Targeted Dose Finding of Canakinumab (ACZ885) for Management of Acute Flare in Refractory or Contraindicated Gout Patients
NCT ID: NCT00798369
Last Updated: 2012-04-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
200 participants
INTERVENTIONAL
2008-11-30
2009-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
Canakinumab
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.
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.
Canakinumab
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.
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.
Canakinumab
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.
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.
Canakinumab
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.
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.
Canakinumab
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.
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.
Triamcinolone acetonide
Randomized patients received triamcinolone acetonide 40 mg i.m. once and placebo matching canakinumab s.c. once, on Day 1.
Interventions
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Canakinumab
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.
Canakinumab
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.
Canakinumab
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.
Canakinumab
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.
Canakinumab
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.
Triamcinolone acetonide
Randomized patients received triamcinolone acetonide 40 mg i.m. once and placebo matching canakinumab s.c. once, on Day 1.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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Novartis
INDUSTRY
Responsible Party
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Novartis Pharmaceuticals
Locations
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Pinnacle Research Group, LLC
Anniston, Alabama, United States
University of Alabama at Birmingham
Birmingham, Alabama, United States
Associated Pharmaceutical Research
Buena Park, California, United States
Northern California Institute for Bone Health
Oakland, California, United States
San Diego Arthritis & Osteoporosis Medical Clinic
San Diego, California, United States
Center for Clinical Trials of San Gabriel
West Covina, California, United States
Tampa Medical Group, P.A.
Tampa, Florida, United States
Florida Medical Clinic, PA
Zephyrhills, Florida, United States
Harbin Clinic
Rome, Georgia, United States
Intermountain Orthopedics
Boise, Idaho, United States
Northwest Clinical Trials
Boise, Idaho, United States
The Arthritis Center
Springfield, Illinois, United States
Cotton O'Neil Clinic
Topeka, Kansas, United States
Arthritis and Diabetes Clinic
Monroe, Louisiana, United States
Arthritis Consultants, Inc.
St Louis, Missouri, United States
Billings Clinic Research Center
Billings, Montana, United States
Montana Medical Research
Missoula, Montana, United States
Heartland Clinical Research, Inc.
Omaha, Nebraska, United States
New Mexico Clinical Research & Osteoporosis Center, Inc.
Albuquerque, New Mexico, United States
Regional Clinical Research Rheumatology Assoc.
Binghamton, New York, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States
Community Research Partners, Inc.
Varnville, South Carolina, United States
Comprehensive Rheumatology
Hendersonville, Tennessee, United States
MultiSpecialty Clinical Research
Johnson City, Tennessee, United States
Integrity Clinical Research, LLC
Milan, Tennessee, United States
Southwest Rheumatology
Mesquite, Texas, United States
Health Research of Hampton Roads
Newport News, Virginia, United States
Novartis Investigative site
Rosario, , Argentina
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Gozée, , Belgium
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Moncton, , Canada
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Mount Pearl, , Canada
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St. John's, , Canada
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Paris, , France
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Bad Nauheim, , Germany
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Bautzen, , Germany
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Berlin, , Germany
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Chemnitz, , Germany
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Dachau, , Germany
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Dresden, , Germany
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Frankfurt, , Germany
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Georgensgmünd, , Germany
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Hamburg, , Germany
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Leipzig, , Germany
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Löhne, , Germany
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Magdeburg, , Germany
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Messkirch, , Germany
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Munich, , Germany
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Schwabach, , Germany
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Zerbst, , Germany
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Poznan, , Poland
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Szczecin, , Poland
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Wroclaw, , Poland
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Chelyabinsk, , Russia
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Moscow, , Russia
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Saint Petersburg, , Russia
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Tyumen, , Russia
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Yaroslavl, , Russia
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Yekaterinburg, , Russia
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Baden, , Switzerland
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Basel, , Switzerland
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Bern, , Switzerland
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Lausanne, , Switzerland
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Adana, , Turkey (Türkiye)
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Ankara, , Turkey (Türkiye)
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Antalya, , Turkey (Türkiye)
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Aydin, , Turkey (Türkiye)
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Gaziantep, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Izmir, , Turkey (Türkiye)
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Manisa, , Turkey (Türkiye)
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Sihhiye/Ankara, , Turkey (Türkiye)
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Antrim, , United Kingdom
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Coventry, , United Kingdom
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Lancashire, , United Kingdom
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Wellingborough, , United Kingdom
Countries
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References
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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.
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.
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.
Other Identifiers
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EudraCT 2008-004666-61
Identifier Type: -
Identifier Source: secondary_id
CACZ885H2255
Identifier Type: -
Identifier Source: org_study_id
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