Overview
Sponsor-declared trial summary
ACPA positive arthralgia
To determine the efficacy and measurement properties (sensitivity, specificity, positive 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) in ACPA positive arthralgia individuals during …
Key facts
- Sponsor
- Amsterdam UMC Stichting, ZonMw
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Musculoskeletal Diseases [C05], Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05], Diseases [C] - Immune System Diseases [C20]
- Trial duration
- 9 Dec 2024 → ongoing
- Decision date (initial)
- 2024-12-09
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-513538-40-02
- EudraCT number
- 2018-001114-15
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Diagnosis
To determine the efficacy and measurement properties (sensitivity, specificity, positive 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) in ACPA positive arthralgia individuals during one year follow-up.
Conditions and MedDRA coding
ACPA positive arthralgia
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10003239 | Arthralgia | 100000004859 |
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2024-513538-40-01 | Positron emission tomography with macrophage targeting to select individuals at risk for rheumatoid arthritis. | Amsterdam UMC Stichting |
| 2024-513538-40-00 | Positron emission tomography with macrophage targeting to select individuals at risk for rheumatoid arthritis. | Amsterdam UMC Stichting |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Patients must be 18 years of age or older.
- Patients must be diagnosed with arthralgia (not secondary to trauma) by a physician.
- Patients must have a positive ACPA blood test, determined as a value of 10 U/mL or higher.
- Patients must be able to adhere to the study appointments and other protocol requirements.
- Patients must be capable of giving informed consent and the consent must have been obtained prior to the study related procedures.
Exclusion criteria 5
- Arthritis and/or tenosynovitis as revealed by physical examination of 44 joints through the Disease Activity Score (DAS) (27) by 2 independent physicians.
- Previous corticosteroid injection in joints.
- Trauma involving joints in the 6 months prior to inclusion
- Pregnancy or breast-feeding.
- Low risk score at developing RA as calculated by a previously investigated clinical prediction rule.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 4
- Sensitivity
- Specificity
- Positive predictive value
- Negative predictive value
Secondary endpoints 2
- Relationship of PET positivity and time to development of clinical arthritis.
- Cut-off value(s) for this/these specific outcome measure(s) in relation todevelopment of RA within one year.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD11535297 · Product
- Active substance
- [18FFLUORO-PEG-FOLATE
- Substance synonyms
- 31-(4-(((2-amino-4-oxo-3,4-dihydropteridin-6-yl)methyl)amino)-benzamido)-1-(4-fluorophenyl)-1,6,28-trioxo-9,12,15,18,21,24-hexaoxa-2,5,27-triazadotriacontan-32-oic acid
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS ADMINISTRATION
- Max daily dose
- 5 mCi millicurie(s)
- Max total dose
- 5 mCi millicurie(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- AMSTERDAM UMC
- Paediatric formulation
- No
- Orphan designation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Amsterdam UMC Stichting
- Sponsor organisation
- Amsterdam UMC Stichting
- Address
- De Boelelaan 1117
- City
- Amsterdam
- Postcode
- 1081 HV
- Country
- Netherlands
Scientific contact point
- Organisation
- Amsterdam UMC Stichting
- Contact name
- Principal investigator
Public contact point
- Organisation
- Amsterdam UMC Stichting
- Contact name
- Principal investigator
ZonMw
- Sponsor organisation
- ZonMw
- Address
- Laan van Nieuw Oost-Indië 334, 2593 CE Den Haag 2593 CE Den Haag
- City
- Den Haag
- Country
- Netherlands
Sponsor responsibilities
- Article 77 compliance
- Amsterdam UMC Stichting
- Contact point sponsor
- Amsterdam UMC Stichting
- Article 77 implementation
- Amsterdam UMC Stichting
Locations
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruiting | 60 | 3 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Netherlands | 2024-12-09 | 2024-12-09 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 3 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2024-513538-40-02 redacted | 7 |
| Recruitment arrangements (for publication) | Empty placeholder | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF redacted | 2 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-22 | Netherlands | Acceptable 2024-12-09
|
2024-12-09 |