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CompletedNCT00798369Updated Apr 10, 2012Results posted

Targeted Dose Finding of Canakinumab (ACZ885) for Management of Acute Flare in Refractory or Contraindicated Gout Patients

A Phase 2 interventional study of Canakinumab and Canakinumab in Acute Gout, sponsored by Novartis. Completed at 75 sites in 11 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2012-04-10.

Sponsored by Novartis · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

This 8-week study is designed to determine the target dose of canakinumab (ACZ885) for the management of acute flare in gout patients who are contraindicated to Non-Steroidal anti-inflammatory drugs and/or colchicine. The efficacy of ACZ885 will be compared to the corticosteroid triamcinolone acetonide.

02

Conditions studied

  • Acute Gout

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Keywords

  • Acute flares
  • Gout
  • Anti-interleukin-1β monoclonal antibody
  • Colchicine
  • Triamcinolone acetonide
03

In context

Gout

232 studies on the registry are indexed under Gout; 45 are open to participants now.

This study's enrollment of 200 is above the median of 121 across 202 interventional studies indexed under Gout.

Browse Gout studies →

Lead sponsor

Novartis is the lead sponsor of 703 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • History of at least 1 gout flare prior to the Screening Visit
  • Meeting the American College of Rheumatology (ACR) 1977 preliminary criteria for the classification of acute arthritis of primary gout.
  • Presence of acute gout flare for no longer than 5 days.
  • Baseline pain intensity > or = to 50 mm on the 0-100 mm VAS.
  • Contraindicated for, intolerant or unresponsive to NSAIDs, colchicine or both.

Exclusion criteria

Exclusion Criteria:

  • Rheumatoid arthritis, evidence/suspicion of infectious/septic arthritis, or other acute inflammatory arthritis.
  • Presence of severe renal function impairment
  • Contraindication to intramuscular injection
  • Known presence or suspicion of active or recurrent bacterial, fungal or viral infection at the time of enrollment
  • Evidence of active pulmonary disease
  • Live vaccinations within 3 months prior to the start of the study
  • Use of forbidden therapy

Other protocol-defined inclusion/exclusion criteria applied

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
200 participants (actual)

Study arms

  • Experimental
    Canakinumab 10 mg

    Canakinumab 10 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once, on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.

    Drug: Canakinumab

  • Experimental
    Canakinumab 25 mg

    Canakinumab 25 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once, on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.

    Drug: Canakinumab

  • Experimental
    Canakinumab 50 mg

    Canakinumab 50 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once, on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.

    Drug: Canakinumab

  • Experimental
    Canakinumab 90 mg

    Canakinumab 90 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once, on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.

    Drug: Canakinumab

  • Experimental
    Canakinumab 150 mg

    Canakinumab 150 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once, on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.

    Drug: Canakinumab

  • Active comparator
    Triamcinolone acetonide 40 mg

    Triamcinolone acetonide 40 mg intramuscularly (i.m) once. The i.m. injection was recommended to be administered deeply into the gluteal muscle. Randomized patients received triamcinolone acetonide 40 mg i.m. once and placebo matching canakinumab s.c. once, on Day 1.

    Drug: Triamcinolone acetonide

Interventions

  • DrugCanakinumab

    Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once, on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.

  • DrugCanakinumab

    Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once, on Day 1.

  • DrugCanakinumab

    Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once, on Day 1.

  • DrugCanakinumab

    Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once, on Day 1.

  • DrugCanakinumab

    Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once, on Day 1.

  • DrugTriamcinolone acetonide

    Randomized patients received triamcinolone acetonide 40 mg i.m. once and placebo matching canakinumab s.c. once, on Day 1.

06

What researchers measure

Primary outcomes

  1. The Dose of Canakinumab for Treatment of Acute Flares in Gout Patients That Leads to the Same Efficacy as Triamcinolone Acetonide With Respect to Pain Intensity on a 0-100 mm Visual Analog Scale (VAS)

    Mean target dose at 24, 48 and 72 hours. Four models: Emax, Logistic, Linear in log-dose, Linear were selected to describe the potential dose-response curve and hence estimate the target dose of canakinumab using baseline Visual Analog Scale (VAS) and Body Mass Index (BMI) as covariates. Target dose was defined as the dose for which the efficacy is equivalent to the efficacy of triamcinolone acetonide 40 mg and was identified by assessing the dose response relationship with regards to the pain intensity in the target joint measured on a 0- 100 mm VAS (0= no pain and 100= unbearable pain).

    Time frame: at 24,48 and 72 hours post-baseline

Secondary outcomes

  1. The Change in Pain Intensity in the Target Joint Following Canakinumab Administration Compared to Triamcinolone Acetonide

    The change in pain intensity from baseline to 72 hours and 7 days post dose as measured on a 0-100 mm Visual Analog Scale(VAS): 0= no pain and 100= severe pain. Analysis of Covariance (ANCOVA) with treatment group, VAS at baseline and Body mass Index (BMI) at baseline as covariates. Change from baseline = (post-baseline measurement - baseline).

    Time frame: Baseline,at 72 hrs post-dose and 7 days post-dose

  2. Percentage of Participants With an Excellent or Good Response With Regards to the Patient's Global Assessment of Response to Treatment

    Participants scored their global assessment of response to treatment using a 5-point Likert scale: Excellent, Good, Acceptable, Slight and Poor.

    Time frame: at 72 hours post-baseline

  3. The Time to 50% Reduction of Baseline Pain Intensity in the Target Joint

    The median time in days to at least 50% reduction in Pain intensity from baseline as measured by Visual Analog Scale (VAS) for each treatment group. Participants scored their pain intensity in the target joint on a 0-100 mm VAS, ranging from no pain (0) to unbearable pain (100).

    Time frame: Baseline, within 7 days after randomization

  4. High Sensitivity C-reactive Protein (hsCRP) at 72 Hours, 7days, 4 Weeks and 8 Weeks Post Dose for Each Treatment Group

    High sensitivity C-reactive protein (hsCRP) was determined in serum at all visits (Visits 1-5) in order to identify the presence of inflammation, to determine its severity, and to monitor response to treatment. ANCOVA with treatment group, protein level at baseline and BMI at baseline as covariates.

    Time frame: at 72 hours and 7 days, 4 and 8 weeks post-dose

  5. Serum Amyloid Protein (SAA) Levels at 72 Hours, 7days, 4 Weeks and 8 Weeks Post Dose for Each Treatment Group

    Serum amyloid A (SAA) were determined in serum at all visits (Visits 1-5) in order to identify the presence of inflammation, to determine its severity, and to monitor response to treatment. ANCOVA with treatment group, protein level at baseline and BMI at baseline as covariates.

    Time frame: at 72 hours and 7 days, 4 and 8 weeks post-dose

  6. Amount of Rescue Medication Taken for Each Treatment Group

    Participants who had difficulty in tolerating their pain after the 6-hour post-dose pain assessments and during the first 7 study days were allowed to take a maximum of 30 mg prednisolone (or equivalent dose of prednisone \[30 mg\]) orally once a day for a maximum of 5 days. In addition, participants could use 500 mg acetaminophen (paracetamol) and/or 30 mg codeine as needed during the first 7 study days. A maximum of 1 g/dose or 3 g/day of acetaminophen and 30 mg/dose or 180 mg/day of codeine was allowed during the first 7 days of the study.

