giant cell arteritis (vasculitis) rheumatoid arthritis
Conditions
Interventions
89Zr-Df-crefmirlimab PET/CT
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: Giant cell arteritis - Age =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 =5 mSv) in the year before inclusion - Urinary or faecal incontinence
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main study endpoints: The main endpoints are arterial 89Zr-Df-crefmirlimab uptake in patients with newly-diagnosed GCA, and synovial 89Zr-Df-crefmirlimab uptake in patients with active RA. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints include: 1) the relationship between 89Zr-Df-crefmirlimab uptake in temporal arteries and the presence of CD8 T cells in histological analysis of temporal artery biopsy in patients with newly-diagnosed, cranial GCA 2) the relationship between 89Zr-Df-crefmirlimab uptake and clinical joint assessment and histological analysis of synovial tissue in patients with RA. | — |
Countries
Netherlands
Outcome results
None listed