Clinical trial NCT01470989: β-RELIEVED - REsponse in Acute fLare and In prEVEntion of episoDes of Re-flare in Gout - Extension 3 (E3)
Official title: An Open-label Extension Study of CACZ885H2356E2 and CACZ885H2357E2 on the Treatment and Prevention of Gout Flares in Patients With Frequent Flares for Whom NSAIDs and/or Colchicine Are Contraindicated, Not Tolerated or Ineffective
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Gouty Arthritis Flares
Keywords: gouty arthritis
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2011-11-11
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Number of Incidence Rate (IR) of Adverse Events, Serious Adverse Events and Death Per 100 Patient-years in Participants
timeFrame: From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
Secondary outcomes:
measure: Number of New Flares Per Participant
timeFrame: From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
measure: Patient's Assessment of Gout Pain Intensity in the Most Affected Joint
timeFrame: up to 7 days post-dose
Other outcomes:
Locations:
city: Anniston
country: United States
facility: Novartis Investigative Site
state: Alabama
city: Mobile
country: United States
facility: Novartis Investigative Site
state: Alabama
city: Norwalk
country: United States
facility: Novartis Investigative Site
state: California
city: Pasadena
country: United States
facility: Novartis Investigative Site
state: California
city: San Diego
country: United States
facility: Novartis Investigative Site
state: California
city: Tustin
country: United States
facility: Novartis Investigative Site
state: California
city: Clearwater
country: United States
facility: Novartis Investigative Site
state: Florida
city: Jupiter
country: United States
facility: Novartis Investigative Site
state: Florida
city: Decatur
country: United States
facility: Novartis Investigative Site
state: Georgia
city: Overland Park
country: United States
facility: Novartis Investigative Site
state: Kansas
city: Topeka
country: United States
facility: Novartis Investigative Site
state: Kansas
city: Wichita
country: United States
facility: Novartis Investigative Site
state: Kansas
city: Metairie
country: United States
facility: Novartis Investigative Site
state: Louisiana
city: Opelousas
country: United States
facility: Novartis Investigative Site
state: Louisiana
city: Flint
country: United States
facility: Novartis Investigative Site
state: Michigan
city: Troy
country: United States
facility: Novartis Investigative Site
state: Michigan
city: Jackson
country: United States
facility: Novartis Investigative Site
state: Mississippi
city: Jackson
country: United States
facility: Novartis Investigative Site
state: Mississippi
city: Missoula
country: United States
facility: Novartis Investigative Site
state: Montana
city: Omaha
country: United States
facility: Novartis Investigative Site
state: Nebraska
city: Freehold
country: United States
facility: Novartis Investigative Site
state: New Jersey
city: Hickory
country: United States
facility: Novartis Investigative Site
state: North Carolina
city: Dayton
country: United States
facility: Novartis Investigative Site
state: Ohio
city: Willoughby Hills
country: United States
facility: Novartis Investigative Site
state: Ohio
city: Charleston
country: United States
facility: Novartis Investigative Site
state: South Carolina
city: Charleston
country: United States
facility: Novartis Investigative Site
state: South Carolina
city: Columbia
country: United States
facility: Novartis Investigative Site
state: South Carolina
city: Varnville
country: United States
facility: Novartis Investigative Site
state: South Carolina
city: Bristol
country: United States
facility: Novartis Investigative Site
state: Tennessee
city: Clarksville
country: United States
facility: Novartis Investigative Site
state: Tennessee
city: Johnson City
country: United States
facility: Novartis Investigative Site
state: Tennessee
city: Danville
country: United States
facility: Novartis Investigative Site
state: Virginia
city: Newport News
country: United States
facility: Novartis Investigative Site
state: Virginia
city: Darlinghurst
country: Australia
facility: Novartis Investigative Site
state: New South Wales
city: St-John's
country: Canada
facility: Novartis Investigative Site
state: Newfoundland and Labrador
city: St. John's
country: Canada
facility: Novartis Investigative Site
state: Newfoundland and Labrador
city: St. John
country: Canada
facility: Novartis Investigative Site
state: Newfoundland and Labrador
city: Sainte-Foy
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Tallinn
country: Estonia
facility: Novartis Investigative Site
city: Tallinn
country: Estonia
facility: Novartis Investigative Site
city: Augsburg
country: Germany
facility: Novartis Investigative Site
city: Loehne
country: Germany
facility: Novartis Investigative Site
city: Magdeburg
country: Germany
facility: Novartis Investigative Site
city: Valmiera
country: Latvia
facility: Novartis Investigative Site
city: Kaunas
country: Lithuania
facility: Novartis Investigative Site
city: Klaipeda
country: Lithuania
facility: Novartis Investigative Site
city: Siauliai
country: Lithuania
facility: Novartis Investigative Site
city: Vilnius
country: Lithuania
facility: Novartis Investigative Site
city: Vilnius
country: Lithuania
facility: Novartis Investigative Site
city: Ekaterinburg
country: Russian Federation
facility: Novartis Investigative Site
city: Moscow
country: Russian Federation
facility: Novartis Investigative Site
city: Petrozavodsk
country: Russian Federation
facility: Novartis Investigative Site
city: St-Petersburg
country: Russian Federation
facility: Novartis Investigative Site
city: Yaroslavl
country: Russian Federation
facility: Novartis Investigative Site
city: Uzhgorod
country: Ukraine
facility: Novartis Investigative Site
city: Zaporizhzhya
country: Ukraine
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: