Wpływ upadacytynibu na częstotliwość występowania ostrego zapalenia przedniego odcinka błony naczyniowej oka u pacjentów ze spondyloatropatią osiową

Kryteria włączenia kto może wziąć udział (16)

1. Subject is ≥18 years of age at the screening visit.
2. 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.
3. For nr-axSpA subjects: must have objective signs of inflammation (elevated CRP and/or positive MRI) based on standard-of-care.
4. 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.
5. 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.
6. Subjects on csDMARDs must discontinue and wash out for ≥28 days prior to baseline.
7. If on bDMARD at screening, must undergo appropriate washout per local SOC.
8. Able to understand, willing to adhere to protocol requirements, and provides written informed consent before any study procedures.
9. Diagnosis of axial spondyloarthritis (axSpA) by a treating rheumatologist.
10. Classification of axSpA according to the 2009 ASAS Classification Criteria.
11. 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)
12. Historical documentation of AAU by an ophthalmologist at any time in the past.
13. 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.
14. Inadequate response to ≥2 different NSAIDs over at least 4 weeks total at maximum tolerated doses, or documented intolerance/contraindication to NSAIDs.
15. Mixed population of: bDMARD-naïve subjects, and bDMARD-inadequate responders (bDMARD-IR) or bDMARD-intolerant subjects.
16. Any condition that, in the opinion of the investigator, would make the subject unsuitable for participation in the study.