A 24-week, dose-ranging, multi-center, double-blind, double-dummy, active-controlled study to evaluate canakinumab (ACZ885) for prophylaxis of signs and symptoms of acute flares in chronic gout patients initiating allopurinol therapy - H2251
- Conditions
- Prophylaxis of signs and symptoms of acute flares in chronic gout patients initiating allopurinol therapyMedDRA version: 9.1Level: LLTClassification code 10064900Term: Gout flare
- Registration Number
- EUCTR2008-005876-28-CZ
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 440
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 - = 80 years.
3. History of at least 2 gout flares in the year prior to the Screening Visit (based on patient history), thus, candidates for initiating uric acid lowering therapy.
4. Confirmed diagnosis of gout meeting the ACR 1977 preliminary criteria for the classification of arthritis of primary gout (Appendix 2).
5. BMI = 40 kg/m2.
6. Willingness to initiate allopurinol therapy as urate lowering agent for their gout therapy or having initiated allopurinol therapy within = 1 month before Screening (Visit 1) or willing to re-initiate allopurinol therapy if this was stopped > 2 months before Screening (Visit 1) for reasons different to toxicity/ intolerance or lack of efficacy.
7. Patient’s and physician’s confirmation that the patient does not have an ongoing acute gout flare and that the associated acute gout pain has disappeared at Screening (Visit 1) and Baseline (Visit 2).
8. Allopurinol maintenance dose depending upon patient’s creatinine clearance as indicated in Table 4-1 at Baseline (Visit 2).
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
1. Acute gout flare within 2 weeks of Screening (Visit 1) and during the Screening period
2. History of allergy or contraindication to colchicine or allopurinol
3. History of intolerance to allopurinol or to oral colchine in appropriate dose for prophylactic use
4. History of bone marrow suppression
5. Absolute or relative contraindication to both naproxen and oral prednisolone/ prednisone
6. Use of the following therapies:
• Chronic NSAID or systemic steroid use at least 1 week prior to enrollment
• Intraarticular or peri-articular injection of corticosteroids within = 4 weeks prior to Baseline (Visit 2)
• Any hypouricemic therapy other than allopurinol, such as but not restricted to probenecid or sulfinpyrazone within = 1 month prior to Baseline (Visit 2)
• Any TNF-a inhibitor within = 8 weeks prior to Baseline (Visit 2)
• Any biologics within = 8 weeks prior to Baseline (Visit 2) and thereafter with the following exceptions:
• Anakinra (Kineret®) within 1 day from Baseline (Day 2)
• Rilonacept within 1 week from Baseline (Day 2)
• Intravenous immunoglobulin therapy within = 8 weeks prior to Baseline (Visit 2)
• Leflunomide within = 4 weeks prior to Baseline (Visit 2). Documentation of a completion of a full cholestyramine elimination procedure after the most recent leflunomide use will be required.
• Any immunosuppressive/immunomodulatory therapy within = 4 weeks prior to Baseline (Visit 2)
• Use of other investigational non-biological drugs at the time of enrollment, within 30 days or 5 half-lives of enrollment, whichever is longer. Wash-out period may be longer according to local requirements.
7. Rheumatoid arthritis, evidence/suspicion of infectious/septic arthritis, or other acute inflammatory arthritis.
8. Presence of severe renal function impairment (e.g. estimated creatinine clearance (CrCl) < 30 ml/min within past 6 months). History of renal trauma, glomerulonephritis, patients with one kidney, or renal failure requiring regular dialysis treatments.
9. History of clinically significant drug allergy. History of hypersensitivity to the study drug or to molecules with similar structures.
10. Donation or loss of 400 ml or more of blood in the 8 weeks before dosing.
11. Live vaccinations within 3 months prior to the start of the study.
12. Known presence or suspicion of active or recurrent bacterial, fungal or viral infection at the time of enrollment, including patients with evidence of Human Immunodeficiency Virus (HIV) infection, Hepatitis B and Hepatitis C infections (based on history and/or clinical findings). Evidence (based on history, including history of positive PPD skin test result with positive or missing chest x-ray and no completion of treatment, and/or clinical findings) of active pulmonary disease (e.g. tuberculosis, fungal diseases).
13. 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).
14. One of the risk factors for TB such as:
• History of any of the following: residence in a congregate setting (e.g. jail or prison, homeless shelter, or chronic care facility), substance abuse (e.g. injection or non-injection); health-care workers with unprotected exposure to patients who are at high risk of TB or patients with TB disease before the identification and correct airborne precautions of the patient, or
• Close contact (i.e. share
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