.
| Participants | Canakinumab | Dexamethasone |
|---|---|---|
| Number of Patients Who Took Rescue Medication | 0 | 0 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Canakinumab | — | 0/3 (0%) | 2/3 (66.7%) |
| Dexamethasone | — | 1/3 (33.3%) | 3/3 (100%) |
| Event | Canakinumab | Dexamethasone |
|---|---|---|
| GoutMetabolism and nutrition disorders | 0/3 | 1/3 |
| Event | Canakinumab | Dexamethasone |
|---|---|---|
| GoutMetabolism and nutrition disorders | 0/3 | 3/3 |
| Ocular hyperaemiaEye disorders | 0/3 | 1/3 |
| ConstipationGastrointestinal disorders | 0/3 | 1/3 |
| Joint injuryInjury, poisoning and procedural complications | 0/3 | 1/3 |
| Alanine aminotransferase increasedInvestigations | 0/3 | 1/3 |
| Aspartate aminotransferase increasedInvestigations | 0/3 | 1/3 |
| Blood urine presentInvestigations | 1/3 | 0/3 |
| HyperuricaemiaMetabolism and nutrition disorders | 1/3 | 0/3 |
| ArthritisMusculoskeletal and connective tissue disorders | 0/3 | 1/3 |
| Age Continuous(years) | Canakinumab | Dexamethasone | Total |
|---|---|---|---|
| Mean | 46.7 ± 10.97 | 46.0 ± 3.46 | 46.3 ± 7.28 |
| Sex: Female, Male(Participants) | Canakinumab | Dexamethasone | Total |
|---|---|---|---|
| Female | 0 | 1 | 1 |
| Male | 3 | 2 | 5 |
This study is completed, as verified in Dec 2012. You cannot join it, but the record below documents what was studied.
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