Clinical trial • Phase III • Immunology|Musculoskeletal
GUSELKUMAB for Psoriatic arthritis
Phase III trial of GUSELKUMAB for Psoriatic arthritis.
Overview
- Trial Therapeutic Area
- Immunology|Musculoskeletal
- Trial Disease
- Psoriatic arthritis
- Trial Stage
- Phase III
- Drug Modality
- Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 15-03-2024
- First CTIS Authorization Date
- 19-04-2024
Trial design
Randomised, guselkumab 1 ml pfs placebo (placebo comparator arm); active investigational product: guselkumab - solution for injection in pre-filled syringe - 100 mg/ml-controlled Phase III trial in Poland, Bulgaria, Czechia and others.
- Randomised
- Yes
- Comparator
- Guselkumab 1 mL PFS Placebo (placebo comparator arm); active investigational product: Guselkumab - solution for injection in pre-filled syringe - 100 mg/mL
- Target Sample Size
- 178
Eligibility
Recruits 178 Vulnerable population is selected in the study record. Consent documentation includes caregiver ICFs and country-specific caregiver ICF/master caregiver ICF documents (indicating provisions for participants who may require caregiver involvement). Participants must be ≥18 years (adult participants) and so provide informed consent; caregiver ICFs are provided where relevant. No explicit assent procedures for minors are provided (minors are excluded by age criterion)..
- Vulnerable Population
- Vulnerable population is selected in the study record. Consent documentation includes caregiver ICFs and country-specific caregiver ICF/master caregiver ICF documents (indicating provisions for participants who may require caregiver involvement). Participants must be ≥18 years (adult participants) and so provide informed consent; caregiver ICFs are provided where relevant. No explicit assent procedures for minors are provided (minors are excluded by age criterion).
Inclusion criteria
- {"criterion_text":"- Be at least 18 years of age\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 criteria at screening.\n- 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. CRP ≥0.3 mg/dL at screening from the central laboratory. NOTE: A 1-time repeat assessment of CRP level is allowed during the 6-week screening phase and the investigator may consider the participant eligible if the test result is within acceptable range on repeat testing in the central laboratory.\n- Have at least 1 of the following PsA subsets: distal interphalangeal joint involvement, polyarticular arthritis with absence of rheumatoid nodules, asymmetric peripheral arthritis, or spondylitis with peripheral arthritis.\n- Have an inadequate response and/or intolerance to anti-TNFα therapy, defined as presence of active PsA despite previous treatment with one prior anti-TNFα agent. Participants may meet either one or both of the following criteria: a. Lack of benefit of no more than one prior anti-TNFα therapy, as documented in the patient history by the treating physician, after at least 12 weeks of etanercept, adalimumab, golimumab, or certolizumab pegol therapy or at least a 14-week dosage regimen of infliximab. Documented lack of benefit may include inadequate improvement in joint counts, physical function, or disease activity AND/OR b. Intolerance to no more than one prior anti-TNFα therapy, as documented in the patient history by the treating physician, to etanercept, adalimumab, golimumab, certolizumab pegol, or infliximab."}
Exclusion criteria
- {"criterion_text":"- Has other inflammatory diseases that might confound the evaluations of benefit of guselkumab therapy in the treatment of PsA, including but not limited to rheumatoid arthritis, ankylosing spondylitis/nonradiographic axial spondyloarthritis, systemic lupus erythematosus, or Lyme disease.\n- Has received more than 1 prior anti-TNFα agent.\n- Has received an anti-TNFα agent within the following timeframes: a. Infliximab or golimumab, within 8 weeks prior to the first administration of study intervention. b. Golimumab SC, adalimumab or certolizumab pegol, within 6 weeks prior to the first administration of study intervention. c. Etanercept within 4 weeks prior to the first administration of study intervention.\n- Has previously received any biologic treatment other than an anti-TNFα agent including, but not limited to, guselkumab, ustekinumab, secukinumab, tildrakizumab, ixekizumab,brodalumab, risankizumab or other investigative biologic treatment."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Proportion of participants who achieve an ACR 20 response at Week 24","definition_or_measurement_approach":"Proportion of participants achieving an ACR20 response at Week 24 (ACR20 measured at Week 24 as the primary efficacy outcome)"}
Recruitment
- Planned Sample Size
- 178
- Recruitment Window Months
- 60
- Consent Approach
- Informed consent obtained from adult participants (age ≥18). Subject information sheets and ICFs are provided; country- and role-specific ICF documents exist (Master and country-specific ICFs, caregiver ICFs, pregnant partner ICFs). Documents and recruitment materials exist in multiple languages (English, Polish, Bulgarian, Czech, Hungarian, Spanish) as indicated by available ICF and recruitment document versions. Caregiver ICFs are provided where relevant; no assent for minors is described (minors excluded by age).
Geography
- Total Number Of Sites
- 34
- Total Number Of Participants
- 229
Poland
- Earliest CTIS Part Ii Submission Date
- 03-04-2024
- Latest Decision Or Authorization Date
- 20-12-2024
- Processing Time Days
- 261
- Number Of Sites
- 12
- Number Of Participants
- 120
Sites
- Site Name
- Centrum Kliniczno-Badawcze J.Brzezicki B.Gornikiewicz-Brzezicka Lekarze sp.p.
- 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
- Ai Centrum Medyczne Sp. z o.o. S.K.
- Principal Investigator Name
- Anna Rychlewska-Hańczewska
- Principal Investigator Email
- a.hanczewska@wp.pl
- Contact Person Name
- Anna Rychlewska-Hańczewska
- Contact Person Email
- a.hanczewska@wp.pl
- 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
- 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
- Malopolskie Centrum Kliniczne
- Principal Investigator Name
- Bożena Rojek-Margas
- Principal Investigator Email
- brojekmargas@mck-krakow.pl
- Contact Person Name
- Bożena Rojek-Margas
- Contact Person Email
- brojekmargas@mck-krakow.pl
- Site Name
- Twoja Przychodnia Nowosolskie Centrum Medyczne Sp. z o.o.
- Principal Investigator Name
- Małgorzata Miakisz
- Principal Investigator Email
- miakisz@twojaprzychodnia.com
- Contact Person Name
- Małgorzata Miakisz
- Contact Person Email
- miakisz@twojaprzychodnia.com
- Site Name
- Medicover Integrated Clinical Services Sp. z o.o.
- Department Name
- MICS Centrum Medyczne Warszawa
- Principal Investigator Name
- Agnieszka Zielińska
- Principal Investigator Email
- agnieszkazielinska@medycynakliniczna.pl
- Contact Person Name
- Agnieszka Zielińska
- Contact Person Email
- agnieszkazielinska@medycynakliniczna.pl
- Site Name
- Klinika Reuma Park Sp. z o.o. S.K.
- Principal Investigator Name
- Ewa Matyska-Piekarska
- Principal Investigator Email
- ewamatyska@wp.pl
- Contact Person Name
- Ewa Matyska-Piekarska
- Contact Person Email
- ewamatyska@wp.pl
- 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
- 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
- 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
- Rheuma Medicus Sp. z o.o.
- 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
Bulgaria
- Earliest CTIS Part Ii Submission Date
- 03-04-2024
- Latest Decision Or Authorization Date
- 06-01-2025
- Processing Time Days
- 278
- Number Of Sites
- 5
- Number Of Participants
- 53
Sites
- 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
- Амбулатория За Специализирана Извънболнична Медицинска Помощ Ревматологичен Център Света Ирина ЕООD
- Department Name
- Not Applicable
- 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
- 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
- UNIMED Medical Center EOOD
- Department Name
- Not Applicable
- Principal Investigator Name
- Plamen Todorov
- Principal Investigator Email
- drtodorovplamen@gmail.com
- Contact Person Name
- Plamen Todorov
- Contact Person Email
- drtodorovplamen@gmail.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
Czechia
- Earliest CTIS Part Ii Submission Date
- 03-04-2024
- Latest Decision Or Authorization Date
- 08-01-2025
- Processing Time Days
- 280
- Number Of Sites
- 6
- Number Of Participants
- 23
Sites
- Site Name
- Rheuma s.r.o.
- Department Name
- Not applicable
- Principal Investigator Name
- Jaroslava Spevakova
- Principal Investigator Email
- spevako.revma@seznam.cz
- Contact Person Name
- Jaroslava Spevakova
- Contact Person Email
- spevako.revma@seznam.cz
- Site Name
- Arthrohelp s.r.o.
- Department Name
- Not applicable
- Principal Investigator Name
- Zdenek Dvorak
- Principal Investigator Email
- revmatologie.dvorak@seznam.cz
- Contact Person Name
- Zdenek Dvorak
- Contact Person Email
- revmatologie.dvorak@seznam.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
- 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
- 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
- Revmatologicky Ustav
- Department Name
- Not applicable
- Principal Investigator Name
- Karel Pavelka
- Principal Investigator Email
- pavelka@revma.cz
- Contact Person Name
- Karel Pavelka
- Contact Person Email
- pavelka@revma.cz
Hungary
- Earliest CTIS Part Ii Submission Date
- 03-04-2024
- Latest Decision Or Authorization Date
- 07-02-2025
- Processing Time Days
- 310
- Number Of Sites
- 7
- Number Of Participants
- 24
Sites
- Site Name
- Uno Medical Trials Kft.
- Principal Investigator Name
- Éva Apostol
- Principal Investigator Email
- broadway21@freemail.hu
- Contact Person Name
- Éva Apostol
- Contact Person Email
- broadway21@freemail.hu
- Site Name
- Kistarcsai Flor Ferenc Korhaz
- Department Name
- Reumatológiai és Fiziotherápiás 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
- Bekes Varmegyei Koezponti Korhaz
- Department Name
- Reumatológiai Osztály
- 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
- University Of Szeged
- Department Name
- Rheumatológiai Klinika
- 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
- Vital-Medicina Kft.
- Principal Investigator Name
- Edit Drescher
- Principal Investigator Email
- dr.dreschere@gmail.com
- Contact Person Name
- Edit Drescher
- Contact Person Email
- dr.dreschere@gmail.com
- Site Name
- Fejer Varmegyei Szent Gyoergy Egyetemi Oktato Korhaz
- Department Name
- Reumatológiai osztály
- Principal Investigator Name
- Judit Pulai
- Principal Investigator Email
- juditpulai@yahoo.com
- Contact Person Name
- Judit Pulai
- Contact Person Email
- juditpulai@yahoo.com
- Site Name
- Betegapolo Irgalmasrend Budai Irgalmasrendi Korhaz
- Department Name
- Reumatológia
- Principal Investigator Name
- Györgyi Mészáros
- Principal Investigator Email
- mesz.gyorgyi@gmail.com
- Contact Person Name
- Györgyi Mészáros
- Contact Person Email
- mesz.gyorgyi@gmail.com
Spain
- Earliest CTIS Part Ii Submission Date
- 03-04-2024
- Latest Decision Or Authorization Date
- 17-12-2024
- Processing Time Days
- 258
- Number Of Sites
- 4
- Number Of Participants
- 9
Sites
- Site Name
- Hospital Quironsalud Sagrado Corazon
- Department Name
- Rheumatology
- 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 De Cruces
- Department Name
- Rheumatology
- Principal Investigator Name
- Fernando Perez Ruiz
- Principal Investigator Email
- Fernando.Perezruiz@osakidetza.eus
- Contact Person Name
- Fernando Perez Ruiz
- Contact Person Email
- Fernando.Perezruiz@osakidetza.eus
- Site Name
- Hospital Universitario Regional De Malaga
- Department Name
- Rheumatology
- 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
- Clinica Gaias Santiago
- Department Name
- Rheumatology
- 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
Sponsor
Primary sponsor
- Full Name
- Janssen - Cilag International
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Belgium
Contract research organisations
- Name
- IQVIA Limited
- Responsibilities
- Blinding data services; data services (multiple sponsor entries indicate IQVIA involvement in data/blinding services)
- Name
- Icon Clinical Research Limited
- Responsibilities
- ePRO Translations Services
Third parties
- {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"Sponsor contact/third party (duties listed by sponsor entries; includes data services and blinding data services in other entries)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"ePROs and ClinROs on a provided electronic tablet","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Qd Solutions Inc.","duties_or_roles":"Branding/creative/logo, Recruitment materials, Print","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"Medical image analysis/ review - X-ray","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Imperial Clinical Research Services International Ltd.","duties_or_roles":"Patient Diary translation and printing","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"EPL Pathology Archives LLC","duties_or_roles":"Lab sample/supply storage","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Almac","duties_or_roles":"Unspecified duties (sponsor entry code 3)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Labcorp Early Development Laboratories Inc.","duties_or_roles":"Laboratory services (sponsor duty code 4)","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"Blinding data services; additional data services","organisation_type":"Pharmaceutical company"}
- {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"ePRO Translations Services","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Ancillare LP","duties_or_roles":"medical supplies/equipment","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Acolad Life Sciences LLC","duties_or_roles":"Translation Service","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"Unspecified duties (sponsor duty code 7)","organisation_type":"Non-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
- euMpNumber PRD2827309; prodAuthStatus 1
- Investigational Product Name
- Guselkumab 1 mL PFS Placebo
- Modality
- Other
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