Research Study

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects With Moderate to Severe Crohn's Disease
Principal Investigator 
James Gray

Overview

Body Locations and Systems 
Crohn's Disease
ClinicalTrials.gov# 
NCT01696396
Status 
Closed to Recruitment
Study Start/End 
Dec 4, 2012 to Dec 28, 2016
Locations 
Vancouver General Hospital
Name/Title 
Keri Earnshaw, Study Coordinator
Email Address 
keri.earnshaw@vch.ca
Purpose of Study 

This is a randomized, double-blind, placebo-controlled, parallel group, multiple dose study to evaluate the efficacy of AMG 181 compared with placebo as measured by the proportion of subjects in remission (CDAI score < 150) at week 8 (primary endpoint). After completing all screening assessments and meeting all eligibility criteria, subjects will be randomized to receive placebo or AMG 181 at various doses per protocol. A maximum of approximately 80% of subjects with any prior anti-TNF agent use will be allowed in the study. At the end of the double blind period, subjects will enter an open-label period during which all subjects will receive open-label AMG 181 at a single dose level according to protocol. Subjects who fail to achieve minimal improvement, or experience disease worsening after initial response are eligible to enter the open-label period early beginning at week 12 or after. Subjects that complete the open-label period or early terminate from the study will enter the 2 year safety follow up period.

Eligibility 

Visit ClinicalTrials.gov for more information.

Disclaimer 

Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers and email addresses are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician.