2024-514489-38-01RecruitingPhase 2
Imaging of inflamed arteries in giant cell arteritis and inflamed joints in rheumatoid arthritis with a PET/CT scan.
CD8 T cell imaging by positron emission tomography with 89Zr-Df-crefmirlimab in giant cell arteritis and rheumatoid arthritis: a pilot study
Source: EU CTIS (euclinicaltrials.eu) · Last updated 5 Aug 2026
Brief summary (registry, in English)
Primary Objective: to evaluate arterial and synovial 89Zr-Dfcrefmirlimab uptake on PET/CT in patients with newly-diagnosed GCA or active RA.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 15 Jul 2024
- Start date
- 26 Nov 2024
- Lead sponsor
- Universitair Medisch Centrum Groningen
- Diseases
- Rheumatoid arthritis
- EU CT number
- 2024-514489-38-01
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 20
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| VUMC Stichting | Amsterdam | Netherlands | Recruiting |
| UMCG | Groningen | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.