2024-514489-38-01招募中2 期
CD8 T cell imaging by positron emission tomography with 89Zr-Df-crefmirlimab in giant cell arteritis and rheumatoid arthritis: a pilot study
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- 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).
研究概览
简要总结
Primary Objective: to evaluate arterial and synovial 89Zr-Dfcrefmirlimab uptake on PET/CT in patients with newly-diagnosed GCA or active RA.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
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).
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).
次要结局
未报告次要终点
研究者
K.S.M. van der Geest
Scientific
Universitair Medisch Centrum Groningen
研究点 (2)
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