Phase 2
N=432
A Study of the Efficacy of Canakinumab in Prevention of Acute Flares in Chronic Gout Patients Initiating Allopurinol Therapy (Core Study) and a Long-term Study of the Efficacy and Safety of Canakinumab in Patients With Gout (Extension Study)
Gout
Bottom Line
View on ClinicalTrials.gov: NCT00819585 ↗Enrolled (actual)
432
Serious AEs
4.0%
Results posted
May 2011
Primary outcome: Primary: Core Study: Mean Number of Gout Flares Per Participant — 0.5; 0.4; 0.2; 0.4 Gout flares
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Canakinumab (Drug); Colchicine (Drug); Allopurinol (Drug); Placebo Matching Canakinumab (Drug); Placebo Matching Colchicine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Aug 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Core Study: Mean Number of Gout Flares Per Participant |
0.5; 0.4; 0.2; 0.4; 0.2; 0.7 | — |
| SECONDARY Core Study: Mean Number of Gout Flares for the Repeat Dose Regimen of Canakinumab as Compared to the Single Doses of Canakinumab |
0.48; 0.43; 0.22; 0.38; 0.21; 0.68 | — |
| SECONDARY Core Study: Percentage of Participants With at Least 1 Gout Flare Within 16 Weeks After Randomization |
27.3; 16.7; 14.8; 18.5; 15.1; 16.7 | — |
| SECONDARY Core Study: Percentage of Participants With Gout Flare at Different Time Points |
5.5; 3.7; 3.7; 3.7; 0.0; 3.8 | — |
| SECONDARY Core Study: Participant's Assessment of Gout Pain on a 0-100 mm Visual Analog Scale up to Day 7 of All Gout Flares |
41.1; 44.6; 56.3; 53.0; 52.2; 66.1 | — |
| SECONDARY Core Study: Participant's Assessment of Gout Pain on a 5-point Likert Scale up to Day 7 of All Gout Flares |
2.8; 3.1; 3.5; 3.2; 3.1; 3.8 | — |
| SECONDARY Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale |
19; 23; 24; 23; 27; 25 | — |
| SECONDARY Extension Study: Participant's Assessment of Gout Pain on a 100 mm Visual Analog Scale During the First Flare |
61.3; 71.8; 23.8; 29.0; 12.4; 6.8 | — |
| SECONDARY Extension Study: Participant's Global Assessment of Response to Treatment on a 5-point Likert Scale |
40; 7; 17; 14; 5; 0 | — |
| SECONDARY Extension Study: Physician's Global Assessment of Response to Treatment on a 5-point Likert Scale |
37; 13; 28; 10; 2; 0 | — |
| SECONDARY Extension Study: Physician's Assessment of Tenderness, Swelling, and Erythema in the Most Affected Joint During the First Flare |
2; 0; 27; 2; 23; 10 | — |
| SECONDARY Extension Study: Amount of Rescue Medication Taken |
1086.8; 954.6; 4.6; 4.2; 650.0; 200.0 | — |
Summary
The 24-week, dose-ranging, multi-center, double-blind, double-dummy, active-controlled core study investigated the prophylactic effect of canakinumab on the signs and symptoms of acute flares in chronic gout patients initiating allopurinol therapy. The core study was followed by a 24-week open-label, multicenter extension study to assess the safety, tolerability, and efficacy of canakinumab in patients with gout who were given canakinumab at the time of gout flare.
Eligibility Criteria
Core study
Inclusion Criteria
- Signed written informed consent before any study procedure is performed.
- History of at least 2 gout flares in the year prior to Screening (Visit 1, based on patient history), thus, candidates for initiating uric acid lowering therapy.
- Confirmed diagnosis of gout meeting the American College of Rheumatology (ACR) 1977 preliminary criteria for the classification of arthritis of primary gout.
- Body Mass Index (BMI) ≤ 40 kg/m^2.
- 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.
Exclusion Criteria
- Acute gout flare within 2 weeks of Screening (Visit 1) and during the Screening period.
- History of allergy or contraindication to colchicine or allopurinol.
- History of intolerance to allopurinol or to oral colchicine in appropriate dose for prophylactic use.
- History of bone marrow suppression.
- Absolute or relative contraindication to both naproxen and oral prednisolone/ prednisone.
Extension study
Inclusion criteria
- Patients who completed the core study. A patient is defined as completing the core study if he/she completed the study up to and including the last visit (Visit 9).
- Patients who have signed a written informed consent before any trial procedure is performed.
Exclusion Criteria
- Patients for whom continuation in the extension study is not considered appropriate by the treating physician.
- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive pregnancy test (serum or urine).
Other protocol-defined inclusion/exclusion criteria applied to the study.
Data sourced from ClinicalTrials.gov (NCT00819585). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.