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

This study is currently recruiting participants.
Verified April 2012 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01431638
First received: August 30, 2011
Last updated: April 27, 2012
Last verified: April 2012
History of Changes
  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: 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:

MedlinePlus related topics: Gout
Drug Information available for: Canakinumab
U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Safety and tolerability of repeated dosing of canakinumab 150mg s.c. PFS [ Time Frame: 36 weeks ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 350
Study Start Date: August 2011
Estimated Primary Completion Date: December 2012 (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

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01431638

Contacts
Contact: Novartis Pharmaceuticals 862-778-8300

  Show 82 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01431638     History of Changes
Other Study ID Numbers: CACZ885H2361E1, 2011-001342-15
Study First Received: August 30, 2011
Last Updated: April 27, 2012
Health Authority: Belgium: Ministry of Social Affairs, Public Health and the Environment
Canada: Canadian Institutes of Health Research
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
Lithuania: State Medicine Control Agency - Ministry of Health
United States: Food and Drug Administration

Keywords provided by Novartis:
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
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013