Induced Adult Refractory Active Crohn's Disease Clinical Relieving by Using Thalidomide

Crohn Disease Clinical Trial

Official title: Induced Adult Refractory Active Crohn's Disease Clinical Relieving by Using Thalidomide: A Randomized, Double-blind, Placebo-controlled Multicenter Clinical Study

Status Recruiting

Clinical Trial Summary

With the development and application of biological agents, the treatment effect was considerable degree improvement on refractory corn's disease. However, there are quite a part of the CD patients lost response during treatment of using response. Moreover, due to various reasons, there still a lot limited on the using of biological agents in China, that make quite a part of the refractory CD patients lack of further medical treatment options. There has been a RCT study which prove that thalidomide effect and safety on treating refractory CD or who were lost response by using biological agents in Italy, but the object of study is only limited in children and adolescents. There are some small sample studies also confirmed the efficacy and safety on refractory corn's disease by using thalidomide, but need more RCT evidence.

Clinical Trial Description

It will be divided two groups of patients by using randomized, double-blind. One group was treated by thalidomide, the other was placebo. It will be unlocked blind and analysis the effect and safety about thalidomide after 8 weeks. The second, patients still use thalidomide after unlock blind to prove its longtime treatment effect and safety. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Crohn Disease

• NCT number: NCT02956538
• Study type: Interventional
• Source: Sixth Affiliated Hospital, Sun Yat-sen University
• Contact: Xiang Peng, MM
• Phone: 18302076916
• Email: stefaniepx@163.com
• Status: Recruiting
• Phase: Phase 0
• Start date: October 2016
• Completion date: October 2018