E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Treatment and prevention of gout flares in patients with frequent flares for whom NSAIDs and/ or colchicine are contraindicated, not tolerated or ineffective |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Nutritional and Metabolic Diseases [C18] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 13.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10018627 |
E.1.2 | Term | Gout |
E.1.2 | System Organ Class | 10027433 - Metabolism and nutrition disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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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E.2.2 | Secondary objectives of the trial |
• 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
- Frequency of new gout flares
- 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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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Selected sites, trained and equipped with the required technology, will participate in an ultrasonography (US) imaging sub-study to assess in patients the impact of their gout on selected joints. |
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E.3 | Principal 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 CACZ885H2356E1 (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 CACZ885H2356 and the first extension study CACZ885H2356E1
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | 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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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
immunogenicity, biomarkers |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 40 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Australia |
Belgium |
Canada |
Estonia |
Germany |
Latvia |
Lithuania |
Poland |
Russian Federation |
Singapore |
Ukraine |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 4 |
E.8.9.2 | In all countries concerned by the trial days | 0 |