An interventional study of Infliximab and Vedolizumab in IBD, sponsored by University Hospital Schleswig-Holstein. Completed at 1 site in Germany. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-07-01.
Sponsored by University Hospital Schleswig-Holstein · Not applicable, Interventional, and Diagnostic
Inflammatory bowel disease (IBD) and psoriasis (Ps) are common, chronic, immune- mediated barrier diseases with shared inflammatory pathways. Current therapeutic interventions with anti-cytokine antibodies (TNF-α, IL-23/IL-12) reflect the intent to disrupt specific pathways of inflammatory immunopathology. Individual responses to biological treatment can be thereby be exploited in a systems biology approach that employs a targeted mechanism of action (MOA) to decipher molecular signatures of therapeutic responses in the context of a distinct disease entity. Using a translational approach to investigate clinical and molecular phenotypes during therapeutic interference with cytokine signaling and leukocyte trafficking, the investigators aim to trace common and unique signatures of drug- and therapy-specific responses.
Patients will undergo endoscopic evaluation of the mucosal surface and gastrointestinal wall by conventional HD-colonoscopy, endoscopic ultrasound and confocal laser endomicroscopy prior to and during specific therapies with biologicals. In parallel, mucosa samples will be obtained to define molecular phenotypes during the course of therapy.
University Hospital Schleswig-Holstein is the lead sponsor of 157 studies on the registry; 25 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
5 mg/kg body weight, week 0/2/6, then every 8 weeks
Drug: Infliximab
300 mg, week 0/2/6, then every 8 weeks
Drug: Vedolizumab
HD-endoscopy, CLE, endoscopic ultrasound after application of TNF alpha antibody
Also known as: Endoscopic assessment after Infliximab
HD-endoscopy, CLE, endoscopic ultrasound after application of Anti-Integrin antibody
Also known as: Endoscopic assessment after Vedolizumab
Mucosal healing week 2
Scoring of mucosal healing according to endoscopic Mayo score at week 2 after initiation of therapy
Time frame: week 2
This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University Hospital Schleswig-Holstein