Phase 3
Completed N=397
Long-Term Safety and Tolerability of Canakinumab Prefilled Syringes in Frequently Flaring Acute Gouty Arthritis Patients
Acute Gouty Arthritis
Source: ClinicalTrials.gov NCT01431638 ↗
Enrolled (actual)
397
Serious AEs
6.6%
Results posted
Jul 2021
Primary outcomePrimary: Number of Participants Who Reported Adverse Events — 78; 65; 64 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
This is a 36 week open-label extension of the canakinumab pre-filled syringe study for safety and tolerability in patients who have frequent flares of acute gouty arthritis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Reported Adverse Events |
78; 65; 64 | — |
| SECONDARY Probability of New Gout Flares at End of Study |
65.50; 75.42; 72.95 | — |
| SECONDARY Number of Participant With New Flares |
35; 46; 36; 17; 7; 26 | — |
| SECONDARY Change From Baseline in Pain Intensity on a 5-point Likert Scale |
-2.5; -2.3; -2.7 | — |
| SECONDARY Change From Baseline in Pain Intensity in the Most Affected Joint (on a 0-100 mm Visual Analogue Scale [VAS]) Over Time |
74.2; 75.5; 74.3; -12.9; -13.0; -10.2 | — |
| SECONDARY Number of Participants Who Responded for Patient's Global Assessment of Response to Treatment |
50; 11; 11; 17; 4; 7 | — |
| SECONDARY Number of Participants Responded for Physician's Assessment of Tenderness, Swelling and Erythema of the Most Affected Joint |
0; 0; 0; 14; 6; 14 | — |
| SECONDARY Number of Participants Responded for Physician's Global Assessment of Response to Treatment |
38; 33; 32; 9; 14; 13 | — |
Eligibility Criteria
Inclusion criteria
- Compliance and completion of the canakinumab PFS core study
- Unchanged significant clinical medical history from entry into core study
Exclusion criteria
- Physician judgment of unsuitability for the study
- Pregnant or nursing women Other protocol-defined inclusion/exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT01431638). 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.