Acute GoutPhase 2NCT00798369
Targeted Dose Finding of Canakinumab (ACZ885) for Management of Acute Flare in Refractory or Contraindicated Gout Patients
A Phase 2 study testing Canakinumab and Triamcinolone acetonide in people with Acute Gout, run by Novartis at 75 sites in 11 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Gout
- What is being tested?
- Canakinumab and Triamcinolone acetonide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 75 sitesin 11 countries
- Study dates
- Nov 2008to Aug 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
75 sites in 11 countries.
75 sites in 11 countries
United States27 sites
New Mexico Clinical Research & Osteoporosis Center, Inc.
Albuquerque, New Mexico, 87106
Pinnacle Research Group, LLC
Anniston, Alabama, 36207-5710
Billings Clinic Research Center
Billings, Montana, 59101
Regional Clinical Research Rheumatology Assoc.
Binghamton, New York, 13905
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Intermountain Orthopedics
Boise, Idaho, 83702
Northwest Clinical Trials
Boise, Idaho, 83704
Associated Pharmaceutical Research
Buena Park, California, 90620
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635
Comprehensive Rheumatology
Hendersonville, Tennessee, 37075
MultiSpecialty Clinical Research
Johnson City, Tennessee, 37601
Southwest Rheumatology
Mesquite, Texas, 75150
Integrity Clinical Research, LLC
Milan, Tennessee, 38358
Montana Medical Research
Missoula, Montana, 59804
Arthritis and Diabetes Clinic
Monroe, Louisiana, 71203
Health Research of Hampton Roads
Newport News, Virginia, 23606
Northern California Institute for Bone Health
Oakland, California, 94609
Heartland Clinical Research, Inc.
Omaha, Nebraska, 68134
Harbin Clinic
Rome, Georgia, 30165
San Diego Arthritis & Osteoporosis Medical Clinic
San Diego, California, 92108
The Arthritis Center
Springfield, Illinois, 62704
Arthritis Consultants, Inc.
St Louis, Missouri, 63141
Tampa Medical Group, P.A.
Tampa, Florida, 33614
Cotton O'Neil Clinic
Topeka, Kansas, 66606
Community Research Partners, Inc.
Varnville, South Carolina, 29944
Center for Clinical Trials of San Gabriel
West Covina, California, 91790
Florida Medical Clinic, PA
Zephyrhills, Florida, 33542
Germany16 sites
Novartis Investigative Site
Bad Nauheim
Novartis Investigative Site
Bautzen
Novartis Investigative Site
Berlin
Novartis Investigative Site
Chemnitz
Novartis Investigative Site
Dachau
Novartis Investigative Site
Dresden
Novartis Investigative Site
Frankfurt
Novartis Investigative Site
Georgensgmünd
Novartis Investigative Site
Hamburg
Novartis Investigative Site
Leipzig
Novartis Investigative Site
Löhne
Novartis Investigative Site
Magdeburg
Novartis Investigative Site
Messkirch
Novartis Investigative Site
Munich
Novartis Investigative Site
Schwabach
Novartis Investigative Site
Zerbst
Turkey (Türkiye)9 sites
Novartis Investigative Site
Adana
Novartis Investigative Site
Ankara
Novartis Investigative Site
Antalya
Novartis Investigative Site
Aydin
Novartis Investigative Site
Gaziantep
Novartis Investigative Site
Istanbul
Novartis Investigative Site
Izmir
Novartis Investigative Site
Manisa
Novartis Investigative site
Sihhiye/Ankara
Russia6 sites
Novartis Investigative site
Chelyabinsk
Novartis Investigative Site
Moscow
Novartis Investigative Site
Saint Petersburg
Novartis Investigative site
Tyumen
Novartis Investigative Site
Yaroslavl
Novartis Investigative site
Yekaterinburg
Switzerland4 sites
Novartis Investigative site
Baden
Novartis Investigative site
Basel
Novartis Investigative site
Bern
Novartis Investigative site
Lausanne
United Kingdom4 sites
Novartis Investigative Site
Antrim
Novartis Investigative Site
Coventry
Novartis Investigative Site
Lancashire
Novartis Investigative Site
Wellingborough
Canada3 sites
Novartis Investigative site
Moncton
Novartis Investigative site
Mount Pearl
Novartis Investigative site
St. John's
Poland3 sites
Novartis Investigative site
Poznan
Novartis Investigative site
Szczecin
Novartis Investigative site
Wroclaw
About this study
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
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.
- Conditions
- Acute Gout
- Being tested
- Canakinumab, Triamcinolone acetonide
- Keywords
- Acute flares, Gout, Anti-interleukin-1β monoclonal antibody, Colchicine, Triamcinolone acetonide
- Medical subject headings
- Gout
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CanakinumabDrug
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.
CanakinumabDrug
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.
CanakinumabDrug
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.
CanakinumabDrug
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.
CanakinumabDrug
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 acetonideDrug
Randomized patients received triamcinolone acetonide 40 mg i.m. once and placebo matching canakinumab s.c. once, on Day 1.
| Study group | Role | What they receive |
|---|---|---|
| Canakinumab 10 mg | Experimental | 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. Receives: Drug: Canakinumab |
| Canakinumab 25 mg | Experimental | 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. Receives: Drug: Canakinumab |
| Canakinumab 50 mg | Experimental | 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. Receives: Drug: Canakinumab |
| Canakinumab 90 mg | Experimental | 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. Receives: Drug: Canakinumab |
| Canakinumab 150 mg | Experimental | 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. Receives: Drug: Canakinumab |
| Triamcinolone acetonide 40 mg | Active comparator | 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. Receives: Drug: Triamcinolone acetonide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: at 24,48 and 72 hours post-baseline
Secondary outcomes (6)
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).
Measured: Baseline,at 72 hrs post-dose and 7 days post-dose
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.
Measured: at 72 hours post-baseline
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).
Measured: Baseline, within 7 days after randomization
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.
Measured: at 72 hours and 7 days, 4 and 8 weeks post-dose
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.
Measured: at 72 hours and 7 days, 4 and 8 weeks post-dose
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.
Measured: 7 days after study drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2008 (estimated)
- Study startNov 2008
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acute GoutStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00798369
- Sponsor's protocol ID
- CACZ885H2255
- Other IDs
- EudraCT 2008-004666-61
- Status last verified
- Apr 2012
- First submitted
- 25 Nov 2008
- Last updated
- 10 Apr 2012
- Results posted
- Yes, on ClinicalTrials.gov
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 24122883Schlesinger 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 21439048So 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
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00798369
- Acronym / sponsor ID
- CACZ885H2255
- Conditions
- Acute Gout
- Keywords
- Acute flares, Gout, Anti-interleukin-1β monoclonal antibody, Colchicine, Triamcinolone acetonide
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 26 Nov 2008 (estimated)
- Results
- Posted 16 May 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Canakinumab 10 mg | Experimental | Drug: CanakinumabCanakinumab 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 | Experimental | Drug: CanakinumabCanakinumab 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 | Experimental | Drug: CanakinumabCanakinumab 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 | Experimental | Drug: CanakinumabCanakinumab 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 | Experimental | Drug: CanakinumabCanakinumab 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 | Active comparator | Drug: Triamcinolone acetonideTriamcinolone 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CanakinumabRandomized 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 10 mg |
| CanakinumabRandomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once, on Day 1. | Drug | Canakinumab 25 mg |
| CanakinumabRandomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once, on Day 1. | Drug | Canakinumab 50 mg |
| CanakinumabRandomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once, on Day 1. | Drug | Canakinumab 90 mg |
| CanakinumabRandomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once, on Day 1. | Drug | Canakinumab 150 mg |
| Triamcinolone acetonideRandomized patients received triamcinolone acetonide 40 mg i.m. once and placebo matching canakinumab s.c. once, on Day 1. | Drug | Triamcinolone acetonide 40 mg |
Primary outcome
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)
Time frame: at 24,48 and 72 hours post-baseline
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).
6 secondary outcomes
The Change in Pain Intensity in the Target Joint Following Canakinumab Administration Compared to Triamcinolone Acetonide
Time frame: Baseline,at 72 hrs post-dose and 7 days post-dose
Percentage of Participants With an Excellent or Good Response With Regards to the Patient's Global Assessment of Response to Treatment
Time frame: at 72 hours post-baseline
The Time to 50% Reduction of Baseline Pain Intensity in the Target Joint
Time frame: Baseline, within 7 days after randomization
High Sensitivity C-reactive Protein (hsCRP) at 72 Hours, 7days, 4 Weeks and 8 Weeks Post Dose for Each Treatment Group
Time frame: at 72 hours and 7 days, 4 and 8 weeks post-dose
Serum Amyloid Protein (SAA) Levels at 72 Hours, 7days, 4 Weeks and 8 Weeks Post Dose for Each Treatment Group
Time frame: at 72 hours and 7 days, 4 and 8 weeks post-dose
Amount of Rescue Medication Taken for Each Treatment Group
Time frame: 7 days after study drug administration
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24122883Chakraborty 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.
- Derived from this study: PubMed 21439048Schlesinger 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.
- Derived from this study: PubMed 20533546So 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
75 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Canakinumab and Triamcinolone acetonide in people with Acute Gout, run by Novartis at 75 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 75 sites in United States, Germany, Turkey (Türkiye), Russia, Switzerland and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 May 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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) (time frame: at 24,48 and 72 hours post-baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00798369, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2012.