Ulcerative Colitis
Conditions
Keywords
Ulcerative Colitis, Golimumab, Physiological Intermolecular Modification Spectroscopy, PIMS
Brief summary
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
Detailed description
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.
Interventions
DRUGGolimumab
Physiological Intermolecular Modification Spectroscopy
Sponsors
Kliniken im Naturpark Altmuehltal
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* moderate to severe active ulcerative colitis * qualified for initiating Golimumab therapy, i.e.inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine or azathioprine or intolerance of medical contraindications to such therapies * must be able and willing to provide written informed consent * must have a negative tuberculosis screening or if inactive (latent) tuberculosis diagnosed anti-tuberculosis therapy to be started before initiation of Golimumab therapy in accordance with local recommendations
Exclusion criteria
* cancer * type one diabetes * current infection and/or inflammation other than related to ulcerative colitis * autoimmune diseases * any contraindications stated by Golimumab product label
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical response | Week 14 | Reduction of partial Mayo Score \> 2 points versus baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Calprotectin stool levels | Week 6 | Change in calprotectin stool levels at week 6 versus baseline |
Other
| Measure | Time frame | Description |
|---|---|---|
| molecular spectral range | Week 14 | Change in molecular spectral ranges versus baseline |
Countries
Germany
Contacts
Primary ContactMatthias G Breidert, MD
Outcome results
None listed