Last updated on January 2017

99mTc-rhAnnexin V-128 a Phase I/IIa Study in Patients With Rheumatoid Arthritis (RA) or Ankylosing Spondylitis (AS)

Brief description of study

The objectives of the study are: Primary objective: - To determine the safety and tolerability of medical imaging with 99mTc-rhAnnexin V-128 Secondary objectives: - To determine the biodistribution, pharmacokinetics and radiation dosimetry of 99mTc-rhAnnexin V-128 - To demonstrate the time-dependant distribution and localization of 99mTc-rhAnnexin V-128 both in RA and AS patients - To determine ability of early imaging with 99mTc-rhAnnexin V-128 to evaluate the presence of lesions before and after short term treatment of either RA or AS patients. Study hypothesis: 99mTc-rhAnnexin V-128 could be used as an adjunct for the diagnosis of early stage rheumatoid arthritis and ankylosing spondylitis and for the assessment of response to treatment of these diseases.

Clinical Study Identifier: NCT02328027

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John Prior, MD, PhD

Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland
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