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:
|
EUCTR |
Last refreshed on:
|
15 July 2013 |
Main ID: |
EUCTR2011-003414-17-LT |
Date of registration:
|
07/09/2011 |
Prospective Registration:
|
Yes |
Primary sponsor: |
|
Public title:
|
Safety and tolerability of ACZ885 (Canakinumab) in patients with gout
|
Scientific title:
|
An open-label extension study of CACZ885H2356E2 and CACZ885H2357E2 on the treatment and prevention of gout flares in patients with frequent flares for whom NSAIDs and/or colchicine are contraindicated, not tolerated or ineffective - H2357E3 |
Date of first enrolment:
|
14/11/2011 |
Target sample size:
|
200 |
Recruitment status: |
Not Recruiting |
URL:
|
https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-003414-17 |
Study type:
|
Interventional clinical trial of medicinal product |
Study design:
|
Controlled: no
Randomised: no
Open: no
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: no
|
Phase:
|
|
|
Countries of recruitment
|
Australia
|
Canada
|
Estonia
|
Germany
|
Latvia
|
Lithuania
|
Russian Federation
|
Ukraine
|
United States
| | | | | | | |
Contacts
|
Name:
|
Clinical Trial Information Desk
|
Address:
|
Konstitucijos av. 7
LT-09308
Vilnius
Lithuania |
Telephone:
|
+3705269 1650 |
Email:
|
DRA.Lithuania@novartis.com |
Affiliation:
|
Novartis Pharma Services Inc. Representative Office in Lithuania |
|
Name:
|
Clinical Trial Information Desk
|
Address:
|
Konstitucijos av. 7
LT-09308
Vilnius
Lithuania |
Telephone:
|
+3705269 1650 |
Email:
|
DRA.Lithuania@novartis.com |
Affiliation:
|
Novartis Pharma Services Inc. Representative Office in Lithuania |
| |
Key inclusion & exclusion criteria
|
Inclusion criteria: 1. Patients who have completed the second extension studies
2. Patients who have already been treated with canakinumab in the core studies or subsequent extensions
*Other protocol-defined inclusion/exclusion criteria may apply Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 180 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria: 1. Continuation in this extension study is considered inappropriate by the treating physician
*Other protocol-defined inclusion/exclusion criteria may apply
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
|
Health Condition(s) or Problem(s) studied
|
Treatment and prevention of gout flares in patients with frequent flares for whom NSAIDs and/or colchicine are contraindicated, not tolerated or ineffective MedDRA version: 14.1
Level: PT
Classification code 10018627
Term: Gout
System Organ Class: 10027433 - Metabolism and nutrition disorders
|
Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
|
Intervention(s)
|
Trade Name: ILARIS Product Name: canakinumab Product Code: ACZ885 Pharmaceutical Form: Powder for solution for injection INN or Proposed INN: CANAKINUMAB CAS Number: 914613-48-2 Current Sponsor code: ACZ885 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150-
|
Primary Outcome(s)
|
Secondary Objective: The study will provide additional safety data of repeated treatment with on-demand use of canakinumab in patients with gouty arthritis. The study may further be used to optimize patients’ Urate Lowering Therapy (ULT) as needed, and collect further safety data on the concomitant use of canakinumab with different ULT regimens.
|
Primary end point(s): Assess the long-term safety and tolerability of canakinumab
|
Timepoint(s) of evaluation of this end point: 18 months
|
Main Objective: The purpose of this third extension study is to provide additional long-term safety and tolerability data of canakinumab over an 18-month time period on patients who have completed the extension studies CACZ885H2356E2 or CACZ885H2357E2.
|
Secondary Outcome(s)
|
Timepoint(s) of evaluation of this end point: 18 months
|
Secondary end point(s): 1) Evaluate the long-term efficacy of canakinumab
2) Evaluate the efficacy of canakinumab with regards to inflammatory markers (hsCRP)
3) Evaluate the immunogenicity of canakinumab
4) Evaluate the safety in the concomitant use of canakinumab with different ULT regimens
|
Secondary ID(s)
|
B-Relieved Extension 3
|
CACZ885H2357E3
|
Source(s) of Monetary Support
|
Novartis Pharma Services AG
|
Results
|
Results available:
|
|
Date Posted:
|
|
Date Completed:
|
|
URL:
|
|
|
|