Taking people in NetherlandsPhase 2
PET scan imaging of immune cells in inflamed arteries and joints
Tests a PET scan that tracks immune cells in giant cell arteritis or rheumatoid arthritis.
Key facts
- Who runs it
- Universitair Medisch Centrum Groningen
- Where
- Amsterdam and Groningen, NetherlandsSee the 2 sites
- Trial code
- Registry title
- Imaging of inflamed arteries in giant cell arteritis and inflamed joints in rheumatoid arthritis with a PET/CT scan.
- Status
- Recruiting
- Phase
- Phase 2
- People taking part
- 20 people, planned
- Started
- 26 Nov 2024
- Expected to end
- 1 Dec 2026
- Type of study
- Interventional
- Record updated
- 5 August 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with newly diagnosed giant cell arteritis (GCA) or active rheumatoid arthritis (RA). It tests a PET/CT scan of inflamed arteries and joints.
- Age
- GCA: over 50 years. RA: at least 30 years.
- Sex
- Men and women can both join.
- Disease stage
- GCA: new diagnosis with symptoms now, high ESR or CRP, and scan or artery biopsy findings that fit GCA. RA: diagnosed by the 2010 ACR/EULAR criteria, with active disease and arthritis in at least one wrist, knee or ankle joint.
- Earlier treatment
- GCA: no glucocorticoids in the 4 weeks before, no DMARDs in the 3 months before. RA: DMARDs, oral corticosteroid up to 10 mg daily and NSAIDs allowed if the dose was stable for at least 4 weeks.
- Biomarker or test result
- GCA: ESR of 50 mm/hr or more, or CRP of 10 mg/L or more.
Main reasons for not taking part
- Pregnant or breast feeding
- Any investigational drug in the previous 3 months
- Research-related radiation of 5 mSv or more in the past year
- Urinary or faecal incontinence
- GCA: age 50 or under; RA: age under 30
The registry criteria, word for word
Show all 2 criteriaShow less
Who can take part
- Giant cell arteritis: - Age > 50 years - Erythrocyte sedimentation rate (ESR) ≥50 mm/hr or C-reactive protein (CRP) ≥ 10 mg/L - Clinical symptoms of GCA present at time of inclusion: • Large vessel GCA (at least one of the following): 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) • 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, transient ischemic attack, jaw or tongue claudication (pain upon mastication). - Imaging findings or temporal artery biopsy findings consistent with GCA at the time of inclusion • Large vessel GCA as suggested by ultrasonography or FDG-PET/CT • Cranial GCA as suggested by ultrasonography FDG-PET/CT or temporal artery biopsy and confirmed by temporal artery biopsy - 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. Rheumatoid arthritis - Patients must be at least 30 years of age - Diagnosis of rheumatoid arthritis according to the 2010 ACR/EULAR Rheumatoid Arthritis classification criteria. - Patients with clinically active disease as assessed by a physician; with arthritis in at least one wrist, knee or ankle joint and have a clinical indication to initiate or escalate treatment - Treatment with disease modifying anti-rheumatic drugs (DMARDS) and oral corticosteroid up to 10 mg daily is allowed, provided that there is a stable dose for at least 4 weeks prior to inclusion - Non-steroidal anti-inflammatory drugs (NSAID) is permitted, provided that there is a stable dose for at least 4 weeks prior to inclusion - 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
Who cannot take part
- Giant cell arteritis - Age ≤ 50 years - Use of oral, intravenous or intramuscular glucocorticoids within 4 weeks prior to inclusion. - Use of disease-modifying antirheumatic drugs (DMARD) within 3 months prior to inclusion. - Treatment with any investigational drug within 3 months prior to inclusion. - Known pregnancy or breast feeding - Research-related radiation exposure (cumulative ≥5 mSv) in the year before inclusion. - Urinary or faecal incontinence Rheumatoid arthritis A potential subject who meets any of the following criteria will be excluded from participation in this study: - Age < 30 years - Use of intra-articular, intramuscular or intravenous corticosteroids within 4 weeks prior to inclusie - Treatment with any investigational drug within the previous 3 months - Known pregnancy or breast feeding - Research related radiation exposure (cumulative ≥5 mSv) in the year before inclusion - Urinary or faecal incontinence
Where in Netherlands
- VUMC StichtingAmsterdam, NetherlandsTaking people
- UMCGGroningen, NetherlandsTaking people
About the trial
What the trial wants to find out
Primary Objective: to evaluate arterial and synovial 89Zr-Dfcrefmirlimab uptake on PET/CT in patients with newly-diagnosed GCA or active RA.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record
Print a page for my doctorData and sources
- Registry record
- Listed on the EU's official list of trials (CTIS).
- Official title
- CD8 T cell imaging by positron emission tomography with 89Zr-Df-crefmirlimab in giant cell arteritis and rheumatoid arthritis: a pilot study
- Plain-language title
- PET scan imaging of immune cells in inflamed arteries and jointsGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 9 November 2026.
- Record updated
- 5 August 2026