Overview
Sponsor-declared trial summary
Psoriasis
The primary objective of this proof-of-concept study is to investigate the feasibility of whole body [18F]Fluoride PET-CT scans to detect axial and peripheral new bone formation, in psoriasis patients that are at risk to develop clinically manifest psoriatic arthritis.
Key facts
- Sponsor
- Stichting Amsterdam UMC
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Skin and Connective Tissue Diseases [C17], Diseases [C] - Musculoskeletal Diseases [C05]
- Trial duration
- 16 Dec 2024 → ongoing
- Decision date (initial)
- 2024-12-16
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-514759-13-01
- EudraCT number
- 2021-001209-57
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Others
The primary objective of this proof-of-concept study is to investigate the feasibility of whole body [18F]Fluoride PET-CT scans to detect axial and peripheral new bone formation, in psoriasis patients that are at risk to develop clinically manifest psoriatic arthritis.
Conditions and MedDRA coding
Psoriasis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10037153 | Psoriasis | 100000004858 |
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2024-514759-13-00 | [18F]Fluoride PET-CT in psoriasis patients at risk for developing psoriatic arthritis | Stichting Amsterdam UMC |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Patients with a diagnosis of psoriasis and an age of 18 years or older
- ≥1 arthralgia and/or enthesiopathy in ≥1 location(s) ≤ 1 year, not secondary to trauma
- ≥1 of the following: Nail psoriasis, First-degree relative with PsA and/or BSA ≥3%
Exclusion criteria 6
- Other rheumatic disease (such as Axial SpA, RA, SLE, Sjögren)
- Osteoarthritis and/or mechanical explanation of the pain in joints and/or tendons
- Clinically evident arthritis (and/or tenosynovitis)
- Systemic therapy for psoriasis (DMARD, bDMARD)
- Treatment with study medication in the past 3 months
- Pregnancy or breast-feeding
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The number of individuals with PET-positive lesions and the distribution of PET-positive lesions.
Secondary endpoints 2
- The correlation between PET outcome and development of PsA in 2 years follow-up
- The quantitative [18F]Fluoride uptake in PET-positive lesions
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Sodium Fluoride (18F) Life Radiopharma 0,1 - 4 GBq/ml solution injectable
PRD9019758 · Product
- Active substance
- Sodium Fluoride (18F)
- Substance synonyms
- SODIUM FLUORIDE F-18
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS INJECTION
- Max daily dose
- 110 MBq megabecquerel(s)
- Max total dose
- 110 MBq megabecquerel(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- V09IX06 — -
- Marketing authorisation
- BE571822
- MA holder
- ALLIANCE MEDICAL RP BERLIN GMBH
- MA country
- Belgium
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- As the registered product RadioFlu is not available, [18F]SodiumFluoride is manufactured under a 3.17 license by Tracer Center Amsterdam. The composition of the product is slightly different, as the registered product is only in Water for injection and the product manufactured by Tracer Center Amsterdam is buffered in Phosphate Buffered Solution. The pH of both products is the same, namely 5.0-8.5. The radioactive concentration is similar.
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Stichting Amsterdam UMC
- Sponsor organisation
- Stichting Amsterdam UMC
- Address
- De Boelelaan 1117
- City
- Amsterdam
- Postcode
- 1081 HV
- Country
- Netherlands
Scientific contact point
- Organisation
- Stichting Amsterdam UMC
- Contact name
- Prof. J. van der Laken
Public contact point
- Organisation
- Stichting Amsterdam UMC
- Contact name
- Prof. A.E. Voskuyl
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruiting | 15 | 1 |
| 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 | 2024-12-16 | 2024-12-16 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 4 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2024-514759-13-01 | 5.0 |
| Recruitment arrangements (for publication) | K1_Placeholder | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF | 6.0 |
| Summary of Product Characteristics (SmPC) (for publication) | G1_Placeholder | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-11-28 | Netherlands | Acceptable 2024-12-16
|
2024-12-16 |