E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10064900 |
E.1.2 | Term | Gout flare |
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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 |
To evaluate, in the extension study, the safety and tolerability in gout patients A. who were randomized to canakinumab in the core study, and who have been treated with canakinumab (for at least one flare) in the extension study B. who were randomized to canakinumab in the core study, and who have not received treatment with canakinumab in the extension study C. who were randomized to colchicine in the core study, and who have been treated with canakinumab (for at least one flare) in the extension study D. who were randomized to colchicine in the core study, and who have not received treatment with canakinumab in the extension study |
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E.2.2 | Secondary objectives of the trial |
To evaluate the long term follow-up safety and tolerability of prophylactic treatment of canakinumab observed in the core + extension study in patients: B.who were randomized to canakinumab in the core study, and who have not received treatment with canakinumab in the extension study D.who were randomized to colchicine in the core study, and who have not received treatment with canakinumab in the extension study
To assess, the efficacy of canakinumab in the treatment of recurrent acute flares of gout in the extension study in patients who were treated with canakinumab (for at least one flare) in the extension study, as measured by: Patient’s assessment of gout pain (VAS/Likert scale) Patient/Physician’s global assessment of response to treatment (Likert scale) Use of rescue medication after study drug intake Physician’s assessment of tenderness, swelling and erythema in most affected joint High sensitivity C-reactive protein (hsCRP) and serum amyloid A (SAA) protein |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Patients who completed the core study CACZ885H2251. A patient is defined as completing the core study if he/she completed the study up to and including Visit 9. 2. Patients who have signed a written informed consent before any trial procedure is performed. |
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E.4 | Principal exclusion criteria |
1. Patients for whom continuation in the extension 1 is not considered appropriate by the treating physician. 2. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive pregnancy test (serum or urine). 3. Female patients being physiologically capable of becoming pregnant, UNLESS they are: o Female patients whose career, lifestyle, or sexual orientation precludes intercourse with a male partner o Female patients whose partners have been sterilized by vasectomy or other means. o 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 study drug discontinuation. |
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E.5 End points |
E.5.1 | Primary end point(s) |
See main objective in section E.2.1 |
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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 |
tolerability, immunogenicity |
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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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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 | Yes |
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) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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 | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 100 |
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 | Information not present in EudraCT |
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 |
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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 | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 14 |