    Time frame: 7 days after study drug administration

07

Results

Posted May 16, 2011

Participant flow

Participant flow — Overall Study
MilestoneCanakinumab 10 mgCanakinumab 25 mgCanakinumab 50 mgCanakinumab 90 mgCanakinumab 150 mgTriamcinolone Acetonide 40 mg
Started282929292857
Completed272827282754
Not completed112113
Withdrew: Subject withdrew consent001102
Withdrew: Lost to follow-up111010
Withdrew: Adminstrative problems000001

Outcome measures

SecondaryThe Change in Pain Intensity in the Target Joint Following Canakinumab Administration Compared to Triamcinolone Acetonide

The change in pain intensity from baseline to 72 hours and 7 days post dose as measured on a 0-100 mm Visual Analog Scale(VAS): 0= no pain and 100= severe pain. Analysis of Covariance (ANCOVA) with treatment group, VAS at baseline and Body mass Index (BMI) at baseline as covariates. Change from baseline = (post-baseline measurement - baseline).

Time frame:
Baseline,at 72 hrs post-dose and 7 days post-dose
Reported as:
Least squares mean · Units on a scale
The Change in Pain Intensity in the Target Joint Following Canakinumab Administration Compared to Triamcinolone Acetonide
Units on a scaleCanakinumab 10 mgCanakinumab 25 mgCanakinumab 50 mgCanakinumab 90 mgCanakinumab 150 mgTriamcinolone Acetonide 40 mg
72 hrs post-dose (n= 28, 28, 26, 28, 27, 53)-48.6 ± 4.36-46.6 ± 4.39-48.6 ± 4.56-52.7 ± 4.35-62.5 ± 4.58-43.3 ± 3.16
7 days post-dose (n= 26, 28, 27, 27, 26, 51)-57.6 ± 4.06-53.9 ± 3.93-63.4 ± 4.00-61.2 ± 3.96-66.4 ± 4.19-56.0 ± 2.88
SecondaryPercentage of Participants With an Excellent or Good Response With Regards to the Patient's Global Assessment of Response to Treatment

Participants scored their global assessment of response to treatment using a 5-point Likert scale: Excellent, Good, Acceptable, Slight and Poor.

Time frame:
at 72 hours post-baseline
Reported as:
Number · Percentage of Participants
Percentage of Participants With an Excellent or Good Response With Regards to the Patient's Global Assessment of Response to Treatment
Percentage of ParticipantsCanakinumab 10 mgCanakinumab 25 mgCanakinumab 50 mgCanakinumab 90 mgCanakinumab 150 mgTriamcinolone Acetonide 40 mg
Percentage of Participants With an Excellent or Good Response With Regards to the Patient's Global Assessment of Response to Treatment646271668954
SecondaryThe Time to 50% Reduction of Baseline Pain Intensity in the Target Joint

The median time in days to at least 50% reduction in Pain intensity from baseline as measured by Visual Analog Scale (VAS) for each treatment group. Participants scored their pain intensity in the target joint on a 0-100 mm VAS, ranging from no pain (0) to unbearable pain (100).

Time frame:
Baseline, within 7 days after randomization
Reported as:
Median · Days
The Time to 50% Reduction of Baseline Pain Intensity in the Target Joint
DaysCanakinumab 10 mgCanakinumab 25 mgCanakinumab 50 mgCanakinumab 90 mgCanakinumab 150 mgTriamcinolone Acetonide 40 mg
The Time to 50% Reduction of Baseline Pain Intensity in the Target Joint2.9 (1.0 to 4.0)2.9 (2.0 to 3.0)1.0 (1.0 to 2.9)1.0 (1.0 to 2.0)1.0 (0.5 to 2.0)2.0 (1.0 to 3.6)
SecondaryHigh Sensitivity C-reactive Protein (hsCRP) at 72 Hours, 7days, 4 Weeks and 8 Weeks Post Dose for Each Treatment Group

High sensitivity C-reactive protein (hsCRP) was determined in serum at all visits (Visits 1-5) in order to identify the presence of inflammation, to determine its severity, and to monitor response to treatment. ANCOVA with treatment group, protein level at baseline and BMI at baseline as covariates.

