Phase 2
Completed 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)
Source: ClinicalTrials.gov NCT00819585 ↗Enrolled (actual)
432
Serious AEs
4.0%
Results posted
May 2011
Primary outcomePrimary: Core Study: Mean Number of Gout Flares Per Participant — 0.5; 0.4; 0.2; 0.4 Gout flares
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.
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 | — |
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. Informational only — not medical advice.