U3P study - Upadacitinib in Psoriatic Arthritis Pain Processing

Prior treatment

• Prior exposure to any Janus kinase (JAK) inhibitor
• Uncontrolled severe concomitant disease
• Requirement for immunization with live vaccine during the trial period or within 4 weeks preceding baseline
• Investigational study drug within 4 weeks (or 5 half-lives, whichever is longer) prior to enrollment
• Anti-CCP- Antibody positivity
• Any severe active infection, e.g. hepatitis B or C, SARS-CoV 2 (COVID 19), or active tuberculosis as defined by a positive Quantiferon TB-test. If presence of latent tuberculosis is established then treatment according to local guidelines must have been initiated prior to enrollment
• Have a known history of serious infections (e.g., hepatitis, pneumonia, or pyelonephritis) in the previous 3 months

Other illness

• Known hypersensitivity to upadacitinib or any other drug components
• History of venous thrombosis or pulmonary embolism, inherited coagulation disorder, planned major surgery, immobilisation
• History of atherosclerotic cardiovascular disease or other cardiovascular risk factors
• Clinically significant cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, neurologic, gastrointestinal, immunologic, or other major diseases
• Have a history of alcohol or substance abuse within the preceding 6 months that, in the opinion of the investigator, may increase the risks associated with study participation or study agent administration, or may interfere with interpretation of results
• Any other autoimmune or inflammatory disease such as SLE, PSS, MCTD, Behcet disease, vasculitis or autoimmune hepatitis
• malignancy risk factors (e.g. current malignancy or history of malignancy)

Lab values

• Evidence of severe renal dysfunction defined as: eGFR < 30 ml/min/1,73 m2 (calculated using the CKD-EPI formula) at screening (Visit 1)
• Abnormal liver function tests such as GOT (AST), GPT (ALT), alkaline phosphatase or bilirubin. The investigator should be guided by the following criteria: o GOT, GPT, alkaline phosphatase: any single parameter may not exceed 3x upper limit of normal (ULN). A single parameter elevated up to and including 3x ULN should be re-checked once more as soon as possible. o Total bilirubin: if total bilirubin concentration is increased above 2x ULN, total bilirubin should be differentiated into direct and indirect reacting bilirubin. In any case, serum bilirubin should not exceed the value of 1,6mg/dl (exemption: the diagnose of gilbert´s syndrome has already been established or based on higher levels of unconjugated bilirubin without either signs of other liver problems or red blood cell breakdown can be made)
• Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study
• ANC < 1.000/mm3, ALC < 500/mm3 or hemoglobin < 8g/dl

Age

• Patients who are younger than 18 years or are incapable to understand the aim, importance and consequences of the study and to give legal informed consent

Other

• Immunocompromised patients
• Pregnant or lactating females
• Current of past long-time smokers
• Any contraindication to perform MRI

• Patients fulfilling CASPAR criteria for PsA
• Must be able to adhere to the study visit schedule and other protocol requirements
• Male subjects (including those who have had a vasectomy) must agree to use barrier contraception (latex condoms) when engaging in reproductive sexual activity with females of childbearing potential (FCBP) while on study medication and for at least 28 days after taking the last dose of study medication
• Females of childbearing potential (FCBP) must have a negative urine pregnancy test at baseline and must be willing to use one highly-effective form of birth control when engaging in reproductive sexual activity while on study medication and for at least 28 days after taking the last dose of study medication
• Subjects must have active hand joint involvement (at least one swollen/tender joint)
• Indication for systemic treatment
• Subjects who failed to respond to or are intolerant to at least one csDMARD
• Subjects who were not exposed to more than one bDMARD before; for bDMARDs the wash-out period should be at least three times the half-life of the bDMARD concerned
• Eligibility for the treatment with Upadacitinib according to the EU label
• Glucocorticoids less than 10mg/day will be allowed
• Must understand and voluntarily sign an informed consent form including written consent for data protection
• Adults aged ≥ 18 years and <65 years at time of consent