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Completed

NCT Number: NCT00663169

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

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.

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Key information

Conditions

Arthritis, Gouty Arthritis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Crystal Arthropathies Genetic Diseases, Inborn Gout Joint Diseases Metabolic Diseases Metabolism, Inborn Errors Musculoskeletal Diseases Neurologic Manifestations Nutritional and Metabolic Diseases Pain Pathological Conditions, Signs and Symptoms Purine-Pyrimidine Metabolism, Inborn Errors Rheumatic Diseases Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novartis Investigator Site, Lausanne, Switzerland

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • score over 50 on the 0-100 VAS pain scale
  • acute, confirmed gout flare for no longer than 3 days

Exclusion criteria

  • Treatment with biological anti-tumor necrosis factor (anti-TNF) within the past 3 months
  • Anti-inflammatory medication for the treatment of acute gout within the previous 24 hours
  • Pregnant or breastfeeding women
  • Major surgery with high infection risk
  • History of severe allergy to food or drugs
  • History or risk of tuberculosis
  • Active infection

Other protocol-defined inclusion/exclusion criteria may apply

Treatment and study plan

canakinumab

Biological

10 mg/kg intravenous infusion 250 mL over 2 hours.

Other names: ACZ885, Ilaris®

Dexamethasone

Drug

12 mg intravenous infusion 50 mL over 30 minutes.

placebo matching canakinumab

Other

5% glucose in water intravenous infusion.

placebo matching dexamethasone

Other

Placebo intravenous infusion.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Non-inferiority of a Single Dose of Canakinumab Compared to Dexamethasone During Treatment Period

    Time frame: 72 hours

  2. 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.

  3. Time to Walk Independently (if Applicable) During Treatment Period

    Time frame: 4 months

  4. 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.

  5. 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.

  6. 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.

  7. 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).

  8. 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.

  9. 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.

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Apr 22, 2008
Registry last updated
Jan 7, 2013

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.

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