Prophylaxis of signs and symptoms of acute flares in chronic gout patients initiating allopurinol therapy MedDRA version: 9.1 Level: LLT Classification code 10064900 Term: Gout flare
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: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is: • To determine the target dose of canakinumab that leads to at least comparable efficacy as colchicine with respect to the mean number of gout flares occurring during 16 weeks after randomization. The target dose is defined as the minimum single dose that leads to at least the same efficacy as the comparator colchicine. ;Secondary Objective: • To evaluate the efficacy of a repeat dose regimen of canakinumab (50 mg s.c. at Days 1 and 29 and 25 mg s.c. at Days 57 and 85) as compared to the single doses of canakinumab with regards to the mean number of gout flares up to 16 weeks after randomization • To evaluate the number of patients with gout flares with canakinumab as compared to colchicine up to 16 weeks after randomization • To evaluate the time to first gout flare with canakimunab as compared to colchicine up to 16 weeks after randomization • To evaluate Patient’s global pain intensity on a 0-100 mm VAS and 5-point Likert scale during gout flares with canakinumab as compared to colchicine up to 16 weeks after randomization • To evaluate the efficacy of canakinumab as compared to colchicine with regards to the Physician’s global assessment of response to therapy on a 5-point Likert scale up to 16 weeks after randomization [...];Primary end point(s): To determine the target dose of canakinumab that leads to at least comparable efficacy as colchicine with respect to the mean number of gout flares occurring during 16 weeks after randomization. The target dose is defined as the minimum single dose that leads to at least the same efficacy as the comparator colchicine. | — |
Countries
Czech Republic, Germany, Hungary, Portugal, Slovakia, Spain, United Kingdom
Outcome results
None listed