Physiological Intermolecular Modification Spectroscopy (PIMS) in Ulcerative Colitis With Golimumab

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02186886
• Other study ID #: 50831-PIMS-Golimumab-UC
• Status: Recruiting
• Phase: Phase 4
• First received: July 1, 2014
• Last updated: July 9, 2014
• Start date: June 2014
• Est. completion date: December 2015

Study information

• Verified date: July 2014
• Source: Kliniken im Naturpark Altmuehltal
• Contact: Matthias G Breidert, MD
• Phone: +49845671
• Email: matthias.breidert[@]klinik-koesching.de
• Is FDA regulated: No
• Health authority: Germany: The National Association of Statutory Health Insurance FundsGermany: Association of SHI physicians in Bavaria
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• Golimumab
Physiological Intermolecular Modification Spectroscopy

Locations

Country	Name	City	State
Germany	Kliniken im Naturpark Altmuehltal; Klinik Koesching	Kosching

Sponsors (1)

Lead Sponsor	Collaborator
Kliniken im Naturpark Altmuehltal

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	molecular spectral range	Change in molecular spectral ranges versus baseline	Week 14	No
Primary	Clinical response	Reduction of partial Mayo Score > 2 points versus baseline	Week 14	No
Secondary	Calprotectin stool levels	Change in calprotectin stool levels at week 6 versus baseline	Week 6	No
Secondary	Calprotectin stool levels	Change in calprotectin stool levels at week 14 versus baseline	Week 14	No