Impact Of Upadacitinib On The Frequency Of Acute Recurrent Anterior Uveitis In Patients With Axial Spondyloarthritis (UP-FOR-U)

Conditions

Acute Anterior Uveitis, Axial Spondyloarthritis

Brief summary

Change in exposure-adjusted opthalmologist (or optometrist or rheumatologist)-diagnosed AAU event rate per 100 patient years (EAER) over 52 weeks on upadacitinib compared to the AAU EAER in the 104 week pre-study period, separately in bDMARD-naive and bDMARD experienced groups.

Detailed description

Percentage of Participants Achieving Ankylosing Spondylitis Disease Activity Score Low Disease Activity (ASDAS LDA [< 2.1]) at week 24 in (i) bDMARD-IR (ii) bDMARD-naive groups, Percentage of participants Achieving Ankylosing Spondylitis Disease Activity Score Low Disease Activity (ASDAS LDA [< 2.1]) at weeks 24 and 52 in (i) bDMARD-IR; (ii) bDMARD-naive groups, Percentage of Participants Achieving Assessment of Spondyloarthritis International Society Health Index (ASAS-HI) Score of less than or equal to 5, up to week 52 in (i) bDMARD-IR; (ii) bDMARD-naive groups, Incidence of Adverse Events (AEs) and Adverse Events of Special Interest (AESIs), AEs and AESIs leading to withdrawal from study drug, and serious AEs (SAEs).

Related papers

No related papers found yet.

Interventions

DRUGRINVOQ 15 mg prolonged-release tablets

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Change in exposure-adjusted opthalmologist (or optometrist or rheumatologist)-diagnosed AAU event rate per 100 patient years (EAER) over 52 weeks on upadacitinib compared to the AAU EAER in the 104 week pre-study period, separately in bDMARD-naive and bDMARD experienced groups.	—

Secondary

Measure	Time frame
Percentage of Participants Achieving Ankylosing Spondylitis Disease Activity Score Low Disease Activity (ASDAS LDA [< 2.1]) at week 24 in (i) bDMARD-IR (ii) bDMARD-naive groups, Percentage of participants Achieving Ankylosing Spondylitis Disease Activity Score Low Disease Activity (ASDAS LDA [< 2.1]) at weeks 24 and 52 in (i) bDMARD-IR; (ii) bDMARD-naive groups, Percentage of Participants Achieving Assessment of Spondyloarthritis International Society Health Index (ASAS-HI) Score of less than or equal to 5, up to week 52 in (i) bDMARD-IR; (ii) bDMARD-naive groups, Incidence of Adverse Events (AEs) and Adverse Events of Special Interest (AESIs), AEs and AESIs leading to withdrawal from study drug, and serious AEs (SAEs).	—

Measure

Time frame

Percentage of Participants Achieving Ankylosing Spondylitis Disease Activity Score Low Disease Activity (ASDAS LDA [< 2.1]) at week 24 in (i) bDMARD-IR (ii) bDMARD-naive groups, Percentage of participants Achieving Ankylosing Spondylitis Disease Activity Score Low Disease Activity (ASDAS LDA [< 2.1]) at weeks 24 and 52 in (i) bDMARD-IR; (ii) bDMARD-naive groups, Percentage of Participants Achieving Assessment of Spondyloarthritis International Society Health Index (ASAS-HI) Score of less than or equal to 5, up to week 52 in (i) bDMARD-IR; (ii) bDMARD-naive groups, Incidence of Adverse Events (AEs) and Adverse Events of Special Interest (AESIs), AEs and AESIs leading to withdrawal from study drug, and serious AEs (SAEs).

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Outcome results

None listed