E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Evaluate the long-term safety, tolerability and immunogenicity of canakinumab 150 mg s.c. administered as pre-filled syringe (PFS). |
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E.1.1.1 | Medical condition in easily understood language |
Long-term safety and tolerability of Canakinumab pre-filled syringe (PFS) in frequently flaring acute gouty arthritis patients |
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E.1.1.2 | Therapeutic area | Diseases [C] - Immune System Diseases [C20] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10018628 |
E.1.2 | Term | Gout acute |
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 |
Evaluate the long-term safety, tolerability and immunogenicity of canakinumab 150 mg s.c. administered as pre-filled syringe (PFS). |
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E.2.2 | Secondary objectives of the trial |
Evaluate
- Time to first new gouty arthritis flare since initial dose in core study
- Frequency of new gouty arthritis flares
Assess the long-term efficacy of canakinumab 150 mg s.c. PFS with respect to the treatment of signs and symptoms of new gouty arthritis flares, defined as:
- Patient's assessment of acute gouty arthritis pain intensity in the most affected joint (Likert scale) over time
- Patient's assessment of acute gouty arthritis pain intensity in the most affected joint (on a 0-100 mm visual analogue scale [VAS]) over time
- Patient's global assessment of response to treatment (Likert scale) over time
- Physician's assessment of tenderness, swelling and erythema of the most affected joint over time
- Physician's global assessment of response to treatment (Likert scale) over time
- To evaluate the pharmacokinetics of canakinumab 150 mg s.c. PFS |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Signed written informed consent before any study procedure is performed.
- Completion of the core study CACZ885H2361 up to and including the End of Study visit (Visit 8) having fulfilled the entry criteria, completed the study and with acceptable compliance (no protocol deviations).
- Patients remain with unchanged significant clinical medical history from entry to completion of the core study CACZ885H2361. |
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E.4 | Principal exclusion criteria |
- If entering in this extension study would be considered inappropriate by the treating physician.
- 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).
- Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partner has been sterilized by vasectomy or other means. Women are
considered post menopausal and not of child-bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor
symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal
litigation at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment is she considered not of child
bearing potential, unless they are using effective methods of contraception during dosing of study treatment. Effective contraception methods include:
a. Use of oral, injected or implanted hormonal methods of contraception
b. Placement of an intrauterine device (IUD) or intrauterine system (IUS)
c. Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository
d. Total abstinence or male/female sterilization
- No additional exclusions may be applied by the investigator, in order to ensure that the study
population will be representative of all eligible patients. |
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E.5 End points |
E.5.1 | Primary end point(s) |
To assess adverse events including local injection site reactions and anti-ACZ885 antibodies |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
- The time to the first new gouty arthritis flare since the initial flare in the core study
- The frequency of new gouty arthritis flares since entry into the core study
- To evaluate gouty arthritis pain intensity and resolution using a Visual Analog and Likert pain scales
- To assess the signs and symptoms of each new gouty arthritis flare using patient and physician questionnaires
- To evaluate the pharmacokinetics of canakinumab 150mg s.c. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | No |
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 |
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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 | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
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.8.2.4 | Number of treatment arms in the trial | 1 |
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 | 10 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 28 |
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 |
Belgium |
Canada |
Germany |
Hungary |
United States |
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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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The end of the trial will occur up to 12 weeks beyond the end of study visit of the last patient in the event that a subject has been dosed within 12 weeks prior to the end of study visit and a PK, immunogenicity sample would be necessary. |
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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 |