Study on the Effects of Upadacitinib for Patients with Active Psoriatic Arthritis and Axial Spondyloarthritis

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What is this study about?

This clinical trial is focused on studying the effects of a medication called Upadacitinib on patients with two specific conditions: Psoriatic Arthritis and Axial Spondyloarthritis. Psoriatic Arthritis is a type of arthritis that affects some people who have the skin condition psoriasis, while Axial Spondyloarthritis is a form of arthritis that primarily affects the spine and the joints connecting the spine to the pelvis. The study will compare the effects of Upadacitinib to a placebo, which is a substance with no active ingredients.

The purpose of the study is to evaluate how well Upadacitinib can reduce symptoms such as inflammation and pain in the spine and joints of patients with active symptoms of these conditions. Participants will take the medication or placebo orally in the form of a modified-release tablet. The study will last for a period of 24 weeks, during which participants will be monitored for changes in their symptoms and any side effects they may experience.

Throughout the study, participants will undergo various assessments, including imaging tests like MRI (Magnetic Resonance Imaging), to measure inflammation in the spine and joints. The study aims to provide valuable information on the effectiveness of Upadacitinib in managing symptoms of Psoriatic Arthritis and Axial Spondyloarthritis, potentially offering a new treatment option for individuals affected by these conditions.

1 initial visit

Upon joining the study, an initial visit is conducted to confirm eligibility. This includes a review of medical history and current medications.

A physical examination is performed, and necessary laboratory tests are conducted to ensure all criteria are met.

2 baseline assessment

A baseline assessment is conducted to evaluate the current state of psoriatic arthritis. This includes imaging tests such as MRI to assess inflammation in the spine and sacroiliac joints.

The assessment also involves completing questionnaires to measure disease activity and symptoms.

3 medication administration

Participants are randomly assigned to receive either the study medication, upadacitinib, or a matching placebo (a tablet with no active ingredients).

Upadacitinib is administered as a 15 mg modified-release tablet taken orally once daily.

4 ongoing monitoring

Regular follow-up visits are scheduled to monitor health and response to the medication. These visits include physical examinations, laboratory tests, and imaging as needed.

Participants are required to report any side effects or changes in symptoms during these visits.

5 final assessment

At the end of the 12-week treatment period, a final assessment is conducted. This includes imaging tests and questionnaires to evaluate changes in disease activity and symptoms.

The results are compared to the baseline assessment to determine the impact of the treatment.

Who Can Join the Study?

Must be between 18 and 64 years old at the start of the study.
Females who can have children must not be pregnant or breastfeeding and must use effective birth control methods during the study and for 30 days after the last dose of the study drug.
Must have a diagnosis of Psoriatic Arthritis by a rheumatologist.
Must meet specific criteria for Psoriatic Arthritis classification, including evidence of psoriasis or a family history of psoriasis.
Must have evidence of axial involvement (spine-related symptoms) shown by previous imaging tests like X-rays or MRIs.
Must have active inflammation in the spine or sacroiliac joints (joints in the lower back) as shown by an MRI scan.
Must have had chronic back pain for at least 3 months before the study.
Must have active disease with specific scores on pain and inflammation scales at the start of the study.
Must have tried at least two different NSAIDs (non-steroidal anti-inflammatory drugs) for 4 weeks without adequate relief, or have a reason they cannot take these drugs.
Must be able to understand and agree to follow all study requirements and sign a consent form.
If taking certain medications for Psoriatic Arthritis, must be on a stable dose for a specified period before starting the study.
If previously treated with biological DMARDs (a type of medication for arthritis), must have stopped them for a certain period before the study.

Who Cannot Join the Study?

Patients with any other type of arthritis that is not Psoriatic Arthritis or Axial Spondyloarthritis cannot participate.
Patients who do not have chronic back pain for at least 3 months cannot participate. Chronic means the pain has been present for a long time.
Patients with a BASDAI score less than 4 cannot participate. BASDAI is a measure of how active the disease is, based on symptoms like fatigue and pain.
Patients with a TBP score less than 4 cannot participate. TBP is a score that measures the level of back pain.
Patients who do not have active inflammation in the Sacroiliac Joints (SIJ) or spine as shown on an MRI cannot participate. Inflammation is when a part of the body becomes red, swollen, and painful.
Patients with degenerative disc disease at the affected areas cannot participate. This is a condition where the discs in the spine wear down over time.

Where you can join this trial?

Verified and Recommended Sites

Site Name	City	Country	Status
Samodzielny Publiczny Szpital Kliniczny Nr 4 W Lublinie	Lublin	Poland
Narodowy Instytut Geriatrii Reumatologii I Rehabilitacji Im Prof. Dr Hab. Med. Eleonory Reicher	Warsaw	Poland

Verified Sites

Site Name	City	Country	Status
CENTRUM MEDYCZNE REUMA PARK	Warsaw	Poland
Katholieke Universiteit te Leuven	Leuven	Belgium

Other Sites

Site Name	City	Country
Rcmed Oddzial Sochaczew	Sochaczew	Poland
Reumed Sp. z o.o.	Lublin	Poland
Clinical Research Center Sp. z o.o. Medic-R sp.k.	Poznan	Poland
Rheuma Medicus Sp. z o.o.	Warsaw	Poland
Niepubliczny Zaklad Opieki Zdrowotnej Biogenes Sp. z o.o	Wroclaw	Poland
Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy	Bydgoszcz	Poland
NIEPUBLICZNY ZAKŁAD OPIEKI ZDROWOTNEJ BIF-MED S.C. A. Wawiernia,M. Roykiewicz,R. Roykiewicz	Bytom	Poland
REUMA CENTRUM Specjalistyczna Praktyka Lekarska Dr n. med. Jakub Trefler	Warsaw	Poland
Skfeonl Ugzlhuriuyocq W Kbfwrczo	Cracow	Poland

Trial status

Country	Status	Recruitment Start
Belgium	Recruiting	04.03.2025
Poland	Recruiting	04.03.2025

Trial locations

Investigated drugs:

Upadacitinib

Upadacitinib is a medication being studied for its potential to help people with psoriatic arthritis, a condition that causes joint pain and swelling. In this clinical trial, researchers are looking at how well upadacitinib can reduce symptoms like back pain and inflammation in the spine and joints. The goal is to see if this medication can improve the quality of life for people with active psoriatic arthritis by reducing pain and inflammation as seen on MRI scans. Upadacitinib works by targeting specific pathways in the immune system that are involved in causing inflammation. This could help in managing the symptoms of psoriatic arthritis more effectively.

Investigated diseases:

Axial spondyloarthritis

Psoriatic Arthritis – Psoriatic arthritis is a chronic inflammatory condition that affects the joints and is associated with psoriasis, a skin disease. It typically causes joint pain, stiffness, and swelling, which can affect any part of the body, including the spine and fingers. The disease often progresses with periods of flare-ups and remissions. Over time, it can lead to joint damage and reduced range of motion. The inflammation can also affect tendons and ligaments, leading to additional discomfort and mobility issues. Skin symptoms, such as red patches with silvery scales, often accompany the joint symptoms.

Axial Spondyloarthritis – Axial spondyloarthritis is a type of inflammatory arthritis that primarily affects the spine and the sacroiliac joints, which connect the lower spine to the pelvis. It is characterized by chronic back pain and stiffness, particularly in the lower back and buttocks. The disease can lead to inflammation of the vertebrae, causing pain and discomfort. Over time, it may result in the fusion of the vertebrae, reducing flexibility and leading to a hunched posture. The condition can also cause inflammation in other parts of the body, such as the eyes and intestines. Symptoms often begin in early adulthood and can vary in severity.

Trial ID:

2023-510242-24-00

Protocol code:

B24-033

NCT ID:

NCT06454188

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effects of Upadacitinib for Patients with Active Psoriatic Arthritis and Axial Spondyloarthritis

What is this study about?

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Who Cannot Join the Study?