3P study - Upadacitinib in Psoriatic Arthritis Pain Processing

Phase 1

Active, not recruiting

Conditions: Psoriatic arthritis
MedDRA version: 21.1Level: PTClassification code 10037162Term: Psoriatic arthropathySystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Registration Number: EUCTR2020-005518-16-DE

Lead Sponsor: niversitätsklinikum Erlangen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Recruiting

Sex: All

Target Recruitment: 20

Inclusion Criteria

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
Patients fulfilling CASPAR criteria for PsA
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
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.
Must be able to adhere to the study visit schedule and other protocol requirements

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 13
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 7

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:
oGOT, 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.
oTotal 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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method

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