Clinical trial NCT00927810: Long Term Study of Canakinumab (ACZ885) in Patients With Gout
Official title: A 24-week Open-label, Multicenter, Follow-up and Extension Study to CACZ885H2251, to Assess Safety, Tolerability and Efficacy of Canakinumab (ACZ885) in Patients With Gout Who Were Given Canakinumab at the Time of Gout Flare
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gouty Arthritis
Keywords: Gouty
Gouty arthritis
Gout flares
Anti-interleukin-1β monoclonal antibody
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2009-06-25
Enrollment: 341
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: Number of Participants With Adverse Events and Serious Adverse Events
timeFrame: From start of study up to study completion (up to 14 months)
Secondary outcomes:
measure: Difference Change From Baseline in Participant's Gout Pain During First Flare
timeFrame: Baseline and Day 7
measure: Number of Participants Achieved Patient's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category
timeFrame: 24 weeks
measure: Number of Participants Achieved Physician's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category
timeFrame: 24 weeks
measure: 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
timeFrame: 24 weeks
measure: Amount of Rescue Medication After Study Drug Intake in Participants Treated With Canakinumab by Flare Order, Medication and Group
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Novartis Investigative site
state: Washington
city: Capital Federal Buenos Aires
country: Argentina
facility: Novartis Investigative site
city: Jette
country: Belgium
facility: Novartis Investigative site
city: Barranquilla
country: Colombia
facility: Novartis Investigative site
city: Bogotá
country: Colombia
facility: Novartis Investigative site
city: Bucaramanga
country: Colombia
facility: Novartis Investigative site
city: Floridablanca
country: Colombia
facility: Novartis Investigative site
city: Praha 5
country: Czechia
facility: Novartis Investigative site
state: Czech Republic
city: Sachsen
country: Germany
facility: Novartis Investigative site
state: Dresden / Schützenhöhe 16
city: Bayern
country: Germany
facility: Novartis Investigative site
state: München / Mühlbaurstraße 16
city: Dessau
country: Germany
facility: Novartis Investigative site
state: Roßlau / Kühnauer Straße 70 Sachsen- Anhalt
city: Guatemala City
country: Guatemala
facility: Novartis Investigative site
city: Debrecen
country: Hungary
facility: Novartis Investigative site
state: Bartók B U 2-26
city: Kistarcsa
country: Hungary
facility: Novartis Investigative site
state: Semmelweis Tér 1.
city: Eger
country: Hungary
facility: Novartis Investigative site
state: Széchenyi U 27-29
city: Zalaegerszeg
country: Hungary
facility: Novartis Investigative site
state: Zrínyi U 1
city: Poznań
country: Poland
facility: Novartis Investigative site
city: Wrocław
country: Poland
facility: Novartis Investigative site
city: Lisboa
country: Portugal
facility: Novartis Investigative site
city: Chelyabinsk
country: Russian Federation
facility: Novartis Investigative site
city: Moscow
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: Saint Petersburg
country: Russian Federation
facility: Novartis Investigative site
city: Saint Petersburg
country: Russian Federation
facility: Novartis Investigative site
city: Yaroslavl
country: Russian Federation
facility: Novartis Investigative site
city: Singapore
country: Singapore
facility: Novartis Investigative site
city: Bratislava
country: Slovakia
facility: Novartis Investigative site
city: Košice
country: Slovakia
facility: Novartis Investigative site
city: Nitra
country: Slovakia
facility: Novartis Investigative site
city: Piešťany
country: Slovakia
facility: Novartis Investigative site
city: Trenčín
country: Slovakia
facility: Novartis Investigative site
city: Pretoria
country: South Africa
facility: Novartis Investigative site
state: Gauteng
city: Madrid
country: Spain
facility: Novartis Investigative site
city: Kaohsiung
country: Taiwan
facility: Novartis Investigative site
city: Kaohsiung
country: Taiwan
facility: Novartis Investigative site
city: Taichung
country: Taiwan
facility: Novartis Investigative site
city: Taipei
country: Taiwan
facility: Novartis Investigative site
city: Ankara
country: Turkey
facility: Novartis Investigative site
state: Bahcellievler
city: Adana
country: Turkey
facility: Novartis Investigative site
state: Balcali
city: İzmir
country: Turkey
facility: Novartis Investigative site
state: Inciraltı
city: Aydın
country: Turkey
facility: Novartis Investigative site
state: Merkez
city: Manisa
country: Turkey
facility: Novartis Investigative site
state: Merkez
city: Gaziantep
country: Turkey
facility: Novartis Investigative site
state: Sehitkamil
city: Jarrow
country: United Kingdom
facility: Novartis Investigative site
state: Tyne & Wear
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Schlesinger N, Mysler E, Lin HY, De Meulemeester M, Rovensky J, Arulmani U, Balfour A, Krammer G, Sallstig P, So A. Canakinumab reduces the risk of acute gouty arthritis flares during initiation of allopurinol treatment: results of a double-blind, randomised study. Ann Rheum Dis. 2011 Jul;70(7):1264-71. doi: 10.1136/ard.2010.144063. Epub 2011 May 3.