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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. |
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Register:
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EUCTR |
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Last refreshed on:
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19 April 2022 |
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Main ID: |
EUCTR2010-020060-38-NL |
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Date of registration:
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02/07/2010 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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An open-label extension study of CACZ885H2357E1 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 - H2357E2
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Scientific title:
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An open-label extension study of CACZ885H2357E1 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 - H2357E2 |
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Date of first enrolment:
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09/08/2010 |
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Target sample size:
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200 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-020060-38 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: no
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
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Netherlands
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
Patients eligible for inclusion in this study have to fulfill all of the following criteria:
1. Signed written informed consent before any study procedure is performed.
2. Patients who have either:
• Completed the first extension study CACZ885H2357E1 (a patient is defined as completing the first extension study if they completed the study up to and including Visit 10) or
• Experienced a ninth new flare requiring treatment with study drug within the core study CACZ885H2357 and the first extension study CACZ885H2357E1
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 fulfilling any of the following criteria are not eligible for inclusion in this study:
1. Continuation in this extension study is considered inappropriate by the treating physician.
2. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception, confirmed by a positive pregnancy test (serum or urine), and until the termination of gestation.
3. Female patients being physiologically capable of becoming pregnant UNLESS they are:
• Female patients whose career, lifestyle, or sexual orientation precludes intercourse with a male partner
• Female patients whose partners have been sterilized by vasectomy or other means
• Using an acceptable method of contraception with a failure rate (Pearl Index (PI)) < 1, reliable contraception should be maintained throughout the study and for 2 months after last study drug administration.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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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: 12.1
Level: LLT
Classification code 10018627
Term: Gout
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Intervention(s)
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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
Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Trade Name: ILARIS
Product Name: Canakinumab
Product Code: ACZ885
Pharmaceutical Form: Solution for injection
INN or Proposed INN: CANAKINUMAB
CAS Number: 914613-48-2
Current Sponsor code: ACZ885
Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 150-
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Primary Outcome(s)
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Main Objective: The primary objective of this study is to confirm the long-term safety and tolerability of canakinumab 150 mg s.c.
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Secondary Objective: • To evaluate the long-term efficacy of canakinumab 150 mg s.c. with respect to the treatment of signs and symptoms of new gout flares, defined as:
- To evaluate the time to the first new gout flare
- Patient’s assessment of gout pain intensity in the currently most affected joint (Likert scale) over time
- Patient’s global assessment of response to treatment (Likert scale) over time
- Physician’s assessment of tenderness, swelling and erythema over time
- Physician’s global assessment of response to treatment (Likert scale) over time
• To evaluate the efficacy of canakinumab 150 mg s.c. with regards to inflammatory markers (high sensitivity C-reactive protein [hsCRP] and serum amyloid A protein [SAA])
• To evaluate the immunogenicity of canakinumab 150 mg s.c.
• To evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of canakinumab 150 mg s.c.
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Primary end point(s): The primary objective of this study is to confirm the long-term safety and tolerability of canakinumab 150 mg s.c.
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Secondary ID(s)
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CACZ885H2357E2
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date: 09/08/2010
Contact:
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