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Long-Term Safety and Tolerability of Canakinumab Prefilled Syringes in Frequently Flaring Acute Gouty Arthritis Patients

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ClinicalTrials.gov Identifier: NCT01431638
Recruitment Status : Completed
First Posted : September 9, 2011
Last Update Posted : November 17, 2017
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
This is a 36 week open-label extension of the canakinumab pre-filled syringe study for safety and tolerability in patients who have frequent flares of acute gouty arthritis.

Condition or disease Intervention/treatment Phase
Acute Gouty Arthritis Drug: Canakinumab 150mg in prefilled syringe Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 233 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A 36-week Open-label Extension Study of CACZ885H2361 on the Safety and Tolerability of Canakinumab 150 mg s.c. Pre-filled Syringe (PFS) in Treating Acute Gouty Arthritis Flares in Frequently Flaring Patients
Study Start Date : August 2011
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Gout
MedlinePlus related topics: Arthritis
Drug Information available for: Canakinumab

Arm Intervention/treatment
Experimental: Canakinumab 150mg
Canakinumab 150mg in prefilled syringe subcutaneously
Drug: Canakinumab 150mg in prefilled syringe
Canakinumab 150mg in prefilled syringe will be given in a single dose subcutaneously upon demand for gouty arthritis flares




Primary Outcome Measures :
  1. Safety and tolerability of repeated dosing of canakinumab 150mg s.c. PFS [ Time Frame: 36 weeks ]
    Frequency and severity of adverse event reports in patients who have received repeat dosing of canakinumab 150mg s.c. PFS


Secondary Outcome Measures :
  1. Immunogenicity of repeated dosing of canakinumab 150mg s.c. PFS [ Time Frame: 36 weeks ]
    Presence or absence of Anti-ACZ885 antibody concentrations will be measured in patients who have received repeated dosing of canakinumab 150mg s.c. PFS

  2. The time to the first new gouty arthritis flare since the entry into the core study [ Time Frame: 36 weeks ]
    Time will be measured to the onset of the first gouty arthritis flare from the time of the initial dose of study drug in the CACZ885H2361 core study.

  3. Frequency of new gouty arthritis flares [ Time Frame: 36 Weeks ]
    The number of gouty arthritis flares will be recorded for the duration of the trial

  4. Signs and symptoms of new gouty arthritis flares [ Time Frame: 36 Weeks ]
    Likert and visual analogue (VAS) pain scales, patient and physician global assessment scales and the physician's assessment of tenderness, swelling and erythema of the most affected joint will be collected during every gouty arthritis flare and at the end of the study.

  5. Pharmacokinetics (PK) of canakinumab 150mg s.c. PFS [ Time Frame: 36 Weeks ]
    PK assessments at various time points will be carried out to characterize the PK properties of the PFS form of canakinumab, as well as provide supporting data in the interpretation of any immunogenicity findings.



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Compliance and completion of the canakinumab PFS core study
  • Unchanged significant clinical medical history from entry into core study

Exclusion criteria:

  • Physician judgment of unsuitability for the study
  • Pregnant or nursing women 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): NCT01431638


