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

Browse trials for

• Arthritis 3,554
• Arthritis, Gouty 59

Keywords

• Gout
• arthritis
• gout flare
• acute gout
• gouty
• rheumatic disease
• uric acid

Arthritis

3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.

This study's enrollment of 397 is above the median of 90 across 2,377 interventional studies indexed under Arthritis.

Lead sponsor

Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.

Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.

Study arms

• Experimental
  Canakinumab, pre-filled syringes (PFS)

  Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.

  Drug: Canakinumab pre-filled syringe · Drug: Placebo

• Active comparator
  Canakinumab, lyophilizate (LYO)

  The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized powder and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.

  Drug: Canakinumab lyophilized powder · Drug: Placebo

• Active comparator
  Triamcinolone Acetonide

  The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.

  Drug: Triamcinolone Acetonide · Drug: Placebo

Interventions

• DrugCanakinumab pre-filled syringe

  Canakinumab pre-filled syringe

• DrugCanakinumab lyophilized powder

  Canakinumab lyophilized powder

• DrugTriamcinolone Acetonide

  Triamcinolone Acetonide

• DrugPlacebo

  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

   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.

   Time frame: 72 hours post dose

Secondary outcomes

1. Pain Intensity on a 0 - 100 mm VAS Between the Canakinumab 150 mg PFS and Canakinumab 150 mg LYO Groups

   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.

   Time frame: 72 hours post dose

2. Patient's Assessment of Pain Intensity on a 0-100mm VAS

   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.

   Time frame: 14 days

3. Patient's Assessment of Pain Intensity on a 5-point Likert Scale

   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.

   Time frame: 72 hours

4. Number of Patients With at Least One New Gouty Arthritis Flare After Baseline

   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 frame: 12 weeks

5. Time to the First New Gouty Arthritis Flare

   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 frame: 12 weeks

6. Time to 50% Reduction in Baseline Pain on a 0 - 100 VAS

   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 frame: 14 days

7. Time to Resolution of Gouty Arthritis Flare as Reported by Patient

   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.

   Time frame: 14 days

8. Patient's Global Assessment of Response to Treatment on a 5-point Likert Scale

   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.

   Time frame: 72 hours

9. Physician's Global Assessment of Response to Treatment on a 5 Point Likert Scale

   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).

   Time frame: 72 hours

10. Physician's Assessment of Tenderness

    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.

    Time frame: 72 hours

11. Physician's Assessment of Swelling

    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.

    Time frame: 72 hours

12. Physician's Assessment of Erythema

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

    Time frame: 72 hours

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

    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).

    Time frame: 72 hours

14. Proportion of Patients With Rescue Medication Intake

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

    Time frame: 12 weeks

15. Time to First Rescue Medication Intake

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

    Time frame: 14 days

16. Amount of Rescue Medication Taken (mg)

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

    Time frame: 14 days

17. C-reactive Protein Level

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

    Time frame: 72 hours

Baseline characteristics