Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

β-RELIEVED - REsponse in Acute fLare and In prEVEntion of episoDes of Re-flare in Gout - Extension 3 (E3) (β-RELIEVED)

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: NCT01470989
Recruitment Status : Completed
First Posted : November 11, 2011
Last Update Posted : February 23, 2017
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Tracking Information
First Submitted Date  ICMJE August 16, 2011
First Posted Date  ICMJE November 11, 2011
Last Update Posted Date February 23, 2017
Study Start Date  ICMJE November 2011
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 11, 2016)
safety and tolerability [ Time Frame: 18 months ]
long-term safety and tolerability of canakinumab
Original Primary Outcome Measures  ICMJE
 (submitted: November 9, 2011)
Safety and tolerability of canakinumab [ Time Frame: 18 months ]
Safety and tolerability will be evaluated by summarizing adverse events (including infections and malignancies), vital signs and laboratory data in patients exposed to canakinumab
Change History Complete list of historical versions of study NCT01470989 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 11, 2016)
long-term efficacy [ Time Frame: 18 months ]
long-term efficacy of canakinumab defined as frequency of new flares
Original Secondary Outcome Measures  ICMJE
 (submitted: November 9, 2011)
  • Long-term efficacy of canakinumab defined as frequency of new flares [ Time Frame: 18 months ]
    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 ]
    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 ]
    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 ]
    hsCRP will be measured at scheduled (every 6 months) and unscheduled visits (flare/control visits)
  • Immunogenicity of canakinumab [ Time Frame: 18 months ]
    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 ]
    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
Current Other Pre-specified Outcome Measures
 (submitted: April 11, 2016)
long-term efficacy [ Time Frame: 18 months ]
long-term efficacy of canakinumab, defined as patient's assessment of gout pain intensity (Likert scale) over time
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE β-RELIEVED - REsponse in Acute fLare and In prEVEntion of episoDes of Re-flare in Gout - Extension 3 (E3)
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acute Gouty Arthritis Flares
Intervention  ICMJE Drug: ACZ885
canakinumab 150 mg s.c., given on demand upon new flares
Study Arms  ICMJE Experimental: canakinumab
canakinumab 150 mg s.c.
Intervention: Drug: ACZ885
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: April 11, 2016)
135
Original Estimated Enrollment  ICMJE
 (submitted: November 9, 2011)
200
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:

  • 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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (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 Australia,   Canada,   Estonia,   Germany,   Latvia,   Lithuania,   Russian Federation,   Ukraine,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01470989
Other Study ID Numbers  ICMJE CACZ885H2357E3
2011-003414-17
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 February 2017

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