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NCT Number: NCT00819585

A Study of the Efficacy of Canakinumab in Prevention of Acute Flares in Chronic Gout Patients Initiating Allopurinol Therapy (Core Study) and a Long-term Study of the Efficacy and Safety of Canakinumab in Patients With Gout (Extension Study)

The 24-week, dose-ranging, multi-center, double-blind, double-dummy, active-controlled core study investigated the prophylactic effect of canakinumab on the signs and symptoms of acute flares in chronic gout patients initiating allopurinol therapy. The core study was followed by a 24-week open-label, multicenter extension study to assess the safety, tolerability, and efficacy of canakinumab in patients with gout who were given canakinumab at the time of gout flare.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novartis Investigative site, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

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

Core study

Inclusion criteria

  • Signed written informed consent before any study procedure is performed.
  • History of at least 2 gout flares in the year prior to Screening (Visit 1, based on patient history), thus, candidates for initiating uric acid lowering therapy.
  • Confirmed diagnosis of gout meeting the American College of Rheumatology (ACR) 1977 preliminary criteria for the classification of arthritis of primary gout.
  • Body Mass Index (BMI) ≤ 40 kg/m^2.
  • Willingness to initiate allopurinol therapy as urate lowering agent for their gout therapy or having initiated allopurinol therapy within ≤ 1 month before Screening (Visit 1) or willing to re-initiate allopurinol therapy if this was stopped > 2 months before Screening (Visit 1) for reasons different to toxicity/ intolerance or lack of efficacy.

Exclusion criteria

  • Acute gout flare within 2 weeks of Screening (Visit 1) and during the Screening period.
  • History of allergy or contraindication to colchicine or allopurinol.
  • History of intolerance to allopurinol or to oral colchicine in appropriate dose for prophylactic use.
  • History of bone marrow suppression.
  • Absolute or relative contraindication to both naproxen and oral prednisolone/ prednisone.

Extension study

Inclusion criteria

  • Patients who completed the core study. A patient is defined as completing the core study if he/she completed the study up to and including the last visit (Visit 9).
  • Patients who have signed a written informed consent before any trial procedure is performed.

Exclusion criteria

  • Patients for whom continuation in the extension study is not considered appropriate by the treating physician.
  • Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive pregnancy test (serum or urine).

Other protocol-defined inclusion/exclusion criteria applied to the study.

Treatment and study plan

Canakinumab

Drug

Canakinumab was supplied in glass vials as a lyophilized powder.

Colchicine

Drug

0.5 mg capsule orally once daily for 16 weeks.

Allopurinol

Drug

100-300 mg orally once daily for 24 weeks.

Placebo Matching Canakinumab

Drug

Subcutaneous injection.

Placebo Matching Colchicine

Drug

Capsule orally once daily for 16 weeks.

Primary outcomes

  1. Core Study: Mean Number of Gout Flares Per Participant

    Time frame: Baseline of the core study to Week 16

    A gout flare was defined as an increase in participant-reported gout pain in the most affected joint during a gout attack.

Secondary outcomes

  1. Core Study: 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

  2. Core Study: Percentage of Participants With at Least 1 Gout Flare Within 16 Weeks After Randomization

    Time frame: Baseline of the core study to Week 16

    The percentage of participants experiencing at least 1 gout flare within 16 weeks after randomization. A gout flare was defined as an increase in participant-reported gout pain in the most affected joint during a gout attack.

  3. Core Study: Percentage of Participants With Gout Flare at Different Time Points

    Time frame: Days 2, 4, 6, and Weeks 2, 4, 6, 10, and 16 of the core study

    A gout flare was defined as an increase in participant-reported gout pain in the most affected joint during a gout attack.

  4. Core Study: Participant's Assessment of Gout Pain on a 0-100 mm Visual Analog Scale up to Day 7 of All Gout Flares

    Time frame: Baseline of the core study to Week 16

    Participants rated the intensity of pain in the most affected joint on a 0-100 mm visual analog scale, which ranged from no pain (left end, 0) to unbearable pain (right end, 100). Participants assessed pain intensity on the day of onset of the gout flare and in the morning of the 6 following days.

  5. Core Study: Participant's Assessment of Gout Pain on a 5-point Likert Scale up to Day 7 of All Gout Flares

    Time frame: Baseline of the core study to Week 16

    Participants assessed the intensity of pain in the most affected joint on a 5-point Likert scale, which ranged from 1 to 5 (1=None, 2=Mild, 3=Moderate, 4=Severe, 5=Extreme). Participants assessed pain intensity on the day of onset of the gout flare and in the morning of the 6 following days.

  6. Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale

    Time frame: Days 15, 29, 57, 85, 113, and 141 of the core study

    The study physician made a global assessment of the participant's response to treatment on a 5-point Likert scale (Very good, Good, Fair, Poor, Very poor) at Days 15, 29, 57, 85, 113, and 141. The category 'Not assessed' includes missing data and 'not done'. The number of participants in each of the 5 categories of the Likert scale are reported.

  7. Extension Study: Participant's Assessment of Gout Pain on a 100 mm Visual Analog Scale During the First Flare

    Time frame: Baseline of the extension study until 7 days after the onset of the first gout flare (up to 24 weeks)

    Participant's rated the intensity of pain in the most affected joint during the first flare on a 0-100 mm visual analog scale, which ranged from no pain (left end, 0) to unbearable pain (right end, 100). Assessments were made pre-dose and 24 hours, 3 days, 4 days, and an average of 5-7 days post-dose

  8. Extension Study: Participant's Global Assessment of Response to Treatment on a 5-point Likert Scale

    Time frame: Baseline of the extension study until the end of the study (up to 24 weeks)

    Study participants made a global assessment of their response to treatment on a 5-point Likert scale (Excellent, Good, Acceptable, Slight, Poor) at the control visit 7±2 days following each of their first 3 flares. The number of participants in each of the 5 categories of the Likert scale are reported.

  9. Extension Study: Physician's Global Assessment of Response to Treatment on a 5-point Likert Scale

    Time frame: Baseline of the extension study until the end of the study (up to 24 weeks)

    The study physician made a global assessment of the participant's response to treatment on a 5-point Likert scale (Very good, Good, Fair, Poor, Very poor) at the control visit 7±2 days following each of the first 3 flares. The category 'Not assessed' includes missing data and 'not done'. The number of participants in each of the 5 categories of the Likert scale are reported.

  10. Extension Study: Physician's Assessment of Tenderness, Swelling, and Erythema in the Most Affected Joint During the First Flare

    Time frame: Baseline of the extension study until the end of the study (up to 24 weeks)

    Tenderness was rated on a 0-3 point scale: 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 most affected joint. Swelling was rated on a 0-3 point scale: 0="no swelling", 1="palpable", 2="visible", and 3=bulging beyond the joint margins". Erythema was rated as present, absent, or not assessable. Assessments were performed at the flare and control visits.

  11. Extension Study: Amount of Rescue Medication Taken

    Time frame: Baseline of the extension study until the end of the study (up to 24 weeks)

    The amount of naproxen and prednisolone taken after receiving treatment for each of the first 3 flares was recorded.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

A 24-week, Dose-ranging, Multicenter, Double-blind, Double-dummy, Active-controlled Core Study to Evaluate Canakinumab for Prophylaxis of Signs and Symptoms of Acute Flares in Chronic Gout Patients Initiating Allopurinol Therapy and a 24-week Open-label, Multicenter Extension Study to Assess Safety, Tolerability and Efficacy of Canakinumab in Patients With Gout Who Are Given Canakinumab at the Time of Gout Flare

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Jan 9, 2009
Registry last updated
Jul 17, 2018

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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