Treatment of acute gouty arthritis flares in frequently flaring patients MedDRA version: 14.1 Level: PT Classification code 10018627 Term: Gout System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients eligible for inclusion in this study have to fulfill all of the following criteria: At screening: 1. Signed written informed consent before any study procedure is performed. 2. Male or female patients aged = 18 - = 85 years 3. Meeting the ACR 1977 preliminary criteria for the classification of acute arthritis of primary gout. 4. History of = 3 gout flares within the previous 12 months (based on patient history, referral letter and/or patient interview) 5. Evidence of contraindication (absolute or relative), or intolerance, or lack of efficacy for: • NSAIDs and/or • colchicine BMI = 45 kg/m2 Additional criteria at randomization: 1. If on urate lowering therapy (e.g. allopurinol), patient should be receiving a stable dose and schedule with no changes in therapy for 2 weeks prior to randomization 2. Onset of current acute gouty arthritis flare within 3 days prior to randomization 3. Patient’s assessment of gouty arthritis pain intensity in the most affected joint of = 50 mm on the 0-100 mm VAS 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 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: 1. Use of the following therapies: Corticosteroids: • A dose of = 10 mg of prednisolone or equivalent within 24 hours prior to randomization for any indication • Chronic corticosteroid treatment (defined as a prednisolone dose of = 5 mg/day or equivalent taken for > 28 days) • Intra-articular corticosteroids into the most affected joint within 14 days prior to randomization • Intra-muscular corticosteroids for any indication within 14 days prior to randomization Narcotics (opiates and tramadol) within 24 hours prior to randomization Topical ice/cold packs within 6 hours prior to randomization Chronic opiate treatment within 14 days prior to randomization Any IL-1 blocker, TNF inhibitor, other biologic or investigational drug within 30 days or 5 half-lives prior to randomization, whichever is longer, or as instructed by local regulations NSAIDs (including Cox-2 inhibitors), and other pain medication as defined below: • Any ibuprofen within 4 hours before randomization (Day 1) or > 400 mg within 8 hours prior to randomization (i.e. 0-400 mg ibuprofen allowed between 4-8 hours prior to randomization) • Any acetaminophen (paracetamol) within 4 hours prior to randomization or > 1 g within 24 hours prior to randomization • Any aspirin within 4 hours prior to randomization or > 600 mg within 24 hours prior to randomization • Over-the-counter analgesic aspirin-based or paracetamol-based combination medications: any number of tablets within 4 hours before randomization or > 2 tablets within 24 hours prior to randomization • Diclofenac: any diclofenac within 8 hours prior to randomization or > 50 mg within 24 hours before randomization • Naproxen: any naproxen within 12 hours prior to randomization or > 500 mg within 24 hours before randomization • Cox-2 inhibitors within 48 hours prior to randomization • Other NSAIDs within 24 hours prior to randomization Colchicine > 1.2 mg within 24 hours prior to randomization 2. Hemodialysis 3. Live vaccinations within 3 months prior to randomization 4. Donation or loss of 400 mL or more of blood in the 12 weeks prior to randomization 5. Secondary gout (e.g. chemotherapy induced gout, lead induced gout, transplant gout, etc.) 6. Rheumatoid arthritis, evidence/suspicion of infectious/septic arthritis, or other acute inflammatory arthritis 7. History of hypersensitivity to the study drugs or to molecules with similar structures, or contraindication to intramuscular injection (e.g. patients on anticoagulants, thrombocytopenia, known hemostasis disease) 8. Presence of idiopathic thrombocytopenic purpura 9. Any conditions or significant medical problems which in the opinion of the investigator immunocompromises the patient and/or places the patient at unacceptable risk for immunomodulatory therapy, or • Any active or recurrent bacterial, fungal or viral infection at the time of randomization, where an IL-1 blocker might have an impact on an underlying severe, immunocompromised disease state • Presence of Human Immunodeficiency Virus (HIV) infection, Hepatitis B or Hepatitis C infections based on screening lab results • Presence of tuberculosis (TB) established during screening, if there are signs of tuberculosis it should be confirmed as inactive and that adequate treatment was completed and successful prior to randomization • Requirement for administration of antibiotics against latent tuberculosis e.g., isoniazide (courses of antibiotic therapy started prior to entering the s
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To confirm that canakinumab 150 mg s.c. administered as pre-filled syringe (PFS) is superior to triamcinolone acetonide 40 mg i.m with respect to patient’s assessment of acute gouty arthritis pain intensity in the joint most affected at randomization measured after 72 hours (on a 0-100 mm VAS) ;Secondary Objective: To evaluate treatment comparisons a) canakinumab PFS vs. triamcinolone acetonide and b) canakinumab PFS vs. canakinumab LYO • Percentage of patients with at least 1 new gouty arthritis flare • Time to first new gouty arthritis flare Efficacy with respect to the treatment of signs and symptoms of the baseline acute gouty arthritis flare defined as: • Time to 50% reduction of acute gouty arthritis pain intensity (VAS) in the joint most affected at randomization • Time to resolution of acute gouty arthritis flare as reported by the patient • Patient’s assessment of acute gouty arthritis pain intensity in the most affected joint (on a 0-100 mm VAS) over time, during the flare • Patient’s assessment of acute gouty arthritis pain intensity in the most affected joint (Likert scale) over time, during the flare • Patient’s global assessment of response to treatment (Likert scale) over time, during the flare please refer to the protocol;Primary end point(s): Primary end point is not applicable according to the protocol design.;Timepoint(s) of evaluation of this end point: Not applicable. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary end point is not applicable according to the protocol design.;Timepoint(s) of evaluation of this end point: Not applicable. | — |
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