Status:
UNKNOWN
Physiological Intermolecular Modification Spectroscopy (PIMS) in Ulcerative Colitis With Golimumab
Lead Sponsor:
Kliniken im Naturpark Altmuehltal
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 pr...
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 interact...
Eligibility Criteria
Inclusion
- 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
- cancer
- type one diabetes
- current infection and/or inflammation other than related to ulcerative colitis
- autoimmune diseases
- any contraindications stated by Golimumab product label
Key Trial Info
Start Date :
June 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2015
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT02186886
Start Date
June 1 2014
End Date
December 1 2015
Last Update
July 10 2014
Active Locations (1)
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1
Kliniken im Naturpark Altmuehltal; Klinik Koesching
Kösching, Germany, 85092