Scintigraphic detection of tumor necrosis factor with radioactive labeled TNFa-blocker in patients with active rheumatoid arthritis and active axial and peripheric spondyloarthropathy.

Ghent University Hospital0 个研究点目标入组 36 人开始时间: 2012年4月11日最近更新: 2019年11月25日

试验速览

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•- age between 18 and 70 years old
•- diagnosed with rheumatoid arthrosis according to the ACR-criteria,
•diagnosed with axial spondyloarthropathy according to the ASAS criteria (of which 5 of them should meet the modified New York criteria),
•diagnosed with peripheral spondylarthropathy
•- no active tuberculosis
•- no pregnant women or women who are not using contraceptives when applicable
•- patients need to understand the study and give informed consent
•OR diagnosed with erosive hand OA
•OR diagnosed with active Crohn's disease
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 26
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 10

•- no experimental (non-) biological therapy in the last 3 months, or within 5 halflives befor baseline visit
•- no anti-TNF therapy
•- no rituximab and/or abatacept
•- known hypersensitivity vs certolizumab pegol or one of his components
•- medical history of serious progressive uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurological or cerebreal diseases
•- serious or life-threatening infections over the last 6 months, or signs of current or recent infection
•- active or latent tuberculosis
•- known previous or current viral hepatitis B or C
•- known HIV infection
•- presence of malignity or history of maligne pathology
•- History or signs of lyph-proliferative condition
•- mild to serious cardiac failure

发起方