Skip to main content
OpenTrials
Completed

NCT Number: NCT01356602

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Acute Gouty Arthritis Arthritis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Connective Tissue Diseases Crystal Arthropathies Genetic Diseases, Inborn Gout Joint Diseases Metabolic Diseases Metabolism, Inborn Errors Musculoskeletal Diseases Nutritional and Metabolic Diseases Purine-Pyrimidine Metabolism, Inborn Errors Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novartis Investigative Site, St. John's, Newfoundland and Labrador, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 3 or more gout flares within last year
  • Contraindication, intolerance or lack of efficacy for NSAIDs and/or colchicine
  • Body mass index of less than or equal to 45 kg/m2

Exclusion criteria

  • Use of the following therapies (within varying protocol defined timeframes): corticosteroids, narcotics, topical ice/cold packs, chronic opiate treatment, NSAIDs (such as aspirin), colchicine.
  • Hemodialysis
  • Live vaccine within 3 months before first dose
  • Donation or loss of 400 mL or more within 3 months before first dose
  • Gout brought on by other factors such as chemotherapy, lead, transplant, etc.
  • Presence of other acute inflammatory arthritis such as Rheumatoid Arthritis
  • Any conditions or significant medical problems that puts the patient at an unacceptable immunological risk to receive this type of therapy such as HIV, Hepatitis, Tuberculosis and other infections/conditions
  • Significant cardiovascular conditions such as uncontrolled hypertension
  • Significant medical diseases such as uncontrolled diabetes, thyroid disease
  • History of malignancy of any organ system within the past 5 years
  • Women who are pregnant or nursing
  • Other protocol-defined inclusion/exclusion criteria may apply

Treatment and study plan

Canakinumab pre-filled syringe

Drug

Canakinumab pre-filled syringe

Canakinumab lyophilized powder

Drug

Canakinumab lyophilized powder

Triamcinolone Acetonide

Drug

Triamcinolone Acetonide

Placebo

Drug

Matching placebo to Canakinumab (PFS), Canakinumab (LYO) and Triamcinolone Acetonide

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. Physician'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. Study physicians scored their assessment of the patients' response to treatment on a 5-point Likert scale (very good, good, fair, poor, very poor).

  10. Physician's Assessment of Tenderness

    Time frame: 72 hours

    The study physician assessed the most affected joint for tenderness. Tenderness was measured on a 0 - 3 point scale as follows: 0 = no pain, 1 = patient states that "there is pain", 2 = patient states "there is pain and winces" and 3 = patient states "there is pain, winces and withdraws" on palpation or passive movement of the affected study joint.

  11. Physician's Assessment of Swelling

    Time frame: 72 hours

    The study physician assessed the most affected joint for swelling. Swelling was measured on a 0 - 3 point scale as follows: 0 = no swelling, 1 = palpable, 2= visible and 3 = bulging beyond the joint margins.

  12. Physician's Assessment of Erythema

    Time frame: 72 hours

    The study physician assessed the most affected joint for erythema. Erythema was assessed as present, absent or not assessable.

  13. Physician's Assessment of Range of Motion of the Most Affected Joint

    Time frame: 72 hours

    The study physician assessed the patient's range of motion of the most affected joint on a 5 point Likert scale (normal, mildly restricted, moderately restricted, severely restricted and immobilized).

  14. Proportion of Patients With Rescue Medication Intake

    Time frame: 12 weeks

    Patients used a diary to record the time of intake of rescue medication and the amount taken.

  15. Time to First Rescue Medication Intake

    Time frame: 14 days

    Patients used a diary to record the time of intake of rescue medication and the amount taken.

  16. Amount of Rescue Medication Taken (mg)

    Time frame: 14 days

    Patients used a diary to record the time of intake of rescue medication and the amount taken.

  17. C-reactive Protein Level

    Time frame: 72 hours

    A central laboratory was used for analysis of all blood samples collected.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

A Randomized, Double-blind, Active-controlled Study of Canakinumab Prefilled Syringes or Reconstituted Lyophilizate Versus Triamcinolone Acetonide for Treating Acute Gouty Arthritis Flares in Frequently Flaring Patients

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
May 19, 2011
Registry last updated
Jan 29, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.