Psoriatic arthritis MedDRA version: 21.1 Level: PT Classification code 10037162 Term: Psoriatic arthropathy System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Trade Name: RINVOQ 15mg Retardtabletten
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: UPADACITINIB
Other descriptive name: UPADACITINIB
Concentration unit: mg milligram(s)
Concent
Sponsors
Universitätsklinikum Erlangen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Must understand and voluntarily sign an informed consent form including written consent for data protection Adults aged = 18 years and =65 years) yes F.1.3.1 Number of subjects for this age range 7
Exclusion criteria
Exclusion criteria: - Prior exposure to any Janus kinase (JAK) inhibitor - ANC < 1.000/mm3, ALC < 500/mm3 or hemoglobin < 8g/dl - Any contraindication to perform MRI - Anti-CCP- Antibody positivity - Any other autoimmune or inflammatory disease such as SLE, PSS, MCTD, Behcet`s disease, vasculitis or autoimmune hepatitis. - Malignancy risk factors (e.g. current malignancy or history of malignancy) - 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 - Immunocompromised patients - Uncontrolled severe concomitant disease - Pregnant or lactating females - Known hypersensitivity to upadacitinib or any other drug components - Requirement for immunization with live vaccine during the trial period or within 4 weeks preceding baseline - History of venous thrombosis or pulmonary embolism, inherited coagulation disorder, planned major surgery, immobilisation - History of atherosclerotic cardiovascular disease or other cardiovascular risk factors - Current or past long-time smokers - Clinically significant cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, neurologic, gastrointestinal, immunologic, or other major diseases - Evidence of severe renal dysfunction defined as: eGFR < 30 ml/min/1,73 m2 (calculated using the MDRD formula) at screening (Visit 1) - Evidence of severe hepatic insufficiency defined as Child-Pugh score = 10 (C) - 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 - 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 (according to § 40 Abs. 4 and § 41 Abs. 2 and Abs. 3 AMG). - 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 - Patients who possibly are dependent on the Sponsor, the Principal Investigator or Investigator (e.g. family members) - Have participated in this study before with respect to having received upadacitinib. Re-Screening is allowed once
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To describe early and long term central nervous system (CNS) pain response due to blood oxygenation level dependent (BOLD) signal changes in fMRI of the brain to upadacitinib treatment in psoriatic arthritis;Secondary Objective: To identify biomarkers associated with early and long term (CNS) pain response due Blood oxygenation level dependent (BOLD) signal changes in fMRI of the brain to upadacitinib treatment in psoriatic arthritis;Primary end point(s): BOLD signal voxel count at week 1 and week 12 compared to baseline;Timepoint(s) of evaluation of this end point: baseline (BL), week one and week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): fMRI: (week 1 and week 12 compared to baseline) - activation size of the BOLD signal (number) at week 1 and week 12 compared to baseline - amplitude of the BOLD signal (number) at week 1 and week 12 compared to baseline - graph-theoretical parameters for all structures along the pain pathway at baseline and week 1 and week 12 - changes in brain anatomy defined as rewiring of brain centers at week 12 compared to baseline. Clinical evaluation, PROs and Composite outcome measures: - Patient global assessment of pain, Patient global assessment of disease activity, Physician global assessment of disease activity (VAS) - Joint count: 66/68 - DAS28 (CRP) - DAPSA - SPARCC - LEI - MASES - Dactylitis Score - PASI - PSAID - PASDAS - SF 36 - MDA - HAQ-DI - FACIT-Fatigue PATIENT DIARY Ultrasound Synovitis Score of the MCP joints TISSUE EXPLORATIVE SERUM BIOMARKERS ;Timepoint(s) of evaluation of this end point: BL, week 1, week 4, week 12) | — |
Countries
Germany
Contacts
Public ContactMedizinische Klinik 3
Universitätsklinikum Erlangen
Outcome results
None listed