Safety and tolerability of ACZ885 (Canakinumab) in patients with gout

• Register: EUCTR
• Last refreshed on: 30 September 2013
• Main ID: EUCTR2011-003414-17-DE
• Date of registration: 07/10/2011
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharma Services AG
• 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: 02/12/2011
• 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

Countries of recruitment

Australia, Canada, Estonia, Germany, Latvia, Lithuania, Russian Federation, Ukraine, United States

Contacts

• Name: Medizinischer Infoservice
• Affiliation: Novartis Pharma GmbH

• Name: Medizinischer Infoservice
• Affiliation: Novartis Pharma GmbH

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

Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

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: 14.0 Level: PT Classification code 10018627 Term: Gout System Organ Class: 10027433 - Metabolism and nutrition disorders

Intervention(s)

Trade Name: ILARIS
Product Name: canakinumab
Product Code: ACZ885
Pharmaceutical Form: Solution for injection in pre-filled syringe
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)

Primary end point(s): Assess the long-term safety and tolerability of canakinumab

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 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.

Timepoint(s) of evaluation of this end point: 18 months

Secondary Outcome(s)

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

Timepoint(s) of evaluation of this end point: 18 months

Secondary ID(s)

2011-003414-17-LT

CACZ885H2357E3

B-Relieved Extension 3

Source(s) of Monetary Support

Novartis Pharma Services AG