GoutPhase 2NCT00819585
A Study of the Efficacy of Canakinumab in Prevention of Acute Flares in Chronic Gout Patients Initiating Allopurinol Therapy (Core Study) and a Long-term Study of the Efficacy and Safety of Canakinumab in Patients With Gout (Extension Study)
A Phase 2 study testing Canakinumab, Colchicine and Allopurinol in people with Gout, run by Novartis Pharmaceuticals at 89 sites in 18 countries.
Trial summary
The 24-week, dose-ranging, multi-center, double-blind, double-dummy, active-controlled core study investigated the prophylactic effect of canakinumab on the signs and symptoms of acute flares in chronic gout patients initiating allopurinol therapy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gout
- What is being tested?
- Canakinumab, Colchicine and Allopurinol
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 432 participants
- Where
- 89 sitesin 18 countries
- Study dates
- Dec 2008to Aug 2010
- 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
- Signed written informed consent before any study procedure is performed.
- History of at least 2 gout flares in the year prior to Screening (Visit 1, based on patient history), thus, candidates for initiating uric acid lowering therapy.
- Confirmed diagnosis of gout meeting the American College of Rheumatology (ACR) 1977 preliminary criteria for the classification of arthritis of primary gout.
- Body Mass Index (BMI) ≤ 40 kg/m^2.
- Willingness to initiate allopurinol therapy as urate lowering agent for their gout therapy or having initiated allopurinol therapy within ≤ 1 month before Screening (Visit 1) or willing to re-initiate allopurinol therapy if this was stopped > 2 months before Screening (Visit 1) for reasons different to toxicity/ intolerance or lack of efficacy.
- Patients who completed the core study. A patient is defined as completing the core study if he/she completed the study up to and including the last visit (Visit 9).
- Patients who have signed a written informed consent before any trial procedure is performed.
Who cannot join
- Acute gout flare within 2 weeks of Screening (Visit 1) and during the Screening period.
- History of allergy or contraindication to colchicine or allopurinol.
- History of intolerance to allopurinol or to oral colchicine in appropriate dose for prophylactic use.
- History of bone marrow suppression.
- Absolute or relative contraindication to both naproxen and oral prednisolone/ prednisone.
- Extension study
Show all 9Show fewer
- Patients for whom continuation in the extension study is not considered appropriate by the treating physician.
- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive pregnancy test (serum or urine).
- Other protocol-defined inclusion/exclusion criteria applied to the study.
Trial locations and contacts
89 sites in 18 countries.
89 sites in 18 countries
United States19 sites
NM Clinical Research & Osteoporosis Ct.
Albuquerque, New Mexico
Dolby Research, LLC
Baton Rouge, Louisiana, 70809
Columbia Clinical Research
Columbia, South Carolina, 29201
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635
Upstate Pharmaceutical Research
Greenville, South Carolina, 29615
East-West Medical Research institute
Honolulu, Hawaii, 96814
Talbert Medical Group
Huntington Beach, California, 92646
MultiSpecialty Clinical Research
Johnson City, Tennessee
Health Awareness
Jupiter, Florida, 33458
Health Research of Oklahoma, PLLC
Oklahoma City, Oklahoma, 73103
Heartland Clinical Research, Inc.
Omaha, Nebraska
Pinnacle Medical Research
Overland Park, Kansas, 66215
Rochester clinical Research
Rochester, New York, 14609
Shores Rheumatology
Saint Clair Shores, Michigan, 48081
iMED Internal medicine, PA
San Antonio, Texas, 78228
San Diego Arthritis & Osteoporosis Medical clinic
San Diego, California
The Family Doctors
Shreveport, Louisiana, 71115
Cotton O'Neil Clinical Research Institute
Topeka, Kansas
Castlerock Clinical Research Consultants, LLC
Tulsa, Oklahoma, 74136
Germany12 sites
Novartis Investigative Site
Bautzen
Novartis Investigative Site
Chemnitz
Novartis Investigative Site
Dresden
Novartis Investigative Site
Frankfurt
Novartis Investigative Site
Georgensgmünd
Novartis Investigative Site
Göttingen
Novartis Investigative Site
Hamburg
Novartis Investigative Site
Magdeburg
Novartis Investigative Site
Messkirch
Novartis Investigative Site
München
Novartis Investigative Site
Riedlhuette
Novartis Investigative Site
Schwabach
Turkey (Türkiye)8 sites
Baskent University Medical Faculty
Adana
Baskent University Medical Faculty
Ankara
Adnan Menderes University Medical Faculty
Aydin
Cukurova University Medical Faculty
Balcali Adana
Pamukkale University medical Faculty
Denizli Kampus
Gaziantep University Medical Faculty
Gaziantep
Dokuz Eylul University Medical Faculty
Izmir
Celal Bayar University Medical Faculty
Manisa
Slovakia7 sites
Novartis Investigative Site
Banská Bystrica
Novartis Investigative Site
Bratislava
Novartis Investigative Site
Košice
Novartis Investigative Site
Nové Zámky
Novartis Investigative Site
Piešťany
Novartis Investigative Site
Považská Bystrica
Novartis Investigative site
Trebišov
Russia6 sites
Novartis Investigative Site
Chelyabinsk
Novartis Investigative site
Moscow
Novartis Investigative Site
Petrozavodsk
Novartis Investigative Site
Saint Petersburg
Novartis Investigative Site
Yaroslavl
Novartis Investigative Site
Yekaterinburg
Czechia5 sites
Novartis Investigative site
Havířov
Novartis Investigative site
Ostrava
Novartis Investigative site
Pardubice
Novartis Investigative site
Uherské Hradiště
Novartis Investigative site
Zlín
Colombia4 sites
Novartis Investigative Site
Bacaramanga
Novartis Investigative Site
Barranquilla
Novartis Investigative Site
Bogotá
Fundación Cardiovascular de Colombia
Florida Blanca
Hungary4 sites
Novartis Investigative Site
Debrecen
Novartis Investigative Site
Eger
Novartis Investigative Site
Kistarcsa
Novartis Investigative Site
Zalaegerszeg
Spain4 sites
Novartis Investigative Site
Barakaldo
Novartis Investigative site
Madrid
Novartis Investigative site
Mérida
Novartis Investigative site
Valencia
Argentina3 sites
Novartis Investigative site
Buenos Aires
Novartis Investigative Site
Córdoba
Novartis Investigative site
Rosario
Portugal3 sites
Novartis Investigative site
Coimbra
Novartis Investigative site
Lisbon
Novartis Investigative site
Ponte de Lima
South Africa3 sites
Novartis Investigative site
Cape Town
Novartis Investigative site
Panorama
Novartis Investigative site
Port Elizabeth
Taiwan3 sites
Novartis Investigative site
Kaohsiung City
Novartis Investigative site
Taichung
Novartis Investigative site
Taipei
Belgium2 sites
Novartis Investigative Site
Gozée
Novartis Investigative site
Oostham
Poland2 sites
Novartis Investigative Site
Poznan
Novartis Investigative Site
Wroclaw
United Kingdom2 sites
Gables Medicentre
Coventry
Flyde Coast Clinical Research Ltd
Lancashire
About this study
Official title: A 24-week, Dose-ranging, Multicenter, Double-blind, Double-dummy, Active-controlled Core Study to Evaluate Canakinumab for Prophylaxis of Signs and Symptoms of Acute Flares in Chronic Gout Patients Initiating Allopurinol Therapy and a 24-week Open-label, Multicenter Extension Study to Assess Safety, Tolerability and Efficacy of Canakinumab in Patients With Gout Who Are Given Canakinumab at the Time of Gout Flare
The 24-week, dose-ranging, multi-center, double-blind, double-dummy, active-controlled core study investigated the prophylactic effect of canakinumab on the signs and symptoms of acute flares in chronic gout patients initiating allopurinol therapy. The core study was followed by a 24-week open-label, multicenter extension study to assess the safety, tolerability, and efficacy of canakinumab in patients with gout who were given canakinumab at the time of gout flare.
- Conditions
- Gout
- Being tested
- Canakinumab, Colchicine, Allopurinol, Placebo Matching Canakinumab, Placebo Matching Colchicine
- Keywords
- Gout, Chronic gout, Gouty arthritis, Gout flares
- Medical subject headings
- Gout, Arthritis, Gouty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CanakinumabDrug
Canakinumab was supplied in glass vials as a lyophilized powder.
ColchicineDrug
0.5 mg capsule orally once daily for 16 weeks.
AllopurinolDrug
100-300 mg orally once daily for 24 weeks.
Placebo Matching CanakinumabDrug
Subcutaneous injection.
Placebo Matching ColchicineDrug
Capsule orally once daily for 16 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Core study: Canakinumab 25 mg | Experimental | Canakinumab 25 mg subcutaneously (sc) once at Day 1, placebo sc at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg-300 mg) for 24 weeks. Receives: Drug: Canakinumab; Drug: Allopurinol; Drug: Placebo Matching Canakinumab; Drug: Placebo Matching Colchicine |
| Core study: Canakinumab 50 mg | Experimental | Canakinumab 50 mg sc once at Day 1, placebo sc at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg-300 mg) for 24 weeks. Receives: Drug: Canakinumab; Drug: Allopurinol; Drug: Placebo Matching Canakinumab; Drug: Placebo Matching Colchicine |
| Core study: Canakinumab 100 mg | Experimental | Canakinumab 100 mg sc once at Day 1, placebo sc at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg-300 mg) for 24 weeks. Receives: Drug: Canakinumab; Drug: Allopurinol; Drug: Placebo Matching Canakinumab; Drug: Placebo Matching Colchicine |
| Core study: Canakinumab 200 mg | Experimental | Canakinumab 100 mg sc once at Day 1, placebo sc at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg-300 mg) for 24 weeks. Receives: Drug: Canakinumab; Drug: Allopurinol; Drug: Placebo Matching Canakinumab; Drug: Placebo Matching Colchicine |
| Core study: Canakinumab 300 mg | Experimental | Canakinumab 300 mg sc once at Day 1, placebo sc at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg-300 mg) for 24 weeks. Receives: Drug: Canakinumab; Drug: Allopurinol; Drug: Placebo Matching Canakinumab; Drug: Placebo Matching Colchicine |
| Core study: Canakinumab q4wk | Experimental | Canakinumab 50 mg sc at Days 1, and 29 followed by canakinumab 25 mg sc on Days 57, and 85 plus daily placebo capsules for 16 weeks, repeated every 4 week (q4wk). Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg-300 mg) for 24 weeks. Receives: Drug: Canakinumab; Drug: Allopurinol; Drug: Placebo Matching Colchicine |
| Core study: Colchicine 0.5 mg | Active comparator | Colchicine 0.5 mg capsule orally once daily throughout the whole treatment phase of 16 weeks plus placebo matching canakinumab s.c. at Days 1, 29, 57, and 85. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg-300 mg) for 24 weeks. Receives: Drug: Colchicine; Drug: Allopurinol; Drug: Placebo Matching Canakinumab |
| Extension study: Group A | Experimental | Participants who were randomized to canakinumab in the core study and were treated with canakinumab for at least 1 flare in the extension study. Receives: Drug: Canakinumab |
| Extension study: Group B | Experimental | Patients who were randomized to canakinumab in the core study but did not receive treatment with canakinumab in the extension study. Receives: Drug: Canakinumab |
| Extension study: Group C | Experimental | Patients who were randomized to colchicine in the core study and were treated with canakinumab for at least 1 flare in the extension study. Receives: Drug: Canakinumab; Drug: Colchicine |
| Extension study: Group D | Experimental | Patients who were randomized to colchicine in the core study but did not receive treatment with canakinumab in the extension study. Receives: Drug: Colchicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Core Study: Mean Number of Gout Flares Per Participant
A gout flare was defined as an increase in participant-reported gout pain in the most affected joint during a gout attack.
Measured: Baseline of the core study to Week 16
Secondary outcomes (11)
Core Study: Mean Number of Gout Flares for the Repeat Dose Regimen of Canakinumab as Compared to the Single Doses of Canakinumab
Measured: up to 16 weeks after randomization
Core Study: Percentage of Participants With at Least 1 Gout Flare Within 16 Weeks After Randomization
The percentage of participants experiencing at least 1 gout flare within 16 weeks after randomization. A gout flare was defined as an increase in participant-reported gout pain in the most affected joint during a gout attack.
Measured: Baseline of the core study to Week 16
Core Study: Percentage of Participants With Gout Flare at Different Time Points
A gout flare was defined as an increase in participant-reported gout pain in the most affected joint during a gout attack.
Measured: Days 2, 4, 6, and Weeks 2, 4, 6, 10, and 16 of the core study
Core Study: Participant's Assessment of Gout Pain on a 0-100 mm Visual Analog Scale up to Day 7 of All Gout Flares
Participants rated the intensity of pain in the most affected joint on a 0-100 mm visual analog scale, which ranged from no pain (left end, 0) to unbearable pain (right end, 100). Participants assessed pain intensity on the day of onset of the gout flare and in the morning of the 6 following days.
Measured: Baseline of the core study to Week 16
Core Study: Participant's Assessment of Gout Pain on a 5-point Likert Scale up to Day 7 of All Gout Flares
Participants assessed the intensity of pain in the most affected joint on a 5-point Likert scale, which ranged from 1 to 5 (1=None, 2=Mild, 3=Moderate, 4=Severe, 5=Extreme). Participants assessed pain intensity on the day of onset of the gout flare and in the morning of the 6 following days.
Measured: Baseline of the core study to Week 16
Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale
The study physician made a global assessment of the participant's response to treatment on a 5-point Likert scale (Very good, Good, Fair, Poor, Very poor) at Days 15, 29, 57, 85, 113, and 141. The category 'Not assessed' includes missing data and 'not done'. The number of participants in each of the 5 categories of the Likert scale are reported.
Measured: Days 15, 29, 57, 85, 113, and 141 of the core study
Extension Study: Participant's Assessment of Gout Pain on a 100 mm Visual Analog Scale During the First Flare
Participant's rated the intensity of pain in the most affected joint during the first flare on a 0-100 mm visual analog scale, which ranged from no pain (left end, 0) to unbearable pain (right end, 100). Assessments were made pre-dose and 24 hours, 3 days, 4 days, and an average of 5-7 days post-dose
Measured: Baseline of the extension study until 7 days after the onset of the first gout flare (up to 24 weeks)
Extension Study: Participant's Global Assessment of Response to Treatment on a 5-point Likert Scale
Study participants made a global assessment of their response to treatment on a 5-point Likert scale (Excellent, Good, Acceptable, Slight, Poor) at the control visit 7±2 days following each of their first 3 flares. The number of participants in each of the 5 categories of the Likert scale are reported.
Measured: Baseline of the extension study until the end of the study (up to 24 weeks)
Extension Study: Physician's Global Assessment of Response to Treatment on a 5-point Likert Scale
The study physician made a global assessment of the participant's response to treatment on a 5-point Likert scale (Very good, Good, Fair, Poor, Very poor) at the control visit 7±2 days following each of the first 3 flares. The category 'Not assessed' includes missing data and 'not done'. The number of participants in each of the 5 categories of the Likert scale are reported.
Measured: Baseline of the extension study until the end of the study (up to 24 weeks)
Extension Study: Physician's Assessment of Tenderness, Swelling, and Erythema in the Most Affected Joint During the First Flare
Tenderness was rated on a 0-3 point scale: 0="no pain", 1=patient states that "there is pain", 2=patient states "there is pain and winces", and 3=patient states "there is pain, winces and withdraws" on palpation or passive movement of the most affected joint. Swelling was rated on a 0-3 point scale: 0="no swelling", 1="palpable", 2="visible", and 3=bulging beyond the joint margins". Erythema was rated as present, absent, or not assessable. Assessments were performed at the flare and control visits.
Measured: Baseline of the extension study until the end of the study (up to 24 weeks)
Extension Study: Amount of Rescue Medication Taken
The amount of naproxen and prednisolone taken after receiving treatment for each of the first 3 flares was recorded.
Measured: Baseline of the extension study until the end of the study (up to 24 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2009 (estimated)
- Study startDec 2008
- Primary completionAug 2010
- Study completionAug 2010
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.
- Other trials for GoutStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 432 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00819585
- Sponsor's protocol ID
- CACZ885H2251
- Other IDs
- EudraCT : 2008-005876-28
- Status last verified
- Jun 2018
- First submitted
- 8 Jan 2009
- Last updated
- 17 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 24-week, Dose-ranging, Multicenter, Double-blind, Double-dummy, Active-controlled Core Study to Evaluate Canakinumab for Prophylaxis of Signs and Symptoms of Acute Flares in Chronic Gout Patients Initiating Allopurinol Therapy and a 24-week Open-label, Multicenter Extension Study to Assess Safety, Tolerability and Efficacy of Canakinumab in Patients With Gout Who Are Given Canakinumab at the Time of Gout Flare
- ClinicalTrials.gov ID
- NCT00819585
- Acronym / sponsor ID
- CACZ885H2251
- Conditions
- Gout
- Keywords
- Gout, Chronic gout, Gouty arthritis, Gout flares
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 432 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 9 Jan 2009 (estimated)
- Results
- Posted 6 May 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The 24-week, dose-ranging, multi-center, double-blind, double-dummy, active-controlled core study investigated the prophylactic effect of canakinumab on the signs and symptoms of acute flares in chronic gout patients initiating allopurinol therapy. The core study was followed by a 24-week open-label, multicenter extension study to assess the safety, tolerability, and efficacy of canakinumab in patients with gout who were given canakinumab at the time of gout flare.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 11
| Arm | Type | Receives |
|---|---|---|
| Core study: Canakinumab 25 mg | Experimental | Drug: Canakinumab, Drug: Allopurinol, Drug: Placebo Matching Canakinumab, Drug: Placebo Matching ColchicineCanakinumab 25 mg subcutaneously (sc) once at Day 1, placebo sc at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg-300 mg) for 24 weeks. |
| Core study: Canakinumab 50 mg | Experimental | Drug: Canakinumab, Drug: Allopurinol, Drug: Placebo Matching Canakinumab, Drug: Placebo Matching ColchicineCanakinumab 50 mg sc once at Day 1, placebo sc at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg-300 mg) for 24 weeks. |
| Core study: Canakinumab 100 mg | Experimental | Drug: Canakinumab, Drug: Allopurinol, Drug: Placebo Matching Canakinumab, Drug: Placebo Matching ColchicineCanakinumab 100 mg sc once at Day 1, placebo sc at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg-300 mg) for 24 weeks. |
| Core study: Canakinumab 200 mg | Experimental | Drug: Canakinumab, Drug: Allopurinol, Drug: Placebo Matching Canakinumab, Drug: Placebo Matching ColchicineCanakinumab 100 mg sc once at Day 1, placebo sc at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg-300 mg) for 24 weeks. |
| Core study: Canakinumab 300 mg | Experimental | Drug: Canakinumab, Drug: Allopurinol, Drug: Placebo Matching Canakinumab, Drug: Placebo Matching ColchicineCanakinumab 300 mg sc once at Day 1, placebo sc at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg-300 mg) for 24 weeks. |
| Core study: Canakinumab q4wk | Experimental | Drug: Canakinumab, Drug: Allopurinol, Drug: Placebo Matching ColchicineCanakinumab 50 mg sc at Days 1, and 29 followed by canakinumab 25 mg sc on Days 57, and 85 plus daily placebo capsules for 16 weeks, repeated every 4 week (q4wk). Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg-300 mg) for 24 weeks. |
| Core study: Colchicine 0.5 mg | Active comparator | Drug: Colchicine, Drug: Allopurinol, Drug: Placebo Matching CanakinumabColchicine 0.5 mg capsule orally once daily throughout the whole treatment phase of 16 weeks plus placebo matching canakinumab s.c. at Days 1, 29, 57, and 85. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg-300 mg) for 24 weeks. |
| Extension study: Group A | Experimental | Drug: CanakinumabParticipants who were randomized to canakinumab in the core study and were treated with canakinumab for at least 1 flare in the extension study. |
| Extension study: Group B | Experimental | Drug: CanakinumabPatients who were randomized to canakinumab in the core study but did not receive treatment with canakinumab in the extension study. |
| Extension study: Group C | Experimental | Drug: Canakinumab, Drug: ColchicinePatients who were randomized to colchicine in the core study and were treated with canakinumab for at least 1 flare in the extension study. |
| Extension study: Group D | Experimental | Drug: ColchicinePatients who were randomized to colchicine in the core study but did not receive treatment with canakinumab in the extension study. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Signed written informed consent before any study procedure is performed.
- History of at least 2 gout flares in the year prior to Screening (Visit 1, based on patient history), thus, candidates for initiating uric acid lowering therapy.
- Confirmed diagnosis of gout meeting the American College of Rheumatology (ACR) 1977 preliminary criteria for the classification of arthritis of primary gout.
- Body Mass Index (BMI) ≤ 40 kg/m^2.
- Willingness to initiate allopurinol therapy as urate lowering agent for their gout therapy or having initiated allopurinol therapy within ≤ 1 month before Screening (Visit 1) or willing to re-initiate allopurinol therapy if this was stopped > 2 months before Screening (Visit 1) for reasons different to toxicity/ intolerance or lack of efficacy.
Key exclusion criteria (9 listed)
- Acute gout flare within 2 weeks of Screening (Visit 1) and during the Screening period.
- History of allergy or contraindication to colchicine or allopurinol.
- History of intolerance to allopurinol or to oral colchicine in appropriate dose for prophylactic use.
- History of bone marrow suppression.
- Absolute or relative contraindication to both naproxen and oral prednisolone/ prednisone.
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 |
|---|---|---|
| CanakinumabCanakinumab was supplied in glass vials as a lyophilized powder. | Drug | Core study: Canakinumab 100 mg, Core study: Canakinumab 200 mg, Core study: Canakinumab 25 mg, Core study: Canakinumab 300 mg, Core study: Canakinumab 50 mg, Core study: Canakinumab q4wk, Extension study: Group A, Extension study: Group B, Extension study: Group C |
| Colchicine0.5 mg capsule orally once daily for 16 weeks. | Drug | Core study: Colchicine 0.5 mg, Extension study: Group C, Extension study: Group D |
| Allopurinol100-300 mg orally once daily for 24 weeks. | Drug | Core study: Canakinumab 100 mg, Core study: Canakinumab 200 mg, Core study: Canakinumab 25 mg, Core study: Canakinumab 300 mg, Core study: Canakinumab 50 mg, Core study: Canakinumab q4wk, Core study: Colchicine 0.5 mg |
| Placebo Matching CanakinumabSubcutaneous injection. | Drug | Core study: Canakinumab 100 mg, Core study: Canakinumab 200 mg, Core study: Canakinumab 25 mg, Core study: Canakinumab 300 mg, Core study: Canakinumab 50 mg, Core study: Colchicine 0.5 mg |
| Placebo Matching ColchicineCapsule orally once daily for 16 weeks. | Drug | Core study: Canakinumab 100 mg, Core study: Canakinumab 200 mg, Core study: Canakinumab 25 mg, Core study: Canakinumab 300 mg, Core study: Canakinumab 50 mg, Core study: Canakinumab q4wk |
Primary outcome
Core Study: Mean Number of Gout Flares Per Participant
Time frame: Baseline of the core study to Week 16
A gout flare was defined as an increase in participant-reported gout pain in the most affected joint during a gout attack.
11 secondary outcomes
Core Study: Mean Number of Gout Flares for the Repeat Dose Regimen of Canakinumab as Compared to the Single Doses of Canakinumab
Time frame: up to 16 weeks after randomization
Core Study: Percentage of Participants With at Least 1 Gout Flare Within 16 Weeks After Randomization
Time frame: Baseline of the core study to Week 16
Core Study: Percentage of Participants With Gout Flare at Different Time Points
Time frame: Days 2, 4, 6, and Weeks 2, 4, 6, 10, and 16 of the core study
Core Study: Participant's Assessment of Gout Pain on a 0-100 mm Visual Analog Scale up to Day 7 of All Gout Flares
Time frame: Baseline of the core study to Week 16
Core Study: Participant's Assessment of Gout Pain on a 5-point Likert Scale up to Day 7 of All Gout Flares
Time frame: Baseline of the core study to Week 16
Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale
Time frame: Days 15, 29, 57, 85, 113, and 141 of the core study
Extension Study: Participant's Assessment of Gout Pain on a 100 mm Visual Analog Scale During the First Flare
Time frame: Baseline of the extension study until 7 days after the onset of the first gout flare (up to 24 weeks)
Extension Study: Participant's Global Assessment of Response to Treatment on a 5-point Likert Scale
Time frame: Baseline of the extension study until the end of the study (up to 24 weeks)
Extension Study: Physician's Global Assessment of Response to Treatment on a 5-point Likert Scale
Time frame: Baseline of the extension study until the end of the study (up to 24 weeks)
Extension Study: Physician's Assessment of Tenderness, Swelling, and Erythema in the Most Affected Joint During the First Flare
Time frame: Baseline of the extension study until the end of the study (up to 24 weeks)
Extension Study: Amount of Rescue Medication Taken
Time frame: Baseline of the extension study until the end of the study (up to 24 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
89 sites in 18 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Canakinumab, Colchicine and Allopurinol in people with Gout, run by Novartis Pharmaceuticals at 89 sites in 18 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 7 inclusion and 9 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 17 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 89 sites in United States, Germany, Turkey (Türkiye), Slovakia, Russia and 13 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 6 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?
Core Study: Mean Number of Gout Flares Per Participant (time frame: Baseline of the core study to Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jul 2018.