Study on Guselkumab for Treating Psoriatic Arthritis in Patients New to Biologic Therapy

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What is this study about?

This clinical trial is focused on studying the effects of a medication called Guselkumab on individuals with a condition known as Psoriatic Arthritis, specifically targeting those with active axial disease. 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. Axial disease refers to inflammation in the spine and the joints that connect the spine to the pelvis. The medication being tested, Guselkumab, is administered as an injection and is being compared to a placebo to evaluate its effectiveness and safety.

The purpose of this study is to assess how well Guselkumab can reduce symptoms related to the axial part of Psoriatic Arthritis. Participants in the study will receive either Guselkumab or a placebo through subcutaneous injections, which means the medication is injected under the skin. The study will follow participants over a period of time to observe changes in their symptoms and overall health. The main focus will be on the reduction of symptoms such as spinal pain and inflammation, which are common in individuals with this condition.

Throughout the study, participants will be monitored to ensure their safety and to gather data on the effectiveness of the treatment. The study aims to provide valuable information on whether Guselkumab can be a beneficial treatment option for those suffering from Psoriatic Arthritis with axial involvement. This research is important as it seeks to improve the quality of life for individuals affected by this chronic condition.

1 joining the study

Upon joining the study, the participant is confirmed to meet the inclusion criteria, which include being at least 18 years old, having a diagnosis of psoriatic arthritis for at least 6 months, and having active psoriatic arthritis with specific symptoms and test results.

2 initial assessment

An initial assessment is conducted to evaluate the participant’s baseline condition. This includes measuring the number of swollen and tender joints, assessing spinal pain, and confirming psoriatic arthritis through imaging.

3 treatment administration

Participants receive either guselkumab or a placebo. Guselkumab is administered as a solution for injection in a pre-filled syringe, with a dosage of 100 mg/mL, given subcutaneously (under the skin).

4 treatment duration

The treatment is administered over a period leading up to Week 24. The specific schedule and frequency of administration are determined by the study protocol.

5 monitoring and follow-up

Throughout the study, participants are monitored for changes in their condition, particularly focusing on the reduction of axial symptoms of psoriatic arthritis. This includes regular assessments of the BASDAI score, which measures disease activity.

6 completion of study

At the end of the study period, a final assessment is conducted to evaluate the overall efficacy and safety of the treatment. The primary endpoint is the change in the BASDAI score from baseline to Week 24.

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. Psoriatic Arthritis is a type of arthritis that affects some people with the skin condition psoriasis.
  • Meet the CASPAR criteria for Psoriatic Arthritis at the time of screening. CASPAR criteria are a set of guidelines used to diagnose Psoriatic Arthritis.
  • Have active Psoriatic Arthritis, which means having at least 3 swollen joints and at least 3 tender joints at the time of screening and at the start of the study. Also, have a C-reactive protein level of 0.3 mg/dL or higher at screening. C-reactive protein is a substance in the blood that increases when there is inflammation in the body.
  • Have a BASDAI score of at least 4. BASDAI is a tool used to measure the severity of symptoms in people with certain types of arthritis.
  • Have Psoriatic Arthritis affecting the spine, confirmed by magnetic resonance imaging (MRI). MRI is a type of scan that uses magnets and radio waves to create detailed images of the inside of the body.
  • Have a spinal pain score of at least 4. This score measures the level of pain in the spine.
  • Have active plaque psoriasis, which means having at least one psoriatic plaque that is 2 cm or larger in diameter, or nail changes that are consistent with psoriasis. Plaque psoriasis is a skin condition that causes red, scaly patches on the skin.
  • Have active Psoriatic Arthritis despite previous treatment with non-biologic DMARDs, apremilast, and/or NSAIDs. DMARDs are drugs that slow down the progression of arthritis. Apremilast is a medication used to treat Psoriatic Arthritis. NSAIDs are non-steroidal anti-inflammatory drugs used to reduce pain and inflammation.

Who Cannot Join the Study?

  • Patients who do not have Psoriatic Arthritis cannot participate.
  • Patients who are not within the specified age range cannot participate. The age range is typically defined in the study details.
  • Patients who are not part of the specified clinical trial group cannot participate. This group is usually defined by specific characteristics or conditions.
  • Patients who are part of a vulnerable population, which may include groups like children, pregnant women, or those unable to give consent, cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Narodowy Instytut Geriatrii Reumatologii I Rehabilitacji Im Prof. Dr Hab. Med. Eleonory Reicher Warsaw Poland
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Revmatologicky Ustav Prague Czechia
Kistarcsai Flor Ferenc Korhaz Kistarcsa Hungary
Bekes Varmegyei Koezponti Korhaz Gyula Hungary
CCAB Centro Clinico Academico Braga Associacao Braga Portugal
Hospital Universitario Basurto Bilbao Spain
Reumed Sp. z o.o. Lublin Poland
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
Clinicmed Daniluk Nowak Sp. k. Bialystok Poland
Qualiclinic Kft. Budapest Hungary
Malopolskie Badania Kliniczne Sp. z o.o. Cracow Poland
Instituto Portugues De Reumatologia Lisbon Portugal
Unidade Local De Saude Do Alto Minho E.P.E. Ponte De Lima Portugal
L.K.N. Arthrocentrum s.r.o. Hlucin Czechia
Mbal Lyulin EAD Sofia Bulgaria
ISA Interdisciplinary Study Association GmbH Berlin Germany
Frederiksberg Hospital Frederiksberg Denmark
Medical Plus s.r.o. Uherske Hradiste Czechia
Revmacentrum MUDr. Mostera s.r.o. Brno-Zidenice Czechia
Wromedica I Bielicka A Strzalkowska s.c. Wroclaw Poland
Rheuma Medicus Sp. z o.o. Warsaw Poland
Ambulatorium Sp. z o.o. Elblag Poland
Reumex s.r.o. Rimavska Sobota Slovakia
Thermium s.r.o. Piestany Slovakia
Medman s.r.o. Martin Slovakia
Obudai Egeszseguegyi Centrum Kft. Dunaújváros Hungary
Fejer Varmegyei Szent Gyoergy Egyetemi Oktato Korhaz Szekesfehervar Hungary
Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy Bydgoszcz Poland
Universita’ Degli Studi Di Verona Verona Italy
Hospital Clinic De Barcelona Barcelona Spain
Karolinska University Hospital Solna Sweden
Hospital Universitario De Cruces Barakaldo Spain
Sygehus Lillebaelt Vejle Sygehus Vejle Denmark
Universita’ Politecnica Delle Marche Ancona Italy
Ko-Med Centra Kliniczne Sp. z o.o. Zamosc Poland
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD Sofia Bulgaria
Medical Center Artmed Ltd. Plovdiv Bulgaria
St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr Herne Germany
Unidade Local De Saude Da Guarda E.P.E. Guarda Portugal
Reum.hapi s.r.o. Nove Mesto Nad Vahom Slovakia
Tomasz Blicharski Lubelskie Centrum Diagnostyczne Swidnik Poland
Multi-profile Hospital for Active Treatment Heart and Brain EAD Pleven Bulgaria
Azienda Ospedaliera Universitaria Di Cagliari Monserrato Italy
Twoja Przychodnia Poznańskie Centrum Medyczne Sp. z o.o. Poznan Poland
Region Sjaelland Holbæk Denmark
Centrum Medyczne Amed Sp. z o.o. Warsaw Poland
NZOZ Lecznica Mak Med s.c. Nadarzyn Poland
Vital-Medicina Kft. Veszprem Hungary
Niepubliczny Zaklad Opieki Zdrowotnej Bif Med Bytom Poland
Mmuencpej Iaoloralkw Cenodyrh Swpskflq Sbd z opgs Warsaw Poland
Rpkessm pou snpeop Karvina Czechia
Mzowc Rxbauoukim smyvpo Poruba Czechia
Rjsjmnfk Pvweom saemuq Poprad Slovakia
Pqiu Tpqyc Hmrrwutt Umcrgwytjoib Sabadell Spain
Bcvkskqlmq Inunorxqeeim Btapa Imyyztmgdmsut Kawbnb Budapest Hungary
Pvnefcd Mjyypq Slm z Oaxa Ewl Pvvjycfcp Poniatowa Poland
Mupxmqp Cijvfp Eandki Mhwyjl Ott Pleven Bulgaria
Urjooje Ubgazwmmtt Hmgboayk Uppsala Sweden
Afwtzqd Ujp Irfuc Dc Rbviuk Etaodu Reggio Emilia Italy
Hrghjijw Upuwitoxzlxcz df A Cdjthl A Coruna Galicia Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Bulgaria Bulgaria
Not recruiting
30.09.2021
Czechia Czechia
Not recruiting
30.09.2021
Denmark Denmark
Not recruiting
30.09.2021
Germany Germany
Not recruiting
30.09.2021
Hungary Hungary
Not recruiting
30.09.2021
Italy Italy
Not recruiting
30.09.2021
Poland Poland
Not recruiting
30.09.2021
Portugal Portugal
Not recruiting
30.09.2021
Slovakia Slovakia
Not recruiting
30.09.2021
Spain Spain
Not recruiting
30.09.2021
Sweden Sweden
Not recruiting
30.09.2021

Trial locations

Investigated drugs:

Guselkumab is a medication used in this clinical trial to treat people with active psoriatic arthritis, specifically focusing on symptoms affecting the spine and pelvic area. It is administered through an injection under the skin. The goal of using guselkumab in this study is to see how well it can reduce the symptoms related to the axial part of the disease, which includes pain and inflammation in the spine and surrounding areas.

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 reduced range of motion. The condition can also affect the spine, leading to back pain and stiffness. Symptoms can vary in severity and may come and go in cycles.

Trial ID:
2023-504716-15-00
Protocol code:
CNTO1959PSA4002
Trial Phase:
Therapeutic confirmatory (Phase III)

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