Gouty ArthritisPhase 2NCT00927810

Long Term Study of Canakinumab (ACZ885) in Patients With Gout

A Phase 2 study testing Canakinumab in people with Gouty Arthritis, run by Novartis Pharmaceuticals at 45 sites in 18 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This 24-week open-label extension study is designed to provide additional long-term safety data up to a total of 1-year for patients rolling over from the core study, and to collect further efficacy and tolerability data for all the patients, irrespective whether they have an acute flare of gout or not. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Gouty Arthritis
What is being tested?: Canakinumab
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 341 participants
Where: 45 sitesin 18 countries
Study dates: 5 Jun 2009to 4 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

Patients who completed the core study CACZ885H2251. 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

Patients for whom continuation in the extension 1 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).
Female patients who were physiologically capable of becoming pregnant, unless they were:
Female patients whose career, lifestyle, or sexual orientation precluded intercourse with a male partner.
Female patients whose partners had been sterilized by vasectomy or other means.
Using an acceptable method of contraception with a failure rate (Pearl Index (PI)) < 1.
Reliable contraception had to be maintained throughout the study and for 2 months after study drug discontinuation.
Other protocol defined inclusion/exclusion criteria may apply

Trial locations and contacts

45 sites in 18 countries.

Country

City, postcode or hospital

45 sites in 18 countries

Russia7 sites

Novartis Investigative site
Chelyabinsk, 454047
Novartis Investigative site
Moscow, 115522
Novartis Investigative site
Moscow, 127473
Novartis Investigative site
Petrozavodsk
Novartis Investigative site
Saint Petersburg, 190068
Novartis Investigative site
Saint Petersburg, 193015
Novartis Investigative site
Yaroslavl, 150003

Other trials in Russia

Turkey (Türkiye)6 sites

Novartis Investigative site
Adana, Balcali, 01330
Novartis Investigative site
Ankara, Bahcellievler, 06490
Novartis Investigative site
Aydin, Merkez, 09100
Novartis Investigative site
Gaziantep, Sehitkamil, 27310
Novartis Investigative site
Izmir, Inciraltı, 35340
Novartis Investigative site
Manisa, Merkez, 45010

Other trials in Turkey (Türkiye)

Slovakia5 sites

Novartis Investigative site
Bratislava, N/A 813 69
Novartis Investigative site
Košice, N/A 042 66
Novartis Investigative site
Nitra, N/A 949 01
Novartis Investigative site
Piešťany, N/A 921 12
Novartis Investigative site
Trenčín, N/A 911 50

Other trials in Slovakia

Colombia4 sites

Novartis Investigative site
Barranquilla
Novartis Investigative site
Bogotá
Novartis Investigative site
Bucaramanga
Novartis Investigative site
Floridablanca

Other trials in Colombia

Hungary4 sites

Novartis Investigative site
Debrecen, Bartók B U 2-26, 4043
Novartis Investigative site
Eger, Széchenyi U 27-29, 3301
Novartis Investigative site
Kistarcsa, Semmelweis Tér 1., 2143
Novartis Investigative site
Zalaegerszeg, Zrínyi U 1, 8900

Other trials in Hungary

Taiwan4 sites

Novartis Investigative site
Kaohsiung City, 80756
Novartis Investigative site
Kaohsiung City, 81346
Novartis Investigative site
Taichung, 40705
Novartis Investigative site
Taipei, 11217

Other trials in Taiwan

Germany3 sites

Novartis Investigative site
Bayern, München / Mühlbaurstraße 16, D-81677
Novartis Investigative site
Dessau, Roßlau / Kühnauer Straße 70 Sachsen- Anhalt, D-06846
Novartis Investigative site
Sachsen, Dresden / Schützenhöhe 16, D-01099

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Poland2 sites

Novartis Investigative site
Poznan, NA 61- 734
Novartis Investigative site
Wroclaw, NA 50-333

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United States1 site

Novartis Investigative site
Seattle, Washington, 98101

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Argentina1 site

Novartis Investigative site
Capital Federal Buenos Aires, 1027

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Belgium1 site

Novartis Investigative site
Jette, 1090

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Czechia1 site

Novartis Investigative site
Prague, Czech Republic, 15006

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Guatemala1 site

Novartis Investigative site
Guatemala City, 01015

Other trials in Guatemala

Portugal1 site

Novartis Investigative site
Lisbon, 1749-004

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Singapore1 site

Novartis Investigative site
Singapore, 169611

Other trials in Singapore

South Africa1 site

Novartis Investigative site
Pretoria, Gauteng, 0153

Other trials in South Africa

Spain1 site

Novartis Investigative site
Madrid, 28046

Other trials in Spain

United Kingdom1 site

Novartis Investigative site
Jarrow, Tyne & Wear, NE32 3DT

Other trials in United Kingdom

About this study

Official title: A 24-week Open-label, Multicenter, Follow-up and Extension Study to CACZ885H2251, to Assess Safety, Tolerability and Efficacy of Canakinumab (ACZ885) in Patients With Gout Who Were Given Canakinumab at the Time of Gout Flare

Conditions: Gouty Arthritis
Being tested: Canakinumab
Keywords: Gouty, Gouty arthritis, Gout flares, Anti-interleukin-1β monoclonal antibody
Medical subject headings: Arthritis, Gouty

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CanakinumabDrug

Study groups in NCT00927810
Study group	Role	What they receive
canakinumab	Experimental	Not described Receives: Drug: Canakinumab

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Adverse Events and Serious Adverse Events
Adverse events (AEs) were defined as any unfavourable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events (SAEs) were defined as any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalisation, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgement of investigators represent significant hazards
Measured: From start of study up to study completion (up to 14 months)

Secondary outcomes (5)

Difference Change From Baseline in Participant's Gout Pain During First Flare
Gout pain was assessed using Visual analogue scale (VAS) with a range of 0 to 100 where 0= no pain, 100= unbearable pain. Difference from time of study drug administration (pre-dose) was reported.
Measured: Baseline and Day 7
Number of Participants Achieved Patient's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category
Patient's global assessment of response to treatment is 5-point Likert scale:1.Excellent, 2.Good, 3.Acceptable, 4.Slight, 5.Poor. Lower the score better the outcome.
Measured: 24 weeks
Number of Participants Achieved Physician's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category
Physician's global assessment of response to treatment is 5-point Likert scale:1.Very good, 2.Good, 3.Fair, 4.Poor, 5.Very poor. Lower the score better the outcome.
Measured: 24 weeks
Number of Participants Reported No Pain, No Swelling, Absent Erythema on Physician's Assessment of Tenderness, Swelling and Erythema in Most Affected Joint During the First Flare in Participants Treated With Canakinumab by Parameter, Visit and Group
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: 24 weeks
Amount of Rescue Medication After Study Drug Intake in Participants Treated With Canakinumab by Flare Order, Medication and Group
The amount of naproxen and prednisolone taken after receiving treatment for each of the first 3 flares was recorded.
Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Jun 20094 Aug 2010

First posted25 Jun 2009 (estimated)
Study start5 Jun 2009
Primary completion4 Aug 2010
Study completion4 Aug 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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Gouty ArthritisStudies 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: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 341 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00927810
Sponsor's protocol ID: CACZ885H2251E1
Status last verified: Jun 2021
First submitted: 23 Jun 2009
Last updated: 2 Jul 2021
Results posted: Yes, on ClinicalTrials.gov

Publications

Schlesinger N, Mysler E, Lin HY, De Meulemeester M, Rovensky J, Arulmani U, Balfour A, Krammer G, Sallstig P, So A. Canakinumab reduces the risk of acute gouty arthritis flares during initiation of allopurinol treatment: results of a double-blind, randomised study. Ann Rheum Dis. 2011 Jul;70(7):1264-71. doi: 10.1136/ard.2010.144063. Epub 2011 May 3.
PubMed 21540198

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Gouty Arthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 24-week Open-label, Multicenter, Follow-up and Extension Study to CACZ885H2251, to Assess Safety, Tolerability and Efficacy of Canakinumab (ACZ885) in Patients With Gout Who Were Given Canakinumab at the Time of Gout Flare
ClinicalTrials.gov ID: NCT00927810
Acronym / sponsor ID: CACZ885H2251E1
Conditions: Gouty Arthritis
Keywords: Gouty, Gouty arthritis, Gout flares, Anti-interleukin-1β monoclonal antibody
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 341 participants (actual)
Lead sponsor: Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: 5 Jun 2009 (actual)
Primary completion: 4 Aug 2010 (actual)
Study completion: 4 Aug 2010 (actual)
First posted: 25 Jun 2009 (estimated)
Results: Posted 9 Jun 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
canakinumab	Experimental	Drug: Canakinumab

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Patients who completed the core study CACZ885H2251. 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.

