Trial Outcomes & Findings for Efficacy and Safety of a Single Dose of Canakinumab (ACZ885) in Hospitalized Patients With Acute Gout (NCT NCT00663169)

NCT ID: NCT00663169

Last Updated: 2013-01-07

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 6 participants
• Primary outcome timeframe: 72 hours
• Results posted on: 2013-01-07

Participant Flow

Participant milestones

Measure	Canakinumab Canakinumab 10 mg/kg intravenous infusion and placebo matching dexamethasone intravenous infusion on Day 1.	Dexamethasone Dexamethasone 12 mg intravenous infusion and placebo matching canakinumab on Day 1.
Overall Study STARTED	3	3
Overall Study COMPLETED	3	3
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy and Safety of a Single Dose of Canakinumab (ACZ885) in Hospitalized Patients With Acute Gout

Baseline characteristics by cohort

Measure	Canakinumab n=3 Participants Canakinumab 10 mg/kg intravenous infusion and placebo matching dexamethasone intravenous infusion on Day 1.	Dexamethasone n=3 Participants Dexamethasone 12 mg intravenous infusion and placebo matching canakinumab on Day 1.	Total n=6 Participants Total of all reporting groups
Age Continuous	46.7 years STANDARD_DEVIATION 10.97 • n=5 Participants	46.0 years STANDARD_DEVIATION 3.46 • n=7 Participants	46.3 years STANDARD_DEVIATION 7.28 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: 72 hours

Population: Pharmacodynamic set included all randomized subjects with evaluable (or complete) pharmacodynamic parameter data.

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.

Outcome measures

Measure	Canakinumab n=3 Participants Canakinumab 10 mg/kg intravenous infusion and placebo matching dexamethasone intravenous infusion on Day 1.	Dexamethasone n=3 Participants Dexamethasone 12 mg intravenous infusion and placebo matching canakinumab on Day 1.
Percentage of Participants With Improvement in Gout at 72 Hours Post-dose Using a Likert Scale	100 Percentage of participants	100 Percentage of participants

SECONDARY outcome

Timeframe: 72 hours

Population: Since the study only recruited 6 subjects this analysis was not done.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 4 months

Population: Since the study recruited only 6 subjects this analysis was not done.

Time to recurrence is defined as from the point of improvement (good to excellent on Likert scale) to recurrence.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 4 months

Population: Since the study recruited only 6 subjects this analysis was not done.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 4 months

Additional safety information can be found in the Adverse Event section.

Outcome measures

Measure	Canakinumab n=3 Participants Canakinumab 10 mg/kg intravenous infusion and placebo matching dexamethasone intravenous infusion on Day 1.	Dexamethasone n=3 Participants Dexamethasone 12 mg intravenous infusion and placebo matching canakinumab on Day 1.
Number of Participants With Discontinuation of Treatment Due to Adverse Events, Deaths or Serious Adverse Events During the Study Discontinuation from treatment	0 Participants	0 Participants
Number of Participants With Discontinuation of Treatment Due to Adverse Events, Deaths or Serious Adverse Events During the Study Death	0 Participants	0 Participants
Number of Participants With Discontinuation of Treatment Due to Adverse Events, Deaths or Serious Adverse Events During the Study Serious Adverse Event	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline, Month 4

Population: Pharmacodynamic set included all randomized patients with evaluable (or complete) pharmacodynamic parameter data.

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.

Outcome measures

Measure	Canakinumab n=3 Participants Canakinumab 10 mg/kg intravenous infusion and placebo matching dexamethasone intravenous infusion on Day 1.	Dexamethasone n=3 Participants Dexamethasone 12 mg intravenous infusion and placebo matching canakinumab on Day 1.
Change in C-reactive Protein (CRP) From Baseline at Month 4	-22.23 mg/L Standard Deviation 16.822	-30.30 mg/L Standard Deviation 51.963

SECONDARY outcome

Timeframe: Baseline, Month 4

Population: Pharmacodynamic set included all randomized patients with evaluable (or complete) pharmacodynamic parameter data.

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.

Outcome measures

Measure	Canakinumab n=3 Participants Canakinumab 10 mg/kg intravenous infusion and placebo matching dexamethasone intravenous infusion on Day 1.	Dexamethasone n=3 Participants Dexamethasone 12 mg intravenous infusion and placebo matching canakinumab on Day 1.
Change in Serum Amyloid A Protein (SAA) From Baseline at Month 4	-579.980 mg/L Standard Deviation 563.7449	-260.327 mg/L Standard Deviation 463.8600

SECONDARY outcome

Timeframe: Baseline, Days 0.25, 1, 3, 6, 20, 34, 55 and 119

Population: Pharmacodynamic set included all randomized subjects with evaluable (or complete) pharmacodynamic parameter data.

