Acute gout MedDRA version: 9.1 Level: LLT Classification code 10018628 Term: Gout acute
Conditions
Interventions
Product Name: ACZ885
Product Code: ACZ885
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: Canakinumab (WHO approval pending)
CAS Number: -
Current Sponsor code: ACZ885
Other
Sponsors
Novartis Pharma Services
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female subjects aged 18 to 80 years (inclusive). 2. Female subjects of childbearing potential must use two acceptable methods of contraception. Postmenopausal females must have had no regular menstrual bleeding for at least one (1) year prior to initial dosing. Menopause will be confirmed by a plasma FSH level of >40 IU/L at screening Female subjects who report surgical sterilization must have had the procedure at least six (6) months prior to initial dosing. Periodic adstinence (e.g. calender, ovulation, symptom-termal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. 3. Male subjects must use two acceptable methods of contraception , (e.g., spermicidal gel plus condom) for the entire duration of the study, up to the Study Completion visit, and refrain from fathering a child in the six (6) months following study completion. Periodic adstinence and withdrawal are not accpetable methods of contraception. 4. Subjects must weigh at least 50 kg to participate in the study, and must have a body mass index (BMI) within the range of 18 to 35 kg/m2. See Appendix 3 of this protocol for BMI ranges. 5, Patients must score over 40 on the 0-100 VAS pain scale. 6. Patients must be willing to undergo diagnostic arthrocentesis and must have MSU crystals documented by joint aspiration and subsequent microscopy to confirm acute gout if there is no record of a previous aspiration. A repeat aspiration is not required if a history of MSU crystals by microscopic exam documented in the medical record is present. The crystals may have been identified in any joint or from a tophus. Crystals observed in a urinalysis are not acceptable, since this may be a normal finding. 7. Presence of acute gout flare for no longer than 4 days at screening. 8. Able to return to the hospital or Investigator-affiliated clinic for outpatient follow up assessments. 9. Able to communicate well with the investigator, to understand and comply with the requirements of the study. Understand and sign the written informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Smokers whose smoking habits interfere with the conduct of the study. 2. Use of any TNF inhibitor within the past 3 months. 3. Use of any concomitant medication for the treatment of acute gout within the previous 24 hours prior to screening other than a dose of 180 mmHg or diastolic blood pressure > 110 mmHg 19. Uncontrolled diabetes (screening blood glucose > 300 mg/dl) 20. History of drug or alcohol abuse which in the opinion of the investigator places a participating patient at increased risk and/or interferes with the conduct of the study. 21. Presence or history of underlying metabolic, endocrine, hematologic, pulmonary, cardiac, blood, renal, hepatic, infectious, psychiatric or gastrointestinal conditions which in the opinion of the investigator immunocompromises the patient and/or places the patient at unacceptable risk for the participation in a study of an immunomodulatory therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effect of a single dose of ACZ885 on the Likert scale response in patients with acute gout at 72 hours post dose.;Secondary Objective: To confirm that there is non-inferiority of a single dose of 10mg/kg ACZ885 compared to the active comparator Dexamethasone 12mg i.v. To assess the safety, tolerability and immunogencitiy following administration of ACZ885 to patients with acute gout. To assess the use of rescue medication, time to walk independently and time to recurrence of the symptoms of acute gout (if applicable) To evaluate change in C-reactive protein (CRP) and serum amyloid A protein (SAA) from baseline. To evaluate the pharmacokinetics (PK) of ACZ885. To assess any change in pain following ACZ885 administration via a 0-100 mm Visual Analog Scale.;Primary end point(s): Positive proof of concept will be determined if at least 13 out of the 22 subjects included in the ACZ885 arm of the study score ‘good’ or ‘excellent’ on the Likerts scale within 72 hours post dose without the requirement for rescue medication. | — |
Countries
United Kingdom
Outcome results
None listed