AN OPEN-LABEL EXTENSION AND SAFETY MONITORING STUDY OF PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE PREVIOUSLY ENROLLED IN THE ETROLIZUMAB PHASE III PROTOCOL GA29144

Clinical Studies - Aug 28, 2017 - Aug 28, 2021

Automatically Closed

Project leader: Borovicka Jan
Members: Dora Barbara, Frei Remus, Knellwolf Christina, Semadeni Gian-Marco, Sulz Michael

A PHASE III, RANDOMIZED, DOUBLEBLIND, PLACEBOCONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ETROLIZUMAB AS AN INDUCTION AND MAINTENANCE TREATMENT FOR PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE

Clinical Studies - Aug 1, 2017 - Aug 1, 2021

Automatically Closed

Project leader: Borovicka Jan, Brand Stephan
Members: Dora Barbara, Frei Remus, Knellwolf Christina, Semadeni Gian-Marco, Sulz Michael

A Phase 3, Randomized, Double-Blinded, Placebo-Controlled, Multicenter Study of Amiselimod (MT-1303) in the Induction and Maintenance of Clinical Response and Remission in Subjects With Moderate to Severe Ulcerative Colitis

Clinical Studies - Jun 1, 2017 - Sep 27, 2022

Automatically Closed

Members: Knellwolf Christina, Dora Barbara, Krieger-Grübel Claudia, Sulz Michael

A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of subjects with active Crohn’s disease.

Clinical Studies - Dec 1, 2016 - Dec 1, 2018

Completed

Members: Dora Barbara, Knellwolf Christina, Krieger-Grübel Claudia, Sulz Michael

Randomized, double-blind, double-dummy, placebo-controlled, Phase III clinical trial on the efficacy and safety of a 48-weeks treatment with gastroresistant phosphatidylcholine (LT-02) versus placebo versus mesalamine for maintenance of remission in...

Clinical Studies - Dec 1, 2016 - Dec 1, 2018

Completed

Members: Dora Barbara, Knellwolf Christina, Krieger-Grübel Claudia, Sulz Michael

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of ABT-494 for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis

Clinical Studies - Dec 1, 2016 - Dec 1, 2018

Automatically Closed

Members: Dora Barbara, Knellwolf Christina, Krieger-Grübel Claudia, Sulz Michael

Entyvio (vedolizumab) long-term safety study: An international observational prospective cohort study comparing vedolizumab to other biologic agents in patients with ulcerative colitis or Crohn’s Disease. This is a prospective, observational, multi-...

Clinical Studies - Jul 28, 2016 - Jun 28, 2022

Automatically Closed

Project leader: Brand Stephan
Members: Dora Barbara, Knellwolf Christina, Sulz Michael, Krieger-Grübel Claudia

Randomized, double-blind, double-dummy, placebo-controlled, Phase III clinical trial on the efficacy and safety of a 12-weeks add-on treatment with LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo in patients with ulcerative colitis...

Clinical Studies - Mar 1, 2016 - Dec 31, 2017

Aborted

Members: Dora Barbara, Knellwolf Christina, Sulz Michael, Krieger-Grübel Claudia

GA29103: PHASE III, RANDOMIZED, MULTICENTER DOUBLE-BLIND, DOUBLE-DUMMY STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ETROLIZUMAB COMPARED WITH INFLIXIMAB IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS

Clinical Studies - Jun 28, 2015 - Jun 28, 2020

Automatically Closed

Project leader: Borovicka Jan
Members: Dora Barbara, Frei Remus, Knellwolf Christina, Sulz Michael, Semadeni Gian-Marco

A Multicenter, Open-Label Study to Evaluate the Long Term Efficacy, Safety, and Tolerability of Repeated Administration of Adalimumab in Subjects with Crohn's Disease

Clinical Studies - Mar 1, 2015 - Dec 1, 2017

Completed

Project leader: Borovicka Jan
Members: Frei Remus, Knellwolf Christina, Semadeni Gian-Marco, Sulz Michael

A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis This Phase 3 study design includes a Screening...

Clinical Studies - Mar 1, 2015 - Feb 1, 2018

Automatically Closed

Project leader: Borovicka Jan
Members: Dora Barbara, Frei Remus, Knellwolf Christina, Semadeni Gian-Marco, Sulz Michael

A Multicenter, Randomisierte, Double-Blind Study to Evaluate the Efficacyand Safety of Two Adalimumab Induction Regimens in Subjects with Moderately to Severely Active Crohns Disease and Evidence of Mucosal Ulceration

Clinical Studies - Feb 1, 2015 - Feb 15, 2018

Automatically Closed

Members: Frei Remus, Knellwolf Christina, Semadeni Gian-Marco, Sulz Michael, Dora Barbara

PHASE III, BLINDED, PLACEBO-CONTROLLED, MULTICENTER STUDY OF THE EFFICACY AND SAFETY OF ETROLIZUMAB DURING INDUCTION AND MAINTENANCE IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO ARE REFRACTORY TO OR INTOLERANT OF TNF INHIBITORS

Clinical Studies - Jan 1, 2015 - Dec 31, 2017

Automatically Closed

Project leader: Borovicka Jan
Members: Dora Barbara, Frei Remus, Knellwolf Christina, Semadeni Gian-Marco, Sulz Michael

GA28951: AN OPEN-LABEL EXTENSION AND SAFETY MONITORING STUDY OF MODERATE TO SEVERE ULCERATIVE COLITIS PATIENTS PREVIOUSLY ENROLLED IN ETROLIZUMAB PHASE III STUDIES

Clinical Studies - Jun 28, 2014 - Jun 28, 2020

Completed

Project leader: Borovicka Jan
Members: Dora Barbara, Frei Remus, Knellwolf Christina, Semadeni Gian-Marco, Sulz Michael

An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting The primary objective is to assess the effect of adalimu...

Clinical Studies - Jun 14, 2012 - Jun 30, 2014

Completed

Project leader: Borovicka Jan
Members: Frei Remus, Knellwolf Christina

The primary objective of this registry is to collect long-term (5 years) safety data including data on the incidence of colorectal cancer, in subjects with moderate to severe active ulcerative colitis (UC) who have been exposed to infliximab (Remicad...

Clinical Studies - Jul 22, 2010 - Jul 22, 2010

Automatically Closed

Project leader: Binek Janek
Members: Knellwolf Christina

Die Auswahl eines TNF-alpha Hemmers für einen Patienten geschieht meist nach einer Erläuterung der verschiedenen Therapieoptionen durch den behandelnden Arzt. Dabei verlässt sich der Patient häufig auf die Empfehlung des Arztes. Bis zum aktuellen Zei...

Clinical Studies - Jan 1, 2010 - Dec 31, 2010

Automatically Closed

Project leader: Binek Janek
Members: Knellwolf Christina

Retrospektive und prospektive multizentrische Cohorten-Studie ohne therapeutische Interventinen. Es werden Informationen zum klinischen Verlauf der chronisch-entzündlichen Darmerkrankungen erhoben. Diese Informationen werdern zum Teil aus den Kranken...

Clinical Studies - Dec 1, 2006 - Dec 31, 2015

Automatically Closed

Project leader: Borovicka Jan
Members: Frei Remus, Krieger-Grübel Claudia, Meyenberger Christa, Sawatzki Mikael, Semadeni Gian-Marco, Sulz Michael, Knellwolf Christina, Künzler-Heule Patrizia