Clinical trial • Phase III • Immunology
adalimumab for Crohn's disease | Spondyloarthritis | Rheumatoid arthritis | Ulcerative colitis
Phase III trial of adalimumab for Crohn's disease | Spondyloarthritis | Rheumatoid arthritis | Ulcerative colitis. 33 participants.
Overview
- Trial Therapeutic Area
- Immunology
- Trial Disease
- Crohn's disease | Spondyloarthritis | Rheumatoid arthritis | Ulcerative colitis
- Trial Stage
- Phase III
- Drug Modality
- Monoclonal antibody|Diagnostic agent
Key dates
- Initial CTIS Submission Date
- 20-09-2024
- First CTIS Authorization Date
- 03-10-2024
Trial design
Phase III trial in Netherlands.
- Target Sample Size
- 33
Eligibility
Recruits 33 No vulnerable populations selected (isVulnerablePopulationSelected: false); consent/assent procedures not specified in the provided record..
- Vulnerable Population
- No vulnerable populations selected (isVulnerablePopulationSelected: false); consent/assent procedures not specified in the provided record.
Recruitment
- Planned Sample Size
- 33
- Recruitment Window Months
- 22
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 33
Netherlands
- Latest Decision Or Authorization Date
- 04-08-2025
- Number Of Sites
- 1
- Number Of Participants
- 33
Sites
- Site Name
- University Medical Center Groningen
- Department Name
- Department of Gastroenterology and Hepatology
- Principal Investigator Name
- Wouter Nagengast
- Principal Investigator Email
- w.b.nagengast@umcg.nl
- Contact Person Name
- Wouter Nagengast
- Contact Person Email
- w.b.nagengast@umcg.nl
Sponsor
Primary sponsor
- Full Name
- Universitair Medisch Centrum Groningen
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Netherlands
Investigational products
- Investigational Product Name
- adalimumab-800CW
- Active Substance
- adalimumab
- Modality
- Monoclonal antibody|Diagnostic agent
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