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Impact Of Upadacitinib On The Frequency Of Acute Recurrent Anterior Uveitis In Patients With Axial Spondyloarthritis
EU CTIS ID: 2025-522118-21-00
What this study is testing
To evaluate the impact of upadacitinib on the frequency of recurrent acute anterior uveitis (AAU) over 52 weeks in subjects with active axial spondyloarthritis (axSpA) and a prior AAU event in the 104 weeks prior to baseline, who are switching from bDMARDs (in North America and Europe), or who are bDMARD-naïve (in Europe), in real-world practice.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Subject is ≥18 years of age at the screening visit.
- Classification of axSpA according to the 2009 ASAS Classification Criteria.
- History of at least one acute anterior uveitis (AAU) event in the 104 weeks prior to baseline, diagnosed by an ophthalmologist (or optometrist/rheumatologist as necessary)
- Historical documentation of AAU by an ophthalmologist at any time in the past.
- Active axSpA disease, defined by: BASDAI ≥ 4, and Total Back Pain (TBP) ≥ 4 on a 0–10 numerical rating scale at both screening and baseline.
- Inadequate response to ≥2 different NSAIDs over at least 4 weeks total at maximum tolerated doses, or documented intolerance/contraindication to NSAIDs.
You likely can't join if
- Subject with chronic inflammatory articular disease (other than axSpA or systemic autoimmune diseases)
- History of major adverse cardiovascular event (MACE), including but not limited to myocardial infarction and cerebrovascular accident
- Clinically significant laboratory abnormalities at screening (e.g., hemoglobin < 9 g/dL, ALT or AST > 2 × ULN, eGFR < 30)
- Positive pregnancy test at screening or baseline.
- Any gastrointestinal condition or surgical history that could interfere with the absorption of oral medication.
- Subject who is breastfeeding or planning pregnancy during the study or within 30 days after the last dose.
See the full eligibility criteria
- Subject is ≥18 years of age at the screening visit.
- Classification of axSpA according to the 2009 ASAS Classification Criteria.
- History of at least one acute anterior uveitis (AAU) event in the 104 weeks prior to baseline, diagnosed by an ophthalmologist (or optometrist/rheumatologist as necessary)
- Historical documentation of AAU by an ophthalmologist at any time in the past.
- Active axSpA disease, defined by: BASDAI ≥ 4, and Total Back Pain (TBP) ≥ 4 on a 0–10 numerical rating scale at both screening and baseline.
- Inadequate response to ≥2 different NSAIDs over at least 4 weeks total at maximum tolerated doses, or documented intolerance/contraindication to NSAIDs.
- Mixed population of: bDMARD-naïve subjects, and bDMARD-inadequate responders (bDMARD-IR) or bDMARD-intolerant subjects.
- Any condition that, in the opinion of the investigator, would make the subject unsuitable for participation in the study.
- Treatment history requirements by region: Europe: may be bDMARD-naïve (up to 100 subjects) or bDMARD-IR/intolerant. USA: must have received TNFi and be a TNFi-inadequate responder or intolerant. Canada: must have previously received a bDMARD and be bDMARD-IR or intolerant.
- For nr-axSpA subjects: must have objective signs of inflammation (elevated CRP and/or positive MRI) based on standard-of-care.
- Contraception/pregnancy-related requirements for females of childbearing potential: Negative serum pregnancy test at screening and negative urine pregnancy test at baseline. Must use protocol-specified birth control methods from Day 1 through at least 30 days after the last dose. Must not be pregnant, breastfeeding, or planning pregnancy during study and for 30 days after last dose.
- Stable doses required before baseline for the following medications: NSAIDs or analgesics (including low-potency opioids) for ≥7 days. Oral corticosteroids (≤10 mg prednisone equivalent/day) for ≥14 days.
- Subjects on csDMARDs must discontinue and wash out for ≥28 days prior to baseline.
- If on bDMARD at screening, must undergo appropriate washout per local SOC.
- Able to understand, willing to adhere to protocol requirements, and provides written informed consent before any study procedures.
- Diagnosis of axial spondyloarthritis (axSpA) by a treating rheumatologist.
- Subject with chronic inflammatory articular disease (other than axSpA or systemic autoimmune diseases)
- History of major adverse cardiovascular event (MACE), including but not limited to myocardial infarction and cerebrovascular accident
- Clinically significant laboratory abnormalities at screening (e.g., hemoglobin < 9 g/dL, ALT or AST > 2 × ULN, eGFR < 30)
- Positive pregnancy test at screening or baseline.
- Any gastrointestinal condition or surgical history that could interfere with the absorption of oral medication.
- Subject who is breastfeeding or planning pregnancy during the study or within 30 days after the last dose.
- History of hypersensitivity to upadacitinib or any of its components
- Primary or secondary immunodeficiency
- Previous exposure to upadacitinib or other Janus kinase (JAK) inhibitors
- Use of any investigational drug or device within 30 days or five half-lives (whichever is longer) prior to baseline.
- Use of systemic immunosuppressants (e.g., methotrexate, azathioprine, cyclosporine) within 28 days prior to baseline.
- Evidence of active, serious, or chronic infection, including localized infections.
- Known history of, or active, tuberculosis (TB), or latent TB without completion of adequate anti-TB therapy prior to baseline.
- Chronic infection of human immunodeficiency virus (HIV), hepatitis B, hepatitis C, or other clinically significant viral infection.
- Current or recent (within 5 years) malignancy, except for adequately treated non-melanoma skin cancer or in situ cervical cancer.
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.