β-RELIEVED - REsponse in Acute fLare and In prEVEntion of episoDes of Re-flare in Gout - Extension 3 (E3)

Phase 3

Completed

• Conditions: Acute Gouty Arthritis Flares
• Interventions: Drug: ACZ885; Drug: Triamcinolone acetonide 40 mg

• Registration Number: NCT01470989
• Lead Sponsor: Novartis Pharmaceuticals

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-08-16
• Study Start: 2011-11
• Study First Submitted QC: 2011-11-09
• Study First Posted: 2011-11-11
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Results First Submitted: 2021-05-13
• Status Verified: 2021-06
• Results First Submitted QC: 2021-06-17
• Last Update Submitted: 2021-06-17
• Results First Posted: 2021-07-09
• Last Update Posted: 2021-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 136

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
canakinumab	Triamcinolone acetonide 40 mg	canakinumab 150 mg s.c.
canakinumab	ACZ885	canakinumab 150 mg s.c.

Primary Outcome Measures

Name	Time	Method
Number of Incidence Rate (IR) of Adverse Events, Serious Adverse Events and Death Per 100 Patient-years in Participants	From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)	Adverse events (AEs) were defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline,or, if present at baseline, appears to worsen. Serious adverse events (SAEs) were defined as any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgement of investigators represent significant hazards.

Secondary Outcome Measures

Name	Time	Method
Number of New Flares Per Participant	From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)	Flare rate was calculated as the number of new flares over the period of observation in years. New flares occurred before first study medication dose in extension 3 study were considered.
Patient's Assessment of Gout Pain Intensity in the Most Affected Joint	up to 7 days post-dose	Participant scored their current pain intensity in the most affected joint of the gout flare on a 5-point Likert Scale (none or mild).

Trial Locations

Locations (1)

Novartis Investigative Site; 🇺🇦 Zaporizhzhya, Ukraine