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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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10018627 |
E.1.2 | Term | Gout |
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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 subcutaneously (s.c) compared to triamcinolone acetonide 40 mg intramuscularly (i.m). |
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E.2.2 | Secondary objectives of the trial |
• To evaluate the time to the first new gout flare • To evaluate the frequency of new gout flares • To evaluate the severity of new gout flares • To evaluate the efficacy with respect to the treatment of signs and symptoms of each new gout flare, defined as: - Patient’s assessment of gout pain intensity in the target joint (on a 0-100 mm VAS) over time - Patient’s assessment of gout pain intensity in the target 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 assessment of range of motion of the target joint (Likert scale) over time - Physician’s global assessment of response to treatment (Likert scale) over time - Rescue medication use during new gout flares • To evaluate the efficacy with regards to inflammatory markers (high sensitivity C-reactive protein [hsCRP] and serum amyloid A protein [SAA]) [...]
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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 |
Ultrasonography 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. Completion of the core study CACZ885H2356. A patient is defined as completing the core study if they completed the study up to and including Visit 7. |
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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 subcutaneously (s.c) compared to triamcinolone acetonide 40 mg intramuscularly (i.m). |
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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 | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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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 | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
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) | Yes |
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 | Information not present in EudraCT |
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 | 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 | 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 | 9 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 9 |