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Study on Upadacitinib for Pain Management in Patients with Psoriatic Arthritis

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a medication called Upadacitinib on individuals with Psoriatic Arthritis. Psoriatic Arthritis is a type of arthritis that affects some people who have psoriasis, a condition that features red patches of skin topped with silvery scales. The medication being tested, Upadacitinib, is taken in the form of prolonged-release tablets, which means the medicine is released slowly into the body over time.

The purpose of this study is to understand how Upadacitinib affects pain processing in the brain of people with Psoriatic Arthritis. This is done by observing changes in brain activity using a method called fMRI, which stands for functional magnetic resonance imaging. This imaging technique helps researchers see how different parts of the brain respond to the medication over time.

Participants in the study will take Upadacitinib and have their brain activity monitored at different points during the study. The study will last for several weeks, and participants will have regular check-ups to monitor their progress and any changes in their condition. The goal is to gather information on how the medication affects pain and brain activity in the short and long term.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying the presence of psoriatic arthritis and active hand joint involvement.
A negative urine pregnancy test is required for females of childbearing potential. Males must agree to use barrier contraception during the study and for 28 days after the last dose.
Step 2
Baseline measurements
Baseline measurements are taken, including a functional MRI (fMRI) of the brain to assess blood oxygenation level dependent (BOLD) signals. This helps in understanding the central nervous system's response to pain.
Step 3
Medication administration
The medication used in this study is RINVOQ 15 mg prolonged-release tablets, containing the active substance upadacitinib. It is taken orally once daily.
The treatment aims to observe changes in pain processing in the brain over time.
Step 4
Follow-up assessments
Follow-up assessments are scheduled at week 1 and week 12. These include additional fMRI scans to compare BOLD signal changes from the baseline.
The primary goal is to measure the BOLD signal voxel count at these intervals.
Step 5
Completion of study
The study is estimated to conclude by December 31, 2025. Participants will have completed all required assessments and medication administration by this time.

Who can join the trial?

12 criteria

Patients must meet the CASPAR criteria for Psoriatic Arthritis (PsA). The CASPAR criteria are a set of guidelines used to diagnose Psoriatic Arthritis.
Must be able to follow the study visit schedule and other study requirements.
Male participants, including those who have had a vasectomy, must agree to use barrier contraception, like latex condoms, during sexual activity with females who can become pregnant while on the study medication and for at least 28 days after the last dose.
Females who can become pregnant must have a negative urine pregnancy test at the start and must agree to use a highly effective form of birth control during sexual activity while on the study medication and for at least 28 days after the last dose.
Participants must have active hand joint involvement, meaning at least one swollen or tender joint.
There must be a need for systemic treatment, which means treatment that affects the entire body.
Participants must have not responded to or cannot tolerate at least one conventional synthetic disease-modifying antirheumatic drug (csDMARD).
Participants must not have been exposed to more than one biological disease-modifying antirheumatic drug (bDMARD) before. For bDMARDs, there should be a wash-out period, which is a break from the medication, of at least three times the half-life of the bDMARD.
Participants must be eligible for treatment with Upadacitinib according to the European Union (EU) guidelines.
Participants can take glucocorticoids, a type of steroid medication, but less than 10 mg per day.
Must understand and voluntarily sign an informed consent form, which includes written consent for data protection.
Participants must be adults aged 18 years or older and younger than 65 years at the time of giving consent.

Who cannot join the trial?

10 criteria

Patients who have any other serious health conditions that could interfere with the study.
Patients who are currently participating in another clinical trial.
Patients who have had a recent infection that required treatment with antibiotics.
Patients who have a history of allergic reactions to similar medications.
Patients who are pregnant or breastfeeding.
Patients who have a history of drug or alcohol abuse.
Patients who have been diagnosed with a mental health disorder that is not well controlled.
Patients who have had a recent surgery or are planning to have surgery during the study period.
Patients who have a history of cancer, unless it has been in remission for a certain period.
Patients who have a history of heart disease or uncontrolled high blood pressure.

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Verified sites

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Universitaetsklinikum Erlangen AöR
Verified
Erlangen, Germany

Trial locations

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Investigated drugs

Upadacitinib is a medication being studied for its effects on pain processing in patients with psoriatic arthritis. The trial aims to observe how this medication influences the central nervous system's response to pain by using brain imaging techniques. Upadacitinib is being evaluated for its potential to improve pain management in individuals with this condition.

Upadacitinib

What is already known about the treatment

Upadacitinib – This medication is administered orally in the form of tablets. It is currently being studied in clinical trials for its effects on psoriatic arthritis, particularly focusing on pain processing in the central nervous system. Upadacitinib is primarily used to treat inflammatory conditions like psoriatic arthritis. It works by inhibiting specific enzymes known as Janus kinases (JAKs), which play a role in the inflammatory process. Upadacitinib is classified as a JAK inhibitor, a type of medication that helps reduce inflammation and alleviate symptoms associated with autoimmune diseases.

Investigated diseases

Psoriatic arthritis – Psoriatic arthritis is a chronic inflammatory condition that affects both the skin and joints. It is associated with psoriasis, a skin disease characterized by red, scaly patches. The disease can cause joint pain, stiffness, and swelling, which may worsen over time. It often affects the fingers and toes, leading to a sausage-like appearance known as dactylitis. In some cases, it can also affect the spine, causing back pain and stiffness. The progression of psoriatic arthritis can vary, with periods of increased symptoms followed by times of remission.