A Randomized, Double-blind, Double-dummy, Active Controlled Study of Canakinumab (ACZ885) 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
- -M10M10
- Registration Number
- PER-149-09
- Lead Sponsor
- OVARTIS BIOSCIENSES PERU S.A.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 0
• Informed consent in writing signed before performing any study procedure.
• Patients both men and women between> 18 and <85 years of age
• Meet the preliminary criteria of the 1977 ACR for the classification of acute arthritis by primary QOta.
• Start of current acute gout attack within 5 days prior to randomization.
• Evaluation of the patient of the intensity of the basal pain> 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
• 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 <35%) are excluded from the study.
• Unstable heart arrhythmias or unstable symptomatic coronary ischemia
• Secondary gout (for example, chemotherapy-induced gout, lead-induced gout, transplant gout, etc.)
• Rheumatoid arthritis, evidence or suspicion of infection or septic arthritis or other type of acute inflammatory arthritis.
• History of hypersensitivity to the drugs under study or to molecules with similar structures or contraindication for intramuscular injection (for example patients with anticoagulants, thrombocytopenia, known hemostatic disease).
• Presence of idiopathic thrombocytopenic purpura.
• Known presence or suspicion of active or recurrent bacterial, fungal or viral infection at the time of inclusion, where an IL-1 blocker could cause an impact on some underlying severe immunosuppressive disease such as evidence of infection with Human Immunodeficiency Virus (HIV), Hepatitis B and Hepatitis C infections (based on history and / or clinical results).
• One of the risk factors for TB
• History of active, chronic or recurrent infectious disease or evidence of tuberculosis infection determined according to local guidelines / local medical practice (see also Section 6.2.21. If the presence of tuberculosis is established, then treatment (according to local guidelines) must have ended before randomization.
• Prolonged QT or QTc interval syndrome> 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>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)<br><br>Measure:The Change in the Gout Pain Intensity in the Target Joint Following ACZ885 Administration Measured by Visual Analog Scale (VAS)<br>Timepoints:at 72 hours post-dose<br>;<br>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<br><br>Measure:Time to First New Flare: Survival Analysis by Treatment: Kaplan Meier Analysis<br>Timepoints:12 weeks<br>
- Secondary Outcome Measures
Name Time Method