Clinical trial • Phase IV • Immunology

Guselkumab for Psoriatic arthritis

Phase IV trial of Guselkumab for Psoriatic arthritis.

Overview

Trial Therapeutic Area
Immunology
Trial Disease
Psoriatic arthritis
Trial Stage
Phase IV
Drug Modality
Monoclonal antibody

Key dates

Initial CTIS Submission Date
28-03-2024
First CTIS Authorization Date
02-05-2024

Trial design

Randomised, placebo (guselkumab 1 ml pfs placebo) versus guselkumab - solution for injection in pre-filled syringe - 100 mg/ml administered subcutaneously; dosing schedule not specified in the provided ctis data.-controlled Phase IV trial across 75 sites in Spain, Portugal, Bulgaria and others.

Randomised
Yes
Comparator
Placebo (Guselkumab 1 mL PFS Placebo) versus Guselkumab - solution for injection in pre-filled syringe - 100 mg/mL administered subcutaneously; dosing schedule not specified in the provided CTIS data.
Target Sample Size
172

Eligibility

Recruits 172 Vulnerable population selected in CTIS (isVulnerablePopulationSelected = true). Country-specific caregiver information and informed consent forms are provided (documents titled 'SIS and ICF Caregiver', 'Caregiver ICF', 'Country Specific Master Caregiver ICF' etc.). Subject information sheets (SIS) and ICF Master documents and country-specific addenda are included, indicating caregiver-specific consent pathways are available. Participants must be adults (inclusion: "Be at least 18 years of age")..

Vulnerable Population
Vulnerable population selected in CTIS (isVulnerablePopulationSelected = true). Country-specific caregiver information and informed consent forms are provided (documents titled 'SIS and ICF Caregiver', 'Caregiver ICF', 'Country Specific Master Caregiver ICF' etc.). Subject information sheets (SIS) and ICF Master documents and country-specific addenda are included, indicating caregiver-specific consent pathways are available. Participants must be adults (inclusion: "Be at least 18 years of age").

Inclusion criteria

  • {"criterion_text":"- 1. Be at least 18 years of age"}
  • {"criterion_text":"- 2. Have a diagnosis of 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."}
  • {"criterion_text":"- 3. Have active PsA as defined by: At least 3 swollen joints and at least 3 tender joints at screening and at baseline and C-reactive protein ≥0.3 mg/dL at screening from the central laboratory."}
  • {"criterion_text":"- 4. Have a BASDAI score of at least 4."}
  • {"criterion_text":"- 5. Have magnetic resonance imaging-confirmed PsA axial disease"}
  • {"criterion_text":"- 6. Have a spinal pain score of at least 4."}
  • {"criterion_text":"- 7. Have active plaque psoriasis, with at least one psoriatic plaque of ≥2 cm diameter and/or nail changes consistent with psoriasis, or documented history of plaque psoriasis."}
  • {"criterion_text":"- 8. Have active PsA despite previous non-biologic DMARD, apremilast, and/or NSAID therapy."}

Exclusion criteria

  • {"criterion_text":"- 1. Has other inflammatory diseases that might confound the evaluations of benefit of guselkumab therapy, including but not limited to rheumatoid arthritis, ankylosing spondylitis/non-radiographic-axial spondyloarthritis, systemic lupus erythematosus, or Lyme disease."}
  • {"criterion_text":"- 10. Has or has had a serious infection or has been hospitalized or received IV antibiotics for an infection within 2 months prior to screening."}
  • {"criterion_text":"- 2. Has previously received any biologic treatment including, but not limited to, guselkumab, ustekinumab, secukinumab, tildrakizumab, ixekizumab, brodalumab, risankizumab or other investigative biologic treatment."}
  • {"criterion_text":"- 3. Has ever received a Janus kinase inhibitor including but not limited to tofacitinib, baricitinib, filgotinib, peficitinib, decernotinib, upadacitinib or any other investigational JAK inhibitor."}
  • {"criterion_text":"- 4. Has received any systemic immunosuppressants within 4 weeks of the first administration of study intervention."}
  • {"criterion_text":"- 5. Has received apremilast within 4 weeks prior to the first administration of study intervention."}
  • {"criterion_text":"- 6. Has received non-biologic DMARDs other than MTX, SSZ, HCQ, LEF, within 4 weeks before the first administration of study intervention."}
  • {"criterion_text":"- 7. Currently has a malignancy or has a history of malignancy within 5 years prior to screening"}
  • {"criterion_text":"- 8. Has a history of lymphoproliferative disease, including lymphoma; a history of monoclonal gammopathy of undetermined significance; or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy or splenomegaly."}
  • {"criterion_text":"- 9. Has a history of chronic or recurrent infectious disease, including but not limited to chronic renal infection, chronic chest infection, recurrent urinary tract infection fungal infection, or open, draining, or infected skin wounds or ulcers."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Change from baseline in BASDAI at Week 24.","definition_or_measurement_approach":"BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) score measured at baseline and at Week 24; primary endpoint is the change from baseline at Week 24."}

Recruitment

Planned Sample Size
172
Recruitment Window Months
66
Consent Approach
Informed consent is handled with Subject Information Sheets (SIS) and Informed Consent Forms (ICF) (documents titled 'SIS and ICF Master', country-specific addenda, 'Pregnant Partner ICF', 'Caregiver ICF', 'Withdrawal ICF', 'Optional Sub Study ICF', etc.). Country-specific ICF addenda and caregiver ICFs are provided (multiple languages/country versions are present in the documents list: PT, SE, DE, IT, CZ, BG, ES, HU, SK, PL and others). Consent is provided by the participant; caregiver-specific consent forms are available where relevant. Participants must be ≥18 years; no assent for minors is indicated in the provided materials.

Methods

  • Country-specific recruitment materials (posters, participant posters) — documents titled 'REDACTED_K2_Recruitment material_Participant Poster' (multiple country-specific versions, e.g., PT, SE, HU, BG, IT, CZ, PL, SK, ES, etc.).
  • Participant recruitment brochures and resource/participant guides — documents titled 'Participant Recruit Brochure' / 'Participant Resource Guide' (country-specific versions).
  • ICF Flip / Flipchart materials for informed consent discussions — documents titled 'ICF Flip', 'ICF Flip Chart' (country-specific).
  • Placebo leaflets and informational leaflets — documents titled 'Placebo Leaflet' (country-specific).
  • Appointment reminder cards, visit cards, thank-you cards and subject wallet cards — documents titled 'Appointment Reminder Card', 'Visit Card', 'Thank you Card', 'Subject Wallet Card' (country-specific).
  • Recruitment flyers and detection-of-potential-patients materials — documents titled 'Recruitment material Flyer', 'Detection Potential Patients' (country-specific).

Geography

Total Number Of Sites
75
Total Number Of Participants
236

Spain

Earliest CTIS Part Ii Submission Date
18-04-2024
Latest Decision Or Authorization Date
30-04-2026
Processing Time Days
742
Number Of Sites
11
Number Of Participants
15

Sites

Site Name
Complexo Hospitalario Universitario A Coruna
Department Name
Reumatology
Principal Investigator Name
Francisco Javier Blanco Garcia
Principal Investigator Email
fblagar@sergas.es
Contact Person Name
Francisco Javier Blanco Garcia
Contact Person Email
fblagar@sergas.es
Site Name
Hospital Quironsalud Sagrado Corazon
Department Name
Reumatology
Principal Investigator Name
Paula Cejas Caceres
Principal Investigator Email
pcejashil@gmail.com
Contact Person Name
Paula Cejas Caceres
Contact Person Email
pcejashil@gmail.com
Site Name
Hospital Universitario Regional De Malaga
Department Name
Reumatology
Principal Investigator Name
Antonio Fernandez Nebro
Principal Investigator Email
afnebro@gmail.com
Contact Person Name
Antonio Fernandez Nebro
Contact Person Email
afnebro@gmail.com
Site Name
Hospital Universitario De Cruces
Department Name
Reumatology
Principal Investigator Name
Fernando Perez Ruiz
Principal Investigator Email
Fernando.Perezruiz@osakidetza.eus
Contact Person Name
Fernando Perez Ruiz
Site Name
Parc Tauli Hospital Universitari
Department Name
Reumatology
Principal Investigator Name
Jordi Gratacos Masmitja
Principal Investigator Email
jgratacosmas@gmail.com
Contact Person Name
Jordi Gratacos Masmitja
Contact Person Email
jgratacosmas@gmail.com
Site Name
Hospital Universitario Virgen De La Macarena
Department Name
Reumatology
Principal Investigator Name
Jose Perez Venegas
Principal Investigator Email
perez.venegas@gmail.com
Contact Person Name
Jose Perez Venegas
Contact Person Email
perez.venegas@gmail.com
Site Name
Hospital General Universitario Reina Sofia
Department Name
Reumatology
Principal Investigator Name
Maria Dolores Lopez Montilla
Principal Investigator Email
mariadolores.lopezmontilla@gmail.com
Contact Person Name
Maria Dolores Lopez Montilla
Site Name
Hospital Universitario Basurto
Department Name
Reumatology
Principal Investigator Name
Eva Galindez
Principal Investigator Email
EVA.GALINDEZAGUIRREGOIKOA@osakidetza.eus
Contact Person Name
Eva Galindez
Site Name
Hospital Clinic De Barcelona
Department Name
Reumatology
Principal Investigator Name
Julio Ramirez
Principal Investigator Email
fjramire@clinic.cat
Contact Person Name
Julio Ramirez
Contact Person Email
fjramire@clinic.cat
Site Name
Clinica Gaias Santiago
Department Name
Reumatology
Principal Investigator Name
Juan Amarelo Ramos
Principal Investigator Email
juan.amarelo@gaiasresearch.com
Contact Person Name
Juan Amarelo Ramos
Contact Person Email
juan.amarelo@gaiasresearch.com
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
Reumatology
Principal Investigator Name
Jose Andres Roman Ivorra
Principal Investigator Email
roman_jan@gva.es
Contact Person Name
Jose Andres Roman Ivorra
Contact Person Email
roman_jan@gva.es

Portugal

Earliest CTIS Part Ii Submission Date
18-04-2024
Latest Decision Or Authorization Date
30-12-2025
Processing Time Days
621
Number Of Sites
7
Number Of Participants
5

Sites

Site Name
Unidade Local de Saude de Sao Joao E.P.E.
Department Name
Serviço de Reumatologia
Principal Investigator Name
Miguel Bernardes
Principal Investigator Email
mbernardes09@gmail.com
Contact Person Name
Miguel Bernardes
Contact Person Email
mbernardes09@gmail.com
Site Name
Instituto Portugues De Reumatologia
Department Name
Serviço de Reumatologia
Principal Investigator Name
Luis Cunha Miranda
Principal Investigator Email
lcunhamiranda@hotmail.com
Contact Person Name
Luis Cunha Miranda
Contact Person Email
lcunhamiranda@hotmail.com
Site Name
Unidade Local De Saude Da Guarda E.P.E.
Department Name
Serviço de Reumatologia
Principal Investigator Name
Claudia Vaz
Principal Investigator Email
claudiacvaz@gmail.com
Contact Person Name
Claudia Vaz
Contact Person Email
claudiacvaz@gmail.com
Site Name
Unidade Local De Saude De Santa Maria E.P.E.
Department Name
Serviço de Reumatologia
Principal Investigator Name
Elsa Sousa
Principal Investigator Email
elsa-sousa@hotmail.com
Contact Person Name
Elsa Sousa
Contact Person Email
elsa-sousa@hotmail.com
Site Name
CCAB Centro Clinico Academico Braga Associacao
Department Name
Serviço de Reumatologia
Principal Investigator Name
Marcos Cerqueira
Principal Investigator Email
marcos.m.cerqueira@gmail.com
Contact Person Name
Marcos Cerqueira
Contact Person Email
marcos.m.cerqueira@gmail.com
Site Name
Unidade Local De Saude De Lisboa Ocidental E.P.E.
Department Name
Serviço de Reumatologia
Principal Investigator Name
Fernando Pimentel Santos
Principal Investigator Email
pimentel.santos@gmail.com
Contact Person Name
Fernando Pimentel Santos
Contact Person Email
pimentel.santos@gmail.com
Site Name
Unidade Local De Saude Do Alto Minho E.P.E.
Department Name
Serviço de Reumatologia
Principal Investigator Name
Jose Antonio Costa
Principal Investigator Email
jose.costa@ulsam.min-saude.pt
Contact Person Name
Jose Antonio Costa
Contact Person Email
jose.costa@ulsam.min-saude.pt

Bulgaria

Earliest CTIS Part Ii Submission Date
18-04-2024
Latest Decision Or Authorization Date
23-04-2026
Processing Time Days
735
Number Of Sites
6
Number Of Participants
21

Sites

Site Name
University Multiprofile Hospital For Active Treatment Dr. Georgi Stranski EAD
Department Name
Rheumatology Clinic
Principal Investigator Name
Borislava Zhelezarova-Vasileva
Principal Investigator Email
borislavav@yahoo.com
Contact Person Name
Borislava Zhelezarova-Vasileva
Contact Person Email
borislavav@yahoo.com
Site Name
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD
Department Name
Clinic of Rheumatology
Principal Investigator Name
Rasho Rashkov
Principal Investigator Email
proff_rashkov@yahoo.com
Contact Person Name
Rasho Rashkov
Contact Person Email
proff_rashkov@yahoo.com
Site Name
Medical Center Artmed Ltd.
Department Name
Not applicable
Principal Investigator Name
Mariela Geneva-Popova
Principal Investigator Email
genevapopova@yahoo.com
Contact Person Name
Mariela Geneva-Popova
Contact Person Email
genevapopova@yahoo.com
Site Name
Medical Center Exacta Medica OOD
Department Name
Not applicable
Principal Investigator Name
Krasimira Tsoneva
Principal Investigator Email
ktsoneva2011@abv.bg
Contact Person Name
Krasimira Tsoneva
Contact Person Email
ktsoneva2011@abv.bg
Site Name
University Multiprofile Hospital For Active Treatment Kaspela EOOD
Department Name
Rheumatology Clinic
Principal Investigator Name
Anastas Batalov
Principal Investigator Email
abatalov@hotmail.com
Contact Person Name
Anastas Batalov
Contact Person Email
abatalov@hotmail.com
Site Name
Mbal Lyulin EAD
Department Name
Rheumatology department
Principal Investigator Name
Krasimira Stanimirova
Principal Investigator Email
krasina_stan@abv.bg
Contact Person Name
Krasimira Stanimirova
Contact Person Email
krasina_stan@abv.bg

Czechia

Earliest CTIS Part Ii Submission Date
18-04-2024
Latest Decision Or Authorization Date
02-04-2026
Processing Time Days
714
Number Of Sites
6
Number Of Participants
10

Sites

Site Name
Revmatologicky Ustav
Department Name
Not applicable
Principal Investigator Name
Herman Mann
Principal Investigator Email
mann@revma.cz
Contact Person Name
Herman Mann
Contact Person Email
mann@revma.cz
Site Name
Revmacentrum MUDr. Mostera s.r.o.
Department Name
Not applicable
Principal Investigator Name
Erik Moster
Principal Investigator Email
emoster@revmacentrum.cz
Contact Person Name
Erik Moster
Contact Person Email
emoster@revmacentrum.cz
Site Name
L.K.N. Arthrocentrum s.r.o.
Department Name
Not applicable
Principal Investigator Name
Libor Novosad
Principal Investigator Email
libor.novosad@email.cz
Contact Person Name
Libor Novosad
Contact Person Email
libor.novosad@email.cz
Site Name
MUDr. Rosypalova s.r.o.
Department Name
Not applicable
Principal Investigator Name
Miroslava Rosypalova
Principal Investigator Email
mirka.rosypalova@seznam.cz
Contact Person Name
Miroslava Rosypalova
Contact Person Email
mirka.rosypalova@seznam.cz
Site Name
Revimex pro s.r.o.
Department Name
Not applicable
Principal Investigator Name
Gabriela Stolarz
Principal Investigator Email
revimex@email.cz
Contact Person Name
Gabriela Stolarz
Contact Person Email
revimex@email.cz
Site Name
Medical Plus s.r.o.
Department Name
Not applicable
Principal Investigator Name
Eva Dokoupilova
Principal Investigator Email
evadokoupil@gmail.com
Contact Person Name
Eva Dokoupilova
Contact Person Email
evadokoupil@gmail.com

Sweden

Earliest CTIS Part Ii Submission Date
18-04-2024
Latest Decision Or Authorization Date
23-12-2025
Processing Time Days
614
Number Of Sites
2
Number Of Participants
4

Sites

Site Name
Karolinska University Hospital
Department Name
Reumatologkliniken
Principal Investigator Name
Aikaterini Chatzidonysiou
Principal Investigator Email
aikaterini.chatzidionysiou@ki.se
Contact Person Name
Aikaterini Chatzidonysiou
Site Name
Uppsala University Hospital
Department Name
Reumatologmottagningen
Principal Investigator Name
Agnes Sarolta Szentpetery
Principal Investigator Email
agnes.sarolta.szentpetery@akademiska.se
Contact Person Name
Agnes Sarolta Szentpetery

Germany

Earliest CTIS Part Ii Submission Date
18-04-2024
Latest Decision Or Authorization Date
07-01-2026
Processing Time Days
629
Number Of Sites
2
Number Of Participants
4

Sites

Site Name
St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr
Department Name
Rheumatologie
Principal Investigator Name
Uta Kiltz
Principal Investigator Email
uta.kiltz@elisabethgruppe.de
Contact Person Name
Uta Kiltz
Contact Person Email
uta.kiltz@elisabethgruppe.de
Site Name
ISA Interdisciplinary Study Association GmbH
Principal Investigator Name
Margrit Simon
Principal Investigator Email
msimon@isa-research.de
Contact Person Name
Margrit Simon
Contact Person Email
msimon@isa-research.de

Denmark

Earliest CTIS Part Ii Submission Date
18-04-2024
Latest Decision Or Authorization Date
22-12-2025
Processing Time Days
613
Number Of Sites
3
Number Of Participants
11

Sites

Site Name
Frederiksberg Hospital
Department Name
Parker Instituttet
Principal Investigator Name
Bjarke Brandt Hansen
Principal Investigator Email
bjarke.brandt.hansen@regionh.dk
Contact Person Name
Bjarke Brandt Hansen
Site Name
Region Sjaelland
Department Name
Rheumatological Outpatient Department
Principal Investigator Name
Ada Colic
Principal Investigator Email
adco@regionsjaelland.dk
Contact Person Name
Ada Colic
Contact Person Email
adco@regionsjaelland.dk
Site Name
Lillebaelt Hospital
Department Name
Medicinsk afdeling
Principal Investigator Name
Tine Lottenburger
Principal Investigator Email
Tine.Lottenburger@rsyd.dk
Contact Person Name
Tine Lottenburger
Contact Person Email
Tine.Lottenburger@rsyd.dk

Italy

Earliest CTIS Part Ii Submission Date
18-04-2024
Latest Decision Or Authorization Date
23-12-2025
Processing Time Days
614
Number Of Sites
6
Number Of Participants
7

Sites

Site Name
Azienda Ospedaliero Universitaria Delle Marche
Department Name
Dipartimento di Medicina Interna - Clinica Medica
Principal Investigator Name
Michele Maria Luchetti
Principal Investigator Email
m.luchetti@staff.univpm.it
Contact Person Name
Michele Maria Luchetti
Contact Person Email
m.luchetti@staff.univpm.it
Site Name
Azienda Ospedaliera Universitaria Integrata Verona
Department Name
UOC Reumatologia
Principal Investigator Name
Angelo Fassio
Principal Investigator Email
angelo.fassio@aovr.veneto.it
Contact Person Name
Angelo Fassio
Contact Person Email
angelo.fassio@aovr.veneto.it
Site Name
Azienda Ospedaliero-Universitaria Di Cagliari
Department Name
UO Reumatologia
Principal Investigator Name
Alberto Cauli
Principal Investigator Email
cauli@unica.it
Contact Person Name
Alberto Cauli
Contact Person Email
cauli@unica.it
Site Name
Azienda Ospedaliera Policlinico Universitario Tor Vergata
Department Name
UOC Reumatologia
Principal Investigator Name
Maria Sole Chimenti
Principal Investigator Email
maria.sole.chimenti@uniroma2.it
Contact Person Name
Maria Sole Chimenti
Site Name
Azienda USL IRCCS Di Reggio Emilia
Department Name
UO Reumatologia
Principal Investigator Name
Filippo Crescentini
Principal Investigator Email
Filippo.crescentini@ausl.re.it
Contact Person Name
Filippo Crescentini
Contact Person Email
Filippo.crescentini@ausl.re.it
Site Name
Humanitas Research Hospital
Department Name
UO Reumatologia e Immunologia
Principal Investigator Name
Francesco Selmi
Principal Investigator Email
carlo.selmi@hunimed.eu
Contact Person Name
Francesco Selmi
Contact Person Email
carlo.selmi@hunimed.eu

Slovakia

Earliest CTIS Part Ii Submission Date
18-04-2024
Latest Decision Or Authorization Date
03-02-2026
Processing Time Days
656
Number Of Sites
5
Number Of Participants
22

Sites

Site Name
Reum.hapi s.r.o.
Department Name
Reumatologická ambulancia
Principal Investigator Name
Marianna Hauptvoglová
Principal Investigator Email
hauptvoglova.reumhapi@gmail.com
Contact Person Name
Marianna Hauptvoglová
Site Name
Reumamed Poprad s.r.o.
Department Name
Reumatologická ambulancia
Principal Investigator Name
Daniela Tkáčová
Principal Investigator Email
dankabud@hotmail.com
Contact Person Name
Daniela Tkáčová
Contact Person Email
dankabud@hotmail.com
Site Name
Reumex s.r.o.
Department Name
Reumatologická ambulancia
Principal Investigator Name
Viola Husárová
Principal Investigator Email
husarov001@gmail.com
Contact Person Name
Viola Husárová
Contact Person Email
husarov001@gmail.com
Site Name
Thermium s.r.o.
Department Name
Reumatologická ambulancia
Principal Investigator Name
Ivan Rybár
Principal Investigator Email
ivan.rybar@yahoo.com
Contact Person Name
Ivan Rybár
Contact Person Email
ivan.rybar@yahoo.com
Site Name
Medman s.r.o.
Department Name
Reumatologická ambulancia
Principal Investigator Name
Viliam Maňka
Principal Investigator Email
vilcoo@gmail.com
Contact Person Name
Viliam Maňka
Contact Person Email
vilcoo@gmail.com

Hungary

Earliest CTIS Part Ii Submission Date
18-04-2024
Latest Decision Or Authorization Date
06-05-2026
Processing Time Days
748
Number Of Sites
8
Number Of Participants
22

Sites

Site Name
Betegapolo Irgalmasrend Budai Irgalmasrendi Korhaz
Principal Investigator Name
Gyorgyi Meszaros
Principal Investigator Email
mesz.gyorgyi@gmail.com
Contact Person Name
Gyorgyi Meszaros
Contact Person Email
mesz.gyorgyi@gmail.com
Site Name
Bekes Varmegyei Koezponti Korhaz
Department Name
Reumatológia
Principal Investigator Name
Péter Keszthelyi
Principal Investigator Email
keszthelyi.peter@bmkk.eu
Contact Person Name
Péter Keszthelyi
Contact Person Email
keszthelyi.peter@bmkk.eu
Site Name
Obudai Egeszseguegyi Centrum Kft.
Principal Investigator Name
Gyorgyi Tatar
Principal Investigator Email
reuma@hotmail.hu
Contact Person Name
Gyorgyi Tatar
Contact Person Email
reuma@hotmail.hu
Site Name
Fejer Varmegyei Szent Gyoergy Egyetemi Oktato Korhaz
Department Name
Reumatológia
Principal Investigator Name
Judit Pulai
Principal Investigator Email
juditpulai@yahoo.com
Contact Person Name
Judit Pulai
Contact Person Email
juditpulai@yahoo.com
Site Name
Vasarhelyi Sarkanyfu Kft.
Department Name
Reumatologia
Principal Investigator Name
Eva Balazs
Principal Investigator Email
jimbies@gmail.hu
Contact Person Name
Eva Balazs
Contact Person Email
jimbies@gmail.hu
Site Name
Qualiclinic Kft.
Department Name
Reumatologia
Principal Investigator Name
Istvan Szombati
Principal Investigator Email
i.szombati@qclinic.hu
Contact Person Name
Istvan Szombati
Contact Person Email
i.szombati@qclinic.hu
Site Name
Kistarcsai Flor Ferenc Korhaz
Principal Investigator Name
Edit Toth
Principal Investigator Email
drtothedit@florhosp.hu
Contact Person Name
Edit Toth
Contact Person Email
drtothedit@florhosp.hu
Site Name
Vital-Medicina Kft.
Principal Investigator Name
Edit Drescher
Principal Investigator Email
drescher@invitel.hu
Contact Person Name
Edit Drescher
Contact Person Email
drescher@invitel.hu

Poland

Earliest CTIS Part Ii Submission Date
18-04-2024
Latest Decision Or Authorization Date
07-05-2026
Processing Time Days
749
Number Of Sites
19
Number Of Participants
115

Sites

Site Name
Twoja Przychodnia Poznańskie Centrum Medyczne Sp. z o.o.
Principal Investigator Name
Agata Wytyk-Nowak
Principal Investigator Email
wytyk@twojaprzychodnia.com
Contact Person Name
Agata Wytyk-Nowak
Contact Person Email
wytyk@twojaprzychodnia.com
Site Name
Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A.
Principal Investigator Name
Joanna Hilt
Principal Investigator Email
j.hilt@ctw.com.pl
Contact Person Name
Joanna Hilt
Contact Person Email
j.hilt@ctw.com.pl
Site Name
Reumedika Sp. z o.o.
Principal Investigator Name
Wieslawa Porawska
Principal Investigator Email
wporawska@reumedika.pl
Contact Person Name
Wieslawa Porawska
Contact Person Email
wporawska@reumedika.pl
Site Name
Ambulatorium Sp. z o.o.
Principal Investigator Name
Anna Bazela-Ostromecka
Principal Investigator Email
ambulatorium@ambulatorium.pl
Contact Person Name
Anna Bazela-Ostromecka
Contact Person Email
ambulatorium@ambulatorium.pl
Site Name
Velocity Nova Sp. z o.o.
Department Name
Velocity Lublin
Principal Investigator Name
Katarzyna Zelazowska
Principal Investigator Email
katarzyna.zelazowska@komed-ck.pl
Contact Person Name
Katarzyna Zelazowska
Site Name
Centrum Medyczne Amed Sp. z o.o.
Department Name
Centrum Medyczne AMED Targowek
Principal Investigator Name
Agnieszka Jurek-Urbanowska
Principal Investigator Email
agnieszka.urbanowska@futuremeds.com
Contact Person Name
Agnieszka Jurek-Urbanowska
Site Name
Malopolskie Badania Kliniczne Sp. z o.o.
Principal Investigator Name
Bogdan Batko
Principal Investigator Email
bogbat@poczta.onet.pl
Contact Person Name
Bogdan Batko
Contact Person Email
bogbat@poczta.onet.pl
Site Name
Rheuma Medicus Sp. z o.o.
Principal Investigator Name
Maria Rell-Bakalarska
Principal Investigator Email
rejestracja@rheuma-medicus.pl
Contact Person Name
Maria Rell-Bakalarska
Contact Person Email
rejestracja@rheuma-medicus.pl
Site Name
Dermed Centrum Medyczne Sp. z o.o.
Principal Investigator Name
Andrzej Kaszuba
Principal Investigator Email
andrzej.kaszuba@dermed.com.pl
Contact Person Name
Andrzej Kaszuba
Contact Person Email
andrzej.kaszuba@dermed.com.pl
Site Name
Reumed Sp. z o.o.
Department Name
Reumed Zespol Poradni Specjalistycznych Filia nr 1
Principal Investigator Name
Marcin Mazurek
Principal Investigator Email
mamazurek@tlen.pl
Contact Person Name
Marcin Mazurek
Contact Person Email
mamazurek@tlen.pl
Site Name
Medicover Integrated Clinical Services Sp. z o.o.
Department Name
MICS Centrum Medyczne Torun
Principal Investigator Name
Slawomir Jeka
Principal Investigator Email
s.jeka@wp.pl
Contact Person Name
Slawomir Jeka
Contact Person Email
s.jeka@wp.pl
Site Name
Futuremeds Sp. z o.o.
Department Name
Centrum Medyczne AMED oddzial w Lodzi
Principal Investigator Name
Katarzyna Bartnicka-Maslowska
Principal Investigator Email
katarzyna.bartnicka@amed.med.pl
Contact Person Name
Katarzyna Bartnicka-Maslowska
Site Name
NZOZ Lecznica Mak Med s.c.
Principal Investigator Name
Marek Krogulec
Principal Investigator Email
marekkrogulec@wp.pl
Contact Person Name
Marek Krogulec
Contact Person Email
marekkrogulec@wp.pl
Site Name
Pro Life Medica Sp. z o.o.
Department Name
ETG Lublin
Principal Investigator Name
Barbara Nieradko-Iwanicka
Principal Investigator Email
b.nieradkoiwanicka@etg-network.com
Contact Person Name
Barbara Nieradko-Iwanicka
Site Name
Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy
Department Name
Klinika Reumatologii i Układowych Chorób Tkanki Łącznej
Principal Investigator Name
Rafal Wojciechowski
Principal Investigator Email
praktykalekarska@gmail.com
Contact Person Name
Rafal Wojciechowski
Contact Person Email
praktykalekarska@gmail.com
Site Name
Medicover Integrated Clinical Services Sp. z o.o.
Department Name
MICS Centrum Medyczne Warszawa
Principal Investigator Name
Agnieszka Zielinska
Principal Investigator Email
agnieszkazielinska@medycynakliniczna.pl
Contact Person Name
Agnieszka Zielinska
Site Name
Wromedica I Bielicka A Strzalkowska s.c.
Principal Investigator Name
Jerzy Swierkot
Principal Investigator Email
jurekswierkot0@poczta.onet.pl
Contact Person Name
Jerzy Swierkot
Contact Person Email
jurekswierkot0@poczta.onet.pl
Site Name
Tomasz Blicharski Lubelskie Centrum Diagnostyczne
Principal Investigator Name
Tomasz Blicharski
Principal Investigator Email
blicharski@vp.pl
Contact Person Name
Tomasz Blicharski
Contact Person Email
blicharski@vp.pl
Site Name
Clinicmed Daniluk Nowak Sp. k.
Principal Investigator Name
Stefan Daniluk
Principal Investigator Email
daniluk@clinicmed.pl
Contact Person Name
Stefan Daniluk
Contact Person Email
daniluk@clinicmed.pl
Site Name
Twoja Przychodnia Nowosolskie Centrum Medyczne Sp. z o.o.
Department Name
Twoja Przychodnia - Centrum Medyczne Nowa Sol
Principal Investigator Name
Malgorzata Miakisz
Principal Investigator Email
miakisz@twojaprzychodnia.com
Contact Person Name
Malgorzata Miakisz
Contact Person Email
miakisz@twojaprzychodnia.com

Sponsor

Primary sponsor

Full Name
Janssen - Cilag International
Organisation Type
Pharmaceutical company
Country Of Registered Address
Belgium

Contract research organisations

Name
Iqvia Rds Inc.
Responsibilities
responsible for non-core country management for Philippines and Georgia
Name
IQVIA Limited
Responsibilities
PK Office and Blinding Data Services
Name
Almac Clinical Technologies LLC
Responsibilities
sponsorDuties code 3 (responsibility entry present in CTIS record)
Name
Bioclinica Inc.
Responsibilities
Medical Imaging
Name
Kcas LLC
Responsibilities
PK analysis

Third parties

  • {"country":"Denmark","full_name":"Nordic Bioscience A/S","duties_or_roles":"Serum analysis of specific (joint/axial) disease markers","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Iqvia Rds Inc.","duties_or_roles":"responsible for non-core country management for Philippines and Georgia","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Infinity Biologix LLC","duties_or_roles":"PMDA genetic testing","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Qd Solutions Inc.","duties_or_roles":"Branding/creative/logo, recruitment materials, print and production","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"PK Office and Blinding Data Services","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Kcas LLC","duties_or_roles":"PK analysis","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Pestka Biomedical Laboratories Inc.","duties_or_roles":"Targeted PD and Disease markers","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Almac Clinical Technologies LLC","duties_or_roles":"code 3 (sponsorDuties entry without textual value in CTIS record)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"ePRO vendor","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"Medical Imaging","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"central laboratory services (sponsorDuties code 4)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Ancillare LP","duties_or_roles":"medical supplies/equipment","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Guselkumab - solution for injection in pre-filled syringe - 100 mg/mL
Active Substance
Guselkumab
Modality
Monoclonal antibody
Routes Of Administration
Subcutaneous use
Route
Subcutaneous
Authorisation Status
Authorised (prodAuthStatus=1)
Investigational Product Name
Guselkumab 1 mL PFS Placebo
Modality
Other

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