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

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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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Karolinska University Hospital Solna Sweden
Sygehus Lillebaelt Vejle Sygehus Vejle Denmark
Mbal Lyulin EAD Sofia Bulgaria
Hospital Universitario De Cruces Barakaldo Spain
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD Sofia Bulgaria
Medical Center Artmed Ltd. Plovdiv Bulgaria
Tomasz Blicharski Lubelskie Centrum Diagnostyczne Swidnik Poland
Bekes Varmegyei Koezponti Korhaz Gyula Hungary
Revmacentrum MUDr. Mostera s.r.o. Brno-Zidenice Czechia
Rheuma Medicus Sp. z o.o. Warsaw Poland
Centrum Medyczne Amed Sp. z o.o. Warsaw Poland
Rcrqaebykvhyrn Uondu Prague Czechia
Mogreectn Iskvhplfbw Cjcucfnp Sfjlapqb Smr z oriy Warsaw Poland
Rswavi Sswfknwre Holbæk Denmark
Hbicnkkq Ubgtajkgwqxqt dk A Cdlzgs A Coruna Galicia Spain
Ujafhynvhjiongibb Dcedo Szttf Dw Vuxeex Verona Italy
Uprsfza Uruphfsaqf Hyfacryv Uppsala Sweden
Hxnpsmak Cwbpfh Di Berdfcsru Barcelona Spain
Uvgoahxhsnuerkvmw Pvpovcdzdiz Denny Msztpq Ancona Italy
Cesi Ckvdzq Cgsnvcl Acssbahnm Bkhcy Awvuuxlbse Braga Portugal
Fzyeu Vhcivybfj Suyse Gwvcoms Eequzaoi Ollrtf Kooofn Szekesfehervar Hungary
Pqcx Tevjy Hcyiluld Uhzqxafjrtif Sabadell Spain
Tkrfc Pyvmdlefcpv Pwtyogwphw Cfhqaty Mcpieamg Sgk z ondh Poznan Poland
Sduqykq Uumankiwybrko Nc 2 Ic Dv Jftn Bcoxunz W Bfpkwaolle Bydgoszcz Poland
Caffkna Gvtpn Scvbfvtg Santiago De Compostela Spain
Kajdkypgcr Fadl Fukxwn Kzbuuc Kistarcsa Hungary
Bqlallgxix Irnuzwzkeogz Bebao Iwybojeuwditb Kflqab Budapest Hungary
Pwfnzwr Mypnum Svu z Ojva Ezd Pmssmiirg Poniatowa Poland
Mcqyy Rcsvemxtjc swjrwh Poruba Czechia
Rwxvgohi Pbuull syxfnk Poprad Slovakia
Mqdlktx Cejnsz Etidba Mvlbea Oxf Pleven Bulgaria
Rzmvunt pnd sjcydq Karvina Czechia
Oofxpf Ehkxltpzatwvo Chsfxvx Kqir Dunaújváros Hungary
Kvzpxo Cykpkt Ksiljaicu Ssv z ojbc Zamosc Poland
Arfiwof Umd Iorvo Ds Rfsube Elxpwr Reggio Emilia Italy
Seq Esvefhhqe Gxztvq Glye Kdkmzzfjagb Kfdovmlh Rozkgehjop Herne Germany
Utkflgg Ltqpx Di Synoq De Gknpsm Eejtdd Guarda Portugal
Rtogegtym sfwmzn Nove Mesto Nad Vahom Slovakia
Fjyaleaqdvvot Hsuxutug Frederiksberg Denmark
Waqbtydpv I Bxeaehag A Stgnittavwzb sjea Wroclaw Poland
Harigxmq Udhlpplsgzjdt Bqpbpki Bilbao Spain
Mtnsvll Potq svnhtn Uherske Hradiste Czechia
Mwognb siwpcv Martin Slovakia
Rzeura Sib z oqle Lublin Poland
Tqhgj Povulliiqpd Nlbwcdcxivl Cnjmatd Mxaxlzff Sic z oweg Nowa Sol Poland
Hkxildle Qitinamjuqg Stgtmqr Cznwnxw Sevilla Spain
Ugvbzdwqpi Muzdwuizhnyy Hestywdi Fdc Afezdl Thlqcucrm Kpxpedv Eeop Plovdiv Bulgaria
Cbtqregpx Dzltsre Nlqhi Sms ki Bialystok Poland
Ruvznu suyyjo Rimavska Sobota Slovakia
Qkjlddidgia Kwfk Budapest Hungary
Tgwukjsp srndbb Piestany Slovakia
Mghiimrplue Bddmlsw Kjbturhuk Scm z ohed Cracow Poland
Ifwtpbpuo Poxghamjl Db Rbioyhfgomgv Lisbon Portugal
Udwscpl Lkgsh Dz Sizmr Db Amtp Mhgvl Ehktro Ponte De Lima Portugal
Auoyyshbuqnp Sbe z ozge Elblag Poland
Cbzgqqe Tqpnfda Wkoxwithbawn Jvwq Jetoikfbtsza Suocgs Lodz Poland
Ibk Iybjplkjypkevcrgt Savsq Afgpmwpepkm Gwpv Berlin Germany
Mdrwttdtjgtpe Hmaepysw fnx Ataunj Tbvmbylve Hpzyw aqh Bdrfe Eyy Pleven Bulgaria
Lkbdkm Andkoycnfrcti slhdyz Hlucin Czechia
Aimnyez Oyxibfhvyio Uutvgtxdsdshu Dq Ccwhhjcw Monserrato Italy
Noyp Lfegawbd Mop Mni swug Nadarzyn Poland
Vpurdsugwojoqf Knjy Veszprem Hungary
Nkmsothcqzpy Zuukvj Oiqoai Zenmlqqbib Bkm Mfr Bytom Poland

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.

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, 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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