Acute gout (patients who are refractory or contraindicated to NSAIDs and/or colchicine) MedDRA version: 9.1 Level: LLT Classification code 10018628 Term: Gout acute
Conditions
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Signed written informed consent before any study procedure is performed. Male or female patients aged = 18 - = 80 years. History of at least 1 gout flare prior to the Screening Visit (based on patient history). Meeting the ACR 1977 preliminary criteria for the classification of acute arthritis of primary gout. Presence of acute gout flare for no longer than 5 days. Baseline pain intensity = 50 mm on the 0-100 mm VAS. Refractory (previous unsatisfactory outcome) to NSAID and/or colchicine use OR Absolutely or relatively contraindicated (e.g. due to co-morbidities such as kidney insufficiency, type 2 diabetes, gastrointestinal intolerance or other reasons) to NSAID and/or colchicine use. Patients on urate lowering therapy (e.g. allopurinol, probenecid) or on prophylactic colchicine must be on a stable dose and schedule with no changes in therapy for 4 weeks prior to randomization and expected to remain on a stable regimen during study participation. Patients with a BMI = 40 kg/m2. 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: Ibuprofen within 4 hours before screening (Day 1) or > 400 mg within 8 hours before screening. Paracetamol within 4 hours before screening or > 1 g within 24 hours before screening. Aspirin within 4 hours before screening or > 600 mg within 24 hours before screening. Aspirin- or paracetamol-based combination medications: any number of tablets within 4 hours before screening or > 2 tablets within 24 hours before screening. Diclofenac within 8 hours before screening or > 50 mg within 24 hours before screening. Naproxen within 12 hours before screening or > 500 mg within 24 hours before screening. Cox-2 inhibitors within 48 hours before screening. NSAIDs within 24 hours before screening. Systemic corticosteroids within 24 hours before screening (dose 450 msec for males and > 470 msec for females at screening or baseline. Significant medical problems, including but not limited to the following: uncontrolled hypertension (= 200/105 mmHg), CHF [NYHA IV], uncontrolled diabetes type I and II (
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to determine the target dose of canakinumab for the treatment of acute flares in gout patients who are refractory or contraindicated to NSAIDs and/or colchicine. The target dose is the dose that leads to the same efficacy as the comparator and will be identified by assessing the dose response relationship of various doses of canakinumab with regards to the pain intensity in the target joint at 72 hours (Day 4) post-dose measured on a 0-100 mm Visual Analog Scale (VAS).;Secondary Objective: Change in pain intensity in the target joint following canakinumab vs triamcinolone acetonide on a 0-100 mm VAS at 6, 12, 24, 48, 72 and hours 4, 5, 6 and 7 days post-dose. Change in pain intensity in the target joint following canakinumab vs triamcinolone acetonide via a 5-point Likert scale at 6, 12, 24, 48, 72 hours and 4, 5, 6 and 7 days post-dose. Efficacy of canakinumab as compared to triamcinolone acetonide with regards to - Patient’s global assessment of response to treatment at 72 hours and 7 days post-dose, - Time to 50% reduction of baseline pain intensity in the target joint, - hsCRP and SAA protein levels at 72 hours, 7 days, 4 and 8 weeks post-dose, - Amount of rescue medication taken, - Time to first rescue medication intake, - Time to first recurrence of acute gout flare after study drug administration. Safety, tolerability and immunogenicity following single administration of canakinumab (at different doses). PK/PD.;Primary end point(s): Target dose of canakinumab for the treatment of acute flares in gout patients who are refractory or contraindicated to NSAIDs and/or colchicine. The target dose is the dose that leads to the same efficacy as the comparator and will be identified by assessing the dose response relationship of various doses of canakinumab with regards to the pain intensity in the target joint at 72 hours (Day 4) post-dose measured on a 0-100 mm Visual Analog Scale (VAS). | — |
Countries
Belgium, Finland, France, Germany, United Kingdom
Outcome results
None listed