Acute Gouty ArthritisPhase 3NCT01593527
Canakinumab in the Treatment of Gouty Arthritis Flare(s) and Prevention of New Flares in Patients With Chronic Kidney Disease
A Phase 3 study testing ACZ885 and Triamcinelone acetonide in people with Acute Gouty Arthritis, run by Novartis Pharmaceuticals.
Trial summary
The purpose of this study is to confirm the efficacy and safety results obtained in a chronic kidney disease (CKD) subgroup of patients participating in Phase III studies in a larger, independent patient population with difficult to treat gouty arthritis and moderate to severe CKD (stage 3 - 4). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Acute Gouty Arthritis
- What is being tested?
- ACZ885 and Triamcinelone acetonide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2012to Sep 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of gouty arthritis History of ≥ 3 gouty arthritis flares within the previous 12 months
- Confirmed diagnosis/ documented history of chronic kidney disease (CKD) Stages 3or4
- Onset of current acute gouty arthritis flare within 3 days prior to randomization
Who cannot join
- Hemodialysis CKD Stage 5 Organ transplantation
- Rheumatoid arthritis, evidence/suspicion of infectious/septic arthritis, or other acute inflammatory arthritis
- Live vaccinations within 3 months prior to randomization Other protocol-defined inclusion/exclusion criteria may apply
About this study
Official title: A Randomized Double-blind Active-controlled Trial of Canakinumab Versus Triamcinolone Acetonide on Reducing the Proportion of Patients With Any New Gouty Arthritis Flare(s) in Patients With Chronic Kidney Disease
The purpose of this study is to confirm the efficacy and safety results obtained in a chronic kidney disease (CKD) subgroup of patients participating in Phase III studies in a larger, independent patient population with difficult to treat gouty arthritis and moderate to severe CKD (stage 3 - 4).
- Conditions
- Acute Gouty Arthritis
- Being tested
- ACZ885, Triamcinelone acetonide
- Keywords
- Frequent flares, Frequent attacks, gout, gouty arthritis, Chronic kidney disease, renal impairment, Anti-interleukin-1β monoclonal antibody, anti-inflammatory therapy
- Medical subject headings
- Gout, Arthritis, Gouty, Renal Insufficiency, Chronic, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACZ885Drug
Canakinumab 150 mg s.c.
Triamcinelone acetonideDrug
Triamcinelone acetonide 40 mg i.m.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Canakinumab 150 mg s.c. Receives: Drug: ACZ885 |
| Arm 2 | Experimental | Triamcinelone acetonide 40 mg i.m. Receives: Drug: Triamcinelone acetonide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients experiencing new gouty arthritis flares during 12-week follow-up from dosing
Measured: 12 Weeks
Secondary outcomes (5)
The time to the first new gout flare
Measured: 12 Weeks
Score on Visual Analog Scale at 72 hours to measure gouty arthritis pain intensity and resolution
Measured: 12 weeks
Number of patients needing rescue medication use during acute gouty arthritis flare(s)
Measured: 12 Weeks
Measurement of efficacy using inflammatory markers
Measured: 12 Weeks
Time to 50% reduction of baseline pain intensity in the most affected joint
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2012 (estimated)
- Study startSep 2012
- Primary completionSep 2012 (estimated)
- Study completionSep 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01593527
- Sponsor's protocol ID
- CACZ885H2402
- Other IDs
- 2011-001766-18
- Status last verified
- Aug 2013
- First submitted
- 3 May 2012
- Last updated
- 20 Apr 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double-blind Active-controlled Trial of Canakinumab Versus Triamcinolone Acetonide on Reducing the Proportion of Patients With Any New Gouty Arthritis Flare(s) in Patients With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT01593527
- Acronym / sponsor ID
- CACZ885H2402
- Conditions
- Acute Gouty Arthritis
- Keywords
- Frequent flares, Frequent attacks, gout, gouty arthritis, Chronic kidney disease, renal impairment, Anti-interleukin-1β monoclonal antibody, anti-inflammatory therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Sep 2012 (estimated)
- Study completion
- Sep 2012 (estimated)
- First posted
- 8 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to confirm the efficacy and safety results obtained in a chronic kidney disease (CKD) subgroup of patients participating in Phase III studies in a larger, independent patient population with difficult to treat gouty arthritis and moderate to severe CKD (stage 3 - 4).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: ACZ885Canakinumab 150 mg s.c. |
| Arm 2 | Experimental | Drug: Triamcinelone acetonideTriamcinelone acetonide 40 mg i.m. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Confirmed diagnosis of gouty arthritis History of ≥ 3 gouty arthritis flares within the previous 12 months
- Confirmed diagnosis/ documented history of chronic kidney disease (CKD) Stages 3or4
- Onset of current acute gouty arthritis flare within 3 days prior to randomization
Key exclusion criteria (3 listed)
- Hemodialysis CKD Stage 5 Organ transplantation
- Rheumatoid arthritis, evidence/suspicion of infectious/septic arthritis, or other acute inflammatory arthritis
- Live vaccinations within 3 months prior to randomization 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 |
|---|---|---|
| ACZ885Canakinumab 150 mg s.c. | Drug | Arm 1 |
| Triamcinelone acetonideTriamcinelone acetonide 40 mg i.m. | Drug | Arm 2 |
Primary outcome
Proportion of patients experiencing new gouty arthritis flares during 12-week follow-up from dosing
Time frame: 12 Weeks
5 secondary outcomes
The time to the first new gout flare
Time frame: 12 Weeks
Score on Visual Analog Scale at 72 hours to measure gouty arthritis pain intensity and resolution
Time frame: 12 weeks
Number of patients needing rescue medication use during acute gouty arthritis flare(s)
Time frame: 12 Weeks
Measurement of efficacy using inflammatory markers
Time frame: 12 Weeks
Time to 50% reduction of baseline pain intensity in the most affected joint
Time frame: 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2017.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ACZ885 and Triamcinelone acetonide in people with Acute Gouty Arthritis, run by Novartis Pharmaceuticals.
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 3 inclusion and 3 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: withdrawn, as of the sponsor's last update on 20 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Proportion of patients experiencing new gouty arthritis flares during 12-week follow-up from dosing (time frame: 12 Weeks). 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 20 Apr 2017.