Clinical trial • Phase III • Immunology
Methotrexate for Rheumatoid arthritis
Phase III trial of Methotrexate for Rheumatoid arthritis. 16 participants.
Overview
- Trial Therapeutic Area
- Immunology
- Trial Disease
- Rheumatoid arthritis
- Trial Stage
- Phase III
- Drug Modality
- Small molecule|Small molecule
Key dates
- Initial CTIS Submission Date
- 07-07-2025
- First CTIS Authorization Date
- 19-08-2025
Trial design
Phase III trial across 1 site in Netherlands.
- Target Sample Size
- 16
- Trial Duration For Participant
- 225
Eligibility
Recruits 16 No vulnerable population selected; no additional consent/assent information provided..
- Vulnerable Population
- No vulnerable population selected; no additional consent/assent information provided.
Recruitment
- Planned Sample Size
- 16
- Recruitment Window Months
- 7
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 16
Netherlands
- Earliest CTIS Part Ii Submission Date
- 15-08-2025
- Latest Decision Or Authorization Date
- 24-04-2026
- Processing Time Days
- 252
- Number Of Sites
- 1
- Number Of Participants
- 16
Sites
- Site Name
- Centre for Human Drug Research
- Department Name
- Internal Medicine
- Principal Investigator Name
- Naomi Klarenbeek
- Principal Investigator Email
- clintrials@chdr.nl
- Contact Person Name
- Naomi Klarenbeek
- Contact Person Email
- clintrials@chdr.nl
- Number Of Participants
- 16
Sponsor
Primary sponsor
- Full Name
- Amplio Pharma B.V.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Netherlands
Investigational products
- Investigational Product Name
- Methotrexate
- Active Substance
- Methotrexate
- Modality
- Small molecule
- Investigational Product Name
- Novobiocin
- Active Substance
- Novobiocin
- Modality
- Small molecule
- Combination Treatment
- Yes
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