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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:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01431638
First received: August 30, 2011
Last updated: June 13, 2014
Last verified: June 2014

August 30, 2011
June 13, 2014
August 2011
May 2013   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01431638 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Long-Term Safety and Tolerability of Canakinumab Prefilled Syringes in Frequently Flaring Acute Gouty Arthritis Patients
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

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.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Acute Gouty Arthritis
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
Experimental: Canakinumab 150mg
Canakinumab 150mg in prefilled syringe subcutaneously
Intervention: Drug: Canakinumab 150mg in prefilled syringe
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
233
May 2013
May 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   Germany,   Lithuania
 
NCT01431638
CACZ885H2361E1, 2011-001342-15
Yes
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP