Impact Of Upadacitinib On The Frequency Of Acute Recurrent Anterior Uveitis In Patients With Axial Spondyloarthritis

1. Active infection(s) requiring treatment with parenteral anti-infectives within 30 days, or oral antiinfectives within 14 days prior to the baseline Visit; Chronic recurring infection and/or active viral infection that based on the investigator's clinical assessment makes the subject an unsuitable candidate for the study.

2. COVID-19: In subjects who tested positive for COVID-19, at least 5 days must have passed between a COVID-19 positive test result and the Baseline visit of asymptomatic subjects. Subjects with mild/moderate COVID-19 infection can be enrolled if fever is resolved without use of antipyretics for 24 hours and other symptoms improved, or if 5 days have passed since the COVID-19 positive test result (whichever comes last). Subjects may be rescreened if deemed appropriate by the investigator based upon the subject's health status

3. Suspected COVID-19: subjects with signs/symptoms suggestive of COVID-19, known exposure, or high-risk behavior should undergo molecular (e.g., PCR) testing to rule out SARS-CoV-2 infection or must be asymptomatic for 5 days from a potential exposure;

4. History of recurrent (more than one episode) herpes zoster or disseminated/multi-dermatomal (a single episode) herpes zoster or disseminated (a single episode) herpes simplex.

5. Primary or secondary immunodeficiency.

6. Subjects with active TB or who meet TB exclusionary parameters (specific requirements for TB testing are provided in Section 7.0: TB Testing/TB Prophylaxis)

7. Chronic infection with hepatitis B virus. At screening HBsAg and anti-HBc will be tested. Subjects who are HBsAg positive will be excluded. In case of HBsAg negativity, but anti-HBc positivity, participation in the study is possible if HBV-DNA testing is negative and no exclusionary liver function tests.

8. Chronic infection with hepatitis C (HCV) (HCV ribonucleic acid (RNA) detectable in any subject with anti-HCV antibody (HCV Ab), or Human Immunodeficiency Virus (HIV) infection confirmed by positive HIV-antibody and antigen test.

9. Female subjects who are breastfeeding, pregnant, or plan to become pregnant during the study or within 4 weeks following the last dose of study drug.

10. Subjects with chronic inflammatory articular disease (other than axSpA or systemic autoimmune diseases, e.g., systemic lupus erythematosus, Sjögren´s syndrome, RA, unequivocal chronic fatigue syndrome, or unequivocal fibromyalgia. Subjects with a diagnosis of Crohn's disease or ulcerative colitis are allowed as long as they have no active symptomatic disease within 4 weeks prior to BL.

11. Concomitant treatment with strong inductors or inhibitors of cytochrome P450 3A (e.g., Ketoconazole, Fluconazole, Rifampicin, Clarithromycin, St-John´s-wort).

12. Prior treatment with upadacitinib or another JAK-inhibitor or TYK2-inhibitor for axSpA.

13. History of hypersensitivity to any component of upadacitinib tablets.

14. Treatment with intravenous, intramuscular or intraarticular/periarticular, or intrarectal steroids within 4 weeks prior to baseline Visit; treatment with oral steroids in a dose of \>10 mg prednisolone equivalent per day within 4 weeks prior to baseline visit.

15. Subject must not have been treated with any investigational drug of chemical or biologic nature within a minimum of 30 days or five half-lives (whichever is longer) prior to the first dose of study drug or is currently enrolled in another interventional clinical study.

16. History of an infected joint prosthesis at any time, with the prosthesis still in situ.

17. Actual malignancies or history of malignancies with curative treatment within 5 years prior to screening, except successfully treated non-metastatic squamous cell or basal cell carcinoma of the cutis or carcinoma in situ of the cervix.

18. A subject with any condition possibly affecting oral drug absorption, e.g., gastrectomy, clinically significant diabetic gastroenteropathy, or certain types of bariatric surgery such as gastric bypass. Procedures such as gastric banding, that simply divides the stomach into separate chambers, are NOT exclusionary.

19. Significant trauma or surgery procedure within 4 weeks prior to baseline.

20. Evidence of other severe uncontrolled gastrointestinal, hepatic (serum albumin \<25 mg/l or ChildPugh-Score \>10), renal, pulmonary, cardiovascular, nervous or endocrine disorders.

21. Any history of prior cardiovascular event, including but not limited to cerebrovascular accident, myocardial infarction, coronary stenting, and aorto-coronary bypass surgery.

22. History of thrombosis and/or hematological disorder increasing the propensity to thrombosis.

23. Any subject who has been vaccinated with live or attenuated vaccines within the 4 weeks prior to the first dose of study medication or is to be vaccinated with these vaccines at any time during treatment or within 4 weeks after the last dose of study drug.

24. Any of the following lab abnormalities detected at screening: a) Hemoglobin \<9 g/dl; b) Absolute neutrophil count (ANC) \<1.2 x 109/L (\<1020/mm3) c) Absolute lymphocyte count (ALC) \<0.750 x 109/L (\<750/mm3) d) Platelet count \<9 g/dL e) Liver function tests (LFT) \>2 x ULN f) Serum apartate transaminase (AST) \>2 x ULN g) Serum alanine transaminase (ALT) \>2 x ULN; h) Estimated glomerular filtration rate (GFR) by simplified 4-variable MDRD formula \< 30 mL/min/1.73 m2; i) Total white blood cell (WBC) count \< 2,500/μL

Impact Of Upadacitinib On The Frequency Of Acute Recurrent Anterior Uveitis In Patients With Axial Spondyloarthritis

What this study is about

Impact Of Upadacitinib On The Frequency Of Acute Recurrent Anterior Uveitis In Patients With Axial Spondyloarthritis

What this study is about