An Open-label Extension Study With Canakinumab on the Treatment and Prevention of Gout Flares up to 3 Years (B-Relieved)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01470989
First received: August 16, 2011
Last updated: May 15, 2014
Last verified: May 2014

August 16, 2011
May 15, 2014
November 2011
May 2013   (final data collection date for primary outcome measure)
Safety and tolerability of canakinumab [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Safety and tolerability will be evaluated by summarizing adverse events (including infections and malignancies), vital signs and laboratory data in patients exposed to canakinumab
Same as current
Complete list of historical versions of study NCT01470989 on ClinicalTrials.gov Archive Site
  • Long-term efficacy of canakinumab defined as frequency of new flares [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Flare rate will be calculated as the number of new gout flares over the period of observations in years
  • Long-term efficacy of canakinumab defined as Patient's assessment of gout pain intensity (Likert scale) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Patient's assessment of gout pain intensity (Likert scale) will be measured on a daily basis over 14 days after each new flare starting one day after re-dosing until control visit
  • Long-term efficacy of canakinumab defined as global assessment of response to treatment (Likert scale) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Global assessment of response to treatment (Likert scale) will be measured on a daily basis over 14 days after each new flare starting one day after re-dosing until control visit
  • Long-term efficacy of canakinumab with regards to inflammatory markers (high sensitivity C-reactive protein) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    hsCRP will be measured at scheduled (every 6 months) and unscheduled visits (flare/control visits)
  • Immunogenicity of canakinumab [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Immunogenicity will be assessed at scheduled (every 6 months) and unscheduled visits (flare visits)
  • Safety in the concomitant use of canakinumab with different urate lowering therapy regimens [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Safety in the concomitant use with different ULT regimens will be evaluated by summarizing adverse events (including infections and malignancies), urate lowering concomitant medications, vital signs and laboratory data in patients initiating or modifying their urate lowering therapy while exposed canakinumab
Same as current
Not Provided
Not Provided
 
An Open-label Extension Study With Canakinumab on the Treatment and Prevention of Gout Flares up to 3 Years
An Open-label Extension Study of CACZ885H2356E2 and CACZ885H2357E2 on the Treatment and Prevention of Gout Flares in Patients With Frequent Flares for Whom NSAIDs and/or Colchicine Are Contraindicated, Not Tolerated or Ineffective

The purpose of this third extension study is to provide additional long-term safety and tolerability data of canakinumab over an 18-month time period on patients who have completed the extension studies CACZ885H2356E2 and CACZ885H2357E2. Overall, the treatment and follow-up period from the initial baseline visit in the core studies, and all subsequent extensions will amount to a total of up to 3 years.The study will provide additional safety data of repeated treatment with on-demand use of canakinumab in patients with gouty arthritis. The study may further be used to optimize patients' Urate Lowering Therapy (ULT) as needed, and collect further safety data on the concomitant use of canakinumab with different ULT regimens.

Not Provided
Interventional
Phase 3
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Gouty Arthritis
Biological: canakinumab
Canakinumab 150 mg
Experimental: Canakinumab
Intervention: Biological: canakinumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
229
Not Provided
May 2013   (final data collection date for primary outcome measure)

Inclusion criteria:

  • Patients who have completed the second extension studies
  • Patients who have already been treated with canakinumab in the core studies or subsequent extensions

Exclusion criteria:

  • Continuation in this extension study is considered inappropriate by the treating physician
  • 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,   Australia,   Canada,   Estonia,   Germany,   Latvia,   Lithuania,   Russian Federation,   Ukraine
 
NCT01470989
CACZ885H2357E3, 2011-003414-17
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceticals Novartis Pharmaceuticals
Novartis
May 2014

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