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Locations
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United States, Alabama
Novartis Investigative Site
Anniston, Alabama, United States, 36207-5710
Novartis Investigative Site
Gulf Shores, Alabama, United States, 36547
Novartis Investigative Site
Mobile, Alabama, United States, 36608
United States, Arizona
Novartis Investigative Site
Chandler, Arizona, United States, 85224
Novartis Investigative Site
Scottsdale, Arizona, United States, 85251
United States, California
Novartis Investigative Site
Buena Park, California, United States, 90620
Novartis Investigative Site
Norwalk, California, United States, 90650
Novartis Investigative Site
Westlake Village, California, United States, 91361
United States, Florida
Novartis Investigative Site
Jupiter, Florida, United States, 33458
Novartis Investigative Site
Largo, Florida, United States, 33773
Novartis Investigative Site
South Miami, Florida, United States, 33143
United States, Georgia
Novartis Investigative Site
Augusta, Georgia, United States, 30904
Novartis Investigative Site
Decatur, Georgia, United States, 30035
United States, Kansas
Novartis Investigative Site
Topeka, Kansas, United States, 66606
United States, Kentucky
Novartis Investigative Site
Louisville, Kentucky, United States, 40217
Novartis Investigative Site
Owensboro, Kentucky, United States, 42303
United States, Louisiana
Novartis Investigative Site
Metairie, Louisiana, United States, 70006
United States, Michigan
Novartis Investigative Site
Troy, Michigan, United States, 48085
United States, Mississippi
Novartis Investigative Site
Belzoni, Mississippi, United States, 39038
Novartis Investigative Site
Jackson, Mississippi, United States, 39209
Novartis Investigative Site
Picayune, Mississippi, United States, 39466
United States, Montana
Novartis Investigative Site
Missoula, Montana, United States, 59804
United States, Nebraska
Novartis Investigative Site
Lincoln, Nebraska, United States, 68516
Novartis Investigative Site
Omaha, Nebraska, United States, 68114
Novartis Investigative Site
Omaha, Nebraska, United States, 68134
United States, New York
Novartis Investigative Site
Mineola, New York, United States, 11501
Novartis Investigative Site
New Hyde Park, New York, United States, 11042
Novartis Investigative Site
Roslyn, New York, United States, 11576
United States, North Carolina
Novartis Investigative Site
Asheville, North Carolina, United States, 28801
Novartis Investigative Site
Cary, North Carolina, United States, 27518
Novartis Investigative Site
Charlotte, North Carolina, United States, 28209
Novartis Investigative Site
Greensboro, North Carolina, United States, 27401
Novartis Investigative Site
Salisbury, North Carolina, United States, 28144
Novartis Investigative Site
Shelby, North Carolina, United States, 28152
Novartis Investigative Site
Wilmington, North Carolina, United States, 28401
United States, North Dakota
Novartis Investigative Site
Fargo, North Dakota, United States, 58103
United States, Ohio
Novartis Investigative Site
Mogadore, Ohio, United States, 44260
United States, Pennsylvania
Novartis Investigative Site
Duncansville, Pennsylvania, United States, 16635
United States, South Carolina
Novartis Investigative Site
Charleston, South Carolina, United States, 29412
Novartis Investigative Site
Columbia, South Carolina, United States, 29204
Novartis Investigative Site
Greer, South Carolina, United States, 29651
Novartis Investigative Site
Ninety Six, South Carolina, United States, 29666
Novartis Investigative Site
Varnville, South Carolina, United States, 29944
United States, Tennessee
Novartis Investigative Site
Bristol, Tennessee, United States, 37620
Novartis Investigative Site
Johnson City, Tennessee, United States, 37601
Novartis Investigative Site
Memphis, Tennessee, United States, 38125
United States, Texas
Novartis Investigative Site
Bedford, Texas, United States, 76021
Novartis Investigative Site
Dallas, Texas, United States, 75231
Novartis Investigative Site
Houston, Texas, United States, 77034
United States, Utah
Novartis Investigative Site
Bountiful, Utah, United States, 84010
United States, Virginia
Novartis Investigative Site
Danville, Virginia, United States, 24541
Novartis Investigative Site
Midlothian, Virginia, United States, 23114
Novartis Investigative Site
Newport News, Virginia, United States, 23606
United States, Washington
Novartis Investigative Site
Bellevue, Washington, United States, 98004
Canada, Newfoundland and Labrador
Novartis Investigative Site
St-John's, Newfoundland and Labrador, Canada, A1E 2C2
Novartis Investigative Site
St. John, Newfoundland and Labrador, Canada, A1B 5E8
Canada, Quebec
Novartis Investigative Site
Sainte-Foy, Quebec, Canada, G1v 3M7
Germany
Novartis Investigative Site
Berlin, Germany, 13125
Novartis Investigative Site
Loehne, Germany, 32584
Novartis Investigative Site
Magdeburg, Germany, 39110
Novartis Investigative Site
Regensburg, Germany, 93053
Novartis Investigative Site
Weener, Germany, 26826
Lithuania
Novartis Investigative Site
Kaunas, LT, Lithuania, 50128
Novartis Investigative Site
Kaunas, LT, Lithuania, 51349
Novartis Investigative Site
Vilnius, LT, Lithuania, 01117
Novartis Investigative Site
Klaipeda, Lithuania, 92288
Novartis Investigative Site
Vilnius, Lithuania, 09020
Novartis Investigative Site
Vilnius, Lithuania, LT-08661
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Additional Information:
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01431638     History of Changes
Other Study ID Numbers: CACZ885H2361E1
2011-001342-15
First Posted: September 9, 2011    Key Record Dates
Last Update Posted: November 17, 2017
Last Verified: November 2017
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Gout
arthritis
gout flare
acute gout
gouty
rheumatic disease
uric acid
podagra
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
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs