Phase 2
N=341
Long Term Study of Canakinumab (ACZ885) in Patients With Gout
Gouty Arthritis
Bottom Line
View on ClinicalTrials.gov: NCT00927810 ↗Enrolled (actual)
341
Serious AEs
4.0%
Results posted
Jun 2021
Primary outcome: Primary: Number of Participants With Adverse Events and Serious Adverse Events — 31; 52; 9; 15 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Canakinumab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Aug 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events and Serious Adverse Events |
31; 52; 9; 15 | — |
| SECONDARY Difference Change From Baseline in Participant's Gout Pain During First Flare |
-51.7; -67.4 | — |
| SECONDARY Number of Participants Achieved Patient's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category |
40; 7; 17; 14; 5; 0 | — |
| SECONDARY Number of Participants Achieved Physician's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category |
37; 13; 28; 10; 2; 0 | — |
| SECONDARY Number of Participants Reported No Pain, No Swelling, Absent Erythema on Physician's Assessment of Tenderness, Swelling and Erythema in Most Affected Joint During the First Flare in Participants Treated With Canakinumab by Parameter, Visit and Group |
2; 0; 60; 21; 5; 0 | — |
| SECONDARY Amount of Rescue Medication After Study Drug Intake in Participants Treated With Canakinumab by Flare Order, Medication and Group |
1086.8; 954.6; 4.6; 4.2; 650.0; 200.0 | — |
Summary
This 24-week open-label extension study is designed to provide additional long-term safety data up to a total of 1-year for patients rolling over from the core study, and to collect further efficacy and tolerability data for all the patients, irrespective whether they have an acute flare of gout or not. Patients will be treated on demand with canakinumab (ACZ885) in this extension study.
Eligibility Criteria
Inclusion Criteria
- Patients who completed the core study CACZ885H2251. 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 1 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).
- Female patients who were physiologically capable of becoming pregnant, unless they were:
- Female patients whose career, lifestyle, or sexual orientation precluded intercourse with a male partner.
- Female patients whose partners had been sterilized by vasectomy or other means.
- Using an acceptable method of contraception with a failure rate (Pearl Index (PI)) < 1.
- Reliable contraception had to be maintained throughout the study and for 2 months after study drug discontinuation.
Other protocol defined inclusion/exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT00927810). 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.