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

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.
 
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 )

Tracking Information
First Submitted Date  ICMJE August 30, 2011
First Posted Date  ICMJE September 9, 2011
Last Update Posted Date November 17, 2017
Study Start Date  ICMJE August 2011
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 8, 2011)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01431638 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 8, 2011)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Long-Term Safety and Tolerability of Canakinumab Prefilled Syringes in Frequently Flaring Acute Gouty Arthritis Patients
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acute Gouty Arthritis
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: Canakinumab 150mg
Canakinumab 150mg in prefilled syringe subcutaneously
Intervention: Drug: Canakinumab 150mg in prefilled syringe
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 13, 2014)
233
Original Estimated Enrollment  ICMJE
 (submitted: September 8, 2011)
350
Actual Study Completion Date  ICMJE May 2013
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Germany,   Lithuania,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01431638
Other Study ID Numbers  ICMJE CACZ885H2361E1
2011-001342-15
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novartis ( Novartis Pharmaceuticals )
Study Sponsor  ICMJE Novartis Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
PRS Account Novartis
Verification Date November 2017

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