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Canakinumab in the Treatment of Gouty Arthritis Flare(s) and Prevention of New Flares in Patients With Chronic Kidney Disease

Primary Purpose

Acute Gouty Arthritis

Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
ACZ885
Triamcinelone acetonide
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Gouty Arthritis focused on measuring Frequent flares, Frequent attacks, gout, gouty arthritis, Chronic kidney disease, renal impairment, Anti-interleukin-1β monoclonal antibody, anti-inflammatory therapy

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

  • Confirmed diagnosis of gouty arthritis History of ≥ 3 gouty arthritis flares within the previous 12 months
  • Confirmed diagnosis/ documented history of chronic kidney disease (CKD) Stages 3or4
  • Onset of current acute gouty arthritis flare within 3 days prior to randomization

Exclusion criteria:

  • Hemodialysis CKD Stage 5 Organ transplantation
  • Rheumatoid arthritis, evidence/suspicion of infectious/septic arthritis, or other acute inflammatory arthritis
  • Live vaccinations within 3 months prior to randomization Other protocol-defined inclusion/exclusion criteria may apply

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Arm 1

    Arm 2

    Arm Description

    Canakinumab 150 mg s.c.

    Triamcinelone acetonide 40 mg i.m.

    Outcomes

    Primary Outcome Measures

    Proportion of patients experiencing new gouty arthritis flares during 12-week follow-up from dosing

    Secondary Outcome Measures

    The time to the first new gout flare
    Score on Visual Analog Scale at 72 hours to measure gouty arthritis pain intensity and resolution
    Number of patients needing rescue medication use during acute gouty arthritis flare(s)
    Measurement of efficacy using inflammatory markers
    Time to 50% reduction of baseline pain intensity in the most affected joint

    Full Information

    First Posted
    May 3, 2012
    Last Updated
    April 19, 2017
    Sponsor
    Novartis Pharmaceuticals
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01593527
    Brief Title
    Canakinumab in the Treatment of Gouty Arthritis Flare(s) and Prevention of New Flares in Patients With Chronic Kidney Disease
    Official Title
    A Randomized Double-blind Active-controlled Trial of Canakinumab Versus Triamcinolone Acetonide on Reducing the Proportion of Patients With Any New Gouty Arthritis Flare(s) in Patients With Chronic Kidney Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2013
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    September 2012 (undefined)
    Primary Completion Date
    September 2012 (Anticipated)
    Study Completion Date
    September 2012 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Novartis Pharmaceuticals

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this study is to confirm the efficacy and safety results obtained in a chronic kidney disease (CKD) subgroup of patients participating in Phase III studies in a larger, independent patient population with difficult to treat gouty arthritis and moderate to severe CKD (stage 3 - 4).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Gouty Arthritis
    Keywords
    Frequent flares, Frequent attacks, gout, gouty arthritis, Chronic kidney disease, renal impairment, Anti-interleukin-1β monoclonal antibody, anti-inflammatory therapy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Arm 1
    Arm Type
    Experimental
    Arm Description
    Canakinumab 150 mg s.c.
    Arm Title
    Arm 2
    Arm Type
    Experimental
    Arm Description
    Triamcinelone acetonide 40 mg i.m.
    Intervention Type
    Drug
    Intervention Name(s)
    ACZ885
    Intervention Description
    Canakinumab 150 mg s.c.
    Intervention Type
    Drug
    Intervention Name(s)
    Triamcinelone acetonide
    Intervention Description
    Triamcinelone acetonide 40 mg i.m.
    Primary Outcome Measure Information:
    Title
    Proportion of patients experiencing new gouty arthritis flares during 12-week follow-up from dosing
    Time Frame
    12 Weeks
    Secondary Outcome Measure Information:
    Title
    The time to the first new gout flare
    Time Frame
    12 Weeks
    Title
    Score on Visual Analog Scale at 72 hours to measure gouty arthritis pain intensity and resolution
    Time Frame
    12 weeks
    Title
    Number of patients needing rescue medication use during acute gouty arthritis flare(s)
    Time Frame
    12 Weeks
    Title
    Measurement of efficacy using inflammatory markers
    Time Frame
    12 Weeks
    Title
    Time to 50% reduction of baseline pain intensity in the most affected joint
    Time Frame
    12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion criteria: Confirmed diagnosis of gouty arthritis History of ≥ 3 gouty arthritis flares within the previous 12 months Confirmed diagnosis/ documented history of chronic kidney disease (CKD) Stages 3or4 Onset of current acute gouty arthritis flare within 3 days prior to randomization Exclusion criteria: Hemodialysis CKD Stage 5 Organ transplantation Rheumatoid arthritis, evidence/suspicion of infectious/septic arthritis, or other acute inflammatory arthritis Live vaccinations within 3 months prior to randomization Other protocol-defined inclusion/exclusion criteria may apply

    12. IPD Sharing Statement

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    Canakinumab in the Treatment of Gouty Arthritis Flare(s) and Prevention of New Flares in Patients With Chronic Kidney Disease

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