search
Back to results

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

Primary Purpose

Acute Gout

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Canakinumab
Canakinumab
Canakinumab
Canakinumab
Canakinumab
Triamcinolone acetonide
Sponsored by
Novartis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Gout focused on measuring Acute flares, Gout, Anti-interleukin-1β monoclonal antibody, Colchicine, Triamcinolone acetonide

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pinnacle Research Group, LLC
  • University of Alabama at Birmingham
  • Associated Pharmaceutical Research
  • Northern California Institute for Bone Health
  • San Diego Arthritis & Osteoporosis Medical Clinic
  • Center for Clinical Trials of San Gabriel
  • Tampa Medical Group, P.A.
  • Florida Medical Clinic, PA
  • Harbin Clinic
  • Intermountain Orthopedics
  • Northwest Clinical Trials
  • The Arthritis Center
  • Cotton O'Neil Clinic
  • Arthritis and Diabetes Clinic
  • Arthritis Consultants, Inc.
  • Billings Clinic Research Center
  • Montana Medical Research
  • Heartland Clinical Research, Inc.
  • New Mexico Clinical Research & Osteoporosis Center, Inc.
  • Regional Clinical Research Rheumatology Assoc.
  • Altoona Center for Clinical Research
  • Community Research Partners, Inc.
  • Comprehensive Rheumatology
  • MultiSpecialty Clinical Research
  • Integrity Clinical Research, LLC
  • Southwest Rheumatology
  • Health Research of Hampton Roads
  • Novartis Investigative site
  • Novartis Investigative site
  • Novartis Investigative site
  • Novartis Investigative site
  • Novartis Investigative site
  • Novartis Investigative site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative site
  • Novartis Investigative site
  • Novartis Investigative site
  • Novartis Investigative site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative site
  • Novartis Investigative Site
  • Novartis Investigative site
  • Novartis Investigative site
  • Novartis Investigative site
  • Novartis Investigative site
  • Novartis Investigative site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Canakinumab 10 mg

Canakinumab 25 mg

Canakinumab 50 mg

Canakinumab 90 mg

Canakinumab 150 mg

Triamcinolone acetonide 40 mg

Arm Description

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 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 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 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 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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).
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.
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).
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.
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.
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.

Full Information

First Posted
November 25, 2008
Last Updated
April 9, 2012
Sponsor
Novartis
search

1. Study Identification

Unique Protocol Identification Number
NCT00798369
Brief Title
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

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Novartis

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Gout
Keywords
Acute flares, Gout, Anti-interleukin-1β monoclonal antibody, Colchicine, Triamcinolone acetonide

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Canakinumab 10 mg
Arm Type
Experimental
Arm Description
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.
Arm Title
Canakinumab 25 mg
Arm Type
Experimental
Arm Description
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.
Arm Title
Canakinumab 50 mg
Arm Type
Experimental
Arm Description
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.
Arm Title
Canakinumab 90 mg
Arm Type
Experimental
Arm Description
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.
Arm Title
Canakinumab 150 mg
Arm Type
Experimental
Arm Description
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.
Arm Title
Triamcinolone acetonide 40 mg
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Canakinumab
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Canakinumab
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Canakinumab
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Canakinumab
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Canakinumab
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Triamcinolone acetonide
Intervention Description
Randomized patients received triamcinolone acetonide 40 mg i.m. once and placebo matching canakinumab s.c. once, on Day 1.
Primary Outcome Measure Information:
Title
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)
Description
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 Outcome Measure Information:
Title
The Change in Pain Intensity in the Target Joint Following Canakinumab Administration Compared to Triamcinolone Acetonide
Description
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
Title
Percentage of Participants With an Excellent or Good Response With Regards to the Patient's Global Assessment of Response to Treatment
Description
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
Title
The Time to 50% Reduction of Baseline Pain Intensity in the Target Joint
Description
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
Title
High Sensitivity C-reactive Protein (hsCRP) at 72 Hours, 7days, 4 Weeks and 8 Weeks Post Dose for Each Treatment Group
Description
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
Title
Serum Amyloid Protein (SAA) Levels at 72 Hours, 7days, 4 Weeks and 8 Weeks Post Dose for Each Treatment Group
Description
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
Title
Amount of Rescue Medication Taken for Each Treatment Group
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Pinnacle Research Group, LLC
City
Anniston
State/Province
Alabama
ZIP/Postal Code
36207-5710
Country
United States
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Associated Pharmaceutical Research
City
Buena Park
State/Province
California
ZIP/Postal Code
90620
Country
United States
Facility Name
Northern California Institute for Bone Health
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
Facility Name
San Diego Arthritis & Osteoporosis Medical Clinic
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
Center for Clinical Trials of San Gabriel
City
West Covina
State/Province
California
ZIP/Postal Code
91790
Country
United States
Facility Name
Tampa Medical Group, P.A.
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
Florida Medical Clinic, PA
City
Zephyrhills
State/Province
Florida
ZIP/Postal Code
33542
Country
United States
Facility Name
Harbin Clinic
City
Rome
State/Province
Georgia
ZIP/Postal Code
30165
Country
United States
Facility Name
Intermountain Orthopedics
City
Boise
State/Province
Idaho
ZIP/Postal Code
83702
Country
United States
Facility Name
Northwest Clinical Trials
City
Boise
State/Province
Idaho
ZIP/Postal Code
83704
Country
United States
Facility Name
The Arthritis Center
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62704
Country
United States
Facility Name
Cotton O'Neil Clinic
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Facility Name
Arthritis and Diabetes Clinic
City
Monroe
State/Province
Louisiana
ZIP/Postal Code
71203
Country
United States
Facility Name
Arthritis Consultants, Inc.
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Billings Clinic Research Center
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
Montana Medical Research
City
Missoula
State/Province
Montana
ZIP/Postal Code
59804
Country
United States
Facility Name
Heartland Clinical Research, Inc.
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68134
Country
United States
Facility Name
New Mexico Clinical Research & Osteoporosis Center, Inc.
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
Regional Clinical Research Rheumatology Assoc.
City
Binghamton
State/Province
New York
ZIP/Postal Code
13905
Country
United States
Facility Name
Altoona Center for Clinical Research
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Community Research Partners, Inc.
City
Varnville
State/Province
South Carolina
ZIP/Postal Code
29944
Country
United States
Facility Name
Comprehensive Rheumatology
City
Hendersonville
State/Province
Tennessee
ZIP/Postal Code
37075
Country
United States
Facility Name
MultiSpecialty Clinical Research
City
Johnson City
State/Province
Tennessee
ZIP/Postal Code
37601
Country
United States
Facility Name
Integrity Clinical Research, LLC
City
Milan
State/Province
Tennessee
ZIP/Postal Code
38358
Country
United States
Facility Name
Southwest Rheumatology
City
Mesquite
State/Province
Texas
ZIP/Postal Code
75150
Country
United States
Facility Name
Health Research of Hampton Roads
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23606
Country
United States
Facility Name
Novartis Investigative site
City
Rosario
Country
Argentina
Facility Name
Novartis Investigative site
City
Gozée
Country
Belgium
Facility Name
Novartis Investigative site
City
Moncton
Country
Canada
Facility Name
Novartis Investigative site
City
Mount Pearl
Country
Canada
Facility Name
Novartis Investigative site
City
St. John's
Country
Canada
Facility Name
Novartis Investigative site
City
Paris cedex 10
Country
France
Facility Name
Novartis Investigative Site
City
Bad Nauheim
Country
Germany
Facility Name
Novartis Investigative Site
City
Bautzen
Country
Germany
Facility Name
Novartis Investigative Site
City
Berlin
Country
Germany
Facility Name
Novartis Investigative Site
City
Chemnitz
Country
Germany
Facility Name
Novartis Investigative Site
City
Dachau
Country
Germany
Facility Name
Novartis Investigative Site
City
Dresden
Country
Germany
Facility Name
Novartis Investigative Site
City
Frankfurt
Country
Germany
Facility Name
Novartis Investigative Site
City
Georgensgmuend
Country
Germany
Facility Name
Novartis Investigative Site
City
Hamburg
Country
Germany
Facility Name
Novartis Investigative Site
City
Leipzig
Country
Germany
Facility Name
Novartis Investigative Site
City
Loehne
Country
Germany
Facility Name
Novartis Investigative Site
City
Magdeburg
Country
Germany
Facility Name
Novartis Investigative Site
City
Messkirch
Country
Germany
Facility Name
Novartis Investigative Site
City
Munich
Country
Germany
Facility Name
Novartis Investigative Site
City
Schwabach
Country
Germany
Facility Name
Novartis Investigative Site
City
Zerbst
Country
Germany
Facility Name
Novartis Investigative site
City
Poznan
Country
Poland
Facility Name
Novartis Investigative site
City
Szczecin
Country
Poland
Facility Name
Novartis Investigative site
City
Wroclaw
Country
Poland
Facility Name
Novartis Investigative site
City
Chelyabinsk
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Moscow
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
St. Petersburg
Country
Russian Federation
Facility Name
Novartis Investigative site
City
Tyumen
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Yaroslavl
Country
Russian Federation
Facility Name
Novartis Investigative site
City
Yekaterinburg
Country
Russian Federation
Facility Name
Novartis Investigative site
City
Baden
Country
Switzerland
Facility Name
Novartis Investigative site
City
Basel
Country
Switzerland
Facility Name
Novartis Investigative site
City
Bern
Country
Switzerland
Facility Name
Novartis Investigative site
City
Lausanne
Country
Switzerland
Facility Name
Novartis Investigative Site
City
Adana
Country
Turkey
Facility Name
Novartis Investigative Site
City
Ankara
Country
Turkey
Facility Name
Novartis Investigative Site
City
Antalya
Country
Turkey
Facility Name
Novartis Investigative Site
City
Aydin
Country
Turkey
Facility Name
Novartis Investigative Site
City
Gaziantep
Country
Turkey
Facility Name
Novartis Investigative Site
City
Istanbul
Country
Turkey
Facility Name
Novartis Investigative Site
City
Izmir
Country
Turkey
Facility Name
Novartis Investigative Site
City
Manisa
Country
Turkey
Facility Name
Novartis Investigative site
City
Sihhiye/Ankara
Country
Turkey
Facility Name
Novartis Investigative Site
City
Antrim
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Coventry
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Lancashire
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Wellingborough
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
24122883
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.
Results Reference
derived
PubMed Identifier
21439048
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.
Results Reference
derived
PubMed Identifier
20533546
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs