Phase 3 Gout Trial, Completed NCT01029652 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 compared two treatments for gout flares: canakinumab (150 mg) and triamcinolone acetonide (a steroid injection, 40 mg). A total of 115 people were enrolled in each group — 230 participants altogether — for the initial 12-week period, with smaller numbers continuing into two follow-up periods extending out to 72 weeks. The trial was measuring how quickly pain eased after treatment, how many participants went on to have new gout flares, and how long it took before any new flare occurred. The reported data shows that, when looking at how long it took for participants to experience at least a 50% reduction in their worst joint pain, the canakinumab group reached that point at a median (midpoint of the group) of 48 hours, compared with 72 hours in the steroid group. For complete disappearance of pain over time, the median time was not able to be calculated for either group — meaning not enough participants in either group fully reached zero pain during the measurement window. By the end of 12 weeks, about 34.5% of canakinumab participants and 31.3% of steroid participants had reported complete resolution of pain at some point. Regarding new gout flares during those 12 weeks, the reported data shows approximately 18.6% of the canakinumab group experienced at least one new flare, compared with 34.8% in the steroid group. The average number of new flares per person over 12 weeks was reported as 0.21 in the canakinumab group and 0.53 in the steroid group. The time-to-first-new-flare figures were also not able to be calculated from the data submitted. 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

NCT01029652
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 have been diagnosed with acute gout according to a standard set of medical classification rules (confirm with trial site)
  • Your current gout flare started within the last 5 days before joining the study
  • Your pain level is at least 50 out of 100 on a pain rating scale at the start of the study
  • You have had 3 or more gout flares in the 12 months before joining the study
  • You cannot take common anti-inflammatory medicines (such as NSAIDs) or colchicine because they don't work for you, you can't tolerate them, or they are not safe for you to use

Who may not be able to join:

  • You have rheumatoid arthritis, a joint infection, or another type of inflammatory joint condition
  • You have severely reduced kidney function
  • You have recently used certain pain relief or immune-system medicines, including steroids, strong painkillers, ibuprofen, paracetamol/acetaminophen, colchicine, or certain biological medicines (confirm specific timeframes with trial site)
  • You have received a live vaccine in the 3 months before joining the study
  • You need antibiotics to treat latent (inactive) tuberculosis
  • You have severe, advanced heart failure
  • You have unstable heart rhythm problems or unstable reduced blood flow to the heart
  • You currently have or frequently get bacterial, fungal, or viral infections
  • You were unable to complete an earlier part of the study (applies to the follow-on study stages only)
  • Your doctor feels it would not be appropriate for you to continue into the follow-on study stages

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
Novartis Investigative Site, Fitzroy, Victoria
Novartis Investigative Site, Heidelberg, Victoria
Novartis Investigative Site, Daw Park SA,

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 December 2009
Est. completion
1 October 2010

Where this trial is recruiting

🇦🇺 Australia 🇧🇪 Belgium 🇨🇦 Canada 🇨🇴 Colombia 🇪🇪 Estonia 🇩🇪 Germany Guatemala 🇱🇻 Latvia 🇱🇹 Lithuania 🇲🇽 Mexico 🇳🇴 Norway 🇵🇱 Poland 🇷🇺 Russia 🇸🇬 Singapore 🇸🇪 Sweden 🇨🇭 Switzerland 🇺🇦 Ukraine

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

Primary endpoints

Time to First New Flare; Self-assessed Pain Intensity in the Joint Most Affected at Baseline Measured on a Visual Analog Scale (0-100mm VAS); Number of Participants With Adverse Events (AE), Death and Serious Adverse Events (24 Weeks Overall); Number of Participants With Adverse Events (AE), Death and Serious Adverse Events (72 Weeks Overall)

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