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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00927810
Recruitment Status : Completed
First Posted : June 25, 2009
Results First Posted : June 9, 2021
Last Update Posted : July 2, 2021
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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.

Condition or disease Intervention/treatment Phase
Gouty Arthritis Drug: Canakinumab Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 341 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : June 5, 2009
Actual Primary Completion Date : August 4, 2010
Actual Study Completion Date : August 4, 2010

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Gout
MedlinePlus related topics: Gout
Drug Information available for: Canakinumab

Arm Intervention/treatment
Experimental: canakinumab Drug: Canakinumab

Primary Outcome Measures :
  1. Number of Participants With Adverse Events and Serious Adverse Events [ Time Frame: From start of study up to study completion (up to 14 months) ]
    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

Secondary Outcome Measures :
  1. Difference Change From Baseline in Participant's Gout Pain During First Flare [ Time Frame: Baseline and Day 7 ]
    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.

  2. Number of Participants Achieved Patient's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category [ Time Frame: 24 weeks ]
    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.

  3. Number of Participants Achieved Physician's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category [ Time Frame: 24 weeks ]
    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.

  4. 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 [ Time Frame: 24 weeks ]
    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.

  5. Amount of Rescue Medication After Study Drug Intake in Participants Treated With Canakinumab by Flare Order, Medication and Group [ Time Frame: 24 weeks ]
    The amount of naproxen and prednisolone taken after receiving treatment for each of the first 3 flares was recorded.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00927810

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United States, Washington
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Seattle, Washington, United States, 98101
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Capital Federal Buenos Aires, Argentina, 1027
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Jette, Belgium, 1090
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Barranquilla, Colombia
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Bogotá, Colombia
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Bucaramanga, Colombia
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Floridablanca, Colombia
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Praha 5, Czech Republic, Czechia, 15006
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Sachsen, Dresden / Schützenhöhe 16, Germany, D-01099
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Bayern, München / Mühlbaurstraße 16, Germany, D-81677
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Dessau, Roßlau / Kühnauer Straße 70 Sachsen- Anhalt, Germany, D-06846
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Guatemala City, Guatemala, 01015
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Debrecen, Bartók B U 2-26, Hungary, 4043
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Kistarcsa, Semmelweis Tér 1., Hungary, 2143
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Eger, Széchenyi U 27-29, Hungary, 3301
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Zalaegerszeg, Zrínyi U 1, Hungary, 8900
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Poznań, Poland, NA 61- 734
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Wrocław, Poland, NA 50-333
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Lisboa, Portugal, 1749-004
Russian Federation
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Chelyabinsk, Russian Federation, 454047
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Moscow, Russian Federation, 115522
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Moscow, Russian Federation, 127473
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Petrozavodsk, Russian Federation
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Saint Petersburg, Russian Federation, 190068
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Saint Petersburg, Russian Federation, 193015
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Yaroslavl, Russian Federation, 150003
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Singapore, Singapore, 169611
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Bratislava, Slovakia, N/A 813 69
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Košice, Slovakia, N/A 042 66
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Nitra, Slovakia, N/A 949 01
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Piešťany, Slovakia, N/A 921 12
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Trenčín, Slovakia, N/A 911 50
South Africa
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Pretoria, Gauteng, South Africa, 0153
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Madrid, Spain, 28046
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Kaohsiung, Taiwan, 80756
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Kaohsiung, Taiwan, 81346
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Taichung, Taiwan, 40705
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Taipei, Taiwan, 11217
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Ankara, Bahcellievler, Turkey, 06490
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Adana, Balcali, Turkey, 01330
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İzmir, Inciraltı, Turkey, 35340
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Aydın, Merkez, Turkey, 09100
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Manisa, Merkez, Turkey, 45010
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Gaziantep, Sehitkamil, Turkey, 27310
United Kingdom
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Jarrow, Tyne & Wear, United Kingdom, NE32 3DT
Sponsors and Collaborators
Novartis Pharmaceuticals
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Publications of Results:
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Responsible Party: Novartis Pharmaceuticals Identifier: NCT00927810    
Other Study ID Numbers: CACZ885H2251E1
First Posted: June 25, 2009    Key Record Dates
Results First Posted: June 9, 2021
Last Update Posted: July 2, 2021
Last Verified: June 2021
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Gouty arthritis
Gout flares
Anti-interleukin-1β monoclonal antibody
Additional relevant MeSH terms:
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Arthritis, Gouty
Joint Diseases
Musculoskeletal Diseases
Crystal Arthropathies
Rheumatic Diseases
Purine-Pyrimidine Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases