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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Novartis

ClinicalTrials.gov Identifier:

NCT00663169

First received: April 18, 2008

Last updated: December 4, 2012

Last verified: December 2012

History of Changes

Results First Received: August 30, 2012

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Condition:	Arthritis, Gouty
Interventions:	Biological: canakinumab Drug: dexamethasone Other: placebo matching canakinumab Other: placebo matching dexamethasone

Participant Flow

Hide Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
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.

Participant Flow: Overall Study

	Canakinumab	Dexamethasone
STARTED	3	3
COMPLETED	3	3
NOT COMPLETED	0	0

Baseline Characteristics

Hide Baseline Characteristics

Reporting Groups

	Description
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.
Total	Total of all reporting groups

Baseline Measures

	Canakinumab	Dexamethasone	Total
Number of Participants [units: participants]	3	3	6
Age [units: years] Mean ± Standard Deviation	46.7 ± 10.97	46.0 ± 3.46	46.3 ± 7.28
Gender [units: participants]
Female	0	1	1
Male	3	2	5

Outcome Measures

Show All Outcome Measures

1. Primary:

Percentage of Participants With Improvement in Gout at 72 Hours Post-dose Using a Likert Scale [ Time Frame: 72 hours ]

Show Outcome Measure 1

2. Secondary:

Non-inferiority of a Single Dose of Canakinumab Compared to Dexamethasone During Treatment Period [ Time Frame: 72 hours ]

Show Outcome Measure 2

3. Secondary:

Time to Recurrence of the Symptoms of Acute Gout (if Applicable) During Treatment Period [ Time Frame: 4 months ]

Show Outcome Measure 3

4. Secondary:

Time to Walk Independently (if Applicable) During Treatment Period [ Time Frame: 4 months ]

Show Outcome Measure 4

5. Secondary:

Number of Participants With Discontinuation of Treatment Due to Adverse Events, Deaths or Serious Adverse Events During the Study [ Time Frame: 4 months ]

Show Outcome Measure 5

6. Secondary:

Change in C-reactive Protein (CRP) From Baseline at Month 4 [ Time Frame: Baseline, Month 4 ]

Show Outcome Measure 6

7. Secondary:

Change in Serum Amyloid A Protein (SAA) From Baseline at Month 4 [ Time Frame: Baseline, Month 4 ]

Show Outcome Measure 7

8. Secondary:

ACZ885 (Canakinumab) Pharmacokinetics (PK) Serum Concentration During the Treatment Period [ Time Frame: Baseline, Days 0.25, 1, 3, 6, 20, 34, 55 and 119 ]

Show Outcome Measure 8

9. Secondary:

Change From Baseline in Pain Using a Visual Analog Scale at Month 4 [ Time Frame: Baseline, Month 4 ]

Show Outcome Measure 9

10. Secondary:

Number of Patients Who Took Rescue Medication [ Time Frame: 4 months ]

Show Outcome Measure 10

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

Hide More Information

Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Study Director
Organization: Novartis Pharmaceuticals
phone: 862-778-8300

No publications provided

Responsible Party:	Novartis
ClinicalTrials.gov Identifier:	NCT00663169 History of Changes
Other Study ID Numbers:	CACZ885A2212
Study First Received:	April 18, 2008
Results First Received:	August 30, 2012
Last Updated:	December 4, 2012
Health Authority:	United States: Food and Drug Administration Switzerland: Swissmedic United Kingdom: Medicines and Healthcare Products Regulatory Agency

To Top