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Register:	EUCTR
Last refreshed on:	19 March 2012
Main ID:	EUCTR2007-001665-15-IT
Date of registration:	05/10/2007
Prospective Registration:	Yes
Primary sponsor:	NOVARTIS FARMA
Public title:	A 54-week, phase II, multi-center, open-label extension study to evaluate the efficacy, safety and tolerability of ACZ885 (anti-interleukin-1 monoclonal antibody) in patients with rheumatoid arthritis - ND
Scientific title:	A 54-week, phase II, multi-center, open-label extension study to evaluate the efficacy, safety and tolerability of ACZ885 (anti-interleukin-1 monoclonal antibody) in patients with rheumatoid arthritis - ND
Date of first enrolment:	10/12/2007
Target sample size:	179
Recruitment status:	Not Recruiting
URL:	https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-001665-15
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: Placebo: Other:
Phase:

Countries of recruitment
Germany	Italy	Netherlands	Spain

Contacts

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Key inclusion & exclusion criteria

Inclusion criteria:
Patients (male and non-pregnant, non-lactating females) who completed the core CACZ885A2204, CACZ885A2206, or CACZ885A2207 study without serious or severe drug-related adverse effects may enter the extension study upon signing informed consent. A patient is defined as completing the study if he/she completed the core CACZ885A2204 study up to and including visit 18 (Week 30), or the core CACZ885A2206 study up to and including visit 7 (Day 43 / Week 6), or the core CACZ885A2207 study up to and including visit 7 (Day 85 / Week 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) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1. Patients for whom continued treatment in the extension is not considered appropriate by the treating physician. 2. Patients who were non-compliant or who demonstrated a major protocol violation in the core study. 3. Patients who did not complete / discontinued from the core study. 4. Patients with drug related serious adverse events or severe adverse events.

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

rheumatoid arthritis
MedDRA version: 6.1 Level: PT Classification code 10039073

Intervention(s)

Product Name: Canakinumab
Product Code: ACZ885
Pharmaceutical Form: Powder and solvent for solution for injection
Current Sponsor code: ACZ885
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 600-

Primary Outcome(s)

Secondary Objective: To evaluate the efficacy of ACZ885 by assessing the time course of the response to treatment according to ACR20, ACR50, ACR70, and ACR90 criteria, and by using the Simplified Disease Activity Index (SDAI) and DAS28 scoring. To assess the effect of ACZ885 on ACR components, including a marker of inflammation (C-reactive protein). To characterize the magnitude of ACZ885 joint structure preservation and/or improvement using magnetic resonance imaging (MRI) in RA patients who participated in the core study CACZ885A2204 and had completed baseline and 26 weeks assessments. To evaluate the effect of ACZ885 treatment on radiographically detectable change in joint structure (hands and feet) using change in modified Sharp/van der Heidje score in RA patients who participated in the core study CACZ885A2204 and had completed baseline and 26 weeks assessments. PLS SEE PROTOCOL

Primary end point(s): To assess the long-term safety and tolerability (and in particular the infection occurrence) of ACZ885 in patients with rheumatoid arthritis (RA) who participated in the core CACZ885A2204, CACZ885A2206, or CACZ885A2207 studies.

Main Objective: To assess the long-term safety and tolerability (and in particular the infection occurrence) of ACZ885 in patients with rheumatoid arthritis (RA) who participated in the core CACZ885A2204, CACZ885A2206, or CACZ885A2207 studies.

Secondary Outcome(s)

Secondary ID(s)

2007-001665-15-ES

CACZ885A2211

Source(s) of Monetary Support

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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