Clinical Trial: Efficacy and Safety of a Single Dose of Canakinumab (ACZ885) in Hospitalized Patients With Acute Gout

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

Official Title: A Randomized, Double-blind, Double-dummy, Active-controlled, Parallel Group Study of a Single Dose of ACZ885 in Hospitalized Patients With Acute Gout

Brief Summary: This is an exploratory proof-of-concept study to evaluate the safety and efficacy of canakinumab (ACZ885) for inflammation and pain associated with acute gouty arthritis.

Detailed Summary:
Sponsor: Novartis

Current Primary Outcome: Percentage of Participants With Improvement in Gout at 72 Hours Post-dose Using a Likert Scale [ Time Frame: 72 hours ]

72 hours following treatment, patients were asked the question: "How would you rate the improvement in your gout since receiving the study medication?" Patients rated their improvement on the Likert 5-point scale: 1=Excellent, 2=Good, 3=Acceptable,4=Slight and 5=Poor. Improvement was assessed by determining patients who scored a "good" or "excellent" response.


Original Primary Outcome: Self-assessed response to treatment at 72 hours post-dose.

Current Secondary Outcome:

  • Non-inferiority of a Single Dose of Canakinumab Compared to Dexamethasone During Treatment Period [ Time Frame: 72 hours ]
  • Time to Recurrence of the Symptoms of Acute Gout (if Applicable) During Treatment Period [ Time Frame: 4 months ]
    Time to recurrence is defined as from the point of improvement (good to excellent on Likert scale) to recurrence.
  • Time to Walk Independently (if Applicable) During Treatment Period [ Time Frame: 4 months ]
  • Number of Participants With Discontinuation of Treatment Due to Adverse Events, Deaths or Serious Adverse Events During the Study [ Time Frame: 4 months ]
    Additional safety information can be found in the Adverse Event section.
  • Change in C-reactive Protein (CRP) From Baseline at Month 4 [ Time Frame: Baseline, Month 4 ]
    Blood was collected at Baseline and Month 4 for CRP to identify the presence of inflammation, to determine its severity, and to monitor response to treatment. A negative change from baseline indicates improvement.
  • Change in Serum Amyloid A Protein (SAA) From Baseline at Month 4 [ Time Frame: Baseline, Month 4 ]
    Blood was collected at Baseline and Month 4 for SAA to identify the presence of inflammation, to determine its severity, and to monitor response to treatment. A negative change from baseline indicates improvement.
  • ACZ885 (Canakinumab) Pharmacokinetics (PK) Serum Concentration During the Treatment Period [ Time Frame: Baseline, Days 0.25, 1, 3, 6, 20, 34, 55 and 119 ]
    Blood was collected for ACZ885 (canakinumab) levels at baseline and Days 0.25, 1, 3, 6, 20, 34, 55 and 119. Serum was analyzed by means of a competitive Enzyme linked immunosorbant assay (ELISA).
  • Change From Baseline in Pain Using a Visual Analog Scale at Month 4 [ Time Frame: Baseline, Month 4 ]
    Patients rated their pain on a 100 millimeter (mm) visual analog scale, ranging from no pain (0) to unbearable pain (100). A negative change from baseline indicates improvement.
  • Number of Patients Who Took Rescue Medication [ Time Frame: 4 months ]
    Patients who did not improve by 72 hours post-dose (i.e. patients who show a pain Visual Analog (VAS) decrease of less than 50 % from baseline (Day 1, pre-dose) would have been treated with rescue medication of methylprednisolone 80 mg intravenous or intramuscular once at the discretion of the clinical investigator.


Original Secondary Outcome:

  • non-inferiority of a single dose of ACZ885 compared to the active comparator during treatment period
  • safety, tolerability and immunogenicity following administration of ACZ885 to patients with acute gout during treatment period
  • time to walk independently and time to recurrence of the symptoms of acute gout (if applicable) during treatment period
  • change in C-reactive protein (CRP) and serum amyloid A protein (SAA) from baseline to last visit
  • pharmacokinetics (PK) of ACZ885 during treatment period
  • change in pain following ACZ885 administration via a 0-100 mm Visual Analog Scale during treatment period


Information By: Novartis

Dates:
Date Received: April 18, 2008
Date Started: April 2008
Date Completion:
Last Updated: December 4, 2012
Last Verified: December 2012