Clinical trial • Phase III • Immunology
GUSELKUMAB for Psoriatic arthritis
Phase III trial of GUSELKUMAB for Psoriatic arthritis.
Overview
- Trial Therapeutic Area
- Immunology
- Trial Disease
- Psoriatic arthritis
- Trial Stage
- Phase III
- Drug Modality
- Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 21-06-2024
- First CTIS Authorization Date
- 24-07-2024
Trial design
Randomised, placebo to guselkumab solution for injection in pre-filled syringe 100 mg/ml (placebo comparator). active investigational product: guselkumab - solution for injection in pre-filled syringe - 100 mg/ml. dose and schedule not specified in the ctis part i product listing.-controlled Phase III trial in Slovakia, Poland, Greece and others.
- Randomised
- Yes
- Comparator
- Placebo to Guselkumab Solution for injection in pre-filled syringe 100 mg/ml (placebo comparator). Active investigational product: Guselkumab - solution for injection in pre-filled syringe - 100 mg/mL. Dose and schedule not specified in the CTIS Part I product listing.
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 548
- Trial Duration For Participant
- 1092
Eligibility
Recruits 548 Vulnerable population flag selected in CTIS. Informed consent obtained from each adult participant (minimum age 18). Country-specific subject information and informed consent forms (ICFs) are provided, including 'Country ICF Main Adult', caregiver ICFs, genetic research ICFs and 'Pregnant Partner' information forms. ICFs and recruitment materials (brochures, posters, patient letters, study guides) are available in local languages and in English as shown in the document set. Because minimum age is 18, no minor assent processes are required..
- Vulnerable Population
- Vulnerable population flag selected in CTIS. Informed consent obtained from each adult participant (minimum age 18). Country-specific subject information and informed consent forms (ICFs) are provided, including 'Country ICF Main Adult', caregiver ICFs, genetic research ICFs and 'Pregnant Partner' information forms. ICFs and recruitment materials (brochures, posters, patient letters, study guides) are available in local languages and in English as shown in the document set. Because minimum age is 18, no minor assent processes are required.
Inclusion criteria
- {"criterion_text":"-Be at least 18 years of age (or the legal age of consent in the jurisdiction in which the study is taking place)\n-If currently using non-biologic DMARDs (limited to MTX, SSZ, HCQ, or LEF), participants should have started treatment at least 3 months and the dose must be stable for at least 4 weeks before first administration of study intervention and should have no serious toxic side effects attributable to the non-biologic DMARD. If currently not using MTX, SSZ, or HCQ, must not have received for at least 4 weeks before first administration of study intervention. If currently not using LEF, must not have received for at least 12 weeks before first administration of study intervention. a.If using MTX, the route of administration and dose must be stable and the dose must be ≤25 mg/week. b.If receiving SSZ, the dose must be ≤3g/day. c.If receiving HCQ, the dose must be ≤400 mg/day. d.If receiving LEF, the dose must be ≤20 mg/day.\n-Have active plaque psoriasis, with at least one psoriatic plaque of ≥ 2cm diameter and/or nail changes consistent with psoriasis.\n-If using NSAIDs or other analgesics for PsA at baseline, participants must be on a stable dose for at least 2 weeks prior to the first administration of study intervention. If currently not using NSAIDs or other analgesics for PsA, must not have received NSAIDs or other analgesics for PsA within 2 weeks prior to the first administration of study intervention.\n-If using oral corticosteroids at baseline, participants must be on a stable dose equivalent to ≤10 mg of prednisone/day for at least 2 weeks prior to the first administration of study intervention. If not currently using oral corticosteroids, the participant must not have received oral corticosteroids within 2 weeks prior to the first administration of study intervention.\n-Have active PsA despite previous non-biologic DMARD, apremilast, and/or NSAID therapy.\n-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.\n-Have active PsA as defined by: a. At least three swollen joints and three tender joints at screening and at baseline -AND- b. CRP ≥ 0.3 mg/dL at screening from the central laboratory.\n-Have ≥2 joints with erosions on baseline radiographs of the hands and feet as determined by central read.\n-Have at least one of the following PsA subsets: distal interphalangeal joint involvement, polyarticular arthritis with absence of rheumatoid nodules, asymmetric peripheral arthritis, or spondylitis with peripheral arthritis."}
Exclusion criteria
- {"criterion_text":"-Has known allergies, hypersensitivity, or intolerance to study intervention or its excipients.\n-Has other inflammatory diseases that might confound the evaluations of benefit of guselkumab therapy, including but not limited to RA, axial spondyloarthritis (AS)/non-radiographic axial spondyloarthritis (nr- axSpA), systemic lupus erythematosus, or Lyme disease (confirmed by Western blot).\n-Has the arthritis mutilans subset of PsA.\n-Has previously received any biologic treatment including, but not limited to, guselkumab, ustekinumab, secukinumab, anti-TNFα agents (such as adalimumab, etanercept, infliximab, golimumab SC or intravenous (IV), certolizumab pegol, or their respective biosimilars), tildrakizumab, ixekizumab, brodalumab, risankizumab or other investigative biologic treatment for PsA or psoriasis.\n-Has ever received tofacitinib, baricitinib, filgotinib, peficitinib, decernotinib, upadacitinib or any other Janus kinase (JAK) inhibitor.\n-Has received any systemic immunosuppressants (eg, azathioprine, cyclosporine, 6 thioguanine, mercaptopurine, mycophenolate mofetil, hydroxyurea, tacrolimus) within 4 weeks of the first administration of study intervention.\n-Has received non-biologic DMARDs other than MTX, SSZ, HCQ, LEF, within 4 weeks before the first administration of study intervention.\n-Is receiving 3 or more non-biologic DMARDs specified in Table 3 at baseline. Note: participants cannot be on concomitant MTX and LEF.\n-Has received phototherapy or any systemic medications/treatments that could affect psoriasis evaluations (including, but not limited to, retinoids, 1,25-dihydroxy vitamin D3 and analogues, psoralens, fumaric acid derivatives, with the exception of those in Table 3) within 4 weeks of the first administration of study intervention."}
Endpoints
Primary endpoints
- {"endpoint_text":"-Proportion of participants with American College of Rheumatology (ACR) 20 response at Week 24.","definition_or_measurement_approach":"Measured as the proportion of participants achieving an ACR20 response at Week 24 (ACR20 response assessed per American College of Rheumatology criteria at Week 24)."}
Recruitment
- Planned Sample Size
- 548
- Recruitment Window Months
- 78
- Consent Approach
- Informed consent is obtained from each participant (minimum age 18). Country-specific ICFs (Country ICF Main Adult) are provided for each participating country; caregiver ICFs, genetic research ICFs and 'Pregnant Partner' information are available where applicable. ICFs are provided in local languages and English as per the document list. Consent is provided by the participant; no minor assent is required because the minimum inclusion age is 18.
Methods
- Recruitment brochures (K1 Recruitment Brochure) provided in country-specific languages and English — channel: printed/handout materials targeting potential participants with PsA.
- Dear Patient letters (K1 Recruitment Dear Patient Letter) — channel: personalised letters to potential participants via sites.
- Recruitment posters (K1 Recruitment Poster) displayed at sites/clinics — channel: poster outreach targeting clinic visitors and patients.
- Study guides (K1 Recruitment Study Guide) for participants/site staff — channel: printed materials describing study procedures and participation.
- EU CTR transition/placeholder patient recruitment procedure documents (site-level guidance) — channel: procedural guidance for sites.
- Materials are localised per country (multiple languages) as evidenced by country-specific K1 and L1 documents for Spain, Poland, Greece, Slovakia, Bulgaria, Czechia, Italy, Hungary, Latvia, Lithuania, Estonia, Croatia, Germany, Slovenia, etc.
Geography
- Total Number Of Sites
- 93
- Total Number Of Participants
- 421
Slovakia
- Earliest CTIS Part Ii Submission Date
- 05-07-2024
- Latest Decision Or Authorization Date
- 26-07-2024
- Processing Time Days
- 21
- Number Of Sites
- 4
- Number Of Participants
- 16
Sites
- Site Name
- Chiremed s.r.o.
- Department Name
- SK10005:Reumatologicka a interna ambulancia
- Principal Investigator Name
- Daniela Janikova
- Principal Investigator Email
- janikova.daniela20@gmail.com
- Contact Person Name
- Daniela Janikova
- Contact Person Email
- janikova.daniela20@gmail.com
- Site Name
- Artromac N.O.
- Department Name
- SK10003
- Principal Investigator Name
- Michaele Zarikova
- Principal Investigator Email
- m.zarikova@gmail.com
- Contact Person Name
- Michaele Zarikova
- Contact Person Email
- m.zarikova@gmail.com
- Site Name
- Medman s.r.o.
- Department Name
- SK10002:Reumatologická ambulancia
- Principal Investigator Name
- Viliam Manka
- Principal Investigator Email
- vilcoo@gmail.com
- Contact Person Name
- Viliam Manka
- Contact Person Email
- vilcoo@gmail.com
- Site Name
- Reumex s.r.o.
- Department Name
- SK10001:Reumatologicka ambulancia
- Principal Investigator Name
- Viola Husarova
- Principal Investigator Email
- husarov001@gmail.com
- Contact Person Name
- Viola Husarova
- Contact Person Email
- husarov001@gmail.com
Poland
- Earliest CTIS Part Ii Submission Date
- 05-07-2024
- Latest Decision Or Authorization Date
- 04-08-2024
- Processing Time Days
- 30
- Number Of Sites
- 17
- Number Of Participants
- 90
Sites
- Site Name
- Prywatna Praktyka Lekarska Prof. dr hab.med. Pawel Hrycaj
- Department Name
- PL10007: Rheumatology
- Principal Investigator Name
- Pawel Hrycaj
- Principal Investigator Email
- pawel.hrycaj@gmail.com
- Contact Person Name
- Pawel Hrycaj
- Contact Person Email
- pawel.hrycaj@gmail.com
- Site Name
- Ambulatorium Sp. z o.o.
- Department Name
- PL10005: Rheumatology
- Principal Investigator Name
- Anna Bazela - Ostromecka
- Principal Investigator Email
- bazela.ann@gmail.com
- Contact Person Name
- Anna Bazela - Ostromecka
- Contact Person Email
- bazela.ann@gmail.com
- Site Name
- Twoja Przychodnia Nowosolskie Centrum Medyczne Sp. z o.o.
- Department Name
- PL10010: Rheumatology
- Principal Investigator Name
- Malgorzata Miakisz
- Principal Investigator Email
- miakisz@twojaprzychodnia.com
- Contact Person Name
- Malgorzata Miakisz
- Contact Person Email
- miakisz@twojaprzychodnia.com
- Site Name
- Medicover Integrated Clinical Services Sp. z o.o.
- Department Name
- PL10013: Rheumatology
- Principal Investigator Name
- Agnieszka Zielinska
- Principal Investigator Email
- agnieszkazielinska@medycynakliniczna.pl
- Contact Person Name
- Agnieszka Zielinska
- Contact Person Email
- agnieszkazielinska@medycynakliniczna.pl
- Site Name
- Clinicmed Daniluk Nowak Sp. k.
- Department Name
- PL10015: Rheumatology
- Principal Investigator Name
- Stefan Daniluk
- Principal Investigator Email
- daniluk@clinicmed.pl
- Contact Person Name
- Stefan Daniluk
- Contact Person Email
- daniluk@clinicmed.pl
- Site Name
- Klinika Reuma Park Sp. z o.o. S.K.
- Department Name
- PL10002: Rheumatology
- Principal Investigator Name
- Anna Zubrzycka - Sienkiewicz
- Principal Investigator Email
- annazub1@wp.pl
- Contact Person Name
- Anna Zubrzycka - Sienkiewicz
- Contact Person Email
- annazub1@wp.pl
- Site Name
- Pratia S.A.
- Department Name
- PL10012: Rheumatology
- Principal Investigator Name
- Anna Sylwestrzak
- Principal Investigator Email
- asylwestrzak@pratia.pl
- Contact Person Name
- Anna Sylwestrzak
- Contact Person Email
- asylwestrzak@pratia.pl
- Site Name
- Centrum Kliniczno-Badawcze J.Brzezicki B.Gornikiewicz-Brzezicka Lekarze sp.p.
- Department Name
- PL10001: Rheumatology
- Principal Investigator Name
- Jan Brzezicki
- Principal Investigator Email
- janisb@poczta.onet.pl
- Contact Person Name
- Jan Brzezicki
- Contact Person Email
- janisb@poczta.onet.pl
- Site Name
- Medicover Integrated Clinical Services Sp. z o.o.
- Department Name
- PL10008: Rheumatology
- Principal Investigator Name
- Katarzyna Kolossa
- Principal Investigator Email
- k.kolossa@naszlekarz.pl
- Contact Person Name
- Katarzyna Kolossa
- Contact Person Email
- k.kolossa@naszlekarz.pl
- Site Name
- Medicover Integrated Clinical Services Sp. z o.o.
- Department Name
- PL10026: Rheumatology
- 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
- Pratia S.A.
- Department Name
- PL10009: Rheumatology
- Principal Investigator Name
- Mariusz Korkosz
- Principal Investigator Email
- mariusz.korkosz@pratia.com
- Contact Person Name
- Mariusz Korkosz
- Contact Person Email
- mariusz.korkosz@pratia.com
- Site Name
- Mak-Med Clinic Sp. z o.o.
- Department Name
- PL10024: Rheumatology
- Principal Investigator Name
- Marek Krogulec
- Principal Investigator Email
- marekkrogulec@wp.pl
- Contact Person Name
- Marek Krogulec
- Contact Person Email
- marekkrogulec@wp.pl
- Site Name
- Reumed Sp. z o.o.
- Department Name
- PL10021: Rheumatology
- Principal Investigator Name
- Marcin Mazurek
- Principal Investigator Email
- mamazurek@tlen.pl
- Contact Person Name
- Marcin Mazurek
- Contact Person Email
- mamazurek@tlen.pl
- Site Name
- Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy
- Department Name
- PL10004: Klinika Reumatologii i Ukladowych Chorob Tkanki Lacznej
- Principal Investigator Name
- Rafal Wojciechowski
- Principal Investigator Email
- r.wojciechowski@wp.eu
- Contact Person Name
- Rafal Wojciechowski
- Contact Person Email
- r.wojciechowski@wp.eu
- Site Name
- Dermmedica Sp. z o.o.
- Department Name
- PL10022: Rheumatology
- Principal Investigator Name
- Jolanta Weglowska
- Principal Investigator Email
- jolaweglowska@tlen.pl
- Contact Person Name
- Jolanta Weglowska
- Contact Person Email
- jolaweglowska@tlen.pl
- Site Name
- Rheuma Medicus Sp. z o.o.
- Department Name
- PL10011: Rheumatology
- Principal Investigator Name
- Maria Rell-Bakalarska
- Principal Investigator Email
- rell-bakalarska@wp.pl
- Contact Person Name
- Maria Rell-Bakalarska
- Contact Person Email
- rell-bakalarska@wp.pl
- Site Name
- Osteo Medic s.c. Artur Racewicz Jerzy Supronik
- Department Name
- PL10002: Rheumatology
- Principal Investigator Name
- Artur Racewicz
- Principal Investigator Email
- artur.racewicz@gmail.com
- Contact Person Name
- Artur Racewicz
- Contact Person Email
- artur.racewicz@gmail.com
Greece
- Earliest CTIS Part Ii Submission Date
- 12-09-2024
- Latest Decision Or Authorization Date
- 11-10-2024
- Processing Time Days
- 29
- Number Of Sites
- 1
- Number Of Participants
- 2
Sites
- Site Name
- Hippokration Hospital
- Department Name
- GR10005: 2nd Department of Internal Med
- Principal Investigator Name
- Dimitrios Vassilopoulos
- Principal Investigator Email
- dvassilop@med.uoa.gr
- Contact Person Name
- Dimitrios Vassilopoulos
- Contact Person Email
- dvassilop@med.uoa.gr
Spain
- Earliest CTIS Part Ii Submission Date
- 05-07-2024
- Latest Decision Or Authorization Date
- 24-07-2024
- Processing Time Days
- 19
- Number Of Sites
- 7
- Number Of Participants
- 27
Sites
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- ES10004: Reumatología
- Principal Investigator Name
- Beatriz Joven Ibáñez
- Principal Investigator Email
- beatrizesther.joven@salud.madrid.org
- Contact Person Name
- Beatriz Joven Ibáñez
- Contact Person Email
- beatrizesther.joven@salud.madrid.org
- Site Name
- Hospital Quironsalud Sagrado Corazon
- Department Name
- ES10015: Reumatología
- Principal Investigator Name
- Paula Cejas Caceres
- Principal Investigator Email
- paula.cejas@quironsalud.es
- Contact Person Name
- Paula Cejas Caceres
- Contact Person Email
- paula.cejas@quironsalud.es
- Site Name
- Hospital Universitario Reina Sofia
- Department Name
- ES10005: Reumatología
- Principal Investigator Name
- Maria López Montilla
- Principal Investigator Email
- Mariad.lopez.montilla.sspa@juntadeandalucia.es
- Contact Person Name
- Maria López Montilla
- Contact Person Email
- Mariad.lopez.montilla.sspa@juntadeandalucia.es
- Site Name
- Hospital Universitario Regional De Malaga
- Department Name
- ES10003: Reumatología
- Principal Investigator Name
- Antonio Fernández Nebro
- Principal Investigator Email
- antonio.fernandez.nebro.sspa@juntadeandalucia.es
- Contact Person Name
- Antonio Fernández Nebro
- Contact Person Email
- antonio.fernandez.nebro.sspa@juntadeandalucia.es
- Site Name
- Complexo Hospitalario Universitario A Coruna
- Department Name
- ES10008: Hematología
- Principal Investigator Name
- Francisco Blanco Garcia
- Principal Investigator Email
- fblagar@sergas.es
- Contact Person Name
- Francisco Blanco Garcia
- Contact Person Email
- fblagar@sergas.es
- Site Name
- Complexo Hospitalario Universitario De Santiago
- Department Name
- ES10002: Reumatología
- Principal Investigator Name
- Antonio Mera Varela
- Principal Investigator Email
- antonio.mera.varela@sergas.es
- Contact Person Name
- Antonio Mera Varela
- Contact Person Email
- antonio.mera.varela@sergas.es
- Site Name
- Clinica Gaias Santiago
- Department Name
- ES10009: Reumatología
- Principal Investigator Name
- Juan José Amarelo Ramos
- Principal Investigator Email
- juan.amarelo@gaiasresearch.com
- Contact Person Name
- Juan José Amarelo Ramos
- Contact Person Email
- juan.amarelo@gaiasresearch.com
Estonia
- Earliest CTIS Part Ii Submission Date
- 05-07-2024
- Latest Decision Or Authorization Date
- 25-07-2024
- Processing Time Days
- 20
- Number Of Sites
- 3
- Number Of Participants
- 10
Sites
- Site Name
- Kliiniliste Uuringute Keskus OÜ
- Department Name
- EE10003
- Principal Investigator Name
- Airi Poder
- Principal Investigator Email
- airi.poder@std.ee
- Contact Person Name
- Airi Poder
- Contact Person Email
- airi.poder@std.ee
- Site Name
- Innomedica OÜ
- Department Name
- EE10004: Outpatient
- Principal Investigator Name
- Sandra Meisalu
- Principal Investigator Email
- sandra.meisalu@innomedica.ee
- Contact Person Name
- Sandra Meisalu
- Contact Person Email
- sandra.meisalu@innomedica.ee
- Site Name
- North Estonia Medical Centre Foundation
- Department Name
- EE10002: Internal Medicine
- Principal Investigator Name
- Eve-Kai Raussi
- Principal Investigator Email
- eve-kai.raussi@regionaalhaigla.ee
- Contact Person Name
- Eve-Kai Raussi
- Contact Person Email
- eve-kai.raussi@regionaalhaigla.ee
Italy
- Earliest CTIS Part Ii Submission Date
- 05-07-2024
- Latest Decision Or Authorization Date
- 07-08-2024
- Processing Time Days
- 33
- Number Of Sites
- 7
- Number Of Participants
- 6
Sites
- Site Name
- Azienda Ospedaliera Ordine Mauriziano Di Torino
- Department Name
- IT10012: Reumatologia
- Principal Investigator Name
- Annamaria Iagnocco
- Principal Investigator Email
- aiagnocco@mauriziano.it
- Contact Person Name
- Annamaria Iagnocco
- Contact Person Email
- aiagnocco@mauriziano.it
- Site Name
- Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
- Department Name
- IT10003: UOC Reumatologia
- Principal Investigator Name
- Giovanna Cuomo
- Principal Investigator Email
- giovanna.cuomo@unicampania.it
- Contact Person Name
- Giovanna Cuomo
- Contact Person Email
- giovanna.cuomo@unicampania.it
- Site Name
- Azienda Ospedaliera Universitaria Integrata Verona
- Department Name
- IT10007
- Principal Investigator Name
- Angelo Fassio
- Principal Investigator Email
- fassio.reumato@gmail.com
- Contact Person Name
- Angelo Fassio
- Contact Person Email
- fassio.reumato@gmail.com
- Site Name
- Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
- Department Name
- IT10001: Reumatologia
- Principal Investigator Name
- Rosario Foti
- Principal Investigator Email
- rosfoti5@gmail.com
- Contact Person Name
- Rosario Foti
- Contact Person Email
- rosfoti5@gmail.com
- Site Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Department Name
- IT10005: Reumatologia
- Principal Investigator Name
- Maria Antonietta d'Agostino
- Principal Investigator Email
- mariaantonietta.dagostino@policlinicogemelli.it
- Contact Person Name
- Maria Antonietta d'Agostino
- Contact Person Email
- mariaantonietta.dagostino@policlinicogemelli.it
- Site Name
- Ospedale San Raffaele S.r.l.
- Department Name
- IT10008
- Principal Investigator Name
- Lorenzo Dagna
- Principal Investigator Email
- dagna.lorenzo@unisr.it
- Contact Person Name
- Lorenzo Dagna
- Contact Person Email
- dagna.lorenzo@unisr.it
- Site Name
- Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
- Department Name
- IT10006: Reumatologia
- Principal Investigator Name
- Giuliana Guggino
- Principal Investigator Email
- giuliana.guggino@policlinico.pa.it
- Contact Person Name
- Giuliana Guggino
- Contact Person Email
- giuliana.guggino@policlinico.pa.it
Latvia
- Earliest CTIS Part Ii Submission Date
- 05-07-2024
- Latest Decision Or Authorization Date
- 06-08-2024
- Processing Time Days
- 32
- Number Of Sites
- 5
- Number Of Participants
- 20
Sites
- Site Name
- M & M centrs SIA
- Department Name
- LV10006: Medical practice
- Principal Investigator Name
- Janis Arajs
- Principal Investigator Email
- jarajs@yahoo.com
- Contact Person Name
- Janis Arajs
- Contact Person Email
- jarajs@yahoo.com
- Site Name
- Rigas 1. slimnica SIA
- Department Name
- LV10003: Dermatology
- Principal Investigator Name
- Ingmars Mikazans
- Principal Investigator Email
- ingmars@apollo.lv
- Contact Person Name
- Ingmars Mikazans
- Contact Person Email
- ingmars@apollo.lv
- Site Name
- Orto klinika SIA
- Department Name
- LV10002: Rheumatology
- Principal Investigator Name
- Anna Mihailova
- Principal Investigator Email
- annamihailova@inbox.lv
- Contact Person Name
- Anna Mihailova
- Contact Person Email
- annamihailova@inbox.lv
- Site Name
- Rigas Austrumu kliniska universitates slimnica SIA
- Department Name
- LV10007
- Principal Investigator Name
- Anda Kadisa
- Principal Investigator Email
- anda_kadish@inbox.lv
- Contact Person Name
- Anda Kadisa
- Contact Person Email
- anda_kadish@inbox.lv
- Site Name
- J.Kisis SIA
- Department Name
- LV10004: Dermatology
- Principal Investigator Name
- Ilona Radionova
- Principal Investigator Email
- dr.i.radionova@gmail.com
- Contact Person Name
- Ilona Radionova
- Contact Person Email
- dr.i.radionova@gmail.com
Bulgaria
- Earliest CTIS Part Ii Submission Date
- 05-07-2024
- Latest Decision Or Authorization Date
- 29-07-2024
- Processing Time Days
- 24
- Number Of Sites
- 14
- Number Of Participants
- 90
Sites
- Site Name
- University Multiprofile Hospital For Active Treatment Eurohospital Plovdiv Ltd.
- Department Name
- BG10008: Rheumatology
- Principal Investigator Name
- Dimitar Penev
- Principal Investigator Email
- d_penev@hotmail.com
- Contact Person Name
- Dimitar Penev
- Contact Person Email
- d_penev@hotmail.com
- Site Name
- Diagnostic Consultative Center Sveti Georgi EOOD
- Department Name
- BG10004
- 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
- University Multiprofile Hospital For Active Treatment Kaspela EOOD
- Department Name
- BG10014: Clinic of Rheumatology
- 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
- BG10018: Rheumatology
- Principal Investigator Name
- Bogdan Penev
- Principal Investigator Email
- bogdanique@posteo.net
- Contact Person Name
- Bogdan Penev
- Contact Person Email
- bogdanique@posteo.net
- Site Name
- University Multiprofile Hospital For Active Treatment Eurohospital Plovdiv Ltd.
- Department Name
- BG10003: Rheumatology
- Principal Investigator Name
- Asen Atanasov
- Principal Investigator Email
- assen_a@abv.bg
- Contact Person Name
- Asen Atanasov
- Contact Person Email
- assen_a@abv.bg
- Site Name
- Diagnostic Consulting Center XVII Sofia Ltd.
- Department Name
- BG10007: Rheumatology
- Principal Investigator Name
- Rodina Nestorova-Licheva
- Principal Investigator Email
- rodina_usd@yahoo.com
- Contact Person Name
- Rodina Nestorova-Licheva
- Contact Person Email
- rodina_usd@yahoo.com
- Site Name
- Medical Center Medconsult Pleven OOD
- Department Name
- BG10006
- Principal Investigator Name
- Krasimira Tsoneva
- Principal Investigator Email
- dr.krasimira.tsoneva@abv.bg
- Contact Person Name
- Krasimira Tsoneva
- Contact Person Email
- dr.krasimira.tsoneva@abv.bg
- Site Name
- Medical Center Teodora EOOD
- Department Name
- BG10001
- Principal Investigator Name
- Margarita Velkova
- Principal Investigator Email
- dr_margarita_velkova@mail.bg
- Contact Person Name
- Margarita Velkova
- Contact Person Email
- dr_margarita_velkova@mail.bg
- Site Name
- Medical Center Excelsior OOD
- Department Name
- BG10010
- Principal Investigator Name
- Tsvetanka Petranova
- Principal Investigator Email
- dr_petranova@yahoo.com
- Contact Person Name
- Tsvetanka Petranova
- Contact Person Email
- dr_petranova@yahoo.com
- Site Name
- UNIMED Medical Center EOOD
- Department Name
- BG10016
- Principal Investigator Name
- Plamen Todorov
- Principal Investigator Email
- drtodorovplamen@gmail.com
- Contact Person Name
- Plamen Todorov
- Contact Person Email
- drtodorovplamen@gmail.com
- Site Name
- Meditsinski Tsentar-N.I Pirogov EOOD
- Department Name
- BG10009
- Principal Investigator Name
- Reneta Dimitrova
- Principal Investigator Email
- reniikalin@abv.bg
- Contact Person Name
- Reneta Dimitrova
- Contact Person Email
- reniikalin@abv.bg
- Site Name
- University Multiprofessional Hospital For Active Treatment Plovdiv AD
- Department Name
- BG10005: Rheumatology
- Principal Investigator Name
- Ivan Goranov
- Principal Investigator Email
- goranov_ivan@yahoo.com
- Contact Person Name
- Ivan Goranov
- Contact Person Email
- goranov_ivan@yahoo.com
- Site Name
- Dkc Fokus-5 Lzip OOD
- Department Name
- BG10015
- 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
- Diagnostics And Consultation Center Convex Ltd.
- Department Name
- BG10012
- Principal Investigator Name
- Vladimira Boyadzhieva
- Principal Investigator Email
- vladimira.boyadzhieva@gmail.com
- Contact Person Name
- Vladimira Boyadzhieva
- Contact Person Email
- vladimira.boyadzhieva@gmail.com
Croatia
- Earliest CTIS Part Ii Submission Date
- 05-07-2024
- Latest Decision Or Authorization Date
- 26-07-2024
- Processing Time Days
- 21
- Number Of Sites
- 4
- Number Of Participants
- 15
Sites
- Site Name
- KBC Split
- Department Name
- HR10007
- Principal Investigator Name
- Dijana Perkovic
- Principal Investigator Email
- dijana.perkovic@hotmail.com
- Contact Person Name
- Dijana Perkovic
- Contact Person Email
- dijana.perkovic@hotmail.com
- Site Name
- Clinical Hospital Centre Rijeka
- Department Name
- HR10003
- Principal Investigator Name
- Srdan Novak
- Principal Investigator Email
- srdan.novak@gmail.com
- Contact Person Name
- Srdan Novak
- Contact Person Email
- srdan.novak@gmail.com
- Site Name
- Klinicki Bolnicki Centar Osijek
- Department Name
- HR10002
- Principal Investigator Name
- Jasminka Milas-Ahic
- Principal Investigator Email
- jmilasahic@gmail.com
- Contact Person Name
- Jasminka Milas-Ahic
- Contact Person Email
- jmilasahic@gmail.com
- Site Name
- Medicinski centar Kuna Peric d.o.o.
- Department Name
- HR10004
- Principal Investigator Name
- Porin Peric
- Principal Investigator Email
- porin.peric@gmail.com
- Contact Person Name
- Porin Peric
- Contact Person Email
- porin.peric@gmail.com
Czechia
- Earliest CTIS Part Ii Submission Date
- 05-07-2024
- Latest Decision Or Authorization Date
- 25-07-2024
- Processing Time Days
- 20
- Number Of Sites
- 12
- Number Of Participants
- 60
Sites
- Site Name
- CCR Ostrava s.r.o.
- Department Name
- CZ10002
- Principal Investigator Name
- Sylva Brtnikova
- Principal Investigator Email
- sylva.brtnikova@ccrostrava.com
- Contact Person Name
- Sylva Brtnikova
- Contact Person Email
- sylva.brtnikova@ccrostrava.com
- Site Name
- PV-Medical s.r.o.
- Department Name
- CZ10008
- Principal Investigator Name
- Petr Vitek
- Principal Investigator Email
- pv.medical@seznam.cz
- Contact Person Name
- Petr Vitek
- Contact Person Email
- pv.medical@seznam.cz
- Site Name
- MuDr. Zuzana Stejfova
- Department Name
- CZ10007: Revmatologicka ambulance
- Principal Investigator Name
- Zuzana Stejfova
- Principal Investigator Email
- stejfova.zuzana@seznam.cz
- Contact Person Name
- Zuzana Stejfova
- Contact Person Email
- stejfova.zuzana@seznam.cz
- Site Name
- Fakultni Nemocnice V Motole
- Department Name
- CZ10004: Odd.revmatol. deti a dospelych
- Principal Investigator Name
- Rudolf Horvath
- Principal Investigator Email
- rudolf.horvath@fnmotol.cz
- Contact Person Name
- Rudolf Horvath
- Contact Person Email
- rudolf.horvath@fnmotol.cz
- Site Name
- Revmacentrum MUDr. Mostera s.r.o.
- Department Name
- CZ10009: Revmatologie a interna
- Principal Investigator Name
- Erik Moster
- Principal Investigator Email
- emoster@revmacentrum.cz
- Contact Person Name
- Erik Moster
- Contact Person Email
- emoster@revmacentrum.cz
- Site Name
- Pratia Pardubice a.s.
- Department Name
- CZ10003
- Principal Investigator Name
- Marcela Svobodova
- Principal Investigator Email
- joz.svo@centrum.cz
- Contact Person Name
- Marcela Svobodova
- Contact Person Email
- joz.svo@centrum.cz
- Site Name
- Revmatologie s.r.o.
- Department Name
- CZ10005
- Principal Investigator Name
- Leona Prochazkova
- Principal Investigator Email
- revmatologie.prochazkova@seznam.cz
- Contact Person Name
- Leona Prochazkova
- Contact Person Email
- revmatologie.prochazkova@seznam.cz
- Site Name
- MUDr. Rosypalova s.r.o.
- Department Name
- CZ10011: Revmatologicka ambulance
- 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
- Revmaclinic s.r.o.
- Department Name
- CZ10010
- Principal Investigator Name
- Vlastimil Racek
- Principal Investigator Email
- vlastimil.racek@seznam.cz
- Contact Person Name
- Vlastimil Racek
- Contact Person Email
- vlastimil.racek@seznam.cz
- Site Name
- Affidea Praha s.r.o.
- Department Name
- CZ10013
- Principal Investigator Name
- Jan Rosa
- Principal Investigator Email
- rosaj@affidea-praha.cz
- Contact Person Name
- Jan Rosa
- Contact Person Email
- rosaj@affidea-praha.cz
- Site Name
- Revmatologicky Ustav
- Department Name
- CZ10014
- Principal Investigator Name
- Olga Sleglova
- Principal Investigator Email
- sleglova@revma.cz
- Contact Person Name
- Olga Sleglova
- Contact Person Email
- sleglova@revma.cz
- Site Name
- Medical Plus s.r.o.
- Department Name
- CZ10015
- Principal Investigator Name
- Eva Dokoupilova
- Principal Investigator Email
- evadokoupil@gmail.com
- Contact Person Name
- Eva Dokoupilova
- Contact Person Email
- evadokoupil@gmail.com
Hungary
- Earliest CTIS Part Ii Submission Date
- 05-07-2024
- Latest Decision Or Authorization Date
- 25-07-2024
- Processing Time Days
- 20
- Number Of Sites
- 10
- Number Of Participants
- 25
Sites
- Site Name
- Kistarcsai Flor Ferenc Korhaz
- Department Name
- HU10003: Reumatológiai és Fizioterápiás Osztály
- Principal Investigator Name
- Edit Tóth
- Principal Investigator Email
- drtothedit@florhosp.hu
- Contact Person Name
- Edit Tóth
- Contact Person Email
- drtothedit@florhosp.hu
- Site Name
- Szolnoki Mav Korhaz Es Rendelointezet
- Department Name
- HU10002
- Principal Investigator Name
- László Sámson
- Principal Investigator Email
- drsamson@pr.hu
- Contact Person Name
- László Sámson
- Contact Person Email
- drsamson@pr.hu
- Site Name
- Revita Kft.
- Department Name
- HU10009
- Principal Investigator Name
- Márta Megyaszai
- Principal Investigator Email
- m.megyaszai@gmail.com
- Contact Person Name
- Márta Megyaszai
- Contact Person Email
- m.megyaszai@gmail.com
- Site Name
- SYNEXUS Magyarorszag Kft.
- Department Name
- HU10015
- Principal Investigator Name
- Judit Ágnes Urbancsok
- Principal Investigator Email
- Judit.urbancsok@globalaes.com
- Contact Person Name
- Judit Ágnes Urbancsok
- Contact Person Email
- Judit.urbancsok@globalaes.com
- Site Name
- Qualiclinic Kft.
- Department Name
- HU10008
- Principal Investigator Name
- István Szombati
- Principal Investigator Email
- i.szombati@qclinic.hu
- Contact Person Name
- István Szombati
- Contact Person Email
- i.szombati@qclinic.hu
- Site Name
- SYNEXUS Magyarorszag Kft.
- Department Name
- HU10014
- Principal Investigator Name
- Katalin Guba
- Principal Investigator Email
- gubakatalin@gmail.com
- Contact Person Name
- Katalin Guba
- Contact Person Email
- gubakatalin@gmail.com
- Site Name
- University Of Szeged
- Department Name
- HU10006: Reumatológiai és Fizioterápiás Osztály
- Principal Investigator Name
- Attila Balog
- Principal Investigator Email
- balog.attila@med.u-szeged.hu
- Contact Person Name
- Attila Balog
- Contact Person Email
- balog.attila@med.u-szeged.hu
- Site Name
- SYNEXUS Magyarorszag Kft.
- Department Name
- HU10013
- Principal Investigator Name
- Tekla Szilassy
- Principal Investigator Email
- tekla.szilassy@globalaes.com
- Contact Person Name
- Tekla Szilassy
- Contact Person Email
- tekla.szilassy@globalaes.com
- Site Name
- University Of Debrecen
- Department Name
- HU10007: Belgyógyászati Klinika, Reumatológia
- Principal Investigator Name
- Nora Bodnár
- Principal Investigator Email
- drbodnarnora@gmail.com
- Contact Person Name
- Nora Bodnár
- Contact Person Email
- drbodnarnora@gmail.com
- Site Name
- SYNEXUS Magyarorszag Kft.
