β-RELIEVED - REsponse in Acute fLare and In prEVEntion of episoDes of Re-flare in Gout - Extension 3 (E3) (β-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: April 11, 2016
Last verified: April 2016

August 16, 2011
April 11, 2016
November 2011
May 2013   (final data collection date for primary outcome measure)
safety and tolerability [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
long-term safety and tolerability of canakinumab
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
Complete list of historical versions of study NCT01470989 on ClinicalTrials.gov Archive Site
long-term efficacy [ Time Frame: 18 months ] [ Designated as safety issue: No ]
long-term efficacy of canakinumab defined as frequency of new flares
  • 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
long-term efficacy [ Time Frame: 18 months ] [ Designated as safety issue: No ]
long-term efficacy of canakinumab, defined as patient's assessment of gout pain intensity (Likert scale) over time
Not Provided
 
β-RELIEVED - REsponse in Acute fLare and In prEVEntion of episoDes of Re-flare in Gout - Extension 3 (E3)
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
This was an 18-month, multi-center, open-label, clinical extension study. Patients completing earlier second extension studies (CACZ885H2356E2 and CACZ885H2357E2) continued to be treated in this combined extension 3 study for any new gouty arthritis flare on demand with one subcutaneous (s.c.) injection of canakinumab 150 mg.
Not Provided
Interventional
Phase 3
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Acute Gouty Arthritis Flares
Drug: ACZ885
canakinumab 150 mg s.c., given on demand upon new flares
Experimental: canakinumab
canakinumab 150 mg s.c.
Intervention: Drug: ACZ885
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
135
May 2013
May 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients who have completed the second extension studies CACZ885H2356E2 or CACZ885H2357E2
  • Patients treated with canakinumab in the core studies or subsequent extensions

Exclusion Criteria:

- Pregnant or nursing (lactating) women

Both
18 Years and older   (Adult, Senior)
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
Yes
Not Provided
Not Provided
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
April 2016

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