Clinical trial • Phase I • Musculoskeletal
Clinical trial in Rheumatoid arthritis
Phase I trial for Rheumatoid arthritis. open-label, none/not specified-controlled. 46 participants.
Overview
- Trial Therapeutic Area
- Musculoskeletal
- Trial Disease
- Rheumatoid arthritis
- Trial Stage
- Phase I
Key dates
- Initial CTIS Submission Date
- 11-12-2024
- First CTIS Authorization Date
- 11-04-2025
Trial design
open-label, none/not specified-controlled Phase I trial across 10 sites in Germany, Italy, Poland.
- Open Label
- Yes
- Comparator
- None/Not specified
- Target Sample Size
- 46
Eligibility
Recruits 46 Vulnerable population selected (isVulnerablePopulationSelected=true); no details on consent or assent handling available in the provided record..
- Vulnerable Population
- Vulnerable population selected (isVulnerablePopulationSelected=true); no details on consent or assent handling available in the provided record.
Recruitment
- Planned Sample Size
- 46
- Recruitment Window Months
- 51
Geography
- Total Number Of Sites
- 10
- Total Number Of Participants
- 46
Germany
- Earliest CTIS Part Ii Submission Date
- 18-03-2025
- Latest Decision Or Authorization Date
- 25-03-2026
- Processing Time Days
- 372
- Number Of Sites
- 2
- Number Of Participants
- 20
Sites
- Site Name
- Universitaetsklinikum Erlangen AöR
- Department Name
- Medizinische Klinik 3 – Rheumatologie und Immunologie
- Contact Person Name
- Ricardo Grieshaber-Boyer
- Contact Person Email
- Ricardo.grieshaber@fau.de
- Site Name
- Universitaetsklinikum Heidelberg AöR
- Department Name
- Klinik für Hämatologie, Onkologie und Rheumatologie Innere Medizin V
- Contact Person Name
- Hanns-Martin Lorenz
- Contact Person Email
- hanns-martin.lorenz@med.uni-heidelberg.de
Italy
- Earliest CTIS Part Ii Submission Date
- 04-04-2025
- Latest Decision Or Authorization Date
- 20-04-2026
- Processing Time Days
- 381
- Number Of Sites
- 3
- Number Of Participants
- 20
Sites
- Site Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Department Name
- UOC Rheumatology
- Contact Person Name
- Maria Antonietta D’Agostino
- Contact Person Email
- mariaantonietta.dagostino@policlinicogemelli.it
- Site Name
- Humanitas Mirasole S.p.A.
- Department Name
- Division of Rheumatology and Clinical Immunology
- Contact Person Name
- Elisa Gremese
- Contact Person Email
- elisa.gremese@hunimed.eu
- Site Name
- Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
- Department Name
- UOC Rheumatology
- Contact Person Name
- Francesco Ciccia
- Contact Person Email
- francesco.ciccia@unicampania.it
Poland
- Earliest CTIS Part Ii Submission Date
- 23-04-2026
- Latest Decision Or Authorization Date
- 06-05-2026
- Processing Time Days
- 13
- Number Of Sites
- 5
- Number Of Participants
- 6
Sites
- Site Name
- Med Polonia Sp. z o.o.
- Contact Person Name
- Maria Jaraczewska-Baumann
- Contact Person Email
- badania.kliniczne@medpolonia.pl
- Site Name
- Malopolskie Centrum Kliniczne
- Department Name
- CWBK
- Contact Person Name
- Ewa Zimmer-Satora
- Contact Person Email
- biuro@mck-krakow.pl
- Site Name
- Narodowy Instytut Geriatrii Reumatologii I Rehabilitacji Im Prof. Dr Hab. Med. Eleonory Reicher
- Department Name
- CWBK
- Contact Person Name
- Brygida Kwiatkowska
- Contact Person Email
- cwbk@spartanska.pl
- Site Name
- Biokinetica S.A.
- Department Name
- CWBK
- Contact Person Name
- Malgorzata Gryka-Marton
- Contact Person Email
- marta.jeka@medicover.com
- Site Name
- Medicover Integrated Clinical Services Sp. z o.o.
- Contact Person Name
- Malgorzata Gryka-Marton
- Contact Person Email
- marta.jeka@medicover.com
Sponsor
Primary sponsor
- Full Name
- Cullinan Therapeutics Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
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