- Department Name
- HU10002
- Principal Investigator Name
- László Sámson
- Principal Investigator Email
- drsamson@pr.hu
- Contact Person Name
- László Sámson
- Contact Person Email
- drsamson@pr.hu
Germany
- Earliest CTIS Part Ii Submission Date
- 05-07-2024
- Latest Decision Or Authorization Date
- 01-08-2024
- Processing Time Days
- 27
- Number Of Sites
- 3
- Number Of Participants
- 5
Sites
- Site Name
- Institut Fuer Praeventive Medizin & Klinische Forschung GbR
- Department Name
- DE10013
- Principal Investigator Name
- Rüdiger Möricke
- Principal Investigator Email
- prof.moericke@praxis-moericke.de
- Contact Person Name
- Rüdiger Möricke
- Contact Person Email
- prof.moericke@praxis-moericke.de
- Site Name
- Praxis fuer Klinische Studien Dr med Antje und Dr med Georg Dahmen
- Department Name
- DE10004: Dr. Antje Dahmen und Dr. Georg Dahmen
- Principal Investigator Name
- Georg Dahmen
- Principal Investigator Email
- info@georg-dahmen.de
- Contact Person Name
- Georg Dahmen
- Contact Person Email
- info@georg-dahmen.de
- Site Name
- Rheumazentrum Ratingen - Studienambulanz GbR
- Department Name
- DE10003
- Principal Investigator Name
- Siegfried Wassenberg
- Principal Investigator Email
- wassenberg@rhzr.de
- Contact Person Name
- Siegfried Wassenberg
- Contact Person Email
- wassenberg@rhzr.de
Slovenia
- Earliest CTIS Part Ii Submission Date
- 05-07-2024
- Latest Decision Or Authorization Date
- 01-08-2024
- Processing Time Days
- 27
- Number Of Sites
- 1
- Number Of Participants
- 2
Sites
- Site Name
- University Medical Center Ljubljana
- Department Name
- SI10003: Rheumatology
- Principal Investigator Name
- Ziga Rotar
- Principal Investigator Email
- ziga.rotar@kclj.si
- Contact Person Name
- Ziga Rotar
- Contact Person Email
- ziga.rotar@kclj.si
Lithuania
- Earliest CTIS Part Ii Submission Date
- 05-07-2024
- Latest Decision Or Authorization Date
- 07-08-2024
- Processing Time Days
- 33
- Number Of Sites
- 5
- Number Of Participants
- 53
Sites
- Site Name
- Respublikine Siauliu ligonine VšĮ
- Department Name
- LT10004: Reumatologijos klinika
- Principal Investigator Name
- Vida Basijokiene
- Principal Investigator Email
- vidabasijokiene@yahoo.com
- Contact Person Name
- Vida Basijokiene
- Contact Person Email
- vidabasijokiene@yahoo.com
- Site Name
- Klaipedos universiteto ligonine VšĮ
- Department Name
- LT10005: Klaipeda Hospital
- Principal Investigator Name
- Loreta Bukauskiene
- Principal Investigator Email
- loreta.bukauskiene@kulig.lt
- Contact Person Name
- Loreta Bukauskiene
- Contact Person Email
- loreta.bukauskiene@kulig.lt
- Site Name
- Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos
- Department Name
- LT10002: Reumatologijos klinika
- Principal Investigator Name
- Asta Baranauskaite
- Principal Investigator Email
- asta.baranauskaite@kaunoklinikos.lt
- Contact Person Name
- Asta Baranauskaite
- Contact Person Email
- asta.baranauskaite@kaunoklinikos.lt
- Site Name
- Kaunas city polyclinic Public institution
- Department Name
- LT10003
- Principal Investigator Name
- Gilvina Pociene
- Principal Investigator Email
- gilvina@gmail.com
- Contact Person Name
- Gilvina Pociene
- Contact Person Email
- gilvina@gmail.com
- Site Name
- Inlita UAB
- Department Name
- LT10006
- Principal Investigator Name
- Ruta Lauciuviene
- Principal Investigator Email
- kupstaite@gmail.com
- Contact Person Name
- Ruta Lauciuviene
- Contact Person Email
- kupstaite@gmail.com
Sponsor
Primary sponsor
- Full Name
- Janssen - Cilag International
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Belgium
Contract research organisations
- Name
- Parexel International (IRL) Limited
- Responsibilities
- 1;12;2;6;9
- Name
- Excelya Greece CRO Single Member S.A.
- Responsibilities
- 1;12;15: Country Site Management;2
- Name
- Almac Clinical Technologies LLC
- Responsibilities
- 3
- Name
- Bioclinica Inc.
- Responsibilities
- 7
- Name
- Medidata Solutions Inc.
- Responsibilities
- 1;10;6;7
Third parties
- {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"7","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Infinity Biologix LLC","duties_or_roles":"Genotypiing and RNA Sequencing","organisation_type":"Pharmaceutical company"}
- {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"4","organisation_type":"Pharmaceutical company"}
- {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"1;12;2;6;9","organisation_type":"Pharmaceutical company"}
- {"country":"Greece","full_name":"Excelya Greece CRO Single Member S.A.","duties_or_roles":"1;12;15: Country Site Management;2","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"1;10;6;7","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Denmark","full_name":"Nordic Bioscience A/S","duties_or_roles":"15: Proteomics","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Almac Clinical Technologies LLC","duties_or_roles":"3","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Reify Health Inc.","duties_or_roles":"7","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"United States","full_name":"Pestka Biomedical Laboratories Inc.","duties_or_roles":"15: Proteomics","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Olink Proteomics Inc.","duties_or_roles":"15: Proteomics","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"7","organisation_type":"Laboratory/Research/Testing facility"}
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
- prodAuthStatus 1
- Investigational Product Name
- Placebo to Guselkumab Solution for injection in pre-filled syringe 100 mg/ml.
- Modality
- Other
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