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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01431638
First Posted: September 9, 2011
Last Update Posted: March 22, 2017
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.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
  Purpose
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 Intervention Phase
Acute Gouty Arthritis Drug: Canakinumab 150mg in prefilled syringe Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • 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:
  • 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

  • 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.

  • 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

  • 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.

  • 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.


Enrollment: 233
Study Start Date: August 2011
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
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
  Contacts and Locations
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


  Show 68 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Additional Information:
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01431638     History of Changes
Other Study ID Numbers: CACZ885H2361E1
2011-001342-15
First Submitted: August 30, 2011
First Posted: September 9, 2011
Last Update Posted: March 22, 2017
Last Verified: March 2017

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Gout
arthritis
gout flare
acute gout
gouty
rheumatic disease
uric acid
podagra

Additional relevant MeSH terms:
Arthritis
Arthritis, Gouty
Joint Diseases
Musculoskeletal Diseases
Gout
Rheumatic Diseases
Purine-Pyrimidine Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs