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

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ClinicalTrials.gov Identifier: NCT02186886
Recruitment Status : Unknown
Verified July 2014 by Kliniken im Naturpark Altmuehltal.
Recruitment status was:  Recruiting
First Posted : July 10, 2014
Last Update Posted : July 10, 2014
Sponsor:
Information provided by (Responsible Party):
Kliniken im Naturpark Altmuehltal

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

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Drug: Golimumab Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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)
Study Start Date : June 2014
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Golimumab

Arm Intervention/treatment
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
Drug: Golimumab
Physiological Intermolecular Modification Spectroscopy




Primary Outcome Measures :
  1. Clinical response [ Time Frame: Week 14 ]
    Reduction of partial Mayo Score > 2 points versus baseline


Secondary Outcome Measures :
  1. Calprotectin stool levels [ Time Frame: Week 6 ]
    Change in calprotectin stool levels at week 6 versus baseline

  2. Calprotectin stool levels [ Time Frame: Week 14 ]
    Change in calprotectin stool levels at week 14 versus baseline


Other Outcome Measures:
  1. molecular spectral range [ Time Frame: Week 14 ]
    Change in molecular spectral ranges versus baseline



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02186886


Contacts
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Contact: Matthias G Breidert, MD +49845671 ext 431 matthias.breidert@klinik-koesching.de

Locations
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Germany
Kliniken im Naturpark Altmuehltal; Klinik Koesching Recruiting
Kosching, Germany, 85092
Contact: Matthias G Breidert, MD    +49845671 ext 431    matthias.breidert@klinik-koesching.de   
Principal Investigator: Matthias G Breidert, MD         
Sponsors and Collaborators
Kliniken im Naturpark Altmuehltal
Investigators
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Principal Investigator: Matthias G Breidert, MD Naturpark Kliniken Altmuehltal

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Responsible Party: Kliniken im Naturpark Altmuehltal
ClinicalTrials.gov Identifier: NCT02186886     History of Changes
Other Study ID Numbers: 50831-PIMS-Golimumab-UC
First Posted: July 10, 2014    Key Record Dates
Last Update Posted: July 10, 2014
Last Verified: July 2014
Keywords provided by Kliniken im Naturpark Altmuehltal:
Ulcerative Colitis
Golimumab
Physiological Intermolecular Modification Spectroscopy
PIMS
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs