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Trial record 21 of 29 for:    "Collagen Disease" | "Dexamethasone acetate"

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

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ClinicalTrials.gov Identifier: NCT00663169
Recruitment Status : Completed
First Posted : April 22, 2008
Results First Posted : January 7, 2013
Last Update Posted : January 7, 2013
Sponsor:
Information provided by (Responsible Party):
Novartis

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Arthritis, Gouty
Interventions Biological: canakinumab
Drug: dexamethasone
Other: placebo matching canakinumab
Other: placebo matching dexamethasone
Enrollment 6
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Canakinumab Dexamethasone
Hide Arm/Group Description Canakinumab 10 mg/kg intravenous infusion and placebo matching dexamethasone intravenous infusion on Day 1. Dexamethasone 12 mg intravenous infusion and placebo matching canakinumab on Day 1.
Period Title: Overall Study
Started 3 3
Completed 3 3
Not Completed 0 0
Arm/Group Title Canakinumab Dexamethasone Total
Hide Arm/Group Description Canakinumab 10 mg/kg intravenous infusion and placebo matching dexamethasone intravenous infusion on Day 1. Dexamethasone 12 mg intravenous infusion and placebo matching canakinumab on Day 1. Total of all reporting groups
Overall Number of Baseline Participants 3 3 6
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 3 participants 3 participants 6 participants
46.7  (10.97) 46.0  (3.46) 46.3  (7.28)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 6 participants
Female
0
   0.0%
1
  33.3%
1
  16.7%
Male
3
 100.0%
2
  66.7%
5
  83.3%
1.Primary Outcome
Title Percentage of Participants With Improvement in Gout at 72 Hours Post-dose Using a Likert Scale
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacodynamic set included all randomized subjects with evaluable (or complete) pharmacodynamic parameter data.
Arm/Group Title Canakinumab Dexamethasone
Hide Arm/Group Description:
Canakinumab 10 mg/kg intravenous infusion and placebo matching dexamethasone intravenous infusion on Day 1.
Dexamethasone 12 mg intravenous infusion and placebo matching canakinumab on Day 1.
Overall Number of Participants Analyzed 3 3
Measure Type: Number
Unit of Measure: Percentage of participants
100 100
2.Secondary Outcome
Title Non-inferiority of a Single Dose of Canakinumab Compared to Dexamethasone During Treatment Period
Hide Description [Not Specified]
Time Frame 72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Since the study only recruited 6 subjects this analysis was not done.
Arm/Group Title Canakinumab Dexamethasone
Hide Arm/Group Description:
Canakinumab 10 mg/kg intravenous infusion and placebo matching dexamethasone intravenous infusion on Day 1.
Dexamethasone 12 mg intravenous infusion and placebo matching canakinumab on Day 1.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Time to Recurrence of the Symptoms of Acute Gout (if Applicable) During Treatment Period
Hide Description Time to recurrence is defined as from the point of improvement (good to excellent on Likert scale) to recurrence.
Time Frame 4 months
Hide Outcome Measure Data
Hide Analysis Population Description
Since the study recruited only 6 subjects this analysis was not done.
Arm/Group Title Canakinumab Dexamethasone
Hide Arm/Group Description:
Canakinumab 10 mg/kg intravenous infusion and placebo matching dexamethasone intravenous infusion on Day 1.
Dexamethasone 12 mg intravenous infusion and placebo matching canakinumab on Day 1.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Time to Walk Independently (if Applicable) During Treatment Period
Hide Description [Not Specified]
Time Frame 4 months
Hide Outcome Measure Data
Hide Analysis Population Description
Since the study recruited only 6 subjects this analysis was not done.
Arm/Group Title Canakinumab Dexamethasone
Hide Arm/Group Description:
Canakinumab 10 mg/kg intravenous infusion and placebo matching dexamethasone intravenous infusion on Day 1.
Dexamethasone 12 mg intravenous infusion and placebo matching canakinumab on Day 1.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Number of Participants With Discontinuation of Treatment Due to Adverse Events, Deaths or Serious Adverse Events During the Study
Hide Description Additional safety information can be found in the Adverse Event section.
Time Frame 4 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Canakinumab Dexamethasone
Hide Arm/Group Description:
Canakinumab 10 mg/kg intravenous infusion and placebo matching dexamethasone intravenous infusion on Day 1.
Dexamethasone 12 mg intravenous infusion and placebo matching canakinumab on Day 1.
Overall Number of Participants Analyzed 3 3
Measure Type: Number
Unit of Measure: Participants
Discontinuation from treatment 0 0
Death 0 0
Serious Adverse Event 0 1
6.Secondary Outcome
Title Change in C-reactive Protein (CRP) From Baseline at Month 4
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacodynamic set included all randomized patients with evaluable (or complete) pharmacodynamic parameter data.
Arm/Group Title Canakinumab Dexamethasone
Hide Arm/Group Description:
Canakinumab 10 mg/kg intravenous infusion and placebo matching dexamethasone intravenous infusion on Day 1.
Dexamethasone 12 mg intravenous infusion and placebo matching canakinumab on Day 1.
Overall Number of Participants Analyzed 3 3
Mean (Standard Deviation)
Unit of Measure: mg/L
-22.23  (16.822) -30.30  (51.963)
7.Secondary Outcome
Title Change in Serum Amyloid A Protein (SAA) From Baseline at Month 4
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacodynamic set included all randomized patients with evaluable (or complete) pharmacodynamic parameter data.
Arm/Group Title Canakinumab Dexamethasone
Hide Arm/Group Description:
Canakinumab 10 mg/kg intravenous infusion and placebo matching dexamethasone intravenous infusion on Day 1.
Dexamethasone 12 mg intravenous infusion and placebo matching canakinumab on Day 1.
Overall Number of Participants Analyzed 3 3
Mean (Standard Deviation)
Unit of Measure: mg/L
-579.980  (563.7449) -260.327  (463.8600)
8.Secondary Outcome
Title ACZ885 (Canakinumab) Pharmacokinetics (PK) Serum Concentration During the Treatment Period
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacodynamic set included all randomized subjects with evaluable (or complete) pharmacodynamic parameter data.
Arm/Group Title Canakinumab
Hide Arm/Group Description:
Canakinumab 10 mg/kg intravenous infusion and placebo matching dexamethasone intravenous infusion on Day 1.
Overall Number of Participants Analyzed 3
Mean (Standard Deviation)
Unit of Measure: μg/mL
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 [1]   (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)
[1]
Standard deviation not calculated- data available for only 1 participant.
9.Secondary Outcome
Title Change From Baseline in Pain Using a Visual Analog Scale at Month 4
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacodynamic set included all randomized subjects with evaluable (or complete) pharmacodynamic parameter data.
Arm/Group Title Canakinumab Dexamethasone
Hide Arm/Group Description:
Canakinumab 10 mg/kg intravenous infusion and placebo matching dexamethasone intravenous infusion on Day 1.
Dexamethasone 12 mg intravenous infusion and placebo matching canakinumab on Day 1.
Overall Number of Participants Analyzed 3 3
Mean (Standard Deviation)
Unit of Measure: Score on a scale
-62.0  (3.61) -65.7  (17.62)
10.Secondary Outcome
Title Number of Patients Who Took Rescue Medication
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
All participants.
Arm/Group Title Canakinumab Dexamethasone
Hide Arm/Group Description:
Canakinumab 10 mg/kg intravenous infusion and placebo matching dexamethasone intravenous infusion on Day 1.
Dexamethasone 12 mg intravenous infusion and placebo matching canakinumab on Day 1.
Overall Number of Participants Analyzed 3 3
Measure Type: Number
Unit of Measure: Participants
0 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Canakinumab Dexamethasone
Hide Arm/Group Description Canakinumab 10 mg/kg intravenous infusion and placebo matching dexamethasone intravenous infusion on Day 1. Dexamethasone 12 mg intravenous infusion and placebo matching canakinumab on Day 1.
All-Cause Mortality
Canakinumab Dexamethasone
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Canakinumab Dexamethasone
Affected / at Risk (%) Affected / at Risk (%)
Total   0/3 (0.00%)   1/3 (33.33%) 
Metabolism and nutrition disorders     
Gout  1  0/3 (0.00%)  1/3 (33.33%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Canakinumab Dexamethasone
Affected / at Risk (%) Affected / at Risk (%)
Total   2/3 (66.67%)   3/3 (100.00%) 
Eye disorders     
Ocular hyperaemia  1  0/3 (0.00%)  1/3 (33.33%) 
Gastrointestinal disorders     
Constipation  1  0/3 (0.00%)  1/3 (33.33%) 
Injury, poisoning and procedural complications     
Joint injury  1  0/3 (0.00%)  1/3 (33.33%) 
Investigations     
Alanine aminotransferase increased  1  0/3 (0.00%)  1/3 (33.33%) 
Aspartate aminotransferase increased  1  0/3 (0.00%)  1/3 (33.33%) 
Blood urine present  1  1/3 (33.33%)  0/3 (0.00%) 
Metabolism and nutrition disorders     
Gout  1  0/3 (0.00%)  3/3 (100.00%) 
Hyperuricaemia  1  1/3 (33.33%)  0/3 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthritis  1  0/3 (0.00%)  1/3 (33.33%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
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 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.
Results Point of Contact
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00663169     History of Changes
Other Study ID Numbers: CACZ885A2212
First Submitted: April 18, 2008
First Posted: April 22, 2008
Results First Submitted: August 30, 2012
Results First Posted: January 7, 2013
Last Update Posted: January 7, 2013