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

• Status: Unknown status
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kliniken im Naturpark Altmuehltal
• Treatments: Antibodies, Monoclonal; Golimumab

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