Clinical Trial: Safety and Efficacy of Canakinumab Prefilled Syringes in Frequently Flaring Acute Gouty Arthritis Patients

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Randomized, Double-blind, Active-controlled Study of Canakinumab Prefilled Syringes or Reconstituted Lyophilizate Versus Triamcinolone Acetonide for Treating Acute Gouty Arthri

Brief Summary: This study assessed the safety and efficacy of canakinumab pre-filled syringes in comparison to triamcinolone acetonide 40 mg and canakinumab lyophilizate in patients that have frequent flares of acute gouty arthritis.

Detailed Summary:
Sponsor: Novartis Pharmaceuticals

Current Primary Outcome: Pain Intensity on a 0-100 mm Visual Analog Scale (VAS) Between the Canakinumab 150 mg PFS and Triamcinolone Acetonide 40 mg Groups [ Time Frame: 72 hours post dose ]

The Visual Analog Scale (VAS) is an instrument used to measure a person's subjective quantitative evaluation of an item such as pain intensity. The VAS contains a continuous line between two end points whereby the respondent places a mark on the line to indicate his or her response. In this study, patients scored their pain intensity in the most affected joint of the gout flare on a 0 100 mm VAS. The scale ranged from 0 (no pain) to 100 (unbearable pain). The scores were measured to the nearest millimeter from the left. Missing pain intensity data at 72 hours was imputed using the Last-Observation-Carried-Forward (LOCF) method.


Original Primary Outcome: To assess the change in acute gouty arthritis flare pain intensity on a 0-100 mm Visual Analog Scale [ Time Frame: 72 hours post dose ]

Current Secondary Outcome:

  • Pain Intensity on a 0 - 100 mm VAS Between the Canakinumab 150 mg PFS and Canakinumab 150 mg LYO Groups [ Time Frame: 72 hours post dose ]
    The Visual Analog Scale (VAS) is an instrument used to measure a person's subjective quantitative evaluation of an item such as pain intensity. The VAS contains a continuous line between two end points whereby the respondent places a mark on the line to indicate his or her response. In this study, patients scored their pain intensity in the most affected joint of the gout flare on a 0 100 mm VAS. The scale ranged from 0 (no pain) to 100 (unbearable pain). The scores were measured to the nearest millimeter from the left. Missing pain intensity data at 72 hours was imputed using the Last-Observation-Carried-Forward (LOCF) method.
  • Patient's Assessment of Pain Intensity on a 0-100mm VAS [ Time Frame: 14 days ]
    The Visual Analog Scale (VAS) is an instrument used to measure a person's subjective quantitative evaluation of an item such as pain intensity. The VAS contains a continuous line between two end points whereby the respondent places a mark on the line to indicate his or her response. In this study, patients scored their pain intensity in the most affected joint of the gout flare on a 0 100 mm VAS. The scale ranged from 0 (no pain) to 100 (unbearable pain). The scores were measured to the nearest millimeter from the left. The LOCF method was used to impute post-dose pain intensity VAS measurements up to 14 days.
  • Patient's Assessment of Pain Intensity on a 5-point Likert Scale [ Time Frame: 72 hours ]
    A Likert scale is a type of scale with a range of responses corresponding to an item such as pain. The respondent selects the best response that indicates the respondent's subjective evaluation of the item. Patients scored their pain intensity in the most affected joint of the gout flare on a 5-point Likert scale (none, mild, moderate, severe, extreme). The scores were measured to the nearest millimeter from the left. The LOCF method was used to impute post-dose pain intensity Likert measurements up to 14 days.
  • Number of Patients With at Least One New Gouty Arthritis Flare After Baseline [ Time Frame: 12 weeks ]
    Patients met the definition of a new flare if they had: a flare in a joint, which was not a previously affected joint (at baseline or during the study), or a flare in a joint previously affected (at baseline or during the study) after the previous flare in that joint had resolved completely according to the patient's perception. Patients did NOT meet the criterion of having a new gout flare if they had increasing/renewed gout pain in an affected joint before the flare had resolved completely.
  • Time to the First New Gouty Arthritis Flare [ Time Frame: 12 weeks ]
    Patients met the definition of a new flare if they had: a flare in a joint, which was not a previously affected joint (at baseline or during the study), or a flare in a joint previously affected (at baseline or during the study) after the previous flare in that joint had resolved completely according to the patient's perception. Patients did NOT meet the criterion of having a new gout flare if they had increasing/renewed gout pain in an affected joint before the flare had resolved completely. Less than 50% of patients had new flares. Therefore, the median time to new flare could not be calculated.
  • Time to 50% Reduction in Baseline Pain on a 0 - 100 VAS [ Time Frame: 14 days ]
    The Visual Analog Scale (VAS) is an instrument used to measure a person's subjective quantitative evaluation of an item such as pain intensity. The VAS contains a continuous line between two end points whereby the respondent places a mark on the line to indicate his or her response. In this study, patients scored their pain intensity in the most affected joint of the gout flare on a 0 100 mm VAS. The scale ranged from 0 (no pain) to 100 (unbearable pain). The scores were measured to the nearest millimeter from the left. Kaplan Meier estimate of time to 50% reduction in baseline pain, along with associated 95% confidence interval, were reported.
  • Time to Resolution of Gouty Arthritis Flare as Reported by Patient [ Time Frame: 14 days ]
    Patients completed diary entries at 6, 12, 24, 48 and 72 hours post dose and then daily up to 7 days post-dose and/or daily until resolution of the flare. Kaplan Meier estimate of time to resolution of gouty flare as reported by patient, along with associated 95% confiedence interval, were reported.
  • Patient's Global Assessment of Response to Treatment on a 5-point Likert Scale [ Time Frame: 72 hours ]
    A Likert scale is a type of scale with a range of responses corresponding to an item such as pain. The respondent selects the best response that indicates the respondent's subjective evaluation of the item. Patients scored their response to treatment on a 5-point Likert scale (excellent, good, acceptable, slight, poor). This outcome measure shows the number of patients indicating each score on the scale.
  • Physician's Global Assessment of Response to Tr

    Original Secondary Outcome:

    • The percentage of patients with at least one new gouty arthritis flare [ Time Frame: 12 weeks ]
    • The time to the first new gouty arthritis flare [ Time Frame: 12 weeks ]
    • To evaluate gouty arthritis flare pain intensity and resolution using a Visual Analog Scale [ Time Frame: 12 weeks ]
    • To evaluate use of rescue medication during acute gouty arthritis flares [ Time Frame: 12 weeks ]
    • To assess the signs and symptoms of each new gouty arthritis flare using patient and physician questionnaires [ Time Frame: up to 12 weeks after last dose ]


    Information By: Novartis

    Dates:
    Date Received: May 16, 2011
    Date Started: May 2011
    Date Completion:
    Last Updated: December 10, 2013
    Last Verified: December 2013