|
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:
|
7 October 2014 |
|
Main ID: |
EUCTR2007-000491-16-BE |
|
Date of registration:
|
04/05/2007 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
A 76-week open-label extension study to evaluate the efficacy, safety and tolerability of ACZ885 (anti-interleukin-1ß monoclonal antibody) in patients with active rheumatoid arthritis - not available
|
|
Scientific title:
|
A 76-week open-label extension study to evaluate the efficacy, safety and tolerability of ACZ885 (anti-interleukin-1ß monoclonal antibody) in patients with active rheumatoid arthritis - not available |
|
Date of first enrolment:
|
22/06/2007 |
|
Target sample size:
|
|
|
Recruitment status: |
Not Recruiting |
|
URL:
|
https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-000491-16 |
|
Study type:
|
Interventional clinical trial of medicinal product |
|
Study design:
|
Controlled: yes
Randomised: no
Open: yes
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
|
|
Austria
|
Belgium
|
Germany
|
Spain
| | | | |
|
Contacts
|
|
Name:
|
|
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
|
|
Name:
|
|
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria:
Patients who completed the core CACZ885A2201 study may enter the extension study upon signing informed consent. A patient is defined as completing the study if he/she completed the core CACZ885A2201 study up to and including Visit 12.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
Patients for whom continued treatment in the extension is not considered appropriate by the treating physician.
Patients who were non-compliant or who demonstrated a major protocol violation in the core CACZ885A2201 study.
Patients who discontinued from the core CACZ885A2201 study before Visit 12.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
|
|
Health Condition(s) or Problem(s) studied
|
Rheumatoid Arthritis
MedDRA version: 8.1
Level: LLT
Classification code 10039073
Term: Rheumatoid arthritis
|
|
Intervention(s)
|
Product Code: ACZ885
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Canakinumab (proposed)
Current Sponsor code: ACZ885
Other descriptive name: ACZ885 Drug Substance
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
|
|
Primary Outcome(s)
|
|
Primary end point(s): See Primary Objectives.
|
|
Main Objective: To assess the long-term safety and tolerability of ACZ885 in patients with active RA who participated in the core CACZ885A2201 study.
|
Secondary Objective: To evaluate the efficacy of ACZ885 by assessing the response to treatment according to ACR50, ACR20 and ACR70 criteria, DAS28.
To assess the effect of ACZ885 on ACR components, including a marker of inflammation (hsCRP).
To assess the immunogenicity of ACZ885.
|
|
Secondary ID(s)
|
|
CACZ885A2201E1
|
|
not available
|
|
2007-000491-16-ES
|
|
Source(s) of Monetary Support
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|