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

Study Overview
=================
Brief 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.

Detailed 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.

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

Conditions
-----------------
Crohn Disease

Intervention / Treatment
-----------------
* Drug: Thalidomide
* Drug: placebo(for thalidomide)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-50 years old Diagnosis of patients with CD Disease in the activity: CDA Ⅰ > 150 points, endoscopic see active lesions Refractory: immunosuppressive drugs or biological agents which are used in current treatment is invalid and/or intolerance Exclusion Criteria: Fiber stenosis caused by gastrointestinal obstruction symptoms Fistula exclude anal fistula Pregnancy or lactation Period of women have fertility program during the study Treatment not foot eight weeks after last IFX Central or peripheral nerve disease Abnormal in liver and renal function Heart function failure Malignant tumor Active tuberculosis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: thalidomide<br>thalidomide 100mg tablet by mouth, every night for 8 weeks | Drug: Thalidomide<br> <br> |
| Active Comparator: placebo<br>placebo (for thalidomide) 100mg tablet by mouth, every night for 8 weeks | Drug: placebo(for thalidomide)<br>* sugar pill manufactured to mimic thalidomide 100mg tablet<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| difference CDAI between thalidomide group and placebo group | CDAI means Crohn's Disease Activity Index.The purpose of this crohn's disease activity index (CDAI) calculator is to gauge the progress or lack of progress for people with crohn's disease. The reference article says generally speaking, CDAI scores below 150 indicate a better prognosis than higher scores. | 8 weeks | 
| difference SES-CD score between thalidomide group and placebo group | SES-CD means Simple endoscopic score for Crohn's disease ,which predicts long-term prognosis in Crohn's disease patients with clinical remission. | 8weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| difference CDAI between different thalidomide dosage group | CDAI means Crohn's Disease Activity Index.The purpose of this crohn's disease activity index (CDAI) calculator is to gauge the progress or lack of progress for people with crohn's disease. The reference article says generally speaking, CDAI scores below 150 indicate a better prognosis than higher scores. | 1 year | 
| difference SES-CD score between different thalidomide dosage group | SES-CD means Simple endoscopic score for Crohn's disease ,which predicts long-term prognosis in Crohn's disease patients with clinical remission. | 1 year |