Study on the Effect of Guselkumab for Treating Enthesitis in Patients with Psoriatic Arthritis Who Have Not Used Biologic DMARDs

3 1 1 1

What is this study about?

This clinical trial is focused on studying the effects of a medication called Guselkumab on a condition known as 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, Guselkumab, is administered as a solution for injection, either in a pre-filled syringe or a pre-filled pen. The purpose of the study is to see how effective Guselkumab is in resolving a specific symptom of Psoriatic Arthritis called enthesitis, which is inflammation where tendons or ligaments attach to bone.

The study will involve patients who have not previously been treated with a type of medication known as bDMARDs, which are biologic disease-modifying antirheumatic drugs. Participants will receive Guselkumab injections over a period of up to 52 weeks. The main goal is to observe whether the enthesitis resolves by week 24 of the study. Enthesitis is confirmed using ultrasound, a technique that uses sound waves to create images of the inside of the body, helping to identify inflammation.

This trial is open-label, meaning both the researchers and participants know which treatment is being administered. The study will not use a placebo, and all participants will receive the active medication, Guselkumab. The trial aims to provide valuable information on the effectiveness of Guselkumab in treating enthesitis in patients with Psoriatic Arthritis, potentially offering a new treatment option for those affected by this condition.

1 joining the study

Upon joining the study, the patient must provide written informed consent. This confirms understanding and agreement to participate in the clinical trial.

Eligibility is confirmed based on criteria such as being 18 years or older, having a diagnosis of psoriatic arthritis, and not having used certain types of medications before.

2 initial assessment

An initial assessment is conducted to evaluate the presence of enthesitis, which is inflammation at the sites where tendons or ligaments insert into the bone. This is confirmed through clinical examination and ultrasound.

3 medication administration

The patient receives guselkumab, administered as a 100 mg solution for injection. This is provided either in a pre-filled syringe or a pre-filled pen.

The medication is given subcutaneously, meaning it is injected under the skin.

4 treatment schedule

The treatment involves regular administration of guselkumab. The specific frequency and duration of administration are determined by the study protocol.

5 monitoring and follow-up

Throughout the trial, the patient’s condition is monitored to assess the effect of the medication on enthesitis. This includes both clinical evaluations and ultrasound examinations.

The primary goal is to achieve resolution of enthesitis by week 24, as measured by a specific scoring system.

6 completion of the trial

The trial is expected to conclude by December 31, 2027. The patient’s participation will end upon completion of the study protocol or if they choose to withdraw.

Who Can Join the Study?

The patient must provide written informed consent, which means they agree to participate after understanding the study details.
The patient must be an adult, which means they are 18 years old or older.
The patient must have a diagnosis of Psoriatic Arthritis (PsA), which is a type of arthritis that affects some people with the skin condition psoriasis. This diagnosis should be according to the CASPAR criteria, which are guidelines used to identify PsA.
The patient must have a SPARCC Enthesitis score of 1 or more at the start of the study. Enthesitis is inflammation where tendons or ligaments attach to bone, and SPARCC is a way to measure this.
The patient must be bDMARD naïve, meaning they have not been treated with biologic disease-modifying antirheumatic drugs before.
The patient must have either not responded to or had a bad reaction to at least one csDMARD, which stands for conventional synthetic disease-modifying antirheumatic drugs. Alternatively, they should need to start treatment with Guselkumab due to having moderate-to-severe psoriasis, which is a skin condition with red, scaly patches.
The patient must have a PD Grade of 2 or more for at least one affected area at the start of the study, or a PD Grade of 1 or more for at least two affected areas. PD Grade refers to a way of measuring the severity of enthesitis using ultrasound.

Who Cannot Join the Study?

Patients who have any other serious health conditions that might 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 received certain treatments for psoriatic arthritis recently.
Patients who have a history of cancer, except for certain types of skin cancer.
Patients who have a history of certain blood disorders.
Patients who have a history of liver or kidney disease.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Krankenhaus Porz Am Rhein gGmbH	Cologne	Germany

Other Sites

Site Name	City	Country
Universitaetsklinikum Erlangen AöR	Erlangen	Germany
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Fraunhofer Institute for Translational Medicine and Pharmacology ITMP	Frankfurt	Germany

Trial status

Country	Status	Recruitment Start
Germany	Recruiting	01.05.2024

Trial locations

Investigated drugs:

Guselkumab

Guselkumab is a medication used in this clinical trial to evaluate its effect on reducing inflammation in patients with psoriatic arthritis. It works by targeting specific proteins in the immune system that contribute to inflammation and joint pain. The trial aims to see how well this medication can help resolve enthesitis, which is inflammation of the tendons or ligaments attached to the bone, as confirmed by ultrasound.

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, often affecting fingers and toes. Over time, it may lead to joint damage and deformities if not managed properly. Enthesitis, inflammation where tendons or ligaments attach to bone, is a common feature. The progression of psoriatic arthritis can vary, with periods of flare-ups and remission.

Trial ID:

2024-512459-19-00

Trial Phase:

Therapeutic confirmatory (Phase III)

Other Trials to Consider

#1 Clinical Trials Search in Europe

Study on the Effect of Guselkumab for Treating Enthesitis in Patients with Psoriatic Arthritis Who Have Not Used Biologic DMARDs

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?