Ulcerative Colitis Clinical Trial
Official title:
Personalised Medicine: a Break Through Approach for Early Determination of Anti Tumor Necrosis Factor (TNF) Responders and Non Responders Among Patients With Ulcerative Colitis in a Prospective Study With Golimumab (Simponi)
Aim of this study is to determine wether the macromolecular spectral characteristic of ulcerative colitis patients - measured by Physiological Intermolecular Modification Spectroscopy (PIMS) - is a predictive factor for response to Simponi treatment
It is widely appreciated that almost all proteins and other biological macromolecular in
vivo exist, at least transiently, as components of structural and functional complexes. This
transient interaction in simple component solutions have been studied using well established
daylight light scattering (LS) method which reflects molecular oscillation (7-12). Protein
association, protein unfolding, protein aggregation and cellular crowding are known to
affect the normal function of cellular system (13-19). In many cases, the resulting small
changes in normal protein-protein intra- and intermolecular interactions are thought to lead
to a variety of human diseases (20, 21). Based on these and the acquired knowledge on LS,
the cutting edge technology, PIMS has been developed. PIMS is a label free technology that
is able to study protein-protein and protein-solvent interactions in multi-component
solutions. It provides individual real time dynamic fingerprint of total physiological
macromolecular assemblies in a tissue in presence and absence of exogenous molecules (drug
or drug candidate, peptide or protein).
This technology is based on dynamic molecular resonance of proteins and macromolecules.
Cellular extracts in physiological conditions are frozen at -37°C. Macromolecular spectra
are registered as the temperature within the sample raises from -37 to 37°C. This provides,
within the organ of interest, dynamic fingerprint of an individual entire macromolecular
assemblies. The present technology can therefore rapidly and specifically determine the
response of a tissue or cell when an exogenous molecule is administrated. It reflects
patient molecular capacity to respond to the drugs effect and allows to identifying
different subpopulations within a group in response to a specific treatment. It highlights
the responders from non-responders to a given treatment.
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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