Long Term Study of Canakinumab (ACZ885) in Patients With Gout

Gouty Arthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00927810
• Other study ID #: CACZ885H2251E1
• Status: Completed
• Phase: Phase 2
• Start date: June 5, 2009
• Est. completion date: August 4, 2010

Study information

• Verified date: June 2021
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 341
• Est. completion date: August 4, 2010
• Est. primary completion date: August 4, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Gouty
• Gouty Arthritis

Intervention

Drug:
• Canakinumab

Locations

Country	Name	City	State
Argentina	Novartis Investigative site	Capital Federal Buenos Aires
Belgium	Novartis Investigative site	Jette
Colombia	Novartis Investigative site	Barranquilla
Colombia	Novartis Investigative site	Bogotá
Colombia	Novartis Investigative site	Bucaramanga
Colombia	Novartis Investigative site	Floridablanca
Czechia	Novartis Investigative site	Praha 5	Czech Republic
Germany	Novartis Investigative site	Bayern	München / Mühlbaurstraße 16
Germany	Novartis Investigative site	Dessau	Roßlau / Kühnauer Straße 70 Sachsen- Anhalt
Germany	Novartis Investigative site	Sachsen	Dresden / Schützenhöhe 16
Guatemala	Novartis Investigative site	Guatemala City
Hungary	Novartis Investigative site	Debrecen	Bartók B U 2-26
Hungary	Novartis Investigative site	Eger	Széchenyi U 27-29
Hungary	Novartis Investigative site	Kistarcsa	Semmelweis Tér 1.
Hungary	Novartis Investigative site	Zalaegerszeg	Zrínyi U 1
Poland	Novartis Investigative site	Poznan
Poland	Novartis Investigative site	Wroclaw
Portugal	Novartis Investigative site	Lisboa
Russian Federation	Novartis Investigative site	Chelyabinsk
Russian Federation	Novartis Investigative site	Moscow
Russian Federation	Novartis Investigative site	Moscow
Russian Federation	Novartis Investigative site	Petrozavodsk
Russian Federation	Novartis Investigative site	Saint Petersburg
Russian Federation	Novartis Investigative site	Saint Petersburg
Russian Federation	Novartis Investigative site	Yaroslavl
Singapore	Novartis Investigative site	Singapore
Slovakia	Novartis Investigative site	Bratislava
Slovakia	Novartis Investigative site	Košice
Slovakia	Novartis Investigative site	Nitra
Slovakia	Novartis Investigative site	Pieštany
Slovakia	Novartis Investigative site	Trencín
South Africa	Novartis Investigative site	Pretoria	Gauteng
Spain	Novartis Investigative site	Madrid
Taiwan	Novartis Investigative site	Kaohsiung
Taiwan	Novartis Investigative site	Kaohsiung
Taiwan	Novartis Investigative site	Taichung
Taiwan	Novartis Investigative site	Taipei
Turkey	Novartis Investigative site	Adana	Balcali
Turkey	Novartis Investigative site	Ankara	Bahcellievler
Turkey	Novartis Investigative site	Aydin	Merkez
Turkey	Novartis Investigative site	Gaziantep	Sehitkamil
Turkey	Novartis Investigative site	Izmir	Inciralti
Turkey	Novartis Investigative site	Manisa	Merkez
United Kingdom	Novartis Investigative site	Jarrow	Tyne & Wear
United States	Novartis Investigative site	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Argentina,  Belgium,  Colombia,  Czechia,  Germany,  Guatemala,  Hungary,  Poland,  Portugal,  Russian Federation,  Singapore,  Slovakia,  South Africa,  Spain,  Taiwan,  Turkey,  United Kingdom, 

References & Publications (1)

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, randomi — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Adverse Events and Serious Adverse Events	Adverse events (AEs) were defined as any unfavourable 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) hospitalisation, 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	From start of study up to study completion (up to 14 months)
Secondary	Difference Change From Baseline in Participant's Gout Pain During First Flare	Gout pain was assessed using Visual analogue scale (VAS) with a range of 0 to 100 where 0= no pain, 100= unbearable pain. Difference from time of study drug administration (pre-dose) was reported.	Baseline and Day 7
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	Patient's global assessment of response to treatment is 5-point Likert scale:1.Excellent, 2.Good, 3.Acceptable, 4.Slight, 5.Poor. Lower the score better the outcome.	24 weeks
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	Physician's global assessment of response to treatment is 5-point Likert scale:1.Very good, 2.Good, 3.Fair, 4.Poor, 5.Very poor. Lower the score better the outcome.	24 weeks
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	Tenderness was rated on a 0-3 point scale: 0="no pain", 1=patient states that "there is pain", 2=patient states "there is pain and winces", and 3=patient states "there is pain, winces and withdraws" on palpation or passive movement of the most affected joint. Swelling was rated on a 0-3 point scale: 0="no swelling", 1="palpable", 2="visible", and 3=bulging beyond the joint margins". Erythema was rated as present, absent, or not assessable. Assessments were performed at the flare and control visits.	24 weeks
Secondary	Amount of Rescue Medication After Study Drug Intake in Participants Treated With Canakinumab by Flare Order, Medication and Group	The amount of naproxen and prednisolone taken after receiving treatment for each of the first 3 flares was recorded.	24 weeks