Phase 3
N=397
Safety and Efficacy of Canakinumab Prefilled Syringes in Frequently Flaring Acute Gouty Arthritis Patients
Acute Gouty Arthritis
Bottom Line
View on ClinicalTrials.gov: NCT01356602 ↗Enrolled (actual)
397
Serious AEs
4.3%
Results posted
Jan 2014
Primary outcome: Primary: Pain Intensity on a 0-100 mm Visual Analog Scale (VAS) Between the Canakinumab 150 mg PFS and Triamcinolone Acetonide 40 mg Groups — 17.1; 32 Millimeters
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Canakinumab pre-filled syringe (Drug); Canakinumab lyophilized powder (Drug); Triamcinolone Acetonide (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Sep 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Intensity on a 0-100 mm Visual Analog Scale (VAS) Between the Canakinumab 150 mg PFS and Triamcinolone Acetonide 40 mg Groups |
17.1; 32 | — |
| SECONDARY Pain Intensity on a 0 - 100 mm VAS Between the Canakinumab 150 mg PFS and Canakinumab 150 mg LYO Groups |
17.1; 19.7 | — |
| SECONDARY Patient's Assessment of Pain Intensity on a 0-100mm VAS |
7.9; 8.2; 14.8 | — |
| SECONDARY Patient's Assessment of Pain Intensity on a 5-point Likert Scale |
35.9; 32.6; 23.4; 45.8; 44.2; 36.7 | — |
| SECONDARY Number of Patients With at Least One New Gouty Arthritis Flare After Baseline |
12; 12; 52 | — |
| SECONDARY Time to the First New Gouty Arthritis Flare |
NA; NA; NA | — |
| SECONDARY Time to 50% Reduction in Baseline Pain on a 0 - 100 VAS |
24; 25; 48 | — |
| SECONDARY Time to Resolution of Gouty Arthritis Flare as Reported by Patient |
142; 120; 170 | — |
| SECONDARY Patient's Global Assessment of Response to Treatment on a 5-point Likert Scale |
36.0; 34.8; 20.4; 43.2; 36.5; 31.9 | — |
| SECONDARY Physician's Global Assessment of Response to Treatment on a 5 Point Likert Scale |
46.2; 33.6; 21.5; 35.4; 48.8; 33.9 | — |
| SECONDARY Physician's Assessment of Tenderness |
50.0; 40.0; 29.8; 43.1; 52.8; 47.1 | — |
| SECONDARY Physician's Assessment of Swelling |
60.8; 55.2; 51.2; 26.9; 25.6; 15.7 | — |
| SECONDARY Physician's Assessment of Erythema |
88.3; 82.9; 68.6; 11.7; 17.1; 31.4 | — |
| SECONDARY Physician's Assessment of Range of Motion of the Most Affected Joint |
50.0; 44.8; 35.5; 37.7; 40.8; 37.2 | — |
| SECONDARY Proportion of Patients With Rescue Medication Intake |
29.0; 31.8; 45.7 | — |
| SECONDARY Time to First Rescue Medication Intake |
11; 7.5; 11 | — |
| SECONDARY Amount of Rescue Medication Taken (mg) |
609.2; 1108.3; 2323.1; 12.7; 23.9; 60.8 | — |
| SECONDARY C-reactive Protein Level |
3.65; 3.37; 5.2 | — |
Summary
This study assessed the safety and efficacy of canakinumab pre-filled syringes in comparison to triamcinolone acetonide 40 mg and canakinumab lyophilizate in patients that have frequent flares of acute gouty arthritis.
Eligibility Criteria
Inclusion criteria
- 3 or more gout flares within last year
- Contraindication, intolerance or lack of efficacy for NSAIDs and/or colchicine
- Body mass index of less than or equal to 45 kg/m2
Exclusion criteria
- Use of the following therapies (within varying protocol defined timeframes): corticosteroids, narcotics, topical ice/cold packs, chronic opiate treatment, NSAIDs (such as aspirin), colchicine.
- Hemodialysis
- Live vaccine within 3 months before first dose
- Donation or loss of 400 mL or more within 3 months before first dose
- Gout brought on by other factors such as chemotherapy, lead, transplant, etc.
- Presence of other acute inflammatory arthritis such as Rheumatoid Arthritis
- Any conditions or significant medical problems that puts the patient at an unacceptable immunological risk to receive this type of therapy such as HIV, Hepatitis, Tuberculosis and other infections/conditions
- Significant cardiovascular conditions such as uncontrolled hypertension
- Significant medical diseases such as uncontrolled diabetes, thyroid disease
- History of malignancy of any organ system within the past 5 years
- Women who are pregnant or nursing
- Other protocol-defined inclusion/exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT01356602). 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.