Time frame:
at 72 hours and 7 days, 4 and 8 weeks post-dose
Reported as:
Least squares mean · mg/L
High Sensitivity C-reactive Protein (hsCRP) at 72 Hours, 7days, 4 Weeks and 8 Weeks Post Dose for Each Treatment Group
mg/LCanakinumab 10 mgCanakinumab 25 mgCanakinumab 50 mgCanakinumab 90 mgCanakinumab 150 mgTriamcinolone Acetonide 40 mg
72 hrs post-dose (n= 27, 28, 26, 28, 25, 53)16.7 ± 3.417.9 ± 3.3411.7 ± 3.4913.4 ± 3.349.2 ± 3.5313.4 ± 2.43
7 days post-dose (n= 28, 29, 28, 28, 27, 55)8.0 ± 3.302.5 ± 3.234.3 ± 3.316.3 ± 3.293.7 ± 3.3613.7 ± 2.35
4 week post-dose (n= 27, 28, 27, 28, 27, 55)3.0 ± 3.132.9 ± 3.082.9 ± 3.144.8 ± 3.084.8 ± 3.139.2 ± 2.20
8 weeks post-dose (n= 26, 28, 27, 28, 27, 54)3.8 ± 1.792.0 ± 1.722.6 ± 1.755.2 ± 1.722.9 ± 1.758.6 ± 1.24
SecondarySerum Amyloid Protein (SAA) Levels at 72 Hours, 7days, 4 Weeks and 8 Weeks Post Dose for Each Treatment Group

Serum amyloid A (SAA) were determined in serum at all visits (Visits 1-5) in order to identify the presence of inflammation, to determine its severity, and to monitor response to treatment. ANCOVA with treatment group, protein level at baseline and BMI at baseline as covariates.

Time frame:
at 72 hours and 7 days, 4 and 8 weeks post-dose
Reported as:
Least squares mean · mg/L
Serum Amyloid Protein (SAA) Levels at 72 Hours, 7days, 4 Weeks and 8 Weeks Post Dose for Each Treatment Group
mg/LCanakinumab 10 mgCanakinumab 25 mgCanakinumab 50 mgCanakinumab 90 mgCanakinumab 150 mgTriamcinolone Acetonide 40 mg
72 hrs post-dose (n= 26, 28, 28, 28, 27, 50)50.1 ± 20.0527.6 ± 19.3270.7 ± 19.3729.4 ± 19.2826.9 ± 19.6952.5 ± 14.48
7 days post-dose (n= 28, 28, 28, 28, 26, 49)10.6 ± 10.925.4 ± 10.9111.9 ± 10.9410.5 ± 10.8910.3 ± 11.3339.4 ± 8.26
4 week post-dose (n= 27, 28, 27, 28, 27, 50)4.4 ± 3.534.2 ± 3.464.9 ± 3.5314.3 ± 3.456.2 ± 3.5312.9 ± 2.59
8 weeks post-dose (n= 26, 26, 26, 27, 27, 48)5.5 ± 3.644.6 ± 3.645.7 ± 3.648.2 ± 3.564.1 ± 3.5718.0 ± 2.68
PrimaryThe Dose of Canakinumab for Treatment of Acute Flares in Gout Patients That Leads to the Same Efficacy as Triamcinolone Acetonide With Respect to Pain Intensity on a 0-100 mm Visual Analog Scale (VAS)

Mean target dose at 24, 48 and 72 hours. Four models: Emax, Logistic, Linear in log-dose, Linear were selected to describe the potential dose-response curve and hence estimate the target dose of canakinumab using baseline Visual Analog Scale (VAS) and Body Mass Index (BMI) as covariates. Target dose was defined as the dose for which the efficacy is equivalent to the efficacy of triamcinolone acetonide 40 mg and was identified by assessing the dose response relationship with regards to the pain intensity in the target joint measured on a 0- 100 mm VAS (0= no pain and 100= unbearable pain).

