drugset / Trial / NCT01590966

Scintigraphic Detection of the Biodistribution of Tumor Necrosis Factor With a Radiolabeled Anti-TNFα in Patients With Active Rheumatoid Arthritis and Active Axial and Peripheral Spondyloarthritis

NCT01590966

Phase 3 Completed 41 enrolled University Hospital, Ghent UCB Pharma · collab
NaSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2012-10-18
Primary completion
2019-03-26
Completion
2019-08-20

Drugs

EvaluationDrugModalityDoseRoute
Subject Certolizumab Pegol Protein / enzyme biologic 200 mg/ml Subcutaneous
Subject Certolizumab Pegol Protein / enzyme biologic 750 mbq Subcutaneous