Projekt
GA28950/Hickory
Automatisch geschlossen · 2015 bis 2017
Borovicka Jan, Dora Barbara, Frei Remus, Knellwolf Christina, Semadeni Gian-Marco, Sulz Michael
Art
Klinische Forschung
Reichweite
Multizentrisch, KSSG als teilnehmendes Zentrum
Bereiche
Status
Automatisch geschlossen
Start
2015
Ende
2017
Finanzierungsart
Industrie
Studiendesign
This is a multicenter, Phase III, double-blind, placebo-controlled study evaluating the safety, efficacy and tolerability of etrolizumab during induction and maintenance of remission compared with placebo in the treatment of moderately to severely active UC (Figure 1).
Disease severity will be measured using the Mayo Clinic Score (MCS; see Appendix B), which is the current regulatory authorityapprovable outcome measure for drug development in UC. The study population consists of patients with moderately to severely active UC (defined as Mayo Clinic Score [MCS] of 6 12 and a centrally read endoscopy subscore of 2) and continuous disease activity a minimum of 20 cm from the anal verge.
Kurzbeschreibung/Zielsetzung
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