None listed
Conditions
Interventions
Group 1 Type of group
an injection s.c. of canakinumab 150 mg and an injection I.M. of placebo of identical appearance to triamcinolone acetonide administered in acute attacks of gout.
Group name:Group 2 Type of group
Triamcinolone acetonide 40 mg i.m. and placebo corresponding to canakinumab s.c., administered in acute attacks of gout.
Sponsors
NOVARTIS BIOSCIENSES PERU S.A.,
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: • Informed consent in writing signed before performing any study procedure. • Patients both men and women between> 18 and 50 mm in the VAS of 0-100 mm. • Background of s 3 gout attacks in the 12 months prior to randomization (based on clinical history, reference note and / or patient interview). • Evidence of contraindication (absolute or relative), or intolerance, or lack of effectiveness of NSAIDs (based on clinical history, reference note and / or patient interview) • Evidence of contraindication (absolute or relative), or intolerance, or lack of efficacy of colchicine (not applicable in a country where colchicine is not available or not considered as standard medical practice for the treatment of signs and symptoms of seizures of gout) defined in this way (based on the medical history, reference note and / or patient interview). • If they are in treatment of reduction of urate levels (for example, allopurinol, febuxostat, pegloticase, probenecid), the dose should be stable and the scheme should not be modified for 2 weeks before randomization, and should wait until remain in a stable regimen during participation in the study. • BMI <45 kg / m ^ 2
Exclusion criteria
Exclusion criteria: • Use of the following therapies: a. Corticosteroids b. Narcotics (opiates and tramadol) within 24 hours prior to randomization. C. Acetaminophen / paracetamol within 4 hours prior to randomization. d. Topical ice / cold packs within 6 hours prior to randomization. • Hemodialysis • Live vaccines within 3 months prior to randomization. • Donation or loss of 400 mL or more of blood in the 8 weeks prior to randomization. • Need for administration of antibiotics against latent tuberculosis (IB), for example, isoniazid (antibiotic treatments started before entering the study should not be suspended prematurely to allow inclusion in the study). • Refractory heart failure (Stage D). Patients in whom electrical devices are indicated (for example, with a history of cardiac arrest, ventricular fibrillation or ventricular tachycardia with hemodynamic instability, with LVEF 450 msec for men and> 470 msec for women at the selection visit. • Important medical problems that include but are not limited to the following: uncontrolled hypertension (> 200/105 mmHg), congestive heart failure [New York Cardiology Association Stage D], uncontrolled type I and II diabetes (recent glucose in blood> 300 mg / dl), thyroid disease (unless the patient is taking a stable dose of thyroid hormone or anti-thyroid medications (hyperthyroidism) for at least 12 weeks), which in the opinion of the Researcher, would exclude the patient from the study (each specific case can be discussed with Novartis). • History of malignancy in any organ (other than localized basal cell carcinoma of the skin), treated or untreated, within the previous 5 years regardless of whether there is evidence of local relapse of metastasis. • Any important medical condition or problem that, in the opinion of the investigator, immunocompromises the patient and / or places him at an unacceptable risk for immunomodulatory therapy. • Pregnant or breastfeeding women (breastfeeding), where pregnancy is defined as the status of a woman after conception and until termination of
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:A higher score indicates greater pain intensity. Based on the distribution of pain VAS scores in postsurgical patients (knee replacement, hysterectomy, or laparoscopic myomectomy) who described their postoperative pain intensity as none, mild, moderate, or severe, the following cut points on the pain VAS have been recommended: no pain (0 - 4 mm), mild pain (5- 44 mm), moderate pain (45-74 mm), and severe pain (75- 100 mm) Measure:The Change in the Gout Pain Intensity in the Target Joint Following ACZ885 Administration Measured by Visual Analog Scale (VAS) Timepoints:at 72 hours post-dose ; Outcome name:Measure canakinumab 150 mg s.c. is superior to triamcinolone acetonide 40 mg i.m. with respect to the time to the first new gout flare in observation period of 12 weeks Measure:Time to First New Flare: Survival Analysis by Treatment: Kaplan Meier Analysis Timepoints:12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:A higher score indicates greater pain intensity. Based on the distribution of pain VAS scores in postsurgical patients (knee replacement, hysterectomy, or laparoscopic myomectomy) who described their postoperative pain intensity as none, mild, moderate, or severe, the following cut points on the pain VAS have been recommended: no pain (0 - 4 mm), mild pain (5- 44 mm), moderate pain (45-74 mm), and severe pain (75- 100 mm) Measure:Patients Assessment of Gout Pain Intensity in the Most Effected Joint (0-100mm VAS): Summary Statistics by Timepoint and Treatment Timepoints:baseline through 12 weeks ; Outcome name:Patients will score their current pain intensity in the most affected joint of the gout flare on a 5-point Likert scale (none, mild, moderate, severe, extreme). Measure:Patients Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment Timepoints:baseline through week 12 ; Outcome name:Patients will score their response to pain on a 7-point Likert scale (excellent, good ,acceptable, slight,poor,very poor,not done). Measure:Patients Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale Timepoints:72 hours through week 12 ; Outcome name:Physicians will score their response to pain on a 5-point Likert scale (no pain, pain,pain and winces,pain winces and withdraws and not assessed). Measure:Physicians Assessment of Tenderness: Frequency Table by Timepoint and Treatment Timepoints:baseline 72 hours,7 days 4 weeks, 8 weeks and 12 weeks post dose ; Outcome name:Physicians will score their response to pain on a 5-point Likert scale (no pain, pain,pain and winces,pain winces and withdraws and not assessed). Measure:Physicians Assessment of Swelling: Frequency Table by Timepoint and Treatment Timepoints:baseline 72 hours,7 days 4 weeks, 8 weeks and 12 weeks post dose ; | — |
Countries
Argentina, Chile, Peru, Poland, Singapore
Outcome results
None listed