Clinical trial NCT00798369: Targeted Dose Finding of Canakinumab (ACZ885) for Management of Acute Flare in Refractory or Contraindicated Gout Patients
Official title: An Adaptive Dose-ranging, Multi-center, Single-blind, Double-dummy, Active-controlled Trial to Determine the Target Dose of Canakinumab (ACZ885) in the Treatment of Acute Flares in Gout Patients Who Are Refractory or Contraindicated to NSAIDs and/or Colchicine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Gout
Keywords: Acute flares
Gout
Anti-interleukin-1β monoclonal antibody
Colchicine
Triamcinolone acetonide
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2008-11-26
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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:

* 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

Primary outcomes:
measure: 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)
timeFrame: at 24,48 and 72 hours post-baseline
Secondary outcomes:
measure: The Change in Pain Intensity in the Target Joint Following Canakinumab Administration Compared to Triamcinolone Acetonide
timeFrame: Baseline,at 72 hrs post-dose and 7 days post-dose
measure: Percentage of Participants With an Excellent or Good Response With Regards to the Patient's Global Assessment of Response to Treatment
timeFrame: at 72 hours post-baseline
measure: The Time to 50% Reduction of Baseline Pain Intensity in the Target Joint
timeFrame: Baseline, within 7 days after randomization
measure: High Sensitivity C-reactive Protein (hsCRP) at 72 Hours, 7days, 4 Weeks and 8 Weeks Post Dose for Each Treatment Group
timeFrame: at 72 hours and 7 days, 4 and 8 weeks post-dose
measure: Serum Amyloid Protein (SAA) Levels at 72 Hours, 7days, 4 Weeks and 8 Weeks Post Dose for Each Treatment Group
timeFrame: at 72 hours and 7 days, 4 and 8 weeks post-dose
measure: Amount of Rescue Medication Taken for Each Treatment Group
timeFrame: 7 days after study drug administration
Other outcomes:
Locations:
city: Anniston
country: United States
facility: Pinnacle Research Group, LLC
state: Alabama
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Buena Park
country: United States
facility: Associated Pharmaceutical Research
state: California
city: Oakland
country: United States
facility: Northern California Institute for Bone Health
state: California
city: San Diego
country: United States
facility: San Diego Arthritis & Osteoporosis Medical Clinic
state: California
city: West Covina
country: United States
facility: Center for Clinical Trials of San Gabriel
state: California
city: Tampa
country: United States
facility: Tampa Medical Group, P.A.
state: Florida
city: Zephyrhills
country: United States
facility: Florida Medical Clinic, PA
state: Florida
city: Rome
country: United States
facility: Harbin Clinic
state: Georgia
city: Boise
country: United States
facility: Intermountain Orthopedics
state: Idaho
city: Boise
country: United States
facility: Northwest Clinical Trials
state: Idaho
city: Springfield
country: United States
facility: The Arthritis Center
state: Illinois
city: Topeka
country: United States
facility: Cotton O'Neil Clinic
state: Kansas
city: Monroe
country: United States
facility: Arthritis and Diabetes Clinic
state: Louisiana
city: St. Louis
country: United States
facility: Arthritis Consultants, Inc.
state: Missouri
city: Billings
country: United States
facility: Billings Clinic Research Center
state: Montana
city: Missoula
country: United States
facility: Montana Medical Research
state: Montana
city: Omaha
country: United States
facility: Heartland Clinical Research, Inc.
state: Nebraska
city: Albuquerque
country: United States
facility: New Mexico Clinical Research & Osteoporosis Center, Inc.
state: New Mexico
city: Binghamton
country: United States
facility: Regional Clinical Research Rheumatology Assoc.
state: New York
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
city: Varnville
country: United States
facility: Community Research Partners, Inc.
state: South Carolina
city: Hendersonville
country: United States
facility: Comprehensive Rheumatology
state: Tennessee
city: Johnson City
country: United States
facility: MultiSpecialty Clinical Research
state: Tennessee
city: Milan
country: United States
facility: Integrity Clinical Research, LLC
state: Tennessee
city: Mesquite
country: United States
facility: Southwest Rheumatology
state: Texas
city: Newport News
country: United States
facility: Health Research of Hampton Roads
state: Virginia
city: Rosario
country: Argentina
facility: Novartis Investigative site
city: Gozée
country: Belgium
facility: Novartis Investigative site
city: Moncton
country: Canada
facility: Novartis Investigative site
city: Mount Pearl
country: Canada
facility: Novartis Investigative site
city: St. John's
country: Canada
facility: Novartis Investigative site
city: Paris cedex 10
country: France
facility: Novartis Investigative site
city: Bad Nauheim
country: Germany
facility: Novartis Investigative Site
city: Bautzen
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Chemnitz
country: Germany
facility: Novartis Investigative Site
city: Dachau
country: Germany
facility: Novartis Investigative Site
city: Dresden
country: Germany
facility: Novartis Investigative Site
city: Frankfurt
country: Germany
facility: Novartis Investigative Site
city: Georgensgmuend
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Leipzig
country: Germany
facility: Novartis Investigative Site
city: Loehne
country: Germany
facility: Novartis Investigative Site
city: Magdeburg
country: Germany
facility: Novartis Investigative Site
city: Messkirch
country: Germany
facility: Novartis Investigative Site
city: Munich
country: Germany
facility: Novartis Investigative Site
city: Schwabach
country: Germany
facility: Novartis Investigative Site
city: Zerbst
country: Germany
facility: Novartis Investigative Site
city: Poznan
country: Poland
facility: Novartis Investigative site
city: Szczecin
country: Poland
facility: Novartis Investigative site
city: Wroclaw
country: Poland
facility: Novartis Investigative site
city: Chelyabinsk
country: Russian Federation
facility: Novartis Investigative site
city: Moscow
country: Russian Federation
facility: Novartis Investigative Site
city: St. Petersburg
country: Russian Federation
facility: Novartis Investigative Site
city: Tyumen
country: Russian Federation
facility: Novartis Investigative site
city: Yaroslavl
country: Russian Federation
facility: Novartis Investigative Site
city: Yekaterinburg
country: Russian Federation
facility: Novartis Investigative site
city: Baden
country: Switzerland
facility: Novartis Investigative site
city: Basel
country: Switzerland
facility: Novartis Investigative site
city: Bern
country: Switzerland
facility: Novartis Investigative site
city: Lausanne
country: Switzerland
facility: Novartis Investigative site
city: Adana
country: Turkey
facility: Novartis Investigative Site
city: Ankara
country: Turkey
facility: Novartis Investigative Site
city: Antalya
country: Turkey
facility: Novartis Investigative Site
city: Aydin
country: Turkey
facility: Novartis Investigative Site
city: Gaziantep
country: Turkey
facility: Novartis Investigative Site
city: Istanbul
country: Turkey
facility: Novartis Investigative Site
city: Izmir
country: Turkey
facility: Novartis Investigative Site
city: Manisa
country: Turkey
facility: Novartis Investigative Site
city: Sihhiye/Ankara
country: Turkey
facility: Novartis Investigative site
city: Antrim
country: United Kingdom
facility: Novartis Investigative Site
city: Coventry
country: United Kingdom
facility: Novartis Investigative Site
city: Lancashire
country: United Kingdom
facility: Novartis Investigative Site
city: Wellingborough
country: United Kingdom
facility: Novartis Investigative Site
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.