Phase 4 Uveitis Trial, Completed NCT03020992 Sponsor: UCB Biopharma SRL Condition: Uveitis
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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 (NCT03020992) enrolled 89 people, all of whom received the medicine certolizumab pegol. All participants had active axial spondyloarthritis (a type of inflammatory spinal condition) and a history of anterior uveitis — a painful inflammation at the front of the eye. Eighty-three of the 89 participants completed the study. The trial was mainly measuring how often eye flare-ups (new episodes of anterior uveitis requiring treatment from an eye specialist) occurred during the treatment period. The reported data shows that, looking at the primary outcome, participants experienced an average of 1.9 eye flare-ups before the treatment period, compared with 0.3 during it. For the secondary outcomes, the rate of eye flare-ups was reported as 132.72 flares per 100 patient-years (a way of counting events across the whole group over time) before treatment began, dropping to 18.56 flares per 100 patient-years by week 48, and 17.67 per 100 patient-years by week 96. The reported data shows the same figures applied to the subgroup of participants who had experienced at least one flare-up in the 12 months before the study started. A separate secondary measure tracked overall disease activity using a scoring tool called the ASDAS; the reported data shows an average change of −1.55 points from the start of the study to week 48, where a negative number indicates a lower score (noting that context for interpreting this scale was not fully reported in the submitted data). 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 Uveitis Trial, Completed

NCT03020992
Completed Phase 4

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 spinal arthritis) as an adult, with symptoms lasting at least 3 months, and your diagnosis meets specific international criteria
  • Your disease is currently active, shown by a symptom score of 4 or higher on a standard disease activity questionnaire (BASDAI), and spinal pain rated at least 4 out of 10
  • If you have the non-X-ray confirmed type of the condition, your blood tests show raised inflammation levels and/or an MRI scan shows inflammation in your lower back/pelvis joints
  • If you have the X-ray confirmed type (Ankylosing Spondylitis), your X-rays show specific joint damage in your pelvis area meeting recognised criteria
  • You have a documented history of Anterior Uveitis (inflammation at the front of the eye) diagnosed by an eye doctor, with at least 2 flare-ups in the past, and at least 1 of those flare-ups happened within the last 12 months

Who may not be able to join:

  • You have another type of inflammatory joint disease in addition to your diagnosis
  • You have another non-inflammatory condition that, in the doctor's opinion, could make it hard to assess how well the study treatment is working
  • You have had any type of eye inflammation (uveitis) other than Anterior Uveitis linked to your spinal condition
  • You have any condition that could interfere with the assessment of your eye inflammation
  • You have received a specific long-acting steroid eye implant (Retisert® or Iluvien®) within the last 3 years, or have had complications from one
  • You have had a Retisert® or Iluvien® implant removed within the last 90 days
  • You have received steroid injections in or around the eye within the last 90 days
  • You have received a dexamethasone eye implant (Ozurdex®) within the last 6 months
  • You have taken a medication called cyclophosphamide within the last 30 days
  • You have received methotrexate injected directly into the eye within the last 90 days
  • You have received anti-VEGF therapy injected directly into the eye (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.

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Trial details

Status
Completed
Phase
Phase 4
Sponsor
UCB Biopharma SRL
Registry
ClinicalTrials.gov
Start date
21 December 2016
Est. completion
4 December 2019

Where this trial is recruiting

🇨🇿 Czechia 🇩🇪 Germany 🇳🇱 Netherlands 🇵🇱 Poland 🇪🇸 Spain

Primary endpoints

Number of Distinct Episodes of Anterior Uveitis (AU) Flares During the Treatment Period

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