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).

Outcome measures

Measure	Canakinumab n=3 Participants Canakinumab 10 mg/kg intravenous infusion and placebo matching dexamethasone intravenous infusion on Day 1.	Dexamethasone Dexamethasone 12 mg intravenous infusion and placebo matching canakinumab on Day 1.
ACZ885 (Canakinumab) Pharmacokinetics (PK) Serum Concentration During the Treatment Period Baseline	0.0 μg/mL Standard Deviation 0.00	—
ACZ885 (Canakinumab) Pharmacokinetics (PK) Serum Concentration During the Treatment Period Day 0.25	221.5 μg/mL Standard Deviation 143.58	—
ACZ885 (Canakinumab) Pharmacokinetics (PK) Serum Concentration During the Treatment Period Day 1 (n=2)	276.5 μg/mL Standard Deviation 26.163	—
ACZ885 (Canakinumab) Pharmacokinetics (PK) Serum Concentration During the Treatment Period Day 3 (n=1)	92.3 μg/mL Standard Deviation NA Standard deviation not calculated- data available for only 1 participant.	—
ACZ885 (Canakinumab) Pharmacokinetics (PK) Serum Concentration During the Treatment Period Day 6	136.6 μg/mL Standard Deviation 41,532	—
ACZ885 (Canakinumab) Pharmacokinetics (PK) Serum Concentration During the Treatment Period Day 20	72.37 μg/mL Standard Deviation 11.154	—
ACZ885 (Canakinumab) Pharmacokinetics (PK) Serum Concentration During the Treatment Period Day 34	52.87 μg/mL Standard Deviation 13.194	—
ACZ885 (Canakinumab) Pharmacokinetics (PK) Serum Concentration During the Treatment Period Day 55	31.67 μg/mL Standard Deviation 8.4884	—
ACZ885 (Canakinumab) Pharmacokinetics (PK) Serum Concentration During the Treatment Period Day 119	7.643 μg/mL Standard Deviation 4.6151	—

SECONDARY outcome

Timeframe: Baseline, Month 4

Population: Pharmacodynamic set included all randomized subjects with evaluable (or complete) pharmacodynamic parameter data.

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.

Outcome measures

Measure	Canakinumab n=3 Participants Canakinumab 10 mg/kg intravenous infusion and placebo matching dexamethasone intravenous infusion on Day 1.	Dexamethasone n=3 Participants Dexamethasone 12 mg intravenous infusion and placebo matching canakinumab on Day 1.
Change From Baseline in Pain Using a Visual Analog Scale at Month 4	-62.0 Score on a scale Standard Deviation 3.61	-65.7 Score on a scale Standard Deviation 17.62

SECONDARY outcome

Timeframe: 4 months

Population: All participants.

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.

Outcome measures

Measure	Canakinumab n=3 Participants Canakinumab 10 mg/kg intravenous infusion and placebo matching dexamethasone intravenous infusion on Day 1.	Dexamethasone n=3 Participants Dexamethasone 12 mg intravenous infusion and placebo matching canakinumab on Day 1.
Number of Patients Who Took Rescue Medication	0 Participants	0 Participants

Adverse Events

Canakinumab

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Dexamethasone

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Measure	Canakinumab n=3 participants at risk Canakinumab 10 mg/kg intravenous infusion and placebo matching dexamethasone intravenous infusion on Day 1.	Dexamethasone n=3 participants at risk Dexamethasone 12 mg intravenous infusion and placebo matching canakinumab on Day 1.
Metabolism and nutrition disorders Gout	0.00% 0/3	33.3% 1/3

Other adverse events

Measure	Canakinumab n=3 participants at risk Canakinumab 10 mg/kg intravenous infusion and placebo matching dexamethasone intravenous infusion on Day 1.	Dexamethasone n=3 participants at risk Dexamethasone 12 mg intravenous infusion and placebo matching canakinumab on Day 1.
Eye disorders Ocular hyperaemia	0.00% 0/3	33.3% 1/3
Gastrointestinal disorders Constipation	0.00% 0/3	33.3% 1/3
Injury, poisoning and procedural complications Joint injury	0.00% 0/3	33.3% 1/3
Investigations Alanine aminotransferase increased	0.00% 0/3	33.3% 1/3
Investigations Aspartate aminotransferase increased	0.00% 0/3	33.3% 1/3
Investigations Blood urine present	33.3% 1/3	0.00% 0/3
Metabolism and nutrition disorders Gout	0.00% 0/3	100.0% 3/3
Metabolism and nutrition disorders Hyperuricaemia	33.3% 1/3	0.00% 0/3
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/3	33.3% 1/3

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: 862-778-8300

Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER