A randomized, double-blind, double-dummy, active controlled study of ACZ885 (canakinumab) on the treatment and prevention of gout flares in patients with frequent flares, for whom NSAIDs and/or colchicine are contraindicated, not tolerated or ineffective
- Conditions
- treatment and prevention of gout flares in patients with frequent flares for whom NSAIDs and/ or colchicine are contraindicated, not tolerated or ineffectiveMedDRA version: 17.0Level: PTClassification code 10018627Term: GoutSystem Organ Class: 10027433 - Metabolism and nutrition disorders
- Registration Number
- EUCTR2010-024172-26-PL
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 220
Patients eligible for inclusion in this study have to fulfill all of the following criteria:
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. Onset of current acute gout flare within 5 days prior to randomization.
5. Patient’s assessment of baseline pain intensity = 50 mm on the 0-100 mm VAS.
6. History of = 3 gout flares within the 12 months prior to randomization (based on patient history, referral letter and/ or patient interview).
7. Evidence of contraindication (absolute or relative), or intolerance, or lack of efficacy for:
a. NSAIDs defined as (based on medical history, referral letter, and/ or patient
interview)and/or
b. colchicine (based on medical history, referral letter, and/ or patient interview)
8. If on urate lowering therapy (e.g. allopurinol, febuxostat, pegloticase, probenecid) and/or on prophylactic low-dose colchicine, stable dose and schedule with no changes in therapy for 2 weeks prior to randomization and expected to remain on a stable regimen during study participation.
9. BMI = 45 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
Patients fulfilling any of the following criteria are not eligible for inclusion in this study:
1. Use of the following therapies:
a. Corticosteroids:
• A dose of = 10mg of prednisolone or equivalent within 24 hours before screening
for any indication.
• Chronic corticosteroid treatment (defined as a prednisolone dose of = 5 mg/ day
or equivalent taken for more than 28 days)
• Intra-articular corticosteroids into the most affected joint within 14 days before
screening.
• Intra-muscular corticosteroids for any indication within 14 days before screening.
b. Narcotics (opiates and tramadol) within 24 hours before screening
c. NSAIDs (including Cox-2 inhibitors) and other pain medication as defined below:
• Any acetaminophen (paracetamol) within 4 hours before screening or > 1 g within 24 hours before screening
• Ibuprofen: any ibuprofen within 4 hours before screening (Day 1) or > 400 mg within 8 hours before screening (i.e. 0-400 mg ibuprofen allowed between 4-8 hours before screening)
• Aspirin: any aspirin within 4 hours before screening or> 600 mg within 24 hours
before screening
• Over-the-counter analgesic aspirin-based or paracetamol-based combination
medications: any number of tablets within 4 hours before screening or > 2 tablets within 24 hours before screening
• Diclofenac: any diclofenac within 8 hours before screening or > 50 mg within 24 hours before screening
• Naproxen: any naproxen within 12 hours before screening or > 500 mg within 24 hours before screening
• Cox-2 inhibitors within 48 hours before screening
• Other NSAIDs within 24 hours before screening
d. Colchicine: > 1.2 mg within 24 hours before screening
e. Topical ice/ cold packs within 6 hours before screening
f. Chronic opiate treatment within 14 days before screening
g. Any IL-1 blocker, TNF inhibitor, other biologic or investigational drug within 30 days or 5 half-lives before randomization, whichever is longer, or as instructed by
local regulations.
h. Herbal therapy treatment taken orally for gout indication one month before screening.
Topical herbal therapy packs 6 hours before screening.
i. Acupuncture treatment for gout indication one month before screening
2. Hemodialysis
3. Live vaccinations within 3 months prior to randomization.
4. Donation or loss of 400 mL or more of blood in the 8 weeks prior to randomization.
5. Requirement for administration of antibiotics against latent tuberculosis (TB), e.g.,
isoniazide (courses of antibiotic therapy started prior to entering the study should not be prematurely terminated to allow inclusion into the study).
6. Refractory heart failure (Stage D). Patients for whom electrical device therapy is indicated
(e.g. history of cardiac arrest, ventricular fibrillation, or hemodynamically destabilizing
ventricular tachycardia, with LVEF <35%) are excluded from the study.
7. Unstable cardiac arrhythmias or unstable symptomatic coronary ischemia
8. Secondary gout chemotherapy induced gout, lead induced gout and transplant gout.
9. Rheumatoid arthritis, evidence/suspicion of infectious/septic arthritis, or other acute
inflammatory arthritis.
10. 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).
11. Presence of idiopathic thrombocytopenic purpura.
12. Known presence or suspicion of Human Immunodeficiency Virus (HIV) infection,
Hepatitis B and Hepatitis C infectio
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method