Phase 3 Gout Trial, Completed NCT01470989 Sponsor: Novartis Pharmaceuticals Condition: Gout
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Trial results

AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

According to the results reported on ClinicalTrials.gov, this trial (NCT01470989) enrolled 456 people in total — 227 received a single injection of canakinumab (150 mg) and 229 received a single injection of triamcinolone acetonide (40 mg), a steroid commonly used for gout flares. The trial followed participants across a core study period and up to three extension periods over a longer timeframe. The main thing the trial was measuring was the rate of unwanted medical events (called adverse events), serious adverse events, and deaths, expressed as how often these occurred per 100 years of combined patient participation time. The reported data shows that in the canakinumab group, adverse events occurred at a rate of 873 per 100 patient-years, compared with 451 per 100 patient-years in the triamcinolone acetonide group. Serious adverse events were reported at a rate of 59 per 100 patient-years for canakinumab and 25 per 100 patient-years for triamcinolone acetonide. Deaths were reported at a rate of 2 per 100 patient-years in both groups. As a secondary measure, the reported data shows the average number of new gout flares per person over the observation period was approximately 1.1 in the canakinumab group and 2.5 in the triamcinolone acetonide group. The trial also asked participants to rate their gout pain on a simple scale; the reported data shows that 102 canakinumab retreatment participants and 72 participants from the other group rated their pain as none or mild at one timepoint, and 104 versus 69 at another timepoint, though further detail on timing was not reported in the data provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.

Phase 3 Gout Trial, Completed

NCT01470989
Completed Phase 3 🇦🇺 Australian site

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You must have already completed one of two specific earlier stages of this study (known as CACZ885H2356E2 or CACZ885H2357E2) (confirm with trial site)
  • You must have previously received treatment with the study drug, canakinumab, during the earlier parts of this research program

Who may not be able to join:

  • You cannot participate if you are currently pregnant or breastfeeding

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Australian sites

Novartis Investigative Site, Darlinghurst, New South Wales

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Completed
Phase
Phase 3
Registry
ClinicalTrials.gov
Start date
1 November 2011
Est. completion
1 May 2013

Where this trial is recruiting

🇦🇺 Australia 🇨🇦 Canada 🇪🇪 Estonia 🇩🇪 Germany 🇱🇻 Latvia 🇱🇹 Lithuania 🇷🇺 Russia 🇺🇦 Ukraine 🇺🇸 United States

1 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Number of Incidence Rate (IR) of Adverse Events, Serious Adverse Events and Death Per 100 Patient-years in Participants

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov