A Study of Guselkumab Administered Subcutaneously in Bio-naive Participants With Active Psoriatic Arthritis Axial Disease
Launched by JANSSEN RESEARCH & DEVELOPMENT, LLC · Jun 11, 2021
Trial Information
Current as of July 22, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a medication called guselkumab to see how well it works for people with active psoriatic arthritis (PsA) that affects the spine and pelvis. The goal is to find out if guselkumab can help reduce symptoms like pain and inflammation in these areas. The trial is currently looking for participants who are between 65 and 74 years old, have been diagnosed with PsA for at least six months, and are experiencing significant joint pain and swelling despite using other treatments.
To be eligible for the study, participants must have specific signs of active PsA, including swollen and tender joints, and confirmed inflammation in the spine or pelvic area through MRI scans. Participants will receive the treatment and will be monitored for how well it helps their symptoms. It's important to note that individuals who have previously used certain other treatments or have other specific inflammatory conditions may not be able to join the trial. This study offers a chance to contribute to important research while potentially finding relief from PsA symptoms.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Have a diagnosis of psoriatic arthritis (PsA) for at least 6 months prior to the first administration of study intervention and meet classification criteria for psoriatic arthritis (CASPAR) criteria at screening
- • Have active PsA as defined by: a) at least 3 swollen joints and at least 3 tender joints at screening and at baseline and b) C-reactive protein (CRP) greater than or equal to (\>=) 0.3 milligram/deciliter (mg/dL) at screening from the central laboratory, and despite previous non-biologic disease modifying antirheumatic drug (DMARD), apremilast, and/or nonsteroidal anti-inflammatory drug (NSAID) therapy
- • Have magnetic resonance imaging (MRI)-confirmed PsA axial disease (positive MRI spine and/or sacroiliac \[SI\] joints, shown by a Spondyloarthritis Research Consortium of Canada \[SPARCC\] score of \>= 3 in either the spine or the sacroiliac joints)
- • Have a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of at least 4, and have a spinal pain score (on a visual analog scale \[VAS\]) of at least 4
- • Have active plaque psoriasis, with at least 1 psoriatic plaque of \>= 2 centimeter (cm) diameter and/or nail changes consistent with psoriasis, or documented history of plaque psoriasis
- Exclusion Criteria:
- • Has known allergies, hypersensitivity, or intolerance to guselkumab or its excipients
- • Has other inflammatory diseases that might confound the evaluations of benefit of guselkumab therapy, including but not limited to rheumatoid arthritis (RA), ankylosing spondylitis (AS)/non-radiographic-axial spondyloarthritis (this does not include a primary diagnosis of PsA with spondylitis), systemic lupus erythematosus, or Lyme disease
- • Has previously received any biologic treatment
- • Has ever received a Janus kinase (JAK) inhibitor including but not limited to tofacitinib, baricitinib, filgotinib, peficitinib, decernotinib, upadacitinib or any other investigational JAK inhibitor
- • Has received any systemic immunosuppressants (example, azathioprine, cyclosporine, 6 thioguanine, mercaptopurine, mycophenolate mofetil, hydroxyurea, tacrolimus) within 4 weeks of the first administration of study intervention
About Janssen Research & Development, Llc
Janssen Research & Development, LLC, a subsidiary of Johnson & Johnson, is a leading pharmaceutical company dedicated to advancing innovative therapies in multiple therapeutic areas, including oncology, immunology, neuroscience, infectious diseases, and cardiovascular health. With a strong commitment to scientific excellence and patient-centered research, Janssen leverages cutting-edge technology and collaborative partnerships to drive the development of transformative treatments. The company is focused on addressing unmet medical needs through rigorous clinical trials and a robust pipeline, aiming to improve health outcomes and enhance the quality of life for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Ann Arbor, Michigan, United States
La Jolla, California, United States
Vejle, , Denmark
Toronto, Ontario, Canada
Duncansville, Pennsylvania, United States
Clearwater, Florida, United States
Haifa, , Israel
Seattle, Washington, United States
Seattle, Washington, United States
Iowa City, Iowa, United States
Tucson, Arizona, United States
Amarillo, Texas, United States
San Leandro, California, United States
Manila, , Philippines
Hong Kong, , Hong Kong
Zephyrhills, Florida, United States
Bangkok, , Thailand
Taichung, , Taiwan
Kuala Lumpur, , Malaysia
Stockholm, , Sweden
Sofia, , Bulgaria
Tainan, , Taiwan
Dallas, Texas, United States
Springfield, Missouri, United States
Frankfurt, , Germany
Frederiksberg, , Denmark
Greenville, South Carolina, United States
Herne, , Germany
San Miguel De Tucuman, , Argentina
Leeds, , United Kingdom
Bay Pines, Florida, United States
Bilbao, , Spain
Madrid, , Spain
Quezon City, , Philippines
Danbury, Connecticut, United States
Davao City, , Philippines
Liverpool, , Australia
Manchester, , United Kingdom
Kaohsiung, , Taiwan
Kistarcsa, , Hungary
Austin, Texas, United States
Taipei City, , Taiwan
Roma, , Italy
Cagliari, , Italy
Budapest, , Hungary
Hagerstown, Maryland, United States
Cebu City, , Philippines
Istanbul, , Turkey
Tomball, Texas, United States
Vancouver, British Columbia, Canada
Holon, , Israel
Swidnik, , Poland
Johor Bahru, , Malaysia
Plantation, Florida, United States
Nowa Sol, , Poland
St. John's, Newfoundland And Labrador, Canada
Uherske Hradiste, , Czechia
Barnet, , United Kingdom
Plantation, Florida, United States
Brno, , Czechia
Ramat Gan, , Israel
Ratingen, , Germany
Chicago, Illinois, United States
Tbilisi, , Georgia
Covina, California, United States
Brno Zidenice, , Czechia
Elblag, , Poland
Phoenix, Arizona, United States
Bytom, , Poland
Nadarzyn, , Poland
Taoyuan, , Taiwan
George Town, , Malaysia
Santander, , Spain
Ankara, , Turkey
Verona, , Italy
Bursa, , Turkey
Kaunas, , Lithuania
Porto, , Portugal
Rockford, Illinois, United States
Quebec, , Canada
Glostrup, , Denmark
Adana, , Turkey
Barcelona, , Spain
A Coruña, , Spain
Mesquite, Texas, United States
Bangkok, , Thailand
Budapest, , Hungary
Tbilisi, , Georgia
Berlin, , Germany
Plovdiv, , Bulgaria
Valencia, , Spain
Las Vegas, Nevada, United States
Seremban, , Malaysia
Batu Caves, , Malaysia
Warszawa, , Poland
Omsk, , Russian Federation
Lodz, , Poland
Cordoba, , Spain
Córdoba, , Spain
San Diego, California, United States
Colleyville, Texas, United States
Lubbock, Texas, United States
Brescia, , Italy
Campobasso, , Italy
Rozzano (Mi), , Italy
Sofia, , Bulgaria
Brno, , Czechia
Ostrava, , Czechia
Bydgoszcz, , Poland
Lodz, , Poland
Warsaw, , Poland
Warszawa, , Poland
Chelyabinsk, , Russian Federation
Ekaterinburg, , Russian Federation
Lipetsk, , Russian Federation
Petrozavodsk, , Russian Federation
Rostov, , Russian Federation
Ufa, , Russian Federation
Yaroslavl, , Russian Federation
Yaroslavl, , Russian Federation
Ankara, , Turkey
Antalya, , Turkey
Istanbul, , Turkey
Chernihiv, , Ukraine
Kharkiv, , Ukraine
Kherson, , Ukraine
Khmelnytsky, , Ukraine
Kryvyi Rih, , Ukraine
Odessa, , Ukraine
Ternopil, , Ukraine
Uzhgorod, , Ukraine
Hobart, , Australia
Maroochydore, , Australia
Melbourne, , Australia
T'bilisi, , Georgia
Wrocław, , Poland
Gyula, , Hungary
Bydgoszcz, , Poland
Tbilisi, , Georgia
Tbilisi, , Georgia
Kyiv, , Ukraine
Sofia, , Bulgaria
Sevilla, , Spain
Krakow, , Poland
Tbilisi, , Georgia
Lutsk, , Ukraine
Reggio Emilia, , Italy
Tampa, Florida, United States
Poznan, , Poland
Moscow, , Russian Federation
Kyiv, , Ukraine
Vinnytsia, , Ukraine
Konya, , Turkey
Memphis, Tennessee, United States
Kemerovo, , Russian Federation
Málaga, , Spain
Bangkok, , Thailand
Lublin, , Poland
Buenos Aires, , Argentina
Barakaldo, , Spain
Solna, , Sweden
Saint Clair Shores, Michigan, United States
Fort Worth, Texas, United States
Pardubice, , Czechia
Bochum, , Germany
Székesfehérvár, , Hungary
Vinnytsya, , Ukraine
Mesa, Arizona, United States
Sumy, , Ukraine
Hamburg, , Germany
Budapest, , Hungary
Veszprem, , Hungary
Hifa, , Israel
Braga, , Portugal
Lisboa, , Portugal
Lisboa, , Portugal
Lisboa, , Portugal
Ponte De Lima, , Portugal
Chelyabinsk, , Russian Federation
Newcastle, , United Kingdom
Stoke On Trent, , United Kingdom
Houston, Texas, United States
Sabadell, , Spain
Lviv, , Ukraine
Praha, , Czechia
Kutaisi, , Georgia
Tbilisi, , Georgia
Sevilla, , Spain
Camberwell, , Australia
Sofia, , Bulgaria
Baltimore, Maryland, United States
Ankara, , Turkey
Moscow, , Russian Federation
Cherkasy, , Ukraine
Kyiv, , Ukraine
Zaporizhzhya, , Ukraine
Red Oak, Texas, United States
Chiangmai, , Thailand
Lisboa, , Portugal
Ancona, , Italy
Lodz, , Poland
Corpus Christi, Texas, United States
Hlucin, , Czechia
Budapest, , Hungary
Szeged, , Hungary
Warszawa, , Poland
Poltava, , Ukraine
La Plata, , Argentina
Sfia, , Bulgaria
Orenburg, , Russian Federation
Kyiv, , Ukraine
Grapevine, Texas, United States
Lublin, , Poland
Phoenix, Arizona, United States
Sun City, Arizona, United States
Huntington Beach, California, United States
Tustin, California, United States
Miami, Florida, United States
Hinsdale, Illinois, United States
Ann Arbor, Michigan, United States
Eagan, Minnesota, United States
Salisbury, North Carolina, United States
Vandalia, Ohio, United States
Portland, Oregon, United States
Buenos Aires, , Argentina
Ciudad Autonoma De Buenos Aires, , Argentina
Footscray, , Australia
Melbourne, , Australia
Pleven, , Bulgaria
Pleven, , Bulgaria
Plovdiv, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Targovishte, , Bulgaria
Hamburg, , Germany
Kfar Sava, , Israel
Bialystok, , Poland
Krakow, , Poland
Poznan, , Poland
Torun, , Poland
Warszawa, , Poland
Guarda, , Portugal
Barnaul, , Russian Federation
Ekaterinbourg, , Russian Federation
Izhevsk, , Russian Federation
Korolev, , Russian Federation
Krasnoyarsk, , Russian Federation
Moscow, , Russian Federation
Perm, , Russian Federation
St. Petersburg, , Russian Federation
St. Petersburg, , Russian Federation
Tolyatti, , Russian Federation
Santiago De Compostela, , Spain
Hsin Chu, , Taiwan
Dnipro, , Ukraine
Kharkiv, , Ukraine
Kharkiv, , Ukraine
Kyiv, , Ukraine
Odessa, , Ukraine
Zaporizhzhya, , Ukraine
Zhytomyr, , Ukraine
Bradford, , United Kingdom
Summerville, South Carolina, United States
Warsaw, , Poland
Køge, , Denmark
Searcy, Arkansas, United States
Lubbock, Texas, United States
Mesa, Arizona, United States
Martin, , Slovakia
Rimavska Sobota, , Slovakia
Chandler, Arizona, United States
Fontana, California, United States
Irvine, California, United States
Ciudad Autonoma Buenos Aires, , Argentina
Sofia, , Bulgaria
T'bilisi, , Georgia
T'bilisi, , Georgia
T'bilisi, , Georgia
Tnilisi, , Georgia
Monserrato, , Italy
Kaunas, , Lithuania
Lipa, , Philippines
Manila, , Philippines
Elblag, , Poland
Torun, , Poland
Kosice, , Slovakia
Nove Mesto Nad Vahom, , Slovakia
Piestany, , Slovakia
Zvolen, , Slovakia
Uppsala, , Sweden
Krakow, , Poland
Sofia, , Bulgaria
Tbilisi, , Georgia
Warszawa, , Poland
Hsin Chu, , Taiwan
Krakow, , Poland
Poznan, , Poland
San Fernando, , Philippines
Moscow, , Russian Federation
Sofia, , Bulgaria
Lodz, , Poland
Tolyatti, , Russian Federation
Warsaw, , Poland
Krakow, , Poland
Buenos Aires, , Argentina
Bialystok, , Poland
Lublin, , Poland
Gyula, , Hungary
Székesfehérvár, , Hungary
Warszawa, , Poland
Elblag, , Poland
Warszawa, , Poland
Barcelona, , Spain
A Coruña, , Spain
A Coruna, , Spain
Plovdiv, , Bulgaria
Lodz, , Poland
T'bilisi, , Georgia
Bialystok, , Poland
Poprad, , Slovakia
Coventry, , United Kingdom
Kansas City, Missouri, United States
Lodz, , Poland
Hagerstown, Maryland, United States
Phoenix, Arizona, United States
Eagan, Minnesota, United States
Sofia, , Bulgaria
Kistarcsa, , Hungary
Poznan, , Poland
Hodmezovasarhely, , Hungary
Lodz, , Poland
Nadarzyn, , Poland
Brno Zidenice, , Czechia
Hlucin, , Czechia
Ostrava, , Czechia
Uherske Hradiste, , Czechia
Bytom, , Poland
Krakow, , Poland
Sun City, Arizona, United States
Brno, , Czechia
Bytom, , Poland
Elblag, , Poland
Warsaw, , Poland
Lisboa, , Portugal
Krakow, , Poland
San Fernando Buenos Aires, , Argentina
Warsaw, , Poland
Porto, , Portugal
Lisboa, , Portugal
Barcelona, , Spain
Cordoba, , Spain
Budapest, , Hungary
Bydgoszcz, , Poland
Warszawa, , Poland
Lisboa, , Portugal
Lublin, , Poland
A Coruna, , Spain
St Johns, Newfoundland And Labrador, Canada
Eagan, Minnesota, United States
Quebec, , Canada
Málaga, , Spain
Braga, , Portugal
Lisboa, , Portugal
Lisboa, , Portugal
Porto, , Portugal
Wrocław, , Poland
Willowbrook, Illinois, United States
Tbilisi, , Georgia
Poznan, , Poland
Wroclaw, , Poland
Batumi, , Georgia
Lodz, , Poland
Swidnik, , Poland
Warszawa, , Poland
Warszawa, , Poland
Avondale, Arizona, United States
Irving, Texas, United States
Karvina Frystat, , Czechia
Lisboa, , Portugal
San Fernando, , Argentina
Lublin, , Poland
Fort Worth, Texas, United States
Nadarzyn, , Poland
Patients applied
Trial Officials
Janssen Research & Development, LLC Clinical Trial
Study Director
Janssen Research & Development, LLC
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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