Clinical trial • Phase IV • Musculoskeletal | Immunology | Other
[18F]FLUORO-PEG-FOLATE for ACPA-positive arthralgia | Arthralgia
Phase IV trial of [18F]FLUORO-PEG-FOLATE for ACPA-positive arthralgia | Arthralgia. None/Not specified-controlled. 60 participants.
Overview
- Trial Therapeutic Area
- Musculoskeletal | Immunology | Other
- Trial Disease
- ACPA-positive arthralgia | Arthralgia
- Trial Stage
- Phase IV
- Drug Modality
- Radiopharmaceutical
Key dates
- Initial CTIS Submission Date
- 22-10-2024
- First CTIS Authorization Date
- 09-12-2024
Trial design
None/Not specified-controlled Phase IV trial across 3 sites in Netherlands.
- Comparator
- None/Not specified
- Target Sample Size
- 60
- Trial Duration For Participant
- 365
Eligibility
Recruits 60 No vulnerable populations selected. Participants must be 18 years or older and capable of giving informed consent; consent must be obtained prior to any study-related procedures. No assent procedures described..
- Pregnancy Exclusion
- Pregnancy or breast-feeding.
- Vulnerable Population
- No vulnerable populations selected. Participants must be 18 years or older and capable of giving informed consent; consent must be obtained prior to any study-related procedures. No assent procedures described.
Inclusion criteria
- {"criterion_text":"- Patients must be 18 years of age or older.\n- Patients must be diagnosed with arthralgia (not secondary to trauma) by a physician.\n- Patients must have a positive ACPA blood test, determined as a value of 10 U/mL or higher.\n- Patients must be able to adhere to the study appointments and other protocol requirements.\n- Patients must be capable of giving informed consent and the consent must have been obtained prior to the study related procedures."}
Exclusion criteria
- {"criterion_text":"- Arthritis and/or tenosynovitis as revealed by physical examination of 44 joints through the Disease Activity Score (DAS) (27) by 2 independent physicians.\n- Previous corticosteroid injection in joints.\n- Trauma involving joints in the 6 months prior to inclusion\n- Pregnancy or breast-feeding.\n- Low risk score at developing RA as calculated by a previously investigated clinical prediction rule."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Sensitivity\n- Specificity\n- Positive predictive value\n- Negative predictive value","definition_or_measurement_approach":"Sensitivity, specificity, positive predictive value and negative predictive value of whole-body [18F]PEG-Folate PET (with ≥1 PET positive joint regarded as positive PET scan) for development of clinical arthritis (in at least 1 joint) during one year follow-up."}
Secondary endpoints
- {"endpoint_text":"- Relationship of PET positivity and time to development of clinical arthritis.\n- Cut-off value(s) for this/these specific outcome measure(s) in relation todevelopment of RA within one year.","definition_or_measurement_approach":"Relationship of PET positivity and time to development of clinical arthritis will be assessed (time-to-development of clinical arthritis). Cut-off value(s) will be determined for the specified outcome measures in relation to development of rheumatoid arthritis within one year."}
Recruitment
- Planned Sample Size
- 60
- Recruitment Window Months
- 84
- Consent Approach
- Informed consent is required from each participant; participants must be capable of giving informed consent and consent must be obtained prior to study-related procedures. Participants are adults (≥18). A Subject Information Sheet and Informed Consent Form document is included in the trial documents; Dutch translations are present (Dutch (Netherlands)). No assent process described.
Geography
- Total Number Of Sites
- 3
- Total Number Of Participants
- 60
Netherlands
- Earliest CTIS Part Ii Submission Date
- 20-11-2024
- Latest Decision Or Authorization Date
- 09-12-2024
- Processing Time Days
- 19
- Number Of Sites
- 3
- Number Of Participants
- 60
Sites
- Site Name
- University Medical Center Groningen
- Department Name
- Rheumatology
- Contact Person Name
- Marcel Posthumus
- Contact Person Email
- M.D.Posthumus@mzh.nl
- Site Name
- Stichting Martini Ziekenhuis
- Department Name
- Rheumatology
- Contact Person Name
- Liesbeth Brouwer
- Contact Person Email
- e.brouwer@umcg.nl
- Site Name
- Amsterdam UMC Stichting
- Department Name
- Rheumatology
- Contact Person Name
- Jacoba Van der Laken
- Contact Person Email
- j.vanderlaken@amsterdamumc.nl
Sponsor
Primary sponsor
- Full Name
- Amsterdam UMC Stichting
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Netherlands
Co-sponsors
- ZonMw
Investigational products
- Investigational Product Name
- [18F]Fluor-PEG-Folate
- Active Substance
- [18F]FLUORO-PEG-FOLATE
- Modality
- Radiopharmaceutical
- Routes Of Administration
- INTRAVENOUS ADMINISTRATION
- Route
- Intravenous
- Dose Levels
- 5 mCi
- Maximum Dose
- 5 mCi
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