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

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ClinicalTrials.gov Identifier: NCT00927810
Recruitment Status : Completed
First Posted : June 25, 2009
Results First Posted : June 9, 2021
Last Update Posted : July 2, 2021
Sponsor:
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.



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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
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


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 ClinicalTrials.gov identifier (NCT number): NCT00927810


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