Spondyloarthritis Clinical Trial
Official title:
Phase II Study of 99mTc-rhAnnexin V-128 Radionuclide Imaging in Patients With Clinical Suspicion or Confirmed Diagnosis of Spondyloarthritis (SpA)
This single center, open-label, proof of concept (PoC) Phase II study aimed to assess the
investigational imaging agent 99mTc-rhAnnexin V-128 in detecting spondyloarthritis (SpA)
lesions.
Overall, it was planned to recruit 20 adults with suspected or confirmed SpA. First, 5
patients were enrolled into a "proof of concept" phase, to assess the imaging potential of
99mTc-rhAnnexin V-128 in terms of imaging quality, disease-lesion radiotracer uptake and
medical relevance. Based on these results the Data Monitoring Committee (DMC) was to decide
whether to terminate the study or whether to continue and enroll the next 15 planned
patients.
The study was prematurely terminated by the sponsor after the first 5 patients completed the
PoC phase based on strategic considerations.
Novartis acquired Advanced Accelerator Applications SA.
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