Phase 3
N=456
β-RELIEVED - REsponse in Acute fLare and In prEVEntion of episoDes of Re-flare in Gout - Extension 3 (E3)
Acute Gouty Arthritis Flares
Bottom Line
View on ClinicalTrials.gov: NCT01470989 ↗Enrolled (actual)
456
Serious AEs
12.8%
Results posted
Jul 2021
Primary outcome: Primary: Number of Incidence Rate (IR) of Adverse Events, Serious Adverse Events and Death Per 100 Patient-years in Participants — 873; 451; 59; 25 IR/100 patient-years
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- ACZ885 (Drug); Triamcinolone acetonide 40 mg (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- May 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Incidence Rate (IR) of Adverse Events, Serious Adverse Events and Death Per 100 Patient-years in Participants |
873; 451; 59; 25; 2; 2 | — |
| SECONDARY Number of New Flares Per Participant |
1.109; 2.459 | — |
| SECONDARY Patient's Assessment of Gout Pain Intensity in the Most Affected Joint |
102; 72; 104; 69 | — |
Summary
This was an 18-month, multi-center, open-label, clinical extension study. Patients completing earlier second extension studies (CACZ885H2356E2 and CACZ885H2357E2) continued to be treated in this combined extension 3 study for any new gouty arthritis flare on demand with one subcutaneous (s.c.) injection of canakinumab 150 mg.
Eligibility Criteria
Inclusion Criteria
- Patients who have completed the second extension studies CACZ885H2356E2 or CACZ885H2357E2
- Patients treated with canakinumab in the core studies or subsequent extensions
Exclusion Criteria
- Pregnant or nursing (lactating) women
Data sourced from ClinicalTrials.gov (NCT01470989). 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.