Time frame:
at 24,48 and 72 hours post-baseline
Reported as:
Number · mg
The Dose of Canakinumab for Treatment of Acute Flares in Gout Patients That Leads to the Same Efficacy as Triamcinolone Acetonide With Respect to Pain Intensity on a 0-100 mm Visual Analog Scale (VAS)
mgLinear Model
Target dose at 24 hrs post-baseline37 (5.94 to 103.37)
Target dose at 48 hrs post-baseline23 (2.87 to 96.31)
Target dose at 72 hrs post-baselineNA (NA to NA)
SecondaryAmount of Rescue Medication Taken for Each Treatment Group

Participants who had difficulty in tolerating their pain after the 6-hour post-dose pain assessments and during the first 7 study days were allowed to take a maximum of 30 mg prednisolone (or equivalent dose of prednisone \[30 mg\]) orally once a day for a maximum of 5 days. In addition, participants could use 500 mg acetaminophen (paracetamol) and/or 30 mg codeine as needed during the first 7 study days. A maximum of 1 g/dose or 3 g/day of acetaminophen and 30 mg/dose or 180 mg/day of codeine was allowed during the first 7 days of the study.

Time frame:
7 days after study drug administration
Reported as:
Mean · mg
Amount of Rescue Medication Taken for Each Treatment Group
mgCanakinumab 10 mgCanakinumab 25 mgCanakinumab 50 mgCanakinumab 90 mgCanakinumab 150 mgTriamcinolone Acetonide 40 mg
Acetaminophen1414.3 ± 2628.581656.9 ± 4437.262178.6 ± 2925.671646.6 ± 3161.20607.4 ± 2250.121614.3 ± 2958.51
Codeine42.9 ± 138.1978.6 ± 164.2049.3 ± 139.5727.9 ± 87.074.4 ± 23.0952.0 ± 158.28
Prednisolone/Prednisone13.4 ± 36.8223.8 ± 44.0324.1 ± 59.3613.1 ± 35.376.2 ± 24.5413.3 ± 26.13

Adverse events

Collected over End of study (8 weeks). Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Canakinumab 10 mg—0/28 (0%)2/28 (7.1%)
Canakinumab 25 mg—2/29 (6.9%)7/29 (24.1%)
Canakinumab 50 mg—2/29 (6.9%)5/29 (17.2%)
Canakinumab 90 mg—0/29 (0%)8/29 (27.6%)
Canakinumab 150 mg—0/28 (0%)5/28 (17.9%)
Triamcinolone Acetonide 40 mg—1/57 (1.8%)8/57 (14%)
Most frequent serious events
Most frequent serious events
EventCanakinumab 10 mgCanakinumab 25 mgCanakinumab 50 mgCanakinumab 90 mgCanakinumab 150 mgTriamcinolone Acetonide 40 mg
AppendicitisInfections and infestations0/281/291/290/290/280/57
BronchitisInfections and infestations0/281/290/290/290/280/57
Carotid artery stenosisNervous system disorders0/280/291/290/290/280/57
Cerebrovascular disorderNervous system disorders0/280/290/290/290/281/57
Most frequent other events
Most frequent other events
EventCanakinumab 10 mgCanakinumab 25 mgCanakinumab 50 mgCanakinumab 90 mgCanakinumab 150 mgTriamcinolone Acetonide 40 mg
HeadacheNervous system disorders1/283/291/292/291/284/57
NasopharyngitisInfections and infestations1/281/292/290/291/282/57
Alanine aminotransferase increasedInvestigations0/280/290/292/290/280/57
Aspartate aminotransferase increasedInvestigations0/280/290/292/291/280/57
Blood uric acid increasedInvestigations0/280/290/292/291/280/57
Bone painMusculoskeletal and connective tissue disorders0/280/292/290/290/280/57
Oropharyngeal painRespiratory, thoracic and mediastinal disorders0/280/290/292/291/280/57
HyperhidrosisSkin and subcutaneous tissue disorders0/282/290/290/290/280/57
Urinary tract infectionInfections and infestations0/280/290/291/290/283/57
Pain in extremityMusculoskeletal and connective tissue disorders0/281/291/290/290/283/57

