Overview
Sponsor-declared trial summary
giant cell arteritis
Primary Objective: to evaluate arterial [18F]fluor-PEG-folate uptake on PET/CT in patients with active, large vessel GCA; and in the same patients after 9 months of standard treatment.
Key facts
- Sponsor
- Universitair Medisch Centrum Groningen
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Trial duration
- 12 Nov 2024 → ongoing
- Decision date (initial)
- 2024-09-11
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-514491-40-00
- EudraCT number
- 2020-001019-26
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacokinetic, Diagnosis
Primary Objective: to evaluate arterial [18F]fluor-PEG-folate uptake on PET/CT in patients with active, large vessel GCA; and in the same patients after 9 months of standard treatment.
Conditions and MedDRA coding
giant cell arteritis
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- - Age ≥ 50 years at time of disease onset - Erythrocyte sedimentation rate (ESR) ≥50 mm/hr or C-reactive protein (CRP) ≥ 10 mg/L - Clinical symptoms of large vessel GCA (at least one of the following) at time of inclusion: constitutional symptoms (fatigue, fever, weight loss, and/or night sweats), limb claudication, or symptoms of polymyalgia rheumatica (i.e. shoulder and/or hip girdle pain associated with morning stiffness). - Imaging findings consistent with large vessel GCA at the time of inclusion (e.g. ultrasound, FDG-PET/CT) - 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 1
- - Clinical symptoms suggestive of cranial GCA (at least one of the following): new-onset localized headache, scalp tenderness, temporal artery abnormality (thickening, tenderness, and/or decreased pulsation), ischemia-related vision loss, stroke, transients ischemic attack, jaw or tongue claudication (pain upon mastication). - Ultrasound findings consistent with cranial GCA (e.g. halo sign in temporal or facial artery). - A prior positive temporal artery biopsy. - Initiation or dose escalation of systemic glucocorticoid therapy (oral, IM, IV) in the 4 weeks prior to inclusion - Initiation or dose escalation of disease-modifying antirheumatic drugs (DMARDs) within 3 months prior to inclusion - Treatment with any investigational drug within 3 months prior to inclusion. - Females with child bearing potential. Post-menopausal women with >12 months of amenorrhoea are considered to have no child bearing potential. Given the age distribution of patients with GCA, exclusion of females with child bearing potential will not lead to recruitment bias in the study. - Research-related radiation exposure (cumulative ≥5 mSv) in the year before inclusion.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Arterial [18F]fluor-PEG-folate uptake on PET/CT in patients with active, large vessel GCA; and in the same patients after 9 months of standard treatment.
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 BOLUS USE
- Max daily dose
- 200 MBq megabecquerel(s)
- Max total dose
- 400 MBq megabecquerel(s)
- Max treatment duration
- 9 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- AMSTERDAM UMC
- Paediatric formulation
- No
- Orphan designation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Universitair Medisch Centrum Groningen
- Sponsor organisation
- Universitair Medisch Centrum Groningen
- Address
- Hanzeplein 1
- City
- Groningen
- Postcode
- 9713 GZ
- Country
- Netherlands
Scientific contact point
- Organisation
- Universitair Medisch Centrum Groningen
- Contact name
- K.S.M. van der Geest
Public contact point
- Organisation
- Universitair Medisch Centrum Groningen
- Contact name
- K.S.M. van der Geest
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruiting | 10 | 2 |
| 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 | 2024-11-12 | 2024-11-12 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 5 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2024-514491-40-00_redacted | 4.0 |
| Recruitment arrangements (for publication) | Blanc document | 1 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_Dynamic_Scan_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_Static_Scan_redacted | 2.1 |
| Summary of Product Characteristics (SmPC) (for publication) | Blanc document | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-02 | Netherlands | Acceptable with conditions 2024-09-11
|
2024-09-11 |