Evaluate the long-term safety, tolerability and immunogenicity of canakinumab 150 mg s.c. administered as pre-filled syringe (PFS). MedDRA version: 14.1 Level: LLT Classification code 10018628 Term: Gout acute System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
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. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 300 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the long-term safety, tolerability and immunogenicity of canakinumab 150 mg s.c. administered as pre-filled syringe (PFS).;Secondary Objective: 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;Primary end point(s): To assess adverse events including local injection site reactions and anti-ACZ885 antibodies ;Timepoint(s) of evaluation of this end point: 36 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 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.;Timepoint(s) of evaluation of this end point: 36 weeks | — |
Countries
Belgium, Canada, Germany, Hungary, Lithuania, United States
Contacts
Public ContactClinical Trial Information Desk
Novartis Pharma Services Inc. representative office in Lithuania
Outcome results
None listed