Baseline characteristics

Age, Customized
Age, Customized(participants)Canakinumab 10 mgCanakinumab 25 mgCanakinumab 50 mgCanakinumab 90 mgCanakinumab 150 mgTriamcinolone Acetonide 40 mgTotal
≥18 years - 40 years64358733
≥ 41 - 64 years212119201539135
≥ 65 - 74 years036231024
≥ 75 years1112218
Sex: Female, Male
Sex: Female, Male(Participants)Canakinumab 10 mgCanakinumab 25 mgCanakinumab 50 mgCanakinumab 90 mgCanakinumab 150 mgTriamcinolone Acetonide 40 mgTotal
Female23250214
Male262627242855186
08

Study locations

75 sites
  • Pinnacle Research Group, LLC
    Anniston, Alabama 36207-5710, United States
  • University of Alabama at Birmingham
    Birmingham, Alabama 35294, United States
  • Associated Pharmaceutical Research
    Buena Park, California 90620, United States
  • Northern California Institute for Bone Health
    Oakland, California 94609, United States
  • San Diego Arthritis & Osteoporosis Medical Clinic
    San Diego, California 92108, United States
  • Center for Clinical Trials of San Gabriel
    West Covina, California 91790, United States
  • Tampa Medical Group, P.A.
    Tampa, Florida 33614, United States
  • Florida Medical Clinic, PA
    Zephyrhills, Florida 33542, United States
  • Harbin Clinic
    Rome, Georgia 30165, United States
  • Intermountain Orthopedics
    Boise, Idaho 83702, United States
  • Northwest Clinical Trials
    Boise, Idaho 83704, United States
  • The Arthritis Center
    Springfield, Illinois 62704, United States
  • Cotton O'Neil Clinic
    Topeka, Kansas 66606, United States
  • Arthritis and Diabetes Clinic
    Monroe, Louisiana 71203, United States
  • Arthritis Consultants, Inc.
    St. Louis, Missouri 63141, United States
  • Billings Clinic Research Center
    Billings, Montana 59101, United States
  • Montana Medical Research
    Missoula, Montana 59804, United States
  • Heartland Clinical Research, Inc.
    Omaha, Nebraska 68134, United States
  • New Mexico Clinical Research & Osteoporosis Center, Inc.
    Albuquerque, New Mexico 87106, United States
  • Regional Clinical Research Rheumatology Assoc.
    Binghamton, New York 13905, United States
  • Altoona Center for Clinical Research
    Duncansville, Pennsylvania 16635, United States
  • Community Research Partners, Inc.
    Varnville, South Carolina 29944, United States
  • Comprehensive Rheumatology
    Hendersonville, Tennessee 37075, United States
  • MultiSpecialty Clinical Research
    Johnson City, Tennessee 37601, United States
  • Integrity Clinical Research, LLC
    Milan, Tennessee 38358, United States
  • Southwest Rheumatology
    Mesquite, Texas 75150, United States
  • Health Research of Hampton Roads
    Newport News, Virginia 23606, United States
  • Novartis Investigative site
    Rosario, Argentina
  • Novartis Investigative site
    Gozée, Belgium
  • Novartis Investigative site
    Moncton, Canada
  • Novartis Investigative site
    Mount Pearl, Canada
  • Novartis Investigative site
    St. John's, Canada
  • Novartis Investigative site
    Paris cedex 10, France
  • Novartis Investigative Site
    Bad Nauheim, Germany
  • Novartis Investigative Site
    Bautzen, Germany
  • Novartis Investigative Site
    Berlin, Germany
  • Novartis Investigative Site
    Chemnitz, Germany
  • Novartis Investigative Site
    Dachau, Germany
  • Novartis Investigative Site
    Dresden, Germany
  • Novartis Investigative Site
    Frankfurt, Germany
  • Novartis Investigative Site
    Georgensgmuend, Germany
  • Novartis Investigative Site
    Hamburg, Germany
  • Novartis Investigative Site
    Leipzig, Germany
  • Novartis Investigative Site
    Loehne, Germany
  • Novartis Investigative Site
    Magdeburg, Germany
  • Novartis Investigative Site
    Messkirch, Germany
  • Novartis Investigative Site
    Munich, Germany
  • Novartis Investigative Site
    Schwabach, Germany
  • Novartis Investigative Site
    Zerbst, Germany
  • Novartis Investigative site
    Poznan, Poland
  • Novartis Investigative site
    Szczecin, Poland
  • Novartis Investigative site
    Wroclaw, Poland
  • Novartis Investigative site
    Chelyabinsk, Russian Federation
  • Novartis Investigative Site
    Moscow, Russian Federation
  • Novartis Investigative Site
    St. Petersburg, Russian Federation
  • Novartis Investigative site
    Tyumen, Russian Federation
  • Novartis Investigative Site
    Yaroslavl, Russian Federation
  • Novartis Investigative site
    Yekaterinburg, Russian Federation
  • Novartis Investigative site
    Baden, Switzerland
  • Novartis Investigative site
    Basel, Switzerland
  • Novartis Investigative site
    Bern, Switzerland
  • Novartis Investigative site
    Lausanne, Switzerland
  • Novartis Investigative Site
    Adana, Turkey
  • Novartis Investigative Site
    Ankara, Turkey
  • Novartis Investigative Site
    Antalya, Turkey
  • Novartis Investigative Site
    Aydin, Turkey
  • Novartis Investigative Site
    Gaziantep, Turkey
  • Novartis Investigative Site
    Istanbul, Turkey
  • Novartis Investigative Site
    Izmir, Turkey
  • Novartis Investigative Site
    Manisa, Turkey
  • Novartis Investigative site
    Sihhiye/Ankara, Turkey
  • Novartis Investigative Site
    Antrim, United Kingdom
  • Novartis Investigative Site
    Coventry, United Kingdom
  • Novartis Investigative Site
    Lancashire, United Kingdom
  • Novartis Investigative Site
    Wellingborough, United Kingdom
09

References and documents

Publications

  • Chakraborty A, Van LM, Skerjanec A, Floch D, Klein UR, Krammer G, Sunkara G, Howard D. Pharmacokinetic and pharmacodynamic properties of canakinumab in patients with gouty arthritis. J Clin Pharmacol. 2013 Dec;53(12):1240-51. doi: 10.1002/jcph.162. Epub 2013 Sep 30. PubMed 24122883 ↗
  • Schlesinger N, De Meulemeester M, Pikhlak A, Yucel AE, Richard D, Murphy V, Arulmani U, Sallstig P, So A. Canakinumab relieves symptoms of acute flares and improves health-related quality of life in patients with difficult-to-treat Gouty Arthritis by suppressing inflammation: results of a randomized, dose-ranging study. Arthritis Res Ther. 2011 Mar 25;13(2):R53. doi: 10.1186/ar3297. PubMed 21439048 ↗
  • So A, De Meulemeester M, Pikhlak A, Yucel AE, Richard D, Murphy V, Arulmani U, Sallstig P, Schlesinger N. Canakinumab for the treatment of acute flares in difficult-to-treat gouty arthritis: Results of a multicenter, phase II, dose-ranging study. Arthritis Rheum. 2010 Oct;62(10):3064-76. doi: 10.1002/art.27600. PubMed 20533546 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 10, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00798369
Lead sponsor
Novartis
First posted
Nov 26, 2008
Start date
Nov 2008
Primary completion
Aug 2009
Completion
Aug 2009
Results posted
May 16, 2011
Last update
Apr 10, 2012
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2012. You cannot join it, but the record below documents what was studied.

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