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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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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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Arthritis
Arthritis, Gouty
Joint Diseases
Musculoskeletal Diseases
Gout
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