NL-OMON53860尚未招募2 期
CD8 T cell imaging by positron emission tomography with 89Zr-Df-IAB22M2C in giant cell arteritis and rheumatoid arthritis: a pilot study - CD8 T cell PET in GCA and RA
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Giant cell arteritis
- •- Age > 50 years
- •- Erythrocyte sedimentation rate (ESR) >=50 mm/hr or C-reactive protein (CRP) >=
- •- 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
- •- 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
- •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
研究者
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