ZIRCONIUM (89ZR) CREFMIRLIMAB BERDOXAM for Giant cell arteritis | Rheumatoid arthritis

Inclusion criteria

• {"criterion_text":"- Age > 50 years\n- Erythrocyte sedimentation rate (ESR) ≥50 mm/hr or C-reactive protein (CRP) ≥ 10 mg/L\n- 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).\n- 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\n- Patients must be able to adhere to the study appointments and other protocol requirements.\n- Patients must be capable of giving informed consent and the consent must have been obtained prior to the study related procedures.\n- Patients must be at least 30 years of age\n- Diagnosis of rheumatoid arthritis according to the 2010 ACR/EULAR Rheumatoid Arthritis classification criteria.\n- 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\n- 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\n- Non-steroidal anti-inflammatory drugs (NSAID) is permitted, provided that there is a stable dose for at least 4 weeks prior to inclusion\n- Patients must be able to adhere to the study appointments and other protocol requirements\n- Patients must be capable of giving informed consent and the consent must have been obtained prior to the study related procedures."}

Exclusion criteria

• {"criterion_text":"- Age ≤ 50 years\n- Use of oral, intravenous or intramuscular glucocorticoids within 4 weeks prior to inclusion.\n- Use of disease-modifying antirheumatic drugs (DMARD) within 3 months prior to inclusion.\n- Treatment with any investigational drug within 3 months prior to inclusion.\n- Known pregnancy or breast feeding\n- Research-related radiation exposure (cumulative ≥5 mSv) in the year before inclusion.\n- Urinary or faecal incontinence\n- Age < 30 years\n- Use of intra-articular, intramuscular or intravenous corticosteroids within 4 weeks prior to inclusie\n- Treatment with any investigational drug within the previous 3 months\n- Known pregnancy or breast feeding\n- Research related radiation exposure (cumulative ≥5 mSv) in the year before inclusion\n- Urinary or faecal incontinence"}

Primary endpoints

• {"endpoint_text":"- The primary 89Zr-Df-crefmirlimab PET/CT measurements are the tracer uptake in different arteries or joints whereby the radioactivity concentration in Regions-of-Interest (ROIs) are expressed as SUVs (Standardized Uptake Values).","definition_or_measurement_approach":"Tracer uptake in different arteries or joints measured by 89Zr-Df-crefmirlimab PET/CT; radioactivity concentration in Regions-of-Interest (ROIs) expressed as Standardized Uptake Values (SUVs)."}

Netherlands

Earliest CTIS Part Ii Submission Date

22-07-2024

Latest Decision Or Authorization Date

08-07-2025

Processing Time Days

351

Number Of Sites

2

Number Of Participants

20

Primary sponsor

Full Name

Universitair Medisch Centrum Groningen

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands