Arthritis, GoutyPhase 2NCT00663169
Efficacy and Safety of a Single Dose of Canakinumab (ACZ885) in Hospitalized Patients With Acute Gout
A Phase 2 study testing canakinumab and dexamethasone in people with Arthritis, Gouty, run by Novartis at 4 sites in 3 countries.
Trial summary
This is an exploratory proof-of-concept study to evaluate the safety and efficacy of canakinumab (ACZ885) for inflammation and pain associated with acute gouty arthritis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Arthritis, Gouty
- What is being tested?
- canakinumab and dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 4 sitesin 3 countries
- Study dates
- Apr 2008to Oct 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
- score over 50 on the 0-100 VAS pain scale
- acute, confirmed gout flare for no longer than 3 days
Who cannot join
- Treatment with biological anti-tumor necrosis factor (anti-TNF) within the past 3 months
- Anti-inflammatory medication for the treatment of acute gout within the previous 24 hours
- Pregnant or breastfeeding women
- Major surgery with high infection risk
- History of severe allergy to food or drugs
- History or risk of tuberculosis
- Active infection
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
United States2 sites
Novartis Investigator Site
Birmingham, Alabama, 35249
Novartis Investigator Site
New Brunswick, New Jersey, 08901
About this study
Official title: A Randomized, Double-blind, Double-dummy, Active-controlled, Parallel Group Study of a Single Dose of ACZ885 in Hospitalized Patients With Acute Gout
This is an exploratory proof-of-concept study to evaluate the safety and efficacy of canakinumab (ACZ885) for inflammation and pain associated with acute gouty arthritis.
- Conditions
- Arthritis, Gouty
- Being tested
- canakinumab, dexamethasone, placebo matching canakinumab, placebo matching dexamethasone
- Keywords
- Arthritis Gouty, ACZ885, IL1B protein, Pain
- Medical subject headings
- Arthritis, Gouty, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
canakinumabBiological
Also called ACZ885, Ilaris®
10 mg/kg intravenous infusion 250 mL over 2 hours.
dexamethasoneDrug
12 mg intravenous infusion 50 mL over 30 minutes.
placebo matching canakinumabOther
5% glucose in water intravenous infusion.
placebo matching dexamethasoneOther
Placebo intravenous infusion.
| Study group | Role | What they receive |
|---|---|---|
| Canakinumab | Experimental | Canakinumab 10 mg/kg intravenous infusion and placebo matching dexamethasone intravenous infusion on Day 1. Receives: Biological: canakinumab; Other: placebo matching dexamethasone |
| Dexamethasone | Active comparator | Dexamethasone 12 mg intravenous infusion and placebo matching canakinumab on Day 1. Receives: Drug: dexamethasone; Other: placebo matching canakinumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Improvement in Gout at 72 Hours Post-dose Using a Likert Scale
72 hours following treatment, patients were asked the question: "How would you rate the improvement in your gout since receiving the study medication?" Patients rated their improvement on the Likert 5-point scale: 1=Excellent, 2=Good, 3=Acceptable,4=Slight and 5=Poor. Improvement was assessed by determining patients who scored a "good" or "excellent" response.
Measured: 72 hours
Secondary outcomes (9)
Non-inferiority of a Single Dose of Canakinumab Compared to Dexamethasone During Treatment Period
Measured: 72 hours
Time to Recurrence of the Symptoms of Acute Gout (if Applicable) During Treatment Period
Time to recurrence is defined as from the point of improvement (good to excellent on Likert scale) to recurrence.
Measured: 4 months
Time to Walk Independently (if Applicable) During Treatment Period
Measured: 4 months
Number of Participants With Discontinuation of Treatment Due to Adverse Events, Deaths or Serious Adverse Events During the Study
Additional safety information can be found in the Adverse Event section.
Measured: 4 months
Change in C-reactive Protein (CRP) From Baseline at Month 4
Blood was collected at Baseline and Month 4 for CRP to identify the presence of inflammation, to determine its severity, and to monitor response to treatment. A negative change from baseline indicates improvement.
Measured: Baseline, Month 4
Change in Serum Amyloid A Protein (SAA) From Baseline at Month 4
Blood was collected at Baseline and Month 4 for SAA to identify the presence of inflammation, to determine its severity, and to monitor response to treatment. A negative change from baseline indicates improvement.
Measured: Baseline, Month 4
ACZ885 (Canakinumab) Pharmacokinetics (PK) Serum Concentration During the Treatment Period
Blood was collected for ACZ885 (canakinumab) levels at baseline and Days 0.25, 1, 3, 6, 20, 34, 55 and 119. Serum was analyzed by means of a competitive Enzyme linked immunosorbant assay (ELISA).
Measured: Baseline, Days 0.25, 1, 3, 6, 20, 34, 55 and 119
Change From Baseline in Pain Using a Visual Analog Scale at Month 4
Patients rated their pain on a 100 millimeter (mm) visual analog scale, ranging from no pain (0) to unbearable pain (100). A negative change from baseline indicates improvement.
Measured: Baseline, Month 4
Number of Patients Who Took Rescue Medication
Patients who did not improve by 72 hours post-dose (i.e. patients who show a pain Visual Analog (VAS) decrease of less than 50 % from baseline (Day 1, pre-dose) would have been treated with rescue medication of methylprednisolone 80 mg intravenous or intramuscular once at the discretion of the clinical investigator.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2008 (estimated)
- Study startApr 2008
- Primary completionOct 2009
- Study completionOct 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.
- Other trials for Arthritis, GoutyStudies 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
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis, Principal investigator, Novartis investigator site
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00663169
- Sponsor's protocol ID
- CACZ885A2212
- Status last verified
- Dec 2012
- First submitted
- 18 Apr 2008
- Last updated
- 7 Jan 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Double-dummy, Active-controlled, Parallel Group Study of a Single Dose of ACZ885 in Hospitalized Patients With Acute Gout
- ClinicalTrials.gov ID
- NCT00663169
- Acronym / sponsor ID
- CACZ885A2212
- Conditions
- Arthritis, Gouty
- Keywords
- Arthritis Gouty, ACZ885, IL1B protein, Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 22 Apr 2008 (estimated)
- Results
- Posted 7 Jan 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an exploratory proof-of-concept study to evaluate the safety and efficacy of canakinumab (ACZ885) for inflammation and pain associated with acute gouty arthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Canakinumab | Experimental | Biological: canakinumab, Other: placebo matching dexamethasoneCanakinumab 10 mg/kg intravenous infusion and placebo matching dexamethasone intravenous infusion on Day 1. |
| Dexamethasone | Active comparator | Drug: dexamethasone, Other: placebo matching canakinumabDexamethasone 12 mg intravenous infusion and placebo matching canakinumab 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 (2 listed)
- score over 50 on the 0-100 VAS pain scale
- acute, confirmed gout flare for no longer than 3 days
Key exclusion criteria (8 listed)
- Treatment with biological anti-tumor necrosis factor (anti-TNF) within the past 3 months
- Anti-inflammatory medication for the treatment of acute gout within the previous 24 hours
- Pregnant or breastfeeding women
- Major surgery with high infection risk
- History of severe allergy to food or drugs
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 |
|---|---|---|
| canakinumabAlso: ACZ885, Ilaris®10 mg/kg intravenous infusion 250 mL over 2 hours. | Biological | Canakinumab |
| dexamethasone12 mg intravenous infusion 50 mL over 30 minutes. | Drug | Dexamethasone |
| placebo matching canakinumab5% glucose in water intravenous infusion. | Other | Dexamethasone |
| placebo matching dexamethasonePlacebo intravenous infusion. | Other | Canakinumab |
Primary outcome
Percentage of Participants With Improvement in Gout at 72 Hours Post-dose Using a Likert Scale
Time frame: 72 hours
72 hours following treatment, patients were asked the question: "How would you rate the improvement in your gout since receiving the study medication?" Patients rated their improvement on the Likert 5-point scale: 1=Excellent, 2=Good, 3=Acceptable,4=Slight and 5=Poor. Improvement was assessed by determining patients who scored a "good" or "excellent" response.
9 secondary outcomes
Non-inferiority of a Single Dose of Canakinumab Compared to Dexamethasone During Treatment Period
Time frame: 72 hours
Time to Recurrence of the Symptoms of Acute Gout (if Applicable) During Treatment Period
Time frame: 4 months
Time to Walk Independently (if Applicable) During Treatment Period
Time frame: 4 months
Number of Participants With Discontinuation of Treatment Due to Adverse Events, Deaths or Serious Adverse Events During the Study
Time frame: 4 months
Change in C-reactive Protein (CRP) From Baseline at Month 4
Time frame: Baseline, Month 4
Change in Serum Amyloid A Protein (SAA) From Baseline at Month 4
Time frame: Baseline, Month 4
ACZ885 (Canakinumab) Pharmacokinetics (PK) Serum Concentration During the Treatment Period
Time frame: Baseline, Days 0.25, 1, 3, 6, 20, 34, 55 and 119
Change From Baseline in Pain Using a Visual Analog Scale at Month 4
Time frame: Baseline, Month 4
Number of Patients Who Took Rescue Medication
Time frame: 4 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2013.
- 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 principal investigator
Novartis investigator site
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing canakinumab and dexamethasone in people with Arthritis, Gouty, run by Novartis at 4 sites in 3 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 7 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Switzerland, United Kingdom. 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 7 Jan 2013). 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?
Percentage of Participants With Improvement in Gout at 72 Hours Post-dose Using a Likert Scale (time frame: 72 hours). 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 7 Jan 2013.