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

NCT ID: NCT02186886

Last Updated: 2014-07-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2015-12-31

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.

Conditions

Ulcerative Colitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Golimumab

Golimumab: Patients with body weight less than 80 kg initial dose of 200 mg, followed by 100 mg at week 2, then 50 mg every 4 weeks, thereafter // Patients with body weight greater than or equal to 80 kg initial dose of 200 mg, followed by 100 mg at week 2, then 100 mg every 4 weeks, thereafter

Group Type: OTHER

Golimumab

Intervention Type: DRUG

Physiological Intermolecular Modification Spectroscopy

Interventions

Golimumab

Physiological Intermolecular Modification Spectroscopy

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kliniken im Naturpark Altmuehltal

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Matthias G Breidert, MD

Role: PRINCIPAL_INVESTIGATOR

Naturpark Kliniken Altmuehltal

Locations

Kliniken im Naturpark Altmuehltal; Klinik Koesching

Kösching, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Matthias G Breidert, MD

Role: CONTACT

matthias.breidert@klinik-koesching.de

+49845671 ext. 431

Facility Contacts

Matthias G Breidert, MD

Role: primary

matthias.breidert@klinik-koesching.de

+49845671 ext. 431

Other Identifiers

50831-PIMS-Golimumab-UC

Identifier Type: -

Identifier Source: org_study_id