Trial record 2 of 10 for:    golimumab, ulcerative colitis

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Kliniken im Naturpark Altmuehltal
Sponsor:
Information provided by (Responsible Party):
Kliniken im Naturpark Altmuehltal
ClinicalTrials.gov Identifier:
NCT02186886
First received: July 1, 2014
Last updated: July 9, 2014
Last verified: July 2014
  Purpose

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 Intervention Phase
Ulcerative Colitis
Drug: Golimumab
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Kliniken im Naturpark Altmuehltal:

Primary Outcome Measures:
  • Clinical response [ Time Frame: Week 14 ] [ Designated as safety issue: No ]
    Reduction of partial Mayo Score > 2 points versus baseline


Secondary Outcome Measures:
  • Calprotectin stool levels [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
    Change in calprotectin stool levels at week 6 versus baseline

  • Calprotectin stool levels [ Time Frame: Week 14 ] [ Designated as safety issue: No ]
    Change in calprotectin stool levels at week 14 versus baseline


Other Outcome Measures:
  • molecular spectral range [ Time Frame: Week 14 ] [ Designated as safety issue: No ]
    Change in molecular spectral ranges versus baseline


Estimated Enrollment: 50
Study Start Date: June 2014
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02186886

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

Locations
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
Principal Investigator: Matthias G Breidert, MD Naturpark Kliniken Altmuehltal
  More Information

No publications provided

Responsible Party: Kliniken im Naturpark Altmuehltal
ClinicalTrials.gov Identifier: NCT02186886     History of Changes
Other Study ID Numbers: 50831-PIMS-Golimumab-UC
Study First Received: July 1, 2014
Last Updated: July 9, 2014
Health Authority: Germany: The National Association of Statutory Health Insurance Funds
Germany: Association of SHI physicians in Bavaria

Keywords provided by Kliniken im Naturpark Altmuehltal:
Ulcerative Colitis
Golimumab
Physiological Intermolecular Modification Spectroscopy
PIMS

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Ulcer
Colonic Diseases
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Inflammatory Bowel Diseases
Intestinal Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 23, 2014