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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02956538
• Other study ID #: E2016022
• Status: Recruiting
• Phase: Phase 0
• First received: October 13, 2016
• Last updated: November 3, 2016
• Start date: October 2016
• Est. completion date: October 2018

Study information

• Verified date: November 2016
• Source: Sixth Affiliated Hospital, Sun Yat-sen University
• Contact: Xiang Peng, MM
• Phone: 18302076916
• Email: stefaniepx[@]163.com
• Is FDA regulated: No
• Health authority: China: Health and Family Planning Commission of Guangdong Province
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: October 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Age 18-50 years old

• Diagnosis of patients with CD

• Disease in the activity: CDA ? > 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

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

Intervention

Drug:
• Thalidomide

• placebo(for thalidomide)
sugar pill manufactured to mimic thalidomide 100mg tablet

Locations

Country	Name	City	State
China	Department of Gastroenterology	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sixth Affiliated Hospital, Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	Yes
Secondary	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	Yes
Secondary	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	Yes