In this open-label monocentric explorative pilot trial the objective is to show the biodistribution of TNFα by administration of radiolabeled anti-TNFα in patients with active rheumatoid arthritis and spondylarthropathy. The anti-TNFα used in this trial is certolizumab pegol (Cimzia®), a pegylated Fab'-fragment of a monoclonal antibody with high specificity for TNFα. Certolizumab pegol will be radiolabeled with 99mTechnetium. The aim of this study is to show the TNFα triggered inflammation process in the inflamed joints, especially in patients who have very early joint damage where currently other imaging methods such as X-rays are not sensitive enough for detection.
Age range
18 Years – 70 Years
Sex
ALL
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The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Biodistribution of Cimzia® after administration of radiolabeled Cimzia®.
Timeframe: at baseline
Percentage of remission in patients, treated with Cimzia® after 14 weeks.
Timeframe: After 14 weeks of administration.
Percentage of remission in patients, treated with Cimzia® after 26 weeks.
Timeframe: After 26 weeks of administration.
Percentage of remission in patients, treated with Cimzia® after 38 weeks.
Timeframe: After 38 weeks of administration.
Percentage of remission in patients, treated with Cimzia® after 50 weeks.
Timeframe: After 50 weeks of administration.
Duration of remission in patients, treated with Cimzia® after 14 weeks.
Timeframe: After 14 weeks of administration.
Duration of remission in patients, treated with Cimzia® after 26 weeks.
Timeframe: After 26 weeks of administration.
Duration of remission in patients, treated with Cimzia® after 38 weeks.
Timeframe: After 38 weeks of administration.
Duration of remission in patients, treated with Cimzia® after 50 weeks.
Timeframe: After 50 weeks of administration.