Phase 4 Ankylosing Spondylitis Trial, Completed NCT02509026 Sponsor: Pfizer Condition: Ankylosing Spondylitis
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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 (NCT02509026) enrolled 210 people with ankylosing spondylitis (a type of inflammatory spine condition) and followed them through up to three stages. All participants received etanercept, a medicine given by injection, for 24 weeks (the "induction" period). Those whose disease activity reached a low level then had the medicine withdrawn for up to 40 weeks (the "withdrawal" period), and those whose condition worsened during that time were offered 12 weeks of retreatment. The trial was primarily measuring how many people experienced a "flare" — a return of significant disease activity — after the medicine was stopped. The reported data shows that, of the 119 participants who entered the withdrawal period after stopping etanercept, 74.8% experienced a flare within 40 weeks. The reported median time to flare — that is, the point by which half of those who flared had done so — was around 16.1 weeks after stopping the medicine. The trial also tracked a disease activity score (called ASDAS-CRP, a combined measure of symptoms and a blood marker) at multiple time points. The reported data shows that, during the treatment period, the proportion of participants recorded as having low disease activity on this score rose from less than 1% at the start to around 62.6% by week 24. During the withdrawal period those proportions varied across visits, and during the retreatment period roughly 53–62% of participants were recorded in the low disease activity range at the time points measured. 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 4 Ankylosing Spondylitis Trial, Completed

NCT02509026
Completed Phase 4 🇦🇺 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 axial spondyloarthritis (a type of inflammatory back condition affecting the spine)
  • Your symptoms have lasted more than 3 months but less than 5 years
  • You have back pain that has not improved enough with anti-inflammatory painkillers (such as ibuprofen or naproxen)

Who may not be able to join:

  • You have visible joint damage in the sacroiliac joints (the joints at the base of your spine) shown on an X-ray
  • You have previously been treated with certain types of medications that target the immune system, including TNF inhibitors, biologics, or immunosuppressive drugs (confirm with trial site)

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 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

Contact this trial

Principal Investigator: Pfizer CT.gov Call Center, Pfizer

Australian sites

Genesis Research Services Pty Ltd, Broadmeadow, New South Wales
Hunter Imaging Group, Cardiff, New South Wales
Pacific Radiology, Maroochydore, Queensland
Rheumatology Research Centre, Maroochydore, Queensland
Benson Radiology, North Adelaide, South Australia
The Queen Elizabeth Hospital, Woodville South, South Australia
SKG Radiology Hollywood Hospital, Nedlands, Western Australia
SKG Radiology Subiaco, Subiaco, Western Australia
R.K. Will Pty Ltd, Victoria Park, Western Australia

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

GP referral letter

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Trial details

Status
Completed
Phase
Phase 4
Sponsor
Registry
ClinicalTrials.gov
Start date
24 September 2015
Est. completion
28 May 2019

Where this trial is recruiting

🇦🇺 Australia 🇧🇪 Belgium 🇨🇴 Colombia 🇨🇿 Czechia 🇫🇮 Finland 🇫🇷 France 🇩🇪 Germany 🇭🇺 Hungary 🇳🇱 Netherlands 🇵🇱 Poland 🇪🇸 Spain 🇸🇪 Sweden 🇹🇼 Taiwan 🇺🇸 United States

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

Primary endpoints

Percentage of Participants Who Experienced Flare Within 40 Weeks Following Withdrawal of 24 Weeks of Etanercept Treatment

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