|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 October 2017 |
|
Main ID: |
NCT00663169 |
|
Date of registration:
|
18/04/2008 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Efficacy and Safety of a Single Dose of Canakinumab (ACZ885) in Hospitalized Patients With Acute Gout
|
|
Scientific title:
|
A Randomized, Double-blind, Double-dummy, Active-controlled, Parallel Group Study of a Single Dose of ACZ885 in Hospitalized Patients With Acute Gout |
|
Date of first enrolment:
|
April 2008 |
|
Target sample size:
|
6 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT00663169 |
|
Study type:
|
Interventional |
|
Study design:
|
|
|
Phase:
|
Phase 2
|
|
|
Countries of recruitment
|
|
Switzerland
|
United Kingdom
|
United States
| | | | | |
|
Contacts
|
|
Name:
|
Novartis |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Novartis investigator site |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- score over 50 on the 0-100 VAS pain scale
- acute, confirmed gout flare for no longer than 3 days
Exclusion Criteria:
- Treatment with biological anti-tumor necrosis factor (anti-TNF) within the past 3
months
- Anti-inflammatory medication for the treatment of acute gout within the previous 24
hours
- Pregnant or breastfeeding women
- Major surgery with high infection risk
- History of severe allergy to food or drugs
- History or risk of tuberculosis
- Active infection
Other protocol-defined inclusion/exclusion criteria may apply
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Arthritis, Gouty
|
|
Intervention(s)
|
|
Drug: dexamethasone
|
|
Other: placebo matching dexamethasone
|
|
Biological: canakinumab
|
|
Other: placebo matching canakinumab
|
|
Primary Outcome(s)
|
|
Percentage of Participants With Improvement in Gout at 72 Hours Post-dose Using a Likert Scale
[Time Frame: 72 hours]
|
|
Secondary Outcome(s)
|
|
Non-inferiority of a Single Dose of Canakinumab Compared to Dexamethasone During Treatment Period
[Time Frame: 72 hours]
|
|
Change in C-reactive Protein (CRP) From Baseline at Month 4
[Time Frame: Baseline, Month 4]
|
|
Change in Serum Amyloid A Protein (SAA) From Baseline at Month 4
[Time Frame: Baseline, Month 4]
|
|
Change From Baseline in Pain Using a Visual Analog Scale at Month 4
[Time Frame: Baseline, Month 4]
|
|
ACZ885 (Canakinumab) Pharmacokinetics (PK) Serum Concentration During the Treatment Period
[Time Frame: Baseline, Days 0.25, 1, 3, 6, 20, 34, 55 and 119]
|
|
Time to Recurrence of the Symptoms of Acute Gout (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
[Time Frame: 4 months]
|
|
Time to Walk Independently (if Applicable) During Treatment Period
[Time Frame: 4 months]
|
|
Number of Patients Who Took Rescue Medication
[Time Frame: 4 months]
|
|
Secondary ID(s)
|
|
CACZ885A2212
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|