Study on Guselkumab for Treating Active Psoriatic Arthritis in Patients with Inadequate Response to One Prior Anti-TNF Agent

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What is this study about?

This clinical trial is focused on studying the effects of a medication called Guselkumab in individuals with Psoriatic Arthritis. Psoriatic Arthritis is a condition that causes joint pain and swelling, often occurring in people who have psoriasis, a skin condition. The study involves participants who have not responded well or cannot tolerate a previous treatment known as anti-Tumor Necrosis Factor (anti-TNF) therapy, which is used to reduce inflammation.

The purpose of this study is to evaluate how effective Guselkumab is in reducing the signs and symptoms of Psoriatic Arthritis. Participants will receive Guselkumab through an injection under the skin, using a pre-filled syringe. Some participants will receive a placebo, which looks like the medication but does not contain the active ingredient. The study will compare the effects of Guselkumab to the placebo to determine its effectiveness.

Throughout the study, participants will be monitored to assess their response to the treatment. The main goal is to see how many participants achieve a significant improvement in their condition by the 24th week of the study. This improvement is measured by a standard response called ACR 20, which indicates a 20% improvement in the number of tender and swollen joints, as well as other criteria related to Psoriatic Arthritis. The study aims to provide valuable information on the safety and benefits of using Guselkumab for treating this condition.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying a diagnosis of psoriatic arthritis for at least six months and ensuring active symptoms, such as at least three swollen and three tender joints.

A blood test is performed to measure C-reactive protein (CRP) levels, which should be 0.3 mg/dL or higher. This test may be repeated once if necessary.

2 randomization

Participants are randomly assigned to receive either the study medication, guselkumab, or a placebo. This process is double-blind, meaning neither the participant nor the study team knows which treatment is being administered.

3 treatment administration

The study medication, guselkumab, is administered as a solution for injection using a pre-filled syringe. The dosage is 100 mg/mL, given subcutaneously (under the skin).

The frequency and duration of administration are determined by the study protocol, which is not specified in the provided data.

4 monitoring and follow-up

Participants are monitored regularly to assess the effectiveness and safety of the treatment. This includes evaluating the reduction in signs and symptoms of psoriatic arthritis.

The primary goal is to determine the proportion of participants who achieve an ACR 20 response at Week 24, which indicates a 20% improvement in the number of tender and swollen joints, among other criteria.

5 study completion

The study is estimated to conclude by October 26, 2026. Participants will be informed of their treatment group and the overall study results upon completion.

Who Can Join the Study?

Be at least 18 years old.
Have been diagnosed with Psoriatic Arthritis (PsA) for at least 6 months before starting the study treatment. PsA is a type of arthritis that affects some people with the skin condition psoriasis.
Have active PsA, which means having at least 3 swollen joints and 3 tender joints at the start of the study. Also, have a CRP level of 0.3 mg/dL or higher. CRP is a blood test that shows inflammation in the body.
Have at least one of the following types of PsA:
- Involvement of the joints near the fingertips.
- Arthritis affecting many joints without rheumatoid nodules.
- Asymmetric arthritis, which means it affects different joints on each side of the body.
- Spondylitis with peripheral arthritis, which involves the spine and other joints.
Have not responded well or cannot tolerate anti-TNFα therapy. Anti-TNFα therapy is a treatment for inflammation. This means:
- Not having enough improvement after at least 12 weeks of certain medications like etanercept, adalimumab, golimumab, or certolizumab pegol, or 14 weeks of infliximab.
- Having a bad reaction to one of these medications.

Who Cannot Join the Study?

Patients who have a known allergy or reaction to the study medication or its ingredients cannot participate.
Individuals with a history of certain serious infections, such as tuberculosis, are not eligible.
Patients with a weakened immune system, which means their body has a harder time fighting infections, are excluded.
Those who have received certain treatments for Psoriatic Arthritis recently may not be able to join.
Participants with other significant health conditions that could interfere with the study are not allowed.
Women who are pregnant or breastfeeding cannot take part in the study.
Individuals who are currently participating in another clinical trial are not eligible.
Patients who have a history of certain types of cancer may be excluded.
Anyone with a history of drug or alcohol abuse that could affect their ability to follow the study procedures is not eligible.
Individuals who have had a recent vaccination with a live vaccine may not be able to participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Dermed Centrum Medyczne Sp. z o.o.	Lodz	Poland
Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A.	Lodz	Poland
CENTRUM MEDYCZNE REUMA PARK	Warsaw	Poland

Other Sites

Site Name	City	Country
Revmatologicky Ustav	Prague	Czechia
Kistarcsai Flor Ferenc Korhaz	Kistarcsa	Hungary
UNIMED Medical Center EOOD	Plovdiv	Bulgaria
Bekes Varmegyei Koezponti Korhaz	Gyula	Hungary
Twoja Przychodnia Nowosolskie Centrum Medyczne Sp. z o.o.	Nowa Sol	Poland
Hospital Quironsalud Sagrado Corazon	Sevilla	Spain
University Multiprofile Hospital For Active Treatment Kaspela EOOD	Plovdiv	Bulgaria
Malopolskie Badania Kliniczne Sp. z o.o.	Cracow	Poland
L.K.N. Arthrocentrum s.r.o.	Hlucin	Czechia
Ai Centrum Medyczne Sp. z o.o.	Poznan	Poland
Malopolskie Centrum Kliniczne	Cracow	Poland
Rheuma Medicus Sp. z o.o.	Warsaw	Poland
Arthrohelp s.r.o.	Pardubice	Czechia
Medical Plus s.r.o.	Uherske Hradiste	Czechia
Fejer Varmegyei Szent Gyoergy Egyetemi Oktato Korhaz	Szekesfehervar	Hungary
Hospital Universitario De Cruces	Barakaldo	Spain
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD	Sofia	Bulgaria
Multi-profile Hospital for Active Treatment Heart and Brain EAD	Pleven	Bulgaria
Twoja Przychodnia Poznańskie Centrum Medyczne Sp. z o.o.	Poznan	Poland
University Of Szeged	Szeged	Hungary
Амбулатория За Специализирана Извънболнична Медицинска Помощ Ревматологичен Център Света Ирина ЕООD	Sofia	Bulgaria
Centrum Kliniczno-Badawcze J.Brzezicki B.Gornikiewicz-Brzezicka Lekarze sp.p.	Elblag	Poland
NZOZ Lecznica Mak Med s.c.	Nadarzyn	Poland
Vital-Medicina Kft.	Veszprem	Hungary
Mwhlkflmn Itzokdoksu Cdatqnhg Szqugwcx Slc z ozga	Warsaw	Poland
Rooomn stftws	Breclav	Czechia
Mfqnu Rjwzbcdjnm shuukf	Poruba	Czechia
Byaejhthca Ieufmseeyvxv Bhheg Isnlzcbaczgul Kzsbju	Budapest	Hungary
Uhm Mtixlzu Tsbngo Kkej	Budapest	Hungary

Trial status

Country	Status	Recruitment Start
Bulgaria	Not recruiting	07.10.2021
Czechia	Not recruiting	07.10.2021
Hungary	Not recruiting	07.10.2021
Poland	Not recruiting	07.10.2021
Spain	Not recruiting	07.10.2021

Trial locations

Investigated drugs:

Guselkumab

Guselkumab is a medication used in this clinical trial to treat patients with active psoriatic arthritis. It is administered through an injection under the skin. The purpose of using guselkumab in this study is to see how well it works in reducing the signs and symptoms of psoriatic arthritis in patients who did not respond well or could not tolerate a previous treatment with another type of medication called an anti-TNF agent.

Investigated diseases:

Psoriatic arthropathy

Psoriatic Arthritis – Psoriatic arthritis is a chronic inflammatory condition that affects both the skin and joints. It is associated with psoriasis, a skin disease that causes 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. The progression of the disease can vary, with periods of increased symptoms followed by times of remission. In some cases, it can lead to joint damage if not managed properly.

Trial ID:

2023-504715-33-00

Protocol code:

CNTO1959PSA3005

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Guselkumab for Treating Active Psoriatic Arthritis in Patients with Inadequate Response to One Prior Anti-TNF Agent

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?