Key exclusion criteria (8 listed)

Patients for whom continuation in the extension 1 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).
Female patients who were physiologically capable of becoming pregnant, unless they were:
Other protocol defined inclusion/exclusion criteria may apply

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
Canakinumab	Drug	canakinumab

Primary outcome

Number of Participants With Adverse Events and Serious Adverse Events
Time frame: From start of study up to study completion (up to 14 months)
Adverse events (AEs) were defined as any unfavourable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events (SAEs) were defined as any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalisation, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgement of investigators represent significant hazards

5 secondary outcomes

Difference Change From Baseline in Participant's Gout Pain During First Flare
Time frame: Baseline and Day 7
Number of Participants Achieved Patient's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category
Time frame: 24 weeks
Number of Participants Achieved Physician's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category
Time frame: 24 weeks
Number of Participants Reported No Pain, No Swelling, Absent Erythema on Physician's Assessment of Tenderness, Swelling and Erythema in Most Affected Joint During the First Flare in Participants Treated With Canakinumab by Parameter, Visit and Group
Time frame: 24 weeks
Amount of Rescue Medication After Study Drug Intake in Participants Treated With Canakinumab by Flare Order, Medication and Group
Time frame: 24 weeks

Results and safety

Results posted to the registry on 9 Jun 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Core: Canakinumab, Extension: 150 mg Canakinumab	75	75
Core: Canakinumab, Extension: No Canakinumab	181	173
Core: Colchicine, Extension: 150 mg Canakinumab	25	24
Core: Colchicine, Extension: No Canakinumab	60	58

Primary outcome: Number of Participants With Adverse Events and Serious Adverse Events

Time frame: From start of study up to study completion (up to 14 months). Count of participants. Unit: Participants

Measure	Core: Canakinumab, Extension: 150 mg Canakinumab n = 75	Core: Canakinumab, Extension: No Canakinumab n = 181	Core: Colchicine, Extension: 150 mg Canakinumab n = 25	Core: Colchicine, Extension: No Canakinumab n = 60
Value	31	52	9	15

Population analysed: Safety Set 1 consisted of all participants from the core study who entered the extension study.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: From start of study up to study completion (up to 14 months). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Core: Canakinumab 25 mg	2 of 55 (3.6%)	21 of 55 (38.2%)	0 of 55
Core: Canakinumab 50 mg	2 of 54 (3.7%)	15 of 54 (27.8%)	0 of 54
Core: Canakinumab 100 mg	3 of 54 (5.6%)	14 of 54 (25.9%)	0 of 54
Core: Canakinumab 200 mg	3 of 54 (5.6%)	14 of 54 (25.9%)	0 of 54
Core: Canakinumab 300 mg	3 of 53 (5.7%)	15 of 53 (28.3%)	0 of 53
Core : Canakinumab Q4wk mg	1 of 53 (1.9%)	14 of 53 (26.4%)	0 of 53
Core : Colchicine 0.5 mg	6 of 108 (5.6%)	21 of 108 (19.4%)	1 of 108
Core: Canakinumab, Extension: 150 mg Canakinumab	4 of 75 (5.3%)	21 of 75 (28%)	0 of 75
Core: Canakinumab, Extension: No Canakinumab	6 of 181 (3.3%)	19 of 181 (10.5%)	2 of 181
Core: Colchicine, Extension: 150 mg Canakinumab	0 of 25 (0%)	6 of 25 (24%)	0 of 25
Core: Colchicine, Extension: No Canakinumab	1 of 60 (1.7%)	4 of 60 (6.7%)	0 of 60

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 21540198Schlesinger N, Mysler E, Lin HY, De Meulemeester M, Rovensky J, Arulmani U, Balfour A, Krammer G, Sallstig P, So A. Canakinumab reduces the risk of acute gouty arthritis flares during initiation of allopurinol treatment: results of a double-blind, randomised study. Ann Rheum Dis. 2011 Jul;70(7):1264-71. doi: 10.1136/ard.2010.144063. Epub 2011 May 3.

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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

45 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 in people with Gouty Arthritis, run by Novartis Pharmaceuticals at 45 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 2 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 2 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 45 sites in Russia, Turkey (Türkiye), Slovakia, Colombia, Hungary 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 9 Jun 2021). 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?

Number of Participants With Adverse Events and Serious Adverse Events (time frame: From start of study up to study completion (up to 14 months)). 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 NCT00927810, which also lists 1 linked publication.

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 2 Jul 2021.