Could a common arthritis drug tame recurring eye inflammation?
NCT ID NCT03020992
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether certolizumab pegol (Cimzia), a drug already used for arthritis, can reduce flares of anterior uveitis—a painful eye inflammation—in people with axial spondyloarthritis who have had uveitis before. About 89 adults with active axial spondyloarthritis and a history of uveitis will receive the drug and be monitored for new eye inflammation episodes over 48 weeks. The goal is to see if the drug can prevent or reduce these flares.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- certolizumab pegol (Cimzia)
- What this could lead to
- If it works, this could offer a way to reduce painful eye inflammation flares in people with axial spondyloarthritis.
- What could go wrong
- This is a small, open-label study without a placebo group, so results may be less reliable. The drug may not work for everyone and carries risks like infection.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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89 people
The number who actually took part.
- Started
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Dec 2016
- Finished
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Jan 2020
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Subjects must have a documented diagnosis of adult-onset axial Spondyloarthritis (axSpA) with at least 3 months' symptom duration and meet the Assessment of SpondyloArthritis International Society (ASAS) criteria * Subjects must have active disease at Screening as defined by * Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score \>= 4 * Spinal pain \>= 4 on a 0 to 10 Numerical Rating Scale (NRS; from BASDAI item 2) * Nonradiographic (Nr)-axSpA subjects must either have C-reactive protein (CRP) \> upper limit of normal (ULN) and /or current evidence of sacroiliitis on magnetic resonance imaging (MRI) (no confirmation by central reading) as defined by ASAS criteria * Ankylosing spondylitis (AS) subjects must have evidence of sacroiliitis on x-ray meeting the modified New York (mNY) classification criteria according to the Investigator * Subjects must have a documented history of Anterior Uveitis (AU) diagnosed by an ophthalmologist and have at least 2 AU flares in the past, of which at least 1 AU flare was in the last 12 months prior to Baseline Exclusion Criteria: * Other inflammatory arthritis * Secondary, noninflammatory condition that, in the Investigator's opinion, is symptomatic enough to interfere with evaluation of the effect of study drug on the subject's primary diagnosis of axial spondyloarthritis (axSpA) * Any history of uveitis except for Anterior Uveitis (AU) associated with axSpA * Any condition or complicating factor that may interfere with the AU assessment * Retisert® or Iluvien® (glucocorticosteroid implant) within 3 years prior to the Baseline Visit or has had complications related to the device * Subject has had Retisert or Iluvien (glucocorticosteroid implant) removed within 90 days prior to the Baseline Visit * Intraocular or periocular corticosteroids within 90 days prior to the Baseline visit * Ozurdex® (dexamethasone implant) within 6 months prior to the Baseline Visit * Cyclophosphamide within 30 days prior to the Baseline Visit * Intravitreal methotrexate (MTX) within 90 days prior to the Baseline Visit * Intravitreal anti-vascular endothelial growth factor (VEGF) therapy
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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As0007 101
Brno, Czechia
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As0007 102
Prague, Czechia
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As0007 103
Brno, Czechia
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As0007 105
Prague, Czechia
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As0007 107
Brno, Czechia
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As0007 108
Ostrava, Czechia
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As0007 109
Pardubice, Czechia
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As0007 301
Freiburg im Breisgau, Germany
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As0007 302
München, Germany
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As0007 303
Münster, Germany
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As0007 401
Amsterdam, Netherlands
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As0007 501
Warsaw, Poland
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As0007 502
Torun, Poland
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As0007 504
Wroclaw, Poland
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As0007 505
Warsaw, Poland
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As0007 506
Bialystok, Poland
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As0007 507
Wroclaw, Poland
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As0007 508
Wroclaw, Poland
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As0007 509
Poznan, Poland
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As0007 510
Lublin, Poland
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As0007 511
Poznan, Poland
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As0007 601
Córdoba, Spain
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As0007 604
Barcelona, Spain
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