Clinical Trial: Evaluating Efficacy of Canakinumab (ACZ885) in Prevention of Acute Flares in Chronic Gout Patients Initiating Allopurinol Therapy

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

Official Title: A 24-week, Dose-ranging, Multi-center, Double-blind, Double-dummy, Active-controlled Study to Evaluate Canakinumab (ACZ885) for Prophylaxis of Signs and Symptoms of Acute Flares in Chronic Gout Patien

Brief Summary: A 24-week, dose-ranging, multi-center, double-blind, double-dummy, active-controlled study to evaluate canakinumab (ACZ885) for prophylaxis of signs and symptoms of acute flares in chronic gout patients initiating allopurinol therapy

Detailed Summary:
Sponsor: Novartis Pharmaceuticals

Current Primary Outcome: The Mean Number of Gout Flares for Each Treatment Arm [ Time Frame: 16 weeks after randomization ]

Original Primary Outcome: To determine the target dose of canakinumab that leads to at least comparable efficacy as colchicine with respect to the mean number of gout flares occurring during 16 weeks after randomization. [ Time Frame: 16 weeks ]

Current Secondary Outcome:

• The Mean Number of Gout Flares for the Repeat Dose Regimen of Canakinumab as Compared to the Single Doses of Canakinumab [ Time Frame: up to 16 weeks after randomization ]
• The Percentage of Participants With Gout Flares for Each Canakinumab Treatment Arm as Compared to Colchicine [ Time Frame: 16 weeks after randomization ]
  The percentage of participants experiencing at least one gout flare within 16 weeks after randomization. A gout flare was defined as an increase in patient-reported gout pain in the most affected joint during a gout attack. The start of a gout flare was defined as that day when the patient reported increased pain in the most affected joint for the first time in the patient diary. The end of a gout flare was defined as the patient's confirmation in the diary that the patient felt he/she had recovered from the gout flare or the acute gout pain had disappeared (whichever was first).
• The Percentage of Participants With Gout Flare at Different Time Points for Each Canakinumab Treatment Arm as Compared to Colchicine [ Time Frame: 2 days, 4 days, 6 days, 2 weeks, 4 weeks, 6 weeks, 10 weeks and 16 weeks ]
  A gout flare was defined as an increase in participant-reported gout pain in the most affected joint during a gout attack. The start of a gout flare was defined as that day when the patient reported increased pain in the most affected joint for the first time in the patient diary. The end of a gout flare was defined as the patient's confirmation in the diary that the patient felt he/she had recovered from the gout flare or the acute gout pain had disappeared (whichever was first).
• Patient's Global Pain Intensity on a 0-100 mm Visual Analog Scale (VAS) up to Day 7 During All Gout Flares for Each Canakinumab Treatment Arm as Compared to Colchicine [ Time Frame: up to 16 weeks after randomization ]

  The pain intensity on a 0-100 mm VAS scale, ranging from no pain (0) to unbearable pain (100) in the affected joint (Scores on the 100-mm linear scale were measured to the nearest millimeter from the left)

  • on the day of onset of the gout flare and
  • in the morning of the 6 following days
• Patient's Global Pain Intensity on 5-point Likert Scale up to Day 7 During All Gout Flares for Each Canakinumab Treatment Arm as Compared to Colchicine [ Time Frame: up to 16 weeks after randomization ]

  Participants were handed out a diary at baseline (Visit 2), Day 15 (Visit 3), Day 29 (Visit 4), Day 57 (Visit 5), Day 85 (Visit 6), Day 113 (Visit 7), and Day 141 (Visit 8) to record information on a daily basis during a gout flare. The patients were to score their current amount of acute gout pain in the joint on a 5-point Likert scale 1=None, 2=Mild, 3=Moderate, 4=Severe, 5=Extreme.

  • on the day of onset of the gout flare and
  • in the morning of the 6 following days
• Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale for Each Canakinumab Treatment Arm as Compared to Colchicine [ Time Frame: At Day 15, Day 29, Day 57, Day 85, Day 113 and Day 141 ]
  To evaluate the efficacy of canakinumab as compared to colchicine with regards to the Physician's global assessment of response to therapy on a 5-point Likert scale up to 16 weeks after randomization. The study physician made a global assessment of the patient's response to treatment using a 5-point Likert scale: Very good, Good, Fair, Poor, Very poor. Physician's global assessment was performed at the visits like Day 15 (Visit 3), Day 29 (Visit 4), Day 57 (Visit 5), Day 85 (Visit 6), Day 113 (Visit 7), and Day 141 (Visit 8). The category 'Not assessed' combines the missing and 'not done'.

Original Secondary Outcome:

• To evaluate the efficacy of a repeat dose regimen of canakinumab as compared to the single doses of canakinumab with regards to the mean number of gout flares up to 16 weeks after randomization [ Time Frame: 16 weeks ]
• To evaluate the number of patients with gout flares with canakinumab as compared to colchicine up to 16 weeks after randomization [ Time Frame: 16 weeks ]
• To evaluate the time to first gout flare with canakimunab as compared to colchicine up to 16 weeks after randomization [ Time Frame: 16 weeks ]
• To evaluate Patient's global pain intensity on a 0-100 mm VAS and 5-point Likert scale during gout flares with canakinumab as compared to colchicine up to 16 weeks after randomization [ Time Frame: 16 weeks ]
• To evaluate the efficacy of canakinumab as compared to colchicine with regards to the Physician's global assessment of response to therapy on a 5-point Likert scale up to 16 weeks after randomization [ Time Frame: 16 weeks ]

Dates:
Date Received: January 8, 2009
Date Started: December 2008
Date Completion:
Last Updated: April 12, 2011
Last